Long-term Survival Data from Longeveron’s ELPIS 1 Trial Accepted for Presentation at the 2023 Scientific Sessions of the American Heart Association
MIAMI, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, announced today an abstract highlighting long-term survival data from the Company’s ELPIS 1 trial of Lomecel-B™ for patients with hypoplastic left heart syndrome (HLHS) has been accepted for presentation as a poster at the upcoming meeting of the American Heart Association (AHA).
The poster, titled Long-term Transplant-free Survival Is Improved in Hypoplastic Left Heart Syndrome with Cell-based Therapy (Sunjay Kaushal, et al.), will be presented at the Scientific Sessions of the American Heart Association, to be held in Philadelphia, PA, November 11-13, 2023.
Longeveron previously announced long-term survival data from the ELPIS 1 trial, which showed children in the trial had 100% survival up to 5 years of age after receiving Lomecel-B™ compared to 20% mortality rate observed from historical control data. Lomecel-B™ has received Rare Pediatric Disease Designation, Fast Track Designation, and Orphan Drug Designation by the US Food and Drug Administration (FDA) for the HLHS indication.
About the Longeveron Rights Offering
As a reminder, there is an ongoing, effective rights offering on the registration statement previously filed with the Securities and Exchange Commission to conduct a tradable, subscription rights offering. The rights offering is being made through a distribution of five tradable subscription rights (to be listed on the NASDAQ Capital Market under the ticker symbol LGVNR) to purchase shares of Class A common stock for each share of common stock and warrant to purchase common stock owned on the record date, at a $3.00 subscription price per share.
The calendar for the rights offering is as follows:
| Thursday, August 17 | LGVNV Rights begin to trade. |
| Friday, August 18 | Ex-Rights Day - LGVN shares trade without the rights attached. |
| Friday, August 18 | Record Date – This is the cutoff date that determines the eligibility of stockholders to receive rights. |
| Tuesday, August 22 | Subscription Period Begins – LGVNR rights are credited to brokerage accounts through DTCC. |
| Thursday, September 21 | Subscription Period Ends – 5:00 PM ET unless extended at the Company’s sole discretion discuss clinical trial progress and investment strategies. |
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 medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently advancing Lomecel-B™ through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), 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. 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, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. 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, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. 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:
