Non - opioid pain management
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Scilex Holding Company Announces Closing of Exercise of Warrants for $20.3 Million Gross Proceeds
Globenewswire· 2025-11-25 19:37
Core Viewpoint - Scilex Holding Company has successfully closed the exercise of existing warrants, generating approximately $20.3 million in gross proceeds, which will be used for working capital and general corporate purposes [1][4]. Group 1: Warrants and Proceeds - The company exercised two sets of existing warrants, totaling 904,396 shares, at a reduced exercise price of $22.51 per share [1]. - The April 2024 Warrants were originally priced at $38.50 per share, while the December 2024 Warrants had an exercise price of $22.72 per share [1]. - The gross proceeds from the exercise of these warrants were approximately $20.3 million before deducting fees and expenses [1]. Group 2: New Warrant Issuance - In exchange for the immediate cash exercise of the existing warrants, the company issued a new unregistered warrant for 1,356,594 shares at an exercise price of $29.00 per share, which is exercisable immediately and has a five-year term [3]. - The new warrant was offered in a private placement under Section 4(a)(2) of the Securities Act and Regulation D [5]. Group 3: Company Overview - Scilex is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, as well as neurodegenerative and cardiometabolic diseases [8]. - The company's commercial products include ZTlido, ELYXYB, and Gloperba, which target significant unmet medical needs [9][10]. - Scilex has three product candidates in development, including SP-102, SP-103, and SP-104, which are aimed at various pain management indications [10].
Scilex Holding Company Announces Exercise of Warrants for $20.3 Million Gross Proceeds
Globenewswire· 2025-11-24 11:00
PALO ALTO, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, announced today that it has entered into a definitive agreement for the exercise of certain existing warrants to purchase an aggregate of (i) 428,572 shares of common ...
Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.
Globenewswire· 2025-11-21 20:59
PALO ALTO, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, announced today that, with respect to the voluntary distribution by Datavault AI Inc. (“Datavault AI”) (Nasdaq: DVLT) of Dream Bowl 2026 Meme Coins to record holders o ...
Scilex Holding Company Announces the Sponsorship of Dream Bowl 2026 and Set a Record Date of November 14, 2025 for Its Shareholders to Receive Dream Bowl 2026 Meme Coin Distributed by DataVault AI
Globenewswire· 2025-11-03 14:53
Core Insights - Scilex Holding Company is sponsoring the Dream Bowl 2026 and will distribute a unique digital collectible, the Dream Bowl 2026 Meme Coin, to its shareholders [1][2] - Shareholders as of November 14, 2025, will receive one meme coin for each common share held, with airdrops occurring on or after November 25, 2025 [2] - The Dream Bowl event will take place on January 11, 2026, at AT&T Stadium in Dallas, Texas, featuring elite athletes and e-sports competitions [3] Company Overview - Scilex is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, as well as neurodegenerative and cardiometabolic diseases [1][4] - The company has commercial products including ZTlido® for neuropathic pain, ELYXYB® for acute migraine treatment, and Gloperba® for gout flare prophylaxis [4][5] - Scilex is developing three product candidates: SP-102 for lumbosacral radicular pain, SP-103 for acute pain, and SP-104 for fibromyalgia [5][6] Datavault AI Partnership - Datavault AI is involved in the distribution of the meme coin and offers a cloud-based platform for data experiences and monetization [7] - The partnership aims to enhance the recognition of ownership and provide utility through ticketing and event insights for the Dream Bowl [2][3]
Scilex Holding Company Announces the Completion of the First Tranche of the Oramed Pharmaceuticals, Inc. Warrant Repurchase
Globenewswire· 2025-10-01 13:00
Core Viewpoint - Scilex Holding Company has repurchased 3,130,000 warrants from Oramed Pharmaceuticals for $13 million, as part of a larger option agreement to repurchase a total of 6,500,000 warrants for $27 million, with the option to repurchase the remaining warrants by December 31, 2025 [1] Company Overview - Scilex 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][4] - The company aims to address high unmet needs in the market with non-opioid therapies, enhancing 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 gout flare prophylaxis [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 lidocaine topical system for acute pain, which has completed a Phase 2 trial and also received Fast Track status [4] - SP-104, a low-dose naltrexone hydrochloride capsule for fibromyalgia treatment [4]
