LGVN Longeveron Inc.

3.44
-0.04  -1%
Previous Close 3.48
Open 3.51
52 Week Low 3.27
52 Week High 12.48
Market Cap $65,754,327
Shares 19,114,630
Float 3,279,966
Enterprise Value $51,357,960
Volume 66,544
Av. Daily Volume 161,792
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Upcoming Catalysts

Drug Stage Catalyst Date
Lomecel-B (HERA)
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 (ELPIS II)
Hypoplastic Left Heart Syndrome
Phase 2
Phase 2
Phase 2 trial initiation of dosing announced July 6, 2021. Phase 1 met primary safety endpoint, secondary endpoints suggest Lomecel-B may improve patient long-term clinical outcome after surgery: 100% (10) of infants alive and heart-transplant free, with follow-up ranging two to 3.5 years after cardiac surgery. Noted September 9, 2021.
Lomecel-B
Aging Frailty
Phase 2b
Phase 2b
Phase 2b trial released August 13, 2021. Statistically significant placebo-adjusted difference in 6MWT distance not shown.
Lomecel-B
Alzheimer's Disease
Phase 1
Phase 1
Phase 2 trial to be initiated 2H 2021.

Latest News

  1. -- Jorge Ruiz, M.D., Associate Director for Clinical Affairs, Geriatric Research at the Miami VA Healthcare System, will present Longeveron's Aging Frailty Phase 2b Trial Data

    -- National Institute on Aging-funded study showed significant, dose-dependent improvement in walking distance after infusion with Lomecel-B in subjects with mild-to-moderate Aging Frailty

    MIAMI, Sept. 21, 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 Jorge Ruiz, M.D., Associate Director for Clinical Affairs at the Geriatric Research, Education and Clinical Center (GRECC…

    -- Jorge Ruiz, M.D., Associate Director for Clinical Affairs, Geriatric Research at the Miami VA Healthcare System, will present Longeveron's Aging Frailty Phase 2b Trial Data

    -- National Institute on Aging-funded study showed significant, dose-dependent improvement in walking distance after infusion with Lomecel-B in subjects with mild-to-moderate Aging Frailty

    MIAMI, Sept. 21, 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 Jorge Ruiz, M.D., Associate Director for Clinical Affairs at the Geriatric Research, Education and Clinical Center (GRECC), Miami Veterans Affairs Healthcare System, and lead investigator in the trial, will present the results from the trial titled: A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B Infusion in Patients With Aging Frailty (the "Phase 2b trial") at the 2021 11th Annual International Conference for Frailty & Sarcopenia (ICFSR).

    The trial and results, previously announced by the Company on August 13, 2021, will be presented via a pre-recorded webcast by Dr. Ruiz during a Roundtable on September 29, 2021, which will be followed by a live question and answer session from registered conference attendees. The webcast and recording of the Roundtable will be accessible on the "Events & Presentations" page on the Longeveron website at https://investors.longeveron.com/events-and-presentations/default.aspx after the conference, which runs from September 29 to October 1, 2021.

    About the Phase 2b Trial

    The Phase 2b trial, which was partially funded by a Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA), evaluated the safety and efficacy of a single peripheral intravenous infusion of four different doses of Lomecel-B cell therapy (25 million (n=37), 50 million (n=31), 100 million (n=34) and 200 million (n=16) cells). The primary objective of the study was to assess the effect of Lomecel-B treatment on exercise tolerance and endurance via the six-minute walk test (6MWT).

    • Results showed that frail subjects (average age of 75.2 years) with impaired mobility could walk nearly 50 meters further 180 days after a single infusion of Lomecel-B (200 million Lomecel-B group; p=0.0065). This increase persisted through 270 days (200 million Lomecel-B group change from baseline 47.9 meters; p=0.0115, and p=0.0077 compared to placebo). By comparison, the placebo-treated subjects change from baseline at 180 days and 270 days was 8.0 meters (p=0.5371) and -15.5 meters (p=0.2728), respectively. Additionally, results showed a clear, statistically significant dose-response curve at day 180 using the 6MWT endpoint.

