S-4/A
Table of Contents
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As filed with the Securities and Exchange Commission on April 13, 2023
Registration
No. 333-269705
 
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
Amendment No. 1
to
FORM
S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
 
 
FIRST LIGHT ACQUISITION GROUP, INC.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware
 
6770
 
86-2967193
(State or other jurisdiction of
incorporation or organization)
 
(Primary Standard Industrial
Classification Code Number)
 
(I.R.S. Employer
Identification Number)
11110 Sunset Hills Road #2278
Reston, VA 20190
(202) 503-9255
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
 
 
Thomas Vecchiolla
Chief Executive Officer
11110 Sunset Hills Road #2278
Reston, VA 20190
(202)
503-9255
(Name, address, including zip code, and telephone number, including area code, of agent for service)
 
 
Copies of all communications, including communications sent to agent for service, should be sent to:
 
Raymond O. Gietz, Esq.
Alexander D. Lynch, Esq.
Corey R. Chivers, Esq.
Weil, Gotshal & Manges LLP
767 Fifth Avenue
New York, NY 10153
Tel: (212)
310-8000
Fax: (212)
310-8007
  
Allan Camaisa, Chairman and CEO
Wendy Pizarro, Esq., Chief Legal Officer
Calidi Biotherapeutics, Inc.
4475 Executive Drive, Suite 200,
San Diego, California, 92121
(858)
794-9600
  
Scott E. Bartel, Esq.
Lewis Brisbois Bisgaard & Smith
633 West 5th Street, Suite 4000
Los Angeles, California 90071
(213)
358-6174
 
 
Approximate date of commencement of proposed sale of the securities to the public:
As soon as practicable after this registration statement becomes effective and upon completion of the applicable transactions described in the enclosed proxy statement/prospectus.
If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box:  ☐
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule
12b-2
of the Exchange Act. (Check one):
 
Large accelerated filer     Accelerated filer  
       
Non-accelerated
filer
    Smaller reporting company  
       
        Emerging growth company  
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  
If applicable, place an N in the box to designate the appropriate rule provision relied upon in conducting this transaction:
Exchange Act Rule
13e-4(i)
(Cross-Border Issuer Tender Offer)  ☐
Exchange Act Rule
14d-1(d)
(Cross-Border Third-Party Tender Offer)  ☐
 
 
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
 
 
 


Table of Contents

The information contained in this document is subject to completion or amendment. A registration statement relating to these securities has been filed with the United States Securities and Exchange Commission. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This document is not an offer to sell these securities and it is not soliciting an offer to buy these securities, nor shall there be any sale of these securities, in any jurisdiction in which such offer, solicitation or sale is not permitted or would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

 

PRELIMINARY — SUBJECT TO COMPLETION, DATED APRIL 13, 2023

FIRST LIGHT ACQUISITION GROUP, INC.

11110 Sunset Hills Road #2278

Reston, VA 20190

Dear First Light Acquisition Group, Inc. Stockholders,

On behalf of the board of directors (the “FLAG Board”) of First Light Acquisition Group, Inc., a Delaware corporation (“FLAG,” “we” or “our”), we cordially invite you to a special meeting (the “special meeting”) of stockholders (“FLAG Stockholders”), to be held via live webcast at [●] a.m. Eastern Time, on [●], 2023. The special meeting can be accessed by visiting [●], where you will be able to listen to the meeting live and vote during the meeting. Please note that you will only be able to access the special meeting by means of remote communication.

On January 9, 2023, FLAG entered into an Agreement and Plan of Merger (as the same has been or may be amended, modified, supplemented or waived from time to time, the “Merger Agreement”) with Calidi Biotherapeutics, Inc., a Nevada Corporation (“Calidi”), FLAG Merger Sub Inc., a Nevada corporation and a wholly-owned subsidiary of FLAG (“Merger Sub”), First Light Acquisition Group, LLC, in the capacity as representative for the stockholders of FLAG (the “Sponsor” or the “Purchaser Representative”) and Allan Camaisa, in the capacity as representative of the stockholders of Calidi (“Seller Representative”). Among other things, the Merger Agreement provides for the merger of Merger Sub with and into Calidi, with Calidi surviving such merger as a wholly-owned subsidiary of FLAG (the “Merger,” and the transactions contemplated by the Merger Agreement, the “Business Combination”). Following the consummation of the Business Combination, FLAG will change its name to Calidi Biotherapeutics, Inc. We refer to the new public entity following the consummation of the Business Combination as “New Calidi.” A copy of the Merger Agreement is attached to the accompanying proxy statement/prospectus as Annex A.

Subject to the terms of the Merger Agreement, upon consummation of the Merger, and after giving effect to the conversion of all shares of preferred stock, par value $0.0001 per share, of Calidi (“Calidi Preferred Stock”) and other derivative securities into shares of common stock, par value $0.0001 per share, of Calidi (“Calidi Common Stock”), all shares of Calidi Common Stock outstanding as of the time of the Merger will be converted into (a) the right to receive shares of New Calidi Common Stock, par value $0.0001 per share (“New Calidi Common Stock”) and (b) the contingent right to receive certain escalation shares. The aggregate consideration to be paid to Calidi equityholders (excluding for this purpose options to purchase Calidi Common Stock that remain unvested immediately following the Merger) will be based on an equity value for Calidi of $250,000,000, subject to adjustment dependent upon (a) the difference in Calidi’s “net debt” as of the effective time of the Merger from a target “net debt” amount (as described in greater detail in the accompanying proxy statement/prospectus) and (b) the achievement of certain pre-closing milestones (if any), as further described in the accompanying proxy statement/prospectus. The shares of New Calidi Common Stock to be issued as merger consideration will be valued at $10.00 per share. Assuming no adjustments in the merger consideration, we would expect each share of Calidi Common Stock to be converted into [●] shares of New Calidi Common Stock in the Merger and that the Calidi Stockholders will own [●] of the outstanding shares of New Calidi Common Stock immediately following the consummation of the Business Combination. The preceding sentence reflects numerous assumptions. The accompanying proxy statement/prospectus discloses those assumptions and presents various alternate scenarios regarding the ownership of New Calidi following the Business Combination. The estimated net cash per share of FLAG Common Stock that is being contributed by FLAG to New Calidi is less than the $10.00 per share ascribed to such shares in the Merger Agreement or the amount per share that holders of FLAG Class A Common Stock would be entitled to receive upon exercise of their redemption rights, as described in the accompanying proxy statement/prospectus.

During the five-year period following the consummation of the Business Combination (the “Escalation Period”), Calidi Stockholders may be entitled to receive up to 18,000,000 additional shares of New Calidi Common Stock (the “Escalation Shares”) with incremental releases of 4,500,000 shares upon achievement of each share price hurdle if the trading price of New Calidi Common Stock is $12.00, $14.00, $16.00 and $18.00 for a period of any 20 days within any 30-consecutive-day trading period. Holders of FLAG Class A Common Stock who do not


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redeem their shares will be entitled to their pro rata portion of up to an additional 2,000,000 shares of New Calidi Common Stock (the “Non-Redeeming Continuation Shares”) to be issued at Closing. The Escalation Shares will be placed in escrow and will be outstanding from and after the Closing, subject to cancellation if the applicable price targets are not achieved. While in escrow, the shares will be non-voting.

At the special meeting, FLAG Stockholders will be asked to consider and vote upon:

 

(1)

Proposal No. 1 — a proposal to approve the Business Combination described in the accompanying proxy statement/prospectus, including approving the transactions contemplated by the Merger Agreement and related agreements described in the accompanying proxy statement/prospectus — we refer to this proposal as the “Business Combination Proposal”;

 

(2)

Proposal No. 2 — a proposal to approve and adopt the second amended and restated certificate of incorporation of FLAG, which will be the certificate of incorporation of New Calidi, in the form attached to the accompanying proxy statement/prospectus as Annex B (the “Second Amended and Restated Certificate of Incorporation”) — we refer to this proposal as the “Charter Proposal”;

 

(3)

Proposal No. 3 — a proposal to approve, on a non-binding advisory basis, certain governance provisions in the Second Amended and Restated Certificate of Incorporation, presented separately in accordance with the United States Securities and Exchange Commission (“SEC”) requirementswe refer to this proposal as the “Governance Proposal”;

 

(4)

Proposal No. 4 — a proposal to approve and adopt a new equity incentive plan, in the form attached to the accompanying proxy statement/prospectus as Annex G (the “Incentive Plan”), including the authorization of the initial share reserve thereunder — we refer to this proposal as the “Incentive Plan Proposal”;

 

(5)

Proposal No. 5 — a proposal to approve and adopt a new employee stock purchase plan, in the form attached to the accompanying proxy statement/prospectus as Annex H (the “2023 ESPP”), and the material terms thereof, including the authorization of the initial share reserve thereunder — we refer to this proposal as the “ESPP Proposal”;

 

(6)

Proposal No. 6 — to consider and vote upon a proposal to elect seven directors to serve staggered terms on the New Calidi Board upon the consummation of the Business Combination until the first, second and third annual meetings of stockholders following the date of effectiveness of the Proposed Charter, as applicable, or until the election and qualification of their respective successors — we refer to this proposal as the “New Board Proposal”;

 

(7)

Proposal No. 7—to consider and vote upon a proposal to approve, for purposes of complying with Section 712(b) and Section 713(b) of the NYSE American’s Company Guide, (a) the issuance of more than 20% of FLAG’s issued and outstanding shares of common stock in connection with the Business Combination, including, without limitation, pursuant to the PIPE Investment, if consummated (as described in the accompanying proxy statement/prospectus), and (b) the issuance of more than 20% of FLAG’s issued and outstanding shares to a single holder (which may constitute a change in control under the NYSE American’s Company Guide) in connection with the Business Combination; and

 

(8)

Proposal No. 8 — a proposal to adjourn the special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal or the NYSE American Proposal — we refer to this proposal as the “Adjournment Proposal.

Each of these proposals is more fully described in the accompanying proxy statement/prospectus, which we encourage you to read carefully and in its entirety before voting. Only holders of record of FLAG Common Stock at the close of business on [●], 2023 are entitled to notice of the special meeting and to vote and have their votes counted at the special meeting and any adjournments or postponements thereof.

 

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After careful consideration, the FLAG Board has determined that the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal, the NYSE American Proposal and the Adjournment Proposal are fair to and in the best interests of FLAG and FLAG Stockholders and unanimously recommends that you vote or give instruction to vote “FOR” the Business Combination Proposal, “FOR” the Charter Proposal, “FOR” the Governance Proposal, “FOR” the Incentive Plan Proposal, “FOR” the ESPP Proposal, “FOR” the New Board Proposal, “FOR” the NYSE American Proposal and “FOR” the Adjournment Proposal, if presented. When you consider the FLAG Board’s recommendation of these proposals, you should keep in mind that our directors and officers have interests in the Business Combination that are different from, or in addition to, the interests of FLAG Stockholders generally and that conflict with the interests of FLAG’s public stockholders. Please see the section entitled “Proposal No. 1 — The Business Combination Proposal — Interests of Certain Persons in the Business Combination” in the accompanying proxy statement/prospectus for additional information. The FLAG Board was aware of these interests, among other matters, in evaluating the Business Combination and in recommending to the FLAG Stockholders that they vote in favor of the proposals to be presented at the special meeting.

Consummation of the Business Combination is conditioned on the approval of each of the Business Combination Proposal, the Charter Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal and the NYSE American Proposal. If any of those Proposals are not approved, we will not consummate the Business Combination.

All FLAG Stockholders are cordially invited to attend the special meeting and we are providing the accompanying proxy statement/prospectus and proxy card in connection with the solicitation of proxies to be voted at the special meeting (or any adjournment or postponement thereof). To ensure your representation at the special meeting, however, you are urged to complete, sign, date and return the enclosed proxy card as soon as possible. If your shares are held in an account at a brokerage firm or bank, you must instruct your broker or bank on how to vote your shares or, if you wish to attend the special meeting and vote, obtain a proxy from your broker or bank.

FLAG’s units, Class A common stock and warrants are currently listed on the NYSE American LLC (the “NYSE American”) under the symbols FLAGU, FLAG and FLAGW, respectively. Upon the Closing of the Business Combination, we expect that New Calidi Common Stock and warrants will begin trading on NYSE American under the symbols “CLDI” and “CLDIW,” respectively. As a result, FLAG’s publicly traded units will separate into the component securities upon consummation of the Business Combination and will no longer trade as a separate security.

Pursuant to FLAG’s amended and restated certificate of incorporation, as amended (the “Current Charter”), a holder of public shares may demand that FLAG redeem such shares for cash if the Business Combination is consummated. Holders of public shares will be entitled to receive cash for these shares only if they demand that FLAG redeem their shares for cash no later than the second business day prior to the vote on the Business Combination Proposal by delivering their shares to FLAG’s transfer agent prior to the vote at the meeting. If the Business Combination is not completed, these shares will not be redeemed. If a holder of public shares properly demands redemption, FLAG will redeem each public share for a pro rata portion of the Trust Account holding the proceeds from FLAG’s initial public offering, calculated as of two business days prior to the consummation of the Business Combination.

FLAG is an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) and has elected to comply with certain reduced public company reporting requirements.

FLAG will remain an emerging growth company until the earlier of: (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of the IPO, (b) in which FLAG has total annual gross revenue of at least $1.235 billion, or (c) in which FLAG is deemed to be a large accelerated filer, which means the market value of FLAG Common Stock that is held by non-affiliates exceeds $700 million as of the end of the

 

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prior fiscal year’s second fiscal quarter; and (2) the date on which FLAG has issued more than $1.0 billion in non-convertible debt during the prior three-year period. References herein to “emerging growth company” shall have the meaning associated with it in the JOBS Act.

The accompanying proxy statement/prospectus provides you with detailed information about the Business Combination and other matters to be considered at the special meeting of FLAG Stockholders. We encourage you to carefully read the entire accompanying document, including the Annexes attached to the accompanying proxy statement/prospectus. You should also carefully consider the risk factors described in “Risk Factors” beginning on page 50.

Your vote is important regardless of the number of shares you own. Whether you plan to attend the special meeting or not, please sign, date and return the enclosed proxy card as soon as possible in the envelope provided. If your shares are held in “street name” or are in a margin or similar account, you should contact your broker to ensure that votes related to the shares you beneficially own are properly counted.

The Business Combination described in the accompanying proxy statement/prospectus has not been approved or disapproved by the Securities and Exchange Commission or any state securities commission nor has the Securities and Exchange Commission or any state securities commission passed upon the merits or fairness of the Business Combination, or passed upon the accuracy or adequacy of the disclosure in the accompanying proxy statement/prospectus. Any representation to the contrary is a criminal offense.

Thank you for your participation. We look forward to your continued support.

 

By Order of the Board of Directors

 

 

Thomas Vecchiolla

Chief Executive Officer

[●], 2023

IF YOU RETURN YOUR PROXY CARD WITHOUT AN INDICATION OF HOW YOU WISH TO VOTE, YOUR SHARES WILL BE VOTED IN FAVOR OF EACH OF THE PROPOSALS.

TO EXERCISE YOUR REDEMPTION RIGHTS, YOU MUST ELECT TO HAVE FLAG REDEEM YOUR SHARES FOR A PRO RATA PORTION OF THE FUNDS HELD IN THE TRUST ACCOUNT AND TENDER YOUR SHARES TO FLAG’S TRANSFER AGENT AT LEAST TWO (2) BUSINESS DAYS PRIOR TO THE VOTE AT THE SPECIAL MEETING. YOU MAY TENDER YOUR SHARES BY EITHER DELIVERING YOUR SHARE CERTIFICATE TO THE TRANSFER AGENT OR BY DELIVERING YOUR SHARES ELECTRONICALLY USING THE DEPOSITORY TRUST COMPANY’S DWAC (DEPOSIT AND WITHDRAWAL AT CUSTODIAN) SYSTEM. IF THE BUSINESS COMBINATION IS NOT COMPLETED, THEN THESE SHARES WILL NOT BE REDEEMED FOR CASH. IF YOU HOLD THE SHARES IN STREET NAME, YOU WILL NEED TO INSTRUCT THE ACCOUNT EXECUTIVE AT YOUR BANK OR BROKER TO WITHDRAW THE SHARES FROM YOUR ACCOUNT IN ORDER TO EXERCISE YOUR REDEMPTION RIGHTS. PLEASE SEE THE SECTION ENTITLED “SPECIAL MEETING OF FLAG STOCKHOLDERSREDEMPTION RIGHTS” IN THE ACCOMPANYING PROXY STATEMENT/PROSPECTUS FOR MORE SPECIFIC INSTRUCTIONS.

The accompanying proxy statement/prospectus is dated [], 2023 and is first being mailed to FLAG Stockholders on or about [], 2023.

 

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ADDITIONAL INFORMATION

No person is authorized to give any information or to make any representation with respect to the matters that the accompanying proxy statement/prospectus describes other than those contained in the accompanying proxy statement/prospectus, and, if given or made, the information or representation must not be relied upon as having been authorized by FLAG or Calidi. The accompanying proxy statement/prospectus does not constitute an offer to sell or a solicitation of an offer to buy securities or a solicitation of a proxy in any jurisdiction where, or to any person to whom, it is unlawful to make such an offer or a solicitation. Neither the delivery of the accompanying proxy statement/prospectus nor any distribution of securities made under the accompanying proxy statement/prospectus will, under any circumstances, create an implication that there has been no change in the affairs of FLAG or Calidi since the date of the accompanying proxy statement/prospectus or that any information contained herein is correct as of any time subsequent to such date.

 

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FIRST LIGHT ACQUISITION GROUP, INC.

11110 Sunset Hills Road #2278

Reston, VA 20190

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS

TO BE HELD ON [], 2023

TO THE STOCKHOLDERS OF FIRST LIGHT ACQUISITION GROUP, INC.

NOTICE IS HEREBY GIVEN that a special meeting of stockholders (“FLAG Stockholders”) of First Light Acquisition Group, Inc., a Delaware corporation (“FLAG,” “we” or “our”), will be held via live webcast at [●] a.m. Eastern Time, on [●], 2023. The special meeting can be accessed by visiting [●], where you will be able to listen to the meeting live and vote during the meeting. Please note that you will only be able to access the special meeting by means of remote communication.

On behalf of FLAG’s board of directors (the “FLAG Board”), you are cordially invited to attend the special meeting, to conduct the following business items:

 

(1)

Proposal No. 1 — To consider and vote upon a proposal to approve the Business Combination described in the accompanying proxy statement/prospectus, including approving the transactions contemplated by the Merger Agreement and related agreements described in the accompanying proxy statement/prospectus — we refer to this proposal as the “Business Combination Proposal”;

 

(2)

Proposal No. 2 — To consider and vote upon a proposal to approve and adopt the Second Amended and Restated Certificate of Incorporation of FLAG, which will be the certificate of incorporation of New Calidi, in the form attached to the accompanying proxy statement/prospectus as Annex B (the “Second Amended and Restated Certificate of Incorporation”) — we refer to this proposal as the “Charter Proposal”;

 

(3)

Proposal No. 3 —  To consider and vote upon a proposal to approve, on a non-binding advisory basis, certain governance provisions in the Second Amended and Restated Certificate of Incorporation, presented separately in accordance with the United States Securities and Exchange Commission (“SEC”) requirementswe refer to this proposal as the “Governance Proposal”;

 

(4)

Proposal No. 4 — To consider and vote upon a proposal to approve and adopt the Calidi Biotherapeutics, Inc. 2023 Stock Incentive Plan, in the form attached to the accompanying proxy statement/prospectus as Annex G (the “Incentive Plan”)  — we refer to this proposal as the “Incentive Plan Proposal”;

 

(5)

Proposal No. 5 — To consider and vote upon a proposal to approve the Calidi Biotherapeutics, Inc. Employee Stock Purchase Plan, in the form attached to the accompanying proxy statement/prospectus as Annex H (the “2023 ESPP”)  — we refer to this proposal as the “ESPP Proposal”;

 

(6)

Proposal No. 6 — To consider and vote upon a proposal to elect seven directors to serve staggered terms on the New Calidi Board upon the consummation of the Business Combination until the first, second and third annual meetings of stockholders following the date of effectiveness of the Proposed Charter, as applicable, or until the election and qualification of their respective successors in office — we refer to this proposal as the “New Board Proposal”;

 

(7)

Proposal No. 7 — To consider and vote upon a proposal to approve, for purposes of complying with Section 712(b) and Section 713(b) of the NYSE American’s Company Guide, (a) the issuance of more than 20% of FLAG’s issued and outstanding shares of common stock in connection with the Business Combination, including, without limitation, pursuant to the PIPE Investment, if consummated (as described in the accompanying proxy statement/prospectus), and (b) the issuance of more than 20% of FLAG’s issued and outstanding shares to a single holder (which may constitute a change in control under the NYSE American’s Company Guide) in connection with the Business Combination  — we refer to this proposal as the “NYSE American Proposal”; and

 

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(8)

Proposal No. 8 — To consider and vote upon a proposal to adjourn the special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal or the NYSE American Proposal — we refer to this proposal as the “Adjournment Proposal.”

Each of these proposals is more fully described in the accompanying proxy statement/prospectus, which we encourage you to read carefully and in its entirety before voting. Only holders of record of FLAG Common Stock at the close of business on [●], 2023 are entitled to notice of the special meeting and to vote and have their votes counted at the special meeting and any adjournments or postponements thereof.

After careful consideration, the FLAG Board has determined that the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal, the NYSE American Proposal and the Adjournment Proposal are fair to and in the best interests of FLAG and FLAG Stockholders and unanimously recommends that you vote or give instruction to vote “FOR” the Business Combination Proposal, “FOR” the Charter Proposal, “FOR” the Governance Proposal, “FOR” the Incentive Plan Proposal, “FOR” the ESPP Proposal, “FOR” the New Board Proposal, “FOR” the NYSE American Proposal and “FOR” the Adjournment Proposal, if presented. When you consider the FLAG Board’s recommendation of these proposals, you should keep in mind that our directors and officers have interests in the Business Combination that are different from, or in addition to, the interests of FLAG Stockholders generally and that conflict with the interests of FLAG’s public stockholders. Please see the section entitled “Proposal No. 1  The Business Combination Proposal  Interests of Certain Persons in the Business Combination” for additional information. The FLAG Board was aware of these interests, among other matters, in evaluating the Business Combination and in recommending to the FLAG Stockholders that they vote in favor of the proposals presented at the special meeting.

Consummation of the Business Combination is conditioned on the approval of each of the Business Combination Proposal, the Charter Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal and the NYSE American Proposal. If any of those Proposals are not approved, we will not consummate the Business Combination.

Pursuant to FLAG’s Current Charter, a holder of public shares may demand that FLAG redeem such shares for cash if the Business Combination is consummated. Holders of public shares will be entitled to receive cash for these shares only if they demand that FLAG redeem their shares for cash no later than the second business day prior to the vote on the Business Combination Proposal by delivering their shares to FLAG’s transfer agent prior to the vote at the meeting. If the Business Combination is not completed, these shares will not be redeemed. If a holder of public shares properly demands redemption, FLAG will redeem each public share for a pro rata portion of the Trust Account holding the proceeds from FLAG’s IPO, calculated as of two business days prior to the consummation of the Business Combination.

All FLAG Stockholders are cordially invited to attend the special meeting and we are providing the accompanying proxy statement/prospectus and proxy card in connection with the solicitation of proxies to be voted at the special meeting (or any adjournment or postponement thereof). To ensure your representation at the special meeting, however, you are urged to complete, sign, date and return the enclosed proxy card as soon as possible. If your shares are held in an account at a brokerage firm or bank, you must instruct your broker or bank on how to vote your shares or, if you wish to attend the special meeting and vote, obtain a proxy from your broker or bank.

Your vote is important regardless of the number of shares you own. Whether you plan to attend the special meeting or not, please sign, date and return the enclosed proxy card as soon as possible in the envelope provided. If your shares are held in “street name” or are in a margin or similar account, you should contact your broker to ensure that votes related to the shares you beneficially own are properly counted.

 

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Thank you for your participation. We look forward to your continued support.

 

By Order of the Board of Directors

 

 

Thomas Vecchiolla

Chairman of the Board

[●], 2023

IF YOU RETURN YOUR PROXY CARD WITHOUT AN INDICATION OF HOW YOU WISH TO VOTE, YOUR SHARES WILL BE VOTED IN FAVOR OF EACH OF THE PROPOSALS.

TO EXERCISE YOUR REDEMPTION RIGHTS, YOU MUST ELECT TO HAVE FLAG REDEEM YOUR SHARES FOR A PRO RATA PORTION OF THE FUNDS HELD IN THE TRUST ACCOUNT AND TENDER YOUR SHARES TO FLAG’S TRANSFER AGENT AT LEAST TWO (2) BUSINESS DAYS PRIOR TO THE VOTE AT THE SPECIAL MEETING. YOU MAY TENDER YOUR SHARES BY EITHER DELIVERING YOUR SHARE CERTIFICATE TO THE TRANSFER AGENT OR BY DELIVERING YOUR SHARES ELECTRONICALLY USING THE DEPOSITORY TRUST COMPANY’S DWAC (DEPOSIT AND WITHDRAWAL AT CUSTODIAN) SYSTEM. IF THE BUSINESS COMBINATION IS NOT COMPLETED, THEN THESE SHARES WILL NOT BE REDEEMED FOR CASH. IF YOU HOLD THE SHARES IN STREET NAME, YOU WILL NEED TO INSTRUCT THE ACCOUNT EXECUTIVE AT YOUR BANK OR BROKER TO WITHDRAW THE SHARES FROM YOUR ACCOUNT IN ORDER TO EXERCISE YOUR REDEMPTION RIGHTS. PLEASE SEE THE SECTION ENTITLED “SPECIAL MEETING OF FLAG STOCKHOLDERS  REDEMPTION RIGHTS” FOR MORE SPECIFIC INSTRUCTIONS.

 

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ABOUT THIS PROXY STATEMENT/PROSPECTUS

This document, which forms part of a registration statement on Form S-4 filed with the U.S. Securities and Exchange Commission (“SEC”) by FLAG (File No. 333-                ) (the “Registration Statement”), constitutes a prospectus of FLAG under Section 5 of the Securities Act of 1933, as amended (the “Securities Act”), with respect to the shares of New Calidi Common Stock to be issued if the Business Combination described herein is consummated. This document also constitutes a notice of meeting and a proxy statement under Section 14(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with respect to the special meeting of FLAG Stockholders at which FLAG Stockholders will be asked to consider and vote upon proposals to approve the Business Combination, including approving the transactions contemplated in the Merger Agreement.

This proxy statement/prospectus incorporates important business and financial information about FLAG that is not included in or delivered with the document.

This information is available without charge to you upon written or oral request. To make this request, you should contact our proxy solicitor, Mackenzie Partners, Inc.at: (212) 929-5500 (Call Collect) or Call Toll-Free (800) 322-2885, or by email at proxy@mackenziepartners.com

To obtain timely delivery of requested materials, you must request the information no later than five business days prior to the date of the special meeting.

You may also obtain additional information about us from documents filed with the SEC by following the instruction in the section entitled “Where You Can Find Additional Information.”

 

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TABLE OF CONTENTS

 

FREQUENTLY USED TERMS

     1  

SUMMARY OF THE MATERIAL TERMS OF THE TRANSACTIONS

     9  

QUESTIONS AND ANSWERS ABOUT THE PROPOSALS

     12  

SUMMARY OF THE PROXY STATEMENT/PROSPECTUS

     27  

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

     48  

RISK FACTORS

     50  

SPECIAL MEETING OF FLAG STOCKHOLDERS

     124  

PROPOSAL NO. 1 — THE BUSINESS COMBINATION PROPOSAL

     129  

PROPOSAL NO. 2 — THE CHARTER PROPOSAL

     181  

PROPOSAL NO. 3 — THE GOVERNANCE PROPOSAL

     183  

PROPOSAL NO. 4 — THE INCENTIVE PLAN PROPOSAL

     186  

PROPOSAL NO. 5 — THE ESPP PROPOSAL

     192  

PROPOSAL NO. 6 — THE NEW BOARD PROPOSAL

     196  

PROPOSAL NO. 7 — THE NYSE AMERICAN PROPOSAL

     197  

PROPOSAL NO. 8 — THE ADJOURNMENT PROPOSAL

     198  

OTHER INFORMATION RELATED TO FLAG

     199  

FLAG’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     209  

INFORMATION ABOUT CALIDI

     214  

BUSINESS OF CALIDI BIOTHERAPEUTICS

     214  

DIRECTORS, OFFICERS, EXECUTIVE COMPENSATION AND CORPORATE GOVERNANCE OF CALIDI PRIOR TO THE BUSINESS COMBINATION

     252  

MANAGEMENT OF THE COMPANY FOLLOWING THE BUSINESS COMBINATION

     260  

EXECUTIVE COMPENSATION

     265  

UNAUDITED PRO FORMA COMBINED FINANCIAL INFORMATION

     281  

CALIDI’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     292  

DESCRIPTION OF SECURITIES

     312  

COMPARISON OF STOCKHOLDER RIGHTS

     322  

PRICE RANGE OF SECURITIES AND DIVIDENDS

     331  

BENEFICIAL OWNERSHIP OF SECURITIES

     332  

CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS

     337  

FLAG RELATED PERSON TRANSACTIONS

     337  

APPRAISAL RIGHTS

     338  

SUBMISSION OF STOCKHOLDER PROPOSALS

     338  

FUTURE STOCKHOLDER PROPOSALS

     338  

OTHER STOCKHOLDER COMMUNICATIONS

     338  

LEGAL MATTERS

     339  

EXPERTS

     339  

DELIVERY OF DOCUMENTS TO STOCKHOLDERS

     341  

WHERE YOU CAN FIND MORE INFORMATION

     342  

PART II INFORMATION NOT REQUIRED IN PROSPECTUS

     II-1  

SIGNATURES AND POWER OF ATTORNEY

     II-6  


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FREQUENTLY USED TERMS

Unless otherwise stated in this proxy statement/prospectus or the context otherwise requires, references to:

Accounting Principles” means in accordance with GAAP as in effect at the date of the financial statement to which it refers or if there is no such financial statement, then as of the Closing Date, using and applying the same accounting principles, practices, procedures, policies and methods (with consistent classifications, judgments, elections, inclusions, exclusions and valuation and estimation methodologies) used and applied by the Target Companies in the preparation of the latest audited financial statements of Calidi;

Adjournment Proposal” means the Proposal to be considered at the Meeting to adjourn the Meeting to a later date or dates, if necessary to permit further solicitation and vote of proxies if it is determined by the FLAG Board that more time is necessary or appropriate to approve one or more Proposals at the Meeting;

Adjusted Merger Consideration” means an amount equal to the sum of (i) the Merger Consideration, and (ii) the aggregate amount of the exercise prices for all Calidi Common Stock under vested Calidi Options in accordance with their terms (and assuming no cashless exercise);

Amended and Restated Forward Purchase Agreement” means that certain Amended and Restated Forward Purchase Agreement with Franklin, whereby Franklin may purchase, in its sole discretion, 5,000,000 shares of FLAG Class A Common Stock plus 2,500,000 FLAG Forward Purchase Warrants, exercisable to purchase one share of FLAG Class A Common Stock at $11.50 per share, for an aggregate purchase price of $50,000,000, or $10.00 for one share of FLAG Class A Common Stock and one-half of one FLAG Forward Purchase Warrant, in a private placement to occur concurrently with the Closing, subject to certain conditions;

anchor investors” means certain unaffiliated qualified institutional buyers or institutional accredited investors who have each entered into an Investment Agreement pursuant to which such anchor investors have purchased in the aggregate 1,452,654 founder shares from our Sponsor and Metric at approximately $0.004 per share;

Ancillary Documents” means each agreement, instrument or document attached to the Merger Agreement or executed or delivered in connection with or pursuant to the Merger Agreement;

Assumed Options” means the options to purchase shares of Common Stock to be issued to holders of Calidi Options at the Closing pursuant to the terms of the Merger Agreement;

Business Combination” means the proposed business combination of FLAG with Calidi pursuant to the terms and conditions of the Merger Agreement;

Business Combination Proposal” means the Proposal to be considered at the Meeting to approve the Business Combination;

Calidi” or “Calidi Biotherapeutics” means Calidi Biotherapeutics, Inc., a Nevada corporation;

