Joshua Hare Joshua Hare, MD, FACC, FAHA, Co-Founder, Chief Science Officer and Executive Chairman, Longeveron MIAMI, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative cell therapy for life-threatening rare pediatric and chronic aging-related conditions, today announced that results of its Phase 2b clinical trial were published today in Cell Stem Cell, a Cell Press Journal. The Phase 2b results demonstrated that intravenous la ...

Core Viewpoint - Longeveron Inc. has appointed Stephen H. Willard as the new CEO, effective February 11, 2026, succeeding Than Powell, who served as interim CEO [1][2][5]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, particularly in life-threatening conditions affecting children and the elderly [3][5]. - The company's lead investigational product is laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [3]. Leadership Transition - Stephen H. Willard brings over 30 years of leadership experience in biotechnology and pharmaceuticals, having previously served as CEO for multiple firms [5]. - Than Powell will remain with the company to support the leadership transition and continue his work in business development activities [5]. Clinical Development - Longeveron is currently conducting a pivotal Phase 2b clinical trial for laromestrocel as a potential treatment for hypoplastic left heart syndrome (HLHS), with top-line results expected in the third quarter of 2026 [2][5]. - The company has received important FDA designations for its development programs, including Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the HLHS program [3][6].

Core Viewpoint - Longeveron Inc. has received a patent for the use of its proprietary mesenchymal stem cells (MSCs) to treat female sexual dysfunction, which is a significant unmet medical need affecting up to 46% of women, particularly as they age [1][3][8] Patent Information - The U.S. Patent No. 12,496,316 grants Longeveron patent rights until 2038, with potential for further extensions [2] - The patent covers methods for administering MSCs to improve sexual quality of life in female patients [8] Market Opportunity - Female sexual dysfunction is a common issue with limited treatment options, highlighting a substantial market opportunity for Longeveron's stem cell therapy [3][8] - The company plans to pursue licensing or partnership agreements for the development and commercialization of this therapy [4][8] Product Overview - Laromestrocel (LOMECEL-B) is derived from mesenchymal stem cells isolated from the bone marrow of young, healthy adult donors, and is designed to support the body's repair mechanisms [5][6] - The product has potential applications across various rare and aging-related diseases, with multiple mechanisms of action including anti-inflammatory and regenerative effects [5][6] Company Background - Longeveron is focused on developing regenerative medicines to address unmet medical needs, with a pipeline that includes treatments for hypoplastic left heart syndrome, Alzheimer's disease, and pediatric dilated cardiomyopathy [6]

Core Insights - BioRestorative Therapies, Inc. reported its third quarter financial results for 2025, highlighting strong clinical development and business momentum, with a focus on near- and mid-term value opportunities [2][9] Corporate Developments - The company anticipates a Type B meeting with the FDA regarding an accelerated Biologics License Application (BLA) for its BRTX-100 program aimed at treating chronic lumbar disc disease [4] - BioRestorative achieved a significant intellectual property milestone with the Japanese Patent Office granting a Notice of Allowance for its ThermoStem platform, which focuses on treating obesity and metabolic disorders [5] - The appointment of Crystal Romano as Head of Global Commercial Operations aims to accelerate growth in the cell-based product portfolio [6][8] Financial Highlights - For Q3 2025, the company reported revenues of approximately $11,800, a decrease from $233,600 in Q3 2024, primarily due to the timing of orders for BioCosmeceutical sales [9] - The loss from operations for Q3 2025 was $3.7 million, compared to $2.3 million in the same period of 2024, with a net loss of $3.0 million or $0.33 per share [10] - The company ended Q3 2025 with cash and equivalents of $4.5 million, excluding approximately $1.085 million from a recent financing [11] Business Strategy - The company is focused on executing its near-term revenue strategy within the BioCosmeceutical platform while advancing clinical stage programs, which represent multi-billion dollar market opportunities [2] - BioRestorative is developing cell-based therapies targeting obesity and metabolic disorders, utilizing brown adipose-derived stem cells [14][15] - The company operates a commercial BioCosmeceutical platform, with plans to expand its offerings to include a broader range of cell-based aesthetic products [16]

Core Viewpoint - Longeveron Inc. is advancing its clinical programs, particularly laromestrocel, with significant progress in treating life-threatening pediatric and chronic conditions, aiming for pivotal trial results in 2026 and potential FDA approval thereafter [2][10]. Development Programs Update - Longeveron's lead investigational product, laromestrocel (Lomecel-B), is being evaluated for multiple indications, including Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease, and Pediatric Dilated Cardiomyopathy (DCM) [3][4][5]. - The pivotal Phase 2b clinical trial (ELPIS II) for HLHS is fully enrolled with 40 pediatric patients, and top-line results are expected in Q3 2026 [9][10]. - Laromestrocel has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA for HLHS, and RMAT and Fast Track designations for Alzheimer's disease [10][15]. Financial Results Summary - For the nine months ended September 30, 2025, revenues decreased by 53% to $0.8 million compared to $1.8 million in 2024, primarily due to reduced demand for clinical trials and contract manufacturing services [14]. - General and administrative expenses increased by 22% to approximately $9.1 million, while research and development expenses rose by 52% to approximately $9.3 million [14]. - The net loss for the nine months ended September 30, 2025, increased to approximately $17.3 million, up from $11.9 million in the same period in 2024 [14][22]. Corporate Updates - The company appointed Than Powell as Interim CEO and announced key leadership changes, including Dr. Joshua Hare as Executive Chairman [14]. - Longeveron completed a public offering in August 2025, raising approximately $5.0 million, with potential additional proceeds of up to $12.5 million [14]. - The company is seeking strategic collaborations and partnerships to advance laromestrocel in treating Alzheimer's disease [10][14].

