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Longeveron Inc. (LGVN)

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Previous Close7.65
Open7.21
Bid0.00 x 1400
Ask0.00 x 2200
Day's Range6.90 - 7.70
52 Week Range6.01 - 10.00
Volume288,485
Avg. Volume641,487
Market Cap137.683M
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  • Longeveron Announces Successful Completion of Phase 1 Clinical Study of Lomecel-B Intramyocardial Injection in Hypoplastic Left Heart Syndrome Patients
    GlobeNewswire

    Longeveron Announces Successful Completion of Phase 1 Clinical Study of Lomecel-B Intramyocardial Injection in Hypoplastic Left Heart Syndrome Patients

    Intramyocardial injection of Lomecel-B well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B reported Full results of the Phase 1 clinical trial expected to be released in Q2 2021 Phase 2 trial expected to commence in Q3 2021 MIAMI, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, is pleased to announce completion of the Company’s Phase 1 clinical study of Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell product manufactured under cGMP in Longeveron’s cell processing facility in Miami. The study was conducted by a consortium of leading pediatric cardiac surgeons at centers that included the University of Maryland Medical Center, University of Cincinnati/Children’s Hospital Medical Center and University of Utah Primary Children’s Hospital, and was supported in part by a Maryland Stem Cell Research Fund TEDCO Grant. The Phase 1, open-label single arm study was designed to assess safety and tolerability of intramyocardial injection of Lomecel-B administered to 10 children with HLHS during the Stage 2 bidirectional cavopulmonary anastomosis (BDCPA, or “Glenn procedure”) surgery. HLHS is a rare congenital heart defect that effects approximately 1,000 babies per year in the U.S. Babies with HLHS are born with an underdeveloped left ventricle, which impairs the heart’s ability to pump adequate amounts of blood throughout the body. Without a three-staged reconstructive surgery, the condition is often fatal. Even with surgery, HLHS is still associated with high mortality. Intramyocardial injection of Lomecel-B at doses of 2.5 × 105 cells/kg of body weight was shown to be well-tolerated, with no major cardiac events, and no serious adverse events reported that were considered to be related to the investigational therapy. The Phase 1 safety results have enabled Longeveron to advance its HLHS program into a Phase 2 multi-center trial, with a randomized, double-blind, placebo-controlled trial scheduled to begin in the third quarter of 2021. The Phase 2 trial which will study 32 patients nationwide is being funded by a $5.6M grant from the National Institute of Health’s National Heart, Lung and Blood Institute (NHLBI), and is led by Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery at Lurie Children’s Hospital of Chicago. The full results of the Phase 1 clinical trial are expected to be released in Q2 2021. “We are extremely excited and gratified to have completed Phase 1 and to be able to transition so efficiently to phase 2 for this program,” stated Dr. Kaushal. “Babies with HLHS are very seriously ill and require multiple open-heart operations. This program is designed around helping their hearts recover from this complicated congenital heart disease. We are excited about moving this program forward and potentially adding a key therapeutic in the recovery of these kids.” About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Contact:Crescendo Communications, LLCTel: 212-671-1020Email: lgvn@crescendo-ir.com

  • CEO of Longeveron Inc. to Present at the Intercontinental Summit on Aging & Gerontology
    GlobeNewswire

    CEO of Longeveron Inc. to Present at the Intercontinental Summit on Aging & Gerontology

    MIAMI, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced that Geoff Green, Chief Executive Officer of Longeveron, has been invited to give a presentation titled “A Regenerative Medicine Approach to Aging Frailty” at the Intercontinental Summit on Aging & Gerontology being held virtually on March 8, 2021. He will discuss Longeveron’s ongoing clinical research program in Aging Frailty and Alzheimer’s disease, in addition to the regenerative medicine investigational clinical research field in general for diseases and conditions associated with aging. The Intercontinental Summit on Aging & Gerontology is hosted by the Sciinov Group and helps participants from universities and institutions to network with world-class scientists. This all-day online event unites researchers, scientists, and academicians to discuss and share knowledge in the emerging field of Aging & Gerontology. Information about the event can be found by visiting: agingcongress.com. A copy of the Company’s presentation will also be available on the Company’s website at: www.longeveron.com. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Contact:Crescendo Communications, LLCTel: 212-671-1020Email: lgvn@crescendo-ir.com

  • Longeveron Inc. Announces the Appointment of Prominent Biotech, Capital Markets and Corporate Finance Executives to the Board of Directors
    GlobeNewswire

    Longeveron Inc. Announces the Appointment of Prominent Biotech, Capital Markets and Corporate Finance Executives to the Board of Directors

    MIAMI, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the appointments of Douglas Losordo, M.D., Erin Borger, and Cathy Ross to the Company’s Board of Directors. Douglas Losordo, MDDr. Losordo has worked in the biotech industry for over twenty years, most recently serving as Executive Vice President, Head of Research and Development and Chief Medical Officer of KBP Biosciences Inc. Dr. Losordo was previously the Executive Vice President, Global Head of Research and Development, Chief Medical Officer of Caladrius Biosciences (Nasdaq: CLBS), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse chronic disease, from August 2013 until November 2020. Dr. Losordo has extensive knowledge of clinical, regulatory, manufacturing, supply chain and commercial factors unique to cellular therapy technologies as a result of his prior industry experience. Dr. Losordo’s also previously served as a Professor of Medicine at NYU Langone Medical Center and Northwestern University’s Feinberg School of Medicine. He received his MD from the University of Vermont College of Medicine, and his B.A. in Zoology from the University of Vermont. Erin BorgerMr. Borger is a Managing Director in Wealth Management at UBS Financial Services Inc., where he has worked since 2008. Throughout the years Mr. Borger has also served as a member on a number of medical and non-medical boards and committees, such as the Alzheimer’s Association South Florida, Cystic Fibrosis Foundation, Palisades Medical Center and the University of Miami, Miller School of Medicine, to name a few. Additionally, Mr. Borger has spent a number of years helping to support non-profit organizations with a focus in the medical field through various research and financial support. Mr. Borger received his B.A. in Sociology from Wofford College, and also holds a number of securities licenses from the Financial Industry Regulatory Authority. Cathy RossMs. Ross is a senior finance executive with over 30 years of experience. Since 2016, she has been a member of the Board of Directors and Chair of the Audit Committee of Fraud.Net, Inc., a privately held company that operates a real-time fraud detection and analytics platform. From 2006 to 2012, she was the Chief Financial Officer, President, and a member of the Board of Directors of MotherNature.com, a privately held online retailer and information source for vitamins, supplements, minerals and healthy products. In her role as Chief Financial Officer of MotherNature.com, she managed all aspects of accounting, budgeting and financial reporting. Prior to that, she served as Managing Director, Private Equity of Oasis Capital Partners, Vice President, Investment Banking and Public Offerings of Commonwealth Associates, Product Development and Marketing Manager of Ocwen Financial Corporation, and a Senior Credit Analyst for Chase Manhattan Bank. Ms. Ross earned a Bachelor of Arts Degree, Economics from Brown University in 1989. The appointments of the new directors took effect in connection with the Company’s recent initial public offering and listing on the Nasdaq. Geoff Green, CEO of Longeveron, stated, “We are delighted to announce the appointments of such prominent industry leaders to our board. Each is highly accomplished in their respective fields and are valuable additions as we begin life as a public company, and continue to make progress toward the goal of developing cell therapies for aging-related chronic disease and life-threatening conditions.” About Longeveron Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Contact:Crescendo Communications, LLCTel: 212-671-1020Email: lgvn@crescendo-ir.com