Core Insights - Kalaris Therapeutics has initiated a Phase 1b/2 multiple ascending dose study for TH103 targeting neovascular age-related macular degeneration (nAMD) patients, with initial data expected in the second half of 2026 [1][6] - The Phase 1b/2 study aims to evaluate multiple dose levels of TH103 in up to 80 nAMD patients, following four initial monthly intravitreal injections [1][2] - The ongoing Phase 1a single ascending dose study is on track for data reporting in Q4 2025, which will include safety, preliminary efficacy, and pharmacokinetics [2][6] Company Overview - Kalaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for prevalent retinal diseases, particularly those with significant unmet medical needs [8] - The company was founded by Dr. Napoleone Ferrara, known for his pioneering research in anti-VEGF therapy, which has transformed treatment for cancer and retinal diseases [3][8] - TH103 represents a novel dual-action investigational therapy designed to provide increased and longer-lasting anti-VEGF activity for conditions like nAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO) [6][8] Industry Context - Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss in individuals over 50, affecting millions globally, and highlights the need for continued innovation in therapeutic options [5][6] - Current anti-VEGF therapies have improved treatment outcomes, but many patients still experience progressive vision loss, indicating a gap in effective treatment solutions [5]

Core Viewpoint - Kalaris Therapeutics is advancing its Phase 1 clinical trial of TH103, a novel anti-VEGF agent aimed at treating neovascular Age-related Macular Degeneration (nAMD), with initial clinical data expected in Q4 2025 [1][10]. Business Updates - The company is currently enrolling treatment-naïve nAMD patients in the Phase 1 trial of TH103, which has shown differentiated anti-VEGF properties in preclinical studies [2]. - Kalaris has expanded its leadership team with the appointment of Kristine Curtiss as Senior Vice President of Clinical, bringing over 25 years of experience in ophthalmology-focused biotech [10]. Financial Results for Q2 2025 - As of June 30, 2025, Kalaris reported cash and cash equivalents of $88.4 million, a significant increase from $1.6 million as of December 31, 2024, primarily due to the completion of its merger with AlloVir [4]. - Research and development expenses for Q2 2025 were $8.4 million, up from $3.2 million in Q2 2024, attributed to increased costs related to manufacturing and clinical trials [5]. - General and administrative expenses rose to $3.8 million in Q2 2025 from $1.0 million in Q2 2024, driven by higher insurance, legal, and professional fees [6]. - The net loss for Q2 2025 was $11.4 million, or $0.61 per share, compared to a net loss of $5.7 million, or $4.26 per share, in Q2 2024 [7]. Research and Development Focus - TH103 is a fully humanized, recombinant fusion protein designed to act against VEGF as a decoy receptor, potentially offering improved VEGF inhibition and longer retention in the retina [8]. - The ongoing Phase 1 trial aims to assess the safety, pharmacokinetics, and preliminary treatment effects of TH103 in nAMD patients [10].