LGVN Longeveron Inc.

7.42
+0.08  (+1%)
Previous Close 7.34
Open 7.34
52 Week Low 5.1512
52 Week High 12.48
Market Cap $140,858,141
Shares 18,983,577
Float 3,148,913
Enterprise Value $115,916,753
Volume 71,188
Av. Daily Volume 582,724
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Upcoming Catalysts

Drug Stage Catalyst Date
Lomecel-B
Hypoplastic Left Heart Syndrome
Phase 1
Phase 1
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Lomecel-B
Aging Frailty
Phase 2b
Phase 2b
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Lomecel-B
Aging Frailty
Phase 2
Phase 2
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Lomecel-B
Metabolic Syndrome
Phase 2b
Phase 2b
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Lomecel-B (RECOVER)
Acute Respiratory Distress Syndrome
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Lomecel-B
Alzheimer's Disease
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.

Latest News

  1. MIAMI, June 10, 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, announced today that its Co-founder and Chairman, Joshua M. Hare, MD, will be a panelist at the National Academy of Medicine's (NAM) International Workshop on Science & Technology for Healthy Longevity on June 15 & 17, 2021. Dr. Hare will participate in the symposium, "Transformative Advances in Biological Sciences for Healthy Longevity" on Tuesday, June 15 at 5:10 PM EDT. 

    The workshop is an integral component of an important initiative undertaken by the NAM to develop a Global Roadmap for Healthy Longevity, a comprehensive…

    MIAMI, June 10, 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, announced today that its Co-founder and Chairman, Joshua M. Hare, MD, will be a panelist at the National Academy of Medicine's (NAM) International Workshop on Science & Technology for Healthy Longevity on June 15 & 17, 2021. Dr. Hare will participate in the symposium, "Transformative Advances in Biological Sciences for Healthy Longevity" on Tuesday, June 15 at 5:10 PM EDT. 

    The workshop is an integral component of an important initiative undertaken by the NAM to develop a Global Roadmap for Healthy Longevity, a comprehensive, evidence-based report to assess the challenges presented by population aging, develop recommendations, and demonstrate how these challenges can be translated into opportunities for societies globally.

    Participants in the Science and Technology workshop will explore and recommend avenues for developing, incentivizing, and funding innovative and groundbreaking research and development across basic, clinical, pharmaceutical, social and behavioral sciences, bioengineering, information technology, and assistive technologies.

    "We are honored that our Co-founder, Chairman, and Chief Science Officer, Dr. Hare, has been invited to participate at the prestigious National Academy of Medicine on the subject of healthy aging," said Geoff Green, Chief Executive Officer of Longeveron. "At Longeveron, our research is focused on developing safe and effective regenerative medicine therapeutics for chronic aging-related diseases and disorders, and we consider ourselves leaders in the field of cell-based therapies for Alzheimer's disease and Aging Frailty."

    The Company recently completed two Phase 2 trials in the U.S. evaluating Lomecel-B for Aging Frailty, a geriatric condition characterized by a multisystem loss of function and reserve that leaves elderly individuals at greater risk for poor clinical outcomes such as hospitalization, disability and death. Top-line data from these trials are expected in the third quarter of this year. Additionally, Lomecel-B will be tested in Japanese Aging Frailty patients in a Phase 2 trial that is expected to initiate in the second half of this year and is being conducted by Japan's National Center for Geriatrics & Gerontology and Juntendo University Hospital. The Company's Alzheimer's disease program is advancing to a Phase 2 trial this year after recently successfully completing a Phase 1 safety trial. The Phase 1 results, previously reported by the Company, showed that peripheral IV infusion of Lomecel-B in mild to moderate Alzheimer's disease patients was safe and well-tolerated, and that low dose Lomecel-B significantly slowed cognitive decline compared to placebo as measured by Mini Mental State Exam.

    The panel discussion is open to public audiences and can be accessed via live webcast here. A link to register for the presentation will also be available under "Events & Presentations" in the Investors section of the Company's website at investors.longeveron.com. A replay of the webcast will be accessible on the Longeveron website for approximately 14 days following the event.

