Longeveron® Lomecel-B™ 5-Year Long-term Transplant-free Survival Data in HLHS Selected for Oral Presentation at the Congenital Heart Surgeons’ Society (CHSS) 51st Annual Meeting

Rhea-AI Summary

Longeveron Inc. (NASDAQ: LGVN) announced that its submission titled "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy" has been selected for oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting. The presentation will showcase 5-year long-term survival data from the ELPIS I follow-on study, focusing on the potential of Lomecel-B™ as an adjunct therapy for treating Hypoplastic Left Heart Syndrome (HLHS).

The presentation is scheduled for Sunday, October 27, 2024, during the Scientific Session II. Longeveron's CEO, Wa'el Hashad, expressed excitement about sharing the data at this leading forum for congenital heart disease clinical investigation. The company is currently conducting the ELPIS II Phase 2b clinical trial, which may serve as the foundation for a BLA submission for potential approval of Lomecel-B™ if the results are positive.

Positive

• Selection for oral presentation at a prestigious congenital heart surgeons' conference
• Potential for Lomecel-B™ as an adjunct therapy for HLHS
• Ongoing ELPIS II Phase 2b clinical trial may lead to BLA submission

Negative

• None.

MIAMI, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that its submission entitled “Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy” has been selected for oral presentation at the Congenital Heart Surgeons’ Society (CHSS) 51^st Annual Meeting to be held October 27-28, 2024 in Chicago, Illinois.

“We are extremely excited to share this 5-year long-term survival data from our ELPIS I follow-on study at the CHSS meeting this year, and to have the opportunity to present at a leading forum for congenital heart disease clinical investigation,” said Wa’el Hashad, CEO of Longeveron. “Based on the strength of the ELPIS I data, we are currently conducting the ELPIS II Phase 2b clinical trial, which is evaluating our cellular therapy Lomecel-B™ as a potential adjunct therapy for treating HLHS, and which, if positive, may serve as the foundation for a BLA submission for potential approval of Lomecel-B™.”

Oral Presentation
Date:	Sunday October 27, 2024
Session:	Scientific Session II: IS STAGNATION IN TRANSPLANTATION A MYTH? ADVANCES IN PULSE, PULSELESS AND CELLS
Time:	3:10 pm – 3:25 pm ET
Title:	A07: “Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy”

About Hypoplastic Left Heart Syndrome (HLHS)

HLHS is a rare congenital heart defect that effects approximately 1,000 infants per year in the U.S. Infants 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. The current treatment requires infants to undergo a complex three-stage heart reconstruction surgery process over the first five years of their life. Even with this comprehensive treatment, only 50% to 60% of infants survive to adolescence due to right ventricular failure. There is clearly an important unmet medical need to improve right ventricular function in these infants to positively impact both short- and long-term patient outcomes.

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 pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease (AD), and Aging-related Frailty. Lomecel-B^TM development programs have received five distinct and important U.S. FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.

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 and include, but are not limited to, the anticipated use of proceeds from recent offerings. 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, market and other conditions, 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; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for Aging-related Frailty, Alzheimer’s disease, or other aging-related conditions, or for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to 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; the 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; the 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 the price of our Class A common stock; we could lose our listing on the Nasdaq Capital Market; 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 by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. 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 and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/455da66f-07a0-49fe-9b5d-6b82b97f6e89

FAQ

What is the title of Longeveron's presentation at the CHSS 51st Annual Meeting?

The title of Longeveron's presentation is "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy."

When and where will Longeveron (LGVN) present its ELPIS I follow-on study data?

Longeveron will present its ELPIS I follow-on study data on Sunday, October 27, 2024, at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting in Chicago, Illinois.

What is the focus of Longeveron's (LGVN) ELPIS II Phase 2b clinical trial?

The ELPIS II Phase 2b clinical trial is evaluating Lomecel-B™ as a potential adjunct therapy for treating Hypoplastic Left Heart Syndrome (HLHS).

How long is the survival data that Longeveron (LGVN) will present for its HLHS treatment?

Longeveron will present 5-year long-term survival data from their ELPIS I follow-on study for their HLHS treatment.