Calidi Receives FDA Pre-IND Feedback to Advance CLD-401 Clinical Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Calidi announced that it has received pre-IND regulatory feedback from the 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. 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 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.
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About CLDI
Calidi Biotherapeutics, Inc. is a clinical-stage immuno-oncology company. The Company is developing proprietary allogeneic stem cell-based and enveloped virus platforms to potentiate and deliver oncolytic viruses (vaccinia virus and adenovirus) and, potentially, other molecules to cancer patients. It is focused on developing two proprietary stem cell-based platforms and one enveloped vaccinia virus platform designed to protect the oncolytic virus, whether natural or engineered, from neutralization by the patient’s immune defenses, allowing for greater infection of the tumor cells and leading to a potential improvement in the antitumor activity of oncolytic viruses over traditional naked oncolytic virus therapies. Its product candidates include the CLD-101 product for high grade glioma (HGG), CLD-101 product for Recurrent HGG, CLD-201 product for solid tumors, CLD-301 (AAA) for multiple indications and CLD-400 (RTNova) for certain lung cancer and metastatic solid tumors.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Calidi Biotherapeutics Receives FDA Pre-IND Feedback
- FDA Feedback Confirmation: Calidi Biotherapeutics has received pre-IND feedback from the FDA, confirming its IND-enabling preclinical plans and clinical strategy for CLD-401, marking a significant advancement towards initiating clinical trials expected in early 2027.
- Clinical Trial Preparation: CEO Eric Poma stated that Calidi and the FDA reached alignment on key aspects of CMC and non-clinical programs, laying a solid foundation for the clinical development of CLD-401, showcasing the company's potential in cancer treatment.
- Platform Expansion: Calidi is committed to rapidly advancing CLD-401 into clinical development while expanding the functionality of its RedTail platform, aiming to accelerate clinical progress through strategic partnerships and enhance its competitiveness in the biotechnology sector.
- Targeted Therapy Outlook: As the lead candidate from the RedTail platform, CLD-401 targets high unmet medical needs in non-small cell lung cancer and head and neck cancer, indicating the company's strategic positioning and market opportunities in precision medicine.
See More
Calidi Biotherapeutics Financial Report Update
- Audit Report: Calidi Biotherapeutics disclosed in its 2025 annual report that its independent auditor emphasized the financial statements were prepared under the assumption of going concern, indicating potential financial uncertainties that could affect investor confidence.
- R&D Progress: The company's RedTail platform is advancing with IND-enabling studies for its lead candidate CLD-401, targeting non-small cell lung cancer and head and neck cancer, showcasing the company's potential in addressing high unmet medical needs in oncology.
- Technological Innovation: The engineered enveloped oncolytic virus from the RedTail platform is designed for systemic delivery and targeting metastatic tumors, enhancing the virus's ability to evade immune clearance, which could significantly alter the landscape of cancer treatment.
- Market Risk Advisory: The financial report highlighted risks, including the inability to raise sufficient capital for clinical trials and potential FDA non-approval of therapeutic candidates, which could have a substantial impact on future growth, necessitating careful risk assessment by investors.
See More
Calidi Biotherapeutics Highlights Going Concern in Annual Report
- Audit Report: Calidi Biotherapeutics' 2025 Annual Report includes an audit report from its independent accounting firm, emphasizing that the financial statements were prepared under the assumption of the company's ability to continue as a going concern, indicating potential financial pressures that may affect investor confidence.
- Pipeline Progress: The lead candidate CLD-401 is currently in IND-enabling studies targeting non-small cell lung cancer and head and neck cancer, and successful development could significantly enhance the company's market position in the biopharmaceutical sector.
- Technological Platform Advantage: Utilizing its proprietary RedTail platform, Calidi is developing gene therapies aimed at metastatic tumors, designed to enhance the virus's immune evasion capabilities, which could provide a competitive edge if successful.
- Future Outlook Risks: The statement highlights uncertainties regarding future clinical trial outcomes and the possibility of not receiving FDA approval, which could pose challenges to the company's long-term growth, necessitating cautious risk assessment by investors.
