Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 118

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 118
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 sufficient data to support the safety and efficacy of SEMDEXA, which would provide us with a pathway
for a 505(b)(2) NDA submission. 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

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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 future success depends on our ability to develop, receive regulatory approval for, and introduce new products or product enhancements that will be accepted by the market in a timely manner. The FDA or comparable non-U.S.regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including:

| • |     | it may disagree with the design or implementation of our clinical trials; |

| • |     | we may be unable to demonstrate to such authorities’ satisfaction that a product candidate is safe and 
 effective for its proposed indication;                                                                 |

| • |     | negative or ambiguous results from our clinical trials may not meet the level of statistical significance 
 required for approval by the FDA;                                                                         |

| • |     | it may disagree with our interpretation of data from preclinical studies or clinical trials; |

| • |     | it may not agree that the data collected from clinical trials of our product candidates are acceptable or                                                                                                                     
 sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States, and such authorities may impose requirements for additional preclinical studies or clinical trials; |

| • |     | it may disagree regarding the formulation, labeling and/or the specifications of our product candidates; |

| • |     | such authorities may decline to approve the manufacturing processes or