Semnur Pharmaceuticals, Inc., a wholly owned subsidiary of Scilex Holding Company, and Denali Capital Acquisition Corp. (Nasdaq: DECA) announce the signing of a merger agreement for a proposed business combination

• Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly owned subsidiary of Scilex Holding Company (Nasdaq: SCLX, “Scilex”), and Denali Capital Acquisition Corp. (Nasdaq: DECA, the “SPAC”) announce the signing of an agreement and plan of merger for a proposed business combination (the “Business Combination Agreement”), providing for a pre-transaction equity value of Semnur of $2.5 billion. The Boards of Scilex, Semnur and Denali Capital Acquisition Corp. have approved the proposed transaction.
  
• The proposed business combination would create a publicly traded biopharmaceutical company and additionally invest in Semnur to develop a non-opioid product, SP-102 (10 mg injectable dexamethasone sodium phosphate viscous gel), or SEMDEXA, a novel non-opioid, viscous gel formulation in Phase 3 development of a widely used corticosteroid for epidural injections for the treatment of lumbosacral radicular pain, or sciatica, with FDA Fast Track designation.
  
• Based on the independent market research conducted in 2020 and 2021 by Syneos Health Consulting, given the potential substantial use of SP-102 (SEMDEXA), by the 5^and In the year of launch, annual sales of SEMDEXA for sciatica are expected to reach $1.5 to $2.0 billion.
  
• It is expected that Scilex will be the majority shareholder of the combined company following completion of the proposed business combination, which is expected to close in the first quarter of 2025. The combined company will be led by a management team with a proven track record in the industry.
  
• As previously announced, the Board of Directors of Scilex has approved a resolution to authorize a potential dividend of up to 10% of Scilex’s ownership interest in Semnur in connection with certain transactions, including a merger, subject to the registration of Semnur’s common stock (or such securities, property or other assets into or for which such stock may be exchanged or converted in such transaction) with the Securities and Exchange Commission (“SEC”). No record date has been set for such dividend and the Board of Directors of Scilex may decide not to proceed with such dividend.

NEW YORK, NEW YORK, September 3, 2024 (GLOBE NEWSWIRE) — Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly owned subsidiary of Scilex Holding Company (Nasdaq: SCLX, “Scilex”), an innovative revenue generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, and Denali Capital Acquisition Corp., a Cayman Islands exempted company and special purpose acquisition company (Nasdaq: DECA, the “SPAC”), today 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, providing for a pre-transaction equity value of Semnur of $2.5 billion. Prior to the closing of the transaction, the SPAC will be reincorporated as a Delaware corporation. Upon closing of the transaction, the combined company (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. Closing of the transaction, which is expected to occur in the first quarter of 2025, is subject to the approval of the SPAC’s stockholders, any applicable regulatory approvals and the satisfaction or waiver of certain other closing conditions.

Semnur is a late-stage clinical pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s lead program, SP-102 (SEMDEXA), is the first non-opioid novel injectable corticosteroid gel formulation for patients with moderate to severe chronic radicular pain/sciatica that is free of preservatives, surfactants, solvents, or particles. If approved by the FDA, SP-102 (SEMDEXA) 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 study for SP-102, which met primary and key secondary endpoints, with treatment with SP-102 (SEMDEXA) reducing pain intensity for greater than one month in sciatica patients and resulting in a statistically significant and clinically meaningful improvement in the disability index score, while maintaining safety comparable to placebo. The Phase 3 topline data results were presented at the American Society of Interventional Pain (ASIPP) Conference in Las Vegas in May 2022 in an oral presentation by Dr. Nebojsa Nick Knezevic, MD, PhD, Professor of Anesthesiology and Surgery, College of Medicine, University of Illinois at Chicago, President of the Illinois Society of Interventional Pain Physicians, Executive Director of the North American Society of Neuromodulation, Vice President for Research and Education, Advocate Illinois Masonic Medical Center, Division of Anesthesiology and Pain Management. This Phase 3 study represents a potential significant improvement in the management of adult patients with lumbosacral radicular pain (sciatica) who are struggling with the clinical consequences of a lack of currently FDA-approved therapies, suboptimal formulations of corticosteroids used off-label, and/or excessive pain and disability. Download the presentation by clicking here.