Company: SCLXW
Filing Date: 2025-05-07
Form Type: POS AM
Source: 0001193125-25-115054
Chunk: 247

Company: Scilex Holding Co
Filing Date: 2025-05-07
Form: POS AM
Chunk 247
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102has been evaluated in a number of preclinical studies and clinical trials as a potential treatment for sciatica. Key findings from the preclinical studies and clinical trials include:

| • |     | Repeat injections of SP-102 showed continued pain reduction with no unexpected adverse events based on preliminary results from the SP-102-03 study; |

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| • |     | SP-102 showed an extended local activity with epidural administration in the ES-1504 study; |

| • |     | SP-102 showed an extended residence time and tolerability in the 1014-1512 and the 1014-2847, preclinical studies; and |

| • |     | The introduction of SP-102 into blood vessels did not result in neurological complications in the UPD003-IS21 preclinical toxicology study. |

SP-102(SEMDEXA) Study Details Phase 3 Pivotal Clinical Trial—CLEAR We have completed a pivotal, randomized, double-blind, placebo-controlled Phase 3 trial, CLEAR, that enrolled 401 patients with sciatica at over 40 sites across the United States. The study included an open-label extension where subjects were followed for up to 24 weeks after treatment to evaluate the safety of administering SP-102in a larger patient population. After week 4, subjects who met certain pain criteria received open-label SP-102to investigate the safety of repeat injections and the duration of pain relief following injection. This well-controlled, randomized trial was designed to demonstrate evidence of the analgesic effect and safety of SP-102.The schematic of this Phase 3 trial is demonstrated in the flowchart below. The primary objective of this study was to evaluate the analgesic effect of SP-102on average leg pain, measured using the NPRS following a single transforaminal injection. These results were compared to an intra-muscular injection of placebo over a four-week period. The secondary objectives of this study include (i) evaluation of the degree of disability over time as measured by the Oswestry Disability Index; (ii) characterization of the change of the subject’s radiculopathy symptoms and overall condition, using a combination of PainDETECT, modified Brief Pain Inventory, Clinical Global Impression of Change, and Patient Global Impression of Change and (iii) evaluation of the safety of a single and repeat SP-102injection. Schematic of CLEAR - SP-102(SEMDEXA) Phase 3 Pivotal Trial A full 6-monthdata analysis was completed