Calidi Cash” means, as of the Reference Time for the calculation of Net Debt and as of January 4, 2023 for the calculation of the Net Debt Target, the aggregate cash and cash equivalents (other than Restricted Cash) of the Target Companies on hand or in bank accounts, including deposits in transit, and, minus the aggregate amount of outstanding and unpaid checks issued by or on behalf of the Target Companies as of such time. Subject to the following sentence, with respect to the Reference Time, Calidi Cash shall include the amount of gross proceeds of any Unassisted Permitted Calidi Equity Issuance. In the event that any portion of the gross proceeds from any Unassisted Permitted Calidi Equity Issuance is used to pay all or any portion of the liabilities set forth in Schedule 1.17 of the Calidi disclosure schedules, then the amount of gross proceeds from any

 

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Unassisted Permitted Calidi Equity Issuance that is included in the definition of Calidi Cash at the Reference Time shall be reduced by a like amount. For the avoidance of doubt, Calidi Cash shall not include the amount of any Pre-Closing Milestone Adjustment Amount;

Calidi Common Stock” means the common stock, par value $0.0001 per share, of Calidi;

Calidi Convertible Securities” means, collectively, the Calidi Options, the Calidi SAFEs, all convertible debt of Calidi issued and outstanding immediately prior to the Effective Time, and any other options, warrants or rights to subscribe for or purchase any capital stock of Calidi or securities convertible into or exchangeable for, or that otherwise confer on the holder any right to acquire, any capital stock of Calidi;

Calidi Equity Plan” means, collectively, the Calidi 2016 Equity Incentive Plan, as amended from time to time, and the Calidi 2019 Equity Incentive Plan, as amended from time to time;

Calidi Net Debt” means, as of the Effective Time, Calidi’s indebtedness (assuming all convertible indebtedness is converted into Calidi Common Stock immediately prior to the Effective Time), less Calidi Cash;

Calidi Options” means options to purchase shares of Calidi Common Stock granted pursuant to the Calidi Equity Plan;

Calidi Preferred Stock” means all series of the preferred stock, par value $0.0001 per share, of Calidi;

Calidi Stock” means any shares of Calidi Common Stock and Calidi Preferred Stock;

Calidi Stockholders” means all holders of Calidi Stock immediately prior to the Effective Time;

Calidi SAFEs” means all simple agreements for future equity of Calidi issued and outstanding immediately prior to the Effective Time;

Calidi Securities” means, collectively, the Calidi Stock, the Calidi Options and any other Calidi Convertible Securities;

Calidi Security Holders” means all holders of Calidi Securities immediately prior to the Effective Time;

Charter Proposal” means the Proposal to be considered at the Meeting to approve and adopt the Proposed Charter in the form attached to this proxy statement/prospectus as Annex B;

Closing” means the closing of the Merger and all of the transactions contemplated by the Merger Agreement in accordance with the terms of the Merger Agreement;

Closing Date” means the date on which the Business Combination is consummated;

Common Stock” means the shares of common stock, par value $0.0001 per share, of New Calidi following the Merger, with the rights and preferences and subject to the terms and conditions set forth in the Proposed Charter;

completion window” means the period following the completion of FLAG’s IPO at the end of which, if FLAG has not completed the Business Combination, it will redeem 100% of the public shares at a per share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including interest (net of permitted withdrawals and up to $100,000 of interest to pay dissolution expenses), divided by the number of then outstanding public shares, subject to applicable law and certain conditions. The completion window currently ends on June 14, 2023 (or September 14, 2023 if FLAG exercises the one unexercised three-month extension pursuant to our Current Charter);

 

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Conversion Ratio” means a number of shares of FLAG Common Stock equal to (i) the Per Share Price, divided by (ii) 10;

Current Bylaws” means FLAG’s bylaws in effect as of the date of this proxy statement/prospectus;

Current Charter” means FLAG’s amended and restated certificate of incorporation, as amended, in effect as of the date of this proxy statement/prospectus;

DGCL” means the Delaware General Corporation Law, as amended;

DTC” means The Depository Trust Company;

DWAC” means The Depository Trust Company’s deposit/withdrawal at custodian system;

Effective Time” means the date and time that the Merger becomes effective;

ESPP” means the 2023 Employee Stock Purchase Plan of New Calidi, the form of which is attached as Annex H;

ESPP Proposal” means the Proposal to be considered at the Meeting to approve the ESPP and the material terms thereof, including the authorization of the initial share reserve thereunder;

Exchange Act” means the Securities Exchange Act of 1934, as amended;

Exchange Agent” means Continental Stock Transfer & Trust Company, in its capacity as exchange agent pursuant to the Merger Agreement;

FLAG” means First Light Acquisition Group, Inc., a Delaware corporation;

FLAG Class A Common Stock” means, prior to consummation of the Business Combination, FLAG Class A Common Stock, par value $0.0001 per share and, following consummation of the Business Combination, the common stock, par value $0.0001 per share, of New Calidi;

FLAG Class B Common Stock” means FLAG Class B Common Stock, par value $0.0001 per share;

FLAG Common Stock” means FLAG Class A Common Stock and FLAG Class B Common Stock, collectively;

FLAG Forward Purchase Warrants” means 2,500,000 FLAG Public Warrants to be issued to Franklin in a private placement, pursuant to the Amended and Restated Forward Purchase Agreement between FLAG and Franklin, if Franklin elects to purchase securities thereunder;

FLAG Forward Purchase Securities” means, collectively, the FLAG Forward Purchase Shares and FLAG Forward Purchase Warrants;

FLAG Forward Purchase Shares” means 5,000,000 shares of FLAG Class A Common Stock to be issued to Franklin in a private placement, pursuant to the Amended and Restated Forward Purchase Agreement between FLAG and Franklin, if Franklin elects to purchase securities thereunder;

FLAG Private Placement Warrants” means the redeemable warrants of FLAG purchased by the Sponsor and Metric in a private placement simultaneously with the closing of the IPO;

FLAG Public Warrants” means the redeemable warrants sold as part of the FLAG Units in the IPO (whether they were purchased in the IPO or thereafter in the open market);

 

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FLAG Securities” means FLAG Class A Common Stock, FLAG Class B Common Stock, FLAG Private Placement Warrants, FLAG Public Warrants, FLAG Forward Purchase Warrants, FLAG Units and, upon the Closing, the Common Stock, collectively;

FLAG Stockholders” means all holders of FLAG Common Stock;

FLAG Units” means the units issued in the IPO (including overallotment units acquired by the IPO Underwriter) consisting of one (1) share of FLAG Class A Common Stock and one-half (1/2) of one (1) FLAG Public Warrant;

FLAG Warrants” means the FLAG Private Placement Warrants, FLAG Public Warrants and FLAG Forward Purchase Warrants, collectively;

Franklin” means Franklin Strategic Series — Franklin Small Cap Growth Fund, a Delaware statutory trust;

founder shares” means shares of FLAG Class B Common Stock. The founder shares automatically convert into shares of FLAG Class A Common Stock upon the consummation of the Business Combination;

Fully-Diluted Calidi Shares” means the total number of issued and outstanding shares of Calidi Common Stock outstanding immediately prior to the Effective Time (a) after giving effect to the Calidi Convertible Securities Conversion or otherwise treating Calidi Convertible Securities (other than Calidi Options) on an as-converted to Calidi Common Stock basis and (b) treating all outstanding vested in the money Calidi Options as if the Calidi Option had been exercised with cash as of the Effective Time, but excluding any Calidi Securities described in Section 1.9(b) of the Merger Agreement;

GAAP” means accounting principles generally accepted in the United States of America;

Governance Proposal” means the Proposal to be considered at the special meeting to vote upon, on a non-binding advisory basis, certain governance provisions in the Proposed Charter, presented separately in accordance with requirements of the SEC;

HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended;

Incentive Plan” means the 2023 Stock Incentive Plan of New Calidi, the form of which is attached as Annex G;

Incentive Plan Proposal” means the Proposal to be considered at the Meeting to approve and adopt the Incentive Plan, including the authorization of the initial share reserve thereunder;

Insiders” are to, collectively, the directors and officers of FLAG, including Thomas A. Vecchiolla, Michael J. Alber, Michael Reuttgers, William J. Fallon, Jeanne Tisinger and William J. Weber (until December 21, 2022, the date of his resignation from his office and directorship with FLAG);

Investment Agreement” means each of the investment agreements entered into between our Sponsor, Metric and the anchor investors pursuant to which such anchor investors have purchased in the aggregate 1,452,654 founder shares from our Sponsor and Metric at approximately $0.004 per share;

IPO” means the initial public offering of FLAG Units by FLAG which closed on September 14, 2021;

IPO Prospectus” means the final prospectus of FLAG, dated as of September 9, 2021, and filed with the SEC on September 14, 2021 (File No. 333-259038);

IPO Underwriter” means Guggenheim Securities, LLC, in its capacity as the underwriter of the IPO;

 

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Letter Agreement” means, collectively, each agreement between FLAG and each of (i) the Sponsor, (ii) Metric and (iii) the Insiders, dated as of the IPO, pursuant to which each of the Sponsor, Metric and the Insiders has agreed to waive their redemption rights with respect to any founder shares and public shares held by them in connection with the consummation of the Business Combination;

Listing Condition” means the condition to Closing that the shares of New Calidi Common Stock to be issued as Merger Consideration shall have been approved for listing on the NYSE American;

Meeting” or “special meeting” means the special meeting of stockholders of FLAG to be held via live webcast at [●] a.m. Eastern Time, on [●], 2023;

Merger” means the merger of Merger Sub and Calidi, with Calidi surviving such merger as a wholly-owned subsidiary of FLAG;

Merger Agreement” means that certain Agreement and Plan of Merger, dated as of January 9, 2023, by and among FLAG, Merger Sub, Purchaser Representative, Seller Representative and Calidi, as the same has been or may be amended, modified, supplemented or waived from time to time;

Merger Consideration” means (i) Two Hundred Fifty Million U.S. Dollars ($250,000,000), (ii) plus or minus the Net Debt Adjustment, and subject to Section 1.17 of the Merger Agreement, and (iii) plus the Pre-Closing Milestone Adjustment Amount, if any;

Metric” means Metric Finance Holdings I, LLC, a Delaware limited liability company and an affiliate of Guggenheim Securities, LLC;

Minimum Cash Condition” means the condition to the Closing, that FLAG will have cash or cash equivalents, including funds remaining in the Trust Account (after giving effect to the completion and payment of the Redemption plus the proceeds of the PIPE Investments, if any) following the payment of the unpaid expenses or liabilities of FLAG and Calidi related to the Business Combination, equal to at least $15,000,000;

Net Debt” means, as of the reference time, (i) the aggregate amount of all indebtedness of Calidi and its subsidiaries assuming all indebtedness that is convertible into equity at the Closing has been converted, less (ii) Calidi Cash, in each case of clauses (i) and (ii), on a consolidated basis and as determined in accordance with the Accounting Principles;

Net Debt Adjustment” means the adjustment to the Merger Consideration dependent upon the difference in Calidi’s Net Debt as of the effective time of the Merger from the Net Debt Target;

Net Debt Target” means (i) the aggregate amount of all indebtedness of the Target Companies assuming all indebtedness that is convertible into equity at the Closing has been converted, less (ii) Calidi Cash, in each case of clauses (i) and (ii), as of January 4, 2023, on a consolidated basis and as determined in accordance with the Accounting Principles;

New Board Proposal” means the Proposal to be considered at the special meeting to elect seven directors to serve staggered terms on the New Calidi Board upon the consummation of the Business Combination until the first, second and third annual meetings of stockholders following the date of effectiveness of the Proposed Charter, as applicable, or until the election and qualification of their respective successors;

New Calidi” refers to FLAG immediately following the Merger, which will be renamed “New Calidi” upon the Closing;

 

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New Calidi Board” means the board of directors of New Calidi following the completion of the Business Combination;

New Calidi Common Stock” means, following the consummation of the Business Combination, the common stock, par value $0.0001 per share, of New Calidi.

NRS” means the Nevada Revised Statutes, as amended and in effect from time to time;

NYSE American” means NYSE American LLC;

NYSE American Proposal” means the Proposal to be considered at the Meeting to approve, for the purposes of complying with the applicable provisions of the NYSE American Company Guide, the issuance of shares of Common Stock and securities convertible into shares of Common Stock in the Business Combination and the PIPE Investment;

operating partners” means, collectively, William J. Weber, Michael J. Alber, Michael Papadales, Thomas A. Vecchiolla and Marybeth A. Wootton;

Per Share Price” means an amount equal to (i) the Adjusted Merger Consideration, divided by (ii) the Fully-Diluted Calidi Shares;

Permitted Calidi Equity Issuance” means the amount of gross proceeds raised by Calidi from an offering of Calidi Common Stock (through SAFEs or otherwise) or Calidi’s convertible notes or preferred stock (convertible in either case into Calidi Common Stock upon the consummation of the Merger), or any combination thereof, on commercially reasonable prices and terms consistent with past practices in an aggregate amount up to $40,000,000 during the Interim Period;

PIPE Investment” means the issuance and sale by FLAG of the PIPE Shares expected to occur concurrently with and as a condition to the consummation of the Business Combination;

PIPE Investors” means the investors participating in the PIPE Investment;

PIPE Shares” means shares of FLAG Common Stock to be issued and sold by FLAG in the PIPE Investment;

pro rata share” means with respect to each Calidi Stockholder, a fraction expressed as a percentage equal to (i) the total number of shares of Calidi Common Stock beneficially owned by such Calidi Stockholder (after giving effect to the Calidi Convertible Securities Conversion) immediately prior to the Effective Time, divided by (ii) the total number of shares of Calidi Common Stock issued and outstanding (after giving effect to the Calidi Convertible Securities Conversion) immediately prior to the Effective Time;

Proposed Bylaws” means the bylaws of New Calidi to take effect simultaneously with the Closing, in the form attached to this proxy statement/prospectus as Annex C, as further described in the “Proposal No. 2 — Charter Proposal” section of this proxy statement/prospectus;

Proposed Charter” or “Second Amended and Restated Certificate of Incorporation” means the certificate of incorporation of New Calidi in the form attached to this proxy statement/prospectus as Annex B, proposed to be in effect at and following the Closing of the Business Combination, as further described in the “Proposal No. 2 — The Charter Proposal” section of this proxy statement/prospectus;

Proposals” means, collectively, the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal, the NYSE American Proposal and the Adjournment Proposal;

 

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public shares” means shares of FLAG Class A Common Stock issued as part of FLAG Units in the IPO;

public stockholders” means the holders of FLAG Class A Common Stock, including the Sponsor and FLAG’s officers and directors to the extent the Sponsor and FLAG’s officers or directors purchased or purchase FLAG Class A Common Stock, provided that each of their status as a “public stockholder” shall only exist with respect to such FLAG Class A Common Stock;

Public Securities” means, collectively, all of the FLAG Class A Common Stock (excluding FLAG Class A Common Stock issued upon conversion of FLAG Class B Common Stock in accordance herewith), FLAG Public Warrants and FLAG Units together with all shares of FLAG Class A Common Stock issuable upon exchange, exercise and/or conversion of securities at consummation of the Business Combination;

Purchaser Representative” means the Sponsor, in its capacity as the representative from and after the Closing of the stockholders of FLAG (other than the Calidi Security Holders) for the purposes set forth in the Merger Agreement;

Record Date” means [●], 2023;

Redemption” means a redemption of FLAG Class A Common Stock by public stockholders for the Redemption Price;

Redemption Price” means an amount equal to the price at which public stockholders may redeem or convert their shares of FLAG Class A Common Stock for cash in connection with the Business Combination pursuant to the Redemption;

Sarbanes-Oxley Act” means the Sarbanes-Oxley Act of 2002, as amended;

Securities Act” means the Securities Act of 1933, as amended;

Seller Representative” means Allan Camaisa, in his capacity as the representative from and after the Closing of the Calidi Security Holders for the purposes set forth in the Merger Agreement;

SEC” means the United States Securities and Exchange Commission;

Significant Calidi Holder” means Allan Camaisa and Scott Leftwich;

Sponsor” means First Light Acquisition Group, LLC, a Delaware series limited liability company;

Sponsor Agreement” means the Sponsor Agreement, dated as of January 9, 2023, by and among FLAG, Calidi, the Sponsor, Metric and the Insiders party thereto;

Sponsor-Assisted Permitted Calidi Equity Issuance” means a Permitted Calidi Equity Issuance, which involves the transfer by Sponsor or Metric of FLAG Class B Common Stock or FLAG Private Placement Warrants, or other equity of FLAG held by the Sponsor or Metric to the purchaser of such equity of Calidi in the Permitted Calidi Equity Issuance;

Stockholder Merger Consideration” means the total portion of the Merger Consideration payable to all Calidi Stockholders as a result of the Merger pursuant to the Merger Agreement;

Target Companies” means Calidi and its subsidiaries;

 

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Transmittal Documents” means the Letters of Transmittal and other applicable documentation to be delivered by certain Calidi Security Holders in accordance with the terms of the Merger Agreement prior, and as a condition, to such Calidi Security Holders receiving Merger Consideration, including the Transmittal Documents required to be delivered to the Exchange Agent by holders thereof on or prior to the Closing;

Treasury Shares” means Calidi Securities that are owned by Calidi as treasury shares or any Calidi Securities owned by any direct or indirect subsidiary of Calidi immediately prior to the Effective Time;

Trust” or “Trust Account” means the Trust Account in which net proceeds from the sale of FLAG Units in the IPO were placed following the closing of the IPO pursuant to the Trust Agreement in accordance with the IPO Prospectus;

Trust Agreement” means the Amended Investment Management Trust Agreement, as amended from time to time, dated as of September 9, 2021, by and between FLAG and the Trustee, as well as any other agreements entered into related to or governing the Trust Account, as may be amended or modified;

Trustee” means Continental Stock Transfer & Trust Company, in its capacity as trustee under the Trust Agreement;

US Dollars” and “Dollars” and “$” mean to the legal currency of the United States;

U.S. Holder” means a beneficial owner of FLAG Class A Common Stock that is for U.S. federal income tax purposes: (a) an individual citizen or resident of the United States; (b) a corporation (or other entity treated as a corporation) that is created or organized (or treated as created or organized) in or under the laws of the United States, any state thereof or the District of Columbia; (c) an estate whose income is includible in gross income for U.S. federal income tax purposes regardless of its source; or (d) a trust if (i) a U.S. court can exercise primary supervision over the trust’s administration and one or more U.S. persons are authorized to control all substantial decisions of the trust, or (ii) it has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a U.S. person;

Voting and Lock-Up Agreement” means the Voting and Lock-Up Agreement, dated as of January 9, 2023, and amended on April [12], 2023, by and among FLAG, Calidi and the Calidi Stockholders party thereto, attached hereto as Annex E;

Warrant Agent” means Continental Stock Transfer & Trust Company, in its capacity as warrant agent under the Warrant Agreement; and

Warrant Agreement” means the Warrant Agreement, dated as of September 9, 2021, between FLAG and the Warrant Agent.

 

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SUMMARY OF THE MATERIAL TERMS OF THE TRANSACTIONS

This summary term sheet, together with the sections entitled “Questions and Answers About the Proposals” and “Summary of the Proxy Statement/Prospectus,” summarizes certain information contained in this proxy statement/prospectus, but does not contain all of the information that is important to you. You should read carefully this entire proxy statement/prospectus, including the attached Annexes, for a more complete understanding of the matters to be considered at the special meeting. In addition, for definitions used commonly throughout this proxy statement/prospectus, including this summary term sheet, please see the section entitled “Frequently Used Terms.”

 

   

First Light Acquisition Group, Inc., a Delaware corporation, which we refer to as “FLAG,” “we,” “us,” or “our,” is a special purpose acquisition company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses.

 

   

On September 14, 2021, FLAG consummated its IPO, which, when combined with the exercise of the overallotment option by the IPO Underwriter and subsequent related private placements, generated net proceeds of $230,000,000. The securities offered were the following: (i) units, at an offering price of $10.00 per unit, each consisting of one share of FLAG Class A Common Stock and one-half of one redeemable warrant, (ii) shares of FLAG Class A Common Stock, and (iii) redeemable warrants, with each whole warrant exercisable for one share of FLAG Class A Common Stock at an exercise price of $11.50 per share. Initially, FLAG registered all classes of securities on the New York Stock Exchange. On November 17, 2022, FLAG transferred the listing of its securities to the NYSE American. In connection with the transfer, FLAG voluntarily delisted from the New York Stock Exchange.

 

   

Following the consummation of the IPO, $230,000,000 was deposited into the Trust Account with Continental Stock Transfer & Trust Company acting as Trustee. Except as described in the IPO Prospectus, the proceeds from the Trust Account will not be released until the earliest to occur of: (a) the consummation of the Business Combination (including the release of funds to pay any amounts due to any public stockholders who properly exercise their redemption rights in connection therewith), (b) the redemption of any public shares upon a stockholder vote to approve an amendment to the Current Charter that would modify the substance or timing of our obligation to redeem 100% of our public shares if we have not consummated the Business Combination within the completion window, and (c) the redemption of public shares if we are unable to consummate the Business Combination within the completion window.

 

   

On September 13, 2022, FLAG Stockholders approved an amendment to FLAG’s certificate of incorporation to (i) extend the date by which FLAG must complete its initial business combination (the “Extension”) from September 14, 2022, to December 14, 2022 and (ii) provide the FLAG Board the ability to further extend the date by which FLAG must consummate a business combination up to three additional times for three months each time, for a maximum of 9 additional months, if the Sponsor pays an amount equal to 1% of the amount then on deposit in the Trust Account for each three-month extension, which amount will be deposited in the Trust Account (the “Extension Fee”); provided, that if as of the time of an extension FLAG has filed a Form S-4 or F-4 registration statement under the Securities Act or a proxy, information or tender offer statement with the SEC in connection with such initial business combination, then no Extension Fee would be required in connection with such extension; provided further, that for each three-month extension (if any) following such extension where no deposit into the Trust Account or other payment has been made, our sponsor or its affiliates or designees would be required to deposit into the Trust Account an amount equal to 1% of the amount then on deposit in the Trust Account.

 

   

In connection with the Extension, FLAG Stockholders elected to redeem 18,871,976 shares of FLAG Class A Common Stock. Following such redemptions, 4,128,024 shares of FLAG Class A Common Stock remained issued and outstanding. As of December 31, 2022, there was $42,453,107 in the Trust Account.

 

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On September 13, 2022, FLAG issued two unsecured promissory notes in an aggregate principal amount of $490,000 to the Sponsor and Metric, $412,802 of which was used to fund the Extension and for general working capital purposes. FLAG deposited the funds into the Trust Account. On April 5, 2023, the Sponsor and Metric canceled the promissory notes and discharged all of FLAG’s obligations thereunder. Such Extension Fees will not be required to be repaid upon the consummation of the Business Combination.

 

   

The FLAG Board subsequently approved extensions of the date by which FLAG must complete its initial business combination from (a) December 14, 2022 to March 14, 2023, and the Trust Account was funded with a payment of $415,626 (the “December Extension”) and (b) March 14, 2023 to June 14, 2023, and no fee was required in connection with such extension.

 

   

In order to fund the extension fees in connection with the December Extension, FLAG issued promissory notes to certain officers and directors of FLAG in an aggregate principal amount of $710,000. Under the terms of these notes, FLAG is required to pay interest on the notes at a per annum rate of 50% to 100% of the loan amount evidenced by such notes. Please see the section entitled “Proposal No. 1 — The Business Combination Proposal — Interests of Certain Persons in the Business Combination”. On December 13, 2022, FLAG issued a promissory note to Jackson Investment Group, LLC, an existing investor, with an outstanding principal balance of $205,000 (the “Jackson Note”), the proceeds of which were used to fund the fees in connection with the December Extension. Under the terms of the Jackson Note, FLAG is required to pay interest at a per annum rate of 50% of the loan amount evidenced by the note. Each of the foregoing promissory notes is payable in full on the earliest to occur of (i) the date on which FLAG consummates its initial business combination and (ii) the date that the winding up of FLAG is effective.

 

   

On January 9, 2023, FLAG entered into the Merger Agreement with Calidi, pursuant to which, among other things, Merger Sub will merge with and into Calidi, with Calidi surviving such merger as a wholly-owned subsidiary of FLAG.

 

   

Calidi is a clinical stage biopharmaceutical company that is developing proprietary allogeneic stem cell-based platforms to potentiate and deliver oncolytic viruses and, potentially, other molecules to cancer patients. Calidi is currently developing two proprietary stem cell-based platforms to improve the antitumor activity of oncolytic viruses over traditional “naked” (unprotected) oncolytic virus therapies, by protecting the oncolytic virus, whether natural or engineered, from neutralization by the patient’s immune defenses, allowing for greater targeting of the tumor cells. Calidi expects the novel nature of its product candidates to create significant challenges in obtaining regulatory approval. Few viral immunotherapies have been approved globally or by the FDA to date. While the first viral immunotherapy, talimogene laherparepvec (Imlygic, Amgen), has received FDA approval, regulatory agencies have reviewed relatively few viral immunotherapy product candidates like Calidi’s product candidates. This may lengthen the regulatory review process, increase our development costs and delay or prevent commercialization of Calidi’s product candidates. None of Calidi’s product candidates have received marketing approval from the FDA and no assurances can be given that Calidi will be successful in obtaining marketing approval for any of its product candidates. To our knowledge, there are no FDA-approved products for the treatment of cancer that utilize the adenovirus we are currently using in our clinical trials for CLD-101 or vaccinia virus we are currently using in our clinical trials for CLD-201.

 

   

Subject to the terms of the Merger Agreement, upon consummation of the Merger, and after giving effect to the conversion of all Calidi Convertible Securities, other than Calidi Options, all shares of Calidi Common Stock outstanding as of the time of the Merger will be converted into (a) the right to receive shares of New Calidi Common Stock and (b) the contingent right to receive the Escalation Shares. The aggregate consideration to be paid to Calidi equityholders (excluding for this purpose options to purchase Calidi Common Stock that remain unvested immediately following the Merger) will be based on an equity value for Calidi of $250,000,000, subject to adjustment dependent upon (a) the difference in Calidi’s “net debt” as of the effective time of the Merger from a target “net debt” amount of $3,470,000 (as described in greater detail in this proxy statement/prospectus) and (b) the

 

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achievement of certain pre-closing milestones (if any), as further described in this proxy statement/prospectus. If the Merger had closed on March 27, 2023, Calidi’s “net debt” would have been approximately $7.5 million and its aggregate amount of indebtedness would have been $7.6 million. Holders of $1.7 million of the $7.6 million of Calidi’s indebtedness have indicated their intention to convert such indebtedness into Calidi shares of common stock immediately before the Closing. The shares of New Calidi Common Stock to be issued as merger consideration will be valued at $10.00 per share. Assuming no adjustments in the merger consideration, we would expect each share of Calidi Common Stock to be converted into [●] shares of New Calidi Common Stock in the Merger and that the Calidi Stockholders will own [●] of the outstanding shares of New Calidi Common Stock immediately following the consummation of the Business Combination. The preceding sentence reflects numerous assumptions. This proxy statement/prospectus discloses those assumptions and presents various alternate scenarios regarding the ownership of New Calidi following the Business Combination. The estimated net cash per share of FLAG Common Stock that is being contributed by FLAG to New Calidi is less than the $10.00 per share ascribed to such shares in the Merger Agreement or the amount per share that holders of FLAG Class A Common Stock would be entitled to receive upon exercise of their redemption rights, as described in this proxy statement/prospectus. See the section entitled “Proposal No. 1 — The Business Combination Proposal — General — Merger Consideration.”

 

   

During the Escalation Period, Calidi Stockholders may be entitled to receive up to 18,000,000 Escalation Shares with incremental releases of 4,500,000 shares upon the achievement of each share price hurdle if the trading price of New Calidi Common Stock is $12.00, $14.00, $16.00 and $18.00 for a period of any 20 days within any 30-consecutive-day trading period. Holders of FLAG Class A Common Stock who do not redeem their shares will be entitled to their pro rata portion of up to an additional 2,000,000 Non-Redeeming Continuation Shares to be issued at Closing. The Escalation Shares will be placed in escrow and will be outstanding from and after the Closing, subject to cancellation if the applicable price targets are not achieved. While in escrow, the shares will be non-voting.

 

   

Upon completion of the Business Combination, we anticipate that: (i) FLAG public stockholders will own approximately [●]% of the outstanding shares of New Calidi (ii) the Sponsor and Metric, collectively, will own approximately [●]% of the outstanding shares of New Calidi, and (iii) the Calidi Stockholders will own approximately [●]% of the outstanding shares of New Calidi. These percentages are based on various assumptions. Except as otherwise set forth in this proxy statement/prospectus, these ownership percentages assume no redemptions, no ownership of Escalation Shares and no ownership of shares subject to lock-up agreements. See “Unaudited Pro Forma Combined Financial Information” for discussion of these assumptions and the presentation of alternate scenarios regarding the ownership of New Calidi following the Business Combination.

 

   

FLAG management and the FLAG Board considered various factors in determining whether to approve the Merger Agreement and the Business Combination contemplated thereby, including the Merger. For more information about the reasons that the FLAG Board considered in determining its recommendation, please see the section entitled “Proposal No. 1 — The Business Combination Proposal — Interests of Certain Persons in the Business Combination.” When you consider the FLAG Board’s recommendation of these proposals, you should keep in mind that our directors and officers have interests in the Business Combination that are different from, or in addition to, the interests of FLAG Stockholders generally and conflict with the interests of FLAG’s public stockholders. Accordingly, each such individual is incentivized to complete an acquisition of a less favorable target company or on terms less favorable to FLAG Stockholders rather than to allow FLAG to liquidate. The FLAG Board was aware of these interests, among other matters, in evaluating the Business Combination and in recommending to the FLAG Stockholders that they vote “FOR” the Proposals presented at the special meeting.

 

   

An assumed Closing Date of [●], 2023 has been used throughout this proxy statement/prospectus for illustrative purposes only and is not intended to be a projection of the actual Closing Date.

 

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QUESTIONS AND ANSWERS ABOUT THE PROPOSALS

The questions and answers below highlight only selected information from this proxy statement/prospectus and only briefly address some commonly asked questions about the special meeting and the Proposals to be presented at the special meeting, including with respect to the proposed Business Combination. The following questions and answers do not include all the information that is important to FLAG Stockholders. Stockholders are urged to read carefully this entire proxy statement/prospectus, including the Annexes and the other documents referred to herein, to fully understand the proposed Business Combination and the voting procedures for the special meeting.

Q. Why am I receiving this proxy statement/prospectus?

A. FLAG and Calidi have agreed to the Business Combination under the terms of the Merger Agreement that is described in this proxy statement/prospectus. A copy of the Merger Agreement is attached to this proxy statement/prospectus as [●], and FLAG encourages its stockholders to read it in its entirety. FLAG Stockholders are being asked to consider and vote upon a proposal to approve the business combination transactions contemplated by the Merger Agreement, which, among other things, includes provisions for the merger of Merger Sub with and into Calidi, with Calidi surviving such merger as a wholly-owned subsidiary of FLAG. Please see the section entitled “Proposal No. 1  The Business Combination Proposal.”

This proxy statement/prospectus and its Annexes contain important information about the proposed Business Combination and the other matters to be acted upon at the special meeting. You should read this proxy statement/prospectus and its Annexes carefully and in their entirety.

Your vote is important. You are encouraged to submit your proxy as soon as possible after carefully reviewing this proxy statement/prospectus and its Annexes.

Q. When and where is the Special Meeting?

A. The special meeting will be held via live webcast on [●], 2023 at [●] a.m. Eastern Time. The special meeting can be accessed by visiting [●], where you will be able to listen to the meeting live and vote during the meeting. Please note that you will only be able to access the special meeting by means of remote communication.