See More
Calidi Biotherapeutics Reports Q1 Earnings and Public Offering
- Earnings Report: Calidi Biotherapeutics reported a Q1 GAAP EPS of -$0.43, indicating challenges in profitability that could impact investor confidence.
- Cash Position: As of March 31, 2026, the company had approximately $6.6 million in cash, an increase from $5.6 million as of December 31, 2025, suggesting improved liquidity management.
- Public Offering Plan: Calidi Biotherapeutics plans a $5.2 million underwritten public offering, which, while potentially dilutive to existing shareholders, provides essential funding to support its R&D efforts.
- Stock Price Reaction: Following the announcement of the public offering, Calidi Biotherapeutics' stock price declined, reflecting market concerns about the company's future prospects, which may affect its ability to raise funds and maintain market trust.
See More
Calidi Biotherapeutics Partners with TransferAI to Enhance Drug Submission Process
- Partnership Announcement: Calidi Biotherapeutics has partnered with TransferAI to enhance the efficiency of the investigational new drug submission process for CLD-401, aiming to expedite treatment for non-small cell lung cancer and other tumors.
- Platform Utilization: The RedTail platform developed by Calidi employs enveloped oncolytic viruses to improve targeted delivery to tumors and modify the tumor microenvironment, thereby enhancing treatment efficacy and potentially increasing patient survival rates.
- AI Integration: By leveraging TransferAI's Sofie platform, Calidi will streamline research coordination, cross-referencing, drafting, and review activities, optimizing regulatory workflows and reducing development time and costs.
- Clinical Trial Advancement: Calidi plans to rapidly demonstrate the impact of systemic virotherapies in Phase 1 studies, advancing the development of CLD-401 and CLD-501 while broadening the applications of the RedTail platform to enhance market competitiveness.
See More
Calidi Biotherapeutics Reports FY Loss and Public Offering
- Financial Loss: Calidi Biotherapeutics reported a FY GAAP EPS of -$5.95, indicating significant challenges in profitability that could undermine investor confidence and negatively impact stock performance.
- Cash Flow Status: As of December 31, 2025, the company had approximately $5.6 million in cash, a substantial decrease from $9.6 million in 2024, reflecting liquidity constraints that may limit future operational and R&D investments.
- Public Offering Plan: Calidi plans a $5.2 million underwritten public offering, which aims to strengthen its capital base; however, market reactions may be subdued due to the company's current financial condition, leading to a decline in share price.
- Restricted Cash Situation: The company maintained $0.2 million in restricted cash as of December 31, 2025, indicating a cautious approach to cash utilization that may affect its financial flexibility in the short term.
See More
Calidi Biotherapeutics Receives FDA Pre-IND Feedback
- FDA Feedback Confirmation: Calidi Biotherapeutics has received pre-IND feedback from the FDA, confirming its IND-enabling preclinical plans and clinical strategy for CLD-401, marking a significant advancement towards initiating clinical trials expected in early 2027.
- Clinical Trial Preparation: CEO Eric Poma stated that Calidi and the FDA reached alignment on key aspects of CMC and non-clinical programs, laying a solid foundation for the clinical development of CLD-401, showcasing the company's potential in cancer treatment.
- Platform Expansion: Calidi is committed to rapidly advancing CLD-401 into clinical development while expanding the functionality of its RedTail platform, aiming to accelerate clinical progress through strategic partnerships and enhance its competitiveness in the biotechnology sector.
- Targeted Therapy Outlook: As the lead candidate from the RedTail platform, CLD-401 targets high unmet medical needs in non-small cell lung cancer and head and neck cancer, indicating the company's strategic positioning and market opportunities in precision medicine.
See More
Calidi Biotherapeutics Financial Report Update
- Audit Report: Calidi Biotherapeutics disclosed in its 2025 annual report that its independent auditor emphasized the financial statements were prepared under the assumption of going concern, indicating potential financial uncertainties that could affect investor confidence.
- R&D Progress: The company's RedTail platform is advancing with IND-enabling studies for its lead candidate CLD-401, targeting non-small cell lung cancer and head and neck cancer, showcasing the company's potential in addressing high unmet medical needs in oncology.