    About Joshua M. Hare, MD, FACC, FAHA

    Dr. Hare co-founded Longeveron in 2014 and serves as Chairman of the Board of Directors, and Chief Science Officer. Dr. Hare is a double board-certified cardiologist (Cardiology and Advanced Heart Failure and Transplantation) and is the founding director of the Interdisciplinary Stem Cell Institute at the University of Miami's Miller School of Medicine. He has obtained in excess of $25 million in funding from the National Institutes of Health over the past 15 years to support basic research of cell therapy strategies. He is also a recipient of the Paul Beeson Physician Faculty Scholar in Aging Research Award, and is an elected member of the American Association of Physicians, The American Society for Clinical Investigation, and is an elected Fellow of the American Heart Association. Dr. Hare has also served in numerous leadership roles at the American Heart Association and at the Center for Scientific Review of the National Institutes of Health. Dr. Hare is also a co-founder of Vestion, Inc., and Heart Genomics, LLC, companies that hold cardiac related intellectual property. He received a BA from the University of Pennsylvania, his MD from The Johns Hopkins University School of Medicine, completed fellowships at Johns Hopkins and Brigham and Women's Hospital, and was a Research Fellow at Harvard Medical School.

    About the National Academy of Medicine

    Founded in 1970 as the Institute of Medicine (IOM), the National Academy of Medicine (NAM) is one of three academies that make up the National Academies of Sciences, Engineering, and Medicine (the National Academies) in the United States. Operating under the 1863 Congressional charter of the National Academy of Sciences, the National Academies are private, nonprofit institutions that work outside of government to provide objective advice on matters of science, technology, and health.

    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.

    Investor Contact:

    Brendan Payne

    Stern Investor Relations

    Office Direct: 212-698-8695 | Office Main: 212-362-1200

    | www.sternir.com

    Source: Longeveron Inc

    Source: LGVN



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  2. MIAMI, May 25, 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, announced today that Ursula Ungaro will be joining its Board of Directors as of June 1, 2021.

    Ms. Ungaro was appointed to serve on the federal U.S. District Court for the Southern District of Florida in 1992 after being nominated by President George H.W. Bush and being confirmed by the U.S. Senate. After 29 years of federal service, Ms. Ungaro has announced that she will be retiring from the bench on May 31, 2021. In her time on the federal bench, she presided over and ruled in numerous major civil and criminal cases…

    MIAMI, May 25, 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, announced today that Ursula Ungaro will be joining its Board of Directors as of June 1, 2021.

    Ms. Ungaro was appointed to serve on the federal U.S. District Court for the Southern District of Florida in 1992 after being nominated by President George H.W. Bush and being confirmed by the U.S. Senate. After 29 years of federal service, Ms. Ungaro has announced that she will be retiring from the bench on May 31, 2021. In her time on the federal bench, she presided over and ruled in numerous major civil and criminal cases in legal domains ranging from constitutional principles, equal rights, securities issues, and the use of non-embryonic stem cell therapies, amongst many others. In addition to joining Longeveron's Board, Ms. Ungaro will also be joining, as a Partner, the prestigious law firm Boies Schiller Flexner LLP.

    "We are exceptionally fortunate and pleased to welcome Ms. Ungaro to our Board of Directors and look forward to drawing from her varied expertise after many years in the judiciary and in private practice to help guide Longeveron at this exciting time in its development," said Geoff Green, CEO of Longeveron. "Ms. Ungaro's tremendous reputation, respect of all her peers, and wealth of experience, will prove invaluable as we continue to build Longeveron and advance our cellular therapies through clinical development to commercialization."

    Following her graduation with honors from the University of Florida School of Law in 1975 (one of just 17 women in a class of about 250), Ms. Ungaro practiced law in Miami, Florida where in 1981 she became a partner in Tew, Critchlow, Sonberg, Traum & Friedbauer, P.A. (later merged into Finley, Kumble, Wagner, Heine, Underberg, Manley, Myerson & Casey, a national law firm). She subsequently joined Sparber, Shevin, Shapo & Heilbronner, a prestigious local law firm. She practiced law mainly in the area of complex commercial litigation, including in the areas of securities, corporate and tax law. From 1987 to 1992, Ms. Ungaro served as a trial judge on the Eleventh Judicial Circuit of the State of Florida. She has authored published articles in the areas of administrative law, legal ethics, and civil procedure. She is the recipient of the ORT Jurisprudence Award and has been recognized on several occasions by other organizations for her achievements in the law and service to the community.

    "I am excited to have the opportunity to serve on the Board and to have the chance to participate with some very talented individuals in guiding Longeveron's future success. In fact, a big part of my decision to retire from the judiciary was the opportunity to propel the further growth and success of Longeveron and help advance the exciting cell-based therapeutics the Company is developing," remarked Judge Ungaro.

