As filed with the Securities and Exchange Commission on January 29, 2024. Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 4475 Executive Drive, Suite 200, (I.R.S. Employer Identification No.) San Diego, California 92121 Telephone: (858) 794-9600 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Calidi Biotherapeutics, Inc. (Exact name o ...

As filed with the Securities and Exchange Commission on January 29, 2024. Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2967193 4475 Executive Drive, Suite 200, (I.R.S. Employer Ident ...

As filed with the Securities and Exchange Commission on January 16, 2024. Washington, D.C. 20549 AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-2967193 (Primary Standard Industrial Classification Code Number) Registration No. 333-274885 UNITED STATES SECURITIES AND EXCHANGE COMMISSION (I.R.S. Employer Identifi ...

As filed with the Securities and Exchange Commission on January 16, 2024. Registration No. 333-274885 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-2967193 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identifi ...

As filed with the Securities and Exchange Commission on January 8, 2024. Registration No. 333-274885 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) FORM S-1 (State or other jurisdiction of incorporation or organization) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Delaware 2834 86-2967193 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identific ...

As filed with the Securities and Exchange Commission on January 8, 2024. Registration No. 333-274885 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-2967193 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identific ...

Registration No. 333-274885 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO As filed with the Securities and Exchange Commission on December 12, 2023. FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-2967193 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identif ...

Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. As filed with the Securities and Exchange Commission on December 12, 2023. Registration No. 333-274885 UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-2967193 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identif ...

PART I - FINANCIAL INFORMATION This section presents Calidi Biotherapeutics, Inc.'s unaudited financial statements and management's analysis [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Calidi Biotherapeutics, Inc.'s unaudited consolidated financial statements and notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents Calidi's financial position, detailing assets, liabilities, and stockholders' deficit Condensed Consolidated Balance Sheets (in thousands) | ASSETS (in thousands) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :-------------------- | :----------------------- | :----------- | | Cash | $10,147 | $372 | | Total current assets | $11,687 | $786 | | Total assets | $18,587 | $2,597 | | LIABILITIES (in thousands) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :-------------------- | :----------------------- | :----------- | | Total current liabilities | $10,873 | $42,989 | | Total liabilities | $19,681 | $43,436 | | Total stockholders' deficit | $(1,094) | $(50,440) | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details Calidi's revenues, operating expenses, and net loss for the periods presented Condensed Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | | :-------------------- | :------------------------------ | :------------------------------ | | Total revenues | $0 | $0 | | Total operating expenses | $(7,221) | $(6,986) | | Loss from operations | $(7,221) | $(6,986) | | Total other income (expenses), net | $5,208 | $1,632 | | Net loss | $(2,024) | $(5,355) | | Net loss per share; basic and diluted | $(0.14) | $(0.63) | | Weighted average common shares outstanding; basic and diluted | 14,310 | 8,566 | | Metric (in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------- | :----------------------------- | :----------------------------- | | Total revenues | $0 | $45 | | Total operating expenses | $(19,172) | $(18,485) | | Loss from operations | $(19,172) | $(18,440) | | Total other income (expenses), net | $(1,796) | $783 | | Net loss | $(20,987) | $(17,671) | | Net loss per share; basic and diluted | $(1.98) | $(2.08) | | Weighted average common shares outstanding; basic and diluted | 10,601 | 8,482 | [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) This