Longeveron’s CLEAR MIND Randomized Phase 2a Clinical Trial Evaluating Lomecel-B™ in Mild Alzheimer’s Disease Accepted for Featured Research Session Oral Presentation at the 2024 Alzheimer’s Association International Conference (AAIC)
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MIAMI, April 15, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it has been accepted for a Featured Research Oral Presentation to present the Company’s CLEAR MIND Phase 2a study results. CLEAR-MIND is a Phase 2a randomized clinical trial evaluating Lomecel-BTM in mild Alzheimer’s Disease. In addition to the clinical study results, the Company has been accepted for a poster presentation at the 2024 Alzheimer’s Association International Conference (AAIC), to be held July 28 – August 1, 2024 in Philadelphia, PA, USA and online.
“We are extremely excited to share the full study results of our CLEAR-MIND trial at the AAIC meeting this year, and have the opportunity to present at the leading forum for Alzheimer’s disease clinical investigation,” said Wa’el Hashad, CEO of Longeveron.
| Oral Presentation | |
| Date: | Sunday, July 28, 2024 |
| Time: | 4:15pm – 5:45pm EDT |
| Session: | Featured Research Session, 1-32-FRS-B |
| Title: | “Results from a Phase 2a Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Lomecel-BTM in Mild Alzheimer’s Disease Dementia” |
| Longeveron’s Kevin N. Ramdas, MD, MPH, Director of Clinical Operations, was invited to chair this Featured Research Session. | |
| Poster Presentation | |
| Date: | Tuesday, July 30, 2024 |
| Time: | 7:30am – 4:15pm EDT |
| Session: | In-Person Posters Tuesday; Drug Development |
| Topic: | MRI Imaging results in the CLEAR MIND phase 2a clinical trial of Lomecel-BTM |
Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results from CLEAR MIND on December 20, 2023.
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. 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. 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 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 the 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:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
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