Calidi Biotherapeutics to Present RedTail Data at AACR Conference
Calidi Biotherapeutics will present data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR Immuno-Oncology conference being held in Los Angeles, California, from February 18-21, 2026. RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist, a known T-cell activator, in the TME. BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show efficacy in solid tumors where the TME inhibits T-cell activity. In immunocompetent models of metastatic disease, the RedTail platform has demonstrated that it can alter the TME and induce T-cell activation through its ability to convert tumors into local producers of IL-15 superagonist. Given the high capacity for genetic payloads with RedTail, it is possible to have simultaneous high levels of expression of multiple tumor-localized payloads, such as an IL-15 superagonist, along with a tumor-specific BiTE. 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 application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.
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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.
Calidi Biotherapeutics Accelerates CLD-401 Clinical Trial Initiation
- Clinical Trial Partnership: Calidi has partnered with Australia's Avance Clinical to rapidly initiate the first-in-human clinical trial for CLD-401, which is expected to significantly enhance the drug's market entry speed and strengthen the company's competitive position in oncology.
- Positive FDA Feedback: The company received encouraging feedback from the FDA through Type D interactions, confirming that its manufacturing and analytical approaches align with FDA guidance, with plans to file an IND by the end of 2026, paving the way for CLD-401's clinical development.
- Successful Fundraising: Calidi raised $6 million in gross proceeds from a public offering in Q1 2026 and an additional $0.5 million from ATM sales in Q4 2025, bolstering its financial position and extending its cash runway for ongoing projects.
- Increased R&D Spending: Research and development expenses reached $2.4 million in Q4 2025, up from $1.8 million in the same period of 2024, reflecting the company's ongoing investment in advancing CLD-401 and other projects to meet market demand for innovative therapies.
CALIDI BIOTHERAPEUTICS INC REPORTS Q4 NET LOSS OF $0.57 PER SHARE
Company Overview: Calidi Biotherapeutics is a biotechnology company focused on developing innovative therapies.
Financial Performance: The company reported a net loss of $0.57 per share for the fourth quarter.
Calidi Partners with Avance for First-in-Human Trial of CLD-401
- Partnership for Clinical Trial: Calidi Biotherapeutics has partnered with Avance Clinical to rapidly initiate a first-in-human clinical trial for its investigational candidate CLD-401, marking a significant advancement in addressing high unmet medical needs in non-small cell lung cancer and other tumor types.
- Trial Objectives: The trial aims to evaluate the safety, pharmacodynamics, and efficacy of CLD-401 as a monotherapy in patients with solid tumors who have exhausted all other therapeutic options, indicating a potential positive impact on this patient population.
- FDA Filing Plans: Calidi plans to file an IND for CLD-401 with the FDA in 2026, demonstrating the company's confidence in the drug's development and laying the groundwork for future market access.
- Stock Price Reaction: Following the announcement of the partnership, Calidi's stock rose 3.65% to $0.30 in pre-market trading, reflecting market optimism regarding the collaboration and its potential outcomes.
CALIDI Biotherapeutics Forms Partnership with Avance Clinical to Streamline Australian Regulatory Approval and Expedite CLD-401 Clinical Trials Launch
Partnership Announcement: Calidi Biotherapeutics has announced a partnership with Avance Clinical to facilitate clinical trials in Australia.
Regulatory Approval: The partnership aims to accelerate the initiation of clinical trials for CLD-401, a therapeutic product.
Focus on Clinical Trials: The collaboration will leverage Avance Clinical's expertise to navigate the regulatory landscape in Australia.
Goal of the Initiative: The initiative is designed to expedite the development and testing of innovative therapies in the Australian market.
Calidi Biotherapeutics Completes $6 Million Public Offering
- Funding Amount: Calidi Biotherapeutics successfully raised approximately $6 million through its public offering and the underwriters' over-allotment option, demonstrating market confidence in its genetic therapy technology and strengthening the financial foundation for future R&D.
- Stock Issuance Details: The offering included 12,094,631 shares of common stock along with Series J, K, and L warrants, reflecting investor confidence in the company's growth potential and providing necessary funding for upcoming clinical trials.
