Calidi Biotherapeutics(CLDI) - 2025 Q4 - Annual Results

Drug Development - Calidi plans to file an IND in Q4 2026 for its first RedTail lead candidate, CLD-401, targeting metastatic disease with high concentrations of IL-15 superagonist[5]. - Calidi presented new preclinical data at ASCO on May 30, 2025, demonstrating enhanced biological efficacy of CLD-401 in immunocompetent tumor models[6]. - The Phase I study for CLD-401 is expected to include a basket of solid tumors, such as non-small cell lung cancer and triple-negative breast cancer[9]. - Calidi anticipates proof-of-concept data for the RedTail platform to deliver tumor-localized BiTEs alongside T-cell amplifiers, addressing previous efficacy limitations in solid tumors[9]. - Calidi expects to present proof-of-concept data for non-oncology indications, leveraging selective viral replication in proliferative cells[13]. Financial Performance - The company reduced term debt and notes payable by $3.1 million in 2025, from $3.8 million at December 31, 2024, to $0.7 million at December 31, 2025[9]. - G&A expenses were reduced by $2.3 million in the first nine months of 2025 compared to the same period in 2024[9]. Strategic Initiatives - The company aims to explore new payloads for inflammatory and immune diseases, targeting other cell types via envelope engineering[13]. - Calidi's RedTail platform is designed to avoid immune clearance and deliver genetic medicines effectively to metastatic sites[10]. - The management team was strengthened with the appointment of a new CEO and CMO, both with extensive biopharmaceutical experience[7].