Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119822
Chunk: 213

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 213
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4. We acquired certain rights to GLOPERBA and the exclusive
license to use the trademark “GLOPERBA”, pursuant to the Romeg License Agreement we entered into with Romeg, dated as of June 14, 2022, which agreement was subsequently amended
on January 16, 2025. GLOPERBA is an FDA-approved, liquid, oral medication for the treatment of gout in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the
United States. Gout pain can be excruciating and is a form of inflammatory arthritis that develops in some people who have high levels of uric acid in their blood. It can cause sudden severe episodes of pain and can be disabling with tenderness,
warmth and swelling. Non-steroidal anti-inflammatory drugs, colchicine and corticosteroids are used a majority of time as the first line to treat acute gout. The U.S. is observed to have a high prevalence of
gout, owing to lifestyle issues such as high alcohol intake, obesity, and smoking. We commercialized GLOPERBA in June 2024 and believe we are well positioned to market and distribute the product. We have a direct distribution network to national and
regional wholesalers and pharmacies throughout the U.S. For more information, please see the section titled “Business — Material Agreements — Romeg License and Commercialization Agreement.”

Our Product Candidates

We
acquired SP-102 from Semnur in March 2019 and 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 ESI, which are administered over 12 million times annually in the United States. SEMDEXA has been granted fast
track designation by the FDA and, if approved, could become the only FDA-approved ESI for the treatment of sciatica. According to a report by Decision Resources Group, it was estimated that over
4.8 million patients would suffer from sciatica in the United States in 2022. We received our SP-103 Phase 2 top-line results in August 2023 and the trial achieved
its objectives characterizing safety, tolerability and preliminary efficacy of SP-103 in acute LBP associated with muscle spasms. SP-103 was safe and well tolerated.
Increase of lidocaine load in topical system by three times, compared with approved ZTlido,