    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.

    Investor Contact:

    Brendan Payne

    Stern Investor Relations

    Office Direct: 212-698-8695 |Office Main: 212-362-1200

    | www.sternir.com

    Source: Longeveron Inc

    Source: LGVN 



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  3. MIAMI, May 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 hiring of Dan Gincel, Ph.D. as Senior Vice President, Strategic Collaborations & Scientific Affairs.

    Dr. Gincel brings over 20 years of leadership experience overseeing development and commercialization of regenerative medicines, including cell and gene therapies, as well as establishing public-private collaborations and corporate partnerships. Previously, he served as Vice President of University Partnerships and a member of the Executive Leadership Team at the Maryland Technology Development Corporation…

    MIAMI, May 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 hiring of Dan Gincel, Ph.D. as Senior Vice President, Strategic Collaborations & Scientific Affairs.

    Dr. Gincel brings over 20 years of leadership experience overseeing development and commercialization of regenerative medicines, including cell and gene therapies, as well as establishing public-private collaborations and corporate partnerships. Previously, he served as Vice President of University Partnerships and a member of the Executive Leadership Team at the Maryland Technology Development Corporation (TEDCO), where he oversaw programs to accelerate the commercialization of technologies from federal, state, and private Maryland research institutions. Additionally, he served as Executive Director at the Maryland Stem Cell Research Fund (MSCRF), where he managed over $150+ million in stem cell research funding. During his tenure, he helped create and support more than 55 technology startup companies with over $120 million of follow-on funding and numerous successful exits. Dr. Gincel received both his Ph.D. (2003) and his B.Sc. (1996) from Ben-Gurion University in Israel. He currently serves on numerous boards supporting companies and economic development.

    Geoff Green, CEO of Longeveron, stated, "Dan's scientific and entrepreneurial background will contribute significantly to our organization as we continue to advance our mission to develop and launch new cell therapies for aging-related chronic disease and life-threatening conditions. Having a widely respected entrepreneur of Dan's caliber will also assist us in evaluating strategic collaborations, both in the U.S. and abroad, as well as in-licensing new technologies to further progress our LOMECEL-B™ cell-based therapy platform and overall product pipeline."

    "I have known and collaborated with the outstanding Longeveron team for many years as they have advanced Lomecel-B through trials for Aging Frailty, Hypoplastic Left Heart Syndrome and Acute Respiratory Distress Syndrome and I look forward to bringing to bear my experience and insights in cell therapy to creating value at the company and working with these exciting product candidates," stated Dr. Gincel.

    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:

    Brendan Payne

    Stern IR, Inc.

    Source: Longeveron Inc

    Source: LGVN



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  4. MIAMI, May 14, 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 provided a business update regarding a number of ongoing clinical trials, and also reported its financial results for the first quarter ended March 31, 2021.

    "Aging is the number one risk factor for chronic disease," said Geoff Green, CEO. "Stem cell exhaustion, cellular senescence, and chronic inflammation, together referred to as "inflammaging", compromises our ability to repair and regenerate damaged tissues and organs. Inflammaging is linked to the rise of progressive chronic diseases such as Alzheimer's disease…

    MIAMI, May 14, 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 provided a business update regarding a number of ongoing clinical trials, and also reported its financial results for the first quarter ended March 31, 2021.

    "Aging is the number one risk factor for chronic disease," said Geoff Green, CEO. "Stem cell exhaustion, cellular senescence, and chronic inflammation, together referred to as "inflammaging", compromises our ability to repair and regenerate damaged tissues and organs. Inflammaging is linked to the rise of progressive chronic diseases such as Alzheimer's disease and Aging Frailty. Our focus since day one has been to develop safe and effective allogeneic cell therapy solutions for the treatment and prevention of these diseases."

    In April, Longeveron announced the results of its Phase 1 Alzheimer's disease clinical study, and the Company has confirmed that it currently remains on track to initiate a Phase 2 study in the second half of the year. The Company has submitted the data for publication and plans to present at the 2021 Alzheimer's Association International Conference (AAIC). The Phase 1 study was funded in part by an Alzheimer's Association Part the Cloud Challenge on Neuroinflammation research grant award.