section presents Calidi's net loss and other comprehensive income/loss components for the periods presented Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | | :-------------------- | :------------------------------ | :------------------------------ | | NET LOSS | $(2,024) | $(5,355) | | Foreign currency translation adjustment | $13 | $(13) | | COMPREHENSIVE LOSS | $(2,011) | $(5,368) | | Metric (in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------- | :----------------------------- | :----------------------------- | | NET LOSS | $(20,987) | $(17,671) | | Foreign currency translation adjustment | $10 | $(30) | | COMPREHENSIVE LOSS | $(20,977) | $(17,701) | [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Deficit](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Deficit) This section outlines changes in Calidi's convertible preferred stock and stockholders' deficit - As of September 30, 2023, all Convertible Preferred Stock were converted into common stock due to the FLAG Merger, resulting in **no outstanding preferred shares**[152](index=152&type=chunk)[159](index=159&type=chunk) Stockholders' Deficit (in thousands) | Stockholders' Deficit (in thousands) | Dec 31, 2022 | Sep 30, 2023 | | :----------------------------------- | :----------- | :----------- | | Common stock, amount | $2 | $4 | | Additional paid-in capital | $19,928 | $90,249 | | Accumulated other comprehensive loss | $(14) | $(4) | | Accumulated deficit | $(70,356) | $(91,343) | | Total stockholders' deficit | $(50,440) | $(1,094) | - The total number of common stock shares issued and outstanding increased significantly from **8,583,724** as of December 31, 2022, to **35,436,381** as of September 30, 2023, primarily due to the FLAG Merger and conversions[33](index=33&type=chunk)[154](index=154&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents Calidi's cash flows from operating, investing, and financing activities Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(21,797) | $(9,338) | | Net cash used in investing activities | $(443) | $(333) | | Net cash provided by financing activities | $32,002 | $7,768 | | Net increase (decrease) in cash and restricted cash | $9,775 | $(1,937) | | Cash and restricted cash at end of period | $10,365 | $300 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of Calidi's accounting policies and financial statement components [Note 1. Organization and Nature of Operations](index=10&type=section&id=Note%201.%20Organization%20and%20Nature%20of%20Operations) Calidi is a clinical-stage immuno-oncology company focused on stem cell-based therapies, facing going concern doubts - Calidi is a clinical-stage immuno-oncology company developing novel stem cell-based platforms for oncolytic virus therapies, with key product candidates including **CLD-101** and **CLD-201**[46](index=46&type=chunk) - On September 12, 2023, Calidi completed a merger with First Light Acquisition Group, Inc. (FLAG), with Calidi identified as the **accounting acquirer**[47](index=47&type=chunk) - The company has an accumulated deficit of **$91.3 million** as of September 30, 2023, and used **$21.8 million** in operating activities, raising substantial doubt about its ability to continue as a going concern[54](index=54&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=12&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines Calidi's significant accounting policies, including U.S. GAAP, consolidation, and fair value measurements - The unaudited condensed consolidated financial statements adhere to SEC rules and U.S. GAAP, with historical common share amounts retroactively restated due to the **FLAG Merger's reverse recapitalization**[56](index=56&type=chunk) - Calidi consolidates its wholly-owned subsidiaries and Calidi Cure LLC, identified as a **Variable Interest Entity (VIE)** where Calidi is the primary beneficiary[49](index=49&type=chunk) - Calidi applies the **fair value option (FVO)** to contingently convertible notes and certain term notes, with warrants classified as equity or liability based on terms[65](index=65&type=chunk)[67](index=67&type=chunk) - CIRM grant proceeds of approximately **$0.7 million** and **$2.3 million** were recognized as grant income for the three and nine months ended September 30, 2023, respectively[1](index=1&type=chunk) - Calidi operates as a **single segment**, focusing on research, development, and commercialization of cell-based platforms for oncolytic virus therapies[3](index=3&type=chunk) [Note 3. Merger and Related Transactions](index=22&type=section&id=Note%203.