Longeveron® Announces Licensing of New Cardiac Selective Induced Pluripotent Stem Cell Technology for Cardiovascular Disease

Rhea-AI Summary

Longeveron (NASDAQ: LGVN) has licensed US Patent 12,168,028 B2 from the University of Miami, acquiring technology for deriving GHRH-Receptor+ cardiomyogenic cells from pluripotent stem cells. This breakthrough addresses a significant challenge in cardiovascular stem cell therapy by eliminating the risk of malignant ventricular arrhythmias associated with traditional induced pluripotent stem (iPS) cells.

The patented technology selectively produces cells destined to become cardiomyocytes while eliminating cells with electrical automaticity, potentially offering safer therapeutic solutions for various heart conditions. This advancement complements Longeveron's existing pipeline, which includes programs in hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and pediatric dilated cardiomyopathy.

Positive

• Patent acquisition strengthens intellectual property portfolio in cardiovascular stem cell therapy
• Technology eliminates major safety concern of ventricular arrhythmias in stem cell therapy
• Potential applications in both adult cardiovascular diseases and rare pediatric conditions
• Complements existing pipeline including HLHS and pediatric dilated cardiomyopathy programs

Negative

• Early-stage technology requiring further development and clinical validation
• No immediate revenue impact as technology is still in research phase

Insights

Biotechnology & Regenerative Medicine Expert

Longeveron's acquisition of GHRH-Receptor+ technology solves a critical safety barrier in cardiac stem cell therapy development.

Longeveron has made a strategically significant move by licensing a specialized cardiac stem cell patent from the University of Miami. This technology represents a crucial breakthrough in addressing one of the most challenging safety barriers in cardiac regenerative medicine.

The licensed patent protects a method to derive GHRH-Receptor+ cardiomyogenic cells from pluripotent stem cells. The technical significance cannot be overstated - current induced pluripotent stem cell (iPSC) approaches for heart muscle regeneration have been severely limited by a major safety issue: the risk of malignant ventricular arrhythmias (dangerous heart rhythm disturbances) after cell engraftment.

This new technology elegantly solves this problem through selective isolation of GHRH-Receptor positive cells, which are destined to become pure cardiomyocytes (heart muscle cells) without electrical automaticity properties. This selectivity effectively eliminates the arrhythmia risk while preserving the regenerative capacity.

For Longeveron's therapeutic pipeline, this acquisition creates multiple opportunities. The company can now potentially expand beyond its current focus areas (hypoplastic left heart syndrome, Alzheimer's disease, and pediatric dilated cardiomyopathy) into broader adult cardiovascular disease markets. The technology complements their existing Lomecel-B mesenchymal stem cell platform by adding a cardiac-specific regenerative approach.

Unlike embryonic stem cells, the iPSC approach allows development of patient-specific cardiac cells without ethical concerns, potentially enabling personalized regenerative treatments. By addressing the safety barrier that has hindered clinical translation of cardiac iPSC therapies, Longeveron has positioned itself at the forefront of a therapeutic area with substantial unmet need.

• Longeveron has licensed issued US Patent 12,168,028 B2, entitled “Methods for obtaining cardiomyogenic precursor cells” from the University of Miami
• New patent protects a method to derive GHRH-Receptor+ cardiomyogenic cells from pluripotent stem cells (PSCs)
• New technology substantially advances Longeveron’s repertoire of stem cell therapy technologies
• Opportunity to expand pipeline in cardiovascular, rare and pediatric disease areas

MIAMI, July 21, 2025 (GLOBE NEWSWIRE) --  Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening, rare pediatric, and chronic aging-related conditions, today announced that it has licensed an issued US patent (12,168,028 B2) for a stem cell technology from the University of Miami. The composition of matter patent protects unique induced pluripotent derived cardiomyogenic cells that have widespread therapeutic indications for heart diseases. The stem/precursor cells protected by this patent are obtained by deriving cells that bear a cell surface receptor known as the GHRH-Receptor. These cells are uniquely able to differentiate into human cardiac muscle cells and have the potential to be safer than existing strategies to derive new cardiac heart muscle cells.

“With the significant clinical and regulatory progress we have made in hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease, and our recent IND approval for pediatric dilated cardiomyopathy, the opportunity to license this important and complimentary stem cell technology provides us a unique opportunity to expand our stem cell therapy pipeline,” said Joshua Hare, M.D., Co-founder, Chief Science Officer, and Chairman at Longeveron. “This technology provides a solution to one of the most difficult barriers to the implementation of induced pluripotent stem cells (iPS) technology in the cardiovascular space.”

Developing cardiomyocytes from iPS cells was initially pursued as a potential way to repopulate the myocardium, representing a technology capable of generating an unlimited source of cardiomyocytes and/or cardiac precursors, circumventing ethical dilemmas of using embryonic stem cells, and available from any individual donor. This technology, however, was quickly appreciated to have a substantial side effect, that of causing malignant ventricular arrhythmias after engraftment into mammalian myocardium, and this complication has dramatically slowed the pace of entry into the clinic.

The technology of selecting the fraction of GHRHR+ from cardiomyogenic cells circumvents the complication by selecting for cells destined to become only cardiomyocytes and eliminating cells with electrical automaticity, a property found in conduction tissue cells. In so doing, the technology allows for selection for cells that will engraft, contribute new contractile tissue, but will not cause malignant ventricular arrhythmias.

Longeveron believes this technology may be applicable in a broad range of cardiovascular diseases in adults, as well as rare pediatric diseases.

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 four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty. 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, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. 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 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 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 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 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 product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our 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

FAQ

What is the significance of Longeveron's newly licensed stem cell patent?

The patent (US 12,168,028 B2) enables the production of safer cardiac muscle cells by selecting GHRH-Receptor+ cells, eliminating the risk of dangerous heart arrhythmias common in traditional stem cell therapies.

How does LGVN's new stem cell technology differ from existing methods?

The technology specifically selects for GHRH-Receptor+ cells that become only cardiomyocytes, avoiding cells that cause electrical automaticity and dangerous arrhythmias, making it potentially safer than current methods.

What medical conditions could benefit from Longeveron's new cardiac stem cell technology?

The technology could potentially treat a broad range of cardiovascular diseases in adults and rare pediatric conditions, including hypoplastic left heart syndrome and dilated cardiomyopathy.

What are the current development programs in Longeveron's pipeline?

Longeveron's pipeline includes programs for hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and pediatric dilated cardiomyopathy, with the latter recently receiving IND approval.

Who developed the stem cell technology licensed by Longeveron (LGVN)?

The technology was developed by the University of Miami and licensed to Longeveron through US Patent 12,168,028 B2.