Q. What are the proposals on which I am being asked to vote at the special meeting?

A. The stockholders of FLAG will be asked to consider and vote on the following proposals at the special meeting:

 

  1.

a proposal to approve the Business Combination described in this proxy statement/prospectus, including approving the transactions contemplated by the Merger Agreement and related agreements described in this proxy statement/prospectus. Please see the section entitled “Proposal No. 1 — The Business Combination Proposal”;

 

  2.

a proposal to approve and adopt the Second Amended and Restated Certificate of Incorporation of FLAG, which will be the certificate of incorporation of New Calidi, in the form attached to this proxy statement/prospectus as Annex B. Please see the section entitled “Proposal No. 2 — The Charter Proposal”;

 

  3.

a proposal to vote upon, on a non-binding advisory basis, certain governance provisions in the Second Amended and Restated Certificate of Incorporation, presented separately, in accordance with the requirements of the SEC. Please see the section entitled “Proposal No. 3The Governance Proposal”;

 

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  4.

a proposal to approve and adopt the Incentive Plan, in the form attached to this proxy statement/prospectus as Annex G, including the authorization of the initial share reserve thereunder. Please see the section entitled “Proposal No. 4 — The Incentive Plan Proposal”;

 

  5.

a proposal to approve and adopt the ESPP, in the form attached to this proxy statement/prospectus as Annex H, and the material terms thereof, including the authorization of the initial share reserve thereunder. Please see the section entitled “Proposal No. 5 — The ESPP Proposal”;

 

  6.

a proposal to elect seven directors to serve staggered terms on the New Calidi Board upon the consummation of the Business Combination until the first, second and third annual meetings of stockholders following the date of effectiveness of the Proposed Charter, as applicable, or until the election and qualification of their respective successors. Please see the section entitled “Proposal No. 6The New Board Proposal”;

 

  7.

a proposal to approve, for purposes of complying with Section 712(b) and Section 713(b) of the NYSE American’s Company Guide, (a) the issuance of more than 20% of FLAG’s issued and outstanding shares of common stock in connection with the Business Combination, including, without limitation, pursuant to the PIPE Investment, if consummated (as described below), and (b) the issuance of more than 20% of FLAG’s issued and outstanding shares to a single holder (which may constitute a change in control under the NYSE American’s Company Guide) in connection with the Business Combination. Please see the section entitled “Proposal No. 7NYSE American Proposal”; and

 

  8.

a proposal to adjourn the special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal or the NYSE American Proposal. Please see the section entitled “Proposal No. 8 — Adjournment Proposal.”

FLAG will hold the special meeting of its stockholders to consider and vote upon these proposals. This proxy statement/prospectus contains important information about the proposed Business Combination and the other matters to be acted upon at the special meeting. Stockholders should read it carefully.

Consummation of the Business Combination is conditioned on the approval of each of the Business Combination Proposal, the Charter Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal and the NYSE American Proposal. If any of those Proposals are not approved, we will not consummate the Business Combination. The vote of stockholders is important. Stockholders are encouraged to vote as soon as possible after carefully reviewing this proxy statement/prospectus.

Q. Why is FLAG proposing the Business Combination?

A. FLAG was organized to effect a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or other similar Business Combination with one or more businesses or entities.

Calidi is a clinical stage immuno-oncology company that is developing proprietary allogeneic stem cell-based platforms to potentiate and deliver oncolytic viruses (vaccinia virus and adenovirus) and, potentially, other molecules to cancer patients. Calidi is currently developing two proprietary stem cell-based platforms designed to protect the oncolytic virus, whether natural or engineered, from neutralization by the patient’s immune defenses, allowing for greater infection of the tumor cells and leading to a potential improvement in the antitumor activity of oncolytic viruses over traditional “naked” oncolytic virus therapies.

FLAG management conducted due diligence on Calidi’s business, financial condition, management team, and future growth prospects in executing upon and achieving its business plan. In its review of Calidi, the FLAG Board considered a variety of factors weighing positively and negatively in connection with the Business Combination. After careful consideration, the FLAG Board has determined that the Business Combination

 

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presents an attractive opportunity and is in the best interests of FLAG and FLAG Stockholders. The FLAG Board believes that, based on its review and consideration, the Business Combination presents an opportunity to increase shareholder value. However, there can be no assurance that the anticipated benefits of the Business Combination will be achieved. Shareholder approval of the Business Combination is required by the Merger Agreement and the Current Charter as well as to comply with the applicable provisions of the NYSE American Company Guide.

Please see the section entitled “Proposal No. 1 — The Business Combination Proposal.

Q. Why is FLAG providing stockholders with the opportunity to vote on the Business Combination?

A. Under our Current Charter, we must provide all holders of public shares with the opportunity to have their public shares redeemed upon the consummation of the Business Combination either in conjunction with a tender offer or in conjunction with a stockholder vote. For business and other reasons, we have elected to provide our stockholders with the opportunity to have their public shares redeemed in connection with a stockholder vote rather than a tender offer. Therefore, we are seeking to obtain the approval of our stockholders of the Business Combination Proposal in order to allow our public stockholders to effectuate redemptions of their public shares in connection with the Closing of the Business Combination. In addition, certain elements of the Business Combination cannot be accomplished under applicable law, the Current Charter or listing standards without an affirmative vote of stockholders.

Q. What will happen in the Business Combination?

A. Pursuant to the Merger Agreement, and upon the terms and subject to the conditions set forth therein, FLAG and Calidi will combine in a series of transactions we collectively refer to as the “Business Combination” or the “Transactions.” At the Closing of the Merger contemplated by the Merger Agreement, among other things, Merger Sub will merge with and into Calidi, following which the separate corporate existence of Merger Sub shall cease and Calidi will continue as the surviving corporation and a wholly-owned subsidiary of FLAG.

Q. Following the Business Combination, will FLAG Securities continue to trade on a stock exchange?

A. Yes. In connection with the Business Combination, FLAG will change its name to Calidi Biotherapeutics, Inc., and upon the Closing, we expect that the New Calidi Common Stock and New Calidi Public Warrants will begin trading on the NYSE American under the symbols “CLDI” and “CLDIW,” respectively. As a result, FLAG’s publicly traded units will separate into the component securities upon consummation of the Business Combination and will no longer trade as a separate security.

Q. Will the management of Calidi change in the Business Combination?

A. We anticipate that all executive officers of Calidi will remain with New Calidi following the Merger.

Upon consummation of the Business Combination, seven directors, six of whom will be designated by Calidi and one of whom will be designated by FLAG, will be elected to serve staggered terms on the New Calidi Board upon the consummation of the Business Combination until the first, second and third annual meetings of stockholders following the date of effectiveness of the Proposed Charter, as applicable, or until the election and qualification of their respective successors.

In connection with the Business Combination, Allan Camaisa, Heehyoung Lee, Scott Leftwich, George Ng, James Schoeneck, Alfonso Zulueta and Thomas Vecchiolla have each been nominated to serve as directors of New Calidi upon completion of the Business Combination.

Please see the sections entitled “Proposal No. 6 — The New Board Proposal” and “Management of New Calidi Following the Business Combination” for additional information.

 

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Q: What equity stake will current public stockholders, the Sponsor, the holders of FLAG Public Warrants and the Calidi Stockholders hold in New Calidi immediately after the completion of the Business Combination?

A: As of the date of this proxy statement/prospectus, there are (i) [●] shares of FLAG Common Stock issued and outstanding, which includes the [●] founder shares held by the Sponsor and Metric and the [●] public shares, (ii) 14,897,155 warrants issued and outstanding, which includes the 3,397,155 FLAG Private Placement Warrants held by the Sponsor and Metric and the 11,500,000 FLAG Public Warrants. Each whole warrant entitles the holder thereof to purchase one share of FLAG Class A Common Stock and, following the Business Combination, will entitle the holder thereof to purchase one share of Common Stock. In connection with the Business Combination, in order to incentivize PIPE Investors, each of the Sponsor and Metric agreed to transfer for no consideration to the PIPE Investors up to 100% of its FLAG Private Placement Warrants and up to 25% of its founder shares (such, private placement warrants and founder shares, the “Incentive Securities”). Any Incentive Securities that are unused for PIPE Investors or a Permitted Calidi Equity Issuance will be transferred to FLAG and forfeited.

The following pro forma ownership table has been prepared assuming three alternative levels of redemption into cash of shares of FLAG Class A Common Stock:

 

   

Scenario 1 — Assuming No Redemptions: This scenario assumes that none of FLAG’s public stockholders exercise redemption rights with respect to their public shares and receive an additional 2,000,000 FLAG Non-Redeeming Continuation Shares in connection with the Closing pursuant to the Merger Agreement.

 

   

Scenario 2 — Assuming 50% Redemptions: This scenario assumes that 2,064,012 public shares are redeemed for aggregate redemption payments of approximately $21.2 million (assuming a redemption price of approximately $10.28 per Public Share, based on funds in the Trust Account as of December 31, 2022), which represents 50% of the public shares eligible for redemption in connection with the Closing. This scenario also assumes that an additional 1,000,000 FLAG Non-Redeeming Continuation shares are issued to FLAG’s public shareholders in connection with the Closing, which represents the 50% of the public shares that are not redeemed in connection with the Closing, pursuant to the Merger Agreement. As all of the holders of FLAG’s Class B ordinary shares waived their redemption rights, only redemptions by public shareholders are reflected in this presentation. This scenario includes all adjustments contained in the “no redemption” scenario and presents additional adjustments to reflect the effect of 50% redemptions.

 

   

Scenario 3 — Assuming Maximum Redemptions: This scenario assumes that all 4,128,024 public shares are redeemed for aggregate redemption payments of approximately $42.5 million (assuming a redemption price of approximately $10.28 per public share, based on funds in the Trust Account as of December 31, 2022), which represents the maximum number of public shares eligible for redemption in connection with the Closing and no additional shares are issued to public shareholders. As all of the holders of FLAG’s Class B ordinary shares waived their redemption rights, only redemptions by public shareholders are reflected in this presentation. This scenario includes all adjustments contained in the “no redemption” scenario and presents additional adjustments to reflect the effect of the Maximum Redemptions.

The following pro forma ownership table has been prepared on the assumption that, at the Closing, the Calidi Security Holders will receive an aggregate of 25,000,000 shares of newly issued New Calidi Common Stock as Merger Consideration (excluding unvested Assumed Options in accordance with the terms of the Merger Agreement) and assuming no adjustment to the Merger Consideration for Net Debt and no adjustment for any contingent consideration discussed below. The pro forma ownership table does not take into account shares of New Calidi Common Stock issuable after Closing to holders of unvested Calidi Options that are assumed by New Calidi after the Closing.

 

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The following summarizes anticipated pro forma ownership of outstanding New Calidi Common Stock after giving effect to the Merger under the “no,” “50%” and “maximum” redemption scenarios, taking into account all of the assumptions that are further detailed in the section entitled “Unaudited Pro Forma Combined Financial Information”:

 

     No Redemption     50% Redemption(5)     Maximum
Redemption(6)
 
     Class A
Common Stock
     %     Class A
Common Stock
     %     Class A
Common Stock
     %  

Stockholders

               

Calidi Stockholders(1)

     25,000,000        67.8     25,000,000        73.9     25,000,000        81.3

FLAG public stockholders (redeemable shares)

     4,128,024        11.2     2,064,012        6.1     —          —  

Founder Shares(2)(3)

     5,750,000        15.6     5,750,000        17.0     5,750,000        18.7

FLAG Non-Redeeming Continuation Shares(4)

     2,000,000        5.4     1,000,000        3.0     —          —  
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

Total shares of Common Stock outstanding at closing of the Transaction(7)

     36,878,024        100.0     33,814,012        100.0     30,750,000        100.0
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

 

(1)

The Pro Forma Ownership Table has been prepared based on an assumed issuance of 25,000,000 shares of New Calidi Common Stock to the Calidi Security Holders at the Closing and assuming no adjustment to the Merger Consideration for Calidi indebtedness, net of cash and no adjustment for Escalation Shares, calculated based on the following assumptions: (i) that the number of shares of Calidi Common Stock on an as-converted to New Calidi Common Stock basis as of the Closing Date is the same as the number of shares of Calidi Common Stock outstanding as of December 31, 2022 on an as-converted to Common Stock basis; (ii) that all outstanding Calidi Warrants and vested Calidi Options are net exercised on or prior to the Closing Date in accordance with their terms; (iii) that there is no pre- or post-Closing adjustment to the Merger Consideration for any contingent consideration, and no adjustment on account of Calidi’s Net Debt as of the Closing Date; (iv) that the Conversion Rate, to be determined in accordance with the terms of the Merger Agreement based on the number of shares of Calidi Common Stock, as of the Closing Date, is equal to an estimated 0.36 Conversion Ratio, and (v) that all other Calidi Securities outstanding as of immediately prior to the Closing Date are converted into shares of Calidi Common Stock in accordance with their terms (other than vested Calidi Options which are part of the determination of the Conversion Rate) and all Calidi Options outstanding which will be assumed by FLAG in accordance with the Merger Agreement, which are not included in the Merger Consideration (or the presentation of pro forma ownership reflected in table above). The actual Conversion Ratio and the actual number of shares to be issued to the Calidi Stockholders will be calculated as of the Closing Date and may be different than the assumed Conversion Ratio and the number of such shares presented for purposes of this section.

(2)

Represents 2,575,803 founder shares held by the Sponsor, 871,543 founder shares held by Metric and 2,302,654 founder shares that have been transferred to third party investors.

(3)

Includes founder shares subject to the “lock up” provisions of the Sponsor Agreement as holders of such shares are entitled to vote such shares and receive dividends and other distributions thereon during the lock-up period.

(4)

To be issued to FLAG public stockholders.

(5)

The “50% Redemption” scenario is not presented in the “Unaudited Pro Forma Combined Financial Information” section included elsewhere in this proxy statement/prospectus because this scenario is not considered likely to occur.

(6)

Under the “Maximum Redemptions” scenario as presented in this proxy statement/prospectus and assuming the Minimum Cash Condition is not met, the parties to the Business Combination would have to agree to a mutual waiver to complete the Business Combination without having met the minimum cash at closing condition, which is neither assured nor assumed would occur.

 

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(7)

The table excludes the following:

 

   

The issuance of up to 18,000,000 Escalation Shares;

 

   

11,500,000 unexercised FLAG Public Warrants;

 

   

3,397,155 unexercised FLAG Private Placement Warrants;

 

   

7,051,039 unexercised Assumed Calidi Options;

 

   

New Calidi equity awards pursuant to the 2023 Equity Incentive Plan, if adopted, which is equal to 10% of the issued and outstanding shares of New Calidi determined as of immediately after the closing of the Merger (after giving effect to the Redemption or such lesser amount as determined by the New Calidi Board at such time).

The sensitivity table below sets forth the potential additional dilutive impact of each of the Escalation Shares, FLAG Public Warrants, FLAG Private Placement Warrants, Assumed Calidi Options, and New Calidi equity awards under the 2023 Equity Incentive Plan, in each redemption scenario.

 

     Share Ownership in New Calidi(1)  
     No Redemption     50% Redemption     Maximum Redemption  

Additional Dilution Sources

   Class A
Common Stock
     %     Class A
Common Stock
     %     Class A
Common Stock
     %  

Escalation Shares (2)

     18,000,000        32.8     18,000,000        34.7     18,000,000        36.9

FLAG Public Warrants(3)

     11,500,000        23.8     11,500,000        25.4     11,500,000        27.2

FLAG Private Placement Warrants(4)

     3,397,155        8.4     3,397,155        9.1     3,397,155        9.9

Assumed Calidi Options(5)

     7,051,039        16.1     7,051,039        17.3     7,051,039        18.7

2023 Equity Incentive Plan(6)

     3,687,802        9.1     3,381,401        9.1     3,075,000        9.1
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

Total Additional Dilutive Sources(7)

     43,635,996        54.2     43,329,595        56.2     43,023,194        58.3
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

 

(1)

Percentages in this table assume that the dilutive securities are added to the outstanding shares as of immediately following the Closing as shown in the previous table in the respective redemption scenarios.

(2)

This row assumes issuance of all 18,000,000 Escalation Shares. Percentages in this row represent (a) the Escalation Shares divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) 18,000,000 Escalation Shares.

(3)

This row assumes exercise of all FLAG Public Warrants to purchase 11,500,000 shares of New Calidi Common Stock. Percentages in this row represent (a) the shares of New Calidi Common Stock underlying the FLAG Public Warrants divided by (b) (i) the outstanding shares as of immediately following the Closing as shown in the previous table in the applicable redemption scenario plus (ii) 11,500,000 shares of New Calidi Common Stock underlying the FLAG Public Warrants.

(4)

This row assumes exercise of all FLAG Private Placement Warrants to purchase 3,397,155 shares of New Calidi Common Stock. Percentages in this row represent (a) the shares of New Calidi Common Stock underlying the FLAG Private Placement Warrants divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) 3,397,155 shares of New Calidi Common Stock underlying the FLAG Private Placement Warrants.

(5)

This row assumes the exercise of all 7,051,039 Assumed Options. Percentages in this row represent (a) the shares of New Calidi Common Stock underlying the Assumed Options divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) 7,051,039 shares of New Calidi Common Stock underlying the Assumed Options.

(6)

This row assumes the exercise of New Calidi equity awards under the 2023 Equity Incentive Plan, calculated at 10% of the outstanding shares as of immediately following the Closing for each redemption scenario. Percentages in this row represent (a) the shares of New Calidi Common Stock eligible for issuance under the 2023 Equity Incentive Plan divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) shares of New Calidi Common Stock underlying the New Calidi equity awards under the 2023 Equity Incentive Plan.

 

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(7)

This row assumes the exercise and vesting of all additional dilutive sources listed in the rows above. Percentages in this row represent (a) the shares of New Calidi Common Stock underlying all additional dilutive sources listed in the rows above divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) all shares of New Calidi Common Stock underlying the additional dilutive sources listed in the rows above.

Q. Will FLAG attempt to arrange new financing in connection with the Transactions?

A. Yes. FLAG will attempt to raise a total of up to $40 million via the PIPE Investment. The Sponsor and Metric have agreed to use up to 100% of their FLAG Private Placement Warrants and up to 25% of their founder shares to incentivize PIPE Investors. Any Incentive Securities that are unused for PIPE Investors will be forfeited.

In connection with the Business Combination, Franklin is not obligated under the Amended and Restated Forward Purchase Agreement to purchase the FLAG Forward Purchase Shares and has informed FLAG that it has determined not to purchase such shares in connection with the consummation of the Business Combination.

Q. What conditions must be satisfied to complete the Business Combination?

A. Unless waived by the parties to the Merger Agreement, and subject to applicable law, the consummation of the Business Combination is subject to a number of mutual conditions set forth in the Merger Agreement, including, among other things, (i) approval of the public stockholders or shareholders, as applicable, of FLAG and Calidi, respectively; (ii) expiration of any applicable waiting period under any antitrust laws; (iii) receipt of requisite consents from governmental authorities to consummate the Business Combination, and receipt of specified requisite consents from other third parties to consummate the Business Combination; (iv) the absence of any law or order that would prohibit the consummation of the Business Combination; (v) upon the Closing, after giving effect to the completion of the Redemptions and any PIPE Investment, FLAG shall have net tangible assets of at least $5,000,001; (vi) upon the Closing, FLAG shall have cash and cash equivalents, including funds remaining in the Trust Account and the proceeds of any PIPE Investment, after giving effect to any Redemptions and following the payment of FLAG’s and Calidi’s unpaid transaction expenses, equal to at least $15,000,000; (vii) the members of the New Calidi Board shall have been elected or appointed as of the Closing; (x) the effectiveness of FLAG’s registration statement on Form S-4; and (xi) the shares of New Calidi Common Stock to be issued as Merger Consideration shall have been approved for listing on the NYSE American.

In addition, unless waived by Calidi, the obligations of Calidi to consummate the Transaction are subject to the satisfaction of the following additional Closing conditions, in addition to the delivery by FLAG of customary certificates and other Closing deliverables: (i) the representations and warranties of FLAG being true and correct as of the date of the Closing, except to the extent made as of a particular date (subject to certain materiality qualifiers); (ii) FLAG having performed in all material respects its obligations and complied in all material respects with its covenants and agreements under the Merger Agreement required to be performed or complied with by it on or prior to the date of the Closing; (iii) the absence of any material adverse effect (as defined in the Merger Agreement) with respect to FLAG which is continuing and uncured since the date of the Merger Agreement; (iv) the Sponsor Agreement being in full force and effect as of the Closing, (v) FLAG having provided evidence that the Sponsor and Metric have transferred 25% of the Founder Shares and 100% of the FLAG Private Placement Warrants to the PIPE Investors or that such securities have been cancelled without further consideration, and (vi) the IPO Underwriter shall have waived all of its right, title and interest to and in deferred compensation and expenses from the IPO that would have been paid from the Trust Account.

Unless waived by FLAG, the obligations of FLAG to consummate the Business Combination are subject to the satisfaction of the following additional conditions, in addition to the delivery by Calidi of customary certificates and other Closing deliverables: (i) the representations and warranties of Calidi being true and correct as of the date of the Closing, except to the extent made as of a particular date (subject to certain materiality qualifiers); (ii) Calidi having performed in all material respects its obligations and complied in all material respects with its

 

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covenants and agreements under the Merger Agreement required to be performed or complied with or by it on or prior to the date of the Closing; (iii) the absence of any material adverse effect (as defined in the Merger Agreement) with respect to Calidi and its subsidiaries, taken as a whole, which is continuing and uncured since the date of the Merger Agreement; (iv) each Voting and Lock-Up Agreement being in effect as of the Closing Date; (v) no more than 5% of the issued and outstanding shares of Calidi Common Stock as of the Closing shall, in the aggregate, be (A) dissenting shares (as defined in the Merger Agreement) or (B) shares held by holders of Calidi Stock who, under the provisions of section 92A.380 of the NRS, remain entitled to exercise and perfect appraisal rights in respect of such shares; (vi) FLAG having received evidence reasonably acceptable to FLAG that Calidi shall have converted, terminated, extinguished and cancelled in full any outstanding Calidi Convertible Securities or commitments therefor, other than the Calidi Options; and (vii) FLAG having received evidence that Calidi has terminated certain material contracts.

Unless waived, if any of the foregoing conditions are not satisfied, the Business Combination may not be consummated.

For a further discussion of conditions to consummating the Business Combination, please see “Proposal No. 1 — The Business Combination Proposal.”

Q. What are the material U.S. federal income tax consequences to the FLAG Stockholders as a result of the Merger?

A. FLAG Stockholders will retain their shares of FLAG Class A Common Stock, which will be re-designated as “Common Stock, par value $0.0001, of New Calidi” and will not receive any merger consideration or any additional shares of FLAG Class A Common Stock in the Merger. As a result, there will be no material U.S. federal income tax consequences to the current FLAG Stockholders as a result of the Merger, regardless of whether the Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code. Furthermore, although the Merger is intended to qualify as a “reorganization” within the meaning of Section 368(a) of the Code, and FLAG and Calidi intend to report the Merger consistent with such qualification, such treatment is not a condition to FLAG or Calidi’s obligation to complete the Merger.

Q. What happens if I sell my shares of FLAG Class A Common Stock before the special meeting?

A. The Record Date for the special meeting is earlier than the date that the Business Combination is expected to be completed. If you transfer your public shares after the Record Date, but before the special meeting, unless the transferee obtains from you a proxy to vote those shares, you will retain your right to vote at the special meeting. However, you will not be able to seek redemption of your public shares because you will no longer be able to deliver them for cancellation upon consummation of the Business Combination. If you transfer your public shares prior to the Record Date, you will have no right to vote those shares at the special meeting or redeem those shares for a pro rata portion of the proceeds held in our Trust Account.

Q. What constitutes a quorum at the special meeting?

A. Holders of a majority in voting power of FLAG Common Stock issued and outstanding and entitled to vote at the special meeting, represented via the remote platform or by proxy, constitute a quorum. As of the Record Date for the special meeting, the presence, via the remote platform or by proxy, of holders of [●] shares of our common stock would be required to achieve a quorum.

Q. What vote is required to approve the proposals presented at the special meeting?

A. The approval of each of the Business Combination Proposal, the Governance Proposal (which is a non-binding advisory vote), the Incentive Plan Proposal, the ESPP Proposal, the NYSE American Proposal and the Adjournment Proposal require the affirmative vote of a majority of the votes cast by holders of outstanding shares of FLAG Common Stock represented at the special meeting by attendance via the virtual meeting website or by proxy and entitled to vote at the special meeting. Accordingly, if a valid quorum is established, a FLAG

 

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Stockholder’s failure to vote by proxy or to vote at the special meeting with regard to the Business Combination Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the NYSE American Proposal and the Adjournment Proposal will have no effect on such Proposals.

The approval of the Charter Proposal requires the affirmative vote of at least 65% of the issued and outstanding shares of FLAG Common Stock entitled to vote thereon as of the Record Date. Accordingly, if a valid quorum is established, a FLAG Stockholder’s failure to vote by proxy or to vote at the special meeting with regard to the Charter Proposal will have the same effect as a vote “AGAINST” such Proposal.

Directors are elected by a plurality of all of the votes cast by holders of shares of FLAG Common Stock represented at the special meeting by attendance via the virtual meeting website or by proxy and entitled to vote thereon at the special meeting. This means that the seven director nominees who receive the most affirmative votes will be elected. Holders of FLAG Common Stock may not cumulate their votes with respect to the election of directors. Accordingly, if a valid quorum is established, failure to vote by proxy or to vote at the special meeting with regard to the New Board Proposal will have no effect on such Proposal. Pursuant to the Current Charter, only holders of FLAG Class B Common Stock will have the right to vote on the New Board Proposal.

Q. How many votes do I have at the special meeting?

A. Holders of FLAG Common Stock are entitled to one vote on each proposal presented at the special meeting for each share of FLAG Common Stock held of record as of [●], 2023, the Record Date for the special meeting. As of the close of business on the Record Date, there were [●] outstanding shares of FLAG Common Stock.

Q. Why is FLAG proposing the Governance Proposal?

A. As required by applicable SEC guidance, FLAG is requesting that its stockholders vote upon, on a non-binding advisory basis, a proposal to approve certain governance provisions contained in the Proposed Charter that materially affect stockholder rights. This separate vote is not otherwise required by Delaware law separate and apart from the Charter Proposal, but pursuant to SEC guidance, FLAG is required to submit these provisions to its stockholders separately for approval. However, the stockholder vote regarding this Proposal is an advisory vote, and is not binding on FLAG and the FLAG Board (separate and apart from the approval of the Charter Proposal). Furthermore, the Business Combination is not conditioned on the separate approval of the Governance Proposal (separate and apart from approval of the Charter Proposal). Please see the section entitled “Proposal No. 3 — The Governance Proposal.”

Q. Do I have redemption rights? If so, how do I exercise my redemption rights?

A. Pursuant to our Current Charter, our public stockholders will be provided with the opportunity to redeem their public shares in connection with the vote to approve the Business Combination, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account (less $100,000 of net interest to pay potential dissolution expenses), divided by the number of then outstanding public shares (if the redemption of public shares in connection therewith would not cause FLAG to have net tangible assets of less than $5,000,001).

In order to exercise your redemption rights, prior to 5 p.m., Eastern Time on [●], 2023 (two business days before the special meeting), you must (x) submit a written request to our Transfer Agent that we redeem your public shares for cash, and (y) deliver your stock to our Transfer Agent electronically through the Depository Trust Company, or DTC. The address of Continental Stock Transfer & Trust Company, our Transfer Agent is listed under “Who can help answer my questions?”

Any holder of public shares will be entitled to demand that such holder’s shares be redeemed for a pro rata portion of the amount then in the Trust Account (which, for illustrative purposes, was approximately $[●] or $[●] per share, as of [●], 2023, the Record Date for the special meeting). Such amount, less any owed but unpaid taxes on the funds in the Trust Account, will be paid promptly upon consummation of the Business Combination. However, under Delaware law, the proceeds held in the Trust Account could be subject to claims which could

 

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take priority over those of FLAG’s public stockholders exercising redemption rights, regardless of whether such holders vote for or against the Business Combination Proposal. Therefore, the per-share distribution from the Trust Account in such a situation may be less than originally anticipated due to such claims. Your vote on any Proposal other than the Business Combination Proposal will have no impact on the amount you will receive upon exercise of your redemption rights.

Any request for redemption, once made by a holder of public shares, may be withdrawn at any time up to the time the vote is taken with respect to the Business Combination Proposal at the special meeting. If you deliver your shares for redemption to the Transfer Agent and later decide prior to the special meeting not to elect redemption, you may request that the Transfer Agent return the shares (physically or electronically). You may make such request by contacting the Transfer Agent at the address listed under “Who can help answer my questions?

Q. What is the amount of net cash per share of FLAG Class A Common Stock that is being contributed to New Calidi in the Business Combination?

A. The estimated net cash per share of FLAG Class A Common stock that is being contributed to New Calidi in the Business Combination is approximately $[-] per share, assuming no redemptions, and $[-] per share, assuming the maximum redemptions scenario described under the section entitled “Unaudited Pro Forma Combined Financial Information — Basis of Pro Forma Presentation”. The estimated net cash per share of FLAG Class A Common Stock that is being contributed to New Calidi is calculated as the quotient of (a) (i) the amount of funds held in the trust account (assuming either no redemptions or the maximum redemptions scenario) less (ii) the amount of estimated transaction expenses of $[-] less (iii) the aggregate market value of the FLAG Public Warrants and the FLAG Private Placement Warrants of $[-] (calculated as the trading price of one public warrant multiplied by an aggregate of 14,897,155 FLAG Public Warrants and FLAG Private Placement Warrants anticipated to be outstanding as of the Closing), divided by (b) (i) the number of shares of FLAG Class A Common Stock anticipated to be outstanding as of the closing of the Transactions of [4,128,024], assuming no redemptions, and assuming the maximum redemptions scenario plus (ii) 5,750,000 founder shares. The estimated net cash per share of FLAG Common Stock that is being contributed to New Calidi (in each of the no redemptions scenario and the maximum redemptions scenario) is less than the $10.00 per share ascribed to such shares in the Merger Agreement or the amount per share that holders of FLAG Class A Common Stock would be entitled to receive upon exercise of their redemption rights (which, for illustrative purposes, was approximately $[-] per share as of [●], 2023, the record date for the special meeting).

Q. Do I have appraisal rights if I object to the proposed Business Combination?

A. No. Holders of FLAG Securities do not have appraisal rights in connection with the Business Combination. If Calidi Stockholders approve the Agreement and Plan of Merger and the Merger is consummated, Calidi Stockholders who did not vote in favor of the Merger, and who satisfy certain other conditions, will be entitled to dissenter’s rights in connection with the Merger under Nevada law.

Q. If I am a holder of FLAG Warrants, can I exercise redemption rights with respect to my FLAG Warrants?

A. No. The holders of FLAG Warrants have no redemption rights with respect to FLAG Warrants.

Q. If I am a holder of FLAG Units, can I exercise redemption rights with respect to FLAG Units?

A. No. Holders of outstanding FLAG Units must separate the underlying public shares and FLAG Public Warrants prior to exercising redemption rights with respect to the public shares. If you hold FLAG Units registered in your own name, you must deliver to our Transfer Agent written instructions to separate such FLAG Units into public shares and FLAG Public Warrants. This must be completed far enough in advance so that you may then exercise your redemption rights with respect to the public shares upon the separation of the public shares from the FLAG Units. See “How do I exercise my redemption rights?” above. The address of our Transfer Agent is listed under the question “Who can help answer my questions?” below.

 

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If a broker, dealer, commercial bank, trust company or other nominee holds your FLAG Units, you must instruct such nominee to separate your FLAG Units. Your nominee must send written instructions by facsimile to our Transfer Agent. Such written instructions must include the number of FLAG Units to be split and the nominee holding such FLAG Units. Your nominee must also initiate electronically, using DTC’s deposit withdrawal at custodian (DWAC) system, a withdrawal of the relevant FLAG Units and a deposit of an equal number of public shares and FLAG Public Warrants. This must be completed far enough in advance to permit your nominee to exercise your redemption rights with respect to the public shares upon the separation of the public shares from the FLAG Units. While this is typically done electronically the same business day, you should allow at least one full business day to accomplish the separation. If you fail to cause your public shares to be separated in a timely manner, you will likely not be able to exercise your redemption rights.

Q. What was the original amount deposited in the Trust Account following the IPO and what is the current balance of the Trust Account following the redemptions in connection with the multiple extensions to the deadline to consummate a Business Combination?

A. After deducting the underwriting fee and the IPO expenses, the total net proceeds from the IPO and the concurrent sale of FLAG Private Placement Warrants to the Sponsor and Metric, $230,000,000 was placed in the Trust Account. The funds in the Trust Account have been invested in U.S. government securities with a maturity of 185 days or less or in money market funds meeting certain conditions under Rule 2a-7 under the Investment Company Act, which invest only in direct U.S. government treasury obligations.