%20Merger%20and%20Related%20Transactions) This note details the FLAG Merger, a reverse recapitalization, including consideration and contingent shares - The FLAG Merger, completed on September 12, 2023, was accounted for as a **reverse recapitalization**, with Calidi identified as the accounting acquirer[5](index=5&type=chunk) - Calidi Security Holders received **27,375,600 shares** of Common Stock as merger consideration, valued at approximately **$250.0 million**, plus a **$23.8 million** net debt adjustment[5](index=5&type=chunk) - Up to **18,000,000 Escalation Shares** may be earned by Calidi Stockholders based on achieving specific stock price hurdles[5](index=5&type=chunk) - Calidi received approximately **$1.8 million** in net cash proceeds from the Trust and **$0.7 million** in cash from non-redeeming shareholders[6](index=6&type=chunk) [Note 4. Fair Value Measurements](index=23&type=section&id=Note%204.%20Fair%20Value%20Measurements) This note details Calidi's fair value measurements for assets and liabilities, including valuation methodologies Fair Value Measurements (in thousands) | Fair Value Measurements (in thousands) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :------------------------------------- | :----------------------- | :----------- | | Restricted cash held in a money market account | $218 | $218 | | Forward Purchase Agreement Derivative Asset | $1,290 | $0 | | Total assets, at fair value | $1,508 | $218 | | Public Warrants | $2,530 | $0 | | Private Placement Warrants | $421 | $0 | | Contingently convertible notes payable | $0 | $1,152 | | SAFEs | $0 | $29,190 | | Total liabilities, at fair value | $2,951 | $30,342 | - The fair value of the Forward Purchase Agreement Derivative Asset decreased from **$4.5 million** at merger closing to **$1.3 million** as of September 30, 2023, due to a decrease in stock price[87](index=87&type=chunk) - Upon the FLAG Merger, all CCNPs, SAFEs, and Series B Convertible Preferred Stock were converted into Calidi common stock and are **no longer outstanding**[70](index=70&type=chunk)[77](index=77&type=chunk)[72](index=72&type=chunk) [Note 5. Selected Balance Sheet Components](index=28&type=section&id=Note%205.%20Selected%20Balance%20Sheet%20Components) This note details selected balance sheet components, including legal settlement liability, accrued expenses, and deferred financing costs - A legal settlement liability of approximately **$0.6 million** as of December 31, 2022, was fully paid following the FLAG Merger, resulting in **no outstanding liability**[118](index=118&type=chunk) Accrued Expenses and Other Current Liabilities (in thousands) | Accrued Expenses and Other Current Liabilities (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :------------------------------------------------------------ | :----------- | :----------- | | Accrued compensation | $2,014 | $4,070 | | Accrued vendor and other expenses | $2,967 | $1,277 | | Total accrued expenses and other current liabilities | $4,981 | $5,347 | - Deferred financing costs, including advances for merger transaction costs, were reclassified against **additional paid-in capital** upon the FLAG Merger closing[182](index=182&type=chunk) [Note 6. Machinery and Equipment, net](index=29&type=section&id=Note%206.%20Machinery%20and%20Equipment,%20net) This note details Calidi's machinery and equipment, net of accumulated depreciation, showing an increase in net value Machinery and Equipment (in thousands) | Machinery and Equipment (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :------------------------------------- | :----------- | :----------- | | Machinery and equipment | $2,022 | $1,518 | | Accumulated depreciation | $(891) | $(631) | | Machinery and equipment, net | $1,131 | $887 | - Depreciation expense was approximately **$0.1 million** for the three months and **$0.3 million** for the nine months ended September 30, 2023[124](index=124&type=chunk) [Note 7. Related Party Transactions](index=29&type=section&id=Note%207.