Product 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 delivered to the tumor microenvironment [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, triple-negative breast cancer, and head and neck cancer [9]. - Calidi anticipates proof-of-concept data early in Phase I, with the initial dose cohort expected to be in the therapeutic range [9]. - The company aims to present proof of concept data for the RedTail platform's applicability in non-oncology indications [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]. - General and administrative 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 RedTail platform allows for the simultaneous delivery of tumor-localized BiTEs alongside T-cell amplifiers, addressing previous limitations in solid tumors [9]. - The company is exploring new payloads for inflammatory and immune diseases, targeting other cell types via envelope engineering [13]. - Calidi's management team was bolstered with the hiring of a new CEO and CMO, bringing extensive biopharmaceutical experience [7].
FIRST LIGHT ACQU(FLAG) - 2025 Q4 - Annual Results