Scilex Holding Co Stock Price, News & Analysis

Scilex Bio announces progress in its Phase 2 clinical trial for KDS2010 (Tisolagiline), a novel oral tablet targeting Alzheimer's disease. The trial, currently enrolling 114 patients in South Korea, will expand to include U.S. patients in 2025. KDS2010 is a new reversible selective monoamine oxidase B (MAO-B) inhibitor that also influences astrocytic GABA inhibition.

The drug has shown promising results in preclinical studies, significantly reducing astrocytic GABA levels and improving learning and memory in mouse models. Phase 1 trials with 88 subjects demonstrated favorable safety and suitable pharmacokinetics for once-daily dosing. The global Alzheimer's drug market is projected to exceed $15 billion by 2030 in major markets.

Scilex Bio reports progress on its obesity treatment KDS2010, with an ongoing Phase 2 trial currently enrolling approximately 75 overweight or obese patients in South Korea, planning to expand to the U.S. in 2025. The trial is randomized, double-blind, and placebo-controlled. Phase 1 trials, completed with 88 subjects, demonstrated favorable safety, tolerability, and suitable pharmacokinetics for once-daily dosing.

KDS2010 (Tisolagiline) functions as a selective, reversible MAO-B inhibitor, blocking GABA production in reactive astrocytes and eliminating neuronal inhibition in the Lateral Hypothalamic Area. This mechanism stimulates metabolism and energy expenditure without affecting appetite, potentially offering advantages over current obesity treatments like GLP-1 agonists.

Scilex Bio and NeuroBiogen have signed a binding term sheet for worldwide licensing rights of KDS2010, a novel oral tablet targeting the $150 billion weight loss and Alzheimer's disease markets. The agreement grants Scilex Bio exclusive worldwide rights to develop and commercialize KDS2010 for metabolic diseases (including obesity and type 2 diabetes) and neurodegenerative diseases (including Alzheimer's and Parkinson's).

KDS2010, currently in Phase 2 clinical trials for obesity and Alzheimer's disease, is a potent, selective, and reversible MAO-B inhibitor. The collaboration combines NeuroBiogen's research and development expertise with Scilex's commercial and development capabilities in CNS and primary care diseases.

Scilex Holding Company (NASDAQ: SCLX) has entered into a binding term sheet to form a joint venture, Scilex Bio, with IPMC and Bio Open Innovation Consortium. The venture will develop and commercialize KDS2010, a Phase 2 clinical stage oral tablet targeting obesity and neurodegenerative diseases, including Alzheimer's.

KDS2010 has demonstrated promising results in Phase 1 trials with 88 subjects, showing favorable safety and once-daily dosing potential. The drug works by controlling GABA levels in astrocytes and selectively inhibiting MAO-B enzymes. Scilex will own controlling interest upon contributing $50 million of Semnur Pharmaceuticals stock, while IPMC will own 40% for contributing worldwide rights to KDS2010.

The global obesity drug market is projected to reach $131 billion by 2028, while the Alzheimer's drug market is expected to exceed $15 billion by 2030.

Scilex Holding Company (SCLX) has received a notice from Nasdaq's Listing Qualifications Department on November 21, 2024, indicating non-compliance with listing requirements due to failure to file its Q3 2024 Form 10-Q on time. The company has until January 20, 2025 to submit a compliance plan to Nasdaq. If accepted, Nasdaq may grant an extension until May 19, 2025 to regain compliance. Scilex intends to file the Q3 Form 10-Q as soon as possible or submit a detailed plan outlining steps to file the report if unable to meet the January deadline.

Scilex Holding Company (SCLX) announced a data presentation at the 2024 American College of Rheumatology Convergence conference in Washington, D.C. The presentation focuses on GLOPERBA®, their liquid colchicine formulation for gout patients. The data discusses pharmacokinetic model-derived dosing for patients with moderate and severe chronic kidney disease. GLOPERBA® is notable as the first and only liquid colchicine offering precision dosing, including reduced daily doses (0.3 mg/day) for patients with severe renal impairment, following a recent FDA label update.

Semnur Pharmaceuticals, a subsidiary of Scilex Holding Company (SCLX), announced the filing of an S-4 Registration Statement with the SEC regarding its planned merger with Denali Capital Acquisition Corp (DECA). The business combination, valued at $2.5 billion pre-transaction equity, is expected to close by Q1 2025. Scilex has declared a stock dividend of 5,000,000 shares of Series 1 Mandatory Exchangeable Preferred Stock, representing up to 10% of Scilex's ownership in Semnur post-merger. The record date for this dividend is set for November 7, 2024, with investors required to hold Scilex common stock on this date to receive the dividend.

Scilex Holding Company (SCLX) announced a successful end of Phase II meeting with FDA for SP-103, a triple-strength formulation of ZTlido for chronic neck pain treatment. The FDA provided a clear path to NDA following Phase III trials completion. SP-103, a lidocaine topical system 5.4%, targets the U.S. low back and neck pain market, projected to reach $134.5 billion. According to Syneos Health Consulting research, SP-103's peak sales potential is estimated at $1.2 billion annually by the 6th year post-launch. The company currently has three FDA-approved commercial products: ZTlido, ELYXYB, and Gloperba.

Scilex Holding Company (NASDAQ: SCLX) has set a record date of November 7, 2024, for a preferred stock dividend distribution. The company reports concerns about manipulative and naked short selling of its common stock. Of approximately 197 million outstanding shares: 76 million are restricted until January 2025, 60 million were repurchased, and 60 million constitute the public float. Management believes over 12 million shares are being sold short, with an additional 10 million shares in naked short positions. The company provides guidance to stockholders on recalling loaned shares and demanding delivery of dividend shares from brokerage firms.