v3.26.1
Organization and Nature of Operations
6 Months Ended
Jun. 30, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization and Nature of Operations

1. Organization and Nature of Operations

 

Calidi Biotherapeutics, Inc. is a biotechnology company that is pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The Company’s proprietary RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.

 

As used herein, the “Company” or “Calidi” refers collectively to Calidi Biotherapeutics, Inc., a Delaware corporation, and its consolidated subsidiaries, which include (i) Calidi Biotherapeutics (Nevada), Inc. (“Calidi Nevada”), (ii) StemVac GmbH (“StemVac”), a German company, (iii) Calidi Biotherapeutics Australia Pty Ltd (“Calidi Australia”), an Australian company, and (iv) Redtail Biopharma, Inc. (“Redtail Biopharma”), a Nevada corporation.

 

The Company’s operations to date have focused on organization and staffing, business planning, raising capital, licensing, acquiring and developing technology, establishing intellectual property portfolio, identifying potential product candidates and undertaking preclinical studies, process development and manufacturing for preclinical and clinical trials.

 

StemVac’s primary operating activities include process development and other research and development activities for the Company under a cost-plus intercompany development agreement funded by the Company. Calidi Australia’s principal purpose is for conducting certain clinical enabling activities in Australia. Redtail Biopharma was incorporated in May 2024 as a potential vehicle to facilitate a spinoff or out license of the RedTail technology, should partnering activities develop. To date, the Company has not transferred any intellectual property or assets to Redtail Biopharma, and Redtail Biopharma has had no activity to date.

 

 

Reverse Stock Split

 

On July 27, 2026, the Company filed a Third Certificate of Amendment to its Second Amended and Restated Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to effect a 1-for-16 reverse stock split of the shares of the Company’s Common Stock effective on July 30, 2026 (the “2026 Reverse Stock Split”). As a result of the 2026 Reverse Stock Split, every sixteen shares of issued and outstanding Common Stock were automatically combined into one issued and outstanding share of Common Stock, without any change in the par value per share. No fractional shares were issued as a result of the 2026 Reverse Stock Split, and any fractional shares that would otherwise have resulted from the 2026 Reverse Stock Split were rounded up to the next whole number. The number of authorized shares of Common Stock under the Company’s Second Amended and Restated Certificate of Incorporation, as amended, remained unchanged. Trading of the Company’s shares of Common Stock on the NYSE American, LLC commenced on a split-adjusted basis on July 31, 2026.

 

All references to share and per share amounts for all periods presented in the unaudited condensed consolidated financial statements have been retrospectively restated to reflect the 2025 Reverse Stock Split and 2026 Reverse Stock Split. All rights to receive shares of common stock under outstanding securities, including but not limited to, warrants, options, and restricted stock units (“RSUs”) were adjusted to give effect to the reverse stock split. Furthermore, proportionate adjustments were made to the per share exercise price and the number of shares of Common Stock that may be purchased upon exercise of outstanding stock options granted by the Company, and the number of shares of Common Stock reserved for future issuance under the Company’s 2023 Equity Incentive Plan.

 

Liquidity and Going Concern

 

The unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.

 

The Company has experienced recurring losses from operations and negative cash flows from operating activities, has a significant accumulated deficit and expects to continue to incur net losses into the foreseeable future. The Company had an accumulated deficit of $149.9 million at June 30, 2026, and during the six months ended June 30, 2026, the Company used $8.5 million of cash for operating activities. As of June 30, 2026, the Company had cash of $4.1 million and restricted cash of $0.2 million. The Company expects operating losses and negative cash flows to continue for the foreseeable future.

 

The Company estimates that based on the Company’s liquidity resources, there is substantial doubt about the Company’s ability to continue as a going concern within 12 months from the date of issuance of these unaudited condensed consolidated financial statements. The accompanying unaudited condensed consolidated financial statements have been prepared on the basis of the Company continuing to operate in the normal course of business and does not reflect any adjustments to the assets and liabilities related to the substantial doubt of its ability to continue as a going concern.

 

The Company’s ability to continue as a going concern is dependent upon its ability to raise additional funding. The Company plans to raise additional capital through public or private equity or debt financings to fulfill its operating and capital requirements for the next 12 months from the date of the issuance of the financial statements. However, the Company may not be able to secure such financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders.

 

Risks and Uncertainties

 

Changes in economic conditions, including rising interest rates, public health issues, lower consumer confidence, volatile equity capital markets, ongoing supply chain disruptions and the impacts of geopolitical conflicts, may affect the Company’s operations.