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Calidi Biotherapeutics Provides Corporate Update and Key Value Drivers for 2026

Key Takeaway: Calidi Biotherapeutics provided a corporate update highlighting its achievements in 2025 and outlining key milestones for 2026. The company is advancing its RedTail platform, which targets tumor cells while minimizing systemic exposure. The lead candidate, CLD-401, is in IND-enabling studies, with an IND application expected by year-end. The CEO expressed pride in the team's accomplishments and the platform's potential.
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Market Sentiment Analysis

POSITIVE FACTORS

  • Successful execution of 2025 priorities by Calidi team.
  • RedTail platform shows promise in targeting tumor cells effectively.
  • IND-enabling studies for lead candidate CLD-401 are progressing well.

CONCERNS & RISKS

  • Risks associated with raising sufficient capital for clinical trials.
  • Uncertainty regarding FDA approval for therapeutic candidates.

Full Press Release Details

SAN DIEGO, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, today recapped 2025 successes and provided an update on the Company’s upcoming 2026 milestones.
“I am incredibly proud of the Calidi team for their successful execution of our 2025 priorities,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “We demonstrated that in clinically relevant immunocompetent murine models and ex vivo human immune assays, our RedTail platform has been engineered to prevent immune clearance after systemic administration and to only replicate in tumor cells with high specificity. Our data also demonstrate that the platform can effectively express genetic medicines at the tumor site at levels comparable to those achieved with localized dosing while avoiding systemic exposure. This reflects a scalable therapeutic approach that overcomes the limitations of tumor accessibility. I anticipate that we will complete our IND-enabling studies for CLD-401, the lead candidate from the RedTail platform, and submit an IND application by the end of this year.”

2025 Accomplishments

New members added in October 2025:

2026 Anticipated Milestones

About Calidi

Calidi Biotherapeutics (NYSE American: CLDI) 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.
CLD-401, the lead candidate from the RedTail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentationhere.

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 key milestones, including certain pre-clinical data, meeting expected or planned clinical and regulatory milestones and timelines, planned clinical trials, product development, 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 annual report filed with the SEC on Form 10-K on March 31, 2025, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

For Investors:

Frequently Asked Questions

What is the RedTail platform developed by Calidi?

The RedTail platform is an engineered enveloped oncolytic virus designed for targeted systemic delivery of genetic medicines to tumor sites.

What are the anticipated milestones for Calidi in 2026?

Calidi anticipates completing IND-enabling studies for CLD-401 and submitting an IND application by the end of 2026.

What types of cancer does CLD-401 target?

CLD-401 targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need.

What were Calidi's achievements in 2025?

In 2025, Calidi successfully executed its priorities, demonstrating the effectiveness of its RedTail platform in preclinical models.

Last updated: Jan 29, 2026