%20Related%20Party%20Transactions) This note outlines significant transactions and investments involving related parties, including debt and equity instruments - Calidi's operations have been funded significantly by related parties, including **AJC Capital** and certain directors, through various debt and equity instruments[192](index=192&type=chunk) Related Party Transaction (in thousands) | Related Party Transaction (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :--------------------------------------- | :----------- | :----------- | | Convertible notes payable (AJC Capital, Director B, manager) | $19 | $804 | | Term notes payable (AJC Capital, Directors A, E, executive officer's family office) | $1,442 | $1,962 | | SAFEs (AJC Capital, Directors A, D, E, F, officer, manager) | $0 | $4,615 | | Legal settlement liability (Former Executive) | $0 | $640 | | Lease guaranty (AJC Capital) | $163 | $150 | - Upon the FLAG Merger, many related party debt instruments, including convertible notes and SAFEs, were converted into Calidi common stock or settled, **significantly reducing related party liabilities**[183](index=183&type=chunk) [Note 8. Debt](index=31&type=section&id=Note%208.%20Debt) This note details Calidi's outstanding debt obligations, including conversions and amendments post-FLAG Merger Debt (in thousands) | Debt (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :------------------ | :----------- | :----------- | | Convertible notes payable | $19 | $804 | | Contingently convertible notes payable | $0 | $1,152 | | Term notes payable | $4,280 | $2,469 | | Loans payable | $1,000 | $1,000 | | Total debt | $5,299 | $5,425 | | Long-term debt, net of current portion | $1,954 | $0 | - The weighted average interest rate for outstanding debt not under the fair value option increased from approximately **8.7%** as of December 31, 2022, to **13.7%** as of September 30, 2023[185](index=185&type=chunk) - In connection with the FLAG Merger, all 2018 Convertible Notes, 2019/2020 Contingently Convertible Notes Payable, and various Term Notes were converted to Calidi common stock or had their terms amended[204](index=204&type=chunk)[137](index=137&type=chunk)[130](index=130&type=chunk)[140](index=140&type=chunk)[142](index=142&type=chunk)[133](index=133&type=chunk) [Note 9. Simple Agreement for Future Equity](index=38&type=section&id=Note%209.%20Simple%20Agreement%20for%20Future%20Equity) This note describes Calidi's Simple Agreements for Future Equity (SAFEs), which converted into common stock upon the FLAG Merger - Calidi issued SAFEs in 2021, 2022, and 2023, raising aggregate proceeds of **$7.9 million**, **$10.8 million**, and **$2.8 million** respectively, with no maturity dates or interest[155](index=155&type=chunk)[135](index=135&type=chunk)[157](index=157&type=chunk) - All SAFEs, including those from CCNP conversions, were converted into Calidi common stock upon the FLAG Merger and are **no longer outstanding**[155](index=155&type=chunk)[135](index=135&type=chunk)[157](index=157&type=chunk)[136](index=136&type=chunk) [Note 10. Convertible Preferred Stock, Common Stock and Stockholders' Deficit](index=39&type=section&id=Note%2010.%20Convertible%20Preferred%20Stock,%20Common%20Stock%20and%20Stockholders'%20Deficit) This note details Calidi's equity structure, including preferred and common stock, and warrants, impacted by the FLAG Merger - All Founders, Series A-1, Series A-2, and Series B Convertible Preferred Stock were converted into Calidi common stock upon the FLAG Merger and are **no longer outstanding**[159](index=159&type=chunk)[152](index=152&type=chunk)[172](index=172&type=chunk) - As of September 30, 2023, **35,436,381 shares** of common stock were outstanding, a substantial increase from **8,583,724 shares** at December 31, 2022, due to the FLAG Merger and conversions[173](index=173&type=chunk)[154](index=154&type=chunk) - The company assumed **11,500,000 Public Warrants** and **1,912,154 Private Placement Warrants** upon the FLAG Merger, classified as liabilities and subject to remeasurement at fair value[177](index=177&type=chunk)[178](index=178&type=chunk) - All 2020 Term Note Warrants, 2020 LOC Warrants, and 2021 Term Note Warrants were **cashless exercised** into common stock and exchanged for New Calidi Common Stock upon the FLAG Merger[167](index=167&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk) [Note 11. Stock-Based Compensation](index=46&type=section&id=Note%2011.