Achieve Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
Globenewswire· 2026-03-24 11:00
Core Viewpoint - Achieve Life Sciences is advancing its cytisinicline program for nicotine dependence treatment, announcing a partnership with Adare Pharma Solutions for manufacturing, and is on track for a potential U.S. commercial launch in the first half of 2027 [1][3][4]. Company Developments - Achieve has made significant progress towards regulatory approval, with the FDA accepting the New Drug Application (NDA) for cytisinicline, targeting a PDUFA date of June 20, 2026 [4][8]. - The company completed the ORCA-OL long-term exposure trial with 334 participants, providing extensive safety data that exceeds FDA requirements [4]. - Cytisinicline has been selected for the FDA Commissioner's National Priority Voucher for e-cigarette cessation, which will facilitate expedited review [4][10]. Partnership and Manufacturing - The partnership with Adare Pharma Solutions aims to reduce risks associated with international pharmaceutical importation and lower costs, including potential tariffs [2][3]. - Achieve has begun technology transfer to Adare, enhancing supply chain redundancy and U.S.-based contingency capacity [3][4]. Financial Performance - As of December 31, 2025, Achieve reported cash, cash equivalents, and marketable securities totaling $36.4 million [6]. - Total operating expenses for Q4 2025 were $14.7 million, with a net loss of $14.7 million for the quarter and $54.7 million for the full year [6][17]. Clinical and Scientific Advancements - Achieve's clinical program demonstrates cytisinicline's potential to address nicotine dependence, with findings indicating efficacy regardless of prior treatment history [5][11]. - Recent data published in JAMA Internal Medicine reaffirm cytisinicline's efficacy and tolerability for smoking cessation [4][5].
Sanara MedTech Inc. Reports Fourth Quarter (Unaudited) and Full Year 2025 Financial Results; Reaffirmed Full Year 2026 Financial Guidance
Globenewswire· 2026-03-24 11:00
Core Viewpoint - Sanara MedTech Inc. reported strong financial results for the fourth quarter and full year of 2025, achieving over $100 million in net revenue for the first time, with a year-over-year growth of 19% [5][17]. The company reaffirmed its revenue guidance for 2026, expecting growth of 13% to 17% [21]. Financial Summary - Fourth quarter 2025 net revenue was $27.5 million, a 5% increase from $26.3 million in the fourth quarter of 2024, driven by a $1.2 million increase in soft tissue repair products and a $49,000 increase in bone fusion products [8][9]. - Full year 2025 net revenue reached $103.1 million, up from $86.7 million in 2024, marking a 19% increase, with soft tissue repair products growing by 20% and bone fusion products by 12% [17][19]. Profitability Metrics - Adjusted EBITDA for the fourth quarter of 2025 was $4.7 million, compared to $4.1 million in the fourth quarter of 2024 [15]. For the full year, adjusted EBITDA was $17.0 million, up from $9.1 million in 2024 [19]. - Gross profit for the fourth quarter of 2025 was $25.7 million, a 7% increase from $24.1 million in the fourth quarter of 2024, with a gross margin of 93% [11]. Operational Developments - The company announced a strategic realignment, classifying the operations of Tissue Health Plus as discontinued operations [3][7]. - Sanara plans to introduce the OsStic™ Synthetic Injectable Structural Bio-Adhesive to the U.S. market in Q1 2027, pending FDA clearance [9]. - The BIASURGE product received an Innovative Technology contract from Vizient, enhancing its market access [9]. Cash Flow and Debt - Net cash provided by operating activities in the fourth quarter of 2025 was $3.9 million, compared to $0.9 million in the fourth quarter of 2024 [15]. - As of December 31, 2025, the company had $16.6 million in cash and $46.0 million in long-term debt, compared to $15.9 million and $30.7 million, respectively, as of December 31, 2024 [15]. Future Guidance - The company reaffirmed its financial guidance for 2026, expecting net revenue to range from $116 million to $121 million, representing a growth of approximately 13% to 17% compared to 2025 [21].
