Calidi Biotherapeutics Secures $6.5M, Advances CLD-401 Manufacturing and Trial Initiation
Calidi Biotherapeutics raised $6.5 million in offering and ATM sales, leaving approximately $5.6 million in cash as of December 31, 2025. The company partnered with Avance Clinical and Matica Bio to advance GMP manufacturing and first-in-human trial initiation for CLD-401, targeting an IND filing by end 2026.
1. Financial Results and Cash Position
Company reported a net loss of $4.1 million in Q4 2025 and $25.6 million for full-year 2025, with R&D expenses of $9.7 million and G&A costs of $10.5 million. It raised $6.5 million via public offering and ATM sales, leaving cash and restricted cash of $5.6 million as of December 31, 2025.
2. Clinical Trial Partnership
Calidi partnered with Avance Clinical to expedite initiation of its first-in-human CLD-401 trial in Australia, leveraging the CRO’s regulatory approval experience. This collaboration aims to start the oncolytic virus trial ahead of its planned IND filing by year-end 2026.
3. Manufacturing and Regulatory Progress
The company engaged Matica Bio for GMP manufacturing of CLD-401 at its specialized viral vector facility in College Station, Texas. Following FDA Type D interactions, Calidi’s manufacturing and analytical approaches for CLD-401 align with agency guidance, supporting its planned IND submission by end 2026.
4. RedTail Platform Data and Pipeline
Calidi presented data demonstrating high in situ T-cell engager expression alongside IL-15 superagonist in solid tumor models via its RedTail platform. This novel approach aims to overcome traditional limitations of TCEs in solid tumors, advancing the lead asset toward clinical evaluation.