1. MIAMI, Oct. 20, 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 the activation of two new clinical sites for the currently enrolling ELPIS II Trial, evaluating Lomecel-B injection into the myocardium of infants with Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect. Lomecel-B is an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured in Longeveron's cell processing facility in Miami, Florida.

    The two newly activated clinical sites, which join the Ann and Robert H. Lurie Children's…

    MIAMI, Oct. 20, 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 the activation of two new clinical sites for the currently enrolling ELPIS II Trial, evaluating Lomecel-B injection into the myocardium of infants with Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect. Lomecel-B is an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured in Longeveron's cell processing facility in Miami, Florida.

    The two newly activated clinical sites, which join the Ann and Robert H. Lurie Children's Hospital of Chicago (Principal Investigator Sunjay Kaushal, M.D., Ph.D.) as open for enrollment, are:

    • Advocate Children's Hospital
      • Principal Investigator: Narutoshi Hibino, M.D.
    • Primary Children's Hospital/University of Utah, Salt Lake City, Utah
      • Principal Investigator: S. Adil Husain, M.D.

    "We are pleased with the progress that Dr. Kaushal and the University of Texas Health Sciences Center are making in activating new clinical sites for enrollment," stated Longeveron CEO Geoff Green. "The addition of these exceptional institutions, as well as future sites to be activated, is important for both timely execution of the ELPIS II trial, as well as for providing more options for families with children with HLHS to participate in the research."

    About the ELPIS II Trial

    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 2b 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, M.D., Ph.D., 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 clinicaltrials.gov (NCT04925024), and www.elpistrial.org hosted by the University of Texas Health Sciences Center which serves as the data coordinating center.

    About the ELPIS I Trial

    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. The study met its primary endpoint, showing that intramyocardial injection of Lomecel-B at 2.5 × 106 cells/kg of body weight was well-tolerated, with no major adverse cardiac events (MACE), and no infections reported that were considered to be related to investigational treatment. The trial was partially funded by a grant from the Maryland Stem Cell Research Fund (MSCRF).

    About Hypoplastic Left Heart Syndrome

    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 creates a life-threatening condition due to the heart's inability to pump adequate amounts of blood throughout the body. Children must undergo a complex three-staged reconstructive surgery. Even with the advent of surgical intervention, babies with the condition still have a high rate of needing heart transplant, and are associated with high mortality. In the Phase 1 trial, the primary safety endpoint was met, with no major adverse cardiac events reported. The cell injections also did not cause infections attributable to the study product. Additional clinical safety and efficacy results from the Phase 1 trial are currently being analyzed.

    In HLHS patients, the right ventricle is subject to chronic pressure overload due to the lack of left ventricle, and thus becomes dysfunctional, leading to heart failure. It is believed that the primary therapeutic benefit of MSCs comes from the secretion of bioactive molecules that promote neovascularization, favorable remodeling, and activation of endogenous stem cells and cardiomyocytes, ultimately leading to potential improvement in cardiac structure, function, and durability.

    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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  2. MIAMI, Oct. 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, announced today that Geoff Green, Chief Executive Officer of Longeveron, will present at the Dawson James Small Cap Growth Conference on Thursday, October 21, 2021 at 11:25 a.m. ET in Jupiter, Florida.

    A live webcast of the presentation will be available via the Investors & Media section of the Company website. Following the live webcast, an archived replay of the webcast will be available on the website.

    Longeveron management will be conducting 1x1 meetings during the conference. To schedule a meeting, please visit…

    MIAMI, Oct. 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, announced today that Geoff Green, Chief Executive Officer of Longeveron, will present at the Dawson James Small Cap Growth Conference on Thursday, October 21, 2021 at 11:25 a.m. ET in Jupiter, Florida.

    A live webcast of the presentation will be available via the Investors & Media section of the Company website. Following the live webcast, an archived replay of the webcast will be available on the website.

    Longeveron management will be conducting 1x1 meetings during the conference. To schedule a meeting, please visit Dawson James Small Cap Growth Conference.

    Dawson James' flagship Small Cap Growth Conference will bring together senior executives from approximately 40 small-cap growth companies operating at the forefront of the healthcare, technology and consumer sectors. The conference brings together institutional funds, family offices and high-net-worth accredited investors. For more information on the conference and how to register, please visit https://dawsonjames.com/.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    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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    • Lomecel-B significantly decreased biomarker Tie-2 in Aging Frailty subjects at 270 days compared to placebo
    • Significant, dose-dependent decrease in Tie-2 at Day 270
    • Oral presentation today at the International Conference for Frailty & Sarcopenia Research

    MIAMI, Sept. 29, 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 preliminary top line results from ongoing biomarker analysis from the Company's Phase 2b trial of Lomecel-B investigational cell therapy in Aging Frailty subjects.

    Biomarker analysis, which is considered exploratory in this trial, revealed that administration…

    • Lomecel-B significantly decreased biomarker Tie-2 in Aging Frailty subjects at 270 days compared to placebo

    • Significant, dose-dependent decrease in Tie-2 at Day 270
    • Oral presentation today at the International Conference for Frailty & Sarcopenia Research

    MIAMI, Sept. 29, 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 preliminary top line results from ongoing biomarker analysis from the Company's Phase 2b trial of Lomecel-B investigational cell therapy in Aging Frailty subjects.

    Biomarker analysis, which is considered exploratory in this trial, revealed that administration of Lomecel-B was associated with a statistically significant reduction in serum levels of soluble TIE-2 (sTIE-2) in a dose-dependent fashion at Day 270 compared to placebo. The levels fell by -243.13 ± 1073.21 pg/mL for the combined Lomecel-B arms (95% CI -519.69, -93.61; p=0.0051) at 270 days as compared to an increase of 356.03 ± 1018.95 pg/mL in the placebo group (95% CI -4.06, 786.87; p=0.0524). The difference between the placebo and high dose Lomecel-B (200 million cells) is -936.85 pg/mL (95% CI -1640.27, -233.43; p=0.0095). It is known that reductions in sTIE-2 correlate with anti-inflammatory and pro-vascular effects [1, 2], while elevated levels of sTIE2 have been observed in patients with peripheral arterial disease (PAD) [3].

    TIE-2 is a cell surface receptor tyrosine kinase that can activate biochemical pathways to promote vascular (blood vessel) health [1, 2, 4]. This receptor is present on cells that line blood vessels, and protects against vascular leakage and inflammation [5, 6]. However, TIE-2 can be cleaved from the cell surface, which increases the levels of sTIE-2 in the blood stream [7]. As such, increased levels of sTIE-2 in the blood stream may be indicative of poor vascular health [3] and endothelial dysfunction [8, 9]. Since poor vascular health and endothelial dysfunction are associated with the onset and development of frailty in older adults [10, 11], the finding that Lomecel-B can reduce sTIE-2 suggests that improving vascular and endothelial function may be a potential mechanism of action of this product. This is the first time that a cell therapy has been associated with a reduction in sTIE-2 in the blood stream.

    The Company plans to further explore the Tie-2 changes in additional subject populations with Aging Frailty.

    Virtual Presentation

    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).

    Today's slide deck will be available on the Company's "Events & Presentations" page and the webcast of the presentation will be made available on the Company's website after the conference.

    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.

    References

    1.  Ghosh, C.C., et al., Gene control of tyrosine kinase TIE2 and vascular manifestations of infections. Proc Natl Acad Sci U S A, 2016. 113(9): p. 2472-7.

    2.  Han, S., et al., Amelioration of sepsis by TIE2 activation-induced vascular protection. Sci Transl Med, 2016. 8(335): p. 335ra55.

    3. Findley, C.M., et al., Plasma levels of soluble Tie2 and vascular endothelial growth factor distinguish critical limb ischemia from intermittent claudication in patients with peripheral arterial disease. J Am Coll Cardiol, 2008. 52(5): p. 387-93.

    4.  Maisonpierre, P.C., et al., Angiopoietin-2, a natural antagonist for Tie2 that disrupts in vivo angiogenesis. Science, 1997. 277(5322): p. 55-60.

    5.  Augustin, H.G., et al., Control of vascular morphogenesis and homeostasis through the angiopoietin-Tie system. Nat Rev Mol Cell Biol, 2009. 10(3): p. 165-77.

    6.  Kelly-Goss, M.R., et al., Dynamic, heterogeneous endothelial Tie2 expression and capillary blood flow during microvascular remodeling. Sci Rep, 2017. 7(1): p. 9049.

    7.  Reusch, P., et al., Identification of a soluble form of the angiopoietin receptor TIE-2 released from endothelial cells and present in human blood. Angiogenesis, 2001. 4(2): p. 123-31.

    8.  Idowu, T.O., et al., Identification of specific Tie2 cleavage sites and therapeutic modulation in experimental sepsis. Elife, 2020. 9.

    9.  Thamm, K., et al., Molecular Regulation of Acute Tie2 Suppression in Sepsis. Crit Care Med, 2018. 46(9): p. e928-e936.

    10. Alonso-Bouzon, C., et al., Association between endothelial dysfunction and frailty: the Toledo Study for Healthy Aging. Age (Dordr), 2014. 36(1): p. 495-505.

    11. Amarasekera, A.T., et al., Does vascular endothelial dysfunction play a role in physical frailty and sarcopenia? A systematic review. Age Ageing, 2021. 50(3): p. 725-732.

    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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  3. MIAMI, Sept. 28, 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's Lomecel-B research program will be featured in two presentations and a roundtable discussion at the 11th Annual International Conference on Frailty & Sarcopenia Research (ICFSR), taking place virtually September 29 - October 2, 2021. The ICFSR conference was created to speed the development of high-quality clinical trials in frail older adults with the goal of accelerating the discovery of treatments, prevention methods for healthy aging and prevention of disabilities and dependency…

    MIAMI, Sept. 28, 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's Lomecel-B research program will be featured in two presentations and a roundtable discussion at the 11th Annual International Conference on Frailty & Sarcopenia Research (ICFSR), taking place virtually September 29 - October 2, 2021. The ICFSR conference was created to speed the development of high-quality clinical trials in frail older adults with the goal of accelerating the discovery of treatments, prevention methods for healthy aging and prevention of disabilities and dependency in older adults.

    Roundtable details as follows:

    Title: Topline Results from the Phase 2b Study of Lomecel-B in Patients with Aging Frailty

    Presenter: Dr. Jorge Ruiz, M.D., Geriatrics Research Education and Clinical Center (GRECC), Miami VA Healthcare System

    Date: Wednesday, September 29, 2021

    Time: 11:30 – 12:10 p.m. ET

    A live panel with Dr. Ruiz and Longeveron management will follow the presentation.

