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Proceeds from the funding commitment will be used for Scilex’s three FDA-approved non-opioid pain management products (ZTlido®, Gropelva® and Elyxyb™) are used to treat acute and chronic pain.
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The funding will enable further investment in Silex’s non-opioid pain management portfolio and accelerate the company’s mission to launch innovative non-opioid pain management products in key markets.
PALO ALTO, Calif., March 21, 2023 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX, “Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), announces transformational revenue is raising A production company focused on the acquisition, development and commercialization of non-opioid pain management products for the treatment of acute and chronic pain, has announced that it has entered into a securities purchase agreement with YA II PN, Ltd. Yorkville Advisors Global, LP (“Yorkville”) was responsible for the issuance and sale of unsecured convertible debentures of up to $25 million principal amount.
The convertible debentures will be issued and sold in three tranches as follows: and (iii) a registration statement with the U.S. Securities and Exchange Commission (“SEC”) relating to the underlying common stock of the convertible debentures, and (iii) 7.5 million at the time such registration statement is declared effective by the SEC. dollar.
The convertible notes bear interest at an annual rate of 7.00% and will mature on December 21, 2023, nine months after the initial closing date.
Subject to the terms of the Convertible Debentures, Yorkville has the right, at its option, to convert all or a portion of the Convertible Debentures into shares of Scilex common stock at a price of $8.00 per share (the “Conversion Price”). Equivalent prices are subject to a one-time reset equal to the average daily VWAP of three consecutive trading days immediately preceding the date sixty (60) days after the initial closing date. effect on that date.
Silex will use the proceeds to further commercialize Silex’s three non-opioid pain management products for the treatment of acute and chronic pain. Scilex’s suite of FDA-cleared non-opioid pain management products includes:
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Z torid®, a lidocaine topical system approved for the relief of neuropathic pain associated with postherpetic neuralgia. Z torid® was strategically designed to address the limitations of current prescription lidocaine patches by providing significantly improved adhesion and continuous pain relief throughout the 12-hour dosing period.
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Gropelva®, an FDA-approved novel oral solution of the widely used antigout drug (colchicine) for the prevention of gout flares in adults. There are currently no other liquid formulations approved by the FDA for the treatment of gout.
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ELYXYB™ is a first-line therapy and the only FDA-approved ready-to-use oral solution for the acute treatment of migraine with or without aura in adults.1 There is strong evidence for the use of NSAIDs as first-line treatment for migraine, and ELYXYB™ (celecoxib) is in the same class of drugs, with fast acting and potentially the fewest gastrointestinal side effects of all NSAIDs there is.2 ELYXYB™ has the potential to further expand Scilex’s non-opioid portfolio in a broader range of acute pain indications.
“We are pleased to enter into this agreement with Yorkville, which will provide the funding to expand ZTlido.® Advertise worldwide and strengthen the launch and commercialization of Gloperba® and ELYXYB™. Patients with acute and chronic pain find themselves underperformed by the options currently on the market. A recent report from the Centers for Disease Control and Prevention found that opioids have no clinically meaningful analgesic effect and are not first-line treatments for acute and chronic pain.3said Jaisim Shah, CEO and President of Silex.
The convertible debentures and common stock issued upon conversion thereof are not registered under the United States Securities Act of 1933, as amended (the “Securities Act”) or state securities laws. Accordingly, securities may not be offered or sold in the United States except in accordance with a valid registration statement or an applicable exemption from the securities laws and applicable state law registration requirements. Scilex granted his Yorkville registration rights requiring Scilex to register the resale of the underlying common stock.
