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PALO ALTO - Kalaris Therapeutics, Inc. (NASDAQ:KLRS), a $73 million market cap biotech company, has initiated patient enrollment in a Phase 1b/2 multiple ascending dose study of its investigational therapy TH103 for neovascular age-related macular degeneration (nAMD), the company announced Monday. The stock has shown strong momentum over the past three months, despite recent market volatility.
The new study will evaluate multiple dose levels of TH103 in up to 80 nAMD patients who will receive up to four initial monthly intravitreal injections. This trial replaces a smaller study originally planned to follow the ongoing Phase 1a single ascending dose study.
According to the company, the Phase 1a study remains on track to report data in the fourth quarter of 2025, while initial data from the new Phase 1b/2 study is expected in the second half of 2026.
"The Phase 1b/2 study represents an important milestone in advancing TH103 toward a potential future Phase 3 program," said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics, in the press release. With analyst price targets ranging from $3 to $23 per share, market expectations for the company’s pipeline remain diverse. InvestingPro subscribers can access 8 additional key insights about KLRS’s financial health and market position.
TH103 is a dual-action investigational therapy designed to provide increased and longer-lasting anti-VEGF activity for treating exudative and neovascular retinal diseases. The drug was developed by company co-founder Napoleone Ferrara, MD, whose earlier research led to the development of the anti-VEGF class of drugs used in treating cancer and retinal diseases.
Neovascular AMD affects millions worldwide and is a leading cause of vision loss in people over 50. While current anti-VEGF therapies have improved treatment outcomes, many patients continue to experience progressive vision loss despite treatment.
The safety and efficacy of TH103 have not been established by regulatory authorities.
In other recent news, Kalaris Therapeutics has made significant corporate governance moves by electing Srinivas Akkaraju, M.D., Ph.D., and Andrew Oxtoby as Class II directors during its 2025 annual meeting. Both directors will serve three-year terms concluding at the 2028 annual meeting. In a separate development, Piper Sandler has initiated coverage of Kalaris with a Neutral rating and a price target of $3.00, citing concerns about the differentiation of Kalaris’s anti-VEGF treatment, TH103, from existing standard care options for retinal diseases. Meanwhile, William Blair has reiterated its Outperform rating for Kalaris, maintaining a positive outlook on the company’s future. This follows investor meetings with Kalaris management, where discussions highlighted the company’s lead asset, TH103, which is noted for its potentially greater VEGF affinity and longer eye residence time compared to existing treatments. These recent developments provide investors with a broader understanding of Kalaris’s strategic directions and market perceptions.
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