    About Aging Frailty

    Aging Frailty is a life-threatening geriatric condition affecting approximately 15% of Americans over the age of 65, or 8.1 million individuals. Aging Frailty patients are vulnerable to poor clinical outcomes compared to their age-matched peers despite sharing similar comorbidities and demographics, and therefore it is considered an extreme form of unsuccessful aging. Clinically, frailty manifests as a combination of symptoms that includes loss of muscle and decreased strength, slowed walking, low activity and energy levels, poor endurance, nutritional deficiencies, weight loss and fatigue. Aging Frailty is also associated with chronic low-level sterile inflammation. Individuals with Aging Frailty have decreased reserves and a reduced ability to cope with minor illnesses or stressors that would normally have minimal impact, such as an infection or a fall. As a result, the individual may be more likely to be hospitalized, need long term care, or die. Inflammation can contribute to the physical decline in Aging Frailty through multiple mechanisms, including detrimental effects on muscles, bone tissue, the immune system, cardiovascular function, and cognition.

    The necessity for identifying patients with Aging Frailty is well-acknowledged in the geriatric community, and the treatment of Aging Frailty and promotion of healthful aging are recognized priorities of the National Academy of Medicine and NIA/NIH. Despite the pressing need for interventions, there are no FDA-approved therapies that can slow down, reverse, or prevent Aging Frailty.

    About Lomecel-B

    Lomecel-B is a proprietary allogeneic product comprised of medicinal signaling cells (MSCs) from the bone marrow of adult donors and culture-expanded in Longeveron's current good manufacturing practice (cGMP) cell processing facility.

    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 https://www.longeveron.com/.

    Forward-Looking and Other 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

    212-698-8695

    brendan.payne@sternir.com



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  2. MIAMI, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing its proprietary product, Lomecel-B, and other cellular therapies for chronic aging-related and life-threatening conditions, has entered into an agreement with Kinesiometrics Inc., ("Kinesiometrics") to provide a cutting-edge, digital data-driven solution for objective real-time measurement of functional capacity and quality of life in Longeveron's clinical studies. The data is accessible to Longeveron and recipients of Lomecel-B via an Application downloadable on the subjects' mobile phones.

    Longeveron recently announced the results of a Phase 2b Aging Frailty study, which showed that frail…

    MIAMI, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing its proprietary product, Lomecel-B, and other cellular therapies for chronic aging-related and life-threatening conditions, has entered into an agreement with Kinesiometrics Inc., ("Kinesiometrics") to provide a cutting-edge, digital data-driven solution for objective real-time measurement of functional capacity and quality of life in Longeveron's clinical studies. The data is accessible to Longeveron and recipients of Lomecel-B via an Application downloadable on the subjects' mobile phones.

    Longeveron recently announced the results of a Phase 2b Aging Frailty study, which showed that frail subjects (average age for study was 75.2 years) with impaired mobility could walk nearly 50 meters further 180 days after a single intravenous infusion of Lomecel-B (200 million Lomecel-B group; p=0.0065). This increase was durable, persisting through 270 days (200 million Lomecel-B group change from baseline 47.9 meters; p=0.0115, and p<0.0077 compared to placebo). By comparison, the placebo-treated subjects change from baseline at 180 days and 270 days was 8.0 meters (p=0.5371) and -15.5 meters (p=0.2728), respectively.

    Kinesiometrics will provide Longeveron with a patented Software as a Solution (SaaS), mobile-phone based platform that can collect not only years of historical data regarding a subject's activity levels via steps, distance walked, flights climbed and energy expenditure, but also real-time response information for comparison of activity level changes pre- and post-Lomecel-B infusion. This vital data may be used to understand and gauge outcomes of treatment regimens, and information is presented in an easy to understand and compelling graphical format. With the Kinesiometrics technology, activity levels can be provided continuously, rather than relying solely on single time points throughout the follow-up period. This could provide rapid understanding of the effect of Lomecel-B and has the potential to reduce the number of protocol-specific visits a research subject needs to make to the clinic.

