The Conversation (0)
XZ8tHLoGIPk_2lgcdknuVEZ5vRrftmNcsmHLgp2rcLodtgkc_qnRQtU7Srj3-WneMqxKg6Rbkdoq9vNkKyLHMJPxkpCIo5JWDFYMfEk=" target="_blank" rel="nofollow">Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative cell therapy for life-threatening rare pediatric and chronic aging-related conditions, today announced that results of its Phase 2b clinical trial were published today in XZJ4in-xX4_GynaYfaJ3N4pKREXYKmtviStvNMPPCWl0yHQJirwVohdnlH_YhCerU2wafimxmAs2AxJ-7lD6ye2lFee" target="_blank" rel="nofollow">Cell Stem Cell, a Cell Press Journal. The Phase 2b results demonstrated that intravenous laromestrocel, a mesenchymal stem cell product, improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo. The full publication is available on the XZJ4in-xX4_GynaYfaJ3N4pKREXYKmtviStvNMPPCWl0yHQJirwVohdnlH_YhCerU2wafimxmAs2AxJ-7lD6ye2lFee" target="_blank" rel="nofollow">Cell Stem Cell website X_-qnqhei7-YZhXzmf0Ir9p646bsN1NOc-ZSfjCRTzbAamk=" target="_blank" rel="nofollow">here.
Laromestrocel (LOMECEL-B®) is a proprietary, scalable, allogeneic stem cell (MSC) investigational therapy that is currently being evaluated in multiple indications.
"We are highly encouraged by these Phase 2b results that demonstrate the potential of stem cell therapy to improve the condition of patients with aging-related frailty," said Joshua M. Hare, MD, FACC, FAHA, Chief Science Officer at Longeveron. "Those with Aging Frailty are disproportionately compromised in their ability to cope with every day and acute stressors, are at high vulnerability to disease and injury, and are at increased risk for poor outcomes and death after surgery. This development area is at the core of Longeveron's mission – advancing stem cell therapies addressing life threatening conditions in the most vulnerable populations - children and the elderly."
The Phase 2b, randomized, dose-finding clinical trial evaluated whether laromestrocel, human bone marrow-derived allogeneic MSCs, improves physical functioning and patient self-reported outcomes in 148 ambulatory individuals with frailty (NCT03169231). Laromestorcel infusions resulted in:
- Clinically meaningful, dose-and time-dependent increases in the primary endpoint of the 6-minute walk test (6MWT) compared with placebo: 63.4m (95% confidence interval [CI]: 17.1-109.6m; p=0.0077) at month 9 and 41.3m (95% CI: -2.4-84.9m; p=0.0635) at month 6
- Increased 6MWT distance correlates with PROMIS Physical Function score
- Increasing doses of laromestrocel are associated with decreases in soluble (degraded) tyrosine kinase with immunoglobulin and epidermal growth factor homology domains (TIE-2), the cognate receptor for the angiopoietins, identifying a potential biomarker for laromestrocel responsiveness
These findings identify a possible stem cell therapy approach for the management of patients with hypomobility and other features of aging frailty.
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 laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel 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 Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel development programs have received five distinct and important 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 known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expects," "intend," "looks to," "may," "on condition," "plan," "potential," "predict," "preliminary," "project," "see," "should," "target," "will," "would," or the negative thereof or comparable terminology, although not all forward-looking statements contain these words, 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, the future restoration of executive compensation levels; our intention and ability to repay certain compensation amounts to executives or rehire employees currently furloughed; the grant of certain equity awards; market and other conditions, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our investigational product candidates, and other positive results; the timing and focus of our 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 certain of our investigational product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the investigational product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our investigational product candidates; our ability to obtain and maintain regulatory approval of our investigational product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our investigational product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
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, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company's management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, 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/f106bde7-972a-4687-a91e-03e924f409fc
