Calidi Biotherapeutics, Inc.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 31, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
For the fiscal year ended December 31,2024
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|---|
Commission File Number:001-40789
(Exact name of registrant as specified in its charter)
| Delaware | 86-2967193 |
|---|---|
| (State or other jurisdiction of | (I.R.S. Employer |
| incorporation or organization) | Identification Number) |
| 4475 Executive Drive, Suite 200, San Diego, California | 92121 |
| (Address of principal executive offices) | (Zip Code) |
(858) 794-9600
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | CLDI | NYSE American LLC |
Securities registered pursuant to Section 12(g) of the Act: None.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the issuer was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an 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 | ☒ |
| (Do not check if a 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 13(a) of the Exchange Act.☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). Yes ☐ No ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No☒
The aggregate market value of voting and non-voting common stock held by non-affiliates of the registrant as of June 28, 2024 (the last business day of the registrant’s most recently completed second fiscal quarter) was approximately $14,010,268.
As of March 24, 2025, there were 28,467,580 shares of registrant’s common stock outstanding, excluding 1,800,000 non-voting common stock held in escrow.
Documents incorporated by reference: None.
FORM 10-K ANNUAL REPORT
For the Fiscal Year Ended December 31, 2024
Table of Contents
| PART I | 4 | |
|---|---|---|
| ITEM 1. | BUSINESS | 4 |
| ITEM 1A. | RISK FACTORS | 40 |
| ITEM 1B. | UNRESOLVED STAFF COMMENTS | 99 |
| ITEM 1C. | CYBERSECURITY | 99 |
| ITEM 2. | PROPERTIES | 100 |
| ITEM 3. | LEGAL PROCEEDINGS | 100 |
| ITEM 4. | MINE SAFETY DISCLOSURES | 102 |
| PART II | ||
| ITEM 5. | MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES | 103 |
| ITEM 6. | RESERVED | 103 |
| ITEM 7. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 103 |
| ITEM 7A. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 122 |
| ITEM 8. | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA | 122 |
| ITEM 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | 123 |
| ITEM 9A | CONTROLS AND PROCEDURES | 123 |
| ITEM 9B. | OTHER INFORMATION | 124 |
| ITEM 9C. | DISCLOSURE REGARDING FOREIGN JURISDICTION THAT PREVENTS INSPECTIONS | 124 |
| PART III | ||
| ITEM 10. | DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE | 124 |
| ITEM 11. | EXECUTIVE COMPENSATION | 131 |
| ITEM 12. | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | 150 |
| ITEM 13. | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE | 151 |
| ITEM 14. | PRINCIPAL ACCOUNTANT FEES AND SERVICES | 152 |
| PART IV | ||
| ITEM 15. | EXHIBITS AND FINANCIAL STATEMENT SCHEDULES | 153 |
| SIGNATURES | 158 | |
| FINANCIAL STATEMENTS | F-1 | |
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). These forward-looking statements include, among other things, statements regarding our and our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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. Forward-looking statements in this report may include, for example, statements about:
| ● | We are an immuno-oncology company with a limited operating history and have not generated any revenue to date from product sales; |
| ● | We have no products approved for commercial sale and have not generated revenues. We have incurred significant operating losses since our inception and we anticipate that we will incur continued losses for the foreseeable future; |
| ● | We need to raise substantial additional funding. If we are unable to raise capital when needed, or if at all, we will be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts. In addition, the issuance of a substantial number of shares of common stock as a result of a financing could adversely affect the price of our common stock; |
| ● | our ability to realize the expected benefits of the Business Combination; |
| ● | our ability to maintain the listing of our securities on the NYSE American; |
| ● | our financial and business performance, including our financial projections and business metrics; |
| ● | our market opportunity; |
| ● | changes in our strategy, future operations, financial position, estimated revenues and losses, forecasts, projected costs, prospects and plans; |
| ● | expectations regarding the time during which we will be an emerging growth company under the JOBS Act; |
| ● | our ability to retain or recruit officers, key employees and directors; |
| ● | the impact of the regulatory environment and complexities with compliance related to such environment; |
| ● | the expected costs associated with our research and development initiatives, including investments in technology and product development; |
| ● | our ability to secure sufficient funding and alternative source of funding to support when needed and on terms favorable to us to support our business objective, product development, other operations or commercialization efforts; |
| ● | our ability to enroll patients in our proposed clinical trials and development activities; |
| ● | the impact of governmental laws and regulations; and |
| ● | our ability to obtain, maintain, protect and enforce sufficient patent and other intellectual property rights for our drug candidates and technology. |
The forward-looking statements contained in this report are based on our current expectations and beliefs concerning future developments and their potential effects on our business. There can be no assurance that future developments affecting our business 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 in the section entitled “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time and it is not possible for us to predict all such risk factors, nor can we assess the effect of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.