    Oral presentation details and schedules are as follows:

    Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study in Japan to Investigate the Safety and Efficacy of Lomecel-B administration by Longeveron in patients with Aging Frailty: Study Design and Rationale.

    Abstract ID: OC34

    Date: Wednesday, September 29, 2021

    Time: 01:00 AM EST (release of on-demand recording)



    Title: 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.

    Abstract ID: OC58

    Date: Friday, October 1, 2021

    Time: 01:00 AM EST (release of on-demand recording)

    Those interested in registering for the conference can find more information at the conference website: https://frailty-sarcopenia.com/. All three presentations will be posted to Longeveron's website after the conference under "Events & Presentations" in the Investors section of the Company's website at investors.longeveron.com.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking 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

    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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  4. -- 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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  5. 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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  6. --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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  7. 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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  8. 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

    (tables follow)

    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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  9. -- Study meets one of the two analyses of primary efficacy endpoint: statistically significant dose-response in six-minute walk test (6MWT) at Day 180

    -- Longeveron to hold conference call today at 8:00 AM EDT

    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 announced results from the Company's Phase 2b 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"). Lomecel-B is a proprietary allogeneic product comprised of medicinal…

    -- Study meets one of the two analyses of primary efficacy endpoint: statistically significant dose-response in six-minute walk test (6MWT) at Day 180

    -- Longeveron to hold conference call today at 8:00 AM EDT

    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 announced results from the Company's Phase 2b 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"). 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. 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; sample size reflects any subject that was randomized and received an infusion) compared to placebo (n=30), on signs and symptoms of Aging Frailty, including mobility and exercise tolerance.

    The pre-specified statistical analysis plan for the primary efficacy endpoint, change in six-minute walk test distance at 180 days post-infusion, 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).

    "Improving physical function in older adults with frailty is one of the primary goals in geriatric medicine," said Dr. Jorge G. Ruiz, MD, geriatrician at the Miami Veterans Affairs Healthcare System, Geriatric Research, Education and Clinical Center (GRECC), the study site enrolling the largest number of subjects. "The fact that patients enrolled in this study, with an average age of 75 and with clear mobility limitations, showed 6-month and 9-month placebo-adjusted increases in walking distance of 40 meters and 63 meters, respectively (200 million cell dose), is significant for a number of reasons. Frailty is associated with poor clinical outcomes and high healthcare utilization and being able to improve and extend walking distance suggests preservation of function and potentially independence," Dr. Ruiz continued. "I would consider these results clinically significant and relevant for the older veteran population since one third of American Veterans older than 65 years have frailty."

    "We are very pleased to report a statistically significant dose response curve with our experimental cell therapy," commented Geoff Green, CEO of Longeveron Inc. "One of the main objectives of this trial was to determine whether a dose response relationship could be demonstrated in the primary efficacy endpoint, so this finding is important for the research program," Mr. Green continued. "Furthermore, the safety profile of Lomecel-B continues to look very good, with no Lomecel-B related Serious Adverse Events reported in this study, which is consistent with previous clinical trial data."

    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 efficacy 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.

    The main inclusion criteria for entry into the trial were subjects 70-85 years of age, a screening 6MWT of between 200 to 400 meters, a Canadian Health and Safety Assessment (CHSA) Clinical Frailty Scale score of 5 (mildly frail) to 6 (moderately frail), and a minimum serum TNF-α of ≥ 2.5 pg/mL.

    Longeveron plans to review the trial data during an upcoming steering committee comprised of independent frailty experts, and plan out next steps for the program. The Company plans to present clinical data from this trial at the 2021 International Conference on Frailty & Sarcopenia Research (ICFSR) on September 29th at 11:30 AM EDT during a round table presentation.

    Mr. Green said, "We look forward to engaging with our experts and potentially regulatory authorities to review the data and to advance into the next trial. I want to thank the subjects, their families, and physicians for their participation in this important study, and the NIH's National Institute on Aging for its generous support." Mr. Green added, "We are also expecting our Phase 1/2 "HERA" trial data this quarter, which is designed to evaluate Lomecel-B infusion's effect on immune response to influenza vaccination in Aging Frailty subjects, and we anticipate initiating the Phase 2 Japanese Aging Frailty this year."

    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.aspx by 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 the US Phase 2b Aging Frailty Trial:

    The primary objective of this multi-center study is to assess the effect of Lomecel-B on exercise tolerance and endurance via the six-minute walk test (6MWT). Additional endpoints include 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, various patient reported outcomes (PROs) and activities of daily living (ADLs), and blood-based biomarkers. 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 Phase 2b trial was conducted at eight hospitals and clinics, primarily in South Florida, including the Miami VA Healthcare System, and was funded by a Small Business Innovation Research (SBIR) grant from the NIH's National Institute on Aging (NIA).

    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 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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  10. WEST PALM BEACH, Fla., Aug. 11, 2021 /PRNewswire/ -- BioFlorida has announced five new board members who will support the organization's effort to grow the life sciences industry in Florida.

    "The life sciences industry in Florida is vibrant, and we're excited to welcome Thomas Equels of AIM ImmunoTech, Mark Friedman, PhD of Axogen, Geoff Green of Longeveron, Adam Grossman of ADMA Biologics, and Joe Sardano of Sensus Healthcare," said Nancy Bryan, President and CEO of BioFlorida. "Our new board members are leaders in their fields with a passion to unite with our diverse Board of Directors representing the various sectors and regions in Florida with a collective goal to advance the impressive, diverse life sciences ecosystem."

    Today, the life sciences industry in the state represents 6,700 establishments and research organizations in biopharmaceuticals, medical technology, healthIT and bioagriculture that collectively employ nearly 94,000 Floridians

    "BioFlorida provides Florida's life sciences industry with a venue to collaborate to address global health challenges," said Rob Herzog, Chair of the BioFlorida Board and Vice President of Research and Operations at Advent Health. "I look forward to working with our new board members to continue to build Florida as a life sciences destination."

    The new board members began their two-year term on January 1, 2021. The five new board members are:

    • Thomas K. Equels, CEO, AIM ImmunoTech (Ocala): Mr. Equels has served as the CEO of AIM ImmunoTech since February 2016, after serving as President since 2015. Mr. Equels' successful legal career included extensive experience in the pharmaceutical sector. He also has served as a court-appointed receiver turning around businesses in several different fields. Mr. Equels received his J.D. with high honors from Florida State University. He is a summa cum laude graduate with a B.S. and an M.S. from Troy University. Mr. Equels is also a highly decorated combat aviator, twice awarded the Distinguished Flying Cross, awarded the Purple Heart, the Bronze Star and 15 Air Medals, including three for extraordinary valor. In 2012, he was knighted by Pope Benedict as a knight of the Papal States. Mr. Equels received the BioFlorida Weaver H. Gaines Entrepreneur of the Year for 2020.
    • Mark L. Friedman, PhD, Vice President of Regulatory Affairs & Policy, Axogen, Inc. (Alachua): Dr. Friedman joined Axogen in September 2006, and has served as Vice President of Regulatory Affairs and Quality Assurance for Axogen since November 2011 and Axogen Corporation since June 2011, and previously served as Director of Quality Assurance and Regulatory Affairs from for Axogen Corporation. Prior to joining Axogen, Dr. Friedman held several regulatory and quality leadership positions at Enable Medical Corporation, a medical device company, including Director of Quality Assurance and Vice President of Quality and Regulatory. Dr. Friedman also worked for AtriCure, Inc., a company that develops, manufactures and sells surgical ablation systems to treat atrial fibrillation, as Vice President of Quality and Regulatory and as Vice President of Operations. AtriCure acquired Enable Medical in 2005. Dr. Friedman has over 30 years of experience in developing and directing regulatory strategy and quality systems for medical products, including 15 years with startup medical product firms. Dr. Friedman has a Ph.D. in Chemistry specializing in protein biochemistry from the University of Cincinnati.
    • Geoff Green, CEO, Longeveron, Inc. (Miami): Mr. Green has been with Longeveron (NASDAQ:LGVN) since 2016, and is a veteran of the life sciences and drug development industry. A versatile executive with a career spanning 25 years in both public and private companies, Mr. Green has held a variety of leadership roles throughout his time in the industry. Prior to joining Longeveron, he was VP of Operations at Partikula; VP, Business Development & Clinical Affairs at Accu-Break Pharmaceuticals; President and Acting CEO of DOR BioPharma (now Soligenix (NASDAQ: SNGX)); VP of Business Development & Operations at Heart Genomics; and Director of Clinical Affairs at Innovative Drug Delivery Systems. Early in his career he spent several years managing oncology clinical trials at Memorial Sloan-Kettering Cancer Center, and as a research associate at Paramount Capital, where Mr. Green managed clinical trials for several portfolio companies. Mr. Green received a B.A. in biology from Kenyon College, and an M.B.A. from Barry University's Andreas School of Business.
    • Adam S. Grossman, President & CEO, ADMA Biologics (Boca Raton): Mr. Grossman is a leader in the biopharmaceutical industry and has been the driving force behind ADMA Biologics' mission since its inception to develop and bring to market novel plasma derived products to address certain unmet medical needs for immune compromised patients. Mr. Grossman has over 25 years of experience in the blood and plasma products industry, which includes experience in launching new products, building and managing national and international sales forces, managing, and designing clinical trials as well as developing strategies and executing solutions to resolve complex quality assurance, biologics and pharmaceutical manufacturing and regulatory affairs issues. Additionally, he has negotiated and completed multiple business development and merger and acquisition transactions. Mr. Grossman is a member of the Plasma Protein Therapeutics Association North American Board and has been a member of the ADMA Biologics Board of Directors since 2007, has served as its President and CEO since October 2011, and was the President and COO between 2007 and October 2011. Mr. Grossman is a graduate of American University, receiving a B.S. in Business Administration, with a specialization in International Business and Marketing.
    • Joe Sardano, CEO, Chairman & Founder, Sensus Healthcare (Boca Raton): With over 35 years of management experience with such companies as CTI Molecular Imaging, GE Healthcare, Siemens Medical Systems, Elscint Inc, and Toshiba America Medical Systems, Mr. Sardano is a respected and recognized leader in the healthcare industry. He has been responsible for introducing and commercializing many new technologies and services, including PET and PET/CT, SPECT, MRI, Lithotripsy, Digital Radiography and Electronic Brachytherapy. Mr. Sardano established and led national and international sales and marketing organizations demonstrating consistent overachievement while driving customer centricity and market share. He has led several M & A initiatives from both the "seller" and "buyer" sides while establishing the processes for the integration of multi-faceted organizations and establishing their structures and "go to market" strategies. He currently is the President/CEO of Sensus Healthcare, a Medical Device company addressing the therapeutic treatments of NMSC and Keloid scars. He has been involved with many philanthropic organizations raising millions of dollars for Heart and Cancer research. Joe is originally from Montreal Canada where he graduated from Concordia University. He also attended McGill University, School of Management.

