"We continued to enroll treatment-naïve nAMD patients in our open-label Phase 1 clinical trial of TH103 in the second quarter of 2025" said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. "TH103 has exhibited differentiated anti-VEGF properties in multiple preclinical studies, and we believe it has the potential to improve efficacy and extend treatment duration compared to currently approved agents. We look forward to reporting initial clinical data later this year which will provide an init ...

Market Overview - The global branded anti-VEGF market for retinal neovascular/exudative diseases is approximately $14 billion in 2023 and is projected to grow to approximately $18 billion by 2029[8, 16, 24] - Branded anti-VEGF therapies accounted for approximately 70% of the global anti-VEGF units in retinal disease in 2023, while compounded bevacizumab accounted for approximately 30%[25] TH103 Development - TH103 is a fusion protein targeting VEGF, engineered for longer-lasting and increased anti-VEGF activity, invented by VEGF pioneer Dr Napoleone Ferrara[6, 8, 38] - Preclinical studies demonstrated TH103 achieved 100% inhibition of VEGF-induced endothelial cell proliferation in vitro, compared to 80% by aflibercept[57] - TH103 demonstrated increased retention in the retina compared to aflibercept at two weeks in rabbit retina cross-sections[64] - In a mouse laser CNV model, TH103 demonstrated increased duration of action in reducing mean CNV area after administration at Day -14 compared to aflibercept[72] Clinical Program & Intellectual Property - Kalaris received IND clearance from the FDA in June 2024 for a Phase 1 clinical trial of TH103 for nAMD[84] - Initial clinical data from the Phase 1 trial of TH103 for nAMD is expected in Q4 2025[8, 84, 86] - Kalaris holds US exclusivity for TH103 compositions of matter through the early 2040s[92]

Company Overview - Kalaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing treatments for prevalent retinal diseases [3] - The company is currently developing TH103, a novel anti-VEGF investigational therapy designed to improve VEGF inhibition and retention in the retina [3] Product Development - TH103 is a fully humanized, recombinant fusion protein that acts as a decoy receptor against VEGF [3] - The therapy is currently undergoing a Phase 1 clinical trial for the treatment of neovascular Age-related Macular Degeneration (nAMD) [3] - Kalaris plans to expand the development of TH103 to treat additional retinal diseases, including Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO) [3] Upcoming Events - Kalaris management will participate in a Fireside Chat at the Stifel 2025 Virtual Ophthalmology Forum on May 27, 2025 [1][4] - The event will feature speakers Andrew Oxtoby, CEO, and Matthew Feinsod, CMO [4] - A replay of the event will be available on Kalaris Therapeutics' Investor Relations webpage following the event [2]

PALO ALTO, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Kalaris Therapeutics, Inc. (Nasdaq: KLRS) ("Kalaris"), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent diseases of the retina, today announced financial results for the first quarter ended March 31, 2025 and provided a business update. Actively enrolling nAMD patients in a Phase 1 trial of TH103, a novel, differentiated anti-VEGF agent engineered to potentially provide longer-lasting ...