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Scilex Holding Company announces the U.S. FDA has approved the sNDA for commercial manufacturing of Gloperba® which will be launched in the US in the week of June 10th 2024
GlobeNewswire News Room· 2024-06-06 18:56
Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. The gout treatment market is projected to be $2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.2 Over 70% of gout patients have comorbid conditions that may require do ...
Scilex Holding Company Sends Letters to the U.S. Securities and Exchange Commission and Financial Industry Regulatory Authority Regarding Illegal Market Manipulation of the Common Stock of Scilex Holding Company
Newsfilter· 2024-05-30 17:19
Core Viewpoint - Scilex Holding Company is addressing illegal market manipulation of its common stock, specifically targeting manipulative "naked short" selling practices that violate SEC Regulation SHO, which negatively impacts shareholder value and rights [1][2]. Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain treatment [4][6]. - The company has several commercial products, including ZTlido® for neuropathic pain, ELYXYB® for acute migraine treatment, and Gloperba® for gout flare prophylaxis, with Gloperba® expected to launch in the first half of 2024 [4][5]. Product Pipeline - Scilex has three product candidates in development: - SP-102 (SEMDEXA™) for lumbosacral radicular pain, which has completed Phase 3 studies and received Fast Track status from the FDA [5]. - SP-103, a next-generation formulation of ZTlido for chronic neck pain, recently completed a Phase 2 trial [5]. - SP-104, a low-dose naltrexone for fibromyalgia, with Phase 1 trials completed in Q2 2022 [5]. Regulatory and Market Context - The company is actively engaging with regulatory bodies, including the U.S. Securities and Exchange Commission and the Financial Industry Regulatory Authority, to combat illegal short selling practices [2][3]. - Scilex aims to improve patient outcomes by targeting high unmet needs in pain management with its non-opioid therapies [4].
Scilex Holding Company Sends Letters to the U.S. Securities and Exchange Commission and Financial Industry Regulatory Authority Regarding Illegal Market Manipulation of the Common Stock of Scilex Holding Company
GlobeNewswire News Room· 2024-05-30 17:19
PALO ALTO, Calif., May 30, 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 sends a letter to both the U.S. Securities and Exchange Commission and Financial Industry Regulatory Authority regarding illegal market manipulation of the common stock of Scilex. The practice of manipulative or a ...
Scilex Holding Company Announces it has been Added to the MSCI Global Microcap Index
Newsfilter· 2024-05-24 17:40
For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com PALO ALTO, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, "Scilex" or "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, tod ...
Scilex Holding Company Announces it has been Added to the MSCI Global Microcap Index
globenewswire.com· 2024-05-24 17:40
PALO ALTO, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, "Scilex" or "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 it has received notification that Scilex will be added to the MSCI Global Micro Cap Index as of the close of market on Friday, May 31, 2024. MSCI is a leading provider of critical decision support tools and ...
Scilex Holding Company Sends Letter to U.S. House of Representatives on Illegal Market Manipulation of the Common Stock of Scilex Holding Company
globenewswire.com· 2024-05-24 13:00
PALO ALTO, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, "Scilex" or "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 sends a letter to the U.S. House of Representatives on illegal market manipulation of the common stock of Scilex. The practice of manipulative or abusive "naked short" selling or maintaining "naked short" positions ma ...
Scilex Holding Company Sends Letter to U.S. House of Representatives on Illegal Market Manipulation of the Common Stock of Scilex Holding Company
Newsfilter· 2024-05-24 13:00
PALO ALTO, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, "Scilex" or "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 sends a letter to the U.S. House of Representatives on illegal market manipulation of the common stock of Scilex. The practice of manipulative or abusive "naked short" selling or maintaining "naked short" positions ma ...