%20Stock-Based%20Compensation) This note details Calidi's stock-based compensation, including the 2019 Equity Incentive Plan and option repricing - The 2019 Equity Incentive Plan authorizes various awards, with **stock options** being the sole outstanding type granted to employees, directors, and consultants[189](index=189&type=chunk) - On January 18, 2023, approximately **1.5 million stock options** were repriced, resulting in a noncash compensation charge of approximately **$0.2 million** for the three and nine months ended September 30, 2023[91](index=91&type=chunk) Stock-Based Compensation Expense (in thousands) | Stock-Based Compensation Expense (in thousands) | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | | :---------------------------------------------- | :------------------------------ | :------------------------------ | | Research and development | $242 | $235 | | General and administrative | $867 | $827 | | Total | $1,109 | $1,062 | | Stock-Based Compensation Expense (in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $838 | $469 | | General and administrative | $2,785 | $2,995 | | Total | $3,623 | $3,464 | - As of September 30, 2023, total unamortized stock-based compensation expense was approximately **$8.5 million**, to be amortized over an estimated weighted average life of **3.56 years**[115](index=115&type=chunk) [Note 12. Customer Contracts](index=49&type=section&id=Note%2012.%20Customer%20Contracts) This note describes Calidi's research collaboration agreements, with revenue recognized over time as services were performed - Calidi entered into research collaboration agreements to perform tests on stem cell lines and oncolytic adenoviruses for a customer[115](index=115&type=chunk) - Revenue was recognized over time as services were performed, with **$45,000** in service revenues recognized upon completion of Amendment No. 1[115](index=115&type=chunk) [Note 13. Income Taxes](index=50&type=section&id=Note%2013.%20Income%20Taxes) This note explains Calidi's income tax provision, with no federal or state benefits due to net operating losses - Calidi has incurred net operating losses for U.S. federal and state income tax purposes, with deferred tax assets fully offset by a **valuation allowance**[106](index=106&type=chunk) - The income tax provision for the periods presented was insignificant and entirely attributable to **StemVac operations**, Calidi's German subsidiary[106](index=106&type=chunk) [Note 14. Commitments and Contingencies](index=50&type=section&id=Note%2014.%20Commitments%20and%20Contingencies) This note details Calidi's commitments and contingencies, including leases, legal proceedings, and supplier agreements - Calidi entered into a **48-month operating lease** for its San Diego office and laboratory, with initial monthly rent of **$0.1 million**, secured by a personal guaranty[107](index=107&type=chunk) Future Minimum Lease Commitments (in thousands) | Future Minimum Lease Commitments (in thousands) | Operating Leases | Financing Leases | | :---------------------------------------------- | :--------------- | :--------------- | | 2023 (Oct – Dec) | $347 | $21 | | 2024 | $1,423 | $64 | | 2025 | $1,464 | $43 | | 2026 and thereafter | $1,993 | $46 | | Total minimum lease payments | $5,227 | $174 | | Present value of net minimum lease payments | $4,293 | $158 | - Calidi is involved in a lawsuit with former physicians claiming **3,000,000 vested stock options**, with an estimated loss range of **$0.2 million to $4.9 million**[104](index=104&type=chunk) - Manufacturing and other supplier agreements amount to approximately **$6.6 million** in aggregate commitments as of September 30, 2023[105](index=105&type=chunk) - A separation agreement with George Ng includes a **$0.5 million severance payment** due one year after August 31, 2023, accruing **8.0% interest** if unpaid[193](index=193&type=chunk) [Note 15. Subsequent Events](index=55&type=section&id=Note%2015.%20Subsequent%20Events) This note outlines significant events after September 30, 2023, including debt settlements and executive changes - On October 13, 2023, Calidi settled in cash the full **$1.0 million** principal outstanding related to its line of credit[205](index=205&type=chunk) - Mr. Alan R. Stewart was appointed as a Class I director and Chair of the Audit Committee on October 10, 2023[205](index=205&type=chunk) - Mr. Tony Kalajian resigned as Chief Accounting Officer and interim CFO, and Mr. Andrew Jackson was appointed CFO effective October 30, 2023[205](index=205&type=chunk) - Several term notes payable, totaling approximately **$1.5 million** in principal, were settled in cash in October and November 2023[205](index=205&type=chunk) - A spot bonus of **$0.2 million** was paid to Mr. Tony Kalajian on September 15, 2023, in connection with the completion of the Business Combination[269](index=269&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=55&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's discussion