Announces $15 Million Registered Direct Offering
Summary
, (GLOBE NEWSWIRE) -- (Nasdaq: SCLX, Scilex or the Company), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale of an aggregate of 15,000,000 shares of its common stock, par value per share, and warrants to purchase up to an aggregate of 15,000,000 shares of common stock, at a purchase price of per share of common stock and accompanying warrant to purchase one share of common stock, in a registered direct offering. Electronic copies of the prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting at , 32nd Floor, 10022, by telephone at (212) 540-4414, or by email at info@rodm.com.This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilexs commercial products include: (i) ZTlido\xae (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the (the FDA) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB\xae, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba\xae, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, expected to launch in the first half of 2024.In addition, has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXATM or SP-102), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica for which has completed a Phase 3 study and has granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (SP-103), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which has recently completed a Phase 2 trial in low back pain and has granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (SP-104), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022 and a Phase 2 clinical trial is expected to commence in 2024.This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering, timing, the amount and the intended use of the net proceeds from the offering, Scilexs plans to launch GLOPERBA\xae in 2024 and plans to initiate Phase 2 trial in 2024 for SP-104.Risks and uncertainties that could cause Scilexs actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: statements related to the timing and completion of the offering; the satisfaction of customary closing conditions related to the offering and the intended use of proceeds from the offering; risks associated with the unpredictability of trading markets and whether a market will be established for Scilexs 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 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 Scilexs product candidates; the risk that will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilexs product candidates may not be beneficial to patients or successfully commercialized; the risk that has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilexs most recent periodic reports filed with the , including Scilexs Annual Report on Form 10-K for the year ended and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the , including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.SEMDEXA (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company.