Company: SCLXW
Filing Date: 2025-05-07
Form Type: POS AM
Source: 0001193125-25-115095
Chunk: 260

Company: Scilex Holding Co
Filing Date: 2025-05-07
Form: POS AM
Chunk 260
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rodent animal species, which showed that epidural administration of SP-102 demonstrated an increased local residence half-life and a decreased flow from the injection site.

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Intravascular Injection Study- SEM-005 We conducted a study to evaluate the accidental intravascular injection of SP-102into the vertebral artery of non-rodentanimals. There were no adverse clinical signs associated with the accidental intra-arterial injection of SP-102following a 24-hoursurvival period. SP-103(lidocaine topical system) 5.4% SP-103is an investigational, non-aqueouslidocaine topical system undergoing clinical development in acute LBP. As a higher strength topical lidocaine system, SP-103will build on the learnings from ZTlido because both products share the same adhesive drug delivery formulation and manufacturing technology. The clinical program involves evaluating the safety and efficacy of SP-103for the treatment of acute LBP. A Phase 1 study was completed that demonstrated bioequivalent PK between the administration of a single SP-103and the administration of three commercial ZTlido. The study also showed linear kinetics among multiple applications of SP-103(i.e., one, two or three patches) over a 12-houradministration period. Adhesion performance was assessed and found to be comparable between SP-103and ZTlido. We received our SP-103Phase 2 top-lineresults in August 2023 and the trial achieved its objectives characterizing safety, tolerability and preliminary efficacy of SP-103in acute LBP associated with muscle spasms. SP-103was safe and well tolerated. Increase of lidocaine load in topical system by three times, compared with approved ZTlido, 5.4% vs. 1.8%, did not result in signs of systemic toxicity or increased application site reactions with daily applications over one month treatment. SP-103received FDA Fast Track status in LBP. We will continue to analyze the SP-103Phase 2 trial data along with an investigator study at Johns Hopkins University completed in the second half of 2023, investigating ZTlido in patients with chronic non-radicularneck pain, which also has shown promising top-lineefficacy and safety results. While the phase 2 trial in acute LBP had demonstrated an effect in a subpopulation of patients who had acute LBP associated with more severe muscle spasms, the investigator-initiated