Calidi Biotherapeutics Presents its Innovative and Scalable Manufacturing Process for CLD-401 at the 9th Annual Bioprocessing Summit; FDA Feedback Support Company’s Approach to Manufacturing
Rhea-AI Summary
Calidi Biotherapeutics (NYSE American: CLDI) presented its proprietary, in‑house manufacturing process for CLD-401 at the 9th Annual Bioprocessing Summit in Barcelona on March 12, 2026. The process aims to enable scalable, high‑yield production while preserving the CD55 over‑expressing envelope of the RedTail virus to permit systemic delivery.
Calidi said it has engaged the FDA via a Type D meeting; the agency's feedback supports using this manufacturing and analytical approach for CLD-401’s clinical development. The company expects to submit an IND for CLD-401 by the end of 2026 and is advancing IND‑enabling studies and strategic partnerships.
Positive
- FDA feedback supports use of the manufacturing approach for clinical development
- In‑house process designed for scalable, high‑yield production of CLD-401
- Company plans to submit an IND for CLD-401 by end of 2026
Negative
- No clinical efficacy or safety data for CLD-401 disclosed
- IND remains pending; timeline to end of 2026 presents regulatory timing risk
- Manufacturing claims rely on internal data and regulatory feedback, not final approvals
Key Figures
Market Reality Check
Peers on Argus
CLDI is down 3.89%. Among peers, APRE (-3.8%) and NLSP (-1.05%) are also lower, while CELZ (+1.29%) and INAB (+10.56%) are up, and GNPX is slightly down (-0.5%), indicating mixed stock-specific moves rather than a unified sector trend.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 09 | Equity offering close | Negative | -1.5% | Closed $6.0M underwritten public offering with multiple resettable warrants. |
| Mar 06 | Equity offering pricing | Negative | -53.1% | Priced $5.2M unit offering at $0.50 with additional warrant over-allotment. |
| Mar 05 | Proposed equity offering | Negative | -53.1% | Announced proposed underwritten unit offering for working capital purposes. |
| Feb 20 | RedTail data update | Positive | +8.0% | Presented preclinical RedTail BiTE and IL‑15 SA data, outlining CLD‑401 plans. |
| Feb 12 | Conference presentation plan | Positive | -6.9% | Announced upcoming AACR‑IO late‑breaking abstract on RedTail and CLD‑401. |
Recent equity offerings have coincided with sharp negative reactions, while positive RedTail/CLD-401 data have seen mixed but sometimes favorable price responses.
Over recent months, Calidi has balanced platform progress with significant financing activity. Multiple underwritten public offerings in early March 2026 raised roughly $5.2–6.0 million each and triggered steep declines around -53%. In contrast, RedTail and CLD‑401 presentations at AACR‑IO in February 2026 sometimes produced positive moves, including a 7.97% gain after preclinical data. Today’s manufacturing/FDA feedback update continues the RedTail/CLD‑401 development narrative following those prior scientific disclosures.
Market Pulse Summary
This announcement underscores continued advancement of Calidi’s RedTail platform and CLD‑401, with FDA feedback supporting its scalable manufacturing approach and a targeted IND submission by the end of 2026. It follows earlier preclinical RedTail data and recent capital-raising activity. Investors may focus on execution of IND-enabling work, regulatory interactions, financing needs, and progress toward clinical initiation as key markers of future value realization.
Key Terms
virotherapy medical
tumor microenvironment (TME) medical
il-15 superagonist (il-15 sa) medical
natural killer cell medical
investigational new drug (ind) application regulatory
ind-enabling studies regulatory
AI-generated analysis. Not financial advice.
SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today presented on its proprietary manufacturing process for CLD-401, the Company’s first lead candidate from its RedTail platform, at the BioProcessing Summit in Barcelona.
RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumor cells, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetics at the tumor. CLD-401 is designed to reach metastatic sites, replicate only in tumor cells, and express high levels of IL-15 superagonist (IL-15 SA), a known T-cell and Natural Killer cell activator, in the TME.
At the meeting, Calidi outlined key aspects of its manufacturing system designed to support scalable and high-yield manufacturing of CLD-401. This process, developed in-house, maintains the integrity of the CD55 over-expressing envelope unique to the Company’s RedTail virus that allows for systemic delivery by preventing immune recognition.
Calidi has interacted with the FDA around the Company’s manufacturing and analytical approaches through its Type D meeting request process. The feedback it has received from the agency supports the use of this process for the clinical development of CLD-401.
“The process discussed today highlights key scalability properties of the manufacturing system we have developed for the RedTail platform and CLD-401” said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. “Based on our interactions with the FDA, we believe this process can be used to support CLD-401 through clinical development with the ultimate goal of commercialization.”
“The RedTail platform represents an exciting new approach for the systemic and targeted delivery of genetic payloads to distal sites of disease,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “Early engagement with the FDA on our manufacturing strategy has been an important step in building a scalable and robust manufacturing program, and the feedback we have received supports our approach as we advance CLD‑401 through clinical development”
Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The Company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.
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 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 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 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:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com
FAQ
What manufacturing process did Calidi (CLDI) present for CLD-401 at the March 12, 2026 Bioprocessing Summit?
Did the FDA support Calidi's manufacturing approach for CLD-401 (CLDI)?
When does Calidi (CLDI) expect to file an IND for CLD-401?
What is CLD-401 designed to do and how does manufacturing support it for Calidi (CLDI)?
Will Calidi (CLDI) pursue partnerships to advance CLD-401 development?