Scilex Holding Company Announces Closing of Previously Announced Initial Tranche Investment in Datavault AI
Globenewswire· 2025-09-26 19:57
Core Viewpoint - Scilex Holding Company has completed the initial tranche of a $150 million investment in Datavault AI Inc., acquiring 15 million shares at an effective price of $0.5378 per share, with potential for additional shares pending stockholder approval [1]. Company Overview - Scilex 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 in the market with its non-opioid therapies, aiming to improve patient outcomes [3]. Commercial Products - Scilex's commercial products include: - ZTlido® (lidocaine topical system) 1.8%, approved for neuropathic pain relief [3]. - ELYXYB®, an FDA-approved oral solution for acute migraine treatment [3]. - Gloperba®, the first liquid oral version of colchicine for gout flare prophylaxis [3]. 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 and received Fast Track status from the FDA [4]. - SP-103, a next-generation lidocaine topical system for acute pain, recently completed a Phase 2 trial and has also received Fast Track status [4]. - SP-104, a low-dose naltrexone hydrochloride for fibromyalgia treatment [4]. Investment Details - The initial tranche of the investment in Datavault AI Inc. involves the acquisition of 15 million shares, with the potential for up to 278,914,094 shares in total, subject to stockholder approval [1]. - The effective purchase price for the shares is $0.5378, with adjustments possible for stock splits [1].
ZYUS Life Sciences Activates First Clinical Site and Enrolls First Patient in Phase 2a UTOPIA-1 Cancer Pain Trial
Prnewswire· 2025-08-26 11:00
Phase 2a trial designed to investigate the safety and preliminary analgesic efficacy of Trichomylin® softgel capsules SASKATOON, SK, Aug. 26, 2025 /PRNewswire/ - ZYUS Life Sciences Corporation (the "Company") (TSXV: ZYUS), a clinical-stage life sciences company focused on the development and commercialization of novel non-opioid drug candidates for pain management, today announced the activation of the Centre Hospitalier de l'Université de Montréal ("CHUM") as first clinical site in its Phase 2a UTOPIA-1 (U ...
Zynex(ZYXI) - 2025 Q2 - Earnings Call Transcript
2025-07-31 21:15
Financial Data and Key Metrics Changes - Net revenue for Q2 2025 was $22.3 million, a significant decline from $49.9 million in Q2 2024, primarily due to TRICARE's temporary payment suspension and reduced order growth [24][11] - Gross profit was $15.2 million, representing 68% of revenue, compared to $39.9 million or 80% of revenue in the same quarter last year [24] - Net loss was $20 million, or $0.66 per share, compared to a net income of $1.2 million in Q2 2024, with a noncash charge of $10.3 million related to deferred tax assets included in the loss [25][11] - Adjusted EBITDA loss for Q2 2025 was $8.9 million, compared to an adjusted EBITDA of $3.5 million in Q2 2024 [26] Business Line Data and Key Metrics Changes - Device revenue was $11 million, while supplies revenue was $11.3 million, indicating a decline in both segments due to the payment suspension and sales force reductions [24] - Sales and marketing expenses decreased by 45% to $12.8 million, primarily due to headcount reductions aimed at improving sales rep productivity [25] - General and administrative expenses were $12.7 million, down from $14.5 million in the previous year [25] Market Data and Key Metrics Changes - The company is actively working to diversify its revenue streams and reduce reliance on TRICARE, which has seen a reduction in patient inflow due to the payment suspension [10][36] - The patient monitoring market is estimated to be approximately $3.5 billion globally, with the company aiming to enter this market with its new Nico pulse oximeter technology [22] Company Strategy and Development Direction - The company is refocusing its pain management business model, restructuring its sales force, and streamlining operations to improve efficiency and reduce costs, targeting an annual savings of up to $40 million [5][13] - The new CEO, Steven Dyson, is expected to lead a review of the company's forecasting procedures and align strategies for growth [6][28] - The company aims to improve patient