Core Insights - Karolinska Development AB has invested SEK 7.5 million in BOOST Pharma's financing round, which totals SEK 15 million, aimed at advancing the clinical development of BT-101 for osteogenesis imperfecta [1][3][4] Company Overview - BOOST Pharma is a clinical-stage biopharmaceutical company focused on developing BT-101, a mesenchymal stem cell therapy for infants with osteogenesis imperfecta, a condition that leads to fragile bones and frequent fractures [2][3] - The financing will help BOOST Pharma accelerate its clinical program and work towards providing the first disease-modifying therapy for osteogenesis imperfecta [2] Clinical Development - Following positive results from the Phase 2 BOOSTB4 study, which showed a reduction in fracture rate of over 75% in children treated with BT-101, BOOST Pharma is preparing for a pivotal Phase 3 trial [3] - The BOOSTB4 trial demonstrated that BT-101 was safe and well-tolerated [3] Investment and Ownership - Karolinska Development holds a 14% ownership stake in BOOST Pharma, reflecting its commitment to supporting the development of innovative therapies [4]

Core Insights - Longeveron Inc. is advancing its clinical-stage cellular therapy, laromestrocel, aimed at treating hypoplastic left heart syndrome (HLHS), a severe congenital heart defect [1][2][4] - The pivotal Phase 2b clinical trial, ELPIS II, has completed enrollment, with top-line results expected in Q3 2026 [2][7] - Laromestrocel has shown promising results in previous trials, achieving 100% transplant-free survival up to five years of age compared to a historical mortality rate of approximately 20% [4] Company Overview - Longeveron Inc. focuses on developing regenerative medicines for unmet medical needs, with laromestrocel as its lead investigational product [5] - The company is pursuing multiple indications, including HLHS, Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [5] - Laromestrocel has received several FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, and RMAT designation for Alzheimer's disease [5] Clinical Trial Details - ELPIS II is a pivotal trial conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) and supported by NIH grants [4] - The trial aims to evaluate laromestrocel's efficacy as an adjunct treatment for HLHS, a rare pediatric disease [7] - The FDA has confirmed that successful results from ELPIS II could lead to a Biologics License Application (BLA) submission for full approval [4]

Core Insights - Ocumetics Technology Corp. is participating in the 2025 Maxim Growth Summit, highlighting its role as a leader in advanced ophthalmic technology [1][2] - The company is currently in the early feasibility study phase for a revolutionary intraocular lens designed to provide clear vision at all distances without corrective lenses [5] Company Overview - Ocumetics Technology Corp. is a Canadian research and product development company focused on advanced vision correction solutions aimed at enhancing patients' quality of life [4] - The company is dedicated to transforming ophthalmology through innovative research and development of state-of-the-art intraocular lenses and other vision-enhancing technologies [4] Event Participation - Dean Burns, President and CEO of Ocumetics, will participate in a panel titled 'A vision of Innovation' at the Maxim Growth Summit [2] - The summit will feature keynote speakers and roundtable discussions covering various topics, including biotechnology and ophthalmology [3] Technology Development - Ocumetics is developing an intraocular lens that fits within the natural lens compartment of the eye, potentially eliminating the need for glasses or contact lenses [5] - The lens is designed to utilize the eye's natural muscle activity to shift focus, providing clear vision at all distances [5]

Core Insights - BioRestorative Therapies, Inc. is participating in the 2025 Maxim Growth Summit on October 22nd to 23rd, focusing on regenerative medicine and stem cell therapies [1][2] - The company's management will engage in a panel discussion on stem cell therapy and hold one-on-one meetings with institutional investors [2] Company Overview - BioRestorative develops therapeutic products utilizing adult stem cells, with two main clinical programs targeting disc/spine disease and metabolic disorders [3] - The lead candidate, BRTX-100, is designed for non-surgical treatment of lumbosacral disc disorders, currently in Phase 2 clinical trials for chronic lower back pain [3] - The Metabolic Program, ThermoStem, focuses on using brown adipose-derived stem cells to combat obesity and metabolic disorders, with promising preclinical results [4] - The company also operates a BioCosmeceutical platform, offering a cell-based secretome product aimed at cosmetic improvements, with plans for further product development [5]

Core Viewpoint - Visionary Holdings Inc. has entered into a Global Product and Technology Licensing Agreement with Jiangsu Yike Regenerative Medicine Co., Ltd. to utilize Yike's stem cell technology for diabetes treatment and other regenerative medicine innovations [1][4]. Group 1: Agreement Details - The agreement allows Visionary Holdings to use Yike's proprietary regenerative medicine technology platform and focus on commercialization and clinical applications in areas such as stem cell therapy and cellular rejuvenation [2]. - Revenue-sharing will be based on actual product sales and technology commercialization, with Yike generating revenue from technology licensing and clinical R&D, while Visionary Holdings will benefit from market sales and global business development [3]. Group 2: Market Potential - Diabetes affects over 540 million adults globally, with the treatment market projected to exceed USD 150 billion in 2024, indicating significant growth potential [4]. - Existing diabetes therapies primarily manage symptoms rather than providing a cure, highlighting the importance of Yike's stem cell therapy, which has shown potential for long-term remission and complete cure [4]. Group 3: Future Plans - Visionary Holdings and Yike plan to deepen cooperation in product R&D, clinical validation, and international market expansion, while exploring global certification standards for regenerative medical products [5]. - The collaboration aims to deliver transformative medical solutions and significantly contribute to Visionary Holdings' revenue growth in the upcoming fiscal years [5]. Group 4: Company Overview - Visionary Holdings Inc. is a technology-driven multinational enterprise focused on innovative education, AI applications, and high-tech healthcare solutions, headquartered in Toronto, Canada [6].