Hypoplastic Left Heart Syndrome

MIAMI, March 19, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, announced today that the Company’s Board of Directors has approved a 1-for-10 reverse split of the Company’s Class A common stock, par value $0.001 per share and Class B common stock, par value $0.001 per share (the “common stock”) (the “Reverse Split”). The Reverse Split was previously approved by the Company’s stockholders at a special meeting held on February 21, 2024 The Reverse Split will legally take effect at 11:59 p.m. Eastern Time, on March 26, 2024. The Company’s Class A common stock will open for trading under a new CUSIP number 54303L 203 on The Nasdaq Capital Market on March 27, 2024, on a split-adjusted basis under the current ticker symbol “LGVN.” The Reverse Split is intended to increase the per share trading price of the Company’s common stock to enable the Company to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Reverse Split will automatically convert every ten current shares of the Company’s common stock, whether issued and outstanding or held by the Company as treasury stock, into one share of fully paid and nonassessable common stock. No fractional shares will be issued in connection with the Reverse Split. Stockholders of record who would otherwise be entitled to receive a fractional share of the Company’s common stock following the Reverse Split will be entitled to rounding up of the fractional share to the nearest whole number. The Reverse Split will reduce the aggregate number of shares of outstanding Class A common stock from approximately 10,295,426 shares to approximately 1,029,543 shares, and the number of shares of outstanding Class B common stock from approximately 14,839,993 shares to approximately 1,484,000 shares (based on outstanding shares as of March 18, 2024). The total authorized number of shares will remain unchanged. The terms of all outstanding warrants currently exercisable for shares of Class A common stock, and all equity awards granted under the Company’s equity plans, including the per share exercise price of options and the number of shares issuable under such options, will be proportionally adjusted to maintain their economic value, subject to adjustments for any fractional shares as described above. In addition, the total number of shares of shares of common stock that may be the subject of future grants under the Company’s equity plans, as well as any plan limits on the size of such grants will be adjusted and proportionally decreased as a result of the Reverse Split. Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-Reverse Split shares. Stockholders owning shares through a bank, broker, or other nominee will have their positions automatically adjusted to reflect the Reverse Split, subject to brokers’ particular processes, and will not be required to take any action in connection with the Reverse Split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Colonial Stock Transfer Company, Inc., will send instructions for exchanging those certificates for shares held electronically in book-entry form or for new certificates, in either case representing the post-Reverse Split number of shares, including the impact of any rounding to the nearest whole number of shares in lieu of fractional shares, if applicable. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™ an allogeneic Mesenchymal Stem Cell (MSC) formulation sourced from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action that promote tissue repair and healing with broad potential applications across a spectrum of disease areas. The underlying mechanism(s) of action that may lead to the tissue repair programs include the stimulation of new blood vessel formation, modulation of the immune system, reduction in tissue fibrosis, and the stimulation of endogenous cells to divide and increase the numbers of certain specialized cells in the body. Longeveron is currently pursuing three pipeline indications: Hypoplastic Left Heart Syndrome, Alzheimer’s disease, and Aging-related Frailty. Additional information about the Company is available at www.longeveron.com. Forward-Looking StatementsCertain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, 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. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the Company’s expectations regarding the effect of the Reverse Split and its continued listing on Nasdaq. 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. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our limited operating history and lack of products approved for commercial sale; adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; a history of losses and may not be able to achieve profitability going forward; no FDA-approved allogenic, cell-based therapies for Aging-related Frailty, AD, or other aging-related conditions, nor HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; the use of our product candidates or future products in individuals may expose us to product liability claims, and we may not be able to obtain adequate product liability insurance; if our trade secret and patent position does not adequately protect our product candidates and their uses, others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; intellectual property rights do not necessarily address all potential threats to our competitive advantage; inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; the volatility of price of our Class A common stock; we could lose our listing on the Nasdaq Capital Market if our current share price continues to decrease; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. 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 Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended on Form 10-K/A on March 11, 2024 and its Quarterly Reports on Form 10-Q. 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 ContactMike MoyerLifeSci AdvisorsTel: 617-308-4306Email: mmoyer@lifesciadvisors.com