As of September 19, 2022, following stockholder redemptions in connection with the proposal to extend the date by which FLAG had to consummate the Business Combination from September 14, 2022 to December 14, 2022, as subsequently extended to June 14, 2023 (subject to further extension), certain investors redeemed 18,871,976 shares of FLAG Class A Common Stock resulting in the payment of $190,010,529 from the Trust Account. As of December 31, 2022, FLAG had marketable securities held in the Trust Account of $42,453,107. Interest income on the balance in the Trust Account may be used to pay taxes.

Q. What happens if a substantial number of public stockholders vote in favor of the Business Combination Proposal and exercise their redemption rights?

A. The obligations of FLAG and Calidi to consummate the Business Combination are conditioned upon, among others, the amount of unrestricted cash available in the Trust Account, plus the aggregate amount of cash that has been funded as a result of any PIPE Investment, following the payment of FLAG’s and Calidi’s transaction expenses, being equal to at least the Minimum Cash Condition.

FLAG’s public stockholders may vote in favor of the Business Combination and still exercise their redemption rights. Accordingly, subject to the satisfaction of the Minimum Cash Condition and the Listing Condition, the Business Combination may be consummated even though the funds available from the Trust Account and the number of public stockholders are substantially reduced as a result of redemptions by public stockholders.

Q. What are the federal income tax consequences of exercising my redemption rights?

A: Generally, a FLAG public stockholder that is a U.S. person and exercises its redemption rights to receive cash from the Trust Account in exchange for its shares of FLAG Common Stock will be required to treat the Transaction as a sale of such shares and recognize gain or loss in an amount equal to the difference, if any, between the amount of cash received in the redemption and the tax basis of the shares of FLAG Common Stock redeemed. Such gain or loss should be treated as capital gain or loss if such shares were held as a capital asset on the date of the redemption.

The redemption, however, may be treated as a corporate distribution if (i) it does not result in a “complete termination” of the redeeming stockholder’s interest in FLAG, (ii) it does not effect a meaningful reduction in the redeeming stockholder’s percentage ownership in FLAG and (iii) it is not a “substantially disproportionate

 

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redemption,” in each case, taking into account certain attribution rules to determine the number of shares of FLAG Common Stock owned by the redeeming shareholder. Any such corporate distribution will be treated as dividend income to the extent of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Any distribution in excess of our earnings and profits will reduce the redeeming stockholders’ basis in FLAG Common Stock, and any remaining excess will be treated as gain realized on the sale or other disposition of FLAG Common Stock, as discussed above.

A FLAG public stockholder that is a U.S. person who actually or constructively owns 5 percent (or, if FLAG Common Stock is not then publicly traded, 1 percent) of the outstanding FLAG Common Stock (by vote or value) may be subject to special reporting requirements with respect to a redemption of shares of FLAG Common Stock, and such holders should consult with their tax advisors with respect to their reporting requirements.

If the redemption of a public stockholder that is a non-U.S. person is treated as a distribution, as discussed above in the second paragraph, such a distribution generally will constitute a dividend for U.S. federal income tax purposes to the extent paid out of FLAG’s current or accumulated earnings and profits (as determined under U.S. federal income tax principles) and, provided such dividend is not effectively connected with the non-U.S. Holder’s conduct of a trade or business within the U.S., we will be required to withhold tax from the gross amount of the dividend at a rate of 30%, unless such non-U.S. Holder is eligible for a reduced rate of withholding tax under an applicable income tax treaty and timely provides proper certification of its eligibility for such reduced rate (usually on an IRS Form W-8BEN or W-8BEN-E). Distributions in excess of FLAG’s current and accumulated earnings and profits that are treated as a return of capital or distributions in excess of the non-U.S. Holder’s adjusted tax basis in FLAG Common Stock redeemed will not be subject to the 30% withholding tax. Additionally, a non-U.S. person generally will not be subject to U.S. federal income tax on any gain attributable to a sale or other disposition of FLAG Common Stock (including the portion of any distribution treated as a as a gain recognized on the sale or other taxable disposition of FLAG Common Stock) unless such gain is effectively connected with its conduct of a trade or business in the United States (and, if required by an applicable income tax treaty, is attributable to a permanent establishment or fixed base that such stockholder maintains in the United States). A public stockholder who is a non-U.S. person should consult their own tax advisors with respect to the tax treatment of the redemption of FLAG Common Stock.

Dividend payments and/or proceeds from the redemption (including a deemed sale, as discussed above) of FLAG Common Stock may be subject to information reporting to the IRS and possible U.S. backup withholding.

The tax consequences of a public stockholder redeeming FLAG Common Stock are complex and will vary upon each public stockholder’s unique circumstances. The above is not intended to constitute tax advice and public stockholders are encouraged to consult with their own tax advisors.

Q. What happens if the Business Combination is not consummated?

A. If FLAG is not able to complete the Business Combination within the completion window, we will (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem 100% of the public shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including interest earned and not previously released to us to pay our taxes, if any (less up to $100,000 of interest to pay dissolution expenses), divided by the number of then issued and outstanding public shares, which redemption will completely extinguish the rights of the public stockholders as stockholders (including the right to receive further liquidating distributions, if any), and (iii) as promptly as reasonably possible following such redemption, subject to the approval of our remaining public stockholders and the FLAG Board, liquidate and dissolve, subject in each case to our obligations under Delaware law to provide for claims of creditors and the requirements of other applicable law.

Q. How do the Sponsor, Metric and the Insiders intend to vote on the Proposals?

A. The Sponsor, Metric and the Insiders own of record and are entitled to vote an aggregate of [●]% of the outstanding shares of FLAG Common Stock as of the Record Date. The Sponsor, Metric and the Insiders have

 

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agreed to vote any FLAG Common Stock over which they have voting control (including any public shares owned by them) in favor of the Business Combination and the other proposals that will be considered at the special meeting. The Sponsor and the Insiders have interests in the Business Combination that conflict with your interests as a public stockholder. See the sections entitled “Summary of the Proxy statement/prospectus  Interests of Certain Persons in the Business Combination” and “Proposal No. 1  The Business Combination Proposal — Interests of Certain Persons in the Business Combination.

Q. When do you expect the Business Combination to be completed?

A. It is currently anticipated that the Business Combination will be consummated as soon as practicable following the special meeting, which is set for [●], 2023, subject to the satisfaction of the closing conditions; however, such meeting could be adjourned. For a description of the conditions for the completion of the Business Combination, see “Proposal No. 1: The Business Combination Proposal — Merger Agreement — Conditions to Closing of the Transactions.

Q. What do I need to do now?

A. FLAG urges you to read carefully and consider the information contained in this proxy statement/prospectus, including the Annexes, and to consider how the Business Combination will affect you as a public stockholder and/or warrant holder of FLAG. Holders of FLAG Common Stock should then vote as soon as possible in accordance with the instructions provided in this proxy statement/prospectus and on the enclosed proxy card, or, if you hold your shares through a brokerage firm, bank or other nominee, on the voting instruction form provided by the broker, bank or other nominee.

Q. How do I vote?

A. The special meeting will be held via live webcast at [●] a.m. Eastern Time, on [●], 2023. The special meeting can be accessed by visiting [●], where you will be able to listen to the meeting live and vote during the Meeting. Please note that you will only be able to access the special meeting by means of remote communication.

If you are a holder of record of FLAG Common Stock on [●], 2023, the Record Date for the special meeting, you may vote with respect to the Proposals online during the special meeting, or by completing, signing, dating and returning the enclosed proxy card in the postage-paid envelope to us. If you hold your shares in “street name,” which means your shares are held of record by a broker, bank or other nominee, you should contact your broker, bank or nominee to ensure that votes related to the shares you beneficially own are properly counted. In this regard, you must provide the record holder of your shares with instructions on how to vote your shares or, if you wish to attend the special meeting virtually and vote online, obtain a proxy from your broker, bank or nominee.

Q. If my shares are held in “street name,” will my broker, bank or nominee automatically vote my shares for me?

A. No. Under the rules of various national and regional securities exchanges, your broker, bank or nominee cannot vote your shares with respect to non-routine matters unless you provide instructions on how to vote in accordance with the information and procedures provided to you by your broker, bank or nominee. We believe the Proposals presented to the public stockholders at the special meeting will be considered non-routine and, therefore, your broker, bank or nominee cannot vote your shares without your instruction on any of the Proposals presented at the special meeting. If you do not provide instructions with your proxy, your broker, bank or other nominee may deliver a proxy card expressly indicating that it is NOT voting your shares; this indication that a broker, bank or nominee is not voting your shares is referred to as a “broker non-vote.” Broker non-votes will not be counted for the purposes of determining the existence of a quorum or for purposes of determining the number of votes cast at the special meeting. Your bank, broker or other nominee can vote your shares only if you provide instructions on how to vote. You should instruct your broker to vote your shares in accordance with directions you provide.

 

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Q. How will a broker non-vote impact the results of each proposal?

A. Broker non-votes will count as a vote “AGAINST” the Charter Proposal but will not have any effect on the outcome of any other Proposals if a quorum is present at the special meeting.

Q. May I change my vote after I have mailed my signed proxy card?

A. Yes. You may change your vote by sending a later-dated, signed proxy card or by attending the special meeting virtually and voting. You also may revoke your proxy by sending a notice of revocation to us.

Q. What will happen if I abstain from voting or fail to vote at the special meeting?

A. At the special meeting, we will count a properly executed proxy marked “ABSTAIN” with respect to a particular Proposal as present for purposes of determining whether a quorum is present. A failure to vote or an abstention will have the same effect as a vote “AGAINST” the Charter Proposal. Additionally, if you abstain from voting or fail to vote at the special meeting, you may still exercise your redemption rights (as described above).

Q. What will happen if I sign and return my proxy card without indicating how I wish to vote?

A. Signed and dated proxies received by us without an indication of how the stockholder intends to vote on a proposal will be voted “FOR” the Proposals described herein.

Q. What should I do if I receive more than one set of voting materials?

A. You may receive more than one set of voting materials, including multiple copies of this proxy statement and multiple proxy cards or voting instruction cards. For example, if you hold your shares in more than one brokerage account, you will receive a separate voting instruction card for each brokerage account in which you hold shares. If you are a holder of record and your shares are registered in more than one name, you will receive more than one proxy card. Please complete, sign, date and return each proxy card and voting instruction card that you receive in order to cast your vote with respect to all of your shares of FLAG Common Stock.

Q. Who will solicit and pay the cost of soliciting proxies?

A. FLAG will pay the cost of soliciting proxies for the special meeting. FLAG has engaged MacKenzie Partners, Inc. (“MacKenzie”) to assist in the solicitation of proxies for the special meeting. FLAG has agreed to pay MacKenzie a fee of $10,000 plus costs and expenses, which fee also includes MacKenzie acting as the inspector of elections at the special meeting. FLAG will reimburse MacKenzie for reasonable out-of-pocket expenses and will indemnify MacKenzie and its affiliates against certain claims, liabilities, losses, damages and expenses.

FLAG will also reimburse banks, brokers and other custodians, nominees and fiduciaries representing beneficial owners of shares of FLAG Common Stock for their expenses in forwarding soliciting materials to beneficial owners of FLAG Common Stock and in obtaining voting instructions from those beneficial owners. Our directors and officers may also solicit proxies by telephone, by facsimile, by mail, on the Internet or in person. They will not be paid any additional amounts for soliciting proxies.

Q. Who can help answer my questions?

A. If you have questions about the Proposals or if you need additional copies of this proxy statement or the enclosed proxy card, you should contact:

 

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First Light Acquisition Group, Inc.

11110 Sunset Hills Road #2278

Reston, VA 20190

Tel: (202) 503-9255

You may also contact our proxy solicitor at:

 

LOGO

1407 Broadway, 27th Floor

New York, New York 10018

(212) 929-5500 (Call Collect)

or

Call Toll-Free (800) 322-2885

Email: proxy@mackenziepartners.com

To obtain timely delivery, our public stockholders must request the materials no later than five business days prior to the special meeting.

You may also obtain additional information about us from documents filed with the SEC by following the instructions in the section entitled “Where You Can Find More Information.”

If you are a holder of public shares and you intend to seek redemption of your public shares, you will need to send a letter requesting redemption and deliver your public shares to our Transfer Agent at least two business days prior to the special meeting. If you have questions regarding the redemption or delivery of your stock, please contact:

Continental Stock Transfer & Trust Company

1 State Street, 30th Floor

New York, New York 10004

Attn: Mark Zimkind

E-mail: mzimkind@continentalstock.com

 

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SUMMARY OF THE PROXY STATEMENT/PROSPECTUS

This summary highlights selected information from this proxy statement/prospectus and does not contain all of the information that is important to you. To better understand the Proposals to be submitted for a vote at the special meeting, including the Business Combination Proposal, you should read the entire accompanying document carefully, including the Merger Agreement attached as Annex A to this proxy statement/prospectus. The Merger Agreement is the legal document that governs the Transactions that will be undertaken in connection with the Business Combination. It is also described in detail in this proxy statement/prospectus in the section entitled “Proposal No. 1 — The Business Combination Proposal — Certain Agreements Related to the Business Combination — Merger Agreement.”

The Parties

FLAG

First Light Acquisition Group, Inc. is a blank check company formed in order to effect a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or other similar business combination with one or more businesses or entities. FLAG was incorporated under the laws of Delaware on March 24, 2021.

On September 14, 2021, FLAG closed its IPO of 23,000,000 FLAG Units, including the exercise of the IPO’s underwriter’s over-allotment option to the extent of 3,000,000 FLAG Units, with each FLAG Unit consisting of one share of FLAG Class A Common Stock and one-half of one FLAG Public Warrant. Each whole FLAG Public Warrant entitles its holder to purchase one share of FLAG Class A Common Stock at a purchase price of $11.50 per share, subject to adjustment as provided in FLAG’s IPO Prospectus filed with the Securities and Exchange Commission on September 14, 2021. The FLAG Units from the IPO were sold at an offering price of $10.00 per FLAG Unit, generating total gross proceeds of $230,000,000.

Simultaneously with the consummation of the IPO and the exercise of the IPO Underwriters’ over-allotment option, FLAG consummated the private sale to the Sponsor and Metric of 3,397,155 FLAG Private Placement Warrants at $1.50 per FLAG Private Placement Warrant for an aggregate purchase price of $5,095,733. A total of $230,000,000 was deposited into the Trust Account and $2,081,180 of cash was not held in the Trust Account and was available for working capital purposes to provide for business, legal and accounting due diligence on prospective business combinations and continuing general and administrative expenses. The IPO was conducted pursuant to a registration statement on Form S-1 that became effective on September 9, 2021.

On September 13, 2022, FLAG Stockholders approved an amendment to FLAG’s certificate of incorporation to (i) extend the date by which FLAG must complete its initial business combination from September 14, 2022, to December 14, 2022, as subsequently extended to June 14, 2023, and (ii) provide the FLAG Board the ability to further extend the date by which FLAG must consummate a business combination up to three additional times for three months each time, for a maximum of 9 additional months, if the Sponsor pays an amount equal to 1% of the amount then on deposit in the Trust Account for each three-month extension, which amount will be deposited in the Trust Account; provided, that if as of the time of an extension FLAG has filed a Form S-4 or F-4 registration statement under the Securities Act or a proxy, information or tender offer statement with the SEC in connection with such initial business combination, then no Extension Fee would be required in connection with such extension; provided further, that for each three-month extension (if any) following such extension where no deposit into the Trust Account or other payment has been made, our sponsor or its affiliates or designees would be required to deposit into the Trust Account an amount equal to 1% of the amount then on deposit in the Trust Account.

In connection with the charter amendment, FLAG’s stockholders elected to redeem 18,871,976 shares of FLAG Class A common stock. After giving effect to such redemptions, there was $41,679,745 remaining in the Trust

 

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Account. The FLAG Board subsequently approved extensions of the date by which FLAG must complete its initial business combination from (a) December 14, 2022 to March 14, 2023, and the Trust Account was funded with a payment of $415,626 and (b) March 14, 2023 to June 14, 2023, and no fee was required in connection with such extension.

As of [●], 2023, the Record Date for the special meeting, there was approximately $[●] held in the Trust Account.

FLAG Units, FLAG Class A Common Stock and FLAG Public Warrants are listed on the NYSE American under the symbols FLAGU, FLAG and FLAGW, respectively. Upon the Closing, we expect that the Common Stock and warrants of New Calidi will begin trading on the NYSE American under the symbols “CLDI” and “CLDIW,” respectively.

The mailing address of FLAG’s principal executive office is 11110 Sunset Hills Road #2278 Reston, VA 20190. Its telephone number is (202) 503-9255. After the consummation of the Business Combination, its principal executive office will be that of Calidi.

Merger Sub

FLAG Merger Sub Inc. is a Nevada corporation and a wholly-owned subsidiary of FLAG formed solely for the purpose of effectuating the Merger described herein. Merger Sub was incorporated under the laws of Nevada as a corporation on December 9, 2022. Merger Sub owns no material assets and does not operate any business.

The mailing address of Merger Sub’s principal executive office is 11110 Sunset Hills Road #2278 Reston, VA 20190. Its telephone number is (202) 503-9255. After the consummation of the Business Combination, Merger Sub will cease to exist as a separate legal entity.

Calidi

Calidi Biotherapeutics, Inc., a Nevada corporation, is a clinical stage biopharmaceutical company that is developing proprietary allogeneic stem cell-based platforms to potentiate and deliver oncolytic viruses and, potentially, other molecules to cancer patients. Calidi is currently developing two proprietary stem cell-based platforms to improve the antitumor activity of oncolytic viruses over traditional “naked” (unprotected) oncolytic virus therapies, by protecting the oncolytic virus, whether natural or engineered, from neutralization by the patient’s immune defenses, allowing for greater targeting of the tumor cells. Calidi’s principal executive offices are located at 4475 Executive Drive, Suite 200, San Diego, California, 92121 and its phone number is (858) 794-9600.

Emerging Growth Company

FLAG is an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by the JOBS Act. As such, it is eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive compensation in their periodic reports and proxy statement/prospectus, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. If some investors find our securities less attractive as a result, there may be a less active trading market for FLAG Securities and the prices of our securities may be more volatile.

 

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FLAG will remain an emerging growth company until the earlier of: (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our IPO, (b) in which FLAG has total annual gross revenue of at least $1.235 billion, or (c) in which FLAG is deemed to be a large accelerated filer, which means the market value of FLAG Common Stock that is held by non-affiliates exceeds $700 million as of the end of the prior fiscal year’s second fiscal quarter; and (2) the date on which FLAG has issued more than $1.0 billion in non-convertible debt during the prior three-year period. References herein to “emerging growth company” shall have the meaning associated with it in the JOBS Act.

The Business Combination Proposal

Structure of the Transactions

On January 9, 2023, FLAG entered into the Merger Agreement with Merger Sub, Purchaser Representative, Seller Representative and Calidi. Pursuant to the Merger Agreement, the parties thereto will enter into the Business Combination transaction by which Merger Sub will merge with and into Calidi with Calidi surviving such merger as a wholly-owned subsidiary of FLAG.

Merger Consideration

Subject to the terms of the Merger Agreement, upon consummation of the Merger, and after giving effect to the conversion of all Calidi Convertible Securities, other than Calidi Options, all shares of Calidi Common Stock outstanding as of the time of the Merger will be converted into (a) the right to receive shares of New Calidi Common Stock and (b) the contingent right to receive the Escalation Shares. The aggregate consideration to be paid to Calidi equityholders (excluding for this purpose options to purchase Calidi Common Stock that remain unvested immediately following the Merger) will be based on an equity value for Calidi of $250,000,000, subject to adjustment dependent upon (a) the difference in Calidi’s “net debt” as of the effective time of the Merger from a target “net debt” amount (as described in greater detail in this proxy statement/prospectus) and (b) the achievement of certain pre-closing milestones (if any), as further described in this proxy statement/prospectus. The shares of New Calidi Common Stock to be issued as merger consideration will be valued at $10.00 per share. Assuming no adjustments in the merger consideration, we would expect each share of Calidi Common Stock to be converted into [●] shares of New Calidi Common Stock in the Merger and that the Calidi Stockholders will own [●] of the outstanding shares of New Calidi Common Stock immediately following the consummation of the Business Combination. The preceding sentence reflects numerous assumptions. This proxy statement/prospectus discloses those assumptions and presents various alternate scenarios regarding the ownership of New Calidi following the Business Combination. The estimated net cash per share of FLAG Common Stock that is being contributed to New Calidi is less than the $10.00 per share ascribed to such shares in the Merger Agreement or the amount per share that holders of FLAG Class A Common Stock would be entitled to receive upon exercise of their redemption rights.

See the section entitled “Proposal No. 1 — The Business Combination Proposal — General — Merger Consideration.”

During the Escalation Period, Calidi Stockholders may be entitled to receive up to 18,000,000 Escalation Shares with incremental releases of 4,500,000 shares upon the achievement of each share price hurdle if the trading price of New Calidi Common Stock is $12.00, $14.00, $16.00 and $18.00 for a period of any 20 days within any 30-consecutive-day trading period. Holders of FLAG Class A Common Stock who do not redeem their shares will be entitled to their pro rata portion of up to an additional 2,000,000 Non-Redeeming Continuation Shares to be issued at Closing. The Escalation Shares will be placed in escrow and will be outstanding from and after the Closing, subject to cancellation if the applicable price targets are not achieved. While in escrow, the shares will be non-voting.

 

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For more information regarding the sources and uses of the funds utilized to consummate the Transactions, please see the section entitled “Proposal No. 1 — The Business Combination Proposal — Sources and Uses of Funds for the Transactions.”

Calidi Convertible Securities

Any Calidi Convertible Security other than a Calidi Option, if not exercised or converted prior to the Effective Time, shall be cancelled, retired and terminated and cease to represent a right to acquire, be exchanged for or convert into shares of Calidi Stock.

Exchange and Fractional Shares

Immediately prior to or at the Effective Time, FLAG will deposit, or cause to be deposited, with Continental Stock Transfer & Trust Company, in its capacity as Exchange Agent, evidence in book-entry form of shares of FLAG Class A Common Stock representing the number of shares of FLAG Class A Common Stock sufficient to deliver the Merger Consideration, the Escalation Shares and the Non-Redeeming Continuation Shares.

Notwithstanding anything to the contrary as described in the Merger Agreement, no fraction of a share of New Calidi Common Stock will be issued by virtue of the Merger Agreement or the Transactions contemplated thereby, and each shareholder of Calidi who would otherwise be entitled to a fraction of a share of New Calidi Common Stock (after aggregating all shares of New Calidi Common Stock to which such shareholder of Calidi otherwise would be entitled) will instead have the number of shares of New Calidi Common Stock issued to such shareholder of Calidi rounded down to the nearest whole share of New Calidi Common Stock.

Treatment of Calidi Option Awards

As of the Effective Time, each outstanding Calidi Option (whether vested or unvested) will be assumed by FLAG and automatically converted into an option for shares of New Calidi Common Stock. Subject to the subsequent sentence, each Assumed Option will be subject to the terms and conditions set forth in the Calidi Equity Plan (except any references therein to Calidi or Calidi Common Stock will instead mean New Calidi and New Calidi Common Stock, respectively, and except for any other terms that are rendered inoperative by the transactions). Each Assumed Option will: (i) have the right to acquire a number of shares of New Calidi Common Stock equal to (as rounded down to the nearest whole number) the product of (A) the number of shares of Calidi Common Stock which the Calidi Option had the right to acquire immediately prior to the Effective Time, multiplied by (B) the Conversion Ratio; (ii) have an exercise price equal to (as rounded up to the nearest whole cent) the quotient of (A) the exercise price of the Calidi Option (in U.S. Dollars), divided by (B) the Conversion Ratio; and (iii) be subject to the same vesting schedule as the applicable Calidi Option. FLAG shall take all corporate action reasonably necessary to reserve for future issuance, and shall maintain such reservation for so long as any of the Assumed Options remain outstanding, a sufficient number of shares of New Calidi Common Stock for delivery upon the exercise of such Assumed Option.

Appraisal/Dissenter’s Rights

FLAG Stockholders do not have appraisal rights in connection with the Business Combination under the DGCL. Calidi Stockholders who do not vote in favor of the Business Combination, and satisfy certain other conditions, will be entitled to dissenters’ rights in connection with the Business Combination under Nevada law.

Closing and Effective Time of the Transactions

The Closing of the Transactions will take place promptly following the satisfaction or waiver of the conditions described below under the subsection entitled “Conditions to Closing of the Transactions,” unless FLAG and

 

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Calidi agree in writing to another time or unless the Merger Agreement is terminated. The Transactions are expected to be consummated promptly after the approval of FLAG’s public stockholders at the special meeting described in this proxy statement/prospectus.

Conditions to Closing of the Transactions

General Conditions

Consummation of the Transactions is conditioned on the approval of the FLAG Stockholders of the Business Combination Proposal, the Charter Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal and the NYSE American Proposal, as described in this proxy statement/prospectus.

In addition, the consummation of the Transactions contemplated by the Merger Agreement is conditioned upon, among other things:

 

   

The requisite vote of Calidi Stockholders (including any separate class or series vote that is required, whether pursuant to its organizational documents, any stockholder agreement or otherwise) shall have authorized, approved and consented to, the execution, delivery and performance of the Merger Agreement and each of the Ancillary Documents to which Calidi is or is required to be a party or bound, and the consummation of Transactions;

 

   

Any waiting period (and any extension thereof) applicable to the consummation of the Merger Agreement under any antitrust laws shall have expired or been terminated;

 

   

The consents required to be obtained from or made with any third person (other than a governmental authority) in order to consummate the Transactions contemplated by the Merger Agreement that are set forth on the applicable disclosure schedule to of the Merger Agreement shall have each been obtained or made;

 

   

No governmental authority shall have enacted, issued, promulgated, enforced or entered any law (whether temporary, preliminary or permanent) or order that is then in effect and which has the effect of making the Transactions or agreements contemplated by the Merger Agreement illegal or which otherwise prevents or prohibits consummation of the Transactions contemplated by the Merger Agreement;

 

   

After giving effect to the Redemption and any PIPE Investment, FLAG shall have net tangible assets of at least $5,000,001;

 

   

Satisfaction of the Minimum Cash Condition;

 

   

The members of the post-closing New Calidi Board shall have been elected or appointed as of the Closing;

 

   

The registration statement, of which this proxy statement/prospectus is a part, shall have been declared effective by the SEC and shall remain effective as of the Closing, and no stop order or similar order shall be in effect with respect to the registration statement; and

 

   

Satisfaction of the Listing Condition.

FLAG’s Conditions to Closing

The obligations of FLAG to consummate the Transactions contemplated by the Merger Agreement also are conditioned upon, among other things:

 

   

The representations and warranties of Calidi being true and correct as of the date of the Closing, except to the extent made as of a particular date (subject to certain materiality qualifiers);

 

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Calidi shall have performed in all material respects all of its obligations and complied in all material respects with all of its agreements and covenants under the Agreement to be performed or complied with by it on or prior to the Closing Date;

 

   

No “material adverse effect” shall have occurred with respect to the Target Companies taken as a whole since the date of the Merger Agreement which is continuing and uncured;

 

   

Each Voting and Lock-Up Agreement shall be in full force and effect in accordance with the terms thereof as of the Closing;

 

   

FLAG shall have received a duly executed opinion from Calidi’s local counsel in Germany, in form and substance reasonably satisfactory to FLAG, addressed to FLAG and dated as of the Closing Date;

 

   

FLAG shall have received evidence reasonably acceptable to FLAG that Calidi shall have terminated, extinguished and cancelled in full all outstanding Calidi Convertible Securities or commitments therefor other than the Assumed Options;

 

   

Subject to the requirements of the Merger Agreement, FLAG shall have received written resignations, effective as of the Closing, of each of the directors and officers of Calidi as requested by FLAG prior to the Closing;

 

   

No more than 5% of the issued and outstanding shares of Calidi Stock as of the Effective Time shall, in the aggregate, be (a) dissenting shares or (b) shares held by Calidi Stockholders who, under the provisions of section 92A.380 of the NRS, remain entitled to exercise and perfect appraisal rights in respect of such shares;

 

   

FLAG shall have received evidence reasonably acceptable to FLAG that the contracts involving the Target Companies and/or Calidi Security Holders or other Related Persons set forth in Calidi’s disclosure schedules to the Merger Agreement shall have been terminated with no further obligation or liability of the Target Companies thereunder; and

 

   

FLAG shall have received a certificate from Calidi, dated as the Closing Date, signed by an executive officer of Calidi in such capacity, certifying as to the satisfaction of certain conditions set forth in the Merger Agreement.

Calidi’s Conditions to Closing

The obligations of Calidi to consummate the Transactions contemplated by the Merger Agreement also are conditioned upon, among other things:

 

   

The representations and warranties of FLAG being true and correct as of the date of the Closing, except to the extent made as of a particular date (subject to certain materiality qualifiers);

 

   

FLAG shall have performed in all material respects all of FLAG’s obligations and complied in all material respects with all of FLAG’s agreements and covenants under the Merger Agreement to be performed or complied with by it on or prior to the Closing Date;

 

   

No “material adverse effect” shall have occurred with respect to FLAG since the date of the Merger Agreement which is continuing and uncured;

 

   

The Sponsor Agreement shall be in full force and effect in accordance with the terms thereof as of the Closing;

 

   

The Sponsor shall have provided documentary evidence, satisfactory to Calidi, that the Sponsor and Metric have transferred as incentives to investors in the PIPE Investment or Sponsor-Assisted Permitted Calidi Equity Issuance, or cancelled twenty-five (25%) of their shares of FLAG Class B Common Stock and one hundred (100%) of their Private Placement Warrants without further consideration;

 

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The IPO Underwriter shall have waived all of its right, title and interest in deferred compensation and expenses that FLAG would have been obligated to pay from the proceeds in the Trust Account or otherwise; and

 

   

FLAG shall have delivered to Calidi a certificate, dated the Closing Date, signed by an executive officer of FLAG in such capacity, certifying as to the satisfaction of certain conditions specified in the Merger Agreement.

The foregoing summary of the material provisions of the Merger Agreement is qualified in its entirety by reference to the Merger Agreement, a copy of which is attached to this proxy statement/prospectus as Annex A and which is incorporated by reference in this proxy statement/prospectus. All stockholders are encouraged to read the Merger Agreement in its entirety for a more complete description of the terms and conditions of the Business Combination.

Sponsor Agreement

Simultaneously with the execution of the Merger Agreement, FLAG, Calidi, the Sponsor, Metric and the Insiders entered into the Sponsor Agreement. The following summary of the Sponsor Agreement is qualified by reference to the complete text of the form of Sponsor Agreement, a copy of which is attached as Annex D to this proxy statement/prospectus.

Pursuant to the terms of the Sponsor Agreement, the Sponsor, Metric and the Insiders agreed, among other things, (A) to vote any shares of FLAG Common Stock held by such party in favor of the Business Combination Proposal and the other Proposals described in this proxy statement/prospectus and (B) not to redeem any shares of FLAG Class A Common Stock or FLAG Class B Common Stock, in connection with the Redemption.

Additionally, the Sponsor and Metric agreed to make available up to 3,397,155 FLAG Private Placement Warrants and 643,951 shares of FLAG Class B Common Stock, in the case of the Sponsor, and 217,886 shares of FLAG Class B Common Stock, in the case of Metric, to incentivize PIPE Investors or otherwise forfeit such Incentive Securities for no consideration. The potential transfer of such Incentive Securities by the Sponsor and Metric shall be proportionate to each of the Sponsor’s and Metric’s current respective holdings of Private Placement Warrants and founder shares.

