Clinical Trial Updates - Azer-cel showed a 79% best overall response rate in a Phase 1b trial (N=14)[8, 10] - A 57% overall response/complete response rate was achieved in February 2025 for azer-cel[13] - The company anticipates initiating a pivotal Phase 2/3 registrational trial for azer-cel in CY2026, pending data and regulatory approvals[8] - onCARlytics Phase 1 OASIS trial is currently in Phase 1 in solid cancers in combination with Blinatumomab, showing early results in bile tract cancer and durable stability of disease[8] - VAXINIA received Orphan Drug Designation in September 2024[14] Business and Financial Strategy - The company is out-licensing azer-cel Phase 1b product to Kincell to offset costs and headcount[9] - Cost-cutting measures are ongoing, including headcount reductions and prioritizing programs for value-impacting studies[9] - The company is actively seeking partnering/out-licensing opportunities[9, 14] Upcoming Milestones - Additional Phase 1b azer-cel data is expected to be released in Q3 CY25 and Q4 CY25[14, 16] - An FDA meeting is planned for azer-cel to discuss registrational strategy/pivotal study[8, 16] - The company plans to initiate activity for a registrational/pivotal study for azer-cel[16]

Core Viewpoint - Calidi Biotherapeutics is making significant progress in developing targeted therapies for cancer treatment, particularly through its RedTail platform, which aims to deliver genetic medicines to metastatic sites and enhance the efficacy of oncolytic viruses [2][6]. Financial Results - For Q2 2025, Calidi reported a net loss of $5.7 million, or $1.99 per share, an improvement from a net loss of $7.4 million, or $16.75 per share, in Q2 2024 [4][16]. - Research and development expenses increased to $2.6 million in Q2 2025 from $2.2 million in the same period in 2024 [4]. - General and administrative expenses decreased to $3.1 million in Q2 2025 from $3.6 million in Q2 2024 [5]. Cash Position - As of June 30, 2025, the company had approximately $5.3 million in cash and $0.1 million in restricted cash, down from $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024 [5]. Recent Corporate Developments - Calidi presented preclinical data at ASCO demonstrating the efficacy of its lead compound CLD-401, which targets metastatic tumor sites and reduces immune clearance [6][7]. - The company received FDA Fast Track Designation for CLD-201, a first-in-class stem-cell loaded intratumoral viral therapy for soft tissue sarcoma [6][7]. - Calidi raised $4.6 million in gross proceeds through a warrant inducement offering, increasing total gross proceeds in 2025 to $15.7 million [6][7]. Product Development - The RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery, targeting metastatic sites while avoiding immune clearance [8]. - The lead candidate from the RedTail platform is currently in IND-enabling studies and targets non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [9].