Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 254

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 254
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ology Study — UPD003-IS21

We conducted a preclinical toxicology study designed to simulate the accidental introduction of epidural steroids into arterial blood vessels
providing blood supply to the spinal cord, which is a major cause of neurological complications associated with current administration of suspension steroids containing particulates. A 2 mL (10 mg of dexamethasone) injection of SP-102 was injected over one to two minutes into the vertebral artery of large animal species.

Pre- and post-dose angiography showed no remarkable changes and all animals survived for approximately 24 hours until euthanasia. The veterinary animal health report and the pathology report concluded there were no
vascular, spinal cord or brain injuries associated with injection into the vertebral artery of the animals.

Hydrodynamic Study — SP-PC002

We conducted a hydrodynamic study of SP-102 in non-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