The forward-looking statements made by us in this report speak only as of the date of this report. Except to the extent required under the federal securities laws and rules and regulations of the Securities and Exchange Commission (“SEC”), we disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. In light of these risks and uncertainties, there is no assurance that the events or results suggested by the forward-looking statements will in fact occur, and you should not place undue reliance on these forward-looking statements.
Unless the context otherwise requires, “we,” “us,” “our,” “registrant,” or “Registrant,” “Calidi,” “Calidi Biotherapeutics,” and the “Company” refer to Calidi Biotherapeutics, Inc., a Delaware corporation (f/k/a First Light Acquisition Group, Inc., a Delaware corporation), and its consolidated subsidiaries following the Business Combination. Unless the context otherwise requires, references to “FLAG” refer to First Light Acquisition Group, Inc., a Delaware corporation, prior to the Business Combination. Unless the context otherwise requires, references to “Calidi NV” means Calidi Biotherapeutics (Nevada), Inc. (formerly Calidi Biotherapeutics, Inc.), a Nevada corporation and our wholly-owned subsidiary.
SELECTED DEFINITIONS
Unless the context otherwise requires or has otherwise been defined, the following defined terms shall have the meaning set forth below.
“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 145,265 founder shares from our Sponsor and Metric at approximately $0.04 per share;
“Business Combination” means the business combination of FLAG with Calidi pursuant to the terms and conditions of the Merger Agreement;
“Bylaws” means the Amended and Restated Bylaws, as amended, in effect as of the date of this report;
“Calidi” or “Calidi Biotherapeutics” means Calidi Biotherapeutics, Inc., a Delaware corporation;
“Charter” or “Second Amended and Restated Certificate of Incorporation” means the Second Amended and Restated Certificate of Incorporation in effect.
“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 was consummated which occurred on September 12, 2023;
“common stock” or “Common Stock” means Calidi Common Stock following the Business Combination, with the rights and preferences and subject to the terms and conditions set forth in the Charter;
“DGCL” means the Delaware General Corporation Law, as amended;
“Exchange Act” means the Securities Exchange Act of 1934, as amended;
“FLAG” means First Light Acquisition Group, Inc., a Delaware corporation;
“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 145,265 founder shares from our Sponsor and Metric at approximately $0.04 per share;
“Insiders” are to, collectively, certain prior directors and officers of FLAG, including Thomas A. Vecchiolla, Michael J. Alber, Michael Reuttgers, William J. Fallon, and Jeanne Tisinger;
“Metric” means Metric Finance Holdings I, LLC, a Delaware limited liability company and an affiliate of Guggenheim Securities, LLC;
“Calidi Common Stock” means, following the consummation of the Business Combination, the common stock, par value $0.0001 per share, of Calidi Biotherapeutics, Inc.
“Registration Rights Agreements” mean certain agreements requiring the Company to register the holders’ shares of common stock with the Securities and Exchange Commission consisting of that certain (i) Amended And Restated Registration Rights Agreement dated September 12, 2023; (ii) Voting and Lock-Up Agreement dated as of January 9, 2023, and amended on April 12, 2023, and (iii) Series B Preferred Stock Investors’ Rights Agreement dated June 16, 2023.
“Series B Financing” means the equity financing contemplated by the Securities Purchase Agreements between Calidi Biotherapeutics, Inc., and Jackson Investment Group, LLC and Calidi Cure, LLC, dated June 16, 2023, to secure commitments for the purchase of Series B Convertible Preferred Stock of Calidi.
“Significant Calidi Holder” means Allan Camaisa and/or Scott Leftwich; and
“Sponsor” means First Light Acquisition Group, LLC, a Delaware series limited liability company.
“Sponsor Shares” means 552,709 shares of common stock (net of cancellations from the original 575,000 shares of common stock sold) in the aggregate originally sold to the Sponsor and Metric at $0.04 per share, and subsequently sold to the anchor investors at the same purchase price or transferred other shareholders as an inducement to complete and finance the Business Combination.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.