About Silex Holding Company
Scilex Holding Company 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. Scilex aims to be a global pain management leader committed to social, environmental, economic and ethical principles to responsibly develop medicines that maximize quality of life. increase. In March 2022, results were announced from the pivotal Phase 3 CLEAR program of SEMDEXA™, a novel non-opioid product for the treatment of lumbosacral nerve root pain (sciatica). A meeting aimed at pre-NDA discussions with the FDA. Scilex is a non-opioid therapy for the treatment of patients with moderate to severe pain, targeting indications of high unmet need and significant market opportunity. Scilex Launches First Commercial Product ZTlido® In October 2018, commercial product Goperba was introduced® We are developing our third FDA-approved product, Elyxyb™, in February 2023 in June 2022. We are also developing a late-stage pipeline that includes an important Phase 3 candidate, one Phase 2 candidate and one Phase 1 candidate. 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 to relieve pain associated with postherpetic neuralgia, a form of postherpetic neuralgia. Scilex introduced exclusive rights to commercialize his Gloperba® (Colchicine USP) Oral Solution, FDA-Approved Prophylactic Treatment for Painful Gout Relapses in Adults in the United States Scilex Commercializes the Only FDA-Approved Elyxyb™ (celecoxib oral solution) in the United States and Canada has licensed the exclusive right to Ready-to-use oral solution for the acute treatment of migraine with or without aura in adults. Scilex plans to commercialize Gloperba® Elyxyb™ will be launched in 2023 and is well-positioned for product sales and distribution. Scilex’s three product candidates are SP-102 (an injectable dexamethasone sodium phosphate viscous gel product containing 10 mg of dexamethasone), or SEMDEXA™, widely used for epidural injection to treat lumbosacral radicular pain. corticosteroid phase 3, novel viscous gel formulation, or sciatica, with FDA fast track status. SP-103 (Lidocaine Topical System) 5.4%, Phase 2 Study, 3X Stronger Formulation than ZTlido®, for the treatment of acute low back pain with FDA Fast Track status. SP-104, 4.5 mg delayed-burst-release low-dose naltrexone hydrochloride (DBR-LDN) capsules for the treatment of chronic pain, fibromyalgia, has completed multiple Phase 1 study programs, with Phase 2 in 2023 We plan to initiate a phase trial. For information on SP-102 Phase 3 Efficacy Study, see NCT Identifier NCT03372161 – Corticosteroid Lumbar Epidural Analgesia for Radiculopathy – Full Text – ClinicalTrials.gov.
Scilex Holding Company is headquartered in Palo Alto, California.
Forward-Looking Statements
This press release, and any statements made for presentations or conferences relating to the matters discussed in this press release, expressly state that Scilex and its subsidiaries, under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, contains forward-looking statements. They are also subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include information about the convertible debenture transaction, use of proceeds from such transaction, Scilex’s long-term goals and commercialization plans, Scilex’s potential to attract new capital, Scilex’s future opportunities, and Scilex’s future prospects. Includes statements regarding business strategy and expected cash resources. Scilex and its expected uses. Scilex’s current and future product candidates, planned clinical trials and preclinical activities, potential for product approval and potential market acceptance of approved products, and related market opportunities. ELYXYB™ Statement, SP-102 (SEMDEXA™), SP-103, or SP-104 (if approved by the FDA); Scilex development and commercialization plans. Scilex products, technology and perspectives.
Risks and uncertainties that could cause Scilex’s actual results to differ materially from those expressed in our forward-looking statements include, but are not limited to: . General economic, political and business conditions. Risks associated with the ongoing COVID-19 pandemic. the risk that potential product candidates developed by Scilex will not proceed to clinical development or receive necessary regulatory approvals within expected timelines, or not at all; risks associated with uncertainties regarding regulatory pathways for Scilex’s product candidates; the risk that Scilex will be unable to successfully market and market its product candidates; the risk that Scilex’s product candidates will not be beneficial to patients or will not be successfully commercialized; The risk that Scilex overestimates the size of its target patient population, the willingness to try new therapies, and the willingness of physicians to prescribe these therapies. The risk of unsuccessful results from a phase 2 trial of SP-103 or a phase 1 trial of SP-104. Risk of not replicating previous results from clinical trials of SP-102 (SEMDEXA™), SP-103, or SP-104. Regulatory and Intellectual Property Risks. and other risks and uncertainties presented from time to time and other risks described in Scilex’s filings with the SEC. Investors are cautioned not to place undue reliance on these forward-looking statements. We undertake no obligation to update any forward-looking statements in this press release, which speak only as of the date of this release, except as required by law.
contact address:
investors and media
Silex Holding Company
960 San Antonio Road
Palo Alto, California 94303
Office: (650) 516-4310
Email: [email protected]
Website: www.scilexholding.com
reference
1) Source: Oral celecoxib solution approved for acute migraine in May 2020. https://www.neurologylive.com/view/celecoxib-oral-solution-gets-goahead-for-acute-migraine
2) Source: Acute Migraine: Treatment Strategies. https://www.aafp.org/pubs/afp/issues/2018/0215/p243.html
3) Source: CDC Clinical Practice Guidelines for Opioid Prescribing for Pain — USA, 2022
https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly owned subsidiary of Scilex Holding Company. A review of the proprietary name by the FDA is planned.
Z torid® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly owned subsidiary of Scilex Holding Company.
Gropelva® is subject to an exclusive transferable license to use the registered trademark by Scilex Holding Company.
ELYXYB™ is subject to an exclusive, transferable license to use the trademark by Scilex Holding Company.
All other trademarks are the property of their respective owners.
© 2023 Scilex Holding Company All rights reserved.