    "Our new BioFlorida board members bring invaluable expertise to BioFlorida's mission of progressing product and technological innovation that improves the lives and health of Floridians," said Rob Finizio, Vice Chair of the BioFlorida Board and CEO, Co-Founder and Director of TherapeuticsMD. "I look forward to how BioFlorida's board relationships expand employment in Florida's life science industry and overall nourish the economic interests of the state. I'm also looking forward to working closely with Rob Herzog as I make the transition to Board Chair of the BioFlorida Board of Directors in January 2022."

    The new BioFlorida board members join 31 current board members including: Mario Carranza (Nemours Children's Health System), David Day (DDay Ventures), Rob Herzog (AdventHealth), Emily Gresham (Florida International University), Norma Sue Kenyon (University of Miami), Valerie McDevitt (AdventHealth), Karen Moore (Moore), Adam Hunter (Cherry Bekaert), Jim O'Connell (University of Florida), Jarett Rieger (Moffitt Cancer Center & Research Institute), Raquel Rodriguez (Buchanan Ingersoll & Rooney PC), Svetlana Shtrom (University of Central Florida), David Smith (Akron Biotech), Holly Bates Snow (Amgen), Mark Strong (LifeLink), Sue Washer (AGTC), Julie Watson Lampley (Epstein Becker & Green, P.C.), David Conrad (University of South Florida), Charles Bruce (Mayo Clinic), Nancy Bryan (BioFlorida), Douglas Calder (Vycellix), Les Croland (Legal Counsel), Brian Dorn (Arthrex), Antonio J. Ferreira (Johnson & Johnson), Robert Finizio (TherapeuticsMD), Glenn Ladwig (Saliwanchik, Lloyd & Eisenschenk), Gregory Nelson (Fox Rothschild), Michael Paredes (Genentech), Steve Parkinson (Lakewood-Amedex), Juan Toro (Medtronic), and Juan Carlos Varela (Globant).

    About BioFlorida

    BioFlorida is the voice of Florida's life science industry, representing 6,700 establishments and research organizations in the biopharmaceutical, medical technology, and bioagriculture sectors that collectively employ 94,000 Floridians. BioFlorida's member driven initiatives provide a strong business climate for the advancement of innovative products and technology that improve lives and promote economic benefits to the state.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/bioflorida-announces-five-new-board-members-301353343.html

    SOURCE BioFlorida

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  11. MIAMI, Aug. 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, today announced that the Company will release its second quarter 2021 financial results on Friday, August 13, 2021 before the open of US markets. Management will host a conference call on the same day at 8:00 AM.

    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 of the call will be available through August 19, 2021.

    A webcast of…

    MIAMI, Aug. 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, today announced that the Company will release its second quarter 2021 financial results on Friday, August 13, 2021 before the open of US markets. Management will host a conference call on the same day at 8:00 AM.

    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 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.aspx, where you may also pre-register for the event. The recorded webcast will remain accessible for one year through August 13, 2022.

    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: Brendan.payne@sternir.com

    Source: Longeveron Inc

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  12. • Multicenter, double-blinded, controlled study designed to evaluate safety & efficacy of Lomecel-B intramyocardial injection in infants with HLHS

    • Funded by the National Heart, Lung and Blood Institute (Grant number 1UG3HL148318 and 1U24HL148316) in collaboration with Longeveron

    MIAMI, July 06, 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 the first patient has been enrolled and treated in the Phase 2b clinical study evaluating Lomecel-B intraventricular injection in infants with Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an investigational…

    • Multicenter, double-blinded, controlled study designed to evaluate safety & efficacy of Lomecel-B intramyocardial injection in infants with HLHS

    • Funded by the National Heart, Lung and Blood Institute (Grant number 1UG3HL148318 and 1U24HL148316) in collaboration with Longeveron

    MIAMI, July 06, 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 the first patient has been enrolled and treated in the Phase 2b clinical study evaluating Lomecel-B intraventricular injection in infants with Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured in Longeveron's cell processing facility in Miami, Florida.

    Longeveron' s HLHS program has transitioned to Phase 2, with a randomized, double-blind, controlled trial titled: Evaluation of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. (ELPIS II). The trial is being funded by a grant from the National Institute of Health's National Heart, Lung and Blood Institute (NHLBI), 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 will be enrolling in 7 children's hospitals in major metropolitan centers located throughout the U.S. For more information regarding the trial design and location of clinical sites please visit www.elpistrial.org hosted by the University of Texas Health Sciences Center which serves as the data coordinating center.

    "After demonstrating safety and feasibility in the successfully completed Phase 1 ELPIS trial, we are now embarking upon the next phase of development, which importantly includes a control arm for comparison against babies treated with Lomecel-B injection," remarked Dr. Kaushal. "Our hypothesis is that transplanted Lomecel-B medicinal signaling cells into the right ventricle as an adjunct to HLHS surgery will improve right ventricle structure and performance compared with surgery alone, potentially leading to a clinical benefit. We feel that this trial is a crucial step forward for developing cell-based therapy as an adjunct for surgery in HLHS."

    About Hypoplastic Left Heart Syndrome

    HLHS is a rare congenital heart defect that effects approximately 1,000 babies per year in the U.S. Babies with HLHS are born with an underdeveloped left ventricle, which creates a life-threatening condition due to the heart's inability to pump adequate amounts of blood throughout the body. Children must undergo a complex three-staged reconstructive surgery. Even with the advent of surgical intervention, babies with the condition still have a high rate of needing heart transplant, and is associated with high mortality. In the Phase 1 trial, the primary safety endpoint was met, with no major adverse cardiac events reported.  The cell injections also did not cause infections attributable to the study product. Additional clinical safety and efficacy results from the Phase 1 trial are currently being analyzed.

    In HLHS patients, the right ventricle is subject to chronic pressure overload due to the lack of left ventricle, and thus becomes dysfunctional, leading to heart failure. It is believed that the primary therapeutic benefit of MSCs comes from the secretion of bioactive molecules that promote neovascularization, favorable remodeling, and activation of endogenous stem cells and cardiomyocytes, ultimately leading to improvement in overall structure, function, and durability. The goal of Lomecel-B injection is reduced myocardial fibrosis, increased angiogenesis, and increased cardiomyocyte and endothelial cell proliferation.

    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 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.

    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.

    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

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  13. MIAMI, June 30, 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 two abstracts for Lomecel-B, the Company's investigational cell therapy being developed to treat aging-related life-threatening conditions, have been accepted for poster presentation at the Gerontological Society of America (GSA) 2021 Annual Scientific Meeting, being held November 10-14, 2021 in Phoenix, AZ. The full abstracts, including the dates and times of presentations, will be provided closer to the meeting once the GSA has provided these details to Longeveron. The titles of the presentations…

    MIAMI, June 30, 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 two abstracts for Lomecel-B, the Company's investigational cell therapy being developed to treat aging-related life-threatening conditions, have been accepted for poster presentation at the Gerontological Society of America (GSA) 2021 Annual Scientific Meeting, being held November 10-14, 2021 in Phoenix, AZ. The full abstracts, including the dates and times of presentations, will be provided closer to the meeting once the GSA has provided these details to Longeveron. The titles of the presentations are as follows:

    Title: A Phase 2b Clinical Trial Assessing Lomecel-B Infusion in Individuals with Aging Frailty: Study Design and Rationale.

    Abstract ID: 1027576 



    Title: A Phase 1 Trial Assessing Lomecel-B Infusion in Individuals with Alzheimer's Disease: Study Design and Rationale

    Abstract ID: 1028352

    Additional meeting information can be found on the GSA Annual Scientific Meeting website at www.gsa2021.org. Once published, the presented posters will also be available under "Events & Presentations" in the Investors section of the Company's website at investors.longeveron.com.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    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

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  14. MIAMI, June 24, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing cellular therapies for aging-related and chronic disease, announced today that an abstract summarizing the results of its Phase 1 trial of Lomecel-B infusion for patients with mild Alzheimer's disease has been accepted for a Developing Topics poster presentation at the 2021 Annual Alzheimer's Association International Conference, being held July 26-30, 2021 in Denver, CO and online.

    The abstract is titled "Safety and Efficacy of Lomecel-B in Patients with Mild Alzheimer's Disease: Results of a Double-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial." This 33 subject study was supported by two competitive…

    MIAMI, June 24, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing cellular therapies for aging-related and chronic disease, announced today that an abstract summarizing the results of its Phase 1 trial of Lomecel-B infusion for patients with mild Alzheimer's disease has been accepted for a Developing Topics poster presentation at the 2021 Annual Alzheimer's Association International Conference, being held July 26-30, 2021 in Denver, CO and online.

    The abstract is titled "Safety and Efficacy of Lomecel-B in Patients with Mild Alzheimer's Disease: Results of a Double-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial." This 33 subject study was supported by two competitive Part the Cloud Challenge on Neuroinflammation grants from the Alzheimer's Association. The previously announced results can be found on the "News and Events" page in the Investors section of Longeveron's website at investors.longeveron.com.

    "We are extremely pleased that the Alzheimer's Association has recognized our trial and data by giving us this opportunity to present the findings in poster presentation form at the prestigious AAIC," said Dan Gincel, Ph.D., Senior Vice President of Strategic Collaborations & Scientific Affairs at Longeveron. "The trial met its primary endpoint of demonstrating safety and feasibility, and importantly, no Alzheimer's Related Imaging Abnormalities (ARIA), after infusion with Lomecel-B. Furthermore, we were thrilled to observe that treatment with low-dose Lomecel-B slowed cognitive decline compared to the placebo group as measured by the Mini Mental State Exam (MMSE) score. As a result, we look forward to advancing Lomecel-B into a Phase 2 clinical trial in the second half of 2021."

