On July 21, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported 2026 successes to date and provided an update on the Company’s upcoming milestones.
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"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 (AACR) (Free AACR Whitepaper) 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) (Free ESMO Whitepaper) 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) (Free SITC Whitepaper) 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
(Press release, Calidi Biotherapeutics, JUL 21, 2026, View Source [SID1234669358])