PALO ALTO, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing the treatment for neurodegenerative and cardiometabolic disease, and 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 26, ...

Core Insights - KDS2010 (Tisolagiline) is a new reversible selective monoamine oxidase B (MAO-B) inhibitor being studied for its potential in treating neurodegenerative diseases like Alzheimer's disease, with a Phase 2 clinical trial currently enrolling patients in South Korea and a U.S. cohort expected to be added in 2025 [1][5] - The global Alzheimer's drug market is projected to exceed $15 billion by 2030, driven by the introduction of new drugs that aim to slow cognitive decline [1] Company Overview - Scilex Bio, a joint venture between Scilex Holding Company and IPMC Company, holds the exclusive rights to KDS2010's global license and is focused on developing this novel treatment for Alzheimer's disease [1][15] - Scilex Holding Company is headquartered in Palo Alto, California, and is dedicated to acquiring, developing, and commercializing treatments for neurodegenerative diseases and non-opioid pain management products [11][20] Clinical Development - KDS2010 has shown favorable safety and tolerability in Phase 1 clinical trials involving 88 healthy young adults and elderly subjects, demonstrating adequate pharmacokinetics for once-daily dosing [1][5] - The ongoing Phase 2 clinical trial aims to evaluate the safety and efficacy of KDS2010 in patients with mild cognitive impairment and mild dementia [1][5] Mechanism of Action - KDS2010 not only acts as a MAO-B inhibitor but also influences astrocytic GABA inhibition, which is crucial in regulating neurotransmitter systems and addressing cognitive decline and neuroinflammation in Alzheimer's disease [1][3] - By inhibiting astrocytic GABA signaling, KDS2010 aims to reduce neuroinflammation and restore the balance between excitatory and inhibitory signals in the brain, potentially enhancing cognitive function [3][4] Market Potential - The advancement of small molecules like KDS2010, which can be administered orally once daily, represents a promising alternative to current injectable treatments targeting amyloid, tau, or neuroinflammation in Alzheimer's disease [2]

Core Viewpoint - Scilex Holding Company has received a notice from Nasdaq regarding non-compliance with listing requirements due to the late filing of its Q3 Form 10-Q for the quarter ended September 30, 2024 [1][2]. Compliance and Filing - The company has 60 calendar days from the receipt of the notice, until January 20, 2025, to submit a plan to regain compliance with Nasdaq's Listing Rule [2]. - If Nasdaq accepts the plan, the company may receive an extension of up to 180 calendar days, allowing compliance until May 19, 2025 [2]. - Scilex intends to file the Q3 Form 10-Q as soon as possible to regain compliance, and if not submitted by January 20, 2025, a plan will be submitted outlining steps to file the report [3]. Company Overview - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain [8]. - The company’s commercial products include ZTlido® for neuropathic pain, ELYXYB® for migraine treatment, and Gloperba® for gout flare prophylaxis [8][9]. - Scilex has three product candidates in development: SP-102 for lumbosacral radicular pain, SP-103 for acute pain, and SP-104 for fibromyalgia [9].

Core Viewpoint - Scilex management is actively working to enhance stockholder value and protect stockholder rights by addressing manipulative and naked short selling practices affecting its common stock [1][5][3] Summary by Relevant Sections Stockholder Actions - Scilex has set a record date of November 7, 2024, for the dividend of preferred stock to stockholders, with the payment date yet to be determined [1] - Stockholders are encouraged to recall their shares from brokerage firms and demand immediate delivery of Dividend Shares previously distributed by Sorrento Therapeutics [2][8] Short Selling Concerns - Management believes there are over 12 million shares of Scilex common stock sold short, with more than 10 million Dividend Shares sold as "naked short" positions since January 2023 [3][5] - There are substantial "naked short" positions in approximately 44 million shares that did not cast votes in prior annual meetings, indicating potential violations of SEC Regulation SHO [3][4] Company Background - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain [14][15] - The company has several commercial products, including ZTlido®, ELYXYB®, and Gloperba®, and is developing additional product candidates [14][15]