    Information about the Annual Alzheimer's Association International Conference can be found at www.alz.org/aaic/overview.asp.

    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, 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, Inc.

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

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

    Source: Longeveron Inc

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  15. 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

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

    Source: Longeveron Inc

    Source: LGVN



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  16. 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

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

    Source: Longeveron Inc

    Source: LGVN 



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  17. 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.

    brendan.payne@sternir.com

    Source: Longeveron Inc

    Source: LGVN



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  18. 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: Brendan.payne@sternir.com

    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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  19. 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: Brendan.payne@sternir.com

    Source: Longeveron Inc

    Source: LGVN



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  20. Longeveron recently announced positive results from a Phase 1 study of Lomecel-B in Alzheimer's disease, and the completion of two Phase 2 clinical trials evaluating the safety and efficacy of Lomecel-B infusion in Aging Frailty subjects.

    Top-line results from the Aging Frailty studies are anticipated in Q3 2021

    MIAMI, May 05, 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 Chief Executive Officer Geoff Green will present at the Benzinga Global Small Cap Conference to be held on May 13-14, 2021. Complimentary investor registration can be accessed through…

    Longeveron recently announced positive results from a Phase 1 study of Lomecel-B in Alzheimer's disease, and the completion of two Phase 2 clinical trials evaluating the safety and efficacy of Lomecel-B infusion in Aging Frailty subjects.

    Top-line results from the Aging Frailty studies are anticipated in Q3 2021

    MIAMI, May 05, 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 Chief Executive Officer Geoff Green will present at the Benzinga Global Small Cap Conference to be held on May 13-14, 2021. Complimentary investor registration can be accessed through the conference link below. In addition to the corporate presentation, Mr. Green is an invited panelist for a session titled "Investing in Longevity Science: The New Drugs & Therapies Designed to Prolong Your Lifespan", scheduled for Thursday, May 13 at 1:20pm EDT.

    Event registration link:https://www.benzinga.com/events/small-cap/global/
      
    Presentation date:May 13, 2021
    Presentation time:2:10pm - 2:30pm EDT
      
    Panel:

    Investing in Longevity Science: The New Drugs & Therapies Designed to Prolong Your Lifespan
    Panel time:1:20pm - 1:50pm EDT

    Mr. Green will provide an overview of the Company‘s Aging Frailty clinical research, which spans four clinical programs in the United States, Japan and The Bahamas, and other indications including Alzheimer's disease.

    Designed to bridge the gap between small-cap publicly traded companies, investors and traders, the Benzinga Global Small Cap Conference enables executive leadership of small-cap biotech companies to network and communicate with a broad and diverse investor base in a virtual setting.

    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

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

    Source: Longeveron Inc

    Source: LGVN



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  21. MIAMI, April 27, 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, announces it 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…

    MIAMI, April 27, 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, announces it 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.

    Produced by the non-profit RMF, and in its 16th year, the World Stem Cell Summit is the most inclusive and expansive interdisciplinary, networking, and partnering meeting in the stem cell science and regenerative medicine field. With the overarching purpose of fostering translation of biomedical research, funding, and investments targeting cures, the Summit and co-located conferences serve a diverse ecosystem of stakeholders.

    Geoff Green, CEO of Longeveron, stated, "We are honored to present at this prestigious event, joining leading experts from around the world to discuss new cell-based therapies aimed at treating or reversing chronic aging-related diseases and conditions, as well as potentially extending healthspan."

    Longeveron's Aging Frailty clinical research, which spans four clinical programs across the United States, Japan and The Bahamas, is focused on evaluating cellular therapies derived from young healthy adult donors to repair, regenerate and restore tissue and function in elderly individuals.

      

    "We look forward to sharing our respective experience and latest research surrounding our Lomecel-B cell therapy in addressing key aging-related diseases and conditions such as Aging Frailty and Alzheimer's Disease," said Mr. Green. "In addition to our recently announced positive results from a Phase 1 study in Alzheimer's disease, we have completed two Phase 2 randomized, placebo-controlled double-blind clinical trials evaluating the safety and efficacy of Lomecel-B infusion in Aging Frailty subjects. We look forward to announcing the top-line results of our Aging Frailty studies in the third quarter of this year."

    In addition to the Company's US Aging Frailty research, Longeveron sponsors a Treatment Registry Trial in Nassau, The Bahamas, where eligible participants with either frailty, mild cognitive impairment, or Alzheimer's disease may receive Lomecel-B infusion at their own expense. Longeveron is also preparing for a Phase 2 Aging Frailty trial to initiate this year in Japan. Lomecel-B is considered an investigational therapy in Japan, the US and The Bahamas.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com

    Source: Longeveron Inc

    Source: LGVN 



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  22. Study intended to evaluate safety, and potential immunomodulatory effect of Lomecel-B on aging-associated decline in antibody response to vaccines in vulnerable population.

    Trial funded in part by a grant from Maryland Technology Development Corporation (TEDCO) and the National Institute on Aging (NIA) of the National Institutes of Health (NIH)

    Top-line data expected in Q3 2021

    MIAMI, April 15, 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 the completion of the Company's Phase I/II clinical study of the use of Lomecel-B to improve immune response to influenza…

    Study intended to evaluate safety, and potential immunomodulatory effect of Lomecel-B on aging-associated decline in antibody response to vaccines in vulnerable population.

    Trial funded in part by a grant from Maryland Technology Development Corporation (TEDCO) and the National Institute on Aging (NIA) of the National Institutes of Health (NIH)

    Top-line data expected in Q3 2021

    MIAMI, April 15, 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 the completion of the Company's Phase I/II clinical study of the use of Lomecel-B to improve immune response to influenza ("flu") vaccine in subjects with Aging Frailty. Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured under current good manufacturing practices (cGMP) by Longeveron.

    The two-phase, 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 Fund (MSCRF) under the Maryland Technology Development Corporation (TEDCO) and the National Institute on Aging (NIA).

    It is well established that an aging immune system is less effective at producing protective antibodies following vaccination, and this reduced immune response contributes to the aging process in general (referred to as "inflammaging" by geriatricians). People with aging frailty are more prone to inflammaging and are more likely to have greater susceptibility to infectious diseases and reduced responses to vaccination. Although commercially available vaccines against influenza provide protection and likely lasting immunological memory in children and adults, they are much less effective in older and frail individuals.

    Lomecel-B has the potential to reduce inflammation associated with Aging Frailty, and to promote an anti-inflammatory state by releasing anti-inflammatory molecules, which can balance the immune system and improve the function of B lymphocytes. As B cells are responsible for antibody production in response to vaccines, Lomecel-B may boost antibody generation and immunity following vaccination in subjects with Aging Frailty.

    It is anticipated that the top-line trial results will be announced in the 3rd quarter of 2021. In the open-label Phase I trial, elderly subjects considered to be mild-to-moderately frail per the Clinical Frailty Scale were randomized to receive a single peripheral intravenous (i.v.) infusion of Lomecel-B either one week or four weeks before administration of the flu vaccine to evaluate whether timing of administration of Lomecel-B relative to the vaccine resulted in a significant difference in immune response. Based on the phase 1 results, administration of Lomecel-B one week in advance of flu vaccination was selected for the Phase II randomized, placebo-controlled trial. In Phase II, a total of 39 subjects were enrolled and treated, with 20 receiving placebo and 19 receiving Lomecel-B. The primary objectives of the study were to assess safety, and efficacy of Lomecel-B to improve response to flu vaccine through measurement of serum antibodies. 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.

    "Completion of this clinical study to investigate Lomecel-B as a new therapeutic approach to boost immune response serves as an important initial step to meet the critical unmet medical need for those with Aging Frailty, who often respond poorly to vaccines," said Sean Leng, MD, PhD, Professor of Medicine, Molecular Microbiology and Immunology at Johns Hopkins University School of Medicine and Bloomberg School of Public Health and the study's principal investigator.

    "This is an important milestone in Longeveron's overall Aging Frailty research program and commitment to finding biological solutions for aging. The Longeveron clinical trial spectrum includes our Phase 2b Aging Frailty study that completed in February, our Phase 2 Japanese Aging Frailty study which we intend to initiate this year, and our Aging Frailty Treatment Registry Trial in Nassau, Bahamas," stated Geoff Green, CEO of Longeveron. "From the inception of Longeveron, we have focused our efforts on using a regenerative medicine approach to treat chronic, aging-related diseases and conditions, such as frailty and Alzheimer's disease, with the goal of improving healthspan."

      

    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 by some as an extreme form of unsuccessful aging. Clinically, frailty manifests as a combination of symptoms and signs that include loss of muscle and decreased strength, slowed walking, low physical activity and energy levels, poor endurance, nutritional deficiencies, weight loss and fatigue. Aging Frailty is also associated with chronic low-level inflammation that also impairs the function of the immune system. 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. A consequence of the impaired immune function (i.e. B lymphocytes) in frail individuals is a significantly reduced ability to effectively produce antibodies and generate immunity in response to vaccination. Therefore, improving immunity in this population may reduce the associated adverse health outcomes.   

    Treatment of Aging Frailty and promotion of healthy 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 for Aging Frailty or for improving immunity in response to vaccination in the frail elderly.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com

    Source: Longeveron Inc



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  23. Study meets primary safety endpoint; positive secondary efficacy assessments support potential benefit from Lomecel-B

    Decline in cognitive function slower in patients who received low-dose Lomecel-B as compared with placebo

    Quality of life metrics improved with Lomecel-B compared to placebo

    Complete results being prepared for publication.

    On track to initiate Phase 2 study in the second half of 2021.

    MIAMI, April 13, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) announced today the final results of its Phase I clinical study evaluating 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…

    Study meets primary safety endpoint; positive secondary efficacy assessments support potential benefit from Lomecel-B

    Decline in cognitive function slower in patients who received low-dose Lomecel-B as compared with placebo

    Quality of life metrics improved with Lomecel-B compared to placebo

    Complete results being prepared for publication.

    On track to initiate Phase 2 study in the second half of 2021.

    MIAMI, April 13, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) announced today the final results of its Phase I clinical study evaluating 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. Preliminary results were previously reported in the Company's S-1/A Registration Statement as part of Longeveron's successful Initial Public Offering in the first quarter of 2021. The study met its primary safety endpoint, which paves the way for future trials in subjects with Alzheimer's disease. Importantly, several pre-specified secondary efficacy endpoints and biomarker results support potential benefit from Lomecel-B. The complete trial results are currently being prepared for publication in a peer-reviewed journal, and will be posted on the Company's website in the future. Longeveron also indicated they are on track to commence a Phase 2 study of Lomecel-B in Alzheimer's disease in the second half of 2021.

