PALO ALTO, Calif., Oct. 01, 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, today announced that it has repurchased 3,130,000 warrants to purchase shares of Scilex common stock having an exercise price of $0.01 per share (“Warrants”) from Oram ...

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].

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 ...

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]

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]

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.

Summary of Pacira BioSciences Inc (PCRX) 2025 Conference Company Overview - **Company**: Pacira BioSciences Inc (PCRX) - **Focus**: Non-opioid innovative pain management therapies, primarily through products like EXPAREL, ZILRETTA, and ioverao [4][16] Core Points and Arguments - **Sales Performance**: The company generated over $700 million in sales in 2025, indicating a strong cash flow [4] - **Pipeline Development**: The lead product in the pipeline is PCRX201, aimed at transforming treatment for osteoarthritis of the knee and potentially other joints [5] - **5x30 Strategy**: The company aims to achieve five key objectives by 2030: 1. Help over 3 million patients (currently around 2.4 million) [10] 2. Achieve double-digit growth, moving from historical low single digits [11] 3. Expand margins by at least five percentage points [11] 4. Develop five novel projects by 2030, with PCRX201 as the lead [12] 5. Establish five partnerships for commercialization and development [13] Recent Developments - **Litigation Settlement**: A significant settlement regarding Paragraph IV litigation around EXPAREL provides visibility until 2039, alleviating previous stock overhang concerns [7][18] - **Market Dynamics**: EXPAREL's average daily sales grew by 7% in the first quarter, contrasting with previous low single-digit growth [24] - **Sales Force Reorganization**: Transitioned to three separate sales forces for each product to enhance focus and execution [25] Commercial Strategy - **No Pain Initiative**: The company is seeing early adoption in smaller community settings and ambulatory surgical centers, with expectations for broader uptake in larger health systems [29] - **Reimbursement Dynamics**: Encouraging signs of commercial payer adoption are emerging, with a focus on aligning with CMS reimbursement strategies [32] Pipeline Insights - **PCRX201**: The product shows promising data with 72 patients in Phase 1, demonstrating significant pain relief and durability [36][39] - **Gene Therapy Approach**: The company is exploring gene therapy with a focus on local administration, which may broaden the applicability of gene therapies beyond rare diseases [45] Additional Considerations - **Intellectual Property**: The company holds 19 Orange Book listed patents, enhancing its competitive position [19] - **Future Projects**: There are ongoing discussions about additional projects stemming from the newly acquired GQ Bio platform, emphasizing locally administered therapies [47] Conclusion - Pacira BioSciences is positioned for growth with a robust pipeline and strategic initiatives aimed at expanding its market presence and improving patient outcomes through innovative pain management solutions [48]