and analysis of Calidi's financial condition and operational results [Company Overview](index=56&type=section&id=Company%20Overview) Calidi is a clinical-stage immuno-oncology company developing stem cell-based therapies, facing significant losses and funding needs - Calidi is a clinical-stage immuno-oncology company focused on developing novel stem cell-based platforms for oncolytic virus therapies, with key product candidates **CLD-101** and **CLD-201**[196](index=196&type=chunk) - The company incurred a net loss of **$2.0 million** for the three months and **$21.0 million** for the nine months ended September 30, 2023, with an accumulated deficit of **$91.3 million**[197](index=197&type=chunk) - Management believes there is **substantial doubt** about the company's ability to continue as a going concern without substantial additional funding[197](index=197&type=chunk) [The FLAG Merger and Related Transactions](index=57&type=section&id=The%20FLAG%20Merger%20and%20Related%20Transactions) This section details the FLAG Merger, outlining merger consideration and contingent Escalation Shares - The Business Combination with FLAG closed on September 12, 2023, with Calidi surviving as a **wholly-owned subsidiary** and FLAG renamed 'Calidi Biotherapeutics, Inc.'[198](index=198&type=chunk) - Calidi Security Holders received **27,375,600 shares** of Common Stock as merger consideration, valued at approximately **$250.0 million**, plus a **$23.8 million** net debt adjustment[207](index=207&type=chunk) - Up to **18,000,000 Escalation Shares** are available to Calidi Stockholders, released incrementally upon specific stock price thresholds[200](index=200&type=chunk) [Components of Operating Results](index=58&type=section&id=Components%20of%20Operating%20Results) This section details Calidi's operating results components: R&D, G&A, other income/expenses, and income taxes - Research and development expenses include personnel costs, third-party research funding, manufacturing, preclinical/clinical trial costs, and regulatory compliance[211](index=211&type=chunk) - General and administrative expenses consist of salaries, stock-based compensation, professional services, recruiting, insurance, travel, and facility costs[214](index=214&type=chunk) - Other income or expenses, net, primarily includes changes in the fair value of debt instruments and SAFEs, as well as grant income from CIRM[209](index=209&type=chunk) - Calidi has incurred net operating losses for tax purposes, resulting in **no federal or state income tax benefit**, with the provision solely from its German subsidiary, StemVac[215](index=215&type=chunk) [Results of Operations](index=61&type=section&id=Results%20of%20Operations) This section analyzes Calidi's net loss for the periods presented, highlighting changes in operating expenses and other income Results of Operations (in thousands) | Metric (in thousands) | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Change ($) | Change (%) | | :-------------------- | :------------------------------ | :------------------------------ | :--------- | :--------- | | Research and development | $(3,251) | $(1,945) | $(1,306) | 67% | | General and administrative | $(3,970) | $(5,041) | $1,071 | -21% | | Total other income, net | $5,208 | $1,632 | $3,576 | 219% | | Net loss | $(2,024) | $(5,355) | $3,331 | -62% | Results of Operations (in thousands) | Metric (in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | Change ($) | Change (%) | | :-------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Service revenues | $0 | $45 | $(45) | -100% | | Research and development | $(9,050) | $(4,994) | $(4,056) | 81% | | General and administrative | $(10,122) | $(13,477) | $3,355 | -25% | | Total other income (expenses), net | $(1,796) | $783 | $(2,579) | -329% | | Net loss | $(20,987) | $(17,671) | $(3,316) | 19% | - The **$3.6 million increase** in other income, net, for the three months ended September 30, 2023, was primarily due to a net change in fair value of financial instruments (**$3.7 million**) and increased grant income (**$0.7 million**)[218](index=218&type=chunk) - The **$2.6 million decrease** in other income (expense), net, for the nine months ended September 30, 2023, was mainly due to Series B financing costs (**$2.7 million**), fair value changes (**$0.9 million decrease**), and increased interest expense (**$0.8 million**)[229](index=229&type=chunk) [Liquidity and Capital Resources](index=63&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses Calidi's liquidity and capital resources, including cash, the FLAG Merger impact, and funding efforts - As of September 30, 2023, Calidi had a cash balance of **$10.1 million**, with debt and liability obligations including **$1.0 million** in loans payable and **$3.0 million** in warrant liabilities[227](index=227&type=chunk) - The FLAG Merger resulted in the conversion of all Founders, Series A-1, Series A-2, and Series B Convertible Preferred Stock, Convertible Notes Payable, Contingently Convertible Notes Payable, and SAFEs into **Common Stock**[227](index=227&type=chunk) - Calidi is negotiating an Equity Line of Credit (ELOC) for up to **$50.0 million**, but its securing is not assured[239](index=239&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | Change ($) | Change (%) | | :------------------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Operating activities | $(21,797) | $(9,338) | $(12,459) | 133% | | Investing activities | $(443) | $(333) | $(110) | 33% | | Financing activities | $32,002 | $7,768 | $24,234 | 312% | | Net increase (decrease) in cash and restricted cash | $9,775 | $(1,937) | $11,712 | -605% | - Net cash provided by financing activities increased significantly to **$32.0 million** for the nine months ended September 30, 2023, primarily from Series B Preferred Stock proceeds (**$24.5 million**) and PIPE Agreements (**$2.8 million**)[80](index=80&type=chunk) - Calidi expects expenses to increase due to ongoing R&D, clinical trials, and public company operations, necessitating **substantial additional funding**[81](index=81&type=chunk) [Critical Accounting Policies](index=69&type=section&id=Critical%20Accounting%20Policies) This section highlights Calidi's critical accounting policies, including stock-based compensation and fair value option accounting - Stock options and other stock-based awards are measured at fair value on the grant date and expensed over the vesting period, using the **Black-Scholes option pricing model**[257](index=257&type=chunk)[258](index=258&type=chunk) - Prior to the FLAG Merger, common stock fair value was estimated using **OPM, PWERM, or a hybrid method**, considering various market and business factors[248](index=248&type=chunk) - Calidi elected the **fair value option** for CCNPs and certain term notes payable, with SAFEs and Series B preferred stock also accounted for as liabilities at fair value[84](index=84&type=chunk)[260](index=260&type=chunk) - The Forward Purchase Agreement and Private Placement Warrants are accounted for as derivative assets/liabilities, valued using **Monte Carlo simulation** and **Black-Scholes models**[87](index=87&type=chunk)[88](index=88&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=75&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Calidi faces minimal market risk from interest rate changes and foreign currency fluctuations - Calidi is not currently exposed to significant market risk from changes in interest rates, as most debt is **fixed-rate or equity-linked**[254](index=254&type=chunk) - Foreign currency exchange rate risk is currently not significant but may increase due to operations in Germany and planned clinical trial activities in Australia[254](index=254&type=chunk) - Inflation has not had a **material effect** on Calidi's business, financial condition, or results of operations during the reported periods[254](index=254&type=chunk) [Item 4. Controls and Procedures](index=76&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated Calidi's disclosure controls and procedures as effective, with no material changes in internal control - Calidi's disclosure controls and procedures were evaluated as **effective** at the reasonable assurance level as of September 30, 2023[270](index=270&type=chunk) - No **material changes** in internal control over financial reporting were identified during the quarter ended September 30, 2023[100](index=100&type=chunk) [Recent Accounting Pronouncements](index=76&type=section&id=Recent%20Accounting%20Pronouncements) Calidi does not expect material impact from recent accounting pronouncements and delays adoption as an EGC - Calidi does not anticipate any **material impact** from recently issued accounting standards on its financial statements or operations[93](index=93&type=chunk) - As an **Emerging Growth Company (EGC)**, Calidi has elected to use the extended transition period for complying with new or revised financial accounting