    The phase 1 trial, funded in part by an Alzheimer's Association Part the Cloud Challenge on Neuroinflammation grant, used a randomized, placebo-controlled double-blind design testing single i.v. infusion of Lomecel-B 20 million cells ("low-dose"; (n=15)), Lomecel-B 100 million cells ("high-dose"; n=10)), or placebo (n=8). Subjects were followed for 52 weeks post-infusion.

    Key findings from new and previously disclosed data:

    • Lomecel-B infusion was well-tolerated in this trial, with no treatment-related serious adverse events observed throughout the 1-year follow-up, including no indications of amyloid-related imaging abnormalities (ARIA) as assessed by magnetic resonance imaging (MRI);
    • The average Mini Mental State Exam (MMSE) score, which is a measure of cognitive function, declined more slowly in the low-dose Lomecel-B group compared to the placebo group. At 13 weeks after infusion, the low-dose Lomecel-B group MMSE score was higher (better) compared to placebo (difference of 2.69 ± 1.39 points; p=0.0182; 2-sided 95% CI 0.51 – 4.97);
    • At 26 weeks post-infusion, patients in the low-dose Lomecel-B arm showed a significantly higher (better) average score on the Quality of Life in Alzheimer Disease (QOL-AD) compared to placebo (difference of 3.85 ± 1.943 points; p=0.0444; 2-sided 95% CI 0.13 – 9.12);
    • At 26 weeks post-infusion, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL), a measure of competence in basic and instrumental activities of daily living, was significantly higher (better) in the low-dose Lomecel-B group compared to placebo (difference of 6.95 ± 3.46 points; p=0.0118; 95% CI 1.99 – 13.94);  
    • Biomarkers:
      • Subjects receiving Lomecel-B had significantly increased serum levels of several pro-vascular biomarkers (VEGF, IL4, and IL-6) relative to the placebo group post-infusion.
      • There was a significant increase in D-dimer in the high-dose, but not low-dose, Lomecel-B arm versus placebo;
      • Subjects receiving Lomecel-B had significantly increased serum levels of several anti-inflammatory cytokines (sIL-2Rα, IL-4, IL-10 and IL-12) relative to the placebo group post-infusion;
      • There were no significant changes in the Lomecel-B arms versus the change in placebo for any of neuronal-related biomarkers examined;
      • MRIs showed a significant increase in change in left hippocampus volume in the high-dose Lomecel-B arm versus the change in placebo group at Week 13 (p=0.0311). By Week 26, the difference was no longer significant. The low dose Lomecel-B arm showed no significant difference versus placebo.

    Geoff Green, Chief Executive Officer of Longeveron, stated, "We are pleased and encouraged by the results of this study, which indicate preliminary safety, and potential efficacy of Lomecel-B in mild Alzheimer's disease, and we look forward to initiating our Phase 2 trial in the second half of this year."  

    "I am excited about the potential for this new approach to the treatment of Alzheimer's disease. The use of Lomecel-B cells approaches therapy in a unique and novel way. We are treating the underlying problem of inflammation and possibly stimulating the brain to try to repair itself. These positive results, which includes improved patient reported outcomes, encourages us to continue to look at this approach to the treatment of this devastating degenerative brain disease," said Barry Baumel, MD, of the University of Miami Miller School of Medicine and principal investigator on the study.

    "The study results provide support for our hypothesis that Lomecel-B can potentially reduce Alzheimer's disease associated brain inflammation, improve the function of blood vessels in the brain, reduce brain damage due to Alzheimer's disease progression, and promote regenerative responses," said Anthony Oliva, PhD, of Longeveron. Gary Small, MD, of Hackensack Meridian Health, a member of Longeveron's AD Program Steering Committee, stated, "The results are encouraging that Lomecel-B has potential to eventually become a safe and effective treatment for AD."

    Regarding the MRI findings, Susan Bookheimer, PhD, of the UCLA School of Medicine, and also a member of Longeveron's AD Program Steering Committee, commented that "while preliminary, the MRI results are very promising in suggesting that Lomecel-B may reduce brain damage due to Alzheimer's disease progression, and promote regenerative responses."

    About Alzheimer's Disease

    Fifty million people worldwide currently have dementia, which is a progressive decline in cognitive functioning that can interfere with daily activities, and eventually lead to a loss of independence and death over the course of years. The most common form of dementia is Alzheimer's disease, which is characterized by pathological hallmarks or beta amyloid deposits (also called "plaques") and neurofibrillary tangles in the brain. Some early signs of Alzheimer's disease may include: memory loss; confusion about time and places; impaired problem solving and planning abilities; difficulty with speaking, writing clearly and completing familiar tasks; impaired ability to understand visual images and spatial relationships; and mood or personality changes. In the US alone, approximately 5.4 million people suffer from Alzheimer's disease, and this number is projected to increase to 14 million by 2050 according to the Alzheimer's Association, a leading non-profit organization for dementia research. The cost of care for these patients is already stressing healthcare systems, not to mention the enormous toll it takes on families and care-givers.

    There is thus an urgent need for finding effective treatments for Alzheimer's disease and related dementias. However, there are currently no approved medications that can slow-down, stop, or reverse the progression of Alzheimer's disease. Only 5 medications have received FDA approval for Alzheimer's disease, and none significantly alter the course of disease progression. Three of these (donepezil, galantamine and rivastigmine) fall into a class of drugs called "cholinesterase inhibitors," and another, memantine, is in a class of drugs called "NMDA receptor antagonists." All four of these work by altering the communication between the cells of the brain (these are called neurons). The fifth medication is a combination of two of these drugs (donepezil and memantine). With the exception of these above 5 drugs (which do not appear to ameliorate disease progression), we have witnessed decades of failed attempts to develop small molecule drugs for treating Alzheimer's disease.

    Potential of Lomecel-B for Treating Alzheimer's Disease

    Medicinal Signaling Cells (MSCs), as the main ingredient of Lomecel-B, have numerous mechanisms of action that may potentially treat the complex pathology associated with Alzheimer's disease. Beyond the hallmarks of beta amyloid deposits (plaques) and neurofibrillary tangles, Alzheimer's disease is also characterized by inflammation in the brain (referred to as "neuroinflammation"), poor functioning of the blood vessels of the brain ("neurovasculature dysfunction"), and degeneration of brain cells ("neurodegeneration"), among other features. The properties of MSCs can potentially treat all of these aspects of Alzheimer's disease pathology, and preclinical studies support this conclusion. Using mouse models of Alzheimer's disease, MSCs were shown to be able to decrease inflammation in the brain, promote break-down and clearance of Aβ (the protein component of beta amyloid), decrease the protein that causes neurofibrillary tangles, promote new nerve cell formation ("neurogenesis"), and improve cognitive/behavioral performance.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com



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  24. MIAMI, March 30, 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 reported its financial results for the quarter and full year ended December 31, 2020 and provided a business update.

    Primary Accomplishments in 2020:

    • Received approval from U.S. Food and Drug Administration (FDA) to proceed with Phase 1 clinical trial for Acute Respiratory Distress Syndrome (ARDS) related to either COVID-19 or Influenza infection. This trial initiated in mid-2020 and continues to enroll subjects.
    • Received a $650,000, two-year Maryland Stem Cell Research Fund TEDCO Grant Award for ARDS COVID-19/Influenza…

    MIAMI, March 30, 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 reported its financial results for the quarter and full year ended December 31, 2020 and provided a business update.

    Primary Accomplishments in 2020:

    • Received approval from U.S. Food and Drug Administration (FDA) to proceed with Phase 1 clinical trial for Acute Respiratory Distress Syndrome (ARDS) related to either COVID-19 or Influenza infection. This trial initiated in mid-2020 and continues to enroll subjects.
    • Received a $650,000, two-year Maryland Stem Cell Research Fund TEDCO Grant Award for ARDS COVID-19/Influenza Phase 1 trial.
    • Treated two COVID-19-related ARDS subjects with Lomecel-B infusion under FDA-approved expanded access ("compassionate use") protocol.
    • Lomecel-B approved for Phase 2 Aging Frailty clinical trial by Japanese Pharmaceutical and Medical Devices Agency (PMDA) through a Clinical Trial Notification (CTN) application filed by Japan's National Center for Geriatrics & Gerontology.
    • Successfully completed Phase 1 trial in subjects with Alzheimer's Disease. Preliminary top-line results were included in the Company's S-1 Registration Statement filed with the SEC in February 2021. Final results will be announced in the second quarter of 2021, and a Phase 2 trial is expected to commence in the second half of 2021.
    • Lomecel-B Phase 2 HLHS program awarded a $4.5M multiyear grant award from the National Heart, Lung and Blood Institute (NHLBI).
    • Revenue increased in 2020 from both grants and clinical trial (Bahamas Registry Trial) revenue sources, compared to 2019.

    Highlights from Q1 2021:

    • Completed $29.1 million Initial Public Offering, including partial exercise of over-allotment, and concurrent listing on Nasdaq.
    • Successfully completed 150 subject Phase 2b clinical study of Lomecel-B infusion for Aging Frailty, with top-line trial results anticipated in the third quarter of 2021.
    • Successfully completed Phase 1 clinical study of Lomecel-B intramyocardial injection in Hypoplastic Left Heart Syndrome (HLHS) subjects, with full results expected in the second quarter of 2021, and Phase 2 trial expected to commence in second half of 2021.
    • Granted expanded access ("compassionate use") approval by the U.S. FDA for the administration of Lomecel-B to a child with HLHS. Lomecel-B was administered peri-operatively via intramyocardial injection, and the child was discharged from the hospital and is currently being followed per protocol.
    • Expanded enrollment criteria for the Phase 1 ARDS "RECOVER" trial to include mild ARDS, in addition to moderate and severe ARDS.
    • Expanded and amended the exclusive license agreement (ELA) related to Lomecel-B technology rights with the University of Miami (UM) and entered into a Cooperative Research and Development Agreement (CRADA) with UM.