With respect to the remaining shares of FLAG Class B Common Stock that are held by the Sponsor and Metric, the Sponsor and Metric each agreed that if the Closing occurs, it shall not transfer, with limited exceptions, (i) 50% of such shares of FLAG Class B Common Stock (or FLAG Class A Common Stock issuable on the conversion thereof) until the earliest to occur of (A) six months after the Closing; (B) subsequent to the Closing, the date on which the last reported sale price of the shares of New Calidi Common Stock equals or exceeds $12.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 days within any 30 consecutive day trading period commencing at least 150 days after the Closing; and (C) subsequent to the Closing, the date on which New Calidi completes a liquidation, merger, stock exchange, reorganization or other similar transaction that results in all of the FLAG’s public stockholders having the right to exchange their shares of New Calidi Common Stock for cash, securities or other property (a “Subsequent Transaction”) and (ii) the remaining 50% of such shares of FLAG Class B Common Stock (or FLAG Class A Common Stock issuable on the conversion thereof) until the earliest to occur of (A) twelve months after the Closing; (B) subsequent to the Closing, the date on which the last reported sale price of the shares of New Calidi Common Stock equals or exceeds $12.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 days within any 30-consecutive-day trading period commencing at least 150 days after the Closing; and (C) subsequent to the Closing, the date on which New Calidi completes a Subsequent Transaction.

 

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Registration Rights Agreement

In connection with consummation of the Business Combination, FLAG, Calidi, the Sponsor, Metric, the Significant Calidi Holders and certain other parties thereto will enter into the Registration Rights Agreement. The Registration Rights Agreement will provide these holders (and their permitted transferees) with, among other things, (i) the right to require New Calidi, at New Calidi’s expense, to file a registration statement in respect of the resale of up to 20,062,265 shares of New Calid Common Stock that they hold within 30 days following the Closing Date and on customary terms for a transaction of this type and (ii) customary registration rights, including demand, piggy-back and shelf registration rights.

Voting and Lock-Up Agreement

Simultaneously with the execution of the Merger Agreement, each Significant Calidi Holder entered into a Voting and Lock-Up Agreement with FLAG and Calidi. The following summary of the Voting and Lock-Up Agreement is qualified by reference to the complete text of the form of Voting and Lock-Up Agreement, a copy of which is attached as Annex E to this proxy statement/prospectus.

Pursuant to the Voting and Lock-Up Agreement, each Significant Calidi Holder agreed to execute and deliver an irrevocable written consent to FLAG within fifteen (15) business days following the time that the Registration Statement is declared effective under the Securities Act approving the Merger Agreement and the ancillary agreements under the Transactions and any other matters necessary or appropriate in order to effect the Merger and the Transactions contemplated by the Merger Agreement.

Additionally, with respect to the shares of New Calidi Common Stock received as Merger Consideration, each Significant Calidi Holder agreed that if Closing occurs, he will not transfer, with limited exceptions, (A) with respect to 50% of such shares, until the earliest of (a) the six-month anniversary of the Closing, (b) subsequent to the Closing, the date on which the closing price of New Calidi Common Stock equals or exceeds $12.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 days within any 30 consecutive day trading period commencing at least 150 days after the Closing and (c) subsequent to the Closing, the date on which New Calidi completes a Subsequent Transaction and (B) with respect to the remaining 50% of such shares, until the earliest to occur of (a) the twelve-month anniversary of the Closing, (b) subsequent to the Closing, the date on which the closing price of New Calidi Common Stock equals or exceeds $12.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 days within any 30 consecutive day trading period commencing at least 150 days after the Closing and (c) subsequent to the Closing, the date on which New Calidi completes a Subsequent Transaction. 16,897,774 shares of New Calidi Common Stock are subject to lock-up arrangements pursuant to the Sponsor Agreement and Voting and Lock-Up Agreements.

Incentive Plan

Prior to the consummation of the Business Combination, the FLAG Board is expected to approve and adopt, subject to FLAG Stockholder approval, the 2023 Equity Incentive Plan. If the Incentive Plan is approved by FLAG Stockholders, New Calidi will be authorized to grant equity awards to eligible service providers following consummation of the Merger. The form of the Incentive Plan is attached to this proxy statement/prospectus as Annex G. If the 2023 Incentive Plan is not approved by the FLAG Stockholders, it will not become effective. The 2023 Incentive Plan is described in more detail in the section entitled “Proposal No. 4 — The Incentive Plan Proposal”.

Employee Stock Purchase Plan

The FLAG Board will adopt the 2023 ESPP prior to the Meeting, in substantially the form of Annex H attached to this proxy statement/prospectus, subject to FLAG Stockholder approval at the Meeting. If FLAG Stockholders

 

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approve this Proposal, the 2023 ESPP will become effective on the consummation of the Business Combination. If the 2023 ESPP is not approved by FLAG Stockholders, it will not become effective.

Please see the section entitled “Proposal No. 5 — The ESPP Proposal” for additional information.

Impact of the Business Combination on New Calidi’s Public Float

As of the date of this proxy statement/prospectus, there are (i) [●] shares of FLAG Class A Common Stock issued and outstanding; (ii) [●] founder shares and (iii) [●] FLAG Warrants issued and outstanding. Each whole warrant entitles the holder thereof to purchase one share of FLAG Class A Common Stock and, following the Business Combination, will entitle the holder thereof to purchase one share of New Calidi Common Stock. Therefore, as of the date of this proxy statement/prospectus (without giving effect to the Business Combination) the FLAG fully diluted share capital would be [●] common stock equivalents.

The following pro forma ownership table has been prepared assuming three alternative levels of redemption into cash of shares of FLAG Class A Common Stock:

 

   

Scenario 1 — Assuming No Redemptions: This scenario assumes that none of FLAG’s public stockholders exercise redemption rights with respect to their public shares and receive an additional 2,000,000 FLAG Non-Redeeming Continuation Shares in connection with the Closing pursuant to the Merger Agreement.

 

   

Scenario 2 — Assuming 50% Redemptions: This scenario assumes that 2,064,012 public shares are redeemed for aggregate redemption payments of approximately $21.2 million (assuming a redemption price of approximately $10.28 per Public Share, based on funds in the Trust Account as of December 31, 2022), which represents 50% of the public shares eligible for redemption in connection with the Closing. This scenario also assumes that an additional 1,000,000 FLAG Non-Redeeming Continuation shares are issued to FLAG’s public shareholders in connection with the Closing, which represents the 50% of the public shares that are not redeemed in connection with the Closing, pursuant to the Merger Agreement. As all of the holders of FLAG’s Class B ordinary shares waived their redemption rights, only redemptions by public shareholders are reflected in this presentation. This scenario includes all adjustments contained in the “no redemption” scenario and presents additional adjustments to reflect the effect of 50% redemptions.

 

   

Scenario 3 — Assuming Maximum Redemptions: This scenario assumes that all 4,128,024 public shares are redeemed for aggregate redemption payments of approximately $42.5 million (assuming a redemption price of approximately $10.28 per public share, based on funds in the Trust Account as of December 31, 2022), which represents the maximum number of public shares eligible for redemption in connection with the Closing and no additional shares are issued to public shareholders. As all of the holders of FLAG’s Class B ordinary shares waived their redemption rights, only redemptions by public shareholders are reflected in this presentation. This scenario includes all adjustments contained in the “no redemption” scenario and presents additional adjustments to reflect the effect of the Maximum Redemptions.

The following pro forma ownership table has been prepared on the assumption that, at the Closing, the Calidi Security Holders will receive an aggregate of 25,000,000 shares of newly issued New Calidi Common Stock as Merger Consideration (excluding unvested Assumed Options in accordance with the terms of the Merger Agreement) and assuming no adjustment to the Merger Consideration for Net Debt and no adjustment for any contingent consideration discussed below. The pro forma ownership table does not take into account shares of New Calidi Common Stock issuable after Closing to holders of unvested Calidi Options that are assumed by New Calidi after the Closing.

 

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The following summarizes anticipated pro forma ownership of outstanding New Calidi Common Stock after giving effect to the Merger under the “no,” “50%” and “maximum” redemption scenarios, taking into account all of the assumptions that are further detailed in the section entitled “Unaudited Pro Forma Combined Financial Information”:

 

     No Redemption     50% Redemption(5)     Maximum
Redemption(6)
 
     Class A
Common Stock
     %     Class A
Common Stock
     %     Class A
Common Stock
     %  

Stockholders

               

Calidi Stockholders(1)

     25,000,000        67.8     25,000,000        73.9     25,000,000        81.3

FLAG public stockholders (redeemable shares)

     4,128,024        11.2     2,064,012        6.1     —          —  

Founder Shares(2)(3)

     5,750,000        15.6     5,750,000        17.0     5,750,000        18.7

FLAG Non-Redeeming Continuation Shares(4)

     2,000,000        5.4     1,000,000        3.0     —          —  
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

Total shares of Common Stock outstanding at closing of the Transaction(7)

     36,878,024        100.0     33,814,012        100.0     30,750,000        100.0
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

 

(1)

The Pro Forma Ownership Table has been prepared based on an assumed issuance of 25,000,000 shares of New Calidi Common Stock to the Calidi Security Holders at the Closing and assuming no adjustment to the Merger Consideration for Calidi indebtedness, net of cash and no adjustment for Escalation Shares, calculated based on the following assumptions: (i) that the number of shares of Calidi Common Stock on an as-converted to New Calidi Common Stock basis as of the Closing Date is the same as the number of shares of Calidi Common Stock outstanding as of December 31, 2022 on an as-converted to Common Stock basis; (ii) that all outstanding Calidi Warrants and vested Calidi Options are net exercised on or prior to the Closing Date in accordance with their terms; (iii) that there is no pre- or post-Closing adjustment to the Merger Consideration for any contingent consideration, and no adjustment on account of Calidi’s Net Debt as of the Closing Date; (iv) that the Conversion Rate, to be determined in accordance with the terms of the Merger Agreement based on the number of shares of Calidi Common Stock, as of the Closing Date, is equal to an estimated 0.36 Conversion Ratio, and (v) that all other Calidi Securities outstanding as of immediately prior to the Closing Date are converted into shares of Calidi Common Stock in accordance with their terms (other than vested Calidi Options which are part of the determination of the Conversion Rate) and all Calidi Options outstanding which will be assumed by FLAG in accordance with the Merger Agreement, which are not included in the Merger Consideration (or the presentation of pro forma ownership reflected in table above). The actual Conversion Ratio and the actual number of shares to be issued to the Calidi Stockholders will be calculated as of the Closing Date and may be different than the assumed Conversion Ratio and the number of such shares presented for purposes of this section.

(2)

Represents 2,575,803 founder shares held by the Sponsor, 871,543 founder shares held by Metric and 2,302,654 founder shares that have been transferred to third party investors.

(3)

Includes founder shares subject to the “lock up” provisions of the Sponsor Agreement as holders of such shares are entitled to vote such shares and receive dividends and other distributions thereon during the lock-up period.

(4)

To be issued to FLAG public stockholders.

(5)

The “50% Redemption” scenario is not presented in the “Unaudited Pro Forma Combined Financial Information” section included elsewhere in this proxy statement/prospectus because this scenario is not considered likely to occur.

(6)

Under the “Maximum Redemptions” scenario as presented in this proxy statement/prospectus and assuming the Minimum Cash Condition is not met, the parties to the Business Combination would have to agree to a

 

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  mutual waiver to complete the Business Combination without having met the minimum cash at closing condition, which is neither assured nor assumed would occur.
(7)

The table excludes the following:

 

   

The issuance of up to 18,000,000 Escalation Shares;

 

   

11,500,000 unexercised FLAG Public Warrants;

 

   

3,397,155 unexercised FLAG Private Placement Warrants;

 

   

7,051,039 unexercised Assumed Calidi Options;

 

   

New Calidi equity awards pursuant to the 2023 Equity Incentive Plan, if adopted, which is equal to 10% of the issued and outstanding shares of New Calidi determined as of immediately after the closing of the Merger (after giving effect to the Redemption or such lesser amount as determined by the New Calidi Board at such time).

The sensitivity table below sets forth the potential additional dilutive impact of each of the Escalation Shares, FLAG Public Warrants, FLAG Private Placement Warrants, Assumed Calidi Options, and New Calidi equity awards under the 2023 Equity Incentive Plan, in each redemption scenario.

 

     Share Ownership in New Calidi(1)  
     No Redemption     50% Redemption     Maximum Redemption  

Additional Dilution Sources

   Class A
Common Stock
     %     Class A
Common Stock
     %     Class A
Common Stock
     %  

Escalation Shares(2)

     18,000,000        32.8     18,000,000        34.7     18,000,000        36.9

FLAG Public Warrants(3)

     11,500,000        23.8     11,500,000        25.4     11,500,000        27.2

FLAG Private Placement Warrants(4)

     3,397,155        8.4     3,397,155        9.1     3,397,155        9.9

Assumed Calidi Options(5)

     7,051,039        16.1     7,051,039        17.3     7,051,039        18.7

2023 Equity Incentive Plan(6)

     3,687,802        9.1     3,381,401        9.1     3,075,000        9.1
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

Total Additional Dilutive Sources(7)

     43,635,996        54.2     43,329,595        56.2     43,023,194        58.3
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

 

(1)

Percentages in this table assume that the dilutive securities are added to the outstanding shares as of immediately following the Closing as shown in the previous table in the respective redemption scenarios.

(2)

This row assumes issuance of all 18,000,000 Escalation Shares. Percentages in this row represent (a) the Escalation Shares divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) 18,000,000 Escalation Shares.

(3)

This row assumes exercise of all FLAG Public Warrants to purchase 11,500,000 shares of New Calidi Common Stock. Percentages in this row represent (a) the shares of New Calidi Common Stock underlying the FLAG Public Warrants divided by (b) (i) the outstanding shares as of immediately following the Closing as shown in the previous table in the applicable redemption scenario plus (ii) 11,500,000 shares of New Calidi Common Stock underlying the FLAG Public Warrants.

(4)

This row assumes exercise of all FLAG Private Placement Warrants to purchase 3,397,155 shares of New Calidi Common Stock. Percentages in this row represent (a) the shares of New Calidi Common Stock underlying the FLAG Private Placement Warrants divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) 3,397,155 shares of New Calidi Common Stock underlying the FLAG Private Placement Warrants.

(5)

This row assumes the exercise of all 7,051,039 Assumed Options. Percentages in this row represent (a) the shares of New Calidi Common Stock underlying the Assumed Options divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) 7,051,039 shares of New Calidi Common Stock underlying the Assumed Options.

 

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(6)

This row assumes the exercise of New Calidi equity awards under the 2023 Equity Incentive Plan, calculated at 10% of the outstanding shares as of immediately following the Closing for each redemption scenario. Percentages in this row represent (a) the shares of New Calidi Common Stock eligible for issuance under the 2023 Equity Incentive Plan divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) shares of New Calidi Common Stock underlying the New Calidi equity awards under the 2023 Equity Incentive Plan.

(7)

This row assumes the exercise and vesting of all additional dilutive sources listed in the rows above. Percentages in this row represent (a) the shares of New Calidi Common Stock underlying all additional dilutive sources listed in the rows above divided by (b) (i) the outstanding shares as of immediately following the Closing in the applicable redemption scenario plus (ii) all shares of New Calidi Common Stock underlying the additional dilutive sources listed in the rows above.

Matters Being Voted On

The stockholders of FLAG will be asked to consider and vote on the following proposals at the special meeting:

1. A proposal to approve the Business Combination described in this proxy statement/prospectus, including approving the Transactions contemplated by the Merger Agreement and related agreements described in this proxy statement/prospectus. Please see the section entitled “Proposal No. 1  The Business Combination Proposal”;

2. A proposal to approve and adopt the Second Amended and Restated Certificate of Incorporation of FLAG, which will be the certificate of incorporation of New Calidi, in the form attached to this proxy statement/prospectus as Annex B. Please see the section entitled “Proposal No. 2  The Charter Proposal”;

3. A proposal to vote upon, on a non-binding advisory basis, certain governance provisions in the Second Amended and Restated Certificate of Incorporation, presented separately in accordance with the requirements of the SEC. Please see the section entitled “Proposal No. 3 — The Governance Proposal”;

4. A proposal to approve and adopt the Incentive Plan, in the form attached to this proxy statement/prospectus as Annex G, including the authorization of the initial share reserve thereunder. Please see the section entitled “Proposal No. 4 — The Incentive Plan Proposal”;

5. A proposal to approve and adopt the ESPP, in the form attached to this proxy statement/prospectus as Annex H, and the material terms thereof, including the authorization of the initial share reserve thereunder. Please see the section entitled “Proposal No. 5 — The ESPP Proposal”;

6. A proposal to elect seven directors to serve staggered terms on the New Calidi Board upon the consummation of the Business Combination until the first, second and third annual meetings of stockholders following the date of effectiveness of the Proposed Charter, as applicable, or until the election and qualification of their respective successors. Please see the section entitled “Proposal No. 6 — The New Board Proposal”;

7. A proposal to approve, for purposes of complying with Section 712(b) and Section 713(b) of the NYSE American’s Company Guide, (a) the issuance of more than 20% of FLAG’s issued and outstanding shares of common stock in connection with the Business Combination, including, without limitation, pursuant to the PIPE Investment, if consummated (as described below), and (b) the issuance of more than 20% of FLAG’s issued and outstanding shares to a single holder (which may constitute a change in control under the NYSE American’s Company Guide) in connection with the Business Combination. Please see the section entitled “Proposal No. 7 — NYSE American Proposal”; and

 

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8. A proposal to adjourn the special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal or the NYSE American Proposal. Please see the section entitled “Proposal No. 8 — Adjournment Proposal.”

Date, Time and Place of Special Meeting of FLAG Stockholders

The special meeting of stockholders of FLAG will be held via live webcast at [●] a.m. Eastern Time, on [●], 2023. The special meeting can be accessed by visiting [●], where you will be able to listen to the meeting live and vote during the meeting. Please note that you will only be able to access the special meeting by means of remote communication.

At the special meeting, stockholders will be asked to consider and vote upon the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal, the New Board Proposal and the NYSE American Proposal and the Adjournment Proposal to permit further solicitation and vote of proxies if FLAG is not able to consummate the Transactions.

Voting Power; Record Date

FLAG Stockholders will be entitled to vote or direct votes to be cast at the special meeting if they owned shares of FLAG Common Stock at the close of business on [●], 2023, which is the Record Date for the special meeting. FLAG Stockholders will have one vote for each share of FLAG Common Stock owned at the close of business on the Record Date. If your shares are held in “street name” or are in a margin or similar account, you should contact your broker to ensure that votes related to the shares you beneficially own are properly counted. FLAG Warrants do not have voting rights. On the Record Date, there were [●] shares of FLAG Common Stock outstanding, of which [●] were public shares and [●] were founder shares.

Quorum and Vote of FLAG Stockholders

A quorum of FLAG Stockholders is necessary to hold a valid meeting. A quorum will be present at the FLAG special meeting if a majority of the outstanding shares of FLAG Common Stock entitled to vote at the meeting are represented in person or by proxy. Proxies that are marked “abstain” will be treated as shares present for purposes of determining the presence of a quorum on all matters. Broker non-votes will not be counted for the purposes of determining the existence of a quorum or for purposes of determining the number of votes cast at the special meeting.

The Sponsor, Metric and the Insiders own of record and are entitled to vote an aggregate of [●]% of the outstanding shares of FLAG Common Stock as of the Record Date. The Sponsor, Metric and the Insiders have agreed to vote any FLAG Common Stock over which they have voting control (including any public shares owned by them) in favor of the Transactions. The Proposals presented at the special meeting will require the following votes:

 

   

The approval of each of the Business Combination Proposal, the Governance Proposal (which is a non-binding advisory vote), the Incentive Plan Proposal, the ESPP Proposal, the NYSE American Proposal and the Adjournment Proposal require the affirmative vote of a majority of the votes cast by holders of outstanding shares of FLAG Common Stock represented at the special meeting by attendance via the virtual meeting website or by proxy and entitled to vote at the special meeting. Accordingly, if a valid quorum is established, a FLAG Stockholder’s failure to vote by proxy or to vote at the special meeting with regard to the Business Combination Proposal, the Governance Proposal, the Incentive Plan Proposal, the ESPP Proposal and the NYSE American Proposal and the Adjournment Proposal will have no effect on such proposals.

 

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The approval of the Charter Proposal requires the affirmative vote of at least 65% of the issued and outstanding shares of FLAG Common Stock entitled to vote thereon as of the Record Date. Accordingly, if a valid quorum is established, a FLAG Stockholder’s failure to vote by proxy or to vote at the special meeting with regard to the Charter Proposal will have the same effect as a vote “AGAINST” such Proposal.

 

   

Directors are elected by a plurality of all of the votes cast by holders of shares of FLAG Common Stock represented at the special meeting by attendance via the virtual meeting website or by proxy and entitled to vote thereon at the special meeting. This means that the seven director nominees who receive the most affirmative votes will be elected. Holders of FLAG Common Stock may not cumulate their votes with respect to the election of directors. Accordingly, if a valid quorum is established, failure to vote by proxy or to vote at the special meeting with regard to the director election proposal will have no effect on such proposal. Pursuant to the Current Charter, only holders of FLAG Class B Common Stock will have the right to vote on the New Board Proposal.

Abstentions will have the same effect as a vote “AGAINST” the Charter Proposal, but will have no effect on the other Proposals. Please note that holders of the public shares cannot seek redemption of their shares for cash unless they affirmatively vote “FOR” or “AGAINST” the Business Combination Proposal.

Consummation of the Transactions is conditioned on the approval of each of the Business Combination Proposal, the Charter Proposal, the Incentive Plan Proposal, and the NYSE American Proposal. If any of those Proposals are not approved, we will not consummate the Transactions.

Redemption Rights

Pursuant to FLAG’s Current Charter, holders of public shares may seek to redeem their shares for cash, regardless of whether they vote “FOR” or “AGAINST” the Business Combination Proposal. Any stockholder holding public shares as of the Record Date may demand that FLAG redeem such shares for a pro rata portion of the Trust Account (which, for illustrative purposes, was approximately $[●] per share as of [●], 2023, the Record Date for the special meeting), calculated as of two business days prior to the anticipated consummation of the Business Combination. If a holder properly seeks Redemption as described in this proxy statement/prospectus and the Business Combination is consummated, FLAG will redeem these shares for a pro rata portion of funds deposited in the Trust Account and the holder will no longer own these shares following the Business Combination. Please see the section entitled “Special Meeting of FLAG Stockholders — Redemption Rights” for a detailed description of the procedures to be followed if you wish to redeem your shares for cash.

Notwithstanding the foregoing, a holder of public shares, together with any affiliate of his or any other person with whom he is acting in concert or as a “group” (as defined in Section 13(d)(3) of the Exchange Act), will be restricted from seeking Redemption rights with respect to more than 15% of the public shares.

Accordingly, all public shares in excess of 15% held by a public stockholder, together with any affiliate of such holder or any other person with whom such holder is acting in concert or as a “group,” will not be redeemed for cash.

The Business Combination will not be consummated if FLAG has net tangible assets of less than $5,000,001, after taking into account holders of public shares that have properly demanded Redemption of their shares for cash. The Business Combination also will not be consummated if FLAG does not satisfy the Minimum Cash Condition.

Holders of FLAG Warrants do not have Redemption rights with respect to such securities.

 

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Appraisal Rights

FLAG Stockholders do not have appraisal rights in connection with the Transactions under the DGCL. Calidi Stockholders who do not vote in favor of the Business Combination, and satisfy certain other conditions, will be entitled to dissenters’ rights in connection with the Business Combination under Nevada law.

Proxy Solicitation

Proxies may be solicited by mail, telephone or in person. FLAG has engaged MacKenzie Partners, Inc. to assist in the solicitation of proxies. If a stockholder grants a proxy, it may still vote its shares during the meeting if it revokes its proxy before the special meeting. A stockholder may also change its vote by submitting a later-dated proxy as described in the section entitled “Special Meeting of FLAG Stockholders — Revoking Your Proxy.”

Listing

FLAG Units, FLAG Class A Common Stock and FLAG Public Warrants are publicly traded on the NYSE American under the symbols “FLAGU,” “FLAG” and “FLAGW,” respectively. Following the Closing, New Calidi intends to continue to have its Common Stock and public warrants publicly traded under the proposed symbols “CLDI” and “CLDIW,” respectively.

Comparison of Stockholders’ Rights

Following the Business Combination, the rights of public holders who become stockholders of New Calidi in the Business Combination will no longer be governed by the Current Charter and instead will be governed by the Proposed Charter. See the section entitled “Comparison of Stockholders’ Rights.”

Interests of Certain Persons in the Business Combination

In considering the recommendation of the FLAG Board to vote in favor of approval of the Business Combination Proposal and the other Proposals, public stockholders should keep in mind that the Sponsor and the Insiders have interests in such Proposals that are different from, or in addition to, those of FLAG Stockholders generally and that conflict with the interests of FLAG’s public stockholders. In particular:

 

   

the fact that the Sponsor paid approximately $0.004 per share, or an aggregate of $20,025, for the founder shares initially held by the Sponsor (a portion of which have been transferred to the anchor investors pursuant to the terms of the Investment Agreements), which are shares of FLAG Class B Common Stock that will automatically convert into FLAG Class A Common Stock upon consummation of the Business Combination. The founder shares owned by the Sponsor will have a significantly higher value at the time of the Business Combination, if it is consummated. Based on the closing trading price of FLAG Class A Common Stock on [●], the aggregate value of the founder shares owned by the Sponsor as of the same date is approximately $[●] million. If FLAG does not consummate the Business Combination or another initial business combination within the completion window, and FLAG is therefore required to be liquidated, these shares would be worthless, as the founder shares are not entitled to participate in any redemption or liquidation of the Trust Account. If FLAG consummates the Business Combination, the Sponsor and its members can earn a positive rate of return on their investment, even if other FLAG stockholders experience a negative rate of return on their investment in the combined company;

 

   

the fact that each of FLAG’s directors, officers and operating partners is a member of a series of the Sponsor, a Delaware series limited liability company, and each individual has an indirect economic interest in the FLAG securities owned by the Sponsor through ownership of membership interests of a series of the Sponsor, even though they do not beneficially own such shares. Accordingly, by reason of

 

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the above and other interests referred to below, each such individual is incentivized to complete an acquisition of a less favorable target company or on terms less favorable to FLAG Stockholders rather than to allow FLAG to liquidate;

 

   

the fact that, as of the date hereof, the aggregate amount of capital that is at risk of loss if the Business Combination is not completed within the completion window (including securities held, loans extended, fees due and out-of-pocket expenses subject to reimbursement) is (i) $2,500,000 for the members of the Sponsor who are not Insiders (indirectly through their interest in the Sponsor and directly in their individual capacity) and (ii) $1,656,000 for the Insiders (indirectly through their interest in the Sponsor and directly in their individual capacity). Additionally, the Sponsor has agreed to use its FLAG Private Placement Warrants to incentive PIPE Investors, or otherwise forfeit such securities for no consideration, which it acquired for an aggregate purchase price of $3,675,000, upon the consummation of the Business Combination;

 

   

the fact that FLAG has issued promissory notes to certain directors of FLAG and members of the Sponsor (approximately $710,000 in the aggregate) for working capital purposes and to fund the payment of extension fees in connection with the Extension. FLAG is required to pay interest at a per annum rate of 50% to 100% of the loan amount evidenced by such notes, representing an aggregate amount of interest of $384,000 (assuming the Business Combination is consummated by June 15, 2023). Each of these notes is payable upon the consummation of FLAG’s initial business combination and if FLAG is unable to consummate the Business Combination or another business combination within the completion window, the Sponsor members and the Insiders who contributed such funds to FLAG will not be repaid such loaned amounts and interest, if applicable. Prior to entering into the promissory notes, FLAG sought financing from traditional debt sources but was unable to secure any funds on any terms given the state of the debt markets at the time. FLAG entered into the promissory notes on terms believed by it to be the best available at the time;

 

   

the fact that the Sponsor paid $1.50 per FLAG Private Placement Warrant, or an aggregate of $3,675,000, for the FLAG Private Placement Warrants acquired by the Sponsor in a private placement simultaneous with the IPO. If FLAG consummates the Business Combination, the shares of FLAG Class A Common Stock to be received upon exercise of the FLAG Private Placement Warrants will be converted into shares of Common Stock of New Calidi. However, if FLAG does not consummate the Business Combination within the completion window, and FLAG is therefore required to be liquidated, these securities will be worthless. This provides further incentive to FLAG’s directors, officers and operating partners to complete an acquisition of a less favorable target company or on terms less favorable to FLAG Stockholders rather than to allow FLAG to liquidate;

 

   

the fact that if the Trust Account is liquidated, including in the event FLAG is unable to complete the Business Combination within the completion window, the Sponsor has agreed to indemnify FLAG to ensure that the proceeds in the Trust Account are not reduced below $10.00 per share of FLAG Class A Common Stock, or such lesser amount per share as is in the Trust Account on the liquidation date, by the claims of any third party for services rendered or products sold to us, but only if such a vendor or target business has not executed a waiver of any and all rights to seek access to the Trust Account;

 

   

the fact that FLAG may not be able to reimburse its directors, officers and operating partners for expenses incurred by them related to investigating, negotiating and completing the Business Combination unless the Business Combination is consummated. As of [●], 2023, there are [no]/[●] unpaid expenses reimbursable to the Insiders or operating partners at the Closing. In the future, the Insiders and operating partners may incur additional expenses for which they expect to be reimbursed at the Closing of the Business Combination. There is no limit on the amount of out-of-pocket expenses reimbursable by FLAG. However, if FLAG fails to consummate the Business Combination within the completion window, the Insiders and operating partners will not have any claim against the Trust

 

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Account for reimbursement. Accordingly, FLAG may not be able to reimburse these expenses, if any, if the Business Combination is not completed by such date;

 

   

On September 9, 2021, the Sponsor and the Insiders entered into letter agreements, pursuant to which, among other things, the Insiders agreed to vote any shares of FLAG capital stock held by them to approve a proposed business combination (including any proposals recommended by the Board in connection with such business combination) and not to redeem any shares of FLAG capital stock held by them in connection with such stockholder approval in order to induce FLAG and the IPO Underwriter to enter into an underwriting agreement and to proceed with FLAG’s initial public offering;

 

   

The Sponsor, the Insiders and FLAG entered into the Sponsor Agreement, pursuant to which, among other things, the Sponsor and the Insiders agreed to vote any shares of FLAG capital stock held by them to approve the Business Combination and the other FLAG stockholder matters required pursuant to the Merger Agreement, and not to seek redemption of any of their FLAG securities in connection with the consummation of the Business Combination. Pursuant to the Sponsor Agreement, the Sponsor also agreed to make available all of its FLAG Private Placement Warrants and up to 643,951 of its founder shares to incentivize PIPE Investors or otherwise forfeit such securities for no consideration; and

 

   

Pursuant to the Registration Rights Agreement, the Sponsor and certain related parties will have customary registration rights, including piggy-back rights, subject to cooperation and cut-back provisions with respect to the shares of New Calidi Common Stock held by such parties following the consummation of the Business Combination.

Board of Directors following the Business Combination

Upon consummation of the Business Combination, seven directors, six of whom will be designated by Calidi and one of whom will be designated by FLAG, will be elected to serve staggered terms on the New Calidi Board upon the consummation of the Business Combination until the first, second and third annual meetings of stockholders following the date of effectiveness of the Proposed Charter, as applicable, or until the election and qualification of their respective successors.

In connection with the Business Combination, Allan Camaisa, Heehyoung Lee, Scott Leftwich, George Ng, James Schoeneck, Alfonso Zulueta and Thomas Vecchiolla have each been nominated to serve as directors of New Calidi upon completion of the Business Combination.

Please see the sections entitled “Proposal No. 6 — The New Board Proposal” and “Management After the Business Combination” for additional information.

Opinion of FLAG’s Financial Advisor

In connection with the Merger Agreement, The Benchmark Company, LLC (“Benchmark”), rendered an oral opinion, which was confirmed by delivery of a written opinion, a copy of which is attached to this proxy statement/prospectus as Annex D to the FLAG Board to the effect that, as of January 6, 2023, and based on and subject to the matters considered, the procedures followed, the assumptions made and various limitations of and qualifications to the review undertaken, the Merger Consideration in connection with the Merger was fair, from a financial point of view, to FLAG’s public stockholders.

For a description of the opinion that the FLAG Board received from Benchmark, see “Proposal No. 1 — The Business Combination Proposal — Opinion of FLAG’s Financial Advisor.”

 

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Recommendation to Stockholders

The FLAG Board believes that the Business Combination Proposal and the other Proposals to be presented at the special meeting are fair to and in the best interest of FLAG Stockholders and unanimously recommends that its stockholders vote “FOR” the Business Combination Proposal, “FOR” the Charter Proposal, “FOR” the Governance Proposal, “FOR” the Incentive Plan Proposal, “FOR” the ESPP Proposal, “FOR” the New Board Proposal, “FOR” the NYSE American Proposal and “FOR” the Adjournment Proposal, if presented.

