Scilex pany(SCLX)
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Scilex Holding Company (Nasdaq: SCLX) Announces Effectiveness of Registration Statement on Form S-4 for the Proposed Business Combination of Denali Capital Acquisition Corp. and Semnur Pharmaceuticals, Inc., a Majority-Owned Subsidiary of Scilex
Globenewswire· 2025-08-13 10:00
Core Viewpoint - Scilex Holding Company is advancing a business combination with Denali Capital Acquisition Corp. and Semnur Pharmaceuticals, focusing on non-opioid pain management products, with the SEC declaring the registration statement effective [1][6]. Company Overview - Scilex is dedicated to acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, as well as neurodegenerative and cardiometabolic diseases [5]. - The company’s commercial products include ZTlido, ELYXYB, and Gloperba, targeting high unmet medical needs [5]. Business Combination Details - An extraordinary general meeting for Denali shareholders is scheduled for September 3, 2025, to approve the proposed business combination [2][6]. - The combined company will be renamed Semnur Pharmaceuticals, Inc. upon closing the business combination [6]. Product Pipeline - Scilex has three product candidates: SP-102 (SEMDEXA), SP-103, and SP-104, targeting various pain management needs and conditions [7]. - SP-102 is a novel gel formulation for epidural injections, while SP-103 is a next-generation lidocaine topical system [7]. Market Position - Scilex aims to address significant market opportunities in non-opioid therapies for pain management, focusing on improving patient outcomes [5].
Scilex pany(SCLX) - Prospectus
2025-08-04 21:15
Table of Contents (Exact name of Registrant as specified in its charter) Delaware 2836 92-1062542 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Scilex Holding Company 960 San Antonio Road Palo Alto, CA 94303 (650) 516-4310 As filed with the U.S. Securities and Exchange Commission on August 4, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form ...
Scilex Holding Company Announces Publication on GLOPERBA® Dosing Adjustments in Peer-Review Journal
Globenewswire· 2025-06-05 16:05
Core Insights - Scilex Holding Company announced a publication regarding GLOPERBA dosing adjustments in a peer-reviewed journal, emphasizing its focus on non-opioid pain management products for various conditions [1][5] Company Overview - Scilex Holding Company is dedicated to acquiring, developing, and commercializing non-opioid pain management products aimed at treating acute and chronic pain, neurodegenerative diseases, and cardiometabolic diseases [1][6] - The company’s commercial products include ZTlido, ELYXYB, and GLOPERBA, with GLOPERBA being the first and only liquid oral version of colchicine for gout flare prophylaxis [6][9] Product Details - GLOPERBA allows for precision dosing and is particularly beneficial for over 70% of gout patients who have comorbid conditions requiring dose adjustments [2][4] - The publication highlights the importance of precise dosing for patients with renal impairment, suggesting specific dosages of 0.48 mg for moderate and 0.3 mg for severe renal impairment to maintain therapeutic levels and enhance safety [4][5] Clinical Significance - The publication is expected to provide essential data to guide clinical dosing of colchicine in patients suffering from gout and chronic renal failure, addressing a significant clinical need [5]
Scilex pany(SCLX) - 2025 Q1 - Quarterly Report
2025-05-14 20:33
Financial Performance - Net revenue for Q1 2025 was $5,004,000, a decrease of 54.9% compared to $10,884,000 in Q1 2024[23] - Net loss for Q1 2025 was $26,080,000, compared to a net loss of $24,377,000 in Q1 2024, indicating an increase in loss of 7.0%[23] - The company reported a loss per share of $2.26 for Q1 2025, compared to a loss per share of $8.33 in Q1 2024[23] - The net loss for the three months ended March 31, 2025, was $26.08 million, compared to a net loss of $24.38 million for the same period in 2024[28] - Net cash proceeds from operating activities were $6.01 million, a decrease from $9.39 million in the prior year[28] Assets and Liabilities - Total current assets decreased to $28,704,000 as of March 31, 2025, down from $41,547,000 as of December 31, 2024, representing a decline of 30.9%[20] - Total liabilities increased to $290,460,000 as of March 31, 2025, compared to $285,594,000 as of December 31, 2024, reflecting a rise of 1.0%[20] - Total stockholders' deficit increased to $211,484,000 as of March 31, 2025, compared to $192,641,000 as of December 31, 2024, an increase of 9.7%[20] - Cash and cash equivalents rose to $5,800,000 as of March 31, 2025, up from $3,272,000 as of December 31, 2024, marking an increase of 77.2%[20] Expenses - Research and development expenses for Q1 2025 were $2,456,000, down 20.9% from $3,108,000 in Q1 2024[23] - Selling, general and administrative expenses decreased to $28,060,000 in Q1 2025, a reduction of 4.2% from $29,278,000 in Q1 2024[23] - The Company reported operating losses of $27.9 million during the three months ended March 31, 2025, with cash flows from operating activities amounting to $6.0 million[60] Shareholder Information - The weighted average number of shares during Q1 2025 was 11,565,000, significantly higher than 2,926,000 in Q1 2024[23] - The Company has outstanding warrants totaling 1,000,000 Private Warrants and 57,512,958 December 2024 RDO Common Warrants, with a fair value of derivative warrant liabilities at $7.9 million[92] - As of March 31, 2025, options to purchase 1,022,353 shares of Common Stock were outstanding under all equity incentive plans, with a weighted-average exercise price of $138.17[190] Revenue Sources - The company had three customers that generated 99% of total revenue for the three months ended March 31, 2025, compared to 85% in 2024[39] - The Company will receive 50% of the net revenue generated from the commercialization of Gloperba Products outside the U.S.