    "Both walking speed and walking distance are highly accurate clinical indicators of overall health in older people, as well as powerful predictors of survival," said Dr. Kevin Ramdas, Director of Clinical Affairs at Longeveron. "With this new tool, we will get a richer and more comprehensive understanding of a subject's functional performance before and after infusion with Lomecel-B."

    "We are extremely excited about the collaboration with Kinesiometrics as it fits perfectly with our strategic vision to develop biological solutions for aging," said Geoff Green, CEO of Longeveron. "The Kinesiometrics platform has the potential to help us advance our clinical development program and gain greater insights into how Lomecel-B impacts patient's quality of life and functional capacity. The new data generated may help with FDA regulatory filings and is highly consistent with the introduction of digital wearable technology into advancement of novel therapeutic strategies."

    Dr. Michael Wang, a co-founder of Kinesiometrics and Chief of Neurosurgery at the University of Miami Hospital commented, "We have been looking for a partner that understands the need to use novel and modern digital methods to accelerate how patient outcomes are measured. Longeveron understands the core value of using data visualization that allows clinicians to identify critical inflection points and setbacks during a patient's recovery phase, and we look forward to working with Longeveron to achieve the goal of helping patients increase in their functional capacity and quality of life."

    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.

    About Kinesiometrics Inc.

    Kinesiometrics has created a smartphone-based application to enhance our understanding of the post-surgical and post-treatment for patients. Based on thousands of data points, artificial intelligence will guide the intervention decision-making and recovery process. By partnering with academic medical centers, medical device, pharmaceutical, and insurance companies, we are conducting multiple trials to delineate the relationship between objective physical activity data, and patient outcome as well as its effect on the overall health economics.   The raw accelerometer data gleaned from the patients' smartphones is fully encrypted and Health Insurance Portability and Accountability Act (HIPAA) compliant and uses machine learning algorithms for output.

    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. 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 Investor Relations

    Tel: (212) 362-1200

    Email: Brendan.payne@sternir.com 

    Kinesiometrics Contact

    info@kinesiometrics.org 

    Source: Longeveron Inc

    Source: LGVN

     



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  3. --Study meets primary safety endpoint: no major adverse cardiac events (MACE), nor any treatment-related infections during the first month post-treatment.

    --Secondary endpoints measured per protocol suggest Lomecel-B injection may improve patient long-term clinical outcome after surgery: 100% of infants alive and heart-transplant free, with follow-up ranging two to 3.5 years after cardiac surgery that included injection with Lomecel-B.

    --Randomized, controlled, blinded multicenter Phase 2 study underway at children's hospitals in major metropolitan centers located throughout the U.S.

    MIAMI, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular…

    --Study meets primary safety endpoint: no major adverse cardiac events (MACE), nor any treatment-related infections during the first month post-treatment.

    --Secondary endpoints measured per protocol suggest Lomecel-B injection may improve patient long-term clinical outcome after surgery: 100% of infants alive and heart-transplant free, with follow-up ranging two to 3.5 years after cardiac surgery that included injection with Lomecel-B.

    --Randomized, controlled, blinded multicenter Phase 2 study underway at children's hospitals in major metropolitan centers located throughout the U.S.

    MIAMI, Sept. 09, 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 final clinical results from its Phase I clinical study of Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart disease. Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell (MSC) therapy product manufactured under current good manufacturing practice (cGMP) in Longeveron's cell processing facility in Miami.

    The Phase I, open-label single arm study was designed to assess safety and tolerability of intramyocardial injection of Lomecel-B administered to 10 infants with HLHS during Stage 2 bidirectional cavopulmonary anastomosis (BDCPA, or "Glenn procedure") surgeries. HLHS is a rare congenital heart defect that affects 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 blood throughout the body. HLHS is fatal without surgical intervention, in which 3 surgical procedures must be performed to allow the right ventricle to be configured to pump blood to the body. Even with this surgery, HLHS is still associated with a very high mortality rate and need for heart transplantation. The trial was partially funded by a grant from the Maryland Stem Cell Research Fund (MSCRF).