    Additionally, Longeveron has re-iterated that it expects to announce top-line results from its two recently completed US Phase 2 Aging Frailty trials in the third quarter of this year. The Company plans to present the data at the 2021 International Conference on Frailty & Sarcopenia Research (ICFSR) on September 29th. ICFSR's scientific committee has invited the Company to present the data during a round table presentation. In addition, the Company has been invited to deliver oral presentations on trial design for its Phase 1/2 Aging Frailty and Influenza Vaccine trial (HERA Trial), and its Phase 2 Japanese Aging Frailty trial at the ICFSR conference.

      

    Alzheimer's Disease Phase 1 Study:

    • Lomecel-B well tolerated: Single peripheral intravenous infusion of Lomecel-B was well-tolerated, with no treatment-related serious adverse events (SAEs) reported throughout the 1-year follow-up, and no indication of amyloid-related imaging abnormalities (ARIA) as assessed by magnetic resonance imaging (MRI).



    • Low dose Lomecel-B shows evidence of slowing of cognitive decline: The Mini-Mental State Exam (MMSE) score, a measure of cognitive function, declined more slowly in the low-dose Lomecel-B group compared to the placebo group. At 13 and 39 weeks after infusion, low-dose Lomecel-B group MMSE score was significantly higher (better) compared to placebo (13 week mean difference of 2.69 ± 1.39 points; p=0.0182; 2-sided 95% CI 0.51 – 4.97; 39 week mean difference of 3.25 ± 1.66 points; p=0.0236; 2-sided 95% CI 0.59 – 7.14 ).

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/db4a4485-07b2-45aa-8cbf-3f3843d0427a

    • Additional significant differences were observed at various time points between low dose Lomecel-B compared to placebo in the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) test and the Quality of Life in Alzheimer Disease (QOL-AD) test.

    A summary of Phase 1 trial results can be found on Longeveron's website www.longeveron.com.

    About the planned Phase 2 Alzheimer's disease Clinical Trial:

    Longeveron plans to initiate a Phase 2 trial of Lomecel-B infusion in mild Alzheimer's disease subjects in the second half of 2021. The study is expected to be a randomized, placebo-controlled, multidose trial designed to further evaluate biomarkers, change in cognitive function, and other disease-specific endpoints. Additional details about trial design, endpoints and target enrollment will be provided once the protocol is finalized.

    Aging Frailty Clinical Trials

    • Results from two Aging Frailty trials expected in third quarter 2021: Longeveron plans to announce the top line safety and efficacy results from both the US Phase 2b Aging Frailty trial, and the US Phase 1/2 Influenza Vaccine Aging Frailty trial in the third quarter of 2021.



    • Phase 2 Japanese Aging Frailty trial: The planned Japanese Aging Frailty clinical trial is on track to initiate in the second half of 2021. Trial planning continues with our clinical partners at the National Center for Geriatrics & Gerontology, and Juntendo University Hospital, and the services of a Japan-based Contract Research Organization have been engaged.

    Update on Other Lomecel-B Clinical Programs:

    • Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS): The Company plans to report the final results of the Phase 1 HLHS trial in the second quarter of 2021. The Phase 2 randomized, placebo-controlled multicenter trial is on track to initiate in the third quarter of 2021. The Phase 2 trial is funded by a grant award from National Heart, Lung and Blood Institute (NHLBI).



    • Lomecel-B for Acute Respiratory Distress Syndrome due to COVID 19 Infection: The Phase 1 trial continues to screen and enroll subjects, and is anticipated to continue through 2021, with results in 2022. The Phase 1 trial is funded in part by a grant award from Maryland's TEDCO.

    Upcoming Conferences

    As previously announced, Longeveron has been selected to present at the 2021 World Stem Cell Summit taking place virtually on June 14-18, in combination with the Wake Forest Institute for Regenerative Medicine (WFIRM) and Regenerative Medicine Foundation (RMF). Dr. Joshua Hare, Co-Founder and Chief Science Officer, is scheduled to present in a session titled "The Longevity Agenda: Canceling the Pathologies of Aging." Longeveron will also provide a pre-recorded 4-5 minute presentation as part of the Investment & Commercialization Forum Track of the Summit.