When you consider the FLAG Board’s recommendation of these Proposals, you should keep in mind that our directors and officers have interests in the Business Combination that are different from, or in addition to, the interests of FLAG Stockholders generally. Accordingly, each such individual is incentivized to complete an acquisition of a less favorable target company or on terms less favorable to FLAG Stockholders rather than to allow FLAG to liquidate. Please see the section entitled “Proposal No. 1 — The Business Combination Proposal — Interests of Certain Persons in the Business Combination” for additional information. The FLAG Board was aware of these interests, among other matters, in evaluating the Transactions and in recommending to the FLAG Stockholders that they vote “FOR” the proposals presented at the special meeting.

Tax Consequences of the Business Combination

For a description of certain U.S. federal income tax consequences of the Transactions and the exercise of Redemption rights, please see the information set forth in “Proposal No. 1 — The Business Combination Proposal — Material U.S. Federal Income Tax Consequences of the Redemption to FLAG Stockholders.”

Expected Accounting Treatment of the Transactions

We expect the Transactions to be accounted for as a reverse recapitalization in accordance with GAAP. Under this method of accounting, FLAG is expected to be treated as the “acquired” company for financial reporting purposes. Accordingly, for accounting purposes, the financial statements of New Calidi will represent a continuation of the financial statements of Calidi, with the Transactions treated as the equivalent of Calidi issuing shares for the net assets of FLAG, accompanied by a recapitalization. The net assets of FLAG will be stated at historical cost, with no goodwill or other intangible assets recorded. Operations prior to the Transactions will be those of Calidi in future reports of New Calidi. See the subsection entitled “Proposal No. 1 — The Business Combination Proposal — Expected Accounting Treatment of the Transactions.”

Regulatory Matters

Neither FLAG nor Calidi is aware of any material regulatory approvals or actions that are required for completion of the Business Combination that have not been obtained, except for filings (i) of a certificate of merger necessary to effectuate the Merger, (ii) in connection with HSR approval and (iii) required of solicitation materials pursuant to Rule 14a-12 of the Exchange Act. It is presently contemplated that if any such additional regulatory approvals or actions are required, those approvals or actions will be sought. There can be no assurance, however, that any additional approvals or actions will be obtained.

Risk Factors

In evaluating the Proposals to be presented at the special meeting, you should carefully read this proxy statement/prospectus and especially consider the factors discussed in the section entitled “Risk Factors.” These risks include, but are not limited to the following:

 

   

Calidi is a biopharmaceutical company with a limited operating history and has not generated any revenue to date from product sales;

 

   

Calidi has incurred significant operating losses since its inception and anticipates that it will incur continued losses for the foreseeable future;

 

 

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Calidi has no products approved for commercial sale and has not generated any revenue from product sales;

 

   

Even if the Business Combination is consummated, New Calidi will need to raise substantial additional funding. If New Calidi is unable to raise capital when needed, or if at all, New Calidi would be forced to delay, reduce or eliminate some of its product development programs or commercialization efforts;

 

   

Calidi’s engineered allogeneic stem cell product candidates represent a novel approach to cancer treatment that creates significant challenges.

 

   

Calidi’s business is highly dependent on the success of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG and CLD-201. If Calidi is unable to obtain approval for CLD-101 for newly diagnosed HGG, CLD-201, or CLD-101 for recurrent HGG and effectively commercialize any of these product candidates for the treatment of patients in its approved indications, Calidi’s business would be significantly harmed.

 

   

Calidi’s preclinical studies and clinical trials may fail to demonstrate adequately the safety and efficacy of any of its product candidates, which would prevent or delay development, regulatory approval, and commercialization.

 

   

Calidi’s product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval, if at all.

 

   

Even if Calidi receives marketing approval for its current or future product candidates, its current or future product candidates may not achieve broad market acceptance, which would limit the revenue that Calidi generates from their sales.

 

   

The regulatory approval processes of the FDA and other regulatory authorities are lengthy, time consuming and inherently unpredictable. If Calidi is not able to obtain, or experience delays in obtaining, required regulatory approvals, Calidi will not be able to commercialize CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates as expected, and Calidi’s ability to generate revenue may be materially impaired.

 

   

The Sponsor and the Insiders have interests in the Business Combination that incentivized them to complete an acquisition of a less favorable target company or on terms less favorable to FLAG Stockholders rather than to allow FLAG to liquidate;

 

   

FLAG’s Sponsor, Metric and the Insiders have agreed to vote in favor of the Business Combination, regardless of how FLAG’s public stockholders vote;

 

   

The Merger Agreement includes a Minimum Cash Condition as a Condition to the consummation of the Merger, which may make it more difficult for FLAG to complete the Business Combination as contemplated in the Merger Agreement;

 

   

The exercise of the Insiders’ discretion in agreeing to changes or waivers in the terms of the Transactions may result in a conflict of interest when determining whether such changes to the terms of the Transactions or waivers of conditions are appropriate and in FLAG Stockholders’ best interest;

 

   

The NYSE American may not continue to list FLAG Securities, which could limit investors’ ability to make transactions in FLAG Securities and subject FLAG to additional trading restrictions;

 

   

If a stockholder fails to receive notice of FLAG’s offer to redeem FLAG’s public shares in connection with the Business Combination, or fails to comply with the procedures for tendering its shares, such shares may not be redeemed;

 

   

There is no guarantee that a public stockholder’s decision whether to redeem its shares for a pro rata portion of the Trust Account will put the public stockholder in a better future economic position;

 

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Even if FLAG consummates the Business Combination, there is no guarantee that the FLAG Public Warrants will ever be in the money, and they may expire worthless;

 

   

If third parties bring claims against FLAG, the proceeds held in the Trust Account could be reduced and the per share redemption amount received by stockholders may be less than $10.00 per share;

 

   

FLAG’s directors may decide not to enforce the indemnification obligations of FLAG’s Sponsor, resulting in a reduction in the amount of funds in the Trust Account available for distribution to FLAG’s public stockholders;

 

   

If, after FLAG distributes the proceeds in the Trust Account to FLAG’s public stockholders, FLAG files a bankruptcy petition or an involuntary bankruptcy petition is filed against it that is not dismissed, a bankruptcy court may seek to recover such proceeds, and the members of the FLAG Board may be viewed as having breached their fiduciary duties to FLAG’s creditors, thereby exposing the members of the FLAG Board and FLAG to claims of punitive damages;

 

   

If, before distributing the proceeds in the Trust Account to FLAG’s public stockholders, FLAG files a bankruptcy petition or an involuntary bankruptcy petition is filed against it that is not dismissed, the claims of creditors in such a proceeding may have priority over the claims of FLAG Stockholders and the per-share amount that would otherwise be received by FLAG Stockholders in connection with FLAG’s liquidation may be reduced;

 

   

If FLAG is unable to complete the Business Combination, all FLAG Warrants will expire worthless;

 

   

FLAG’s public stockholders may be held liable for claims by third parties against FLAG to the extent of distributions received by them upon redemption of their shares;

 

   

FLAG has no operating history and its results of operations and those of Calidi may differ significantly from the unaudited pro forma combined financial information included in this proxy statement/prospectus;

 

   

Following the consummation of the Business Combination, New Calidi’s only significant asset will be its ownership interest in the New Calidi business, and such ownership may not be sufficiently profitable or valuable to enable New Calidi to satisfy New Calidi’s other financial obligations. New Calidi does not anticipate paying any cash dividends for the foreseeable future;

 

   

The Proposed Charter will provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between New Calidi and its stockholders and that the federal district courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit New Calidi stockholders’ ability to obtain a favorable judicial forum for disputes with it or its directors, officers or employees or the underwriters or any offering giving rise to such claim;

 

   

A market for New Calidi’s securities may not continue, which would adversely affect the liquidity and price of New Calidi’s securities;

 

   

FLAG does not have a specified maximum redemption threshold. The absence of such a redemption threshold may make it possible for FLAG to complete the Business Combination with which a substantial majority of FLAG Stockholders do not agree; and

 

   

FLAG may be subject to a new 1% U.S. federal excise tax in connection with redemptions of FLAG Common Stock.

Sources and Uses of Funds for the Transactions

The following table summarizes the sources and uses for funding the Transactions. These figures assume (i) that no public stockholders exercise their redemption rights in connection with the Transactions, and (ii) New Calidi

 

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issues 25,000,000 shares of New Calidi Common Stock to the Calidi Stockholders and reserves [●] shares of New Calidi Common Stock for potential future issuance upon the exercise of New Calidi Options or settlement of New Calidi RSUs as part of the Merger Consideration pursuant to the Merger Agreement. These figures do not reflect the issuance of certain term loans by Calidi and FLAG, respectively, which are expected to mature and be paid off at Closing. If the actual facts are different from these assumptions, then the amounts and shares outstanding after the Closing will be different and those changes could be material.

 

Sources

    

Uses

 
($ in millions)  

Cash and investments held in trust account

     42      Cash to balance sheet      30  
      Transaction expenses(1)      12  

FLAG Stockholders

     250      FLAG Stockholders      250  
  

 

 

       

 

 

 

Total sources

     292     

Total uses

     292  
  

 

 

       

 

 

 

 

(1)

Transaction expenses are comprised of FLAG’s legal fees of approximately $6.0 million, Calidi’s legal fees of approximately $2.2 million, D&O insurance expense, including tail policy, of approximately $1.6 million, Benchmark’s fee in connection with the fairness opinion of $300,000 and administrative costs relating to SEC and state filing fees, financial printing fees and mailing and proxy solicitation of approximately $1.9 million.

 

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This proxy statement/prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include, among other things, statements about the parties’ ability to close the Business Combination, the timing of the Closing of the Business Combination, the anticipated benefits of the Business Combination, the financial conditions, results of operations, earnings outlook and prospects of FLAG, Calidi and New Calidi and the period following the consummation of the Business Combination. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would,” “will,” “seek,” “target,” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements are based on information available as of the date of this proxy statement/prospectus and on the current expectations, forecasts and assumptions of the management of FLAG and Calidi, involve a number of judgments, risks and uncertainties and are inherently subject to changes in circumstances and their potential effects and speak only as of the date of such statements. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed, contemplated or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in “Risk Factors,” those discussed and identified in public filings made with the SEC by FLAG and the following:

 

   

changes in domestic and foreign business, market, financial, political and legal conditions;

 

   

the inability of the parties to successfully or timely consummate the proposed Transactions, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect Calidi or the expected benefits of the proposed Transactions or that the approval of the shareholders of FLAG or Calidi is not obtained;

 

   

the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement;

 

   

the potential inability to maintain the listing of FLAG Securities with the NYSE American;

 

   

the outcome of any legal proceedings that may be instituted against FLAG or Calidi following announcement of the proposed Transactions;

 

   

failure to realize the anticipated benefits of the proposed Transactions;

 

   

unanticipated costs related to the Transactions and the potential failure to realize anticipated benefits of the proposed Business Combination or to realize estimated pro forma results and underlying assumptions, including with respect to estimated shareholder redemptions;

 

   

potential exercise of appraisal rights by some Calidi Stockholders, which may reduce available cash;

 

   

the effect of the announcement or pendency of the proposed Business Combination on Calidi’s business relationships, operating results, and business generally;

 

   

risks that the proposed Business Combination disrupts current plans and operations of Calidi;

 

   

the need to obtain regulatory approval for Calidi’s product candidates;

 

   

the risk that preclinical studies and any ensuing clinical trials will not demonstrate that Calidi’s product candidates are safe and effective;

 

   

the risk that Calidi’s product candidates will have adverse side effects or other unintended consequences, which could impair their necessary governmental approvals or marketability;

 

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the risk that Calidi’s product candidates do not satisfy other legal and regulatory requirements for marketability in one or more jurisdictions;

 

   

the risks of enhanced regulatory scrutiny of solutions utilizing oncolytic viruses or human stem cells as a basis;

 

   

the potential inability to achieve Calidi’s goals regarding scalability, affordability and speed of commercialization of its product candidates;

 

   

the anticipated need for additional capital to achieve Calidi’s business goals;

 

   

changes in the industries in which Calidi operates;

 

   

changes in laws and regulations affecting the business of Calidi;

 

   

the amount of redemption requests made by FLAG public stockholders;

 

   

the ability of FLAG or Calidi to issue equity or equity-linked securities in connection with the proposed Transactions or in the future;

 

   

the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and

 

   

the impact of the global COVID-19 pandemic on FLAG, Calidi, or New Calidi’s projected results of operations, financial performance or other financial metrics, or on any of the foregoing risks.

The forward-looking statements contained in this proxy statement/prospectus are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward- looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors.” Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Before a stockholder grants its proxy or instructs how its vote should be cast or votes on the Business Combination Proposal, the Charter Proposal, the Governance Proposal, the Incentive Plan Proposal, the New Board Proposal, the NYSE American Proposal or the Adjournment Proposal, it should be aware that the occurrence of the events described in the “Risk Factors” section and elsewhere in this proxy statement/prospectus may adversely affect us.

 

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RISK FACTORS

Stockholders should carefully consider the following risk factors, together with all of the other information included in this proxy statement/prospectus, before they decide whether to vote or instruct their vote to be cast to approve the proposals described in this proxy statement/prospectus. The following risk factors apply to the business and operations of Calidi and will also apply to the business and operations of New Calidi following the completion of the Business Combination. The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may adversely affect the ability to complete or realize the anticipated benefits of the Business Combination, and may have an adverse effect on the business, cash flows, financial condition and results of operations of New Calidi. You should also carefully consider the following risk factors in addition to the other information included in this proxy statement/prospectus, including matters addressed in the section entitled “Cautionary Note Regarding Forward-Looking Statements.” FLAG or Calidi may face additional risks and uncertainties that are not presently known to FLAG or Calidi, or that we or Calidi currently deem immaterial, which may also impair FLAG’s or Calidi’s business or financial condition. The following discussion should be read in conjunction with the financial statements and notes to the financial statements included herein.

Risks Related to Calidi’s Business

Following the Business Combination, FLAG will be a holding company with no direct operations that relies on dividends, distributions, loans and other payments, advances and transfers of funds from Calidi to pay dividends, pay expenses and meet its other obligations. Accordingly, FLAG’s securityholders will be subject to all of the risks of the businesses of Calidi following the Business Combination. Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us” or “our” refer to the business of Calidi prior to the consummation of the Business Combination, which will be the business of New Calidi following the consummation of the Business Combination. Accordingly, the risks described below relating to Calidi could also materially and adversely affect New Calidi after the consummation of the Business Combination.

Risks Related to Our Business, Financial Position and Capital Requirements

We are a biopharmaceutical company with a limited operating history and have not generated any revenue to date from product sales.

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We were incorporated under the laws of the State of Delaware in August 2015 as StemImmune, Inc. and reincorporated into the State of Nevada in June 2019 as Calidi Biotherapeutics, Inc. Since inception, we have focused substantially all of our efforts and financial resources on raising capital and developing our initial product candidates. We have incurred net losses since our inception, and we had an accumulated deficit of approximately $70.4 million as of December 31, 2022. For the years ended December 31, 2022 and December 31, 2021, we reported net losses of $25.4 million and $10.9 million, respectively. We have no products approved for commercial sale and, therefore, have never generated any revenue from product sales, and we do not expect to do so in the foreseeable future. We have not obtained regulatory approvals for any of our product candidates, and even if our clinical development efforts result in positive data, our product candidates may not receive regulatory approval or be successfully introduced and marketed at prices that would permit us to operate profitably. We expect to continue to incur significant expenses and operating losses over the next several years and for the foreseeable future. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ deficit and working capital.

We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future.

Substantially all of our operating losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect our

 

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research and development expenses to significantly increase in connection with the commencement and continuation of clinical trials of our product candidates. In addition, if we obtain marketing approval for our product candidates, we will incur significant sales, marketing and manufacturing expenses. Upon the completion of our Business Combination, we will incur additional costs associated with operating as a public company. As a result, we expect to continue to incur significant and increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing biopharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if at all. Even if we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis.

The amount of our future losses is uncertain, and our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline. Our quarterly and annual operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following:

 

   

the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;

 

   

our ability to successfully enroll and retain subjects for clinical trials, and any delays caused by difficulties in such efforts;

 

   

our ability to obtain marketing approval for our product candidates, and the timing and scope of any such approvals we may receive;

 

   

the changing and volatile U.S. and global economic environments, including as a result of the COVID-19 pandemic;

 

   

the timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may change from time to time;

 

   

the cost of manufacturing our product candidates, which may vary depending on the quantity of production, and the success of achieving commercial scale manufacturing operations in our new facility or at third-party manufacturers;

 

   

our ability to attract, hire and retain qualified personnel;

 

   

expenditures that we will or may incur to develop additional product candidates;

 

   

the level of demand for our product candidates should they receive approval, which may vary significantly;

 

   

the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future therapeutics that compete with our product candidates; and

 

   

future accounting pronouncements or changes in our accounting policies.

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.

 

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We have no products approved for commercial sale and have not generated any revenue from product sales.

Our ability to become profitable depends upon our ability to generate revenue. To date, we have not generated any revenue from our product candidates, and we do not expect to generate any revenue from the sale of products in the near future, if any. We do not expect to generate significant revenue unless and until we obtain marketing approval of, and begin to sell, one or more of our product candidates. Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to:

 

   

successfully complete our ongoing and planned preclinical studies and clinical trials for our allogeneic stem cell delivery of on oncolytic virus programs;

 

   

timely file and receive acceptance of our Investigational New Drug applications, or INDs, in order to commence our planned clinical trials or future clinical trials;

 

   

successfully enroll subjects in, and complete, clinical trials for our oncolytic viral allogeneic stem cell programs;

 

   

implement measures to help minimize the risk of COVID-19 to our employees as well as patients enrolled in our trials;

 

   

timely file Biologics License Applications (“BLAs”) and receive regulatory approvals for our product candidates from the FDA and other regulatory authorities;

 

   

initiate and successfully complete all safety studies required to obtain U.S. and foreign marketing approval for our product candidates;

 

   

establish commercial manufacturing capabilities through third-party manufacturers for clinical supply and commercial manufacturing of our product candidates;

 

   

obtain and maintain patent and trade secret protection or regulatory exclusivity for our product candidates;

 

   

launch commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;

 

   

maintain a continued acceptable safety profile of the product candidates following approval;

 

   

obtain and maintain acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors;

 

   

position our products to effectively compete with other therapies;

 

   

obtain and maintain favorable coverage and adequate reimbursement by third-party payors for our product candidates;

 

   

enforce and defend intellectual property rights and claims with respect to our product candidates; and

 

   

hire additional staff, including clinical, scientific and management personnel.

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would materially harm our business. If we do not receive regulatory approvals for our product candidates, we may not be able to continue our operations.

Our engineered allogeneic stem cell product candidates represent a novel approach to cancer treatment that creates significant challenges.

We are developing a pipeline of allogeneic stem cell product candidates engineered from healthy donor adipose-derived mesenchymal stem cells to potentiate and deliver oncolytic viruses to the tumor site and are intended for

 

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use in any patient with certain cancers. Advancing these novel product candidates creates significant challenges for us, including:

 

   

manipulating and manufacturing our product candidates to required specifications and in a timely manner to support our clinical trials, and, if approved, commercialization;

 

   

sourcing clinical and, if approved, commercial supplies of adipose and neuronal stem- and other cell types used to manufacture our product candidates;

 

   

understanding and addressing intra-donor variability in the quality and type of donor-derived stem cells, which could ultimately negatively affect our ability to produce a product reliably and consistently, if at all;

 

   

understanding and addressing the sourcing of stem cells for our product candidates;

 

   

educating medical personnel regarding the potential side effect profile of our product candidates, if approved, such as the potential for serious adverse events;

 

   

using medicines to manage adverse side effects or the potential for serious adverse events of our product candidates which may not adequately control such side effects or serious adverse events, and/or may have a detrimental impact on the efficacy of treatment;

 

   

conditioning patients with chemotherapy and possibly checkpoint inhibitors in advance of administering our product candidates, which may increase the risk of adverse side effects or serious adverse events;

 

   

obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with the development and regulation of allogeneic stem cell therapies for cancer; and

 

   

establishing sales and marketing capabilities upon obtaining regulatory approval, if any, in order to gain market acceptance of a novel therapy.

Adverse publicity regarding stem cell-based immunotherapy could have a material adverse impact on our business.

Although we are not utilizing embryonic stem cells, we utilize neural stem cells that have been derived from fetal tissue. Adverse publicity due to ethical and social controversies surrounding the use of such cells or any adverse reported side effects from any stem cell, dendritic or other cell therapy clinical trial or due to the failure of such trials to demonstrate that these therapies are efficacious could materially and adversely affect our ability to raise capital or recruit managerial or scientific personnel or obtain research grants. In addition, in August of 2017, when we were formerly known as StemImmune, Inc. we experienced adverse publicity when the FDA incorrectly identified us as a Stem Cell Clinic, associated with Stem Cell Clinics that the FDA subsequently sued in federal court for alleged violations of the Federal Food, Drug and Cosmetics Act. While we were never named in the FDA’s litigation, our business was temporarily disrupted and our management was forced to spend time correcting the misinformation and rebuilding our reputation with the FDA and state regulatory authorities. Because the use of human stem cells may be controversial to some segments of society, we may experience adverse publicity again, which may disrupt our business and distract our executive management from executing on our business plan.

Even if we consummate the Business Combination, we will need to raise substantial additional funding. If we are unable to raise capital when needed, or if at all, we would be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts.

The development of biopharmaceutical products is capital intensive. We are currently advancing our product candidates through pre-clinical testing and clinical development across a number of potential indications. We have in-licensed our lead product candidate CLD-101 for newly diagnosed high grade glioma (“HGG”) that has

 

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completed a Phase 1 clinical trial sponsored by Northwestern University. We intend to initiate a Phase 1b or Phase 2 clinical trial under our in-licensed IND for CLD-101 for patients with newly diagnosed HGG. Our second program using our SuperNova technology has completed a limited physician investigator-sponsored pre-IND open-label, nonrandomized dose-escalation study prospectively reviewed by the International Cell Surgical Society Institutional Review Board. This study involved a TK-positive oncolytic vaccinia virus delivered by autologous adipose stromal vascular fraction stem cells and was completed in 2018. Since the completion of the study, the FDA has asserted that in-human studies involving autologous adipose stromal vascular fraction stem cells are regulated under the Federal Food, Drug, and Cosmetics Act and require an IND from the FDA in order to conduct clinical trials. We intend to apply for an IND from the FDA and initiate a Phase 1 clinical trial for our product candidate CLD-201 that utilizes allogeneic adipose-derived mesenchymal stem cell (“AD-MSC”) line VP-001 loaded with tumor selective “CAL1” oncolytic vaccinia virus strain. Consequently, we expect our expenses to significantly increase in connection with our ongoing activities, particularly as we continue our pre-clinical studies and initiate our planned clinical trials or initiate future trials on other product candidates and pursue the research and development of, and seek marketing approval for, our product candidates. In addition, depending on the status of regulatory approvals or, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our product candidates or otherwise expand more rapidly than we presently anticipate. Furthermore, upon the consummation of the Business Combination, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate certain of our research and development programs or future commercialization efforts, and may be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

Our future capital requirements will depend on and could increase significantly as a result of many factors, including:

 

   

the scope, progress, results and costs of product discovery, preclinical and clinical development, laboratory testing and clinical trials for the development of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201, or our other potential product candidates;

 

   

the timing of, and the costs involved in, obtaining marketing approvals for CLD-101 in newly diagnosed HGG, CLD-101 for recurrent HGG as well as for CLD-201 in our initial target indications and our other potential product candidates that we may develop;

 

   

if approved, the costs of commercialization activities for CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG or CLD-201 for any approved indications or any other product candidate that receives regulatory approval to the extent such costs are not the responsibility of a collaborator that we may contract with in the future, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;

 

   

the potential additional expenses attributable to adjusting our development plans (including any supply related matters) to the COVID-19 pandemic;

 

   

the scope, prioritization and number of our research and development programs;

 

   

the costs, timing and outcome of regulatory review of our product candidates;

 

   

our ability to establish and maintain additional collaborations on favorable terms, if at all;

 

   

the achievement of milestones or occurrence of other developments that trigger payments under any additional collaboration agreements we may enter into;

 

   

the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under future collaboration agreements, if any;

 

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the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

 

   

the extent to which we acquire or in-license other product candidates and technologies;

 

   

the costs of securing manufacturing arrangements for commercial production;

 

   

the emergence of competing oncolytic viral immunotherapies as well as immuno-oncology therapies in general and other adverse market developments;

 

   

the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates; and

 

   

the ongoing impact of the COVID-19 pandemic, which may exacerbate the magnitude of the factors discussed above.

Identifying potential product candidates and conducting preclinical development testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Disruptions in the financial markets in general have made equity and debt financing more difficult to obtain, and may have a material adverse effect on our ability to meet our fundraising needs. We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing, including a potential private investment in public equity, if any, may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product candidate or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

We may incur significant cash payment obligations under our in-licensing agreements with Northwestern University and City of Hope.

We have entered into certain agreements with Northwestern and City of Hope, in which we are committed to pay up to $10 million in clinical trial costs for CLD-101 for newly diagnosed HGG and CLD-101 for recurrent HGG. Furthermore, we have agreed to pay contingent consideration of up to $18.7 million if certain development milestones related to CLD-101 for newly diagnosed HGG and CLD-101 for recurrent HGG are achieved.

To meet these various cash payment obligations, we may need to sell additional shares of our common stock or other securities or issue debt to raise the required cash, or we may have to divert cash on hand that we would

 

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otherwise use for other business and operational purposes, which could cause us to delay or reduce activities in the development and commercialization of our programs and which may have a material adverse effect on our business, operating results and prospects.

Risks Related to Product Development

Our business is highly dependent on the success of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG and CLD-201. If we are unable to obtain approval for CLD-101 for newly diagnosed HGG, CLD-201, or CLD-101 for recurrent HGG and effectively commercialize any of these product candidates for the treatment of patients in its approved indications, our business would be significantly harmed.

Our business and future success depend on our ability to obtain regulatory approval of, and then successfully commercialize, our most advanced product candidate, CLD-101 for newly diagnosed HGG. CLD-101 for newly diagnosed HGG is in the early stages of development and has only been administered to a limited number of patients in a Phase 1 physician-sponsored clinical trial. The results to date may not predict outcomes for our planned trial or any future studies of CLD-101 for newly diagnosed HGG or any other allogeneic neural stem cell product candidate. Because CLD-101 for newly diagnosed HGG is the first allogeneic product to be evaluated in the clinic, its failure, or the failure of other allogeneic neural stem cell therapies, may significantly influence physicians’ and regulators’ opinions regarding the viability of our entire pipeline of allogeneic neural stem cell therapies. We are also dependent on Northwestern University to conduct an additional non-pivotal CLD-101 for newly diagnosed HGG Phase 1 trial in a timely and appropriate manner so that we can sponsor the pivotal Phase 2 trial for CLD-101 for newly diagnosed HGG. If Northwestern University does not conduct the trial on the timeline we expect, or otherwise fails to support the trial, our leadership position in the allogeneic neural stem cell industry and ability to progress additional product candidates may be significantly harmed.

Our product candidates, including CLD-101 for newly diagnosed HGG, CLD-201 and CLD-101 for recurrent HGG, will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, a substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. In addition, because CLD-101 for newly diagnosed HGG is our most advanced product candidate and our other product candidates are based on similar technology, if CLD-101 for newly diagnosed HGG encounters safety or efficacy problems, manufacturing problems, developmental delays, regulatory issues, or other problems, our development plans and business would be significantly harmed.

Our preclinical studies and clinical trials may fail to demonstrate adequately the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval, and commercialization.

Before obtaining regulatory approvals for the commercial sale of our product candidates, including CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any other product candidates we develop, we must demonstrate the safety and efficacy of our product candidates for use in each target indication through lengthy, complex, and expensive preclinical studies and clinical trials. Failure can occur at any time during the preclinical study and clinical trial processes and there is a high risk of failure, so we may never succeed in developing marketable products. Any preclinical studies or clinical trials that we may conduct may not demonstrate the safety and efficacy necessary to obtain regulatory approval to market any of our product candidates. If the results of our ongoing or future preclinical studies and clinical trials are inconclusive with respect to the safety and efficacy of our product candidates, if we do not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with our product candidates, we may be prevented or delayed in obtaining marketing approval for such product candidates. In some instances, there can be significant variability in safety or efficacy results between different preclinical studies and clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and

 

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adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. While we are currently planning for either a physician-sponsored Phase 1b or a company-sponsored Phase 2 clinical trial for CLD-101 for newly diagnosed HGG and are in early stages of clinical development for CLD-101 for recurrent HGG and CLD-201, it is likely, as is the case with many oncology therapies, that there may be side effects associated with their use.

Results of our trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, our trials could be suspended or terminated, and the FDA or other regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.

Interim, top line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to regulatory audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim, top line or preliminary data from our clinical trials. We may decide to conduct an interim analysis of the data after a certain number or percentage of patients have been enrolled, or after only a part of the full follow-up period but before completion of the trial. Similarly, we may report top line or preliminary results of primary and key secondary endpoints before the final trial results are completed. Preliminary, top line and interim data from our clinical trials may change as more patient data or analyses become available. Preliminary, top line or interim data from our clinical trials are not necessarily predictive of final results and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, more patient data become available and we issue our final clinical trial report. These data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, preliminary, interim and top line data should be viewed with caution until the final data are available. Material adverse changes in the final data compared to the interim data could significantly harm our business prospects.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure.

If the interim, topline, or preliminary data that we report differ from more complete results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain marketing authorization for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

Results of earlier studies and trials of our product candidates may not be predictive of future trial results.

Success in preclinical studies and early clinical trials does not ensure that later clinical trials will be successful. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. As we commence new clinical trials and continue our ongoing clinical trials, issues may arise that could suspend or terminate such clinical trials. A number of companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in clinical trials, even after positive results in earlier preclinical studies or clinical trials. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway and safety or

 

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efficacy observations made in clinical trials, including previously unreported adverse events. Notwithstanding any potential promising results in earlier studies and trials, we cannot be certain that we will not face similar setbacks. In addition, the results of our preclinical animal studies, including our oncology mouse studies and animal studies, may not be predictive of the results of outcomes in human clinical trials. For example, our oncology product candidates that are in preclinical development may demonstrate different chemical and biological properties in patients than they do in laboratory animal studies or may interact with human biological systems in unforeseen or harmful ways.

Additionally, some of past, ongoing and planned clinical trials utilize and “open-label” study design. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect, as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. Moreover, patients selected for early clinical studies often include the most severe sufferers and their symptoms may have improved notwithstanding the new treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge.

Our product candidates are based on a novel approach to the treatment of cancer using allogeneic neural stem cells and allogeneic adipose-derived mesenchymal stem cell (“AD-MSC”) loaded with an oncolytic virus, which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval, if at all.

We have concentrated all of our research and development efforts on our CLD-101 for newly diagnosed HGG and CLD-201 product candidates, and our future success depends on the successful development of these therapeutic approaches. In particular, CLD-101 for newly diagnosed HGG utilizes NSC-CRAd-S-pk7, an engineered oncolytic adenovirus delivered by neural stem cells to activate the innate and adaptive immune system. To our knowledge, there are no FDA-approved products for the treatment of cancer that utilize the adenovirus.

We expect the novel nature of our product candidates using allogeneic neural stem cells and allogeneic adipose-derived mesenchymal stem cells (“AD-MSC”) to create significant challenges in obtaining regulatory approval. Few viral immunotherapies have been approved globally or by the FDA to date. While the first viral immunotherapy, talimogene laherparepvec (Imlygic, Amgen), has received FDA approval, regulatory agencies have reviewed relatively few viral immunotherapy product candidates such as CLD-101 for newly diagnosed HGG and CLD-201. This may lengthen the regulatory review process, increase our development costs and delay or prevent commercialization of our product candidates. Further, any viral immunotherapies that are approved may be subject to extensive post-approval regulatory requirements, including requirements pertaining to manufacturing, distribution and promotion. We may need to devote significant time and resources to compliance with these requirements.