Core Points - Scilex Holding Company has set a record date of November 7, 2024, for a dividend of preferred stock to its stockholders and certain other securityholders [2][4] - The dividend consists of 5,000,000 shares of Series 1 Mandatory Exchangeable Preferred Stock, which will be exchangeable for up to 10% of Scilex's ownership interest in Semnur Pharmaceuticals, Inc. following a business combination [3][4] - The business combination between Semnur and Denali Capital Acquisition Corp. is expected to close by the first quarter of 2025, with a pre-transaction equity value of Semnur estimated at $2.5 billion [1][2] - SP-102 (SEMDEXA™), a product candidate held by Semnur, is projected to have peak sales potential of $3.6 billion annually in the fifth year post-launch [1][9] Company Overview - Scilex is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain [6][8] - The company’s commercial products include ZTlido®, ELYXYB®, and Gloperba®, which target high unmet needs in pain management [6][7] - Scilex has three product candidates in development: SP-102, SP-103, and SP-104, with various stages of clinical trials and FDA designations [7][9] Business Combination Details - The business combination will involve a registration statement filed with the SEC by the end of October 2024 [1][2] - The Series 1 Preferred Stock will automatically exchange for a pro-rata portion based on Scilex's ownership in Semnur or a maximum of $200 million, depending on the closing price of Semnur's common stock [3][4] - The dividend payment is contingent upon the Board's decisions and the effectiveness of the filing with the Secretary of State of Delaware [2][4]

Sales Growth Estimates - ZTlido net sales for Q3 2024 estimated between $11.0 million to $13.0 million, representing growth of approximately 9% to 29% compared to the same period last year[3] - Total product net sales for Q3 2024 estimated between $12.0 million to $14.0 million, representing growth of approximately 19% to 39% compared to the same period last year[3] Financial Reporting - Preliminary unaudited financial results for Q3 2024 were issued in a press release on October 8, 2024[4]

ZTlido net sales for the quarter ended September 30, 2024 were in the range of $11.0 million to $13.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 9% to 29%. Total product net sales for the quarter ended September 30, 2024 were in the range of $12.0 million to $14.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 19% to 39%. PALO ALTO, Calif., Oct. 08, 2024 (GLOBE NEWSWI ...

PALO ALTO, Calif., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (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 the closing of its previously announced registered direct offering of new tranche B senior secured convertible notes (the "Notes") in the aggregate principal amount of $50 million and warrants to purcha ...

Affiliates of Murchinson, 3i LP, and existing senior debt holder, Oramed Pharmaceuticals, Inc. ("Oramed"), are expected to participate in the $50 million convertible note offering, which is expected to close on or about October 7, 2024. The offering involves a refinancing and restructuring of existing debt and is expected to position Scilex for sustainable, long-term growth, as part of its multi-year plan to transform into a potential global and leading non-opioid pain management company. Scilex will receiv ...

Core Viewpoint - Scilex Holding Company is actively participating in the 2024 Annual PAINWeek conference to present its non-opioid pain management product, ZTlido, highlighting its significance in addressing unmet needs in pain management [1][2]. Company Overview - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain [4][6]. - The company’s commercial products include ZTlido (lidocaine topical system) 1.8%, ELYXYB (oral solution for migraine treatment), and Gloperba (liquid oral colchicine for gout) [4][5]. Product Presentations - ZTlido will be featured in several presentations at the PAINWeek conference, including a session on optimizing gabapentinoids for neuropathic pain and analyses on decreased opioid and cost utilization compared to traditional lidocaine patches [2]. Research and Development - Scilex has three product candidates in development: SP-102 (dexamethasone gel for sciatica), SP-103 (next-generation lidocaine topical system), and SP-104 (low-dose naltrexone for fibromyalgia) [5]. - SP-102 has completed a Phase 3 study and received Fast Track status from the FDA, while SP-103 has recently completed a Phase 2 trial [5]. Market Positioning - The company targets high unmet needs in pain management, positioning itself to capitalize on large market opportunities with its non-opioid therapies [4].