Denali Capital Acquisition, Semnur Pharmaceuticals sing merger agreement

Semnur Pharmaceuticals and Denali Capital Acquisition Corp. announced the signing of an agreement and plan of merger for a proposed business combination , by and among Semnur, the SPAC and Denali Merger Sub Inc., a Delaware Corporation and wholly owned subsidiary of the SPAC, which provides for a pre-transaction equity value of Semnur at $2.5 billion. Prior to the closing of the transaction, the SPAC will be redomesticated as a Delaware corporation. Upon closing of the transaction, the combined company will be renamed Semnur Pharmaceuticals, Inc., and its common stock and warrants are expected to be listed on Nasdaq under the ticker symbols “SMNR” and “SMNRW”, respectively. The boards of directors of each of the SPAC, Semnur and Scilex have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the first quarter of 2025, is subject to the approval of the SPAC’s shareholders, any applicable regulatory approval, and the satisfaction or waiver of certain other closing conditions. Semnur is a clinical-late stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s lead program, SP-102, is the first non-opioid novel injectable corticosteroid gel formulation for patients with moderate to severe chronic radicular pain/sciatica, containing no preservatives, surfactants, solvents, or particulates. If approved by the FDA, SP-102 will be available in a pre-filled syringe formulation and will be administered as an epidural injection for the treatment of sciatica. Semnur has completed a Phase 3 trial for SP-102, which met primary and important key secondary endpoints, with SP-102 treatment decreasing pain intensity for over a month in sciatica patients and resulting in statistically significant and clinically meaningful improvement in the disability index score while maintaining safety comparable to placebo. The Phase 3 topline data result was presented at the American Society of Interventional Pain conference in Las Vegas in May 2022 in an oral presentation by Dr. Nebojsa Nick Knezevic, M.D., Ph.D., Professor of Anesthesiology and Surgery, College of Medicine, University of Illinois at Chicago, President of the Illinois Society of Interventional Pain Physicians, Director-at-Large of the North American Society of Neuromodulation, Vice-Chair for Research and Education, Advocate Illinois Masonic Medical Center, Department of Anesthesiology and Pain Management. This Phase 3 study represents a potential significant improvement in treatment of adult patients with lumbosacral radicular pain, who struggle with the clinical consequences of no currently FDA approved therapies, suboptimal formulations of corticosteroids used off-label and/or excess pain and disability. The results of the pivotal registration trial of SP-102 were published in PAIN on June 14, 2024, the official journal of the International Association for the Study of Pain, which features original research on the nature, mechanisms and treatment of pain.