FDA Discussions & Roluperidone Update - The FDA has confirmed that Minerva Neurosciences must conduct an additional confirmatory clinical trial for roluperidone to address deficiencies cited in the Complete Response Letter received in February 2024 [3][4] - The trial will focus on patients diagnosed with schizophrenia who have impairing negative symptoms and stable positive symptoms, with a target of enrolling 25-30% of patients from the USA [4] - The primary endpoint of the trial will be the change from baseline in the PANSS Marder negative symptoms factor score at 12 weeks of treatment [4][5] - The FDA has indicated that a resubmission of the NDA could be considered if it includes a double-blind, placebo- or active-controlled trial lasting at least 52 weeks [4][6] Financial Results - For Q2 2025, research and development expenses were $1.3 million, down from $3.9 million in Q2 2024, primarily due to lower costs associated with drug substance validation and consultant fees [7] - General and administrative expenses for Q2 2025 were $2.1 million, compared to $2.4 million in Q2 2024, reflecting lower professional service fees [8] - The net loss for Q2 2025 was $3.3 million, or a net loss per share of $0.43, compared to a net loss of $8.2 million, or $1.09 per share, in Q2 2024 [10][17] Cash Position - As of June 30, 2025, the company had approximately $15.3 million in cash and cash equivalents, down from $21.5 million at the end of 2024 [11][16] Review of Strategic Alternatives - In light of the confirmatory study requirement and current cash position, the company is exploring strategic alternatives to maximize shareholder value [12]

NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- XWELL, Inc. (Nasdaq: XWEL) ("XWELL" or the "Company"), a leading provider of wellness solutions for people on the go, today announced results for the second quarter ended June 30, 2025. From providing critical biosecurity support to building tech-forward wellness spaces in transportation hubs and local communities, XWELL currently is on a growth trajectory. Through its portfolio of in-airport and off-airport brands, the Company is reimagining what it means to acce ...

Core Viewpoint - Callan JMB Inc. has made significant strides in expanding its logistics services for the healthcare sector, including forming strategic partnerships, launching international operations, and enhancing emergency preparedness capabilities, positioning itself for sustained growth in high-demand markets [2][3]. Business Highlights - A strategic partnership was formed with Revival Health Inc. to create an integrated supply chain infrastructure for health, wellness, and longevity products, enhancing distribution capabilities [2][3]. - The company launched a subsidiary in India, establishing a temperature-controlled warehouse in Pune for pharmaceutical storage and distribution, and has secured agreements with local companies to facilitate U.S. market entry [2][3]. - Callan JMB extended its emergency preparedness contract with the City of Chicago through June 2026, increasing total contract value to $9.1 million with an additional $1.5 million in funding [2][3]. - Christopher Shields was appointed as Senior Vice President for Emergency Preparedness & Response/Government Affairs to expand operations into new markets [2][3]. - The company successfully redistributed over 1,300 MMR II vaccine doses during a measles outbreak response, demonstrating its logistical efficiency and sustainability [2][3]. Financial Highlights - For the three months ended June 30, 2025, revenues were $1.7 million, a decrease from $2.0 million in the same period last year, attributed to reduced demand for emergency preparedness services [8][10]. - Gross profit for the same period was $0.6 million, down from $1.0 million year-over-year [8][11]. - Selling, general, and administrative expenses increased to $2.0 million for the quarter, primarily due to costs associated with being a public entity and new senior staff hires [8][11]. - The net loss for the three months ended June 30, 2025, was $1.4 million, compared to a loss of $0.1 million in the prior year [8][11]. - Cash and cash equivalents as of June 30, 2025, were $4.2 million, an increase from $2.1 million at the end of the previous year [8][13].

FREMONT, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Actelis Networks, Inc. (NASDAQ: ASNS) ("Actelis" or the "Company"), a market leader in cyber-hardened, rapid deployment networking solutions for IoT and broadband applications, today reported financial results for the second quarter ended June 30, 2025. "We navigated a dynamic market environment in the second quarter, while laying the groundwork for improved growth ahead, primarily in our Federal and Military verticals where we are awaiting sizeable busines ...

Operating cash flow grew 22% in the first half of the year Company reaffirms projected 2025 revenue of $30–35 million and 28% EBITDA margin Conference call today at 5:00 pm ET to discuss results DENVER, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Intermap Technologies (TSX: IMP; OTCQB: ITMSF) (“Intermap” or the “Company”), a global leader in 3D geospatial intelligence solutions, today announced its financial results for the three months ended June 30, 2025. Second quarter revenue declined year over year from $3.6 mil ...

