Fractyl Health, which is developing procedural and gene therapies for type 2 diabetes and obesity, filed on Thursday with the SEC to raise up to $100 million in an initial public offering.
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including type 2 diabetes and obesity. Its lead candidate, the Revita DMR System, is an outpatient procedural therapy designed to durably modify duodenal dysfunction. Revita is approved for patients with inadequately controlled T2D in Europe. The company is currently enrolling a pivotal study of Revita in patients with inadequately controlled T2D, with topline data expected in the 4Q24, and plans to evaluate Revita in a clinical study for weight maintenance, expecting to submit an IDE and comparable documents to the FDA in the 1H24. Fractyl is also developing Rejuva, a novel, locally administered, adeno-associated virus delivered pancreatic gene therapy platform, and it plans to nominate its first candidate in the 1Q24.
Fractly Health's filing comes on the heels of diabetes and obesity-focused biotech Carmot Therapeutics (CRMO), which announced earlier this month that it would be acquired by Roche, shortly after filing for an IPO in late November.
The Lexington, MA-based company was founded in 2010 and plans to list on the Nasdaq under the symbol GUTS. Fractyl Health filed confidentially on November 9, 2021. BofA Securities, Morgan Stanley, and Evercore ISI are the joint bookrunners on the deal. No pricing terms were disclosed.
