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Kalaris Therapeutics (NASDAQ:KLRS) has begun enrolling patients in a Phase 1b/2 multiple ascending dose (MAD) study for TH103, targeting neovascular age-related macular degeneration (nAMD). The study will evaluate multiple dose levels in up to 80 nAMD patients, who will receive 4 monthly intravitreal injections.
The Phase 1b/2 study replaces a smaller Part 2 design and will inform dose selection for potential Phase 3 development. Initial data is expected in 2H 2026. Meanwhile, the ongoing Phase 1a single ascending dose study remains on schedule to report data in Q4 2025.
TH103, developed by Lasker Award recipient Dr. Napoleone Ferrara, represents a novel approach to treating exudative and neovascular retinal diseases, building on anti-VEGF therapy research.
Kalaris Therapeutics (NASDAQ:KLRS) has initiated enrollment for a Phase 1b/2 multiple ascending dose (MAD) study of TH103 in patients with neovascular age-related macular degeneration (nAMD). The study will evaluate up to 80 nAMD patients who will receive up to 4 monthly intravitreal injections of TH103.
The company expects to report initial data from the ongoing Phase 1a single ascending dose study in Q4 2025, with Phase 1b/2 data anticipated in 2H 2026. TH103, developed by Lasker Award recipient Dr. Napoleone Ferrara, represents a novel approach to treating exudative and neovascular retinal diseases, building on anti-VEGF therapy research.
Kalaris Therapeutics (NASDAQ:KLRS), a clinical-stage biopharmaceutical company focusing on retinal diseases, reported Q2 2025 financial results and provided business updates. The company continues enrolling patients in its Phase 1 trial of TH103, a novel anti-VEGF treatment for neovascular Age-related Macular Degeneration (nAMD), with initial clinical data expected in Q4 2025.
Financial highlights include cash position of $88.4 million as of June 30, 2025, expected to fund operations into Q4 2026. Q2 2025 resulted in a net loss of $11.4 million ($0.61 per share). The company strengthened its leadership team with the addition of Kristine Curtiss as SVP of Clinical, bringing 25 years of ophthalmology expertise.
Kalaris Therapeutics (NASDAQ: KLRS), a clinical-stage biopharmaceutical company focused on retinal disease treatments, announced its participation in the Stifel 2025 Virtual Ophthalmology Forum. The company's management, including CEO Andrew Oxtoby and CMO Matthew Feinsod, will engage in a Fireside Chat on Tuesday, May 27th, 2025, at 8:00 AM ET. A replay of the event will be available on the company's Investor Relations webpage.
Kalaris Therapeutics (NASDAQ: KLRS) reported its Q1 2025 financial results and provided business updates. The company is advancing its Phase 1 trial of TH103, a novel anti-VEGF treatment for neovascular age-related macular degeneration (nAMD). Initial clinical data is expected in Q4 2025.
Financial highlights include cash and cash equivalents of $101.0 million as of March 31, 2025, up from $1.6 million in December 2024, primarily due to the AlloVir merger. The company reported a net loss of $10.2 million ($2.52 per share) compared to $3.4 million ($2.60 per share) in Q1 2024. R&D expenses increased to $6.0 million from $2.0 million, while G&A expenses rose to $4.3 million from $0.6 million year-over-year.
Kalaris Therapeutics (NASDAQ: KLRS), a clinical-stage biopharmaceutical company focused on retinal disease treatments, has appointed Leone Patterson to its Board of Directors and as Chair of the Board's Audit Committee. Patterson currently serves as Executive Vice President, Chief Business Officer and Chief Financial Officer at Zymeworks, managing corporate finance, business development, and operations.
Patterson brings extensive biotech industry experience, having previously held leadership positions at Tenaya Therapeutics as Chief Financial and Business Officer, and at Adverum Biotechnologies as CFO, President, CEO, and Director. Her career includes senior finance roles at Diadexus, Transcept, Exelixis, Novartis, and Chiron, as well as experience in KPMG's audit practice. She holds a B.S. in business administration and accounting from Chapman University and an executive MBA from St. Mary's College.
Kalaris Therapeutics (NASDAQ: KLRS) has completed its merger with AlloVir, with shares set to trade on Nasdaq from March 19, 2025. The company's focus is on developing TH103, a novel anti-VEGF treatment for retinal diseases, specifically engineered to address limitations in current neovascular Age-related Macular Degeneration (nAMD) therapies.
The clinical-stage biopharmaceutical company's lead candidate has shown promising preclinical results with potent anti-VEGF activity and sustained ocular residence time. Initial data from Part 1 of the ongoing Phase 1 trial in nAMD patients is expected in H2 2025.
Following the merger, Kalaris has approximately $100 million in cash and cash equivalents, projected to fund operations into Q4 2026, extending beyond the planned Phase 2 clinical trial initiation.
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