Calidi Biotherapeutics Reports Q4 and Full-Year 2025 Results: Progress on CLD-401 and Financial Updates

San Diego, March 27, 2026 – Calidi Biotherapeutics, Inc. (NYSE American: CLDI), a clinical-stage biotechnology company focused on targeted genetic medicines for cancer, has released its fourth quarter and full-year 2025 financial results, along with significant operational milestones that could impact its share price and long-term strategic direction. Here is a comprehensive breakdown for investors:

Key Operational Highlights

• Strategic International Partnership: Calidi has entered a partnership with Avance Clinical, a leading Australian contract research organization (CRO), to expedite the initiation of the first-in-human clinical trial for CLD-401 in Australia. This collaboration leverages Avance’s proven track record in obtaining regulatory approvals and clinical trial initiations in Australia.
• Regulatory Progress with the FDA: The company received feedback from the U.S. FDA through Type D interactions and believes its manufacturing and analytical approaches for CLD-401 are in alignment with FDA guidance. Calidi aims to file an Investigational New Drug (IND) application by the end of 2026, a major regulatory milestone that could be price sensitive if timelines are accelerated or delayed.
• Manufacturing Scale-Up: Calidi partnered with Matica Bio, a top-tier CDMO specializing in oncolytic virus manufacturing, for GMP production of CLD-401. Matica’s Texas-based facility is designed for complex viral vectors, ensuring readiness for clinical manufacturing scale-up—a critical risk mitigator for pipeline progress.
• Scientific Advancement: Calidi presented new data on its novel in situ T-cell engagers (TCEs) at the AACR Immuno-Oncology (AACR-IO) conference. The RedTail platform demonstrated high expression of TCEs and T-cell activating agents (like IL-15 superagonist) within the tumor microenvironment, potentially overcoming historical limitations of TCEs in solid tumors. This innovation could represent a significant competitive advantage if validated in clinical trials.
• Capital Raise: The company raised \$6.5 million through a \$6.0 million underwritten public offering in Q1 2026 and \$0.5 million through its ATM facility in Q4 2025, extending the cash runway and supporting ongoing R&D efforts.

Financial Performance

Fourth Quarter 2025

• Net Loss: \$4.1 million, or \$0.57 per share, unchanged from Q4 2024 (though per-share loss improved due to increased share count).
• R&D Expenses: \$2.4 million, stable year-over-year.
• G&A Expenses: \$2.1 million, slightly down from \$2.2 million in Q4 2024.

Full Year 2025

• Net Loss: \$25.6 million, or \$5.95 per share, compared to \$23.8 million, or \$35.70 per share, in 2024. The improvement in per-share loss reflects post-SPAC merger dilution but continued investment in pipeline development.
• R&D Expenses: \$9.7 million, up from \$8.9 million in 2024, reflecting increased activity ahead of clinical trial initiation.
• G&A Expenses: \$10.5 million, down from \$12.9 million in 2024, indicating ongoing cost discipline.
• Cash Position: \$5.6 million in cash and \$0.2 million in restricted cash as of December 31, 2025, vs. \$9.6 million and \$0.2 million at year-end 2024. The company’s recent fundraise improves liquidity but highlights the need for future capital raises to support clinical development.
• Total Equity: \$3.8 million, up from \$2.0 million in 2024, reflecting additional capital inflows.

Pipeline and Strategic Outlook

• CLD-401, the company’s lead asset from the RedTail platform, is a systemically delivered oncolytic virus designed to selectively replicate in tumor cells and induce high concentrations of IL-15 superagonist in the tumor microenvironment. The targeted indications include non-small cell lung cancer, head and neck cancer, and other tumors with high unmet medical need.
• The company is advancing a novel approach to in situ T-cell engagers in solid tumors, expanding the potential of the RedTail platform and potentially differentiating Calidi from competitors in the immuno-oncology space.
• IND-enabling studies are ongoing, with the goal to file an IND with the FDA by the end of 2026, a key inflection point for the stock.

Risks and Shareholder Considerations

• Funding Risk: The company’s cash runway is limited, and additional capital will be required to sustain operations and advance clinical programs. Any delays or difficulties in raising funds could materially impact share value.
• Regulatory Risk: While initial FDA feedback is supportive, successful IND submission and approval are not guaranteed. Any setbacks in regulatory interactions could negatively affect the stock.
• Clinical Risk: Early-stage pipeline candidates carry high technical risk. Clinical results may differ from preclinical data, and the company acknowledges that early signals may not predict final outcomes.
• Operational Risk: Manufacturing scale-up and supply chain management are critical for delivering on clinical milestones. Any disruption or delay may be price sensitive.

Company Overview

Calidi Biotherapeutics is headquartered in San Diego, California, and is focused on leveraging its proprietary RedTail platform—an engineered enveloped oncolytic virus technology for systemic delivery and targeting of metastatic tumor sites. The platform is designed to shield the virus from immune detection, enabling effective virotherapy and in situ delivery of genetic medicines. The company’s innovation in T-cell engager technology, if successful, could represent a significant leap in the treatment of solid tumors.

Conclusion

Calidi Biotherapeutics has made important progress in clinical development, strategic partnerships, and capital raising, but remains at a preclinical stage. The next major catalysts will be the initiation of clinical trials in Australia, the expected IND filing with the FDA by the end of 2026, and ongoing scientific updates from the RedTail platform. Investors should monitor cash runway, regulatory updates, and clinical data releases, as these will likely be key drivers of share price volatility in the coming quarters.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. All forward-looking statements are subject to risks and uncertainties as outlined in Calidi Biotherapeutics’ SEC filings. Investors should conduct their own due diligence and consult with a qualified financial advisor before making investment decisions. The author does not own shares of Calidi Biotherapeutics at the time of publication.

View Calidi Biotherapeutics, Inc. Historical chart here