            

    Financial Results for First Quarter Ended March 31, 2021

    Revenue: Revenue was $0.4 million compared to $1.7 million in the same period in 2020. The difference was due to a decrease in clinical trial revenue and grant revenue, as follows:   

    • Clinical trial revenue, which derives from the Company's Bahamas Registry Trial, was $0.2 million compared to $0.8 million in the same period in 2020, a decrease of $0.6 million, or 78%. Participation in the Bahamas Registry Trial continues to be negatively impacted by the COVID-19 pandemic-related travel concerns.
    • First quarter 2021 grant revenue was $0.2 million compared to $0.9 million in the same period in 2020, a decrease $0.7 million, or 78%, compared to the same period in 2020. The reduction in grant revenue resulted from less research grant funds being available, as various Company clinical trial programs concluded in the quarter.

    R&D Expenses: Research and development expenses were $1.4 million compared to $0.3 million for the same period in 2020. The increase of $1.1 million, or 367%, was primarily due to an increase in research and development expenses that were not reimbursable by grants; including $0.4 million of equity-based compensation recorded for the RSUs granted.

    G&A Expenses: General and administrative expenses were $2.2 million compared to $0.7 million for the same period in 2020. The increase of approximately $1.5 million, or 221%, was primarily related to an increase for compensation, insurance and professional expenses incurred during the current period; including $0.8 million of equity-based compensation recorded for the RSUs granted.

    Net Loss: Net loss was $3.1 million compared to $0.2 million for the same period in 2020.

    Cash: Cash on hand was $24.5 million compared to $0.8 million as of December 31, 2020. The increase in cash period over period was the result of the completion of the Company's initial public offering (IPO) in February of 2021.

    Financial Outlook

    Cash in the first quarter of 2021 was increased by the $29.1 million (gross) in funds received from the IPO. As of March 31, 2021, the Company's cash position was $24.5 million. The Company believes, based on the current operating plan and financial resources, that existing cash on hand will be sufficient to cover expenses and capital requirements through at least the fourth quarter of 2022.

    Conference Call and Webcast

    Management will host a conference call today at 8:30 a.m. Eastern Time to discuss the Company's first quarter 2021 financial results and provide a business update.

    The conference call will be available via telephone by dialing toll free 1-844-200-6205 for U.S. callers; 1-646-904-5544 for local callers; or +44 20-8068-2558 for international callers and using entry code 460592. You may also pre-register for the event. A webcast of the call may be accessed here or on the Company's website at https://www.longeveron.com/.

    An audio replay of the call will be available through May 21, 2021 and can be accessed here and by entering the access code: 402451, and will remain online for one year through May 14, 2022.         

            

    About the Longeveron Alzheimer's Phase 1 Trial:

    Funded in part by an Alzheimer's Association "Part the Cloud Challenge on Neuroinflammation" grant, the Longeveron Alzheimer's Phase 1 trial was a randomized, placebo-controlled double-blind trial designed to evaluate the safety and efficacy of intravenous (i.v.) administration of Lomecel-B, an allogeneic bone marrow-derived medicinal signaling cell (MSC) product, in subjects with mild Alzheimer's disease. This randomized, placebo-controlled, double-blind trial enrolled a total of 33 subjects. Subjects were randomized to receive a single peripheral intravenous infusion of Lomecel-B 20 million cells ("low-dose"; (n=15)), Lomecel-B 100 million cells ("high-dose"; n=10)), or placebo (n=8), and followed for 52 weeks post-infusion. Subjects were followed for 52 weeks post-infusion.

    About the US Phase 2b Aging Frailty Trial:

    The primary objective of this multi-center study is to assess the effect of Lomecel-B treatment on exercise tolerance and endurance via the six-minute walk test (6MWT). Additional endpoints included gait speed, grip strength, short physical performance battery (SPPB), Performance Oriented Mobility Assessment (POMA; measures subject's risk of falling), the Falls Efficacy Scale (measures subject's fear of falling), depression, sexual function, cognition, and various patient reported outcomes (PROs) and activities of daily living (ADLs), and blood-based biomarkers. 149 subjects were randomized to receive a single peripheral intravenous infusion of Lomecel-B (25 million cells, 50 million cells, 100 million cells or 200 million cells), or placebo, followed by a 52-week observation period to evaluate safety and efficacy. The Phase 2b trial was conducted at 8 hospitals and clinics, primarily in South Florida, including the Miami VA Healthcare System, and was funded by a Small Business Administration Grant (SBIR) grant from the NIH's National Institute on Aging (NIA).