    The primary safety endpoint was the incidence of the following treatment-emergent Serious Adverse Events (TE-SAEs): i) major adverse cardiac events (MACE), including sustained/symptomatic ventricular tachycardia requiring intervention with inotropic support, aggravation of heart failure, myocardial infarction, unplanned cardiovascular operation for cardiac tamponade, and death through one-year post-treatment; and ii) infections during the first month post-treatment. Intramyocardial injection of Lomecel-B at 2.5 × 106 cells/kg of body weight was well-tolerated, with no MACE, and no infections reported that were considered to be related to investigational treatment.

    Secondary endpoints were measured per protocol to gain insight into Lomecel-B's potential effect on clinical outcomes and heart function. These secondary endpoint results should be viewed with caution due to the lack of a control arm for comparison, meaning we cannot conclude whether these secondary outcomes were surgery-related, Lomecel-B-related, or both.

    • 100% of infants treated were alive and transplant-free one-year after injection. Patients have now been followed for two-to-3.5 years and remain alive and transplant free. This exceeds historical control results, which estimate only 78% survival free of transplantation following the Glenn procedure. (1)
    • Heart function and structure, including tricuspid regurgitation fraction (the fraction of blood going backwards in the right ventricle), right ventricle ejection fraction (RVEF), RV volume and chamber size did not change significantly from baseline at six and 12 months after Lomecel-B injection.
    • The children's growth matched trends in published literature, suggesting normal development of the children. (2)
    • Through one-year follow-up, one patient had an ascending aortic obstruction requiring angioplasty, and four other patients required re-hospitalization, none considered related to Lomecel-B injection.

    "We are gratified by the very promising finding in this study that 100% of the participating children had a two to four year transplant-free survival which compares very favorably to published mortality rates of up to 22% in HLHS patients after the Glenn procedure," said Dr. Sunjay Kaushal, Principal Investigator of the study. "We are highly motivated to continue our studies of Lomecel-B cell therapy for children with HLHS. If we determine in the future that Lomecel-B reduces the need for heart transplantation in these children, this will represent a major advance in the field, and have a substantial impact on these infants and their families."

    "HLHS is a rare but life-threatening, congenital heart defect for which we currently have limited treatment options and poor outcomes. We are delighted to have been able to support this clinical trial in Maryland and advance this important work with Dr. Sunjay Kaushal and Longeveron", said Dr. Amritha Jaishankar, Executive Director of the Maryland Stem Cell Research Fund. "We are committed to Accelerating Cures, and hope that the results from the HLHS Lomecel-B cell therapy study that our grant helped fund will bring us one step closer to helping these babies and their families."

    Phase 2 Trial (ELPIS II)

    Longeveron is pleased that its research program has advanced into a blinded, controlled trial that is evaluating safety and effectiveness of Lomecel-B as an intervention for HLHS. In this regard, the HLHS program has transitioned into a Phase 2 trial titled: Evaluation of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. (ELPIS II) ELPIS II is being funded by a grant from the National Institute of Health's National Heart, Lung, and Blood Institute (NHLBI; Grant number 1UG3HL148318), in collaboration with Longeveron, and is led by Principal Investigator Sunjay Kaushal, MD, PhD, Division Head, Cardiovascular-Thoracic Surgery, Ann and Robert H. Lurie Children's Hospital of Chicago. With a target enrollment of 38 infants, the trial began enrollment in July, 2021, and it is anticipated that up to seven children's hospitals will be participating, all in major metropolitan centers located throughout the U.S. For more information regarding the trial design and location of clinical sites please visit www.clinicaltrial.gov (NCT04925024), and www.elpistrial.org hosted by the University of Texas Health Sciences Center which serves as the data coordinating center.

    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.

    References

    1. Son JS, James A, Fan C-PS, Mertens L, McCrindle BW, Manlhiot C, Friedberg MK. Prognostic value of serial echocardiography in hypoplastic left heart syndrome. Circulation: Cardiovascular Imaging. 2018; 11(7):e006983.



