Longeveron Announces Completion of Phase 2a Enrollment

Longeveron Announces Completion of Phase 2a Enrollment

MIAMI, Nov. 10, 2022 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical-stage biotechnology company developing regenerative medicines for unmet medical need, announced today completion of enrollment in its Phase 2a trial of Lomecel-BTM in patients with mild Alzheimer’s disease (AD).

“We are pleased to have completed enrollment in our Phase 2a study of Lomecel-BTM for Alzheimer’s disease. We look forward to continuing our Phase 1b study, which met its primary safety endpoint and was published in a leading journal, Alzheimer’s and Dementia, The Journal of the Alzheimer’s Association this year. We are excited to advance our program designed to evaluate the therapeutic potential of Lomecel-B.TM in AD patients,” said Chris Min, MD, Ph.D., interim CEO and chief medical officer of Longeveron.

Phase 2a trial follows previously announced positive results from Lomecel-B’s Phase 1b clinical trial of LongeveronTM for AD. In that trial, the primary safety endpoint was met. That trial was a randomized, placebo-controlled design and included endpoints in several domains, including measures of cognitive function and quality of life, brain volumes using magnetic resonance imaging, and circulating biomarkers.

The phase 2a trial, called the CLEAR MIND trial, is a 48-patient, 4-arm, parallel design, randomized clinical trial of Lomecel-BTM to assess the safety of single and multiple infusions of two different dose levels compared to placebo in patients with mild AD. The primary endpoint is safety as measured by the occurrence of serious adverse events (SAEs) within the first 30 days after Lomecel-B administration.TM. Secondary and exploratory endpoints include magnetic resonance imaging (MRI) brain volumetry, biomarkers relevant to inflammation and the endothelial/vascular systems, and measures of cognitive function.

About Longeveron Inc.

Longeveron is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs. The company’s main investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapeutic isolated from the bone marrow of healthy young adult donors. Lomecel-B™ has a multimodal mechanism of action that is provascular, proregenerative and anti-inflammatory, promoting tissue repair and healing with broad potential applications in a spectrum of disease areas. Longeveron is advancing Lomecel-B™ through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and frailty due to aging. Additional information about the Company is available at www.longeveron.com.

Cautionary Note Regarding 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 regarding future performance and economic conditions. and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made in this document. Forward-looking statements are generally identified by the use of forward-looking terminology such as “believe”, “expect”, “may”, “seek”, “will”, “should”, “plan”, “intend”, “provided” , “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 by any forward-looking statements in this release include, but are not limited to, statements about the ability of Longeveron’s clinical trials to demonstrate the safety and efficacy of product candidates. of the Company, 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 suffering from the target diseases; 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; the Company’s plans related to the further development of its product candidates, including additional disease states or indications that it may pursue; existing regulations and regulatory developments in the US, Japan and other jurisdictions; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions to the terms of existing patents 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 income, capital requirements and additional financing needs; 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 the period over which it estimates that its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Further information regarding factors that may affect the Company’s results and forward-looking statements is 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, 2021, filed with the SEC on March 11, 2022, and the Company’s quarterly reports on Form 10-Q for the periods ended March 31 and June 30, 2022. 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 as required by law, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor contact:

elsie yau
stern go, inc.

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