    About the US Phase 1/2 Aging Frailty Influenza Vaccine Trial ("HERA" Study):

    The HERA trial was designed to evaluate whether Lomecel-B can improve immune response to influenza ("flu") vaccine in subjects with Aging Frailty through measurement of serum antibodies. The two-phase, 59 subject, multicenter, randomized, double-blinded, placebo-controlled study was conducted at 7 hospitals and clinics throughout Florida and Maryland, and was supported in part by a grant from Maryland Stem Cell Research Program (MSCRF) under the Maryland Technology Development Corporation (TEDCO) and the National Institute on Aging (NIA). Additional efficacy measures include assessments of physical strength and endurance, quality-of-life (QOL) and activities of daily living (ADL) assessments, cognitive function, and blood-based biomarkers.

    About the Japanese Phase 2 Aging Frailty Trial:

    The primary objective of this multi-center study is to assess the effect of Lomecel-B treatment on exercise tolerance and endurance via the six-minute walk test (6MWT). Additional endpoints included gait speed, grip strength, short physical performance battery (SPPB), Performance Oriented Mobility Assessment (POMA; measures subject's risk of falling), the Falls Efficacy Scale (measures subject's fear of falling), depression, sexual function, cognition, and various patient reported outcomes (PROs) and activities of daily living (ADLs), and blood-based biomarkers. The trial has a target enrollment of 45 subjects, randomized in a 1:1:1 ration to receive a single peripheral intravenous infusion of Lomecel-B (50 million cells, 100 million cells, or placebo), followed by a 6 month observation period to evaluate safety and efficacy.

    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.

    Cautionary Note Regarding 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 Securities and Exchange Commission, including our Annual Report on Form 10-K filed March 30, 2021. 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.

    Brendan Payne

    Stern Investor Relations

    Tel: (212) 362-1200

    Email:

    Source: Longeveron Inc

    Source: LGVN

    Since the corporate conversion to a Delaware "C" corporation occurred on February 11, 2021, as part of the IPO, the Financial Statements presented for March 31, 2021 and December 31, 2020 are presented as a C corporation and as a limited liability company (LLC), respectively.



    LONGEVERON INC

    SELECTED CONDENSED BALANCE SHEET DATA

    (In thousands, except per share data) (Unaudited)

       March 31, 2021 December 31, 2020
    Cash  $24,461  $816 
    Total assets   32,432   9,240 
    Total liabilities   5,937   7,283 
    Total members' equity

    and stockholders' equity
       26,495   1,957 



    LONGEVERON INC


    CONDENSED STATEMENTS OF OPERATIONS

    (In thousands, except per share data)(Unaudited)

       For the Three Months Ended March 31,
       2021  2020 
    Revenues:       
    Grant revenue  $211  $946 
    Clinical trial revenue   165   762 
    Total revenues   376   1,708 
    Costs of revenues   227   896 
    Gross profit   149   812 
            
    Operating expenses:       
    General and administrative   2,201   686 
    Research and development   1,350   289 
    Selling and marketing   56   50 
    Total operating expenses   3,607   1,025 
            
    Loss from operations   (3,458)  (213)




    Other income and (expenses)
           
    Forgiveness of Paycheck

    Protection Program loan
       300   - 
    Other income, net   47   - 
    Total other income and (expenses), net   347   - 
            
    Net loss  $(3,111) $(213)
    Basic and diluted net loss per share  $(0.18) $- 
    Basic and diluted weighted average

    common shares outstanding
       17,491,066   - 

    _______________________________________________________

    Source: Longeveron Inc

    Source: LGVN



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  5. MIAMI, May 11, 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 the Company will release its first quarter 2021 financial results on Friday, May 14, 2021 before the open of US markets. Management will host a conference call on the same day at 8:30 AM.

    To access the live conference, please dial 1-844-200-6205 from the United States or +44 208-0682-558 from other locations, and using entry code 460592. A webcast of the call may also be accessed from the ‘Investors' page of the Longeveron website at www.longeveron.com. A replay of the call will be available on…

    MIAMI, May 11, 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 the Company will release its first quarter 2021 financial results on Friday, May 14, 2021 before the open of US markets. Management will host a conference call on the same day at 8:30 AM.

    To access the live conference, please dial 1-844-200-6205 from the United States or +44 208-0682-558 from other locations, and using entry code 460592. A webcast of the call may also be accessed from the ‘Investors' page of the Longeveron website at www.longeveron.com. A replay of the call will be available on the Longeveron website shortly after completion of the call.

    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.

    Contact:

    Brendan Payne

    Stern Investor Relations

    Tel: (212) 362-1200

    Email:

    Source: Longeveron Inc

    Source: LGVN



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