outcomes by providing non-opioid alternatives for pain management and enhancing the accuracy of patient monitoring through innovative technologies [29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about returning to positive cash flow by the end of the year, despite current challenges [5][12] - The company is committed to improving its operational sustainability and patient care, while navigating the complexities of the reimbursement landscape [14][29] - Management acknowledged the ongoing challenges with TRICARE but emphasized the importance of continuing to service existing patients [10][50] Other Important Information - The company has submitted its Nico pulse oximeter to the FDA, with expectations for a six-month clearance process following an additional information request [22][33] - The company is actively cooperating with TRICARE and advocating for the resolution of the payment suspension [9][10] Q&A Session Summary Question: Update on Nico submission and expected approval timeline - The company expects to receive additional questions from the FDA in August and anticipates clearance closer to December [32][33] Question: TRICARE payment suspension and patient referrals - The company continues to service existing and new TRICARE patients despite the payment suspension, although patient inflow has decreased due to reduced sales rep headcount [36][50] Question: Sales and marketing expenses outlook for the second half of the year - Continued reductions in sales and marketing expenses are expected, with a projected decrease of 15-20% in Q3 [37][38] Question: Nature of FDA data request and preparation - The FDA is focused on ensuring the new technology performs as well as or better than existing LED technology, and the company is prepared to respond quickly to any inquiries [41][42] Question: Future initiatives under the new CEO - The new CEO is aligned with the company's initiatives to refocus on pain management and improve overall company valuation [43]
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]
Pacira BioSciences Inc (PCRX) 2025 Conference Transcript
2025-06-04 13:47
Summary of Pacira BioSciences Inc (PCRX) Conference Call Company Overview - Pacira BioSciences is a leader in non-opioid pain management therapies, with market-leading products including EXPAREL for post-operative pain, ZILRETTA (the only long-acting FDA-approved steroid lasting up to three months), and ioverao (a cryoneurolysis device) [3][4] Core Points and Arguments - **EXPAREL Settlement**: A recent positive settlement regarding EXPAREL provides total exclusivity until February 2030, followed by a volume-limited market share for generics until February 2039. This settlement removes stock overhang and ensures substantial cash flows for reinvestment [10][11] - **Market Growth Potential**: The company believes there is significant room for growth in the market for EXPAREL, as it remains underpenetrated with a total addressable market (TAM) still in the high single digits [15] - **No Pain Act**: The No Pain Act, effective January 1, 2025, allows for additional reimbursement for innovative products like EXPAREL, which could positively impact the company’s revenue. Approximately 6 million out of 18 million procedures annually are covered under CMS [21][22][26] - **Commercial Payer Adoption**: There is an encouraging trend of commercial payers beginning to adopt policies similar to CMS, which is expected to enhance market penetration over time [26][30] - **Gross Margin Expansion**: The company aims to expand gross margins by five percentage points by 2030, aided by the cessation of low single-digit royalties on EXPAREL and increased manufacturing efficiency [36][37][41] Other Important Content - **Five by 30 Strategy**: The company has outlined a strategic plan to treat over 3 million patients, achieve double-digit growth, expand gross margins, develop five novel programs, and establish partnerships by 2030 [41][45] - **PCRX-201 Development**: The company is optimistic about PCRX-201, a gene therapy for osteoarthritis, citing compelling data and a favorable local delivery method. A Phase 2 study is underway, with results expected by the end of next year [60][62][64] - **Partnership Opportunities**: The company is exploring partnerships to expand its market reach, particularly outside the U.S., and to enhance its product offerings through synergistic sales strategies [46][50][54] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic direction, market opportunities, and product developments.