Core Viewpoint - Sonder Holdings Inc. announced the resignation of Chief Financial Officer Michael Hughes, effective August 15, 2025, while the search for a new CEO is ongoing, with expectations to appoint a permanent successor by the end of 2025 [1][2]. Company Overview - Sonder is a leading global brand offering premium, design-forward apartments and boutique hotels, catering to modern travelers since its launch in 2014 [2]. - The company operates in over 40 markets across nine countries and three continents, providing tech-enabled services and self-service features through the Sonder app [2]. Leadership Transition - The interim CEO, Janice Sears, expressed gratitude for Michael Hughes' contributions and emphasized the importance of identifying world-class executives to maximize Sonder's growth potential [2]. - The new CEO will be actively involved in the search for a new CFO as part of the long-term leadership succession plan [1][2].

Core Viewpoint - Beam Global reported a successful second quarter in 2025, achieving revenue growth and the highest GAAP Gross Margin in its history, while expanding its global market presence through the establishment of Beam Middle East [4]. Financial Highlights - Revenues for Q2 2025 were $7.1 million, a 12% increase from Q1 2025 [5]. - 60% of revenues for the first half of 2025 came from commercial customers, with 37% from international operations [5][6]. - GAAP Gross Margin was 20% for Q2 2025, up 4 percentage points from Q2 2024, while adjusted non-GAAP Gross Margin was 30%, a 12 percentage point increase from the previous year [5][7]. - Operating costs decreased by $1.2 million, or 17%, compared to Q2 2024 [8]. - The net loss for Q2 2025 was $4.3 million, an improvement from $4.9 million in Q2 2024 [9]. Recent Operational Highlights - Beam Global established Beam Middle East LLC, a joint venture to sell and manufacture products in the Middle East and Africa [5]. - The company shipped products to 13 U.S. states and multiple European countries, including Serbia, Romania, and Croatia [5]. - Beam Global received a Sustainability Award for Innovation in Infrastructure at the 2025 Romanian Mayors Congress [5]. - The company expanded its energy storage systems business, securing contracts totaling $2.5 million with defense customers [5]. Cash Position - As of June 30, 2025, Beam Global had cash of $3.4 million, an increase from $2.5 million at the end of Q1 2025 [10]. - The company remains debt-free with a $100 million line of credit available and unused [5]. Company Overview - Beam Global is a clean technology innovator focused on sustainable energy infrastructure and electric vehicle charging solutions, with operations in the U.S., Europe, and the Middle East [15]. - The company develops and manufactures advanced clean technology solutions aimed at enhancing energy security and supporting smart city initiatives [15].

– Well-tolerated safety profile and robust broad-spectrum efficacy sustained over 1-year across all symptom domains including negative symptoms in open label extension (OLE) 1-year trial– – Successful completion of two large randomized double-blind clinical trials, including one Phase 2 and one Phase 3 trial, a 1-year OLE trial, and clinical pharmacology studies designed to support filing of New Drug Application (NDA) – – Planned meeting with Food and Drug Administration (FDA) to discuss brilaroxazine’s pat ...

Breton Hill by Toll Brothers will feature only 13 new homes on up to one-acre home sites with serene views in historic Warwick TownshipFORT WASHINGTON, Pa., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Toll Brothers, Inc. (NYSE:TOL), the nation’s leading builder of luxury homes, today announced its newest Bucks County community, Breton Hill by Toll Brothers, is coming soon to Warwick Township, Pennsylvania. Site work is underway, and the community is expected to open for sale in late 2025. Located in sought-after Warw ...

Core Insights - Eledon Pharmaceuticals reported positive data from an ongoing Phase 1b trial of tegoprubart, showing a mean 12-month estimated glomerular filtration rate (eGFR) of approximately 68 mL/min/1.73 m for kidney transplant patients, significantly higher than the historical mean of 53 mL/min/1.73 m with standard care [1][3] - The company is on track to release topline results from the Phase 2 BESTOW trial in kidney transplantation in November 2025 [1][10] - Eledon has a cash position of $107.6 million as of June 30, 2025, which is expected to fund operations through the end of 2026 [1][5] Business Highlights - Eledon achieved key milestones in advancing tegoprubart for kidney, islet cell, and liver transplantation, as well as xenotransplantation [2] - Updated data presented at the World Transplant Congress indicated that tegoprubart was well tolerated with no severe adverse events reported [3] - The company announced the first three islet cell transplant recipients treated with tegoprubart at the University of Chicago, achieving insulin independence [3] Financial Results - Research and development expenses for Q2 2025 were $20.3 million, up from $10.1 million in Q2 2024 [6] - General and administrative expenses for Q2 2025 were $4.5 million, slightly higher than $4.4 million in Q2 2024 [7] - The net loss for Q2 2025 was $11.2 million, a significant reduction from a net loss of $44.9 million in Q2 2024 [7][16] Upcoming Milestones - The company plans to report topline results from the Phase 2 BESTOW trial in November 2025 [10] - Eledon will launch an investigator-initiated trial at Massachusetts General Hospital to evaluate tegoprubart for inducing donor-specific immune tolerance [10]