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
MWN-AI** Summary
Calidi Biotherapeutics, Inc. (NYSE American: CLDI), a pioneering biotechnology firm, unveiled its innovative and scalable manufacturing process for CLD-401 at the 9th Annual Bioprocessing Summit in Barcelona. CLD-401, the first lead candidate from Calidi's proprietary RedTail platform, represents a novel approach to gene therapy via a systemically delivered virotherapy aimed at selectively targeting tumor cells while modifying the tumor microenvironment (TME). This therapeutic candidate aims to reach metastatic sites, replicate exclusively within tumor cells, and produce elevated levels of IL-15 superagonist (IL-15 SA), a known activator of T-cells and Natural Killer cells.
During the presentation, Calidi detailed its in-house developed manufacturing system that ensures high yield and scalability, essential for the advancement of CLD-401. This process maintains the integrity of the unique CD55 over-expressing envelope of the RedTail virus, which aids in systemic delivery by evading immune detection. The company has been proactive in engaging with the FDA, receiving constructive feedback through Type D meetings, further validating its manufacturing strategies for clinical development.
Dr. Antonio F. Santidrian, Calidi's Chief Scientific Officer, emphasized the scalability potential of their manufacturing system, while CEO Dr. Eric Poma highlighted early FDA engagements as crucial for building a robust production program. Currently, Calidi is conducting IND-enabling studies with CLD-401, with plans to submit an Investigational New Drug application by the year's end. Calidi is also exploring strategic partnerships to enhance the clinical advancement of its RedTail platform, targeting high unmet needs in oncology, including non-small cell lung cancer and head and neck cancer. For more information, visit www.calidibio.com.
MWN-AI** Analysis
Calidi Biotherapeutics (NYSE American: CLDI) has generated positive momentum with its recent presentation at the 9th Annual Bioprocessing Summit regarding the scalable manufacturing process for its lead candidate, CLD-401. This proprietary development, derived from Calidi's innovative RedTail platform, showcases a commitment to advancing targeted genetic medicines, specifically via a virotherapy approach intended to selectively affect tumor cells while evading immune recognition.
The significant interaction with the FDA highlights a growing confidence in Calidi's manufacturing strategies, paving the way for a potential Investigational New Drug (IND) application by the end of 2026. The support from the FDA about Calidi's planned manufacturing processes not only validates the company’s methodologies but also reduces near-term regulatory risks—a key factor for prospective investors.
Investors should pay close attention to CLD-401’s clinical development, especially since it targets unmet medical needs in non-small cell lung cancer and head and neck cancer. The scalability of the manufacturing process is essential, as it indicates the potential for increased production capabilities, which could significantly impact the company’s revenue stream if the therapy receives FDA approval.
Furthermore, Calidi’s ongoing efforts to pursue strategic partnerships could accelerate further clinical developments, expanding the potential applications of the RedTail platform. However, market participants should remain aware of inherent risks, including the unpredictability of clinical trial results and the challenges in securing the necessary funding for operations.
In conclusion, while the current trajectory for Calidi Biotherapeutics suggests a promising outlook, investors should maintain a cautious optimism, monitor forthcoming clinical data, and consider the company’s ability to navigate the complexities of regulatory approvals, which will be pivotal for future growth.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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**
How does the proprietary manufacturing process for CLD-401 by Calidi Biotherapeutics Inc. CLDI ensure scalability and high-yield production while maintaining the integrity of the CD55 over-expressing envelope?
What specific feedback has Calidi Biotherapeutics Inc. CLDI received from the FDA regarding their manufacturing and analytical approaches for CLD-401 during the Type D meeting process?
How does Calidi Biotherapeutics Inc. CLDI plan to utilize its RedTail platform to target different tumor types, and what strategies are in place to expand its clinical development?
What are the potential risks and uncertainties that could impact Calidi Biotherapeutics Inc. CLDI’s ability to achieve FDA approval for CLD-401 and other therapeutic candidates in its pipeline?
**MWN-AI FAQ is based on asking OpenAI questions about Calidi Biotherapeutics Inc. (NYSE: CLDI).
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