Company: SMNR
Filing Date: 2025-04-21
Form Type: S-4/A
Source: 0001193125-25-087342
Chunk: 88

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-04-21
Form: S-4/A
Chunk 88
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 the Convertible Promissory Note. On September 11, 2024, an additional $15,037 was drawn down from the Scilex Convertible Note to fund Denali’s extension of the business combination period.

On August 30, 2024, Denali entered into the Merger Agreement with Semnur and Merger Sub.

Denali’s principal executive office is located at 437 Madison Avenue, 27th Floor, New York, New York, 10022. Its telephone number is (646) 978-5180.

Semnur Pharmaceuticals, Inc.

Semnur is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative non-opioid pain management products for the treatment of acute and chronic pain. Semnur believes that its innovative non-opioid product portfolio has the potential to provide pain management therapies that can have a transformative impact on patients’ lives. Semnur targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Its lead product candidate, SP-102 (10 mg,**

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**dexamethasone sodium phosphate viscous gel) (“SP-102” or “SEMDEXA”), if approved, has the potential to become the 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