[77] - The Elyxyb License Agreement stipulates that the licensee will also receive 50% of the Canadian net revenue from Elyxyb Products[82] Research and Development - The company is developing three product candidates: SP-102, SP-103, and SP-104, with SP-102 having completed a Phase 3 study[33] - The company launched ELYXYB in the U.S. in April 2023 and commercialized GLOPERBA in June 2024[32] - The company incurred $566,000 in in-process research and development expenses during the quarter[28] Debt and Financing - The Company plans to obtain additional resources to fund operations and service debt obligations through equity offerings, debt financings, and strategic transactions[61] - The Company issued Tranche B Notes in October 2024, with an aggregate principal amount of $50.0 million, maturing two years from the issuance date[59] - The aggregate principal repayments for the Company's outstanding debt will be $46.3 million and $19.3 million in 2025 and 2026, respectively[132] Joint Ventures and Acquisitions - The Company formed a joint venture, Scilex Bio, Inc., with IPMC Company on April 17, 2025, to develop a next-generation reversible MAO-B Inhibitor[216] - The Company contributed 5.0 million shares of Semnur Common Stock for a 60% ownership interest in Scilex Bio, Inc.[216] - The Company acquired the SP-104 Assets in May 2022, with a potential Development Milestone Payment of $3.0 million upon FDA approval and a Sales Milestone Payment of $20.0 million based on future sales[63] Fair Value and Liabilities - The fair value of the Oramed Note was $15.0 million, up from $12.2 million as of December 31, 2024, reflecting a loss of $2.8 million in fair value change for the quarter[88] - The Tranche B Notes had a fair value of $24.5 million as of March 31, 2025, compared to $23.6 million at the end of 2024, with a loss of $2.5 million recorded for the three months ended March 31, 2025[89] - The aggregate fair value of the Purchased Revenue Liability was $7.3 million as of March 31, 2025, increasing from $6.8 million as of December 31, 2024, with a loss of $0.8 million for the quarter[90] Stock and Equity - The Company is authorized to issue 45,000,000 shares of Preferred Stock, with two series currently outstanding[162] - The Series 1 Preferred Stock dividend consists of an aggregate of 5,000,000 shares, with specific conditions for holders regarding distributions and voting rights[164] - The Company raised approximately $15 million from the April 2024 Registered Direct Offering by selling 428,572 shares of Common Stock at $35.00 per share[177] Management Discussion - The management discussion emphasizes the need to read financial results in conjunction with the unaudited condensed consolidated financial statements[218] - Forward-looking statements in the management discussion involve risks and uncertainties that could materially affect actual results[218] - The Company does not assume any obligation to update forward-looking statements except as required by law[218]
Scilex Holding Company Regains Compliance with NASDAQ Minimum Bid Price Rule
Globenewswire· 2025-04-30 17:46
Core Viewpoint - Scilex Holding Company has regained compliance with Nasdaq's minimum closing bid price requirement, maintaining a minimum closing bid price of $1.00 per share for at least ten consecutive trading days as of April 30, 2025 [1] Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, as well as neurodegenerative and cardiometabolic diseases [3][5] - The company targets high unmet needs and large market opportunities with non-opioid therapies to improve patient outcomes [3] Commercial Products - Scilex's commercial products include: - ZTlido® (lidocaine topical system) 1.8%, approved for neuropathic pain relief associated with postherpetic neuralgia [3] - ELYXYB®, the only FDA-approved ready-to-use oral solution for acute migraine treatment in adults [3] - Gloperba®, the first liquid oral version of colchicine for the prophylaxis of painful gout flares in adults [3] Product Candidates - Scilex has three product candidates in development: - SP-102 (SEMDEXA), a viscous gel formulation for epidural injections to treat lumbosacral radicular pain, which has completed a Phase 3 study and received Fast Track status from the FDA [4] - SP-103, a next-generation formulation of ZTlido for acute pain, which has recently completed a Phase 2 trial and also received Fast Track status from the FDA [4] - SP-104, a low-dose delayed-release naltrexone hydrochloride for fibromyalgia treatment [4]
Scilex Holding Company Announces FDA Has Approved Our Request for the Orphan Drug Designation for Colchicine for the Treatment of Pericarditis
Globenewswire· 2025-04-16 18:12
Core Insights - Scilex Holding Company has received FDA approval for Orphan drug designation for colchicine to treat pericarditis, enhancing its portfolio in non-opioid pain management products [1][3]. Company Overview - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, with a commitment to improving patient outcomes [5][10]. - The company is headquartered in Palo Alto, California [9][11]. Product Portfolio - Scilex's commercial products include: - ZTlido (lidocaine topical system) 1.8% for neuropathic pain relief [5][7]. - ELYXYB, an oral solution for acute migraine treatment [5][7]. - Gloperba, the first liquid oral version of colchicine for gout flare prophylaxis [6][7]. - The company has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections targeting lumbosacral radicular pain, which has completed Phase 3 studies [8]. - SP-103, a next-generation lidocaine topical system for acute pain, recently completing Phase 2 trials [8]. - SP-104, a low-dose naltrexone hydrochloride for fibromyalgia treatment [8]. Regulatory Insights - The Orphan Drug Act allows the FDA to grant orphan designation to drugs intended for rare diseases, which can lead to seven years of market exclusivity upon first approval [3].
