MIAMI, May 20, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the Company’s Chief Executive Officer, Stephen Willard, issued the following letter to Longeveron stockholders.

Dear Fellow Stockholders,

I am delighted to join Longeveron at what I believe is an extraordinary time for the Company and our stem cell therapy, laromestrocel (Lomecel-B®). Longeveron is progressing through a significant inflection point in the Company’s history.

After taking on the CEO role in February, we embarked on two immediate critical tasks: a comprehensive review of the Company’s assets, development programs and strategic plan, and attracting new investment capital. Following this review, we have taken decisive steps to reposition the Company for long-term value creation, sharpen our strategic focus, and align our development and capital strategy with the most impactful near-term catalysts. With this reorientation, we were able to successfully attract new investment capital from several of the premier investment funds in the life sciences space, Coastlands Capital, Janus Henderson Investors, Logos Capital and Kalehua Capital. In 2026, we are approaching a series of potentially transformative milestones that we believe have the potential to redefine the trajectory of our business.

Today, I am pleased to provide an update on our strategy, recent progress, and key priorities for through the rest of this year.

Strategic Transformation and Corporate Evolution

In early 2026, we initiated a strategic repositioning of Longeveron designed to maximize stockholder value while maintaining disciplined capital allocation. We have transitioned toward a more capital-efficient model with an increased focus on securing strategic licensing partnerships for laromestrocel.

This evolution reflects both the strength of our clinical data and the growing external validation of our programs. We believe that leveraging the commercial infrastructure, capital resources, and global reach of established pharmaceutical partners represents the most efficient pathway to unlock the full value of our assets.

At the same time, we are focusing our development activities to prioritize our most important near-term catalyst: the data readout from our Phase 2b clinical trial (ELPIS II) in Hypoplastic Left Heart Syndrome (HLHS), expected in August of this year. This disciplined prioritization has enabled us to extend our operating runway while maintaining focus on value-driving milestones.

Pipeline-in-a-Product: Laromestrocel

Laromestrocel is an allogeneic mesenchymal stem cell therapy supported by a robust intellectual property portfolio of 52 issued patents worldwide. Its potential mechanisms of action—including anti-inflammatory, pro-vascular, and pro-regenerative effects—support its potential application across multiple high-value indications.

Laromestrocel development programs have received five distinct and important FDA designations, reinforcing both the clinical promise and regulatory positioning of our programs: 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.

We continue to advance a “pipeline-in-a-product” strategy, with multiple indications that can be independently developed, partnered, or licensed, creating multiple pathways for value creation.

Hypoplastic Left Heart Syndrome (HLHS): Lead Value Driver

Our HLHS program represents our most advanced and near-term value catalyst. HLHS is a rare and life-threatening pediatric congenital heart condition with no approved drug therapies and significant mortality despite surgical intervention.

Last year, we completed enrollment in our Phase 2b clinical trial (ELPIS II), a randomized, controlled study evaluating laromestrocel as an adjunct treatment to standard surgical care. We anticipate top-line 12-month data in August 2026.

We believe ELPIS II represents an important and potentially transformative catalyst for the Company. We are optimistic that positive results could potentially support a path toward a Biologics License Application (BLA) following FDA review of all of the available data, and position HLHS as a first-in-class therapeutic option in this underserved population.

Importantly, the HLHS program is eligible for a Priority Review Voucher (PRV) upon BLA approval. Based on recent transactions, PRVs have achieved market values of approximately $150 million to $200 million, representing a significant potential non-dilutive asset. In our March 2026 Private Placement financing, the Company agreed to sell to the participating investors an interest in 50% of proceeds received from the potential future sale of a Rare Pediatric Disease PRV, to the extent received from the FDA in connection with the Company’s laromestrocel program for HLHS.

Pediatric Dilated Cardiomyopathy (PDCM): Strategic Expansion Opportunity

Building on the cardiac signal observed in HLHS, we have expanded our pipeline into Pediatric Dilated Cardiomyopathy (PDCM), a rare and severe pediatric cardiovascular condition with high mortality and limited treatment options.

The FDA has accepted our Investigational New Drug (IND) application, allowing us to proceed directly into a single, Phase 2 registrational clinical trial. We believe this program represents a compelling follow-on asset with significant licensing potential, and we anticipate initiating this clinical trial in 2027, subject to receipt of financing or partnership support.

