Calidi Biotherapeutics 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
SAN DIEGO, June 16, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE:CLDI) ("Calidi" or "the Company"), a biotechnology company pioneering the development of targeted genetic medicines, today announces that it has received pre-IND regulatory feedback from the U.S. Food and Drug Administration (FDA) providing alignment and clarity on Calidi's IND-enabling preclinical plans and clinical strategy for CLD-401 prior to advancing the drug candidate into Phase 1 clinical studies.
"We thank the FDA for its regulatory feedback, and we believe we are in agreement with the agency on our overall IND strategy for CLD-401," said Calidi Biotherapeutics Chief Executive Officer Eric Poma, Ph.D. "We look forward to our regulatory submission for CLD-401, a potentially ground-breaking oncolytic virus with in situ delivery of an IL-15 superagonist, which we are targeting by year-end. This positions us to initiate our first-in-human clinical trial in early 2027."
In the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs as well as feedback on the overall design for the proposed first-in-human clinical study. This pre-IND (Type B) interaction builds on the engagement and alignment achieved through early scientific advice as part of a Type D interaction with the FDA.
Calidi is committed to rapidly advancing CLD-401 into the clinic, believing that early Phase I data for CLD-401 will validate the Company's proprietary RedTail platform. The Company continues to expand the functionality of the RedTail platform while actively pursuing strategic partnerships to accelerate clinical development and broaden its impact.
About Calidi
Calidi Biotherapeutics (NYSE: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 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.
For Investors:
For Media:
