Report

Newron Pharmaceuticals - Evenamide set for a pivotal year

Newron Pharmaceuticals has reported results for FY23, an active period for its lead asset, evenamide, being developed for treatment-resistant schizophrenia (TRS) and poorly managed schizophrenia (non-TRS). Strong 12-month data were shared in January 2024 from the Phase II trial (study 014/015) in TRS patients, and management is gearing up to launch a potentially pivotal Phase III trial. We expect the next major catalyst to be results of the Phase III trial (study 008A) in non-TRS patients, now anticipated in April. Improved liquidity following the recent equity raise and renegotiated debt repayment terms with the EIB provides headroom into 2025, by which time we anticipate a licensing deal for evenamide. We have revised our estimates, segregating evenamide’s potential across TRS and non-TRS populations, and refined some of our assumptions. Our valuation increases to CHF219.1m or CHF12.3/share (CHF7.7/share previously).
Underlying
Newron Pharmaceuticals SpA

Newron Pharmaceuticals is a clinical stage biopharmaceutical company. Co. is focused on the development of drugs for the treatment of central nervous system disorders and pain. Co.'s pipeline include, Xadago® (safinamide), for the treatment of Parkinson's disease (PD) and PD Levodopa-induced dyskinesia; Sarizotan, for the treatment of Rett syndrome (Orphan drug status); Evenamide (NW-3509), for the treatment of Schizophrenia and Clozapine-treatment-resistant schizophrenia; and Ralfinamide for patients with specific rare pain indications (neuropathic pain).

Provider
Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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