    "We are proud of the significant progress made throughout 2020 and into 2021, including our successful IPO in February, which has positioned Longeveron with a stronger balance sheet and the ability to continue to advance the diverse Lomecel-B pipeline of trials," stated Geoff Green, Chief Executive Officer of Longeveron. "The Company was founded with the goal of developing safe and effective "off-the-shelf" cell therapies that could be used to treat chronic aging-related disease, improve health span and potentially extend longevity. In 2020, in conjunction with our funding partner, the Alzheimer's Association, we completed a Phase 1 Alzheimer's disease trial. We are extremely pleased with the safety and preliminary efficacy results. We look forward to announcing the final results in the second quarter of 2021 and initiating the planned Phase 2 multidose trial later this year. Additionally, both of our US Aging Frailty Phase 2 trials will have top line efficacy data available in the 3rd quarter of 2021. This will be very exciting year for Longeveron, with several clinical trial and clinical data-driven catalysts on the near horizon."

    Longeveron's Aging Frailty research program spans 5 clinical programs in 3 different countries, and includes two US randomized, placebo-controlled Phase 2 trials, a sub-study of the effects of Lomecel-B in Aging Frailty subjects with Metabolic Syndrome, a Japanese Phase 2 study pending initiation, and a Treatment Registry Trial in Nassau, The Bahamas.

    "The Japanese PMDA has approved a Phase 2 clinical trial of Lomecel-B infusion in Japanese Aging Frailty subjects, which we expect to initiate in 2021. This trial will be led by the National Center for Geriatrics and Gerontology, the Japanese equivalent to the National Institute on Aging in the US. Similar to our US Phase 2b trial, the objective of this trial is to evaluate the ability for Lomecel-B infusion to improve physical mobility and endurance in Aging Frailty subjects 70 to 85 years of age. Japan is a "super-aged" society and preventing and treating frailty is a priority for the nation. With its progressive and favorable regulatory framework for regenerative medicine products, Japan offers several expedited pathways to market, including conditional marketing approval, at the option of Japanese health regulators, after Phase 2, and a hospital-based approval that is a self-pay model known in Japan as the Act on the Safety of Regenerative Medicine, or ASRM route."

    In 2020, despite the fact that travel into The Bahamas was only allowed for approximately 5 months due to COVID-19, the Company's Treatment Registry Trial participation and revenue exceeded all of 2019. This reflects increased momentum and demand for participation in the Registry, which the Company anticipates will continue as travel begins to return to normal activity.

    The Company's current exception to its focus on chronic aging-related disease is the research program for children born with Hypoplastic Left Heart Syndrome (HLHS), a rare congenital heart defect that affects about 1,000 babies per year. In that program, Lomecel-B is administered via direct injection into the heart during pre-planned standard-of-care reconstructive surgery. In February 2021, the Company announced the completion of a 10 subject Phase 1 safety study, funded in part by a Maryland Stem Cell Research Fund TEDCO grant, and preparation for the Phase 2 randomized, placebo-controlled study are underway. The NHLBI is the funding partner for the Phase 2 study, and it will be conducted through a consortium of leading pediatric cardiac surgeons in the US, led by Dr. Sunjay Kaushal at the Lurie Children's Hospital in Chicago, Illinois.

    The net proceeds from the recent IPO enable the Company to complete current ongoing clinical trials, and to initiate at least 4 additional Phase 2 clinical trials, with 3 of those 4 trials expected to initiate this year: Japan Aging Frailty Phase 2 Trial; multidose Alzheimer's disease Phase 2 trial, and HLHS Phase 2 trial.

    Financial Results:

    Fourth Quarter Ended December 31, 2020 and 2019

    Revenue: Total revenue, consisting of revenue from grants and clinical trials (from our Bahamas Registry Trial) was $1.2 million for the fourth quarter of 2020, compared to revenue of $1.8 million for the fourth quarter of 2019. This decrease was a result of a decrease in grant revenue of $0.8 million for 2020 as compared to the same period in 2019, which was expected and is a function of the pre-planned timing of release of funds according to the terms of the various grants. Revenue from our Bahamas Registry Trial increased by $0.3 million or 119% for 2020 as compared to the same period in 2019; despite international travel being severely negatively impacted by COVID-19.

    R&D Expenses: Research and development expenses were $1.2 million for the fourth quarter of 2020, compared to $0.3 million for the fourth quarter of 2019. The increase was primarily due to an increase in research and development expenses that were not reimbursable by grants.

    G&A Expenses: General and administrative expenses were $0.7 million for the fourth quarter of 2020 and 2019, respectively.

    Net Loss: Net loss was $1.4 million for the fourth quarter of 2020, compared to $0.5 million for the fourth quarter of 2019.

    Years Ended December 31, 2020 and 2019

    Revenue: Total revenue, consisting of revenue from grants, clinical trials (from our Bahamas Registry Trial), and contract manufacturing, was $5.6 million for the years ended December 31, 2020, and 2019. Grant revenue was $4.3 million for the year ended December 31, 2020, compared to $4.1 million for the year ended December 31, 2019. Revenue from the Bahamas Registry Trial was $1.3 million for the year ended December 31, 2020, compared to $1.2 million for the year ended December 31, 2019. Contract manufacturing revenue was $0.1 million for the year ended December 31, 2020, compared to $0.3 million for the year ended December 31, 2019. This decrease was primarily due to COVID-19 related decrease in travel, which restricted the business development and marketing of these services.

    R&D Expenses: Research and development expenses were $2.7 million for the year ended December 31, 2020, compared to $1.8 million for the year ended December 31, 2019. The increase was primarily due to an increase in research and development expenses that were not reimbursable by grants. We expect that our research and development expenses will increase in the future as we increase our headcount to support increased research and development activities relating to our clinical programs, as well as incur additional expenses related to our clinical trials.

    G&A Expenses: General and administrative expenses were $2.7 million for the year ended December 31, 2020, compared to $2.8 million for the year ended December 31, 2019. Expenses remained relatively consistent for 2020 compared to 2019; general and administrative expenses consisted primarily of rent, professional fees, insurance, and paid and accrued compensation costs. We expect that our general and administrative expenses will increase in the future as we increase our headcount to support increased administrative activities relating to our becoming a public company. We also expect to incur additional expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements; director and officer insurance costs; and investor and public relations costs.

    Net Loss: Net loss was $3.7 million for the year ended December 31, 2020, compared to $3.0 million for the year ended December 31, 2019.

    Cash: Cash as of December 31, 2020 was $0.8 million, compared to $1.9 million as of December 31, 2019.

    Financial Outlook

    Our cash in the first quarter of 2021 was increased by the $29.1 million (gross) in funds received from our IPO. As of March 30, 2021, our cash position was $24.5 million. We believe, based on the current operating plan and financial resources, 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 8:30 a.m. Eastern Time to discuss its fiscal 2020 financial results and provide a business update.

    The conference call will be available via telephone by dialing toll free 1-855-979-6654 for U.S. callers or +44 20-3936-2999 for international callers and using entry code 094408. 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 of the call will be available through April 6, 2021 and can be accessed here and by entering the access code: 40245, and will remain online for one year through March 30, 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 SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com

    Since the corporate conversion to a Delaware "C" corporation occurred on February 11, 2021, as part of the IPO, the Financial Statements presented for December 31, 2020 and 2019 are for a limited liability company (LLC).

    LONGEVERON LLC

    SELECTED BALANCE SHEET DATA

     As of December 31,
     2020 2019
    Cash$815,800  $1,865,874 
    Total assets 9,240,044   10,584,415 
    Total liabilities 7,282,977   6,139,373 
    Total members' equity 1,957,067   4,445,042 



    LONGEVERON LLC

    STATEMENTS OF OPERATIONS

     For the Years Ended December 31,
     2020  2019 
    Revenues:     
    Grant revenue$4,260,605  $4,149,044 
    Clinical trial revenue 1,313,500   1,199,500 
    Contract manufacturing revenue 55,426   290,922 
    Total revenues 5,629,531   5,639,466 
    Costs of revenues 3,803,261   3,885,390 
    Gross profit 1,826,270   1,754,076 
          
    Operating expenses:     
    General and administrative 2,731,174   2,774,953 
    Research and development 2,674,370   1,791,842 
    Selling and marketing 199,003   185,387 
    Total operating expenses 5,604,547   4,752,182 
          
    Loss from operations (3,778,277)  (2,998,106)
          
    Other income 57,469   38,229 
          
    Net loss$(3,720,808) $(2,959,877)

    Source: Longeveron, Inc.



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  25. MIAMI, March 26, 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 it will host a conference call at 8:30 a.m. Eastern Time on Tuesday, March 30, 2021 to discuss its fiscal 2020 financial results and provide a business update.

    The conference call will be available via telephone by dialing toll free 1-855-979-6654 for U.S. callers or +44 20-3936-2999 for international callers and using entry code 094408. 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…

    MIAMI, March 26, 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 it will host a conference call at 8:30 a.m. Eastern Time on Tuesday, March 30, 2021 to discuss its fiscal 2020 financial results and provide a business update.

    The conference call will be available via telephone by dialing toll free 1-855-979-6654 for U.S. callers or +44 20-3936-2999 for international callers and using entry code 094408. 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 of the call will be available through April 6, 2021 and can be accessed here and by entering the access code: 40245, and will remain online for one year through March 30, 2022.         

    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:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com 



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  26. MIAMI, March 15, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or the "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced that the underwriters of its previously completed initial public offering of Class A common stock have partially exercised their over-allotment option to purchase an additional 250,000 shares. The thirty-day over-allotment option was granted in connection with the Company's initial public offering of 2,660,000 shares of Class A common stock at a public offering price of $10.00. After giving effect to the partial exercise of the over-allotment option, the total number of shares sold by Longeveron…

    MIAMI, March 15, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or the "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced that the underwriters of its previously completed initial public offering of Class A common stock have partially exercised their over-allotment option to purchase an additional 250,000 shares. The thirty-day over-allotment option was granted in connection with the Company's initial public offering of 2,660,000 shares of Class A common stock at a public offering price of $10.00. After giving effect to the partial exercise of the over-allotment option, the total number of shares sold by Longeveron in the offering increased to 2,910,000 shares, resulting in aggregate gross proceeds of $29,100,000 prior to deducting underwriting discounts, commissions, and other offering expenses.

    Kingswood Capital Markets, division of Benchmark Investments, Inc., acted as sole book-runner for the offering. Alexander Capital L.P. acted as co-manager.

    Buchanan Ingersoll & Rooney PC acted as counsel to the Company. Nelson Mullins Riley & Scarborough LLP acted as counsel to the underwriters.