    2. Burch, P. T., E. Gerstenberger, C. Ravishankar, D. A. Hehir, R. R. Davies, S. D. Colan, L. A. Sleeper, et al. 2014. "Longitudinal Assessment of Growth in Hypoplastic Left Heart Syndrome: Results From the Single Ventricle Reconstruction Trial." Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease. doi:10.1161/JAHA.114.000079.

    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. 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.

    Research referred to in this press release is being supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number UG3HL148318. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

    Contact:

    Brendan Payne

    Stern Investor Relations

    Tel: (212) 362-1200

    Email: Brendan.payne@sternir.com

    Source: Longeveron Inc

    Source: LGVN



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  4. MIAMI, Sept. 01, 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 management will present virtually at the H.C. Wainwright 23rd Annual Global Investor Conference.

    The corporate presentation will be available for on-demand viewing beginning September 13, 2021 at 7:00 a.m. EDT via the Investors & Media section of the Company website. An archived replay of the webcast will be available on the website for approximately 90 days following the presentation.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for…

    MIAMI, Sept. 01, 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 management will present virtually at the H.C. Wainwright 23rd Annual Global Investor Conference.

    The corporate presentation will be available for on-demand viewing beginning September 13, 2021 at 7:00 a.m. EDT via the Investors & Media section of the Company website. An archived replay of the webcast will be available on the website for approximately 90 days following the presentation.

    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.

    Investor Contact:

    Brendan Payne

    Stern Investor Relations

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

    brendan.payne@sternir.com | www.sternir.com

    Source: Longeveron Inc

    Source: LGVN



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  5. MIAMI, Aug. 13, 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 and reported its financial results for the quarter ended June 30, 2021.

    "We continue to make excellent progress advancing our Lomecel-B clinical research programs forward," said Geoff Green, CEO of Longeveron. "Today we announced encouraging top-line results from our Phase 2b Aging Frailty trial evaluating the safety and efficacy of four different doses of Lomecel-B compared to placebo in Aging Frailty subjects. And, we anticipate announcing top-line results from our other Phase 1/2…

    MIAMI, Aug. 13, 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 and reported its financial results for the quarter ended June 30, 2021.

    "We continue to make excellent progress advancing our Lomecel-B clinical research programs forward," said Geoff Green, CEO of Longeveron. "Today we announced encouraging top-line results from our Phase 2b Aging Frailty trial evaluating the safety and efficacy of four different doses of Lomecel-B compared to placebo in Aging Frailty subjects. And, we anticipate announcing top-line results from our other Phase 1/2 Aging Frailty "HERA" trial this quarter. Furthermore, we anticipate initiation of a Phase 2 Alzheimer's disease trial and a Phase 2 Japan Aging Frailty trial later this year, and we are thrilled that the first subject was dosed this past June in the Phase 2 Hypoplastic Left Heart Syndrome trial."

    Mr. Green continued, "In July, we presented our Phase 1 Alzheimer's disease trial data at the Alzheimer's Association International Conference (AAIC), and have submitted a manuscript of the results for peer-review publication. We look forward to additional presentations regarding our various trials and data at the upcoming International Conference on Frailty and Sarcopenia Research (ICFSR) in late September, and the Gerontological Society of America's (GSA) Annual Scientific Meeting in November. Finally, we welcomed key personnel to our management team and board of directors, and look forward to a busy and productive second half of 2021."

    Business Update:

    Statistically Significant Data from Phase 2b Trial of Lomecel-B in Aging Frailty Subjects:

    • On August 13th, 2021 we announced the top-line results of the Phase 2b US Aging Frailty trial. One hundred and forty-eight (148) subjects were randomized and received 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 pre-specified statistical analysis plan involved a primary analysis and a secondary analysis:



      • Primary analysis of the primary efficacy endpoint: The primary analysis compared the change from baseline in 6MWT distance for the four Lomecel-B cohorts to the placebo cohort at Day 180. There were statistically significant increases in the highest 3 doses--50 million, 100 million and 200 million Lomecel-B cohorts--and no significant changes in the placebo or lowest dose of Lomecel-B (25 million=7.8 meters, p=0.5040; 50 million=35.8 meters, p=0.0053; 100 million=24.9 meters p=0.0443; 200 million=49.3 meters, p=0.0065; placebo=8.0 meters, p=0.5371). However, after adjusting for multiple comparisons using the Hochberg method (1988), the four Lomecel-B cohorts did not show a statistically significant placebo-adjusted difference (Δ) (25 million Δ=-0.2, p=0.9902; 50 million Δ=27.7, p=0.1279; 100 million Δ=16.8, p=0.3472; 200 million Δ=41.3, p=0.0635).
      • Secondary analysis of the primary efficacy endpoint: The secondary analysis was to determine whether a dose-response relationship exists using the multiple comparisons and modeling approach by Bretz et. al (2003). The results showed a clear, statistically significant dose-response curve at day 180. Among the various dose-response curves evaluated (Emax, Linear, Exponential, Quadratic, and Sigmoid Emax), all had p-values of less than 0.05, with the Sigmoid Emax model having the most significant dose-response relationship (p=0.0170).
      • Despite not achieving the statistical significance for the pairwise comparison to placebo at Day 180, significant differences from placebo were observed at Day 270, which was a pre-specified exploratory endpoint (25 million Δ=27.5, p=0.1530; 50 million Δ=49.2, p=0.0122; 100 million Δ=31.0, p=0.1071; 200 million Δ=63.4, p=0.0077).
      • The study's key secondary endpoints were day 180 change in the patient reported outcome questionnaire PROMIS—Physical Function—Short Form 20a (SF-20a) total score and day 180 change in serum levels of tumor necrosis factor alpha (TNF-α), an inflammatory cytokine. Lomecel-B cohorts did not show a statistically significant difference compared to the placebo cohort in the SF-20a score, and the TNF-α analysis is pending. The remainder of the endpoints, which included assessments of physical function, sexual function, fear and risk of falling, depression, cognition, frailty status, pulmonary function, and clinical outcomes, were considered exploratory and Lomecel-B-treated groups did not show significant differences versus placebo at most of the time points for any of the endpoints.
      • Lomecel-B infusion was safe and well-tolerated with no Serious Adverse Events reported that were considered related to the product.

    • The Company plans to present clinical data from the Aging Frailty Phase 2b trial at the 2021 International Conference on Frailty & Sarcopenia Research (ICFSR) on September 29th. ICFSR's scientific committee has invited the Company's scientists to present during a round table presentation.



    • The Company has submitted a manuscript for peer-reviewed publication on the Phase 2b trial design, and will present the trial design at the upcoming Gerontological Society of America's (GSA) Annual Scientific Meeting November 10-13 in Phoenix, AZ.



    Aging Frailty Phase 1/2 "HERA" Trial Data This Quarter; Japan Phase 2 On Track:

    • The Company expects to report top-line data this quarter from the recently completed Phase 1/2 Aging Frailty "HERA" trial evaluating Lomecel-B infusion effect on immune response in Aging Frailty subjects receiving the influenza vaccine.



    • The planned Japanese Aging Frailty Phase 2 trial is on track to initiate in the second half of 2021. This is an investigator-initiated randomized, placebo-controlled, double-blind single infusion study being conducted by our clinical partners at the National Center for Geriatrics & Gerontology (NCGG; Nagoya), and Juntendo University Hospital (Tokyo).



    • The Company submitted two abstracts that have been accepted for on demand presentations at the 2021 International Conference on Frailty & Sarcopenia Research (ICFSR) on September 29th:



      • OC34 • A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study in Japan to Investigate the Safety and Efficacy of Lomecel-B administration by Longeveron in subjects with Aging Frailty: Study Design and Rationale Kevin N. Ramdas, MD, Longeveron Inc., Miami, FL (USA)



      • OC58 • Study Design and Rationale for HERA: a Phase I/II Study Evaluating the Effects of Intravenous Delivery of Lomecel-B on Vaccine-Specific Antibody Responses in Subjects with Aging Frailty Kevin N. Ramdas, MD, Longeveron Inc., Miami, FL (USA)



    Positive Data from Alzheimer's Disease Phase 1 Study Presented at AAIC; Phase 2 Trial On Track:

    • An abstract outlining Longeveron's Phase 1 results of Lomecel-B infusion in Alzheimer's disease subjects was accepted for poster presentation at the 2021 Annual Alzheimer's Association International Conference (AAIC), which took place Jul 26-30, 2021. The Phase 1 study was funded by an Alzheimer's Association Part the Cloud Challenge on Neuroinflammation research grant award.