- Technological Innovation: The engineered enveloped oncolytic virus from the RedTail platform is designed for systemic delivery and targeting metastatic tumors, enhancing the virus's ability to evade immune clearance, which could significantly alter the landscape of cancer treatment.
- Market Risk Advisory: The financial report highlighted risks, including the inability to raise sufficient capital for clinical trials and potential FDA non-approval of therapeutic candidates, which could have a substantial impact on future growth, necessitating careful risk assessment by investors.
See More
Calidi Biotherapeutics Highlights Going Concern in Annual Report
- Audit Report: Calidi Biotherapeutics' 2025 Annual Report includes an audit report from its independent accounting firm, emphasizing that the financial statements were prepared under the assumption of the company's ability to continue as a going concern, indicating potential financial pressures that may affect investor confidence.
- Pipeline Progress: The lead candidate CLD-401 is currently in IND-enabling studies targeting non-small cell lung cancer and head and neck cancer, and successful development could significantly enhance the company's market position in the biopharmaceutical sector.
- Technological Platform Advantage: Utilizing its proprietary RedTail platform, Calidi is developing gene therapies aimed at metastatic tumors, designed to enhance the virus's immune evasion capabilities, which could provide a competitive edge if successful.
- Future Outlook Risks: The statement highlights uncertainties regarding future clinical trial outcomes and the possibility of not receiving FDA approval, which could pose challenges to the company's long-term growth, necessitating cautious risk assessment by investors.
See More
Calidi Biotherapeutics Reports Q1 Earnings and Public Offering
- Earnings Report: Calidi Biotherapeutics reported a Q1 GAAP EPS of -$0.43, indicating challenges in profitability that could impact investor confidence.
- Cash Position: As of March 31, 2026, the company had approximately $6.6 million in cash, an increase from $5.6 million as of December 31, 2025, suggesting improved liquidity management.
- Public Offering Plan: Calidi Biotherapeutics plans a $5.2 million underwritten public offering, which, while potentially dilutive to existing shareholders, provides essential funding to support its R&D efforts.
- Stock Price Reaction: Following the announcement of the public offering, Calidi Biotherapeutics' stock price declined, reflecting market concerns about the company's future prospects, which may affect its ability to raise funds and maintain market trust.
See More
Calidi Biotherapeutics Partners with TransferAI to Enhance Drug Submission Process
- Partnership Announcement: Calidi Biotherapeutics has partnered with TransferAI to enhance the efficiency of the investigational new drug submission process for CLD-401, aiming to expedite treatment for non-small cell lung cancer and other tumors.
- Platform Utilization: The RedTail platform developed by Calidi employs enveloped oncolytic viruses to improve targeted delivery to tumors and modify the tumor microenvironment, thereby enhancing treatment efficacy and potentially increasing patient survival rates.
- AI Integration: By leveraging TransferAI's Sofie platform, Calidi will streamline research coordination, cross-referencing, drafting, and review activities, optimizing regulatory workflows and reducing development time and costs.
- Clinical Trial Advancement: Calidi plans to rapidly demonstrate the impact of systemic virotherapies in Phase 1 studies, advancing the development of CLD-401 and CLD-501 while broadening the applications of the RedTail platform to enhance market competitiveness.
See More
Calidi Biotherapeutics Reports FY Loss and Public Offering
- Financial Loss: Calidi Biotherapeutics reported a FY GAAP EPS of -$5.95, indicating significant challenges in profitability that could undermine investor confidence and negatively impact stock performance.
- Cash Flow Status: As of December 31, 2025, the company had approximately $5.6 million in cash, a substantial decrease from $9.6 million in 2024, reflecting liquidity constraints that may limit future operational and R&D investments.
- Public Offering Plan: Calidi plans a $5.2 million underwritten public offering, which aims to strengthen its capital base; however, market reactions may be subdued due to the company's current financial condition, leading to a decline in share price.
- Restricted Cash Situation: The company maintained $0.2 million in restricted cash as of December 31, 2025, indicating a cautious approach to cash utilization that may affect its financial flexibility in the short term.
See More
