• Longeveron recently released its full-year results for the period ended December 31, 2023, and provided a corporate update
• The update outlined the company’s plans to prioritize the development of Lomecel-B(TM) in Hypoplastic Left Heart Syndrome (“HLHS”), a rare, pediatric congenital heart condition characterized by an underdeveloped left side of the heart
• Longeveron plans to complete the enrollment in the ELPIS II trial for HLHS in 2024
• The company also reported that it is exploring opportunities to advance its Alzheimer’s disease program through potential partnerships or other sources of funding

Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing regenerative medicine for life-threatening conditions with unmet medical needs, recently released its full-year results for the period ended December 31, 2023, and provided a corporate update (https://ibn.fm/iORBu). Results from multiple studies using Longeveron’s lead investigational therapeutic candidate, Lomecel-B(TM), were announced by the company last year.

“In 2023 we made significant strides advancing studies of our investigational product, Lomecel-B(TM), in Hypoplastic Left Heart Syndrome (“HLHS”) and Alzheimer’s disease, with long-term survival data from ELPIS I trial presented at the American Heart Association (‘AHA’) annual meeting and clinically meaningful results announced from our Phase 2a CLEAR MIND clinical trial of Lomecel-B(TM) in the treatment of mild Alzheimer’s disease,” said Longeveron CEO Wa’el Hashad.

The ELPIS I trial was an open-label Phase 1 study designed to investigate the safety and potential efficacy of the intramyocardial injection of Lomecel-B(TM) administered to 10 infants with HLHS during the Glenn procedure, the second of three open-heart surgeries performed to correct HLHS, at about 4-5 months of age. (HLHS is a congenital condition characterized by the underdevelopment of the left side of the heart.) The final results from the study, announced in September 2021, showed that the study met its primary safety endpoint and that all patients were alive, transplant-free, and maintained their expected rate of growth one year after treatment (https://ibn.fm/nTsZs).

Nonetheless, after ELPIS I came to its planned end, investigators elected to extend the follow-up of the 10 infants for a total period of five years. It is the data from this ongoing extended long-term follow-up that the company presented as a poster at the 2023 annual AHA meeting. The company also summarized this data in its recent corporate update, noting that children in the ELPIS I trial had 100% transplant-free survival up to five years of age after receiving Lomecel-B(TM) compared to about 20% mortality rate observed from historical control data. This data, the update continued, reinforces the potential survival benefit of Lomecel-B(TM) for patients with HLHS.

The update also emphasized Longeveron’s prioritization of the development of Lomecel-B(TM) in HLHS. “For 2024 our main strategic priority will be focused on our lead clinical program in HLHS, our most important near-term value driver. Accordingly, we made the strategic decision to discontinue our Phase 2 clinical program in Aging-related Frailty in Japan,” explained Hashad.

The company is expecting to complete enrollment in the ELPIS II trial, a Phase 2 controlled clinical trial, in the fourth quarter of calendar 2024. (The company announced in August last year that it had surpassed 50% enrollment threshold) (https://ibn.fm/eBxKN). To achieve this target, Longeveron plans to implement additional measures that the company’s management outlined during the conference call that accompanied the release of the financial results (https://ibn.fm/vVij1).

For instance, Longeveron is in the process of activating new sites to add to its existing seven sites. Additionally, the company is working with advocacy groups to increase awareness among patients and is planning to hold an investigator meeting during which the company intends to take additional measure with the goal of expediting study enrollment.

“We are also exploring opportunities to advance our Alzheimer’s disease program through potential partnerships or other sources of funding. These steps will allow us to focus our available resources on completing enrollment in our follow-on ELPIS II study in 2024. HLHS patients are in critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication,” Hashad continued.

Longeveron’s focus on its Alzheimer’s disease program comes on the back of positive results from the Phase 2a CLEAR MIND trial of Lomecel-B(TM) for the treatment of mild Alzheimer’s disease. According to the corporate update, the study met its primary safety and secondary endpoints. These results, Longeveron stated, support the therapeutic potential of Lomecel-B(TM) in treating mild Alzheimer’s disease and provide evidence-based support for potential further clinical development.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: [email protected]

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

Forward-Looking Statements

Certain statements in this article 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, 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 and its Quarterly Reports on Form 10-Q. The forward-looking statements contained in this article are made as of the date of this article, 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.

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