      • The results of the Phase 1 trial, which have been previously reported, showed that single intravenous infusion of Lomecel-B at 20 million and 100 million cell doses was safe and well tolerated, with no Serious Adverse Events (SAEs) reported that were considered related to the investigational product, nor any evidence of Amyloid Related Imaging Abnormalities (ARIA). Among other findings, subjects receiving the 20 million cell dose showed a statistically significantly slower rate of decline in cognitive function compared to placebo at 13 weeks and 39 weeks, as measured by the Mini Mental State Exam (MMSE) score.



      • A manuscript of the trial results has been submitted for peer-review and publication.



      • The Company will present the completed Phase 1 Alzheimer's Disease trial design at the upcoming Gerontological Society of America's (GSA) Annual Scientific Meeting November 10-13 in Phoenix, AZ.



    • Building from encouraging Phase 1 trial results, the Company anticipates initiation of a Phase 2 study in Alzheimer's disease subjects later this year. The Phase 2 trial is expected to be a randomized, placebo-controlled, trial designed to evaluate biomarkers, change in cognitive function, and other disease-specific endpoints. Further details about trial design, endpoints and target enrollment will be provided once the protocol is finalized.



    Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS)

    • On July 6, 2021 Longeveron announced that the first subject was administered Lomecel-B in the Phase 2 randomized, double-blind, controlled clinical trial evaluating Lomecel-B intraventricular injection in infants with HLHS. With a target enrollment of 38 infants, the trial will be enrolling in seven children's hospitals in major metropolitan centers located throughout the United States.



    • The trial's funding agency, the National Heart, Lung, and Blood Institute (NHLBI), approved the transition of the grant to UH3 phase, which means the program met its preliminary milestones and has been approved for full funding.



    • Top-line Phase 1 safety results (n=10), which have been previously reported by the Company, showed that intraventricular injection of Lomecel-B was safe and well tolerated, with no Major Adverse Cardiac Events (MACE), nor any treatment-related infections within the first 30 days post administration. The Company anticipates announcing additional data from this trial in Q3 2021.



    Lomecel-B for Acute Respiratory Distress Syndrome Due to COVID 19 Infection:

    • The Phase 1 trial continues to screen subjects at three participating centers in the U.S. The Company expects enrollment to continue through 2021, with results expected late 2022.



    Executive Appointments:

    • On May 18, 2021 Longeveron added the experience and skills of Dan Gincel, Ph.D. to its management team in the role of Senior Vice President, Strategic Collaborations & Scientific Affairs. Dan brings over 20 years leadership experience overseeing development and commercialization of regenerative medicines, including cell and gene therapies. He will be assisting Longeveron in evaluating strategic collaborations, both in the U.S. and abroad, as well as grant applications and strategy, and in-licensing new technologies to further progress and potentially expand the overall product pipeline.



    • On May 25, 2021 Longeveron welcomed the appointment of former federal U.S. District Court Judge Ursula Ungaro to its board of directors. In her time on the federal bench, Ms. Ungaro 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. At the time of joining Longeveron's board, Ms. Ungaro specifically remarked how propelling the growth and success of Longeveron was a key part of her decision to retire from the judiciary.



    Financial Results for Second Quarter Ended June 30, 2021

    Revenue: Revenue in the second quarter 2021 was $0.5 million compared to $0.9 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 in the second quarter of 2021 compared to zero revenue in the same period in 2020, an increase of $0.2 million, or 100%. During 2020, COVID-19-related travel restrictions into the Bahamas resulted in zero participation in the Registry, and although activity has increased in 2021, participation continues to be negatively impacted by COVID-19-related travel concerns.
    • Second quarter 2021 grant revenue was $0.3 million compared to $0.9 million in the same period in 2020, a decrease of $0.6 million, or 68%. The reduction in grant revenue is due to the completion of several grant-funded clinical trials.