PPHC Added to Russell 2000® and Russell 3000® Indexes
Globenewswire· 2026-03-24 11:00
Core Insights - Public Policy Holding Company, Inc. (PPHC) has been added to the Russell 2000® and Russell 3000® Indexes as of March 23, 2026, following its U.S. IPO on Nasdaq in January 2026 [2][3]. Company Overview - PPHC operates a portfolio of 12 advisory firms with approximately 450 employees, serving over 1,400 active clients across various sectors of the economy [3][7]. - The company provides strategic communications services, including government relations, public affairs, corporate communications, research and analytics, digital advocacy campaigning, and compliance support [6][8]. Market Impact - The inclusion in the Russell indexes is expected to enhance PPHC's exposure to institutional investors and index-linked capital, potentially improving trading liquidity over time [4]. - Approximately $10.6 trillion in assets are benchmarked to Russell's U.S. indexes, indicating the significance of this inclusion for PPHC [5].
Fennec Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Globenewswire· 2026-03-24 11:00
Core Insights - Fennec Pharmaceuticals achieved record annual revenue with net product sales of $44.6 million for the fiscal year 2025, reflecting a 50% year-over-year growth, and Q4 2025 net product sales of $13.8 million, representing a 75% increase over Q4 2024 [1][8][9] - The company executed a clinical data strategy to expand real-world validation of its product PEDMARK across new tumor types and patient populations through independent research [1][4] - Fennec reported strong patient enrollments and conversion rates in Q4 2025, indicating effective field execution and growing adoption of PEDMARK [1][3] - The company completed an oversubscribed equity offering of $42 million, enhancing its financial position [1][3] - Positive topline results were announced from a clinical study in Japan evaluating PEDMARK for reducing cisplatin-induced hearing loss [1][5] Financial Performance - For Q4 2025, net product sales were $13.8 million, up from $7.9 million in Q4 2024, marking a 75% increase [8][10] - Full-year net product sales reached approximately $44.6 million, compared to $29.6 million in 2024, a 50% increase [8][10] - Selling and marketing expenses for Q4 2025 were $6.1 million, up from $3.9 million in Q4 2024, primarily due to increased payroll and marketing efforts [8][10] - General and administrative expenses for Q4 2025 were $8.9 million, compared to $4.2 million in Q4 2024, driven by higher legal and payroll costs [8][10] - Cash and cash equivalents stood at $36.8 million as of December 31, 2025, reflecting a $10.2 million increase from the previous year [8][11] Business Highlights - Continued growth in key PEDMARK accounts, with increasing adoption among adolescent and young adult (AYA) patients across various tumor types [4][5] - Expansion of the field team to enhance customer engagement and support more cancer patients in protecting their hearing [4] - New real-world data presented at the 2026 Multidisciplinary Head and Neck Cancers Symposium indicated the safe administration of PEDMARK in adults with head and neck cancer [4][5] - Initiation of two institution-led clinical studies evaluating PEDMARK for preventing cisplatin-induced ototoxicity in adult cancer patients [4][5] Upcoming Events - Management will host one-on-one investor meetings at the Piper Sandler Spring Biopharma Symposium on April 15-16, 2026 [6]
American Shared Hospital Services Announces Fourth Quarter and Full Year Financial Results Conference Call
Globenewswire· 2026-03-24 11:00
Core Viewpoint - American Shared Hospital Services (AMS) is set to hold a conference call on March 31, 2026, to discuss its fourth quarter and full year 2025 financial results, with a press release to be issued before market opening on the same day [1][2]. Group 1: Conference Call Details - The conference call will take place at 12:00 PM ET on March 31, 2026 [1]. - Domestic callers can join by dialing 1-844-413-3972, while international callers can dial 1-412-317-5776 [3]. - A simultaneous webcast will be available on the company's website, and a replay of the call will be accessible until April 7, 2026 [3]. Group 2: Company Overview - AMS is a leading provider of turnkey solutions for cancer treatment centers, health systems, and cancer networks across North and South America [4]. - The company collaborates with partners to enhance cancer service lines and deliver integrated cancer care locally [4]. - AMS shares capital investment costs and profitability with health system partners based on ownership interests [4].
