Company: SMNR
Filing Date: 2025-07-23
Form Type: S-4/A
Source: 0001193125-25-163401
Chunk: 94

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-07-23
Form: S-4/A
Chunk 94
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 first U.S. Food and Drug Administration (“FDA”) approved non-opioid novel injectable corticosteroid gel formulation for patients with moderate to severe lumbosacral radicular pain (“LRP”) (also known as sciatica), containing no preservatives, surfactants, solvents, or particulates and is expected to be available in a pre-filled syringe formulation following approval by the FDA.

Semnur is developing SP-102 to be an injectable viscous gel formulation of a widely used corticosteroid designed to address the serious risks posed by off-label epidural steroid injections (“ESI”), which are administered over 12 million times annually in the United States. SP-102 has been granted fast track designation by the FDA and, if approved, could become the only FDA-approved ESI for the treatment of sciatica. Although such designation has been granted, it may not lead to a faster development or regulatory review process and such designation does not increase the likelihood that SP-102 will receive marketing approval. According to a report by Decision Resources Group published in May 2017, it was estimated that over 4.8 million patients would suffer from sciatica in the United States in 2024.

Semnur’s guiding principle has always been and remains a patient-first approach, which drives its mission to meet the increasing global demand for more effective and safer non-opioid pain management solutions. Through rigorous research and development, Semnur believes it is on the cusp of establishing Semnur as the preeminent name in commercial non-opioid pain management, specifically targeting the unmet needs in both acute and chronic pain sectors with its innovative and leading therapies. Semnur believes that it has made substantial progress in demonstrating the rapid onset and enhanced tolerability of its product candidate.

Denali Merger Sub Inc.

Merger Sub is a Delaware corporation and a wholly owned subsidiary of Denali formed for the purpose of consummating the Business Combination. Following the consummation of the Business Combination, Merger Sub will have merged with and into Semnur, with Semnur surviving the Merger as a wholly owned subsidiary of Denali. Merger Sub owns no material assets and does not operate any business.

Merger Sub’s principal executive office is located at Denali’s principal executive offices at 437 Madison Avenue, 27 Floor, New York, NY 10022.

The Merger Agreement

On August 30, 2024, Denali, Merger Sub, and