Secures Significant Series B Funding to Prepare for Phase 3 Trial and Strengthen Financial Position

Claris Biotherapeutics, a US-based ophthalmic biotechnology company located in New Jersey, has successfully completed a $118 million Series B equity financing round, led by Samsara BioCapital and Catalio Capital Management. This round also included participation from prominent biotech investors such as Sofinnova Investments and Novo Holdings, bringing Claris' total funding to over $170 million. The secured funds will primarily support the initiation of a Phase 3 clinical trial for CSB-001 (oremepermin alfa), an innovative drug candidate targeting limbal stem cell deficiency (LSCD), a rare corneal disease. This substantial funding, achieved amidst a challenging biotech venture capital market, demonstrates strong market confidence in the therapeutic potential and commercial value of the new drug.

Strategic Repositioning and Early Clinical Signals for HGF-Targeted Therapy

Originally developed as a treatment for neurotrophic keratitis (NK), CSB-001 demonstrated significant improvements in vision among patients with other corneal conditions in early clinical trials, leading to a strategic decision to pivot its development towards LSCD. CSB-001 is a recombinant human gene-modified hepatocyte growth factor (dHGF) protein that targets hepatocyte growth factor (HGF), promoting corneal epithelial regeneration while simultaneously modulating inflammation and fibrosis in the eye. Since acquiring global ophthalmic rights from Kringle Pharma (TSE: 4884) in 2020, Claris has been actively sharing data to refine the drug's value proposition. The upcoming Phase 2 proof-of-concept (PoC) clinical data, expected in the second half of this year, will be a key indicator of the success of Claris' strategic shift.

Experienced Leadership to Accelerate Clinical Development and Commercialization

In conjunction with the funding, Claris has appointed Stephen Brady, former CEO of Tempest Therapeutics (TPST), as its new Chief Executive Officer, marking the beginning of an accelerated clinical development phase. Additionally, Marc de Garidel, CEO of Abivax (ABVX), has been appointed as Chairman of the Board, and Brian Baum, who successfully led the US commercial launch of Dompe Pharmaceuticals' ophthalmic drug, Oxervate, has been appointed as Chief Commercial Officer (CCO). This comprehensive leadership overhaul reflects a clear vision to transform Claris from a research-focused early-stage biotech into a market-ready company with a robust clinical pipeline, regulatory approvals, and a well-established commercial infrastructure. The addition of experienced professionals with a strong track record in ophthalmic commercialization is a strategic move to ensure rapid market penetration following a successful Phase 3 trial.

Opportunity to Establish a Leading Position in the High-Unmet-Need LSCD Market

Limbal stem cell deficiency (LSCD) is a rare and debilitating corneal disease characterized by permanent damage to the limbal stem cells, leading to corneal opacification and eventual blindness. Currently, over 30,000 patients in the US are undergoing treatment, but the actual number of potential patients is estimated to exceed 60,000 due to underdiagnosis. In Europe, Chiesi's Holoclar, an autologous stem cell therapy, has received conditional approval, but its complex and expensive manufacturing process limits its accessibility. There are currently no FDA-approved drug therapies available in the US. With this significant unmet medical need, the launch of CSB-001, the first topical drug therapy for LSCD, has the potential to replace invasive stem cell transplantation procedures, significantly improving patient convenience and rapidly establishing itself as the standard of care (SoC) in the market.