Business
Kalaris Reports Full Year 2025 Financial Results and Provides Business Updates
Positive initial data reported from Phase 1a Single Ascending Dose study in nAMD in December 2025; preliminary data from ongoing Phase 1b/2 study expected in
About this update from Kalaris Therapeutics, Inc.
[{"type":"text","content":"Positive initial data reported from Phase 1a Single Ascending Dose study in nAMD in December 2025; preliminary data from ongoing Phase 1b/2 study expected in 1H 2027 Intend to initiate Phase 3 clinical trials by year-end 2027 Completed oversubscribed $50.0 million private placement in December 2025 $118.0 million in cash, cash equivalents and marketable securities as of December 31, 2025 is expected to fund operations into the fourth quarter of 2027 and through key clinical milestones BERKELEY HEIGHTS, N.J., March 17, 2026 (GLOBE NEWSWIRE) -- Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced financial results for the full year ended December 31, 2025 and provided business updates. “This past year was truly transformational for Kalaris,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Following our initial listing as a public company in March 2025, we continued to advance our clinical program for TH103 throughout the year, culminating with the disclosure of positive initial Phase 1a single ascending dose data and concurrent oversubscribed private placement. In Q3 2025, we began to enroll patients in our Phase 1b/2 multiple ascending dose trial which is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development.” Q4 2025 - Business Updates Positive initial Phase 1a data reported in December 2025. The Phase 1a study evaluated a single intravitreal injection of TH103 at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) in treatment-naïve nAMD patients. Thirteen patients completed 6 months of follow-up. Results demonstrated clinical activity on visual acuity and retinal anatomy, as well as pharmacokinetic data that support TH103’s molecular design and preclinical profile, including: Mean 10-letter best corrected visual acuity (BCVA) improvementMean 129μm improvement in central subfield thickness (CST)Mean ~95% reduction in central subfield intraretinal fluid27 to 51-fold lower mean plasma Cmax than current leading approved anti-VEGF agents TH103 was generally well-tolerated and that data supported further dose escalation. No dose-limiting toxicities or treatment-related serious adverse events were obse...