Core Insights - Invivyd, Inc. is entering a transformative phase with a focus on VYD2311 as a promising alternative to COVID-19 vaccination, supported by recent clinical trial data [2][5][7] - The company reported a significant year-over-year increase in net product revenue for PEMGARDA, reaching $11.8 million in Q2 2025, representing a 413% growth [5][9] - Despite not meeting the near-term profitability target for the first half of 2025, Invivyd remains optimistic about achieving profitability with the upcoming respiratory virus season [5][9] Recent Business Highlights - The company is actively designing clinical and go-to-market strategies for VYD2311, which has shown an attractive safety profile and pharmacokinetics in Phase 1/2 trials [2][5] - Invivyd anticipates identifying a best-in-class RSV candidate in Q3 2025 and a preclinical measles candidate by the end of 2025 [2][5] Clinical & Regulatory Developments - Invivyd has aligned with the U.S. FDA on a rapid pathway to full approval for VYD2311, which aims to protect American adults and adolescents from COVID-19 [5][7] - The VYD2311 candidate demonstrated a 76-day observed half-life for intramuscular administration, indicating potential for long-term protection [5][6] Commercial Execution - PEMGARDA's uptake is increasing among healthcare providers for immunocompromised patients, supported by Invivyd's sales force and expanded field presence [6][10] - The product has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas [6] Financial Results - For Q2 2025, Invivyd reported a net loss of $14.7 million, a decrease from $47.2 million in Q2 2024, with a net loss per share of $0.12 [9][28] - Research and development expenses were $9.6 million for the quarter, down from $30.3 million in the same period of 2024, primarily due to reduced clinical trial costs [9][28] Pipeline Expansion - The company is exploring pipeline expansion beyond SARS-CoV-2, including potential targets like RSV and measles [11][19] - Invivyd has formed the SPEAR Study Group to assess monoclonal antibody therapy effects for Long COVID and COVID-19 Post-Vaccination Syndrome [11][19]

Core Viewpoint - Invivyd, Inc. has received guidance from the U.S. FDA on a rapid pathway for Biologics License Application (BLA) approval for its monoclonal antibody candidate VYD2311, aimed at preventing COVID-19, which could provide an alternative to vaccines for the American population [1][2][3] Group 1: FDA Guidance and Clinical Trials - The FDA advised that a single Phase 2/3 randomized, double-blind, placebo-controlled trial could support a BLA submission for VYD2311, focusing on symptomatic COVID-19 events [1][3] - Invivyd plans to study two doses of VYD2311 to evaluate differences in protection levels and safety, aiming to provide more options for COVID-19 protection [2][4] - The primary endpoint for the trial is RT-PCR-confirmed symptomatic COVID-19, with a measurement timepoint expected at 12 weeks, and a potential longer duration of 24 weeks [3][4] Group 2: Product Profile and Market Position - VYD2311 is designed to be a low-dose, intramuscular, scalable, and cost-effective option for adults and adolescents, with potential expansion to pediatric populations [4][5] - The antibody is engineered to neutralize contemporary virus lineages and is based on a common molecular lineage with other successful Invivyd antibodies [2][8] - Invivyd's analysis suggests that VYD2311 may provide robust, long-term protection from symptomatic COVID-19 due to its high potency and long half-life of approximately 76 days [4][5] Group 3: Strategic Importance and Future Plans - The company emphasizes the importance of providing a non-vaccine choice for COVID-19 prevention amidst declining public trust in vaccines [2][3] - Invivyd has quantities of VYD2311 available for clinical supply and potential commercial launch, indicating readiness for market introduction if approved [6][8] - The company aims to finalize a pivotal clinical trial design with the FDA and is committed to advancing innovative solutions for COVID-19 prevention [6][3]

Core Insights - PetVivo Holdings, Inc. reported a significant increase in revenues for the first quarter of fiscal year 2026, with total revenues reaching $298,000, marking a 141% increase compared to the same period last year [5][27][29] - The company is expanding its market presence, particularly in the companion animal sector, and has initiated international sales through a distribution agreement in Mexico [10][11][20] Fiscal Q1 Financial Highlights - Revenues increased to $298,000, a 141% rise year-over-year, driven by product line expansion and increased sales force efforts [5][27] - Gross profit rose 69% to $187,000, with a gross margin of 63% [5][28] - Operating loss decreased by 9% to $1.8 million, attributed to strategic restructuring and cost reduction initiatives [5][29] - Net loss increased 13% to $2.3 million, or $(0.09) per share, due to higher non-cash expenses [5][29] - Cash reserves increased to $3.3 million from $228,000 at the end of the previous quarter, primarily due to financing activities [5][30] - Total liabilities decreased by 39% to $3.1 million, mainly due to lease terminations and modifications of convertible note terms [5][31] Fiscal Q1 Operational Highlights - The company signed a distribution agreement with Eq Especialidades to promote Spryng™ in Mexico, marking its first international market entry [5][20] - A strategic partnership with PiezoBioMembrane aims to develop innovative biomaterials for tissue regeneration [5][24] - Collaboration with Digital Landia focuses on integrating AI technology to enhance veterinary care through real-time analysis of animal behavior [5][17] - Sales and marketing efforts are ramping up for the commercialization of PrecisePRP, a new product for treating osteoarthritis in animals [5][14] - A partnership with Commonwealth Markets integrates Spryng® and PrecisePRP into care protocols for thoroughbred horses [5][21] Industry Outlook - The U.S. animal health market is projected to double to $11.3 billion by 2030, providing significant growth opportunities for PetVivo [5][26] - The veterinary healthcare market in Mexico is expected to grow at a compounded annual growth rate of 11% to reach $2.4 billion by 2031 [10]

Addison, TX, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MDB Capital Holdings, LLC, (NASDAQ: MDBH) (“MDB”), a public venture platform focused on launching category-leading disruptive technology companies, plans to host a Zoom webinar on Wednesday August 27, 2025 at 4:30 p.m. Eastern Time to provide a business update for the second quarter 2025. A press release detailing the results will be issued prior to the call. Christopher Marlett, CEO and Co-Founder of MDB will lead the call and may be joined by other members of ...

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 ...

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].

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 ...