- Warrant Details: The Series J, K, and L warrants were issued with an initial exercise price of $0.50 per share and varying expiration terms, ensuring investor flexibility while also presenting potential capital appreciation opportunities for the company.
- Platform Advantage: Calidi's Redtail platform focuses on targeted therapies and is currently undergoing IND-enabling studies for non-small cell lung cancer and other high unmet medical need tumor types, showcasing the company's innovative capabilities and competitive edge in the biotechnology sector.
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.
Calidi Biotherapeutics Accelerates CLD-401 Clinical Trial Initiation
- Clinical Trial Partnership: Calidi has partnered with Australia's Avance Clinical to rapidly initiate the first-in-human clinical trial for CLD-401, which is expected to significantly enhance the drug's market entry speed and strengthen the company's competitive position in oncology.
- Positive FDA Feedback: The company received encouraging feedback from the FDA through Type D interactions, confirming that its manufacturing and analytical approaches align with FDA guidance, with plans to file an IND by the end of 2026, paving the way for CLD-401's clinical development.
- Successful Fundraising: Calidi raised $6 million in gross proceeds from a public offering in Q1 2026 and an additional $0.5 million from ATM sales in Q4 2025, bolstering its financial position and extending its cash runway for ongoing projects.
- Increased R&D Spending: Research and development expenses reached $2.4 million in Q4 2025, up from $1.8 million in the same period of 2024, reflecting the company's ongoing investment in advancing CLD-401 and other projects to meet market demand for innovative therapies.
CALIDI BIOTHERAPEUTICS INC REPORTS Q4 NET LOSS OF $0.57 PER SHARE
Company Overview: Calidi Biotherapeutics is a biotechnology company focused on developing innovative therapies.
Financial Performance: The company reported a net loss of $0.57 per share for the fourth quarter.
Calidi Partners with Avance for First-in-Human Trial of CLD-401
- Partnership for Clinical Trial: Calidi Biotherapeutics has partnered with Avance Clinical to rapidly initiate a first-in-human clinical trial for its investigational candidate CLD-401, marking a significant advancement in addressing high unmet medical needs in non-small cell lung cancer and other tumor types.
- Trial Objectives: The trial aims to evaluate the safety, pharmacodynamics, and efficacy of CLD-401 as a monotherapy in patients with solid tumors who have exhausted all other therapeutic options, indicating a potential positive impact on this patient population.
- FDA Filing Plans: Calidi plans to file an IND for CLD-401 with the FDA in 2026, demonstrating the company's confidence in the drug's development and laying the groundwork for future market access.
- Stock Price Reaction: Following the announcement of the partnership, Calidi's stock rose 3.65% to $0.30 in pre-market trading, reflecting market optimism regarding the collaboration and its potential outcomes.
CALIDI Biotherapeutics Forms Partnership with Avance Clinical to Streamline Australian Regulatory Approval and Expedite CLD-401 Clinical Trials Launch
Partnership Announcement: Calidi Biotherapeutics has announced a partnership with Avance Clinical to facilitate clinical trials in Australia.
Regulatory Approval: The partnership aims to accelerate the initiation of clinical trials for CLD-401, a therapeutic product.
Focus on Clinical Trials: The collaboration will leverage Avance Clinical's expertise to navigate the regulatory landscape in Australia.
Goal of the Initiative: The initiative is designed to expedite the development and testing of innovative therapies in the Australian market.
Calidi Biotherapeutics Completes $6 Million Public Offering
- Funding Amount: Calidi Biotherapeutics successfully raised approximately $6 million through its public offering and the underwriters' over-allotment option, demonstrating market confidence in its genetic therapy technology and strengthening the financial foundation for future R&D.
- Stock Issuance Details: The offering included 12,094,631 shares of common stock along with Series J, K, and L warrants, reflecting investor confidence in the company's growth potential and providing necessary funding for upcoming clinical trials.
- Warrant Details: The Series J, K, and L warrants were issued with an initial exercise price of $0.50 per share and varying expiration terms, ensuring investor flexibility while also presenting potential capital appreciation opportunities for the company.
- Platform Advantage: Calidi's Redtail platform focuses on targeted therapies and is currently undergoing IND-enabling studies for non-small cell lung cancer and other high unmet medical need tumor types, showcasing the company's innovative capabilities and competitive edge in the biotechnology sector.