Scilex Holding Company Announces 1-for-35 Reverse Stock Split
Newsfilter· 2025-04-11 13:00
Core Viewpoint - Scilex Holding Company will implement a reverse stock split at a ratio of 1-for-35 effective April 15, 2025, to comply with Nasdaq's minimum bid price requirement of $1.00 per share [1][2]. Company Overview - Scilex is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, as well as treatments for neurodegenerative and cardiometabolic diseases through a proposed joint venture with IPMC Company [1][8][9]. - The company’s commercial products include ZTlido®, ELYXYB®, and Gloperba®, targeting high unmet needs in pain management [9][10]. Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 243 million to about 6.9 million [4]. - The split will not affect the authorized number of shares, and stockholders will receive cash payments for any fractional shares [3][5]. - The reverse stock split was approved by stockholders on March 19, 2025, with the board of directors selecting the 1-for-35 ratio on April 3, 2025 [5]. Trading Information - Post-split, Scilex's common stock will continue trading on The Nasdaq Capital Market under the symbol "SCLX" with a new CUSIP number [2]. - Continental Stock Transfer & Trust Company will manage the exchange process for stockholders [6].
Scilex pany(SCLX) - 2024 Q4 - Annual Report
2025-03-31 20:30
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, 2024 ☐ 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 Holding Company Has Appealed Lower Court Decision to the U.S. Court of Appeals for the Federal Circuit in Washington, DC and Will Continue to Vigorously Pursue its Infringement Action Against Aveva
Globenewswire· 2025-03-27 00:24
Core Viewpoint - Scilex Holding Company is actively pursuing an appeal against a lower court decision that ruled in favor of Aveva Drug Delivery Systems, asserting that Aveva infringes on Scilex's ZTlido patents [1][3][4] Company Overview - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for both acute and chronic pain [6][10] - The company has a portfolio that includes ZTlido, ELYXYB, and Gloperba, targeting high unmet medical needs in pain management [6][10] Legal Proceedings - In May 2022, Scilex was notified of Aveva's submission of an Abbreviated New Drug Application (ANDA) that may infringe on Scilex's ZTlido patents, leading to a patent infringement lawsuit filed in June 2022 [2] - The U.S. District Court ruled in July 2024 that Aveva's proposed product did not infringe Scilex's patents, prompting Scilex to appeal the decision [3][4] Intellectual Property - Scilex maintains confidence in the strength and validity of its ZTlido intellectual property and believes that Aveva is infringing on its patents [4] - The company is pursuing additional patents for follow-on programs to further protect its intellectual property portfolio [4]
Scilex Holding Company Announces that the U.S. Bankruptcy Court has Extended the Lockup Period on Shares of Scilex Dividend Stock Previously Distributed by Sorrento to its Stockholders as a Dividend to April 14, 2025
GlobeNewswire News Room· 2025-01-31 14:00
Core Viewpoint - Scilex Holding Company announced the extension of the lock-up period for its Dividend Stock until April 14, 2025, as approved by the U.S. Bankruptcy Court for the Southern District of Texas, affecting shares previously distributed by Sorrento Therapeutics [1][5]. Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, and is also pursuing a joint venture with IPMC Company in neurodegenerative and cardiometabolic diseases [4][8]. - The company targets high unmet needs in the market with non-opioid therapies and aims to improve patient outcomes [4]. Commercial Products - Scilex's commercial products include: - ZTlido® (lidocaine topical system) 1.8%, approved for neuropathic pain relief [4]. - ELYXYB®, an FDA-approved oral solution for acute migraine treatment [4]. - Gloperba®, the first liquid oral version of colchicine for gout flare prophylaxis [4]. Product Candidates - Scilex has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections to treat sciatica, which has completed Phase 3 studies [5][6]. - SP-103, a next-generation lidocaine topical system for acute pain, recently completed Phase 2 trials [6]. - SP-104, a low-dose naltrexone hydrochloride for fibromyalgia treatment [6]. Regulatory Status - SP-102 has received Fast Track status from the FDA, indicating its potential for expedited development [6]. - SP-103 has also been granted Fast Track status for low back pain [6]. Market Position - Scilex is headquartered in Palo Alto, California, and is positioned as a clinical late-stage specialty pharmaceutical company focusing on non-opioid pain therapies [7][8].