Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 68

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 68
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 altered along the way in an effort to optimize processes and results. While these types of changes are
common and are intended to optimize the product candidates for late stage clinical trials, approval and commercialization, such changes carry the risk that they will not achieve their intended objectives.

A Phase 3 trial was completed for SEMDEXA for the treatment of sciatica, a Phase 2 trial was completed for
SP-103 in 2023, and multiple Phase 1 trials were completed in the first half of 2022 for SP-104. We may not have the necessary capabilities, including adequate staffing,
to successfully manage the execution and completion of such clinical trials in a way that leads to our obtaining marketing approval for our product candidates in a timely manner, or at all. Our clinical trials may produce negative or inconclusive
results, and, in the future, we may decide, or regulators may require us, to conduct additional clinical trials and preclinical studies in addition to those we have planned.

In March 2022, we announced final results from our Phase 3 trial for SEMDEXA, which reflect positive results with respect to primary and
secondary endpoints, and we intend to use the results to support a NDA submission seeking approval for the treatment of sciatica. In November 2023, we had a Type C meeting with the FDA to discuss the requirements for filing a 505(b)(2) NDA for
SEMDEXA. In the Type C meeting, the FDA indicated that it disagreed with us that the clinical data we had collected was sufficient to support the safety and efficacy of SEMDEXA. The FDA provided guidance regarding expectations for the additional
confirmatory trial needed prior to a 505(b)(2) NDA filing and the circumstances under which one adequate and well-controlled trial would be sufficient for product registration. In February 2024, we had a Type D meeting with the FDA to preview a
newly designed trial, in order to reduce the potential need for any other additional trials prior to a 505(b)(2) NDA filing. During the Type D meeting, the FDA provided further guidance with respect to efficacy requirements and expectations on the
size of safety database needed to help best position us to be able to satisfy the requirements for a 505(b)(2) pathway approval. Our failure to adequately demonstrate the safety and effectiveness of our product candidates would prevent regulatory
approval and, ultimately, the commercialization of that product for the proposed indication for use.

Interim “top-line”and preliminary