    The Securities and Exchange Commission ("SEC") declared effective a registration statement on Form S-1 relating to these securities on February 11, 2021. A final prospectus relating to this offering was filed with the SEC. Copies of the final prospectus relating to this offering can be obtained at the SEC's website at www.sec.gov or from Kingswood Capital Markets, division of Benchmark Investments Inc., 17 Battery Place, Suite 625, New York, NY 10004, Attention: Syndicate Department, or via email at syndicate@kingswoodcm.com or telephone at (212) 404-7002.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: (212) 671-1020

    Email: lgvn@crescendo-ir.com



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  27. MIAMI, March 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, announced today that the U.S. Food & Drug Administration (FDA) has granted expanded access approval for the administration of Longeveron's investigational cell therapy Lomecel-B to a child with Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured under cGMP in Longeveron's cell processing facility in Miami, Florida. Dr. Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery at Ann & Robert H. Lurie Children's Hospital…

    MIAMI, March 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, announced today that the U.S. Food & Drug Administration (FDA) has granted expanded access approval for the administration of Longeveron's investigational cell therapy Lomecel-B to a child with Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured under cGMP in Longeveron's cell processing facility in Miami, Florida. Dr. Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery at Ann & Robert H. Lurie Children's Hospital of Chicago will administer Lomecel-B during a reconstructive cardiac surgery procedure.

    FDA's Expanded Access program, also called "compassionate use," provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. The Lurie Children's Hospital Internal Review Board (IRB) also reviewed and approved the protocol.

    Dr. Kaushal was the first surgeon in the United States to administer allogeneic MSCs to a baby with HLHS. "The rationale for this approach is to improve the functioning of the right ventricle, the only ventricle in these babies, through regeneration of cardiac tissue. Our goal is to make it pump as strongly as a normal left ventricle," says Dr. Kaushal. "We are grateful to FDA, Lurie Children's Hospital IRB, and Longeveron for making this happen, and we are hoping this therapy will be a game-changer for this baby and others in the future."

    "Our goal is to provide a new way to treat HLHS and we believe, based on previous studies, that the MSCs in Lomecel-B may improve ventricular and vascular function," stated Geoff Green, CEO of Longeveron.

    HLHS is a rare congenital heart defect that effects approximately 1,000 babies per year in the U.S. Babies with HLHS are born with an underdeveloped left ventricle, which impairs the heart's ability to pump adequate amounts of blood throughout the body. Without a three-staged reconstructive surgery, the condition is often fatal. Even with surgery, HLHS is still associated with high mortality and a high rate of cardiac failure necessitating heart transplantation.

    Recently, Longeveron announced the successful completion of its Phase 1 clinical study of Lomecel-B intramyocardial injection in HLHS patients. The study was conducted by a consortium of leading pediatric cardiac surgeons at centers that included the University of Maryland Medical Center, University of Cincinnati/Children's Hospital Medical Center and University of Utah Primary Children's Hospital, and was supported in part by a Maryland Stem Cell Research Fund TEDCO Grant. The intramyocardial injection of Lomecel-B was well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B were reported. The Phase 1 safety results have enabled Longeveron to advance its HLHS program into a Phase 2 multi-center trial, with a randomized, double-blind, placebo-controlled trial scheduled to begin in the third quarter of 2021, and is led by Dr. Kaushal as the Principal Investigator, and funded by the National Heart, Lung and Blood Institute.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com



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  28. MIAMI, March 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 the Company has expanded and amended its exclusive license agreement (ELA) related to Lomecel-B technology rights, and entered into a Collaborative Research and Development Agreement (CRADA) with the University of Miami (UM).

    On November 20, 2014, the Company entered into an ELA with UM for the use of medicinal signaling cell (MSC) technology rights developed at UM by the Company's Chief Science Officer, Joshua Hare, M.D., who is also founding director of the Interdisciplinary Stem Cell Institute…

    MIAMI, March 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 the Company has expanded and amended its exclusive license agreement (ELA) related to Lomecel-B technology rights, and entered into a Collaborative Research and Development Agreement (CRADA) with the University of Miami (UM).

    On November 20, 2014, the Company entered into an ELA with UM for the use of medicinal signaling cell (MSC) technology rights developed at UM by the Company's Chief Science Officer, Joshua Hare, M.D., who is also founding director of the Interdisciplinary Stem Cell Institute at the UM Miller School of Medicine. The expanded and amended ELA includes the following:

    • Two Investigational New Drug (INDs) applications, and all associated research data:
      • BB-IND 15,679: allogeneic human mesenchymal stem cells for Aging Frailty
      • BB-IND 16,045: allogeneic human mesenchymal stem cells for treatment of Hypoplastic Left Heart Syndrome
    • Patent application for methods for treating endothelial dysfunction;
    • Exclusive option to obtain a license to additional intellectual property related to treatment of HLHS and dilated cardiomyopathy;
    • Modification of milestone payments and payment deadlines owed to UM.

    Geoff Green, CEO of Longeveron, stated, "Our relationship with the University of Miami extends back to the founding of Longeveron, and this arrangement gives Longeveron access to additional clinical data to support its development programs and regulatory filings, strengthens the relationship between UM and Longeveron, and facilitates future technology transfer arrangements between the two entities." Mr. Green continued: "I am thrilled to see this CRADA instituted between UM and Longeveron as a means to streamline future technology transfers that are mutually beneficial to the University and the Company."  

    Norma Sue Kenyon, Ph.D., Vice Provost for Innovation at the University of Miami and Chief Innovation Officer of the Miller School of Medicine, commented, "We are excited to expand our collaboration with Longeveron as they have continued to effectively execute against key milestones. Moreover, following the recent IPO to Nasdaq, we believe Longeveron is well capitalized to further advance the platform. These technologies, originally developed by Dr. Hare and his team at the University of Miami, address very significant market opportunities. We believe Longeveron is the ideal partner to advance these technologies through clinical development in order to achieve the ultimate goal of helping patients with severe life-threatening and quality of life issues."

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com



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  29. MIAMI, March 05, 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 enrollment criteria for its Phase 1 Acute Respiratory Distress Syndrome (ARDS) RECOVER trial has been expanded to include mild ARDS, in addition to moderate and severe ARDS. Previously, only ARDS patients intubated with an endotracheal tube for positive pressure ventilation were eligible. The protocol amendment allows for the inclusion of milder cases of ARDS patients who present with the need for supplemental oxygen via high flow nasal cannula, partial or nonrebreathing mask, or non-invasive positive…

    MIAMI, March 05, 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 enrollment criteria for its Phase 1 Acute Respiratory Distress Syndrome (ARDS) RECOVER trial has been expanded to include mild ARDS, in addition to moderate and severe ARDS. Previously, only ARDS patients intubated with an endotracheal tube for positive pressure ventilation were eligible. The protocol amendment allows for the inclusion of milder cases of ARDS patients who present with the need for supplemental oxygen via high flow nasal cannula, partial or nonrebreathing mask, or non-invasive positive pressure mask.

    The RECOVER Trial is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of up to 3 intravenous administrations of either Lomecel-B (allogeneic bone marrow-derived medicinal signaling cells) or placebo in COVID-19 or Influenza-infected ARDS patients. The primary measures of efficacy are functional lung recovery, recovery from infection, inflammatory status, immune status, and lung imaging.

    "The goal here is to reduce the inflammatory response and to either prevent the need for mechanical support, or to allow these individuals to come off of the ventilator and leave the ICU," stated Joe G. N. "Skip" Garcia, MD, a world-renowned pulmonologist and professor of medicine at the University of Arizona College of Medicine. ARDS resulting from COVID-19 or Influenza is driven by severe inflammation, called a cytokine storm. This can lead to accumulation of fluid in the lungs and severe tissue damage, and ultimately decreased ability to oxygenate the blood. The most severe cases lead to respiratory failure and the high mortality rate from COVID-19. Longeveron's Lomecel-B has the potential to reduce the cytokine storm involved in ARDS and thus the possibility to improve clinical outcomes in COVID-19 patients.

    The RECOVER Trial received a prestigious TEDCO award from the Maryland Stem Cell Research Fund (MSCRF) to help support the Phase 1 study.    This is Longeveron's third TEDCO Award since 2017.

    Participating clinical centers currently include the Miami VA Health System, University of Maryland Medical Center, and Wake Forest University Hospital. The Company is in the process of expanding the number of participating clinical sites. Any clinical sites or investigators interested in learning more about participating in the phase 1 trial should contact: Kevin Ramdas, MD, MPH, Associate Director, Medical Affairs; kramdas@longeveron.com.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com



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  30. Trial funded in part by a National Institute on Aging Small Business Innovation Research (SBIR) Grant

    Trial objectives include evaluation of Lomecel-B's effect on physical function, mobility, strength, balance, endurance, fear and risk of falling, inflammatory biomarkers and clinical outcomes

    Top-line data expected in Q3 2021

    MIAMI, March 03, 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 the completion of the Company's Phase 2b clinical study of Lomecel-B infusion for Aging Frailty subjects. Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling…

    Trial funded in part by a National Institute on Aging Small Business Innovation Research (SBIR) Grant

    Trial objectives include evaluation of Lomecel-B's effect on physical function, mobility, strength, balance, endurance, fear and risk of falling, inflammatory biomarkers and clinical outcomes

    Top-line data expected in Q3 2021

    MIAMI, March 03, 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 the completion of the Company's Phase 2b clinical study of Lomecel-B infusion for Aging Frailty subjects. Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured under cGMP in Longeveron's cell processing facility in Miami.

    The multicenter study was conducted at 8 hospitals and clinics, primarily in South Florida, including the Miami VA Healthcare System, and was supported in part by a Small Business Administration Grant (SBIR) grant from the NIH's National Institute on Aging (NIA).

    It is anticipated that the top-line trial results will be announced in the 3rd quarter of 2021. Trial subjects were randomized to receive a single peripheral intravenous infusion of Lomecel-B (25 million, 50 million, 100 million or 200 million cells), or placebo, followed by a 52 week observation period to evaluate safety and efficacy. A total of 149 subjects were treated, and the primary objective of the study is to assess the effect of Lomecel-B treatment on exercise tolerance and endurance via the six-minute walk test (6MWT). Additional endpoints include 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.

