Scilex Holding Company announced that the State of Tennessee added ZTlido as a preferred agent to the Medicaid Preferred Drug List effective as of October 1, 2023. This change has the potential to improve access to ZTlido for all eligible patients which includes approximately 1,500,000 adult lives between the ages of 19 to 64. The company is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life.

Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXATM, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and reached agreement on a path forward to file an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain (Sciatica) with the FDA. Scilex launched its first commercial product ZTlido®?

in October 2018, in-licensed a commercial product Gloperba in June 2022, and launched its third FDA-approved product Elyxyb in April 2023. Its commercial product, ZTlido (lidocaine topical system) 1.8%, or ZTlido, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with post-herpetic neuralgia, which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S.Scilex in- licensed the exclusive rights to commercialize Elyxyb (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.

Scilex's current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity; statements regarding ZTlid, Gloperba, ELYXYB, SP-102 (SemDEXA??), SP-103 or SP-104, if approved by the FDA; Scilex's development and commercialization plans; and Scilex's products, technologies and prospects. R risks and uncertainties that could cause Scilex's actual results to differ materially and adversely from those expressed in forward-looking statements, include, but are not limited to: risks associated with the predictability of trading markets and whether a market will be established for Scilex's common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex's product candidates; the risk that Scilex will be unable to successfully market or gain market market opportunities. Scilex will be able to successfully market or gain market opportunities.