Scilex pany(SCLX) - 2024 Q1 - Quarterly Report
2024-05-13 20:05
Financial Performance - Net revenue for Q1 2024 was $10,884,000, a 2.85% increase from $10,582,000 in Q1 2023[22] - Net loss for Q1 2024 was $24,377,000, compared to a net loss of $30,753,000 in Q1 2023, indicating a 20.7% improvement[22] - For the three months ended March 31, 2024, Scilex Pharma reported a net loss of $24.4 million compared to a net loss of $30.8 million for the same period in 2023, representing a 20% improvement in net loss year-over-year[169] - Net revenue for the three months ended March 31, 2024, was $10.9 million, an increase of $0.3 million compared to $10.6 million in 2023, driven by a 28% increase in gross product sales of ZTlido and the commencement of ELYXYB sales[205] Operating Costs and Expenses - Total operating costs and expenses decreased to $30,362,000 in Q1 2024 from $36,055,000 in Q1 2023, representing a reduction of 15.5%[22] - Selling, general and administrative expenses rose to $29.3 million in Q1 2024 from $28.7 million in Q1 2023, driven by increases in advisory, financing, and personnel expenses[209] - Research and development expenses rose to $3,108,000 in Q1 2024, up from $2,736,000 in Q1 2023, reflecting a 13.6% increase[22] - Research and development expenses increased to $3.1 million in Q1 2024 from $2.7 million in Q1 2023, primarily due to increased costs associated with SP-102 and ELYXYB[208] Cash and Liquidity - Cash and cash equivalents decreased to $1,818,000 as of March 31, 2024, down from $3,921,000 at the end of 2023[20] - As of March 31, 2024, the company had cash and cash equivalents of approximately $1.8 million[215] - The Company reported negative working capital of $215.0 million, with cash and cash equivalents of approximately $1.8 million[53] - The Company has an outstanding balance of $16.3 million under a Revolving Facility with eCapital Healthcare Corp. as of March 31, 2024[51] Assets and Liabilities - Total assets decreased to $91,240,000 as of March 31, 2024, from $101,309,000 at the end of 2023, a decline of 10%[20] - Total liabilities increased to $281,026,000 as of March 31, 2024, compared to $274,247,000 at the end of 2023, an increase of 2.8%[20] - As of March 31, 2024, total indebtedness is $112.5 million, down from $128.9 million as of December 31, 2023, representing a decrease of approximately 12.5%[216] Shareholder and Equity Information - The weighted average number of shares during Q1 2024 was 102,407,000, down from 141,660,000 in Q1 2023[22] - The Company entered into an ATM Sales Agreement allowing for the sale of up to $170 million of Common Stock, with 92,295 shares sold for net proceeds of approximately $0.1 million as of March 31, 2024[131] - The Company issued 4,000,000 shares of Common Stock to a law firm as Retainer Shares for legal services[147] - As of March 31, 2024, there were 20,129,644 shares of Common Stock reserved for future issuance under the 2022 Equity Incentive Plan[137] Product Development and Commercialization - Scilex Holding Company focuses on non-opioid pain management products, with five wholly owned subsidiaries and a business combination with Vickers completed in November 2022[28] - The company launched ELYXYB in April 2023, a first-line treatment for migraines, and expects to commercialize GLOPERBA in the U.S. in the first half of 2024[29] - Scilex is developing three product candidates: SP-102, SP-103, and SP-104, with significant efforts on commercialization of ZTlido, GLOPERBA, and ELYXYB in 2024[30] - The company has a development pipeline that includes three product candidates: SP-102 (SEMDEXA), SP-103, and SP-104, with SP-102 having completed a pivotal Phase 3 study[180] Legal and Regulatory Matters - The Company entered into a settlement agreement with Virpax Pharmaceuticals, which includes an initial payment of $3.5 million and potential future royalty payments of 6% on certain drug candidates[158] - Scilex Pharma is involved in ongoing litigation regarding patent infringements related to ZTlido, with a trial scheduled for July 8, 2024[160] Debt and Financing - The Company fully repaid $25 million in Convertible Debentures in March 2024[50] - The Company entered into a Yorkville SPA to issue Convertible Debentures up to $25.0 million, with $10.0 million funded on March 21, 2023, and subsequent tranches funded in April 2023[80] - The outstanding principal balance of the Oramed Note is $92.9 million as of March 31, 2024, reduced from $96.9 million as of December 31, 2023[217] Miscellaneous - The Company has an accumulated deficit of $514.6 million as of March 31, 2024[53] - The Company recorded goodwill of $13.5 million as of March 31, 2024, with no impairment recognized during the three months ended March 31, 2024[78] - The Company recorded a loss of $0.5 million attributed to warrant liabilities for the three months ended March 31, 2024[67]
Scilex pany(SCLX) - 2023 Q4 - Annual Report
2024-03-11 21:57
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39852 Scilex Holding Company (Exact Name of Registrant as Specified in Its Charter) Delaware 92-1062542 (State or Other Jurisdiction of Incorporat ...
Scilex pany(SCLX) - 2023 Q3 - Quarterly Report
2023-11-14 21:53
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39852 Scilex Holding Company (Exact Name of Registrant as Specified in Its Charter) (I.R.S. Employer Identification No.) (650) 516-4310 ( ...