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Semnur Pharmaceuticals, Inc., a Wholly Owned Subsidiary of Scilex Holding Company, and Denali Capital Acquisition Corp. (Nasdaq: DECA) Enter into a Letter of Intent for a Proposed Business Combination
Denali Capital Acquisition Denali Capital Acquisition (US:DECA) GlobeNewswire News Room·2024-07-02 21:15

Core Insights - Semnur Pharmaceuticals, Inc. is set to undergo a proposed business combination with Denali Capital Acquisition Corp., with a pre-transaction equity value of up to $2.0 billion and expected gross proceeds of up to $40 million [13][26] - The combined company will focus on the development and commercialization of SP-102 (SEMDEXA™), a non-opioid injectable corticosteroid gel for treating lumbar radicular pain or sciatica, which has completed a Phase 3 study and received FDA Fast Track status [5][39] - The market for chronic pain management is significant, with over 30 million people in the U.S. suffering from low back and radicular pain, highlighting the need for effective non-opioid therapies [14][40] Company Overview - Semnur Pharmaceuticals is a clinical-late stage specialty pharmaceutical company focused on non-opioid pain therapies, with its lead program SP-102 being a novel gel formulation for chronic radicular pain [39][44] - Scilex Holding Company, the parent company of Semnur, is dedicated to acquiring and developing non-opioid pain management products, targeting high unmet needs in the pain management market [43] Product Development - SP-102 (SEMDEXA™) is a viscous gel formulation containing 10 mg of dexamethasone sodium phosphate, designed for epidural injections to treat sciatica, showing significant clinical benefits in trials [5][39] - The product has demonstrated a decrease in pain intensity for over a month in patients and has shown statistically significant improvements in disability index scores [39] Market Potential - The peak sales potential for SP-102 is projected to reach up to $3.6 billion annually five years post-launch, indicating a strong market opportunity for the product [27] - The overall estimated number of epidural steroid injection procedures in the U.S. is approximately 12.1 million, with lumbar radiculopathy/sciatica procedures comprising about 88% of these, underscoring the demand for effective treatments [40]