Kalaris Therapeutics and AlloVir Inc. have successfully completed their previously announced merger, creating a strengthened clinical-stage biopharmaceutical company focused on developing innovative treatments for prevalent retinal diseases. The combined entity will operate under the name Kalaris Therapeutics, Inc. and trade on the Nasdaq Global Market under the ticker symbol "KLRS," with Andrew Oxtoby continuing as CEO alongside the existing Kalaris management team.
The merger, first announced in November 2024, received stockholder approval at AlloVir's Special Meeting on March 12, 2025. According to company statements, the combined organization now has approximately $100 million in cash reserves, expected to fund operating expenses and capital requirements into the fourth quarter of 2026.
"We are delighted to close this transaction, which we expect will provide us with the financial resources to continue development of TH103 beyond the initiation of our planned Phase 2 clinical trial," said Andrew Oxtoby, CEO of Kalaris Therapeutics.
TH103: A Novel Approach to Retinal Disease Treatment
The company's lead candidate, TH103, represents a potentially significant advancement in the treatment of neovascular and exudative retinal diseases. Developed by Dr. Napoleone Ferrara, TH103 is a fully humanized, recombinant fusion protein designed as a novel anti-vascular endothelial growth factor (VEGF) agent.
TH103 has been specifically engineered to address key limitations of current therapies for neovascular age-related macular degeneration (nAMD), a leading cause of vision loss in older adults. The drug candidate aims to provide longer-lasting and increased anti-VEGF activity by functioning as a decoy receptor with potentially improved VEGF inhibition and extended retinal retention.
In preclinical studies, TH103 has demonstrated both potent anti-VEGF activity and sustained ocular residence time, properties that could translate to improved efficacy and reduced treatment burden for patients.
Clinical Development Timeline
Kalaris is currently conducting a Phase 1 clinical trial evaluating TH103 in treatment-naïve nAMD patients. The study is designed to assess safety, pharmacodynamics/pharmacokinetics, determine optimal dosing, and gather preliminary evidence of treatment effect.
The company expects to report initial data from part 1 of this ongoing trial in the second half of 2025. Beyond nAMD, Kalaris plans to develop TH103 for additional retinal conditions with significant unmet needs, including Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO).
Market Context and Unmet Needs
Age-related macular degeneration affects millions of people worldwide, with the neovascular form representing approximately 10-15% of cases but accounting for about 90% of severe vision loss associated with AMD. Current anti-VEGF therapies have revolutionized treatment but still face challenges related to treatment burden, durability, and efficacy in some patients.
The global market for retinal disease treatments continues to grow, driven by aging populations and increasing prevalence of conditions like diabetic retinopathy. Innovations that can reduce injection frequency while maintaining or improving efficacy represent significant potential value for patients, physicians, and healthcare systems.
Financial Outlook
The merger provides Kalaris with a strengthened financial position to advance its clinical programs. The approximately $100 million cash position is expected to support operations through late 2026, allowing the company to progress TH103 through key clinical milestones.
The transaction represents a strategic pivot from AlloVir's previous focus on allogeneic T cell immunotherapy for viral diseases in immunocompromised patients to Kalaris' ophthalmology-centered pipeline.
As the newly combined entity moves forward, investors and the ophthalmology community will be watching closely for the upcoming clinical data that could validate TH103's potential to address significant unmet needs in retinal disease treatment.
