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 ...

Core Insights - Kalaris Therapeutics, Inc. announced the presentation of clinical data from its Phase 1 study of TH103 at the 49th Annual Meeting of the Macula Society, scheduled for February 25-28, 2026, in San Diego, California [1][2] Company Overview - Kalaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing treatments for prevalent retinal diseases [5] - The company was founded by Dr. Napoleone Ferrara, a pioneer in anti-VEGF therapy, and aims to advance novel therapeutic approaches for patients with sight-threatening retinal conditions [5] Product Details - TH103 is a novel investigational therapy designed to enhance VEGF inhibition and increase intraocular retention, developed by Dr. Napoleone Ferrara [2] - The upcoming presentation will cover safety, tolerability, pharmacokinetics, and early efficacy outcomes of TH103 in patients with treatment-naive neovascular age-related macular degeneration [2] Presentation Information - The presentation will be part of a scientific session attended by leading retinal specialists and clinical investigators [2][4] - The specific details of the presentation include the title "First-in-Human Evaluation of TH103, a Dual-Targeting VEGF and HSPG Inhibitor: Phase 1 Single Ascending Dose Study in Treatment-Naïve Neovascular AMD," scheduled for February 26, 2026, at 8:15 am PT [6]

Core Points - Kalaris Therapeutics, Inc. has entered into a securities purchase agreement for a private placement, aiming to raise approximately $50.0 million before expenses [1][3] - The private placement includes participation from both new and existing institutional investors [2] - Kalaris plans to use the net proceeds to fund the clinical development of TH103 for neovascular AMD and for general corporate purposes [4] Financial Details - The private placement involves the sale of 4,200,000 shares of common stock at $10.00 per share and pre-funded warrants for 800,000 shares at $9.9999 each [3] - The pricing of the securities reflects a premium over the closing price of Kalaris' common stock over the previous five trading days [3] - The transaction is expected to close on or about December 19, 2025, pending customary closing conditions [3] Company Background - Kalaris Therapeutics is focused on developing treatments for prevalent retinal diseases and was founded by Dr. Napoleone Ferrara, known for his work in anti-VEGF therapy [8]

Core Insights - Kalaris Therapeutics announced positive initial data from its Phase 1a trial of TH103, a treatment for neovascular age-related macular degeneration (nAMD), showing significant improvements in vision and retinal anatomy [2][4][5] - TH103 demonstrated a mean improvement of 10 letters in best corrected visual acuity (BCVA) and a 129 μm reduction in central subfield thickness (CST) after one month [6][9] - The drug showed a 27 to 51-fold lower plasma Cmax compared to leading anti-VEGF agents, indicating enhanced intraocular retention and potential for extended treatment durability [3][9][10] Clinical Trial Results - The Phase 1a trial involved 13 treatment-naïve nAMD patients receiving a single intravitreal injection of TH103 at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) [4] - Results indicated robust visual and anatomical improvements, supporting the molecular design of TH103 [5][6] - No dose-limiting toxicities or serious adverse events related to TH103 were observed, with only mild cases of intraocular inflammation noted [7][8] Pharmacokinetics and Treatment Durability - TH103's pharmacokinetic profile aligns with its engineered properties, showing significantly lower systemic exposure and prolonged intraocular residence time [9] - Following a single injection, 31% of patients did not require additional anti-VEGF treatment during the six-month follow-up, suggesting potential for extended durability [10][11] Next Steps in Development - Kalaris is accelerating its clinical development program, continuing enrollment in a Phase 1b/2 multi-ascending dose study to identify optimal dosing for future Phase 3 trials [11] - Preliminary data from the ongoing study is expected in the second half of 2026 [11]

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]

Core Insights - Kalaris Therapeutics has appointed Matthew Gall as Chief Financial Officer to enhance its leadership team and support the company's growth as it advances its clinical studies [1][2] - The company is focused on developing treatments for retinal diseases, particularly neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) [3] Company Overview - Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing major unmet medical needs in retinal diseases [3] - The company was founded by Dr. Napoleone Ferrara, known for his pioneering research in anti-VEGF therapy [3] Leadership and Experience - Matthew Gall brings extensive experience from previous roles at iTeos Therapeutics, Sarepta Therapeutics, Celgene Corporation, and Gilead Sciences, focusing on financial operations and business development [2] - His appointment is expected to bolster Kalaris' strategic direction and support its clinical development efforts [2]

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]