OTC Markets Group Welcomes Brixton Metals Corp. to OTCQX
Globenewswire· 2026-03-24 11:00
Group 1 - OTC Markets Group Inc. announced that Brixton Metals Corp. has qualified to trade on the OTCQX Best Market, upgrading from the OTCQB Venture Market [1][3] - Brixton Metals Corp. begins trading on OTCQX under the symbol "BBBXF," providing U.S. investors access to current financial disclosures and real-time quotes [2] - The OTCQX Market is designed for established companies that meet high financial standards and corporate governance practices, marking a significant milestone for companies transitioning from OTCQB [3] Group 2 - Brixton Metals Corp. is a Canadian exploration company focused on advancing its mining projects, owning four exploration projects including the flagship Thorn copper-silver-molybdenum Project [4] - The company has optioned its Hog Heaven Project to Ivanhoe Electric Inc. and its Atlin Goldfields Project to Eldorado Gold Corporation, while also holding the Langis and HudBay silver Projects in Ontario [4] - OTC Markets Group Inc. operates regulated markets for trading 12,000 U.S. and international securities, providing efficient access to U.S. financial markets [5]
Rezolute Provides Update on its Congenital Hyperinsulinism Program Following FDA Meeting
Globenewswire· 2026-03-24 11:00
Core Viewpoint - The FDA has encouraged Rezolute, Inc. to submit comprehensive data from the sunRIZE study and the ongoing open-label extension to inform the next steps for the program regarding the treatment of congenital hyperinsulinism with ersodetug [1][9]. Group 1: Study Outcomes - The sunRIZE study demonstrated reductions in hypoglycemia events from baseline, but did not meet its primary endpoint due to lack of statistical significance compared to placebo, which the company attributes to a pronounced study effect [2]. - Consistent and clinically significant improvements in time in hypoglycemia were observed via continuous glucose monitoring (CGM), although nominal statistical significance was not achieved at the pre-specified Week 24 end-of-treatment period [3]. - Summary results presented to the FDA included evidence of pharmacologic activity, consistent improvements in CGM-based glycemic endpoints, and preliminary favorable observations from the ongoing open-label extension [4]. Group 2: FDA Interaction - The FDA acknowledged the challenges posed by behavioral factors affecting clinical trials in this heterogeneous patient population and the limitations of self-monitored blood glucose metrics in measuring hypoglycemia [5][6]. - The agency reiterated the expectation for adequate and well-controlled studies as the standard for evaluating substantial evidence of efficacy for new therapies [7]. - The FDA expressed interest in the outcomes from the pivotal portion of the sunRIZE trial and plans to review the submitted study reports and analysis datasets for independent evaluation [9]. Group 3: Company Statements - The CEO of Rezolute expressed encouragement from the FDA meeting, noting that the agency did not dismiss the sunRIZE study outright despite not meeting its primary endpoint [10]. - The CEO of Congenital Hyperinsulinism International highlighted the importance of the open dialogue between the FDA and Rezolute, reflecting progress toward new treatment options for patients [11]. - Rezolute is focused on making ersodetug available to patients and families in need, emphasizing the commitment to advance meaningful improvements in care [11]. Group 4: Product Information - Ersodetug is a fully human monoclonal antibody designed to decrease receptor over-activation by insulin and related substances, potentially treating hypoglycemia due to any form of hyperinsulinism [12]. - Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, with ersodetug being studied in clinical trials for both congenital and tumor-related HI [13].
