Kalaris Reports Third Quarter 2025 Financial Results and Provides Business Updates

Core Insights - Kalaris Therapeutics is progressing its clinical trials for TH103, a treatment for neovascular age-related macular degeneration (nAMD), with initial clinical data from the Phase 1a trial expected by the end of 2025 [1][2][5] - The company has entered into a formal agreement with KBI Biopharma for clinical supply manufacturing, marking a significant step in its development as a later-stage biotech company [2][5] - Kalaris reported a significant increase in cash reserves to $77.0 million as of September 30, 2025, primarily due to the completion of its merger with AlloVir [6][9] Clinical Development - The Phase 1a single ascending dose trial is designed to assess the safety, pharmacokinetics, and preliminary treatment effects of TH103 in treatment-naïve nAMD patients [5] - The newly initiated Phase 1b/2 multiple ascending dose trial aims to evaluate multiple dose levels of TH103 in up to 80 nAMD patients, with initial data expected in the second half of 2026 [1][5] - The Phase 1b/2 trial will include assessments of safety and preliminary efficacy, with a primary analysis point one month after the last injection [5] Financial Performance - Kalaris reported a net loss of $11.9 million for the third quarter of 2025, a decrease from a net loss of $38.1 million in the same quarter of 2024 [9][15] - Research and development expenses decreased to $9.1 million in Q3 2025 from $36.0 million in Q3 2024, primarily due to a significant royalty obligation in the previous year [7][15] - General and administrative expenses increased to $3.6 million in Q3 2025 from $1.8 million in Q3 2024, reflecting higher costs associated with operating as a public company [8][15] Corporate Developments - Kalaris has expanded its leadership team with the appointment of Matthew Gall as Chief Financial Officer, who brings over 20 years of corporate finance experience [5] - The company has opened a new corporate headquarters in Berkeley Heights, New Jersey, to support its growth and operational needs [5]