Scilex's Semnur Pharma to go public through $2.5B SPAC merger, advancing sciatica treatment

Semnur Pharmaceuticals, a company developing a non-opioid treatment for sciatica, has agreed to merge with Denali Capital Acquisition Corp, a special purpose acquisition company. The merger is valued at $2.5 billion and is expected to be finalized by the first quarter of 2025. Following the completion of this merger, Semnur aims to continue the path toward the potential commercialization of its leading drug candidate, Semdexa.

Semdexa is an injectable corticosteroid gel formulation of dexamethasone sodium phosphate, designed to treat moderate to severe lumbosacral radicular pain, commonly known as sciatica. Sciatica is characterized by pain in the lower back and hips, symptoms that are frequently managed with opioid medications. However, Semnur's parent company, Scilex Holding Company, is promoting Semdexa as a non-opioid alternative.

In a phase 3 clinical trial involving 401 patients, Semdexa demonstrated a "rapid onset" of pain relief, with sustained reduction in pain intensity for more than a month. Scilex reported these positive results in March 2022. If approved by regulatory authorities, Semdexa could become the first medication specifically approved for the treatment of sciatica.

Semdexa's commercial potential is significant, especially in a field where other companies like UCB and Biogen have not found success. According to forecasts by Scilex, based on independent market research conducted by Syneos Health Consulting, the drug could generate sales ranging from $1.5 billion to $2 billion within five years of its launch, solely in the sciatica market.

The treatment has been granted fast-track designation by the FDA, and a pivotal 700-patient trial necessary for potential approval is expected to complete enrollment by 2025. This accelerated pathway could expedite Semdexa's journey to market, offering a new option for patients suffering from sciatica pain.

Scilex's CEO, Jaisim Shah, expressed optimism about the merger and the future of Semdexa. In a company statement, Shah emphasized that the merger would facilitate Scilex's growth strategy, providing access to public markets and opening doors for potential partnerships and global pharmaceutical collaborations. Shah highlighted the value this merger brings to Scilex's shareholders and the company's overall growth trajectory.

Scilex, which was previously a subsidiary of the financially troubled Sorrento Therapeutics, has itself entered the public markets through a SPAC merger with Vickers Vantage Corp. This deal was completed in 2022. Currently, Scilex markets several other treatments, including Elyxyb for migraines, Glopera for preventing gout flares, and the pain patch ZTlido.

This merger and the development of Semdexa are pivotal moments for both Semnur Pharmaceuticals and Scilex Holding Company. With the potential to revolutionize the treatment of sciatica and offer a non-opioid alternative, Semdexa could significantly impact the pain management landscape, providing substantial commercial benefits and addressing a critical need for safer pain relief options.