Calidi Biotherapeutics Announces Bolstered Cash Balance and Termination of its Standby Equity Purchase Agreement

Rhea-AI Summary

Calidi Biotherapeutics (NYSE: CLDI) reported a cash balance of $9.6 million as of December 31, 2024, and announced the termination of its Standby Equity Purchase Agreement (SEPA) with YA II PN, effective January 23, 2025. The company secured significant funding through multiple channels in Q4 2024, including $9.5 million from public offerings, $2.0 million from warrant exercises, and $3.1 million from its ATM facility. In January 2025, an additional public offering raised $4.25 million in gross proceeds.

The company's strengthened financial position led to the termination of the unused SEPA, which had provided the option to sell up to $25 million of common stock over three years. Recent developments include the acceptance of their RTNova platform abstract for presentation at the AACR Annual Meeting and FDA clearance for a Phase 1b/2 trial of CLD-101 for high-grade gliomas, scheduled to begin enrollment in Q1 2025.

Positive

• Secured total funding of $14.6 million in Q4 2024 through multiple sources
• Additional $4.25 million raised in January 2025 through public offering
• Strong cash position of $9.6 million as of December 31, 2024
• FDA clearance received for Phase 1b/2 trial of CLD-101

Negative

• Multiple public offerings and ATM facility usage may indicate dilution of shareholder value

Insights

Financial Analyst

Calidi's financial restructuring demonstrates strategic capital management and growing market confidence. The termination of the $25 million SEPA is particularly significant as it eliminates a potentially dilutive financing mechanism, signaling management's confidence in their current cash position and alternative funding sources.

The company's successful multi-pronged fundraising approach has yielded impressive results:

• $9.5 million from Q4 2024 public offerings
• $2.0 million from warrant exercises
• $3.1 million from ATM facility
• $4.25 million from January 2025 offering

The timing of these financial moves is strategically aligned with key operational milestones, including the upcoming AACR presentation and the FDA-cleared Phase 1b/2 trial. This strengthened financial position, with approximately $9.6 million in cash as of December 2024, provides operational runway while maintaining flexibility through the ATM facility.

The decision to terminate the SEPA before any shares were issued demonstrates disciplined capital management and sensitivity to shareholder dilution concerns. This move, combined with successful traditional fundraising, suggests growing institutional confidence in Calidi's clinical programs and could potentially lead to more favorable financing terms in the future.

Clinical Research Analyst

The strengthened financial position strategically aligns with two critical clinical developments: the FDA-cleared Phase 1b/2 trial for CLD-101 in high-grade gliomas and the upcoming AACR presentation of their RTNova platform. The timing of enrollment initiation in Q1 2025 suggests careful coordination between financial and clinical milestones.

The acceptance of their systemic platform abstract at AACR, a premier oncology conference, represents a significant validation of their RTNova enveloped virotherapies approach. This platform presentation opportunity, combined with the Northwestern University collaboration for the glioma trial, demonstrates growing scientific credibility and potential for their targeted antitumor virotherapy approach.

The robust cash position enables proper execution of these clinical programs without financial constraints potentially compromising trial design or implementation. This is particularly important for high-grade glioma studies, which require careful monitoring and long-term follow-up.

SAN DIEGO, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that its ending cash balance at December 31, 2024 was approximately $9.6 million. Due to Calidi’s bolstered cash balance and success in recent fundraising, including proceeds resulting from its At-The-Market Offering Agreement (“ATM”), Calidi terminated its Standby Equity Purchase Agreement (“SEPA”) with YA II PN, Ltd., an affiliate of Yorkville Advisors, effective January 23, 2025.

In connection with the SEPA executed in December 2023 and amended in January 2024, Calidi was granted the option to sell up to $25 million of common stock over a three-year period, subject to certain trading volume and beneficial ownership provisions. The shares underlying the SEPA have not been registered and Calidi did not exercise any option to sell such shares.

In the fourth quarter of 2024, Calidi secured $9.5 million in gross proceeds, before deducting expenses, through two public offerings, supplemented by $2.0 million from warrant exercises and $3.1 million from its ATM facility. In January 2025, Calidi announced another public offering that raised an additional $4.25 million in gross proceeds, before deducting expenses. These public offerings have bolstered Calidi’s cash position, and together with the availability of the ATM facility, positioned it to meet its capital needs without relying on the SEPA framework.

“Our decision to terminate the SEPA marks an important milestone in our financing strategy,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “With the successful completion of recent financing activities, we are well-positioned to focus on our clinical and operational goals and remove a potential overhang in our stock. This move aligns with our dedication to enhancing shareholder value while building our leadership in both targeted systemic and localized antitumor virotherapies.”

Calidi continues to make strides in the development of its innovative virotherapy platforms, with recent milestones including its systemic platform (RTNova enveloped virotherapies) abstract being accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting in April 2025 and IND clearance by FDA for a Northwestern University-led Phase 1b/2 trial of CLD-101 for high-grade gliomas with plans to start enrollment in the first quarter 2025.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies, are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

Preliminary, Unaudited Financial Disclosures

The data presented above is preliminary and unaudited, based upon our estimates, and subject to further internal review by management and compilation of actual results. Our closing procedures for the fourth quarter and year ended December 31, 2024 are not yet complete. Our management’s estimates are based upon preliminary information currently available from our business. While we expect that our results will be consistent with these preliminary and unaudited estimates, our actual results may differ materially from these preliminary estimates.

This preliminary financial information is not a comprehensive statement of our financial results for this period. Our actual results may differ materially from these estimates due to the completion of our financial closing procedures, final adjustments, and other developments that may arise between now and the time the closing procedures for the quarter are completed.

This preliminary financial information should not be viewed as a substitute for our full interim or annual financial statements prepared in accordance with U.S. generally accepted accounting principles. Accordingly, you should not place undue reliance on this preliminary financial information. The preliminary financial information has been prepared by, and is the responsibility of, our management. Marcum LLP, our independent registered public accounting firm, has not audited, reviewed, compiled or performed any procedures with respect to the accompanying preliminary financial data. Accordingly, Marcum LLP does not express an opinion or any other form of assurance with respect thereto.

Forward-Looking Statements

This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Registration Statements filed with the SEC on (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company’s periodic reports filed with the SEC on (i) Form 10-K filed on March 15, 2024, (ii) Form 10-Q filed on May 14, 2024, (iii) Form 10-Q filed on August 13, 2024, and (iv) Form 10-Q filed on November 12, 2024. These reports may be amended or supplemented by other reports we file with the SEC from time to time.

Corporate Communications:

Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com

Source: Calidi Biotherapeutics, Inc.

FAQ

How much cash did Calidi Biotherapeutics (CLDI) report as of December 31, 2024?

Calidi Biotherapeutics reported a cash balance of approximately $9.6 million as of December 31, 2024.

Why did CLDI terminate its Standby Equity Purchase Agreement (SEPA)?

CLDI terminated the SEPA due to its strengthened cash position from successful recent fundraising activities, including proceeds from public offerings, warrant exercises, and ATM facility.

How much funding did CLDI raise in Q4 2024?

In Q4 2024, CLDI raised $14.6 million total: $9.5 million through public offerings, $2.0 million from warrant exercises, and $3.1 million from its ATM facility.

What is the status of CLDI's CLD-101 clinical trial?

CLDI received FDA clearance for a Northwestern University-led Phase 1b/2 trial of CLD-101 for high-grade gliomas, with enrollment planned to begin in Q1 2025.

How much additional funding did CLDI secure in January 2025?

CLDI raised an additional $4.25 million in gross proceeds through a public offering in January 2025.