standards[264](index=264&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=75&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) Calidi is classified as an EGC and Smaller Reporting Company, benefiting from reduced reporting requirements - Calidi is an **'emerging growth company' (EGC)** under the JOBS Act, allowing delayed adoption of new accounting standards and reduced reporting requirements[264](index=264&type=chunk) - As an EGC, Calidi can present only **two years of audited financial statements**, is exempt from auditor's attestation on internal controls, and has reduced executive compensation disclosures[265](index=265&type=chunk) - Calidi is also a **'smaller reporting company,'** providing similar disclosure exemptions, such as presenting two most recent fiscal years of audited financial statements[265](index=265&type=chunk) PART II — OTHER INFORMATION This section provides additional information beyond financial statements, including legal proceedings and risk factors [Item 1. Legal Proceedings](index=78&type=section&id=Item%201.%20Legal%20Proceedings) Calidi is subject to various claims and contingencies in the ordinary course of business - Calidi may be subject to litigation in the ordinary course of business, including matters related to business, transactions, and employee issues[95](index=95&type=chunk) - Further details on legal proceedings are available in the company's Registration Statement on Form S-1 filed on October 6, 2023[95](index=95&type=chunk) [Item 1A. Risk Factors](index=78&type=section&id=Item%201A.%20Risk%20Factors) Investing in Calidi's securities involves high risk, including stock price volatility and potential delisting - An investment in Calidi's securities involves a **high degree of risk**, and investors should carefully consider the risk factors outlined in the company's Registration Statements[271](index=271&type=chunk) - The price of Calidi's stock may be **highly volatile**, and an active, liquid, and orderly trading market may not be sustained[271](index=271&type=chunk) - Failure to comply with NYSE American listing standards could result in **delisting**, adversely affecting the company's ability to raise financing and trade securities[271](index=271&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=78&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Unregistered sales of equity securities were previously disclosed, with no issuer purchases or applicable use of proceeds - Unregistered sales of equity securities were reported in Current Reports on Form 8-K filed on August 29, 2023, and August 31, 2023[271](index=271&type=chunk) - There were **no issuer purchases** of equity securities during the period[271](index=271&type=chunk) [Item 3. Defaults Upon Senior Securities](index=78&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reporting period - No defaults upon senior securities occurred[271](index=271&type=chunk) [Item 4. Mine Safety Disclosures](index=78&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Calidi Biotherapeutics, Inc - Mine safety disclosures are **not applicable** to the registrant[271](index=271&type=chunk) [Item 5. Other Information](index=77&type=section&id=Item%205.%20Other%20Information) This section includes information about a **$0.2 million** spot bonus payment to the former Interim CFO - A spot bonus of **$0.2 million** was paid to Mr. Tony Kalajian, former Interim Chief Financial Officer, on September 15, 2023, related to the Business Combination[269](index=269&type=chunk) [Item 6. Exhibits](index=78&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents and various agreements - The exhibits include key corporate documents such as the Second Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws[272](index=272&type=chunk) - Agreements related to the FLAG Merger, including Forward Purchase Agreements, Non-Redemption Agreements, and PIPE Subscription Agreements, are listed as exhibits[272](index=272&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to the Sarbanes-Oxley Act are included[272](index=272&type=chunk) [Signatures](index=80&type=section&id=Signatures) The Form 10-Q is signed by the Chairman and CEO, and CFO, on November 14, 2023 - The report is signed by Allan Camaisa, Chairman and Chief Executive Officer, and Andrew Jackson, Chief Financial Officer, on November 14, 2023[103](index=103&type=chunk)

As filed with the Securities and Exchange Commission on October 6, 2023. Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2967193 (I.R.S. Employer Identification No.) 4475 Executive Driv ...