    R&D Expenses: Research and development expenses in the second quarter of 2021 were $2.0 million compared to $0.7 million for the same period in 2020. The increase of $1.3 million, or 205%, was primarily due to an increase in research and development expenses that were not reimbursable by grants; including $0.8 million of equity-based compensation recorded for Restricted Stock Units ("RSUs") and stock options granted during the quarter.

    G&A Expenses: General and administrative expenses in the second quarter of 2021 were $3.3 million compared to $0.6 million for the same period in 2020. The increase of approximately $2.6 million, or 401%, was primarily related to an increase in compensation, insurance and professional expenses incurred during the current period; including $1.4 million of equity-based compensation recorded for RSUs and stock options granted during the quarter.

    Net Loss: Net loss was $5.0 million in the second quarter 2021 compared to $1.2 million for the same period in 2020.

    Per Share: Net loss per share was $0.26 in the second quarter 2021 compared to $0.08 for the same period in 2020.

    Cash: Cash on hand was $16.8 million compared to $0.8 million as of June 30, 2021 and 2020, respectively. The increase in cash period over period was the result of the completion of the Company's initial public offering in February of 2021.

    Financial Outlook

    Based on the Company's current operating plan and financial resources, we believe that our 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 8:00 a.m. Eastern Time to discuss the Company's second 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 + 44 208-068-2558 for international callers and using entry code 874656. An audio replay of the call will be available through August 19, 2021.

    A webcast of the call may be accessed from the "Events & Presentations" page on the Longeveron website at https://investors.longeveron.com/events-and-presentations/default.aspxby selecting today's date from the "Upcoming Events" calendar followed by the "Webcast" link that appears beneath. The recorded webcast will remain accessible for one year through August 13, 2022.



    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 Quarterly Report on Form 10-Q for the period ended June 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: Brendan.payne@sternir.com

    Source: Longeveron Inc

    Source: LGVN

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    LONGEVERON INC.

    SELECTED BALANCE SHEET DATA

    (in thousands)

       June 30, 2021 December 31, 2020
       (unaudited)  
    Cash  $16,833 $816
    Short-term investments   4,555  -
    Property and equipment   3,234  3,597
    Intangible assets   2,390  1,547
    Other assets   2,845  3,280
    Total assets  $29,857 $9,240
    Total liabilities   5,207  7,283
    Total members' equity and stockholders' equity   24,650  1,957
    Total liabilities, member's equity and stockholders' equity  

    $
    29,857 $9,240



    Longeveron Inc.

    Condensed Statements of Operations

    (In thousands, except per share data)

    (Unaudited)

      Three months ended

    June 30,
       Six months ended

    June 30,
      2021 2020   2021   2020  
    Revenues              
    Grant revenue $275  $868  $ 486  $1,814  
    Clinical trial revenue 214  -    379   762  
    Contract revenue -  8    -   8  
    Total revenues 489  876    865   2,584  
    Cost of revenues 281  764    508   1,660  
    Gross profit 208  112    357   924  
                   
    Operating expenses              
    General and administrative 3,257  649    5,460   1,335  
    Research and development 1,960  642    3,309   930  
    Selling and marketing 53  47    109   97  
    Total operating expenses 5,270  1,338    8,878   2,362  
    Loss from operations (5,062) (1,226)   (8,521)  (1,438) 
    Other income and (expenses)                
    Forgiveness of Paycheck Protection Program loan -  -    300   -  
    Interest expense (2) -    (1)  -  
    Other income, net 54  10    101   10  
    Total other income and (expenses), net 52  10    400   10  
    Net loss $(5,010) $(1,216) $ (8,121) $(1,428) 
    Basic and diluted net loss per share $(0.26) $(0.08) $ (0.44) $(0.09) 
    Basic and diluted weighted average common shares outstanding  19,005,007   15,970,421    

    18,252,219
       

    15,970,421
      

    Source: Longeveron Inc.

    Source: LGVN



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