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 Insights - Kalaris Therapeutics has initiated a Phase 1b/2 multiple ascending dose study for TH103 in patients with neovascular age-related macular degeneration (nAMD) to assess safety and preliminary efficacy [1][2] - The study aims to evaluate multiple dose levels of TH103 in up to 80 nAMD patients, with assessments expected to include safety and preliminary efficacy [1][2] - Initial data from the Phase 1b/2 study is anticipated in the second half of 2026, while data from the ongoing Phase 1a study is expected in Q4 2025 [1][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, who is known for his pioneering research in anti-VEGF therapy [8] - Kalaris is committed to advancing novel therapeutic approaches for conditions such as nAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO) [8] Product Insights - TH103 is a dual-action investigational therapy designed to provide increased and longer-lasting anti-VEGF activity for treating exudative and neovascular retinal diseases [6] - The drug is currently being evaluated in both a Phase 1a single ascending dose study and the newly initiated Phase 1b/2 multiple ascending dose study [6][1] - TH103 represents a novel molecular approach to treatment, building on extensive research in anti-VEGF mechanisms [6][4] Industry Context - Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss in individuals over 50, affecting millions globally [5] - Despite advancements in anti-VEGF therapies, many patients still experience progressive vision loss, indicating a need for continued innovation in treatment options [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].

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]

Core Insights - Kalaris Therapeutics is actively enrolling patients in a Phase 1 trial for TH103, a novel anti-VEGF agent aimed at treating neovascular and exudative retinal diseases, with initial clinical data expected in Q4 2025 [1][9] - The company reported cash and cash equivalents of $101 million as of March 31, 2025, which is expected to fund operations into Q4 2026 [1][4] Business Highlights - Kalaris completed its merger with Allovir in March 2025, which significantly increased its cash reserves [2][4] - TH103 was developed by VEGF pioneer Dr. Napoleone Ferrara and is designed to provide longer-lasting anti-VEGF activity compared to current therapies [2][8] - The company has expanded its Board of Directors with the appointment of Leone Patterson as a director and Chair of the Audit Committee [9] Financial Results - Cash and cash equivalents increased from $1.6 million as of December 31, 2024, to $101 million as of March 31, 2025, primarily due to the merger with AlloVir [4] - Research and development expenses for Q1 2025 were $6 million, up from $2 million in Q1 2024, reflecting increased costs related to the Phase 1 trial [5] - General and administrative expenses rose to $4.3 million in Q1 2025 from $0.6 million in Q1 2024, driven by a one-time charge for liability insurance and increased professional fees [6] - The net loss for Q1 2025 was $10.2 million, or $2.52 per share, compared to a net loss of $3.4 million, or $2.60 per share, in Q1 2024 [7][14]