The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of the product candidates based on the completed clinical trials, as the FDA often adheres to the Advisory Committee’s recommendations. Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

In addition, our product candidates are live, gene-modified viruses for which the FDA, and other regulatory authorities and other public health authorities, such as the Centers of Disease Control and Prevention and

 

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hospitals involved in clinical studies, have established heightened safety and contagion rules and procedures, which could establish additional hurdles for the development, manufacture or use of our vectors. These hurdles may lead to delays in the conduct of clinical trials or in obtaining regulatory approvals for further development, manufacturing or commercialization of our product candidates. We may also experience delays in transferring our process to commercial partners, which may prevent us from completing our clinical trials or commercializing our product candidates on a timely or profitable basis, if at all.

Furthermore, there has been limited historical clinical trial experience for the development of products that utilize the adenovirus. Moreover, the design and conduct of our clinical trials utilizing both neural stem cells and adipose-derived mesenchymal stem cells (“AD-MSC”) to deliver oncolytic viruses differs from the design and conduct of previously conducted clinical trials in this area. As a result, there is substantial risk that the design or outcomes of our clinical trials will not be satisfactory to support marketing approval.

We may develop our product candidates in combination with other therapies, which exposes us to additional risks related to other agents or active pharmaceutical or biological ingredients used in combination with our product candidates.

In the future, we may develop our product candidates to be used with one or more currently approved other therapies. Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or other regulatory authorities could revoke approval of the therapy used in combination with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with these existing therapies. Combination therapies are commonly used for the treatment of cancer, and we would be subject to similar risks if we develop any of our product candidates for use in combination with other drugs or for indications other than cancer. This could result in our own products being removed from the market or being less successful commercially.

If the FDA or other regulatory authorities revoke their approval of these other drugs or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with, the drugs we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval.

We may also evaluate our future product candidates in combination with one or more other cancer therapies that have not yet been approved for marketing by the FDA or other regulatory authorities. We will not be able to market any product candidate we develop in combination with any such unapproved cancer therapies that do not ultimately obtain marketing approval. In addition, unapproved therapies face the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delays in their clinical trials and lack of FDA approval.

Negative developments in the field of immuno-oncology and, in particular, oncolytic viral immunotherapy, could damage public perception of any of our product candidates and negatively affect our business.

The commercial success of adenovirus we use in our CLD-101 for newly diagnosed HGG and CLD-101 for recurrent HGG product candidates or ACAM2000, a thymidine kinase (TK)-positive strain of vaccinia virus (used as the current smallpox vaccine in the United States) we anticipate using in our CLD-201 product candidate, will depend in part on public acceptance of the use of immuno-oncology, and, in particular, oncolytic viral immunotherapy. Adverse events in clinical trials of CLD-101 for newly diagnosed HGG, CLD-201 or any other adenovirus or any other ACAM2000-based product candidates which we may develop, or in clinical trials of others developing similar products and the resulting publicity, as well as any other negative developments in the field of immuno-oncology that may occur in the future, including in connection with competitor therapies, could result in a decrease in demand for any adenovirus- or ACAM2000-based product candidates that we may develop. These events could also result in the suspension, discontinuation, or clinical hold of or modification to our clinical trials. If public perception is influenced by claims that the use of oncolytic immunotherapies is unsafe, whether related to our therapies or those of our competitors, our product candidates may not be accepted by the general public or the medical community and potential clinical trial subjects may be discouraged from

 

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enrolling in our clinical trials. In addition, responses by national or state governments to negative public perception may result in new legislation or regulations that could limit our ability to develop or commercialize any product candidates, obtain or maintain regulatory approval or otherwise achieve profitability. More restrictive statutory regimes, government regulations or negative public opinion would have an adverse effect on our business, financial condition, prospects and results of operations and may delay or impair the development and commercialization of our product candidates or demand for any products we may develop. As a result, we may not be able to continue or may be delayed in conducting our development programs.

Our product candidates consist of modified viruses. Adverse developments in clinical trials of other immunotherapy products based on viruses, like oncolytic viruses, may result in a disproportionately negative effect for our technologies as compared to other products in the field of infectious disease and immuno-oncology that are not based on viruses. Future negative developments in the biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of our products. Any increased scrutiny could delay or increase the costs of obtaining marketing approval for our product candidates.

Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval.

Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of completion of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we may experience delays in our clinical trials if we encounter difficulties in enrollment. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other regulatory authorities, or as needed to provide appropriate statistical power for a given trial. In particular, because we are focused on patients with brain cancer for the development of CLD-101 for newly diagnosed HGG and CLD-101 for recurrent HGG, our ability to enroll eligible patients may be limited or enrollment may be slower than we anticipate due to the small eligible patient population. In addition, our ability to enroll patients may be significantly delayed by the COVID-19 pandemic and we are unable to predict the full extent and scope of such delays at this point.

In addition to the potentially small target populations for our planned clinical trials, particularly in brain cancer, the eligibility criteria will further limit the pool of available trial participants as we will require that patients have specific characteristics, such as a certain severity or stage of disease progression, to include them in a trial. Additionally, the process of finding eligible patients may prove costly. We also may not be able to identify, recruit, and enroll a sufficient number of patients to complete our clinical trials because of the perceived risks and benefits of the product candidate under evaluation, the availability and efficacy of competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients, and the patient referral practices of physicians. If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of potential products may be delayed.

The enrollment of patients further depends on many factors, including:

 

   

the proximity of patients to clinical trial sites;

 

   

patient referral practices of physicians;

 

   

the design of the clinical trial, including the number of site visits and invasive assessments required;

 

   

our ability to recruit clinical trial investigators with the appropriate competencies and experience;

 

   

our ability to obtain and maintain patient consents;

 

   

reporting of the preliminary results of any of our clinical trials;

 

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the risk that patients enrolled in clinical trials will drop out of the clinical trials before clinical trial completion; and

 

   

factors we may not be able to control, such as the COVID-19 pandemic that may limit patient participation, hiring of principal investigators or staff or clinical site availability.

In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us because some patients who might have opted to enroll in our clinical trials may instead opt to enroll in a clinical trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites. Moreover, because certain of our product candidates represent a departure from more commonly used methods for cancer treatment and because certain of our product candidates have not been tested in humans before, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, rather than enroll patients in any future clinical trial of our product candidates.

If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenue from any of these product candidates could be delayed or prevented.

Even if we receive marketing approval for our current or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales.

The commercial success of our current or future product candidates, if approved by the FDA or other applicable regulatory authorities, will depend upon the awareness and acceptance of our current or future product candidates among the medical community, including physicians, patients and healthcare payors. Market acceptance of our current or future product candidates, if approved, will depend on a number of factors, including, among others:

 

   

the efficacy of our current or future product candidates as demonstrated in clinical trials, and, if required by any applicable regulatory authority in connection with the approval for the applicable indications, to provide patients with incremental health benefits, as compared with other available medicines;

 

   

limitations or warnings contained in the labeling approved for our current or future product candidates by the FDA or other applicable regulatory authorities;

 

   

the prevalence and severity of adverse events associated with our product candidates or those products with which they may be co-administered in immuno-oncology and, in particular, oncolytic viral immunotherapies;

 

   

the clinical indications for which our current or future product candidates are approved;

 

   

availability of alternative treatments already approved or expected to be commercially launched in the near future;

 

   

the potential and perceived advantages of our current or future product candidates over current treatment options or alternative treatments, including future alternative treatments;

 

   

the willingness of the target patient populations to try new therapies or treatment methods and of physicians to prescribe these therapies or methods in immuno-oncology and, in particular, oncolytic viral immunotherapies;

 

   

the need to dose such product candidates in combination with other therapeutic agents, and related costs;

 

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the strength of marketing and distribution support and timing of market introduction of competitive products;

 

   

publicity concerning our products or competing products and treatments;

 

   

pricing and cost effectiveness;

 

   

the effectiveness of our sales and marketing strategies;

 

   

our ability to increase awareness of our current or future product candidates;

 

   

our ability to obtain sufficient third-party coverage or reimbursement;

 

   

the ability or willingness of patients to pay out-of-pocket in the absence of third-party coverage; and

 

   

potential product liability claims.

If our current or future product candidates are approved but do not achieve an adequate level of acceptance by patients, physicians and payors, we may not generate sufficient revenue from our current or future product candidates to become or remain profitable. Before granting reimbursement approval, healthcare payors may require us to demonstrate that our current or future product candidates, in addition to treating these target indications, also provide incremental health benefits to patients. Our efforts to educate the medical community, patient organizations and third-party payors about the benefits of our current or future product candidates may require significant resources and may never be successful.

We face substantial competition, which may result in others discovering, developing or commercializing product candidates before or more successfully than we do.

The development and commercialization of new product candidates is highly competitive. We face competition from major pharmaceutical, specialty pharmaceutical and biotechnology companies among others with respect to CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG and CLD-201 and will face similar competition with respect to any product candidates that we may seek to develop or commercialize in the future. We compete in pharmaceutical, biotechnology and other related markets that develop immuno-oncology therapies for the treatment of cancer. There are other companies working to develop viral immunotherapies for the treatment of cancer, including divisions of large pharmaceutical and biotechnology companies of various sizes. The large pharmaceutical and biotechnology companies that have commercialized and/or are developing immuno-oncology treatments for cancer include AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, Merck, Novartis, Pfizer and Roche/Genentech.

Some of the products and therapies developed by our competitors are based on scientific approaches that are the same as or similar to our approach, including with respect to the use of viral immunotherapy with adenovirus and other oncolytic viruses. Other competitive products and therapies are based on entirely different approaches. We are aware that Oncorus, Replimune, Amgen, Immavir, Fergene and IconOVir, among others, are developing viral immunotherapies that may have utility for the treatment of indications that we are targeting. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Many of the companies we compete against or may compete against in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved drugs than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in concentration of even more resources among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management

 

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personnel, in establishing clinical trial sites and enrolling subjects for our clinical trials and in acquiring technologies complementary to, or necessary for, our programs.

We could see a reduction or elimination of our commercial opportunity if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, or are more convenient or are less expensive than any products that we or our collaborators may develop. Our competitors also may obtain FDA or foreign regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. The key competitive factors affecting the success of all our product candidates, if approved, are likely to be their efficacy, safety, convenience and price, and if required, the level of biosimilar or generic competition and the availability of reimbursement from government and other third-party payors.

Risks Related to Government Regulation and Commercialization of Our Product Candidates

The regulatory approval processes of the FDA and other regulatory authorities are lengthy, time consuming and inherently unpredictable. If Calidi is not able to obtain, or experience delays in obtaining, required regulatory approvals, Calidi will not be able to commercialize CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates as expected, and Calidi’s ability to generate revenue may be materially impaired.

The time required to obtain approval by the FDA and other regulatory authorities is unpredictable, but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. These regulatory requirements may require us to amend our clinical trial protocols, including to comply with the protocols of any applicable Special Protocol Assessment (“SPA”) we receive from the FDA; conduct additional preclinical studies or clinical trials that may require regulatory or independent institutional review board, or IRB, approval; or otherwise cause delays in obtaining approval or rejection of an application. Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability to generate revenue from the particular product candidate, which may materially harm our business, financial condition, results of operations, stock price and prospects. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. The number and types of preclinical studies and clinical trials that will be required for regulatory approval also varies depending on the product candidate, the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular product candidate. Approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, and there may be varying interpretations of data obtained from preclinical studies or clinical trials, any of which may cause delays or limitations in the approval or a decision not to approve an application. It is possible that CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates will never obtain the appropriate regulatory approvals necessary for us to commence product sales.

Further, clinical trials by their nature utilize a sample of the potential patient population. With a limited number of patients and limited duration of exposure, rare and severe side effects of a product candidate may only be uncovered when a significantly larger number of patients are exposed to the product candidate or when patients are exposed for a longer period of time.

Undesirable side effects caused by CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any future product candidates could also result in denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications or the inclusion of unfavorable information in our product labeling, such as limitations on the indicated uses for which the products may be marketed or distributed, a label with

 

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significant safety warnings, including boxed warnings, contraindications, and precautions, a label without statements necessary or desirable for successful commercialization, or may result in requirements for costly post-marketing testing and surveillance, or other requirements, including REMS, to monitor the safety or efficacy of the products, and in turn prevent us from commercializing and generating revenues from the sale of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates. Any such limitations or restrictions could similarly impact any supplemental marketing approvals we may obtain for CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG and CLD-201. Undesirable side effects may limit the potential market for any approved products or could result in restrictions on manufacturing processes, the discontinuation of the sales and marketing of the product, or withdrawal of product approvals. We could also be sued and held liable for harm caused to patients, or become subject to fines, injunctions or the imposition of civil or criminal penalties.

If CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates are associated with serious adverse events or undesirable side effects or have properties that are unexpected, we may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. The therapeutic-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may materially harm our business, financial condition, results of operations, stock price and prospects.

A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.

We may seek Breakthrough Therapy designation for some or all of our future product candidates. A Breakthrough Therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug or biologic may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Sponsors of product candidates that have been designated as Breakthrough Therapies are eligible to receive more intensive FDA guidance on developing an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. Drugs and biologics designated as Breakthrough Therapies by the FDA may also be eligible for other expedited approval programs, including accelerated approval.

Designation as a Breakthrough Therapy is within the discretion of the FDA. Accordingly, even if we believe one of our product candidates meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy designation for a product candidate may not result in a faster development process, review or approval compared to product candidates developed and considered for approval that have not received Breakthrough Designation and does not assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualify as Breakthrough Therapies, the FDA may later decide that the product no longer meets the conditions for qualification. Thus, even though we may seek Breakthrough Therapy designation for CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or some or all of our future product candidates for the treatment of various cancers, there can be no assurance that we will receive breakthrough therapy designation.

Accelerated approval by the FDA, even if granted for certain of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.

We may seek approval of certain of our current or future product candidates using the FDA’s accelerated approval pathway. A product may be eligible for accelerated approval if it treats a serious or life-threatening condition, generally provides a meaningful advantage over available therapies, and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. As a condition of approval, the FDA may

 

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require that a sponsor of a product receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. These confirmatory trials must be completed with due diligence by the sponsor. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product. Even if we do receive accelerated approval, we may not experience a faster development or regulatory review or approval process, and receiving accelerated approval does not provide assurance of ultimate full FDA approval.

Even if our development efforts are successful, we may not obtain regulatory approval of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any future product candidates in the United States or other jurisdictions, which would prevent us from commercializing CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates. Even if we obtain regulatory approval for CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates, any such approval may be subject to limitations, including with respect to the approved indications or patient populations, which could impair our ability to successfully commercialize CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any future product candidates.

We are not permitted to market or promote or sell CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any future product candidates before we receive regulatory approval from the FDA or other regulatory authorities, and we may never receive such regulatory approval. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy for that indication. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities and clinical trial sites by, the regulatory authorities. If we do not receive approval from the FDA and other regulatory authorities for any of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates, we will not be able to commercialize such product candidates in the United States or in other jurisdictions. If significant delays in obtaining approval for and commercializing CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates occur in any jurisdictions, our business, financial condition, results of operations, stock price and prospects will be materially harmed. Even if CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates are approved, they may:

 

   

be subject to limitations on the indicated uses or patient populations for which they may be marketed, distribution restrictions, or other conditions of approval;

 

   

not be approved with label statements necessary or desirable for successful commercialization; or

 

   

contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of a Risk Evaluation and Mitigation Strategy, or REMS, to monitor the safety or efficacy of the products.

We have not previously submitted a Biologics License Application, or BLA, to the FDA, or a similar marketing application to other regulatory authorities, for CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any product candidate, and we can provide no assurance that we will ultimately be successful in obtaining regulatory approval for claims that are necessary or desirable for successful marketing, if at all.

Changes in product candidate manufacturing or formulation may result in additional costs or delay.

As product candidates are developed through preclinical studies to later-stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Any of these changes could cause CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any future product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. Changes in third-party manufacturers and manufacturing processes may also require additional testing, or notification to, or approval by the FDA or another regulatory authority. Such changes could be further delayed due to development of commercial scale manufacturing operations in our

 

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new facility or at third-party manufacturers. This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates and jeopardize our ability to commence product sales and generate revenue.

Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Separately, in response to the COVID-19 pandemic, on March 10, 2020, the FDA announced its intention to postpone most inspections of foreign manufacturing facilities and products while local, national and international conditions warrant. On March 18, 2020, the FDA announced its intention to temporarily postpone routine surveillance inspections of domestic manufacturing facilities and provided guidance regarding the conduct of clinical trials, which the FDA continues to update. As of June 23, 2020, the FDA noted it was continuing to ensure timely reviews of applications for medical products during the COVID-19 pandemic in line with its user fee performance goals and conducting mission critical domestic and foreign inspections to ensure compliance of manufacturing facilities with FDA quality standards. On July 16, 2020, the FDA noted that it is continuing to expedite oncology product development with its staff teleworking full-time. However, the FDA may not be able to continue its current pace and approval timelines could be extended, including where a pre-approval inspection or an inspection of clinical sites is required, in particular due to the COVID-19 pandemic and related travel restrictions. As of July 2020, utilizing a rating system to assist in determining when and where it is safest to conduct such inspections based on data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments, the FDA is either continuing to, on a case-by-case basis, conduct only mission critical inspections, or, where possible to do so safely, resuming prioritized domestic inspections, which generally include pre-approval inspections. Foreign pre-approval inspections that are not deemed mission-critical remain postponed, while those deemed mission-critical will be considered for inspection on a case-by-case basis. The FDA will use similar data to inform resumption of prioritized operations abroad as it becomes feasible and advisable to do so. The FDA may not be able to maintain this pace and delays or setbacks are possible in the future. Should the FDA determine that an inspection is necessary for approval, and an inspection cannot be completed during the review cycle due to restrictions on travel, the FDA has stated that it generally intends to issue a complete response letter. Further, if there is inadequate information to make a determination on the acceptability of a facility, the FDA may defer action on the application until an inspection can be completed. In 2020, several companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. Regulatory authorities outside the U.S. may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic and may experience

 

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delays in their regulatory activities. If a prolonged government shutdown or other disruption occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact our business by delaying review of our public filings, to the extent such review is necessary, and our ability to access the public markets.

Even if CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any future product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense and limit how we manufacture and market our products.

Any product candidate for which we may obtain marketing approval will be subject to extensive and ongoing requirements of and review by the FDA and other regulatory authorities, including requirements related to the manufacturing processes, post-approval clinical data, labeling, packaging, distribution, adverse event reporting, storage, recordkeeping, export, import, advertising, marketing, and promotional activities for such product. These requirements further include submissions of safety and other post-marketing information, including manufacturing deviations and reports, registration and listing requirements, the payment of annual fees, continued compliance with current good manufacturing practice, or cGMP, requirements relating to manufacturing, quality control, quality assurance, and corresponding maintenance of records and documents, and good clinical practices, or GCPs, for any clinical trials that we conduct post-approval.

The FDA and other regulatory authorities will continue to closely monitor the safety profile of any product even after approval. If the FDA or other regulatory authorities become aware of new safety information after approval of any of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates, they may withdraw approval, issue public safety alerts, require labeling changes or establishment of a REMS or similar strategy, impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance. Any such restrictions could limit sales of the product.

We and any of our suppliers or collaborators, including our contract manufacturers, could be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with cGMPs and other FDA regulatory requirements. Application holders must further notify the FDA, and depending on the nature of the change, obtain FDA pre-approval for product and manufacturing changes.

In addition, later discovery of previously unknown adverse events or that the product is less effective than previously thought or other problems with any products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements both before and after approval, may yield various negative results, including:

 

   

restrictions on manufacturing, distribution, or marketing of such products;

 

   

restrictions on the labeling, including required additional warnings, such as boxed warnings, contraindications, precautions, and restrictions on the approved indication or use;

 

   

manufacturing delays and supply disruptions where regulatory inspections identify observations of noncompliance requiring remediation;

 

   

modifications to promotional pieces;

 

   

issuance of corrective information;

 

   

requirements to conduct post-marketing studies or other clinical trials;

 

   

clinical holds or termination of clinical trials;

 

   

requirements to establish or modify a REMS or similar strategy;

 

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changes to the way the product is administered to patients;

 

   

liability for harm caused to patients or subjects;

 

   

reputational harm;

 

   

the product becoming less competitive;

 

   

warning or untitled letters;

 

   

suspension of marketing or withdrawal of the products from the market;

 

   

regulatory authority issuance of safety alerts, Dear Healthcare Provider letters, press releases, or other communications containing warnings or other safety information about the product;

 

   

refusal to approve pending applications or supplements to approved applications that we submit;

 

   

recalls of products;

 

   

fines, restitution or disgorgement of profits or revenues;

 

   

suspension or withdrawal of marketing approvals;

 

   

refusal to permit the import or export of our products;

 

   

product seizure or detention;

 

   

FDA debarment, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from federal healthcare programs, consent decrees, or corporate integrity agreements; or

 

   

injunctions or the imposition of civil, criminal or administrative penalties, including imprisonment.

Any of these events could prevent us from achieving or maintaining market acceptance of any particular product or could substantially increase the costs and expenses of commercializing such product, which in turn could delay or prevent us from generating significant revenues from its marketing and sale. Any of these events could further have other material and adverse effects on our operations and business and could adversely impact our business, financial condition, results of operations, stock price and prospects.

Further, the FDA’s policies or those of other regulatory authorities may change and could impose extensive and ongoing regulatory requirements and obligations on any product candidate for which we obtain marketing approval. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and be subject to regulatory enforcement action, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

Regulatory approval by the FDA or other regulatory authorities is limited to those specific indications and conditions for which approval has been granted, and we may be subject to substantial fines, criminal penalties, injunctions or other enforcement actions if we are determined to be promoting the use of our products for unapproved or “off-label” uses, or in a manner inconsistent with the approved labeling, resulting in damage to our reputation and business.

We must comply with requirements concerning advertising and promotion for any product candidates for which we obtain marketing approval. Promotional communications with respect to therapeutics are subject to a variety of legal and regulatory restrictions and continuing review by the FDA, Department of Justice, Department of Health and Human Services’ Office of Inspector General, state attorneys general, members of Congress and the public. When the FDA or other regulatory authorities issue regulatory approval for a product candidate, the regulatory approval is limited to those specific uses and indications for which a product is approved. If we are not able to obtain FDA approval for desired uses or indications for CLD-101 for newly diagnosed HGG, CLD-101

 

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for recurrent HGG, CLD-201 and future product candidates, we may not market or promote them for those indications and uses, referred to as off-label uses, and our business, financial condition, results of operations, stock price and prospects will be materially harmed. We also must sufficiently substantiate any claims that we make for any products, including claims comparing those products to other companies’ products, and must abide by the FDA’s strict requirements regarding the content of promotion and advertising.

Physicians may choose to prescribe products for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities. Regulatory authorities in the United States generally do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine. Regulatory authorities do, however, restrict communications by biopharmaceutical companies concerning off-label use.

If we are found to have impermissibly promoted any of CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 and future product candidates, we may become subject to significant liability and government fines. The FDA and other agencies actively enforce the laws and regulations regarding product promotion, particularly those prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted a product may be subject to significant sanctions. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. In the United States, engaging in the impermissible promotion of any products, following approval, for off-label uses can also subject us to false claims and other litigation under federal and state statutes. These include fraud and abuse and consumer protection laws, which can lead to civil and criminal penalties and fines, agreements with governmental authorities that materially restrict the manner in which we promote or distribute therapeutic products and conduct our business. These restrictions could include corporate integrity agreements, suspension or exclusion from participation in federal and state healthcare programs, and suspension and debarment from government contracts and refusal of orders under existing government contracts. These False Claims Act lawsuits against manufacturers of drugs and biologics have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements pertaining to certain sales practices and promoting off-label uses. In addition, False Claims Act lawsuits may expose manufacturers to follow-on claims by private payers based on fraudulent marketing practices. This growth in litigation has increased the risk that a biopharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, as well as criminal and civil penalties, agree to comply with burdensome reporting and compliance obligations, and be excluded from Medicare, Medicaid, or other federal and state healthcare programs. If we do not lawfully promote our approved products, if any, we may become subject to such litigation and, if we do not successfully defend against such actions, those actions may have a material adverse effect on our business, financial condition, results of operations, stock price and prospects.

In the United States, the promotion of biopharmaceutical products is subject to additional FDA requirements and restrictions on promotional statements. If, after CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, CLD-201 or any future product candidates obtains marketing approval, the FDA determines that our promotional activities violate its regulations and policies pertaining to product promotion, it could request that we modify our promotional materials or subject us to regulatory or other enforcement actions, including issuance of warning letters or untitled letters, suspension or withdrawal of an approved product from the market, requests for recalls, payment of civil fines, disgorgement of money, imposition of operating restrictions, injunctions or criminal prosecution, and other enforcement actions. Similarly, industry codes in foreign jurisdictions may prohibit companies from engaging in certain promotional activities, and regulatory agencies in various countries may enforce violations of such codes with civil penalties. If we become subject to regulatory and enforcement actions, our business, financial condition, results of operations, stock price and prospects will be materially harmed.

 

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We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA or other regulatory authority may not permit us to proceed.

The FDA or other regulatory authorities may require us to file separate INDs for additional clinical trials we plan to conduct with our current lead product candidates, CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG and CLD-201. We may not be able to file any additional INDs required for our current product candidates and any future product candidates on the timelines we expect. For example, we may experience manufacturing delays or other delays with IND-enabling studies, including due to the impact of the COVID-19 pandemic on suppliers, study sites or third-party contractors and vendors on whom we depend. Moreover, we cannot be sure that submission of an IND will result in the FDA or other regulatory authorities allowing further clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate clinical trials. Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their requirements in the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs or to a new IND. Any failure to file INDs on the expected timelines to obtain regulatory approvals for our trials may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all. There are similar risks related to the review and authorization of our protocols and amendments by other regulatory authorities.

If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the ACA, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biologic products that are biosimilar to or interchangeable with an FDA-licensed reference biologic product. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of the other company’s product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation and meaning are subject to uncertainty.

We believe that any of our product candidates approved as a biologic product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our investigational medicines to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. Moreover, the extent to which a biosimilar, once licensed, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biologic products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

If competitors are able to obtain marketing approval for biosimilars referencing our products, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and consequences.

The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.

Our current and future target patient populations are based on our beliefs and estimates regarding the incidence or prevalence of certain types of the indications that may be addressable by our product candidates, which is derived from a variety of sources, including scientific literature and surveys of clinics. Our projections may prove

 

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to be incorrect and the number of potential patients may turn out to be lower than expected. The total addressable market opportunity for our product candidates will ultimately depend upon a number of factors including the diagnosis and treatment criteria included in the final label, if approved for sale in specified indications, acceptance by the medical community, patient access, the success of competing therapies and product pricing and reimbursement. Further, the market opportunity for viral immunotherapies is hard to estimate given that it is an emerging field with few globally or FDA-approved therapies, none of which have yet to enjoy broad market acceptance. Even if we obtain significant market share for our product candidates, because the potential target populations could be small, we may never achieve profitability without obtaining regulatory approval for additional indications.

Healthcare reform measures may have a material adverse effect on our business and results of operations.

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our current or any future product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell a product for which we obtain marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements, (ii) additions or modifications to product labeling, (iii) the recall or discontinuation of our products or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. More recently, however, on January 28, 2021, President Biden issued a new Executive Order which directs federal agencies to reconsider rules and other policies that limit Americans’ access to healthcare and to consider actions that will protect and strengthen that access.

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the ACA was passed, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S. pharmaceutical industry. The ACA, among other things, subjects biological products to potential competition by lower-cost biosimilars, addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual fees and taxes on manufacturers of certain branded prescription drugs, and creates a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% (increased pursuant to the Bipartisan Budget Act of 2018, effective as of 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. Various portions of the ACA are currently undergoing legal and constitutional challenges in the Fifth Circuit Court and the United States Supreme Court; the Trump Administration has issued various Executive Orders which eliminated cost sharing subsidies and various provisions that would impose a fiscal burden on states or a cost, fee, tax, penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices; and Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA. It is unclear whether the ACA will be overturned, repealed, replaced, or further amended. We cannot predict what affect further changes to the ACA would have on our business.

In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year, and, due to subsequent legislative

 

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amendments, will remain in effect through 2030 unless additional Congressional action is taken. These Medicare sequester reductions were suspended from May 1, 2020 through March 31, 2021 due to the COVID-19 pandemic. The American Taxpayer Relief Act of 2012 among other things, reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

There has been increasing legislative and enforcement interest in the U.S. with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

At the federal level, budget proposals may contain further drug price control measures that could be enacted during the budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low income patients. Additionally, the prior presidential administration released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of product candidates paid by consumers. The HHS has already started the process of soliciting feedback on some of these measures and, at the same time, is immediately implementing others under its existing authority. For example, in May 2019, the Centers for Medicare and Medicaid Services, or CMS, issued a final rule to allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019. On March 10, 2020, the prior administration sent “principles” for drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases. Further, the Trump administration previously released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contained proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers. Additionally, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing that seek to implement several of the administration’s proposals. As a result, the FDA released a final rule on September 24, 2020, effective November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 20, 2020, the Department of Health and Human Services, or HHS, finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. On November 20, 2020, the CMS issued an interim final rule implementing President Trump’s Most Favored Nation executive order, which would tie Medicare Part B payments for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021. On December 28, 2020, the United States District Court in Northern California issued a nationwide preliminary injunction against implementation of the interim final rule. It is unclear whether the current administration will work to reverse these measures or pursue similar policy initiatives. Any new laws or regulations that result in additional reductions in Medicare and other healthcare funding could have a material adverse effect on customers for our products, if approved, and, accordingly, on our results of operations.

Additionally, on October 1, 2020, the FDA issued a final rule allowing for the importation of certain prescription drugs from Canada. FDA also issued a final guidance document outlining a pathway for manufacturers to obtain an additional National Drug Code, or NDC, for an FDA-approved drug that was originally intended to be

 

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marketed in a foreign country and that was authorized for sale in that foreign country. The regulatory and market implications of the final rule and guidance are unknown at this time, but legislation, regulations or policies allowing the reimportation of drugs, if enacted and implemented, could decrease the price we receive for our products and adversely affect our future revenues and prospects for profitability.

Further, on May 30, 2018, the Right to Try Act, was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new product candidates that have completed a Phase I clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its product candidates At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our current or future product candidates or additional pricing pressures.

Our revenue prospects could be affected by changes in healthcare spending and policy in the U.S. and abroad. We operate in a highly regulated industry and new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare availability, the method of delivery or payment for healthcare products and services could negatively impact our business, operations and financial condition. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States or any other jurisdiction. It is highly possible that additional governmental action is taken to address the COVID-19 pandemic. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future, including repeal, replacement or significant revisions to the ACA. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

 

   

the demand for our current or future product candidates, if we obtain regulatory approval;

 

   

our ability to set a price that we believe is fair for our products;

 

   

our ability to obtain coverage and reimbursement approval for a product;

 

   

our ability to generate revenue and achieve or maintain profitability;

 

   

the level of taxes that we are required to pay; and

 

   

the availability of capital.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.

 

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If, in the future, we are unable to establish sales and marketing and patient support capabilities or enter into agreements with third parties to sell and market our current or future product candidates, we may not be successful in commercializing our current or future product candidates if and when they are approved, and we may not be able to generate any revenue.

We do not currently have a sales or marketing infrastructure and have limited experience in the sales, marketing, patient support or distribution of products. To achieve commercial success for any approved product candidate for which we retain sales and marketing responsibilities, we must build our sales, marketing, patient support, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. In the future, we may choose to build a focused sales and marketing infrastructure to sell, or participate in sales activities with our collaborators for, some of our current or future product candidates if and when they are approved.

There are risks involved with both establishing our own sales and marketing and patient support capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any drug launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our current or future product candidates on our own include:

 

   

our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

 

   

the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to use any future products;

 

   

the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

 

   

unforeseen costs and expenses associated with creating an independent sales and marketing organization.

If we enter into arrangements with third parties to perform sales, marketing, patient support and distribution services, our drug revenues or the profitability of these drug revenues to us are likely to be lower than if we were to market and sell any current or future product candidates that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell and market our current or future product candidates or may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our current or future product candidates effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our current or future product candidates. Further, our business, results of operations, financial condition and prospects will be materially adversely affected.