MIAMI, March 19, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, announced today that the Company’s Board of Directors has approved a 1-for-10 reverse split of the Company’s Class A common stock, par value $0.001 per share and Class B common stock, par value $0.001 per share (the “common stock”) (the “Reverse Split”). The Reverse Split was previously approved by the Company’s stockholders at a special meeting held on February 21, 2024 The Reverse Split will legally take effect at 11:59 p.m. Eastern Time, on March 26, 2024. The Company’s Class A common stock will open for trading under a new CUSIP number 54303L 203 on The Nasdaq Capital Market on March 27, 2024, on a split-adjusted basis under the current ticker symbol “LGVN.” The Reverse Split is intended to increase the per share trading price of the Company’s common stock to enable the Company to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Reverse Split will automatically convert every ten current shares of the Company’s common stock, whether issued and outstanding or held by the Company as treasury stock, into one share of fully paid and nonassessable common stock. No fractional shares will be issued in connection with the Reverse Split. Stockholders of record who would otherwise be entitled to receive a fractional share of the Company’s common stock following the Reverse Split will be entitled to rounding up of the fractional share to the nearest whole number. The Reverse Split will reduce the aggregate number of shares of outstanding Class A common stock from approximately 10,295,426 shares to approximately 1,029,543 shares, and the number of shares of outstanding Class B common stock from approximately 14,839,993 shares to approximately 1,484,000 shares (based on outstanding shares as of March 18, 2024). The total authorized number of shares will remain unchanged. The terms of all outstanding warrants currently exercisable for shares of Class A common stock, and all equity awards granted under the Company’s equity plans, including the per share exercise price of options and the number of shares issuable under such options, will be proportionally adjusted to maintain their economic value, subject to adjustments for any fractional shares as described above. In addition, the total number of shares of shares of common stock that may be the subject of future grants under the Company’s equity plans, as well as any plan limits on the size of such grants will be adjusted and proportionally decreased as a result of the Reverse Split. Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-Reverse Split shares. Stockholders owning shares through a bank, broker, or other nominee will have their positions automatically adjusted to reflect the Reverse Split, subject to brokers’ particular processes, and will not be required to take any action in connection with the Reverse Split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Colonial Stock Transfer Company, Inc., will send instructions for exchanging those certificates for shares held electronically in book-entry form or for new certificates, in either case representing the post-Reverse Split number of shares, including the impact of any rounding to the nearest whole number of shares in lieu of fractional shares, if applicable. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™ an allogeneic Mesenchymal Stem Cell (MSC) formulation sourced from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action that promote tissue repair and healing with broad potential applications across a spectrum of disease areas. The underlying mechanism(s) of action that may lead to the tissue repair programs include the stimulation of new blood vessel formation, modulation of the immune system, reduction in tissue fibrosis, and the stimulation of endogenous cells to divide and increase the numbers of certain specialized cells in the body. Longeveron is currently pursuing three pipeline indications: Hypoplastic Left Heart Syndrome, Alzheimer’s disease, and Aging-related Frailty. Additional information about the Company is available at . Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, 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. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the Company’s expectations regarding the effect of the Reverse Split and its continued listing on Nasdaq. 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. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our limited operating history and lack of products approved for commercial sale; adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; a history of losses and may not be able to achieve profitability going forward; no FDA-approved allogenic, cell-based therapies for Aging-related Frailty, AD, or other aging-related conditions, nor HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; the use of our product candidates or future products in individuals may expose us to product liability claims, and we may not be able to obtain adequate product liability insurance; if our trade secret and patent position does not adequately protect our product candidates and their uses, others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; intellectual property rights do not necessarily address all potential threats to our competitive advantage; inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; the volatility of price of our Class A common stock; we could lose our listing on the Nasdaq Capital Market if our current share price continues to decrease; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. 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 Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended on Form 10-K/A on March 11, 2024 and its Quarterly Reports on Form 10-Q. 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 Mike Moyer LifeSci Advisors Tel: 617-308-4306 Email: mmoyer@lifesciadvisors.com

Researchers say an injectable hydrogel could mitigate damage to the right ventricle of the heart with chronic pressure overload. The research came out of the University of California San Diego, Georgia Institute of Technology and Emory University. Investigators published their work in Journals of the American College of Cardiology: Basic to Translational Science. For this study, they used rodents, but a 2019 FDA-approved Phase 1 trial demonstrated the hydrogel’s safety in humans who suffered a heart attack. As a result of the new preclinical study, the FDA approved an investigational new drug application (NDA). The teams at Emory and Georgia Tech can start a clinical trial with the hydrogel in pediatric patients in the coming months. In a post on the UCSD website, the researchers say they intended the hydrogel for children born with a condition that leaves them with an underdeveloped, nonfunctional left ventricle. This disorder, called hypoplastic left heart syndrome, comprises less than 4% of congenital heart defects. However, the researchers say it holds responsibility for 40% of deaths associated with heart defects in newborns. They cite a 35% survival rate in patients with this disorder. Currently, three open-heart surgeries before the patient turns five constitute the treatment options for this disorder. These surgeries reroute oxygenated blood to the right ventricle. Pediatric patients who survive into childhood post-surgery also receive medication and physical therapy while adhering to a special diet. According to the researchers, eventually, these patients experience right ventricle failure and require a heart transplant. “To the best of our knowledge, it’s the first time that an injectable biomaterial therapy has been evaluated to mitigate right ventricular heart failure,” said Jervaughn D. Hunter, the paper’s first author, out of UCSD. In the rodent study, injecting the hydrogel into the right ventricle improved function and allowed the heart to tolerate increased blood pressure and volume. The treatment also slowed down the rate of tissue scarring and maladaptive muscle growth. Researchers hope the hydrogel injection increases the amount of time the patient’s heart functions. This could lead to dramatically improved quality of life, better cognitive function and enhanced growth. Michael E. Davis, a senior author and professor of biomedical engineering at Georgia Tech and Emory, said this could enable the patients to wait until they can get on an adult heart transplant list. “This isn’t a cure, but our goal is to prolong a patient’s life,” said Karen Christman, a bioengineering professor at UCSD and the paper’s corresponding author. The hydrogel is made from cardiac extracellular matrix that is stripped of the cellular content through a cleansing process, dried and milled into powder form, then liquefied into a fluid that can be easily injected into the heart. Once it hits body temperature and pH, the liquid turns into a semi-solid, porous gel. It then encourages the patient’s own cells to repopulate areas of damaged cardiac tissue and to improve heart function. Researchers say that, in the preclinical trials, they first saw the effects of the treatment two weeks after injection. They also prepared the hydrogel with tissue from both the right and left ventricles of the pig hearts. With this, they found that tissues on each side of the heart differ “vastly.” Hydrogels from either side of the heart led to improved systolic function and reduced heart muscle growth and scarring while prompting arteriole formation and growth. Overall, though, they found that hydrogel derived from left-ventricle tissue proved more effective. The injected hydrogel also affected gene expression, specifically with pathways related to cardiac repair, including the development of the circulatory system, muscle structure and vasculature, plus the regulation of immune response and cellular response to oxygen-containing compounds. The team now hopes to begin recruiting for a clinical trial investigating the treatment’s efficacy in newborns with hypoplastic left heart syndrome.