- Longeveron’s study ELPIS I demonstrated 100% survival and heart transplant-free for up to 5 years of age
- All ten patients enrolled in the study were monitored for at least 3.5 years after treatment with Lomecel-B(TM), the company’s lead investigational product
- Longeveron’s study results show Lomecel-B(TM)’s potential, not just for the potential treatment of HLHS but also for Alzheimer’s disease and Aging-related Frailty
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, recently posted promising results from its ELPIS I clinical trial. Of note was data that showed that 100% of the ten patients who participated in the trial survived and remained heart transplant-free for up to 5 years of age after receiving the company’s lead investigational product, Lomecel-B(TM) (https://ibn.fm/TIOTm).
This study explored Lomecel-B(TM)’s potential to address hypoplastic left heart syndrome (“HLHS”), a congenital disability affecting normal blood flow through the heart. Historical results have shown that children with the condition have approximately 20% mortality by five years, with as many as 1,025, or one out of every 3,841 babies in the U.S. born with the condition (https://ibn.fm/gnCG7).
From the ELPIS I trial, all ten patients enrolled were monitored for at least 3.5 years after treatment with Lomecel-B(TM). To date, 5 out of the 5 eligible patients from the trial have already undergone the last of the three surgeries required to treat the condition, with Longeveron expected to present updated data from this process later in 2023.
“We are pleased to share additional long-term follow-up data demonstrating the continued survival of the ELPIS I trial participants,” noted Joshua M. Hare, M.D., Co-Founder, Chief Science Officer, and Chairman of the Board of Directors at Longeveron (https://ibn.fm/y8WmA).
ELPIS I is an open-label, Phase 1b trial specifically designed to evaluate the safety of Lomecel-B(TM) in patients with HLHS. Initial results demonstrated that the study met its primary safety endpoint and that all patients were alive, transplant-free, and maintained their expected growth rate one year after treatment. With these promising results, Longeveron is optimistic about the results to be shared later in the year. In addition, its management is excited for the next steps in the study, particularly as the company continues to enroll patients at the eight sites in the ELPIS II trial, a 38-patient, randomized (1:1) blinded, controlled Phase 2 clinical trial designed to evaluate the safety and efficacy of intramyocardial injection of Lomecel-B(TM) in infants with HLHS undergoing the Glenn Procedure.
“There is a major unmet need among children with HLHS, and today’s data highlighting the 100% survival rate of ELPIS I patients up to 5 years post-treatment underscore the potential opportunity for Lomecel-B(TM) as a much-needed therapeutic innovation for this patient group,” noted Sunjay Kaushal, M.D., Ph.D. Principal Investigator of the ELPIS I trial.
There is no FDA-approved medical treatment for HLHS, leaving a vast untapped market for Longeveron. So far, the product has received Fast Track Designation, Rare Pediatric Disease Designation, and Orphan Drug Designation from the United States Food and Drug Administration (“FDA”), which represent significant milestones for the company as it continues its work towards seeking FDA approval of Lomecel-B(TM) for HLHS.
With these studies, the company looks to tap into several market opportunities, projecting that the potential market size for its Lomecel-B(TM) in treating HLHS could be up to $1 billion annually, globally. In addition, the company is investigating Lomecel-B(TM) to address Alzheimer’s disease, which represents a market between $5 billion to $10 billion annually, as well as Aging-related Frailty, which represents a market between $4 billion and $8 billion globally per year.
For more information, visit the company’s website at www.Longeveron.com
Certain statements in this corporate profile 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 corporate profile are made as of the date of this corporate profile, 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.
For more information, visit the company’s website at www.Longeveron.com.
NOTE TO INVESTORS: The latest news and updates relating to LGVN are available in the company’s newsroom at http://ibn.fm/LGVN
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