    "Completion of our Phase 2b clinical study of Lomecel-B Infusion to treat Aging Frailty marks a major milestone for the Company," commented, Geoff Green, Chief Executive Officer of Longeveron. "We are grateful to the exceptional clinical trial sites, our partner the National Institute on Aging, and of course the subjects for their participation in this study. We are committed to developing safe and effective cell therapies for chronic aging-related diseases and life-threatening conditions, and we look forward to sharing the trial data later this year."



    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.

    Lomecel-B for the Potential Treatment of Aging Frailty

    Aging Frailty (and aging in general) is characterized by diminished number and function of circulating MSCs. Therefore, treatments that can positively affect and/or replenish these endogenous stem cell functions could be of therapeutic value for Aging Frailty. Lomecel-B has the potential to reduce inflammation associated with Aging Frailty, and to promote an anti-inflammatory state by releasing anti-inflammatory molecules, which can promote physiological restoration to a more normal state.

    Longeveron's Aging Frailty clinical research program is one of the most extensive in the world currently, with two ongoing Phase 2 clinical studies in the United States, a Treatment Registry Trial in Nassau, Bahamas, and a pending Phase 2 clinical trial set to initiate in Japan this year.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com



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  31. Intramyocardial injection of Lomecel-B well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B reported

    Full results of the Phase 1 clinical trial expected to be released in Q2 2021

    Phase 2 trial expected to commence in Q3 2021

    MIAMI, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, is pleased to announce completion of the Company's Phase 1 clinical study of Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell product manufactured under cGMP in Longeveron's…

    Intramyocardial injection of Lomecel-B well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B reported

    Full results of the Phase 1 clinical trial expected to be released in Q2 2021

    Phase 2 trial expected to commence in Q3 2021

    MIAMI, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, is pleased to announce completion of the Company's Phase 1 clinical study of Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell product manufactured under cGMP in Longeveron's cell processing facility in Miami.

    The study was conducted by a consortium of leading pediatric cardiac surgeons at centers that included the University of Maryland Medical Center, University of Cincinnati/Children's Hospital Medical Center and University of Utah Primary Children's Hospital, and was supported in part by a Maryland Stem Cell Research Fund TEDCO Grant.

    The Phase 1, open-label single arm study was designed to assess safety and tolerability of intramyocardial injection of Lomecel-B administered to 10 children with HLHS during the Stage 2 bidirectional cavopulmonary anastomosis (BDCPA, or "Glenn procedure") surgery. HLHS is a rare congenital heart defect that effects approximately 1,000 babies per year in the U.S. Babies with HLHS are born with an underdeveloped left ventricle, which impairs the heart's ability to pump adequate amounts of blood throughout the body. Without a three-staged reconstructive surgery, the condition is often fatal. Even with surgery, HLHS is still associated with high mortality. Intramyocardial injection of Lomecel-B at doses of 2.5 × 105 cells/kg of body weight was shown to be well-tolerated, with no major cardiac events, and no serious adverse events reported that were considered to be related to the investigational therapy.

    The Phase 1 safety results have enabled Longeveron to advance its HLHS program into a Phase 2 multi-center trial, with a randomized, double-blind, placebo-controlled trial scheduled to begin in the third quarter of 2021. The Phase 2 trial which will study 32 patients nationwide is being funded by a $5.6M grant from the National Institute of Health's National Heart, Lung and Blood Institute (NHLBI), and is led by Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery at Lurie Children's Hospital of Chicago.

    The full results of the Phase 1 clinical trial are expected to be released in Q2 2021.     

    "We are extremely excited and gratified to have completed Phase 1 and to be able to transition so efficiently to phase 2 for this program," stated Dr. Kaushal. "Babies with HLHS are very seriously ill and require multiple open-heart operations. This program is designed around helping their hearts recover from this complicated congenital heart disease. We are excited about moving this program forward and potentially adding a key therapeutic in the recovery of these kids."

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com



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  32. MIAMI, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced that Geoff Green, Chief Executive Officer of Longeveron, has been invited to give a presentation titled "A Regenerative Medicine Approach to Aging Frailty" at the Intercontinental Summit on Aging & Gerontology being held virtually on March 8, 2021. He will discuss Longeveron's ongoing clinical research program in Aging Frailty and Alzheimer's disease, in addition to the regenerative medicine investigational clinical research field in general for diseases and conditions associated with aging.

    The Intercontinental…

    MIAMI, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced that Geoff Green, Chief Executive Officer of Longeveron, has been invited to give a presentation titled "A Regenerative Medicine Approach to Aging Frailty" at the Intercontinental Summit on Aging & Gerontology being held virtually on March 8, 2021. He will discuss Longeveron's ongoing clinical research program in Aging Frailty and Alzheimer's disease, in addition to the regenerative medicine investigational clinical research field in general for diseases and conditions associated with aging.

    The Intercontinental Summit on Aging & Gerontology is hosted by the Sciinov Group and helps participants from universities and institutions to network with world-class scientists. This all-day online event unites researchers, scientists, and academicians to discuss and share knowledge in the emerging field of Aging & Gerontology.

    Information about the event can be found by visiting: agingcongress.com. A copy of the Company's presentation will also be available on the Company's website at: www.longeveron.com.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com



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  33. MIAMI, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the appointments of Douglas Losordo, M.D., Erin Borger, and Cathy Ross to the Company's Board of Directors.

    Douglas Losordo, MD
    Dr. Losordo has worked in the biotech industry for over twenty years, most recently serving as Executive Vice President, Head of Research and Development and Chief Medical Officer of KBP Biosciences Inc. Dr. Losordo was previously the Executive Vice President, Global Head of Research and Development, Chief Medical Officer of Caladrius Biosciences (NASDAQ:CLBS), a clinical-stage…

    MIAMI, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the appointments of Douglas Losordo, M.D., Erin Borger, and Cathy Ross to the Company's Board of Directors.

    Douglas Losordo, MD

    Dr. Losordo has worked in the biotech industry for over twenty years, most recently serving as Executive Vice President, Head of Research and Development and Chief Medical Officer of KBP Biosciences Inc. Dr. Losordo was previously the Executive Vice President, Global Head of Research and Development, Chief Medical Officer of Caladrius Biosciences (NASDAQ:CLBS), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse chronic disease, from August 2013 until November 2020. Dr. Losordo has extensive knowledge of clinical, regulatory, manufacturing, supply chain and commercial factors unique to cellular therapy technologies as a result of his prior industry experience. Dr. Losordo's also previously served as a Professor of Medicine at NYU Langone Medical Center and Northwestern University's Feinberg School of Medicine. He received his MD from the University of Vermont College of Medicine, and his B.A. in Zoology from the University of Vermont.

    Erin Borger

    Mr. Borger is a Managing Director in Wealth Management at UBS Financial Services Inc., where he has worked since 2008. Throughout the years Mr. Borger has also served as a member on a number of medical and non-medical boards and committees, such as the Alzheimer's Association South Florida, Cystic Fibrosis Foundation, Palisades Medical Center and the University of Miami, Miller School of Medicine, to name a few. Additionally, Mr. Borger has spent a number of years helping to support non-profit organizations with a focus in the medical field through various research and financial support. Mr. Borger received his B.A. in Sociology from Wofford College, and also holds a number of securities licenses from the Financial Industry Regulatory Authority.

    Cathy Ross

    Ms. Ross is a senior finance executive with over 30 years of experience. Since 2016, she has been a member of the Board of Directors and Chair of the Audit Committee of Fraud.Net, Inc., a privately held company that operates a real-time fraud detection and analytics platform. From 2006 to 2012, she was the Chief Financial Officer, President, and a member of the Board of Directors of MotherNature.com, a privately held online retailer and information source for vitamins, supplements, minerals and healthy products. In her role as Chief Financial Officer of MotherNature.com, she managed all aspects of accounting, budgeting and financial reporting. Prior to that, she served as Managing Director, Private Equity of Oasis Capital Partners, Vice President, Investment Banking and Public Offerings of Commonwealth Associates, Product Development and Marketing Manager of Ocwen Financial Corporation, and a Senior Credit Analyst for Chase Manhattan Bank. Ms. Ross earned a Bachelor of Arts Degree, Economics from Brown University in 1989.

    The appointments of the new directors took effect in connection with the Company's recent initial public offering and listing on the Nasdaq.

    Geoff Green, CEO of Longeveron, stated, "We are delighted to announce the appointments of such prominent industry leaders to our board. Each is highly accomplished in their respective fields and are valuable additions as we begin life as a public company, and continue to make progress toward the goal of developing cell therapies for aging-related chronic disease and life-threatening conditions."

    About Longeveron

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com 



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  34. MIAMI, Feb. 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 the pricing of an underwritten initial public offering of 2,660,000 shares of common stock at a public offering price of $10.00 per share for aggregate gross proceeds of $26,600,000 prior to deducting underwriting discounts, commissions, and other offering expenses. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 399,000 shares at the public offering price less the underwriting discounts and commissions. The offering is expected to close on February…

    MIAMI, Feb. 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 the pricing of an underwritten initial public offering of 2,660,000 shares of common stock at a public offering price of $10.00 per share for aggregate gross proceeds of $26,600,000 prior to deducting underwriting discounts, commissions, and other offering expenses. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 399,000 shares at the public offering price less the underwriting discounts and commissions. The offering is expected to close on February 17, 2021, subject to satisfaction of customary closing conditions.

    The Company has received approval to list its common stock on the Nasdaq Capital Market under the symbol "LGVN", with trading expected to begin on February 12, 2021.

    Kingswood Capital Markets, division of Benchmark Investments, Inc., is acting as sole book-runner for the offering. Alexander Capital L.P. is acting as co-manager.

    Buchanan Ingersoll & Rooney PC is acting as counsel to the Company. Nelson Mullins Riley & Scarborough LLP is acting as counsel to the underwriters.

    The Securities and Exchange Commission ("SEC") declared effective a registration statement on Form S-1 relating to these securities on February 11, 2021. A final prospectus relating to this offering will be filed with the SEC. When available, copies of the final prospectus relating to this offering can be obtained at the SEC's website at www.sec.gov or from Kingswood Capital Markets, division of Benchmark Investments Inc., 17 Battery Place, Suite 625, New York, NY 10004, Attention: Syndicate Department, or via email at syndicate@kingswoodcm.com or telephone at (212) 404-7002. Before investing in this offering, interested parties should read in their entirety the prospectus, which provides more information about the Company and such offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Longeveron Inc.

    Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's lead investigational product is the LOMECEL-B™ cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.

    Forward-Looking Statements

    Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email: lgvn@crescendo-ir.com



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