We believe PDCM provides an attractive opportunity to extend the value of our cardiac platform while creating an additional pathway for monetization.

Alzheimer’s Disease: Partnership-Focused Development

Our development program in mild Alzheimer’s disease has generated encouraging clinical data. Results from our Phase 2a clinical trial (CLEAR MIND) demonstrated a favorable safety profile and showed promising signals, including statistically significant reductions in brain volume loss and improvements in key clinical and biomarker endpoints.

These findings were published in Nature Medicine and presented at leading scientific conferences, reinforcing the credibility of our data within the scientific and medical communities.

We have achieved alignment with the FDA on a single, Phase 2/3 adaptive clinical trial design that, if successful, could potentially support a BLA submission. Notably, to our knowledge, laromestrocel remains the only cellular therapy with RMAT designation in Alzheimer’s disease.

Given the scale and cost of late-stage clinical trials for Alzheimer’s disease, we are actively pursuing strategic partnerships and non-dilutive funding to advance this program.

Aging-related Frailty

Patients with Aging-related 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. Results from our Phase 2b clinical trial demonstrated that intravenous laromestrocel improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo.

These results were published in Cell Stem Cell, further validating laromestrocel’s clinical data sets and providing an engagement point for discussions with potential strategic partners to advance this important but underserved development area.

Intellectual Property and Strategic Value

Our intellectual property portfolio remains a core pillar of our long-term value proposition. With over 52 global patent assets spanning composition of matter, methods of use, and manufacturing processes, we believe we have established a durable competitive moat around laromestrocel.

Combined with regulatory exclusivity pathways, including potential 12-year biologic exclusivity, our IP position enhances the attractiveness of our platform for global licensing partnerships.

Financial Strategy and Capital Allocation

We have taken meaningful steps to reduce cash burn and align our cost structure with our strategic priorities. Our transition to a more capital-light model, combined with a focus on licensing and partnerships, is designed to extend our runway while minimizing stockholder dilution.

As mentioned earlier, with our repositioned strategic approach, we were able complete a financing transaction in March of this year with institutional investors for up to approximately $30 million in gross proceeds, with $15 million already received upfront and up to an additional approximately $15 million in gross proceeds, subject to achieving certain milestone-driven conditions related to the results of the Company’s Phase 2b clinical trial (ELPIS II) in HLHS and share price.

We continue to evaluate multiple sources of capital, including strategic partnerships, non-dilutive funding, and selective financing opportunities, to support our development programs and maximize flexibility.

Near-Term Milestones and Outlook

We are entering a period defined by clear, high-impact catalysts:

• Top-line data from the ELPIS II HLHS trial (Q3 2026)

• Continued FDA engagement regarding HLHS development and regulatory pathway

• Advancement of the PDCM program toward initiation of a Phase 2 clinical trial (2027)

• Strategic partnership progress in Alzheimer’s disease and Aging-related Frailty

We believe these milestones, combined with our repositioned strategy, create a compelling opportunity for value recognition, particularly in light of public market precedents for companies with similar clinical profiles and regulatory positioning.

Conclusion

Longeveron today is a more focused, capital-efficient, and strategically aligned organization. With a differentiated platform, multiple shots on goal, and a clear path to near-term value inflection, we believe we are well-positioned to unlock significant stockholder value.

We remain deeply committed to advancing therapies for life-threatening and chronic conditions affecting some of the most vulnerable populations—children and the elderly—while delivering on our responsibility to our stockholders.

We appreciate your continued support and look forward to updating you on our progress in the months ahead.

Sincerely,

Steve Willard

Chief Executive Officer, Longeveron Inc.

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 ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; our ability to successfully transition toward a more capital-efficient, asset-light operating model; our ability to secure one or more strategic licensing partnerships for our stem cell therapy laromestrocel in our development programs; the ability to reach alignment with the FDA on a potential path toward regulatory approval; receipt of trial results and other available evidence sufficient to support the Company filing a BLA following the readout of top-line results of the ELPIS II data; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; 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, 2025, filed with the Securities and Exchange Commission on March 17, 2026, 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/cde71c09-a5f1-424d-837b-80f8786d82a5

Source: Longeveron