N2OFF via Solterra Expands European Footprint with Entry into Fourth Project – a Battery Storage Venture in Poland
GlobeNewswire· 2025-05-09 11:45
N2OFF to take part in financing a 35MW/140MWh planned Battery Energy Storage System project in Poland Neve Yarak, Israel, May 09, 2025 (GLOBE NEWSWIRE) -- N2OFF, Inc.(NASDAQ: NITO) (FSE:80W) (“N2OFF” and the “Company”), a clean tech company engaged in sustainable solutions for energy and innovation for agri- tech, announced Solterra’s entry into the Polish renewable energy market by participating in the financing of a Battery Energy Storage System (BESS) project in Poland. The project, currently planned at ...
Cognition Therapeutics Presented Data at Association for Research in Vision and Ophthalmology Showing Impact on Retinal Cell Health
GlobeNewswire· 2025-05-09 11:30
PURCHASE, N.Y., May 09, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported preclinical data this week at the Association for Research in Vision and Ophthalmology (ARVO) showing the potential for zervimesine (CT1812) to protect retinal pigment epithelial (RPE) cells from damage in dry age-related macular degeneration (dry AMD). "Dry AMD is driven by a number of factors that contribute to the death of ...
Spectral Medical Announces First Quarter and Provides Corporate Update
GlobeNewswire· 2025-05-09 11:30
Core Insights - Spectral Medical Inc. has completed enrollment for its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock, with topline results expected in August 2025 [1][2][3] - The company has entered into a promissory note agreement with Vantive for up to US$10 million to support PMX commercialization [1][9] Clinical Development - The Tigris trial has enrolled a total of 157 patients, with 151 evaluable patients and 100 treated with PMX [6] - The data lock for the trial is expected to be completed in approximately 90 days, with topline results anticipated two weeks post-data lock [6] - The company is on track to submit clinical results to the FDA by the end of October 2025 [6] Financial Performance - Revenue for Q1 2025 was $572,000, a decrease of 14% from $668,000 in Q1 2024 [10] - Operating expenses increased significantly to $13,174,000, up 173% from $4,825,000 in the prior year, primarily due to non-cash fair value adjustments [11] - The company reported a loss of $12,605,000 for Q1 2025, compared to a loss of $4,160,000 in Q1 2024 [13] Balance Sheet and Financing - As of March 31, 2025, the company had cash of $1,670,000, down from $2,988,000 at the end of 2024 [14] - The promissory note with Vantive includes a four-year maturity and a payment-in-kind interest rate of 9% [15] Commercialization Activities - The company is collaborating with Vantive on post-approval marketing plans for PMX commercialization [15] - Vantive intends to submit a 510(k) application for its PrisMax System, which is expected to be the primary device used for PMX treatments upon commercial launch [15] Regulatory and Clinical Study Insights - The EDEN study, completed in Q4 2023, showed that patients with endotoxic septic shock had a significantly higher mortality rate of 60% compared to 14.1% for other septic shock patients [6] - The results from the EDEN study will inform discussions with the FDA regarding PMX labeling and the addressable population in the U.S. [6]
PyroGenesis Schedules First Quarter 2025 Financial Results and Business Update Conference Call
GlobeNewswire· 2025-05-09 11:30
Core Viewpoint - PyroGenesis Inc. is set to host a conference call on May 14, 2025, to discuss its financial results for Q1 2025 and provide updates on company progress and developments [1]. Company Overview - PyroGenesis is a high-tech company specializing in advanced all-electric plasma processes and sustainable solutions aimed at supporting heavy industries in energy transition, emission reduction, commodity security, and waste remediation [1][3]. - The company has developed proprietary and patented plasma technologies that are being adopted by major industry players in four key markets: iron ore pelletization, aluminum, waste management, and additive manufacturing [3]. - PyroGenesis operates from its Montreal office and has manufacturing facilities of 3,800 m² and 2,940 m², maintaining a competitive edge through continuous technology development and commercialization [3]. - The company is ISO 9001:2015 and AS9100D certified, having been ISO certified since 1997 [3]. - PyroGenesis' shares are publicly traded on the TSX (TSX: PYR), OTCQX (OTCQX: PYRGF), and Frankfurt Stock Exchange (FRA: 8PY1) [3].
Plains All American Reports First-Quarter 2025 Results
GlobeNewswire· 2025-05-09 11:30
HOUSTON, May 09, 2025 (GLOBE NEWSWIRE) -- Plains All American Pipeline, L.P. (Nasdaq: PAA) and Plains GP Holdings (Nasdaq: PAGP) today reported first-quarter 2025 results and provided the following highlights: First-Quarter Results Reported net income attributable to PAA of $443 million and net cash provided by operating activities of $639 millionDelivered Adjusted EBITDA attributable to PAA of $754 millionExited the quarter with 3.3x leverage ratio, toward the low end of our target range of 3.25x - 3.75x ( ...
Transactions of Managers and Closely Associated Persons
GlobeNewswire· 2025-05-09 11:17
Attached is a copy of a filing with the Luxembourg Commission de Surveillance du Secteur Financier (CSSF) regarding transactions of managers and closely associated persons, announcing the acquisition at the market opening of 320,000 shares in Alvotech at ISK 1,255 per share, by Robert Wessman, Chairman and CEO. ...
Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial in the New England Journal of Medicine
GlobeNewswire News Room· 2025-05-09 11:11
Results support potential benefit of efruxifermin (EFX) to elicit fibrosis improvement in patients with compensated cirrhosis (F4 fibrosis) due to MASH 96-week data from SYMMETRY trial presented at EASL Congress 2025 SOUTH SAN FRANCISCO, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced publication of results from the ...
Clearside Biomedical Data Featured in Six Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting
GlobeNewswire· 2025-05-09 11:05
Strong Clinical Evidence Supports Use of the Suprachoroidal Platform in Expanding the Standard of Care for the Treatment of Multiple Macular DiseasesALPHARETTA, Ga., May 09, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that six presentations related to the Company’s lead program, CLS-AX (axitinib injectable ...
uniQure Announces First Quarter 2025 Financial Results and Highlights of Recent Company Progress
GlobeNewswire· 2025-05-09 11:05
~ AMT-130 granted Breakthrough Therapy designation by FDA ~ ~ Initial safety data from third cohort of Phase I/II study show AMT-130 continues to be generally well-tolerated, with no treatment-related serious adverse events ~ ~ Held Type B FDA meetings in the first and second quarters of 2025 to advance BLA preparations for AMT-130; regulatory update expected in the second quarter of 2025 ~ ~ AMT-260 clinical data from first patient to be presented at Epilepsy Therapies & Diagnostics Development Symposium o ...
Anika Reports First Quarter 2025 Financial Results
GlobeNewswire· 2025-05-09 11:05
First Quarter 2025 Commercial Channel revenue up 18% Integrity™ Implant System continues sequential growth and is on pace to more than double procedures in 2025 Key regulatory and clinical milestones achieved for Hyalofast®, Cingal®, and Integrity Updating Fiscal 2025 OEM Channel revenue guidance and Adjusted EBITDA guidance BEDFORD, Mass., May 09, 2025 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (Nasdaq: ANIK), a global leader in the osteoarthritis (“OA”) pain management and regenerative solutions spaces ...