If any product candidate for which we receive regulatory approval does not achieve broad market acceptance among physicians, patients, healthcare payors, and the medical community, the revenues that we generate from its sales will be limited.

Even if our product candidates receive regulatory approval, they may not gain market acceptance among physicians, patients, healthcare payors, and others in the medical community. Commercial success also will depend, in large part, on the coverage and reimbursement of our product candidates by third-party payors,

 

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including private insurance providers and government payors. The degree of market acceptance of any approved product would depend on a number of factors, including:

 

   

the efficacy, safety and tolerability as demonstrated in clinical trials;

 

   

the timing of market introduction of such product candidate as well as competitive products;

 

   

the clinical indications for which the product is approved;

 

   

acceptance by physicians, major operators of cancer or neurology clinics and patients of the product as a safe, tolerable and effective treatment;

 

   

the potential and perceived advantages of the product candidate over alternative treatments;

 

   

the safety and tolerability of the product candidate in a broader patient group;

 

   

the cost of treatment in relation to alternative treatments;

 

   

the availability of adequate reimbursement by third party payors and government authorities;

 

   

changes in regulatory requirements by government authorities for the product candidate;

 

   

relative convenience and ease of administration;

 

   

the prevalence and severity of side effects and adverse events;

 

   

the effectiveness of our sales and marketing efforts; and

 

   

favorable or unfavorable publicity relating to the product or relating to the Company.

Our ability to successfully launch and secure market acceptance of our pipeline candidates, CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG, and CLD-201 (if approved), may be impacted by the evolving COVID-19 pandemic, although we are currently unable to predict or quantify any such potential impact with any degree of certainty. If the spread of COVID-19 and the social distancing measures taken by various governments continue, any commercial launch we may undertake may be hindered by various factors, including challenges in hiring the employees necessary to support commercialization; delays in demand due to impacts on the healthcare system and overall economy; delays in coverage decisions from Medicare and third-party payors; restrictions on our personal interactions with physicians, hospitals, payors, and other customers; interruptions or delays in our commercial supply chain; and increases in the number of uninsured or underinsured patients.

If any product candidate is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate sufficient revenue from these products and we may not become profitable, which would have a material adverse effect on our business.

If we fail to develop additional product candidates, our commercial opportunity could be limited.

We expect initially to develop our lead product candidates, CLD-101 for newly diagnosed HGG, CLD-101 for recurrent HGG and CLD-201. A key part of our strategy, however, is to pursue clinical development of additional product candidates. Developing, obtaining marketing approval for, and commercializing additional product candidates will require substantial funding and will be subject to the risks of failure inherent in medical product development. We cannot assure you that we will be able to successfully advance any of these additional product candidates through the development process.

Even if we obtain approval from the FDA or other regulatory authorities to market additional product candidates for the treatment of solid tumors, we cannot assure you that any such product candidates will be successfully commercialized, widely accepted in the marketplace, or more effective than other commercially available alternatives. If we are unable to successfully develop and commercialize additional product candidates our commercial opportunity may be limited and our business, financial condition, results of operations, stock price and prospects may be materially harmed.

 

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Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.

Although we do not currently have any drugs on the market, if we begin commercializing our current or future product candidates, we will be subject to additional healthcare statutory and regulatory requirements and enforcement by the federal government and the states and foreign governments in which we conduct our business. Healthcare providers, physicians and third-party payors play a primary role in the recommendation and prescription of any current or future product candidates for which we obtain marketing approval. Our future arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our current or future product candidates for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

 

   

the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand. The term remuneration has been interpreted broadly to include anything of value. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. On November 20, 2020, the Office of Inspector General, or OIG, finalized further modifications to the federal Anti-Kickback Statute. Under the final rules, OIG added safe harbor protections under the Anti-Kickback Statute for certain coordinated care and value-based arrangements among clinicians, providers, and others. This rule (with exceptions) became effective January 19, 2021. We continue to evaluate what effect, if any, this rule will have on our business;

 

   

the federal False Claims Act imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. In addition, manufacturers can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. False Claims Act liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties. Government enforcement agencies and private whistleblowers have investigated pharmaceutical companies for or asserted liability under the False Claims Act for a variety of alleged promotional and marketing activities, such as providing free products to customers with the expectation that the customers would bill federal programs for the products; providing consulting fees and other benefits to physicians to induce them to prescribe products; engaging in promotion for “off-label” uses; and submitting inflated best price information to the Medicaid Rebate Program. In addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false of fraudulent claim for purposes of the False Claims Act;

 

   

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

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the federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act” under the ACA require manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to the Department of Health and Human Services information related to physician payments and other transfers of value and the ownership and investment interests of such physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and their immediate family members. Effective January 1, 2022, these reporting obligations will extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners;

 

   

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; and

 

   

analogous state laws and regulations, such as state anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge and may not comply under one or more of such laws, regulations and guidance. Law enforcement authorities are increasingly focused on enforcing fraud and abuse laws, and it is possible that some of our practices may be challenged under these laws. Ensuring that our future business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations, including anticipated activities to be conducted by our sales team, were to be found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our financial results.

We may face potential liability if we obtain identifiable patient health information from clinical trials sponsored by us.

Most healthcare providers, including certain research institutions from which we may obtain patient health information, are subject to privacy and security regulations promulgated under HIPAA, as amended by the HITECH. We are not currently classified as a covered entity or business associate under HIPAA and thus are not directly subject to its requirements or penalties. However, any person may be prosecuted under HIPAA’s criminal provisions either directly or under aiding-and-abetting or conspiracy principles. Consequently,

 

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depending on the facts and circumstances, we could face substantial criminal penalties if we knowingly receive individually identifiable health information from a HIPAA-covered healthcare provider or research institution that has not satisfied HIPAA’s requirements for disclosure of individually identifiable health information. In addition, in the future, we may maintain sensitive personally identifiable information, including health information, that we receive throughout the clinical trial process, in the course of our research collaborations, and directly from individuals (or their healthcare providers) who may enroll in patient assistance programs if we choose to implement such programs. As such, we may be subject to state laws requiring notification of affected individuals and state regulators in the event of a breach of personal information, which is a broader class of information than the health information protected by HIPAA.

The EU General Data Protection Regulation, or GDPR, also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. In addition, the GDPR includes restrictions on cross-border data transfers. The GDPR may increase our responsibility and liability in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, including as implemented by individual countries. Compliance with the GDPR is a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities. Further, the United Kingdom’s decision to leave the European Union, referred to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom. In particular, it is unclear how data transfers to and from the United Kingdom will be regulated now that the United Kingdom has left the European Union.

In addition, California recently enacted and has proposed companion regulations to the California Consumer Privacy Act, or CCPA, which went into effect January 1, 2020. The CCPA creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requires covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California residents with ways to opt-out of certain sales or transfers of personal information. As of March 28, 2020, the California State Attorney General has proposed varying versions of companion draft regulations which are not yet finalized. Despite the delay in adopting regulations, the California State Attorney General commenced enforcement actions against violators on July 1, 2020. While there are currently exceptions for protected health information that is subject to HIPAA and clinical trial regulations, as currently written, the CCPA may impact our business activities. On August 14, 2020, implementing regulations were finalized and became effective as of that date. While clinical trial data and information governed by HIPAA are currently exempt from the current version of the CCPA, other personal information may be applicable and possible changes to the CCPA may broaden its scope. We continue to monitor the impact the CCPA may have on our business activities.

Furthermore, certain health privacy laws, data breach notification laws, consumer protection laws and genetic testing laws may apply directly to our operations and/or those of our collaborators and may impose restrictions on our collection, use and dissemination of individuals’ health information. Patients about whom we or our collaborators may obtain health information, as well as the providers who may share this information with us, may have statutory or contractual rights that limit our ability to use and disclose the information. We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws. Claims that we have violated individuals’ privacy rights or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

If we or third-party contract research organizations, or CROs, or other contractors or consultants fail to comply with applicable federal, state/provincial or local regulatory requirements, we could be subject to a range of regulatory actions that could affect our or our contractors’ ability to develop and commercialize our therapeutic candidates and could harm or prevent sales of any affected therapeutics that we are able to commercialize, or

 

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could substantially increase the costs and expenses of developing, commercializing and marketing our therapeutics. Any threatened or actual government enforcement action could also generate adverse publicity and require that we devote substantial resources that could otherwise be used in other aspects of our business. Increasing use of social media could give rise to liability, breaches of data security or reputational damage.

Additionally, we are subject to other state and foreign equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply regardless of the payor.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

Risks Related to Employee Matters, Managing Growth and General Business Operations

The COVID-19 pandemic, which began in late 2019 and has spread worldwide, may affect our ability to complete our ongoing clinical trials and initiate and complete other preclinical studies, planned clinical trials or future clinical trials, disrupt regulatory activities, disrupt our manufacturing and supply chain or have other adverse effects on our business and operations. In addition, this pandemic has caused substantial disruption in the financial markets and may adversely impact economies worldwide, both of which could result in adverse effects on our business, operations and ability to raise capital.

The COVID-19 pandemic, which began in December 2019 and has spread worldwide, has caused many governments to implement measures to slow the spread of COVID-19 through quarantines, travel restrictions, heightened border scrutiny and other measures. The COVID-19 pandemic and government measures taken in response have also had a significant impact, both directly and indirectly, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. The future progression of the COVID-19 pandemic and its effects on our business and operations are uncertain.

The extent to which COVID-19 impacts our operations or those of the third parties on which we rely will depend on many factors, which are highly uncertain and cannot be predicted with confidence, including the duration of the pandemic, additional or modified government actions, new information that will emerge concerning the severity and impact of COVID-19, and the actions to contain the COVID-19 pandemic or address its impact in the short and long term. Additionally, the conduct of our clinical trials, preclinical studies and manufacturing activities is dependent upon the availability of clinical trial sites, CROs, contract development and manufacturing organization, or CDMOs, researchers and investigators, regulatory agency personnel and logistics providers, all of which may be adversely affected by the COVID-19 pandemic.

 

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Any negative impact that the COVID-19 pandemic has on enrolling or retaining patients in our clinical trials, the ability of our suppliers to provide materials for our product candidates, or the regulatory review process could cause delays with respect to product development activities, which could materially and adversely affect our ability to obtain marketing approval for and to commercialize our product candidates, increase our operating expenses, affect our ability to raise additional capital, and have a material adverse effect on our financial results.

We cannot provide assurance that some factors from the COVID-19 pandemic will not further delay or otherwise adversely affect our clinical development, research, manufacturing and business operations activities, as well as our business generally, in the future.

We and the third-party manufacturers, CROs and academic collaborators that we engage have faced in the past and may face in the future disruptions that could affect our ability to initiate and complete preclinical studies or clinical trials, including disruptions in procuring items that are essential for our research and development activities, such as, for example, raw materials used in the manufacture of our product candidates, laboratory supplies for our preclinical studies and clinical trials, or animals that are used for preclinical testing, in each case, for which there may be shortages because of ongoing efforts to address the COVID-19 pandemic. Three vaccines for COVID-19 have been granted Emergency Use Authorization by the FDA, and more are likely to be authorized in the coming months. The resultant demand for vaccines and potential for manufacturing facilities and materials to be commandeered under the Defense Production Act of 1950, or equivalent foreign legislation, may make it more difficult to obtain materials or manufacturing slots for the products needed for our clinical trials, which could lead to delays in these trials. Additionally, the response to the COVID-19 pandemic may redirect resources with respect to regulatory and intellectual property matters in a way that would adversely impact our ability to pursue marketing approvals and protect our intellectual property. In addition, we may face impediments to regulatory meetings and potential approvals due to measures intended to limit in-person interactions.

In response to the COVID-19 pandemic and in accordance with direction from state and local governmental authorities, we have restricted access to our facility to those individuals who must perform critical research, translational medicine and laboratory support activities that must be completed on site, limited the number of such people that can be present at our facility at any one time, and required that most of our employees work remotely. In the event that governmental authorities were to keep these restrictions in place for an extended period or impose further restrictions, our employees conducting research and development activities may not be able to access our laboratory space, and our core research activities may be significantly limited or curtailed, possibly for an extended period of time.

The COVID-19 pandemic continues to rapidly evolve, and its ultimate scope, duration and effects are unknown. The extent of the impact of the disruptions to our business, preclinical studies and clinical trials as a result of the COVID-19 pandemic will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the COVID-19 pandemic, travel restrictions and actions to contain the COVID-19 pandemic, such as social distancing and quarantines or lock-downs in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

The COVID-19 pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could adversely impact our ability to raise additional funds through public offerings or private placements and may also impact the volatility of our stock price and trading in our stock. Moreover, it is possible the pandemic will significantly impact economies worldwide, which could result in adverse effects on our business and operations. We cannot be certain what the overall impact of the COVID-19 pandemic will be on our business and it has the potential to adversely affect our business, financial condition, results of operations and prospects.

 

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Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on the research and development, clinical, financial, operational and other business expertise of our executive officers, as well as the other principal members of our management, scientific and clinical teams. Although we have entered into employment agreements with our executive officers, each of them may terminate their employment with us at any time. We do not maintain “key person” insurance for any of our executives or other employees. Recruiting and retaining qualified scientific, clinical, manufacturing, accounting, legal and sales and marketing personnel will also be critical to our success.

The loss of the services of our executive officers or other key employees could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain marketing approval of and commercialize products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. Our success as a public company also depends on implementing and maintaining internal controls and the accuracy and timeliness of our financial reporting. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

We expect to expand our development, manufacturing and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

As we seek to advance our product candidates through clinical trials and commercialization, we will need to expand our development, regulatory, manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities. We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug development, clinical, regulatory affairs and, if any product candidate receives marketing approval, sales, marketing and distribution. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

The increasing use of social media platforms presents new risks and challenges.

Social media is increasingly being used to communicate about our clinical development programs and the diseases our therapeutics are being developed to treat, and we intend to utilize appropriate social media in connection with our commercialization efforts following approval of our product candidates, if any. Social media practices in the biotechnology and biopharmaceutical industry continue to evolve and regulations and regulatory guidance relating to such use are evolving and not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business, resulting in potential regulatory actions against us, along with the potential for litigation related to off-label marketing or other prohibited activities and heightened

 

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scrutiny by the FDA, the SEC and other regulators. For example, patients may use social media channels to comment on their experience in an ongoing blinded clinical trial or to report an alleged adverse event. If such disclosures occur, there is a risk that trial enrollment may be adversely impacted, that we may fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our product candidates. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. In addition, we may encounter attacks on social media regarding our company, management, product candidates or products. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to our business.

Our internal computer systems, or those of our third-party CROs that we may use in the future, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product candidates’ development programs.

Despite our implementation of security measures, our internal computer systems, and those of our CROs that we may use in the future, information technology suppliers and other contractors and consultants are vulnerable to damage from computer viruses, cyberattacks and other unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product candidate development programs. For example, the loss of clinical trial data from completed, ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development of any of our product candidates could be delayed.

Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic or other catastrophic event.

We depend on our employees and consultants, CDMOs and CROs that we may use in the future, as well as regulatory agencies and other parties, for the continued operation of our business. While we maintain disaster recovery plans, they might not adequately protect us. Despite any precautions we take for natural disasters or other catastrophic events, these events, including terrorist attack, pandemics, hurricanes, fire, floods and ice and snowstorms, could result in significant disruptions to our research and development, preclinical studies, clinical trials, and, ultimately, commercialization of our products. Long-term disruptions in the infrastructure caused by events, such as natural disasters, the outbreak of war, the escalation of hostilities and acts of terrorism or other “acts of God,” particularly involving cities in which we have offices, manufacturing or clinical trial sites, could adversely affect our businesses. Although we carry business interruption insurance policies and typically have provisions in our contracts that protect us in certain events, our coverage might not respond or be adequate to compensate us for all losses that may occur. Any natural disaster or catastrophic event affecting us, our CDMOs or CROs, regulatory agencies or other parties with which we are engaged could have a significant negative impact on our operations and financial performance.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Upon completion of the Business Combination, we will become subject to the periodic reporting requirements of the Exchange Act. We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in

 

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decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. For example, our directors or executive officers could inadvertently fail to disclose a new relationship or arrangement causing us to fail to make a required related party transaction disclosure. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

Our recurring losses from operations since inception and requirement for additional funding to finance our operations raise substantial doubt about our ability to continue as a going concern.

Our recurring losses from operations since inception and required additional funding to finance our operations raise substantial doubt about our ability to continue as a going concern. These conditions could materially limit our ability to raise additional funds through the issuance of new debt or equity securities or otherwise. There is no assurance that sufficient financing will be available when needed, or at all, to allow us to continue as a going concern. The perception that we may not be able to continue as a going concern may also make it more difficult to operate our business due to concerns about our ability to meet our contractual obligations. Our ability to continue as a going concern is contingent upon, among other factors, the sale of our securities. There is no assurance that sufficient financing will be available when needed, or at all, to allow us to continue as a going concern.

If we are unable to secure additional capital, we may be required to curtail our clinical and research and development initiatives and take additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. These measures could cause significant delays in our clinical and regulatory efforts, which is critical to the realization of our business plan. The consolidated financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern. It is not possible for us to predict at this time the potential success of our business. The revenue and income potential of our proposed business and operations are currently unknown. If we cannot continue as a viable entity, you may lose some or all of your investment.

If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.

Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, is designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could harm our business and have a negative effect on the trading price of our stock.

We will be required to disclose changes made in our internal controls and procedures on a quarterly basis and our management will be required to assess the effectiveness of these controls annually. However, for as long as we are an Emerging Growth Company (“EGC”) under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act. We could be an EGC for up to five years. Our assessment of internal controls and procedures may not detect material weaknesses in our internal control over financial reporting. Undetected material weaknesses in our internal control over financial reporting could lead to financial restatements and require us to incur the expense of remediation, which could have a negative effect on the trading price of our stock.

 

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Risks Related to Legal and Compliance Matters

We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the commercialization of any approved products and/or our product candidates.

The use of our product candidates in clinical trials, and the sale of any product for which we obtain regulatory approval, exposes us to the risk of product liability claims. We face inherent risk of product liability related to the testing of our product candidates in human clinical trials, including liability relating to the actions and negligence of our investigators, and will face an even greater risk if we commercially sell any product candidates that we may develop. For example, we may be sued if any product candidate we develop allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. Product liability claims might be brought against us by consumers, healthcare providers or others using, administering or selling our products. If we cannot successfully defend ourselves against these claims, we will incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defense would require significant financial and management resources. Regardless of merit or eventual outcome, liability claims may result in:

 

   

loss of revenue from decreased demand for our products and/or product candidates;

 

   

impairment of our business reputation or financial stability;

 

   

costs of related litigation;

 

   

substantial monetary awards to patients or other claimants;

 

   

diversion of management attention;

 

   

withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs;

 

   

the inability to commercialize our product candidates;

 

   

significant negative media attention;

 

   

decreases in our stock price;

 

   

initiation of investigations and enforcement actions by regulators; and

 

   

product recalls, withdrawals or labeling, marketing or promotional restrictions, including withdrawal of marketing approval.

We believe we have sufficient insurance coverage in place for our business operations. However, our insurance coverage may not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. Failure to obtain and retain sufficient product liability insurance at an acceptable cost could prevent or inhibit the commercialization of products we develop. On occasion, large judgments have been awarded in class action lawsuits based on therapeutics that had unanticipated side effects. A successful product liability claim or series of claims brought against us could cause our stock price to fall and, if judgments exceed our insurance coverage, could decrease our cash, and materially harm our business, financial condition, results of operations, stock price and prospects.

 

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We are subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as import and export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, financial condition, results of operations, stock price and prospects.

Our operations are subject to anti-corruption laws, including the Foreign Corrupt Practices Act, or FCPA, and other anti-corruption laws that apply in countries where we do business. The FCPA and these other laws generally prohibit us and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. We also may participate in collaborations and relationships with third parties whose actions, if non-compliant, could potentially subject us to liability under the FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the government of the United States, including applicable import and export control regulations, economic sanctions on countries and persons, anti-money laundering laws, customs requirements and currency exchange regulations, collectively referred to as the trade control laws.

We can provide no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws or other legal requirements, including trade control laws. If we are not in compliance with applicable anti-corruption laws or trade control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations, stock price and prospects. Likewise, any investigation of any potential violations of these anti-corruption laws or trade control laws by United States or other authorities could also have an adverse impact on our reputation, our business, financial condition, results of operations, stock price and prospects.

If we fail to comply with federal and state healthcare laws, including fraud and abuse and health and other information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially harmed.

We are subject to many federal and state healthcare laws, including those described in “Business — Government Regulation” such as the federal Anti-Kickback Statute, the federal civil and criminal False Claims Acts, the civil monetary penalties statute, the Medicaid Drug Rebate statute and other price reporting requirements, the Veterans Health Care Act of 1992, or VHCA HIPAA, the FCPA, the ACA and similar state laws. Even though we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, certain federal and state healthcare laws, and regulations pertaining to fraud and abuse, reimbursement programs, government procurement, and patients’ rights are and will be applicable to our business. We would be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states and foreign jurisdictions in which we conduct our business. In the European Union, the data privacy laws are generally stricter than those which apply in the United States and include specific requirements for the collection of personal data of European Union persons or the transfer of personal data outside of the European Union to the United States to ensure that European Union standards of data privacy will be applied to such data.

If we or our operations, including our arrangements with physicians and other healthcare providers, some of whom receive share options or other financial interest in the business as compensation for services provided, are found to be in violation of any federal or state healthcare law, or any other governmental laws or regulations that apply to us, we may be subject to penalties, including civil, criminal, and administrative penalties, damages,

 

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fines, disgorgement, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from participation in U.S. federal or state health care programs, corporate integrity agreements, and the curtailment or restructuring of our operations, any of which could materially adversely affect our ability to operate our business and our financial results. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, it or they may be subject to criminal, civil or administrative sanctions, including but not limited to, exclusions from participation in government healthcare programs, which could also materially affect our business.

Although an effective compliance program can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated. Moreover, achieving and sustaining compliance with applicable federal, state and foreign privacy, data protection, security, reimbursement, and fraud laws may prove costly. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.

Recent changes in tax law may adversely affect our business or financial condition. On December 22, 2017, the U.S. government enacted the Tax Cuts and Jobs Act, or TCJA, which significantly reformed the Internal Revenue Code of 1986, as amended, or the Code. The TCJA, among other things, contains significant changes to corporate taxation, including reducing the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, limiting the tax deduction for net interest expense to 30% of adjusted taxable income (except for certain small businesses), limiting the deduction for NOLs arising in taxable years beginning after December 31, 2017 to 80% of current year taxable income and elimination of NOL carrybacks for losses arising in taxable years ending after December 31, 2017 (though any such NOLs may be carried forward indefinitely), imposing a one-time taxation of offshore earnings at reduced rates regardless of whether they are repatriated, eliminating U.S. tax on foreign earnings (subject to certain important exceptions), allowing immediate deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or repealing many business deductions and credits.

As part of Congress’ response to the COVID-19 pandemic, the Families First Coronavirus Response Act, or FFCR Act, was enacted on March 18, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, was enacted on March 27, 2020, and COVID relief provisions were included in the Consolidated Appropriations Act, 2021 or CAA, which was enacted on December 27, 2020. Both contain numerous tax provisions. In particular, the CARES Act retroactively and temporarily (for taxable years beginning before January 1, 2021) suspends application of the 80%-of-income limitation on the use of NOLs, which was enacted as part of the TCJA. It also provides that NOLs arising in any taxable year beginning after December 31, 2017, and before January 1, 2021 are generally eligible to be carried back up to five years. The CARES Act also temporarily (for taxable years beginning in 2019 or 2020) relaxes the limitation of the tax deductibility for net interest expense by increasing the limitation from 30% to 50% of adjusted taxable income.

Regulatory guidance under the TCJA, the FFCR Act, the CARES Act and the CAA is and continues to be forthcoming, and such guidance could ultimately increase or lessen their impact on our business and financial condition. It is also likely that Congress will enact additional legislation in connection with the COVID-19 pandemic, some of which could have an impact on us. In addition, it is uncertain if and to what extent various states will conform to the TCJA, the FFCR Act, the Cares Act, or the CAA. We urge prospective investors in our common stock to consult with their legal and tax advisors with respect to any recently enacted tax legislation, or proposed changes in law, and the potential tax consequences of investing in or holding our common stock.

 

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If the government or third-party payors fail to provide adequate coverage, reimbursement and payment rates for our product candidates, or if health maintenance organizations or long-term care facilities choose to use therapies that are less expensive or considered a better value, our revenue and prospects for profitability will be limited.

In both domestic and foreign markets, sales of our products will depend in part upon the availability of coverage and reimbursement from third-party payors. Such third-party payors include government health programs such as Medicare and Medicaid, managed care providers, private health insurers, and other organizations. Coverage decisions may depend upon clinical and economic standards that disfavor new therapeutic products when more established or lower cost therapeutic alternatives are already available or subsequently become available, even if our products are alone in a class. If reimbursement is not available, or is available only to limited levels, our product candidates may be competitively disadvantaged, and we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain a market share sufficient to realize a sufficient return on our or their investments. Alternatively, securing favorable reimbursement terms may require us to compromise pricing and prevent us from realizing an adequate margin over cost.

There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved therapeutics. Marketing approvals, pricing, and reimbursement for new therapeutic products vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a therapeutic before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription biopharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay commercial launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our or their investment in one or more product candidates, even if our product candidates obtain marketing approval. Our ability to commercialize our product candidates will depend in part on the extent to which coverage and reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Regulatory authorities and third-party payors, such as private health insurers, and health maintenance organizations, decide which medications they will cover and establish reimbursement levels. The healthcare industry is acutely focused on cost containment, both in the United States and elsewhere. Several third-party payors are requiring that companies provide them with predetermined discounts from list prices, are using preferred drug lists to leverage greater discounts in competitive classes, are disregarding therapeutic differentiators within classes, are challenging the prices charged for therapeutics, and are negotiating price concessions based on performance goals.

Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, in the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. Further, we believe that future coverage and reimbursement will likely be subject to increased restrictions both in the United States and in international markets. Third-party coverage and reimbursement for our products or product candidates for which we receive regulatory approval may not be available or adequate in either the United States or international markets, which could have a negative effect on our business, financial condition, results of operations, stock price and prospects.

Assuming coverage is approved, the resulting reimbursement payment rates might not be adequate. If payors subject our product candidates to maximum payment amounts, or impose limitations that make it difficult to obtain reimbursement, providers may choose to use therapies which are less expensive when compared to our product candidates. Additionally, if payors require high copayments, beneficiaries may seek alternative therapies.

 

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We may need to conduct post-marketing studies in order to demonstrate the cost-effectiveness of any products to the satisfaction of hospitals, other target customers and their third-party payors. Such studies might require us to commit a significant amount of management time and financial and other resources. Our products might not ultimately be considered cost-effective. Adequate third-party coverage and reimbursement might not be available to enable us to maintain price levels sufficient to realize an appropriate return on investment in product development.

In addition, federal programs impose penalties on manufacturers of therapeutics in the form of mandatory additional rebates and/or discounts if commercial prices increase at a rate greater than the Consumer Price Index-Urban, and these rebates and/or discounts, which can be substantial, may impact our ability to raise commercial prices. A few states have also passed or are considering legislation intended to prevent significant price increases. Regulatory authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications, which could affect our ability to sell our product candidates profitably. These payors may not view our products, if any, as cost-effective, and coverage and reimbursement may not be available to our customers, or may not be sufficient to allow our products, if any, to be marketed on a competitive basis. Cost-control initiatives could cause us to decrease, discount, or rebate a portion of the price we, or they, might establish for products, which could result in lower than anticipated product revenues. If the realized prices for our products, if any, decrease or if governmental and other third-party payors do not provide adequate coverage or reimbursement, our prospects for revenue and profitability will suffer.

There may also be delays in obtaining coverage and reimbursement for newly approved therapeutics, and coverage may be more limited than the indications for which the product is approved by the FDA or other regulatory authorities. Such delays have made it increasingly common for manufacturers to provide newly approved drugs to patients experiencing coverage delays or disruption at no cost for a limited period in order to ensure that patients are able to access the drug. Moreover, eligibility for reimbursement does not imply that any therapeutic will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale, and distribution. Interim reimbursement levels for new therapeutics, if applicable, may also not be sufficient to cover our costs and may only be temporary. Reimbursement rates may vary, by way of example, according to the use of the product and the clinical setting in which it is used. Reimbursement rates may also be based on reimbursement levels already set for lower cost products or may be incorporated into existing payments for other services.

In addition, third-party payors are increasingly requiring higher levels of evidence of the benefits and clinical outcomes of new technologies, benchmarking against other therapies, seeking performance-based discounts, and challenging the prices charged. We cannot be sure that coverage will be available for any product candidate that we commercialize and, if available, that the reimbursement rates will be adequate. An inability to promptly obtain coverage and adequate payment rates from both government-funded and private payors for any of our product candidates for which we obtain marketing approval could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Our employees, independent contractors, consultants, commercial partners, principal investigators or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees, independent contractors, consultants, commercial partners, principal investigators, contract manufacturing organizations or CROs could include intentional, reckless, negligent, or unintentional failures to comply with FDA regulations, comply with applicable fraud and abuse laws, provide accurate information to the FDA, properly calculate pricing information required by federal programs, report financial information or data accurately or disclose unauthorized activities to us. This misconduct could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter this type of misconduct, and the precautions we

 

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take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Moreover, it is possible for a whistleblower to pursue a False Claims Act case against us even if the government considers the claim unmeritorious and declines to intervene, which could require us to incur costs defending against such a claim. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, results of operations, stock price and prospects, including the imposition of significant fines or other sanctions.

Violations of or liabilities under environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material adverse effect on the success of our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures, the handling, use, storage, treatment and disposal of hazardous materials and wastes and the cleanup of contaminated sites. Our operations involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. Our operations also produce hazardous waste products. We would incur substantial costs as a result of violations of or liabilities under environmental requirements in connection with our operations or property, including fines, penalties and other sanctions, investigation and cleanup costs and third-party claims. Although we generally contract with third parties for the disposal of hazardous materials and wastes from our operations, we cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

Risks Related to Our Reliance on Third Parties

We depend on banks insured by the Federal Deposit Insurance Corporation (FDIC) to safeguard our cash deposits critical to our operations, including to fund our payroll to our employees, and should our depository bank be put into receivership by the FDIC we could experience delays in accessing our cash deposits or lose our cash deposits that may exceed the FDIC insured amounts of $250,000.

Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. Our ability to pay our employees and to fund our anticipated clinical trials depends on the safety and soundness of the banks that hold our cash deposits. If our depository bank experiences losses or a rapid loss of deposits, it may be put into receivership by the FDIC and its applicable banking regulatory authority. For example, on March 10, 2023, the Federal Deposit Insurance Corporation took control and was appointed receiver of Silicon Valley Bank. Similarly, on March 12, 2023, Signature Bank and Silvergate Capital Corp. were also put into receivership. As of March 10, 2023, we maintained our payroll account with Silicon Valley Bank, as well as our general operating account and a restricted cash balance account that served as security for our office lease. We did not experience any material delay in accessing our cash deposits with Silicon Valley Bank and have moved or are in the process of moving our operating and payroll accounts to another bank. However, if our new bank or other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on our business and financial condition.

 

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Inflation and rapid increases in interest rates have led to a decline in the trading value of previously issued government securities with interest rates below current market interest rates. Although the U.S. Department of Treasury, FDIC and Federal Reserve Board have announced the Bank Term Funding Program to provide up to $25 billion of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for immediate liquidity may exceed the capacity of such program. Additionally, there is no guarantee that the U.S. Department of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion.

Our access to funding sources in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect us, the financial institutions with which we have relationships, or the financial services industry or economy in general. These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, the loss of uninsured deposits, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry.

In addition, any further deterioration in the macroeconomic economy or financial services industry could lead to losses or defaults by our anticipated suppliers or future collaboration partners, which in turn, could have a material adverse effect on our future business operations and results of operations and financial condition. For example, a collaboration partner may fail to make payments when due, default under their agreements with us, become insolvent or declare bankruptcy, or a supplier may determine that it will no longer deal with us as a customer. In addition, a future supplier or future collaboration partner could be adversely affected by any of the liquidit