Company: SMNR
Filing Date: 2025-12-03
Form Type: S-8
Source: 0001193125-25-306962
Chunk: 10

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-12-03
Form: S-8
Chunk 10
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 Combination, Denali changed its name from Denali Capital
Acquisition Corp. to “Semnur Pharmaceuticals, Inc.”

We are 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. We believe that our
innovative non-opioid product portfolio has the potential to provide effective pain management therapies that can have a transformative impact on patients’ lives. We target 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. Our lead product candidate, SP-102 (10 mg, 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.

We are 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.

5

Legacy Semnur was founded in 2013 and we have invested substantial efforts and financial
resources on building our intellectual property portfolio and infrastructure. We have conducted phospholipidosis and toxicology studies, including a Phase 1 pharmacokinetic bridging study, Phase 2 repeat dose study, a pivotal Phase 3 study and the
second Phase 3 study initiated in September