- Company receives positive pre-IND feedback from US FDA for CLD-401, indicating agreement on its current development strategy as it advances towards a first-in-human study; targeting dosing first patient in Q1 2027
- Company demonstrated the versatility of the RedTail platform with new CLD-501 data demonstrating the simultaneous in situ delivery of a TROP-2-targeted tumor-localized T-cell engager (TCE) alongside a T-cell amplifiers. The Company is also advancing its EpCam-targeted In Situ TCE program. In Situ TCEs represent an important advancement of the RedTail platform
- Strengthened Board of Directors with addition of Corsee Sanders, Ph.D., former executive of Genentech/Roche and Celgene
- Company continues to cut G&A costs as it focuses on moving its pipeline into the clinic. Demonstrated $1 million reduction in general and administrative expenses from Q1-2025 to Q1-2026
SAN DIEGO, July 21, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, today recapped 2026 successes to date and provided an update on the Company’s upcoming milestones.
“Calidi continues to execute on its goal of bringing its RedTail platform to the clinic and expanding the utility of this groundbreaking technology,” said Calidi Chief Executive Officer Eric Poma, PhD. “We have had productive discussions with the FDA that support our strategy and timeline for CLD-401 IND filing and we continue to expand the reach of RedTail with the development of in situ TCEs.”
1H26 Accomplishments
- Successful pre-IND meeting with FDA with agreement on pharmacology, toxicology, CMC, and phase I protocol strategy for CLD-401 phase I trial
- In Situ TCEs have the potential to overcome current limitations around T-cell engagers in solid tumors by their ability to deliver high levels of a TCE in situ while simultaneously activating T-cells in the tumor microenvironment. Proof-of-concept data presented in 2026 underscore this potential
- Strengthened the Board of Directors with the addition of Corsee Sanders, Ph.D. Dr. Sanders has served as strategic advisor to Celgene’s Chief Medical Officer (CMO) following Celgene’s acquisition of Juno where she was an Executive Vice President of Development Operations. She also served as Transition Advisor to Bristol Myers Squibb (BMS), which acquired Celgene. Prior to that, Dr. Sanders held numerous leadership positions over the course of 23 years at Genentech/Roche, including serving as Senior Vice President, Global Head of Clinical Operations and Industry Collaboration, for six years
- Reduced debt and G&A expenses by approximately $1M in 1Q26 over 1Q25. Company will maintain a continued focus on cost cutting to ensure sufficient capital to advance pipeline
Upcoming Key Value Drivers
- New data to be presented quantifying positive results from cytotoxicity and IL-15 SA expression in murine tumor cells at the American Association for Cancer Research Drug Discovery and Development (AACR D3) conference being held in Boston, MA from July 21-24, 2026
- New data to be presented expanding in situ TCEs from the RedTail platform to include EpCAM-targeted TCEs, in addition to TROP-2, at the European Society for Medical Oncology (ESMO) conference being held in Madrid, Spain from October 23-27, 2026
- New data to be presented including results from GLP toxicity and IND-enabling studies, as agreed to with the FDA at June 2026 pre-IND meeting, at the Society for Immunology of Cancer (SITC) conference being held in Phoenix, AZ from November 4-8, 2026
- Company targeting first patient dosed in CLD-401 phase I trial in Q1 2027. On track for regulatory submissions with positive feedback from FDA in pre-IND meeting
- First patients’ data in CLD-401 trial anticipated in Q2 2027. The Company believes that early signs of activity and expression in tumor microenvironment (TME) would prove the platform is working as designed and viral and protein payloads are being effectively deployed in the TME
About Calidi
Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology company 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 metastatic non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform including its novel approach to incorporate in situ T-cell engagers in solid tumors.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here.
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, 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 annual report filed with the SEC on Form 10-K on March 27, 2026, 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.
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