Claris Biotherapeutics has closed a $118 million Series B financing and announced several executive and board appointments as the company prepares to advance its lead investigational therapy, CSB-001 (oremepermin alfa ophthalmic solution), into pivotal development for limbal stem cell deficiency (LSCD).

The financing will support completion of the company's ongoing clinical studies, fund a planned phase 3 program expected to begin in the first half of 2027, and support pre-commercialization activities. Claris also expects to report proof-of-concept data from its ongoing LSCD study during the second half of 2026.

CSB-001 is being developed as a topical therapy for LSCD, a sight-threatening disease in which damage to limbal stem cells prevents normal regeneration of the corneal surface. The investigational recombinant human deleted hepatocyte growth factor (dHGF) therapy is designed to promote corneal epithelial regeneration while modulating inflammation and fibrosis. According to Claris, clinical data generated to date have demonstrated substantial improvements in visual acuity.

If approved, CSB-001 could become the first pharmacologic treatment for LSCD, a condition for which no drug therapies are currently approved. The company estimates that at least 30,000 patients in the United States are actively managed for LSCD, although the true prevalence is likely higher because of underdiagnosis.

The Series B round was co-led by new investors Samsara Biocapital and Catalio Capital Management, with participation from Adage Capital Management, Sofinnova Investments, Aisling Capital, and ADAR1 Capital Management. Existing investors Novo Holdings, Janus Henderson Investors, and Mass General Brigham Ventures also participated.

Proceeds from the financing will fund completion of Claris' ongoing open-label proof-of-concept study in 63 patients with LSCD, as well as a prospective natural history study intended to inform pivotal trial design and site selection.

The company plans to launch two pivotal studies during the first half of 2027 enrolling approximately 400 patients with LSCD. The trials will compare CSB-001 with vehicle, with visual acuity serving as the primary efficacy endpoint, supported by anatomical measures.

Leadership expansion

Coinciding with the financing, Claris appointed Stephen Brady as president and CEO and Brian Baum as chief commercial officer.

Mr. Brady brings nearly three decades of experience in corporate strategy, business development, finance, and executive leadership across biotechnology companies. Most recently, he served as chairman and chief executive officer of Tempest Therapeutics. Earlier in his career, he held leadership positions at Immune Design, where he helped guide the company through its initial public offering and eventual acquisition by Merck, and at Proteolix, where he led strategic initiatives culminating in its acquisition by Onyx Pharmaceuticals.

Mr. Baum joins Claris with more than 20 years of commercial leadership experience. Most recently, he served as senior vice president at Dompé Pharmaceuticals, where he led commercial initiatives supporting the U.S. launch and growth of Oxervate for neurotrophic keratitis. Previously, he spent a decade at Genentech in US and global commercial leadership roles, including work supporting the commercialization of Lucentis across multiple retinal disease indications.

"I'm thrilled to join Claris at such a pivotal moment in the company's evolution," Mr. Brady said in a company statement. "The strong interest in CSB-001 reflects both its promise for patients and commercial potential. With the company financed through phase 3 and the team in place to execute, we're ready to advance CSB-001 from a position of strength. The prospect of significantly improving vision with a convenient eye drop is a tremendous advance, and I'm energized by the opportunity to take on a blinding disease like LSCD."

The company also named Marc de Garidel chairman of the board. De Garidel has held senior leadership positions at multiple biotechnology and pharmaceutical companies, including Abivax, CinCor Pharma, Corvidia Therapeutics, Ipsen, Eli Lilly and Company, and Amgen. In conjunction with the financing, Mike Dybbs, PhD, partner at Samsara Biocapital; Matthew Hobson, PhD, principal at Catalio Capital Management; and Maha Radhakrishnan, MD, executive partner at Sofinnova Investments, joined Claris' board of directors.

Claris noted that it maintains a safety data-sharing collaboration with Kringle Pharma, which is developing oremepermin alfa for non-ophthalmic indications, to support the development of CSB-001.