Serina Therapeutics Reveals That The FDA Has Cleared Its Investigational New Drug Application For SER-252, An Investigational Therapy For Advanced Parkinson's Disease

Serina Therapeutics, Inc. ("Serina" or the "Company") (NYSE:SER), a clinical-stage biotechnology company advancing drug candidates enabled by its proprietary POZ PlatformTM drug optimization technology, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SER-252, an investigational therapy for advanced Parkinson's disease.

The IND clearance allows Serina to proceed with regulatory and site-level activities to support initiation of a planned Phase 1b registrational clinical study evaluating SER-252 in patients with advanced Parkinson's disease.

"FDA clearance of the IND is a major milestone for Serina and underscores the promise of the SER-252 program," said Steve Ledger, Chief Executive Officer of Serina Therapeutics. "As we initiate our registrational study, we will begin generating meaningful clinical data for SER-252 in patients with advanced Parkinson's disease. With FDA alignment on a registrational development strategy under a 505(b)(2) NDA pathway, we believe SER-252 has a clear and efficient path forward toward addressing a significant unmet medical need."

As previously disclosed, Serina has engaged in multiple regulatory interactions with the FDA regarding the SER-252 program, including receipt of written FDA feedback supporting the proposed registrational clinical trial design under a 505(b)(2) NDA pathway.