Troilus Completes Basic Engineering and Advances Detailed Engineering as Project Execution Readiness Accelerates
Globenewswire· 2026-03-24 11:00
Core Insights - Troilus Mining Corp. is advancing its copper-gold Troilus Project in Québec, having completed Basic Engineering and progressing to Detailed Engineering, which supports procurement and construction planning [2][10]. Project Execution Progress Highlights - The company is moving decisively from project definition to execution, with engineering advancements occurring alongside contractor integration and technical validation [4]. - A comprehensive geotechnical investigation program is ongoing to refine foundation design and enhance schedule and cost certainty [6]. - Additional metallurgical and process optimization tests are validating plant design assumptions, aiding in equipment sizing and operational planning [7]. - An integrated EPCM structure has been formalized with BBA Consultants and EBC Inc., enhancing execution coordination and reducing interface risk [8][9]. Organizational Strengthening and Construction Preparation - The senior project and operational leadership team has been significantly strengthened, with key appointments including Denis Rivard as EVP Projects, who has over 40 years of experience in global project leadership [13][15]. - Construction planning activities are progressing, including early engagement with regional and Indigenous contractors and suppliers [16]. Current and Upcoming Site Activities - Dewatering of the J Pit has been completed, and preparations are underway for the Z87 Pit [17]. - The accommodation facility is being expanded from 80 to approximately 200 personnel to support ongoing engineering and future construction [18]. - Site upgrades are in progress, including road improvements and enhancements to power infrastructure and communication systems [19].
Outlook Therapeutics Announces Pricing of $5.0 Million Public Offering
Globenewswire· 2026-03-24 11:00
Core Viewpoint - Outlook Therapeutics, Inc. has announced a public offering of 20,000,000 shares of common stock at a price of $0.25 per share, aiming to raise approximately $5.0 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The public offering includes 20,000,000 shares of common stock and warrants to purchase an additional 20,000,000 shares, with each warrant having an exercise price of $0.25 and expiring five years from issuance [1]. - The offering is expected to close on or about March 25, 2026, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for working capital and general corporate purposes [2]. Group 3: Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) to improve the standard of care for retinal diseases [5]. - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for the treatment of wet AMD, with commercial launch initiated in Germany, Austria, and the UK [5]. - In the U.S., ONS-5010/LYTENAVA™ is currently investigational and, if approved, would be the first ophthalmic formulation of bevacizumab for retinal indications [6].
NRx Pharmaceuticals (Nasdaq:NRXP) Reports Full-Year 2025 Results and Highlights Key Regulatory and Commercial Progress
Globenewswire· 2026-03-24 11:00
Core Insights - NRx Pharmaceuticals has made significant progress in advancing two lifesaving drugs towards FDA approval, aiming to initiate commercial operations by the end of 2026 [2] - The company ended 2025 debt-free and attracted long-term investors, reflecting confidence in its mission [2] - NRx has opened its first HOPE Therapeutics Clinics, demonstrating the positive impact of coordinated neuroplastic care on patients suffering from depression, PTSD, and suicidality [2] Financial Performance - For the year ended December 31, 2025, NRx Pharmaceuticals reduced its loss from operations by approximately $2.3 million to $16.2 million from $18.5 million in 2024, primarily due to decreased research and development expenses [5] - Research and development expenses decreased by approximately $2.4 million to $3.8 million compared to $6.2 million in 2024, driven by reduced clinical trial costs [5] - General and administrative expenses decreased by approximately $0.4 million to $13.1 million from $13.5 million in 2024, attributed to ongoing cost reduction initiatives [5] Operational Developments - NRx anticipates FDA approval of at least one new drug, Preservative Free Ketamine, under an ANDA during Q3 2026, following a favorable preliminary bioequivalence determination from the FDA [3] - The company has filed an Investigational New Drug application to study NRX-101 for enhancing Transcranial Magnetic Stimulation (TMS), supported by non-dilutive governmental funding [3] - NRx is developing a sustained-release formulation of D-cycloserine to enhance TMS efficacy, with prior trials showing a doubling of clinical response in depression patients [3] Strategic Partnerships and Growth - NRx has established a nationwide partnership with neurocare AG to develop a network of clinics providing psychiatrist-led neuroplastic therapy, currently operating at 20 sites with over 400 TMS machines [3] - The company expects to significantly increase its revenue-generating footprint in 2026 through its interventional psychiatry clinics [3] - NRx is focused on developing interventional psychiatry centers that utilize neuroplastic therapies for severe depression and PTSD, with future applications for other conditions [3]