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Semnur Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company (NASDAQ:SCLX), and Denali Capital Acquisition Corp. (NASDAQ:DECA), a special purpose acquisition company, signed a letter of intent for a proposed business combination.
The deal provides for a pre-transaction equity value of Semnur up to $2 billion, with expected gross proceeds of up to $40 million depending on the number of SPAC shares redeemed before the business combination is completed.
Semnur is a clinical late-stage specialty pharmaceutical company focused on developing and commercializing novel non-opioid pain therapies. Semnur’s lead program, SP-102 (SEMDEXA), is the first non-opioid novel injectable corticosteroid gel formulation for moderate to severe chronic radicular pain/sciatica, containing no preservatives, surfactants, solvents, or particulates.
If approved by the FDA, SP-102 (SEMDEXA) will be available in a pre-filled syringe formulation. It will be administered as an epidural injection for sciatica treatment.
SP-102 completed a Phase 3 trial, meeting primary and key secondary endpoints. The treatment decreased pain intensity for over a month in sciatica patients. It resulted in statistically significant and clinically meaningful improvement in the disability index score while maintaining safety comparable to placebo.
Sciatica happens when irritation, inflammation, pinching, or compression affects one or more nerves that run down your lower back and into the legs.
The parties anticipate seeking approval from the SPAC’s shareholders in the second half of 2024.
Per Syneos Health Consulting, peak sales potential is projected to be up to $3.6 billion annually five years post-launch.
In the U.S., more than 30 million people live with low back and radicular pain.
According to a proprietary study by Syneos Health, the overall estimated number of epidural steroid injection (ESI) procedures in the U.S. is approximately 12.1 million across all Medicare and private coverage patients, with lumbar radiculopathy/sciatica procedures comprising approximately 88% of all ESIs administered.
Price Action: SCLX shares are up 5.18% at $2.02 at last check Wednesday.
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