MIAMI, Could 20, 2026 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a scientific stage biotechnology firm creating mobile remedy for life-threatening, uncommon pediatric and continual aging-related situations, at the moment introduced that the Firm’s Chief Government Officer, Stephen Willard, issued the next letter to Longeveron stockholders.
Pricey Fellow Stockholders,
I’m delighted to be part of Longeveron at what I imagine is a unprecedented time for the Firm and our stem cell remedy, laromestrocel (Lomecel-B®). Longeveron is progressing by a big inflection level within the Firm’s historical past.
After taking over the CEO position in February, we launched into two quick crucial duties: a complete assessment of the Firm’s property, improvement applications and strategic plan, and attracting new funding capital. Following this assessment, we have now taken decisive steps to reposition the Firm for long-term worth creation, sharpen our strategic focus, and align our improvement and capital technique with probably the most impactful near-term catalysts. With this reorientation, we had been ready to efficiently appeal to new funding capital from a number of of the premier funding funds within the life sciences house, Coastlands Capital, Janus Henderson Buyers, Logos Capital and Kalehua Capital. In 2026, we’re approaching a collection of doubtless transformative milestones that we imagine have the potential to redefine the trajectory of our enterprise.
At present, I’m happy to present an replace on our technique, current progress, and key priorities for by the remainder of this yr.
Strategic Transformation and Corporate Evolution
In early 2026, we initiated a strategic repositioning of Longeveron designed to maximize stockholder worth whereas sustaining disciplined capital allocation. We’ve got transitioned towards a extra capital-efficient mannequin with an elevated concentrate on securing strategic licensing partnerships for laromestrocel.
This evolution displays each the energy of our scientific knowledge and the rising exterior validation of our applications. We imagine that leveraging the business infrastructure, capital sources, and international attain of established pharmaceutical companions represents probably the most environment friendly pathway to unlock the complete worth of our property.
On the identical time, we’re focusing our improvement actions to prioritize our most necessary near-term catalyst: the information readout from our Part 2b scientific trial (ELPIS II) in Hypoplastic Left Coronary heart Syndrome (HLHS), anticipated in August of this yr. This disciplined prioritization has enabled us to prolong our working runway whereas sustaining concentrate on value-driving milestones.
Pipeline-in-a-Product: Laromestrocel
Laromestrocel is an allogeneic mesenchymal stem cell remedy supported by a strong mental property portfolio of 52 issued patents worldwide. Its potential mechanisms of motion—together with anti-inflammatory, pro-vascular, and pro-regenerative results—assist its potential software throughout a number of high-value indications.
Laromestrocel improvement applications have obtained 5 distinct and necessary FDA designations, reinforcing each the scientific promise and regulatory positioning of our applications: for the HLHS program – Orphan Drug designation, Quick Observe designation, and Uncommon Pediatric Illness designation; and, for the AD program – Regenerative Medication Superior Remedy (RMAT) designation and Quick Observe designation.
We proceed to advance a “pipeline-in-a-product” technique, with a number of indications that may be independently developed, partnered, or licensed, creating a number of pathways for worth creation.
Hypoplastic Left Coronary heart Syndrome (HLHS): Lead Worth Driver
Our HLHS program represents our most superior and near-term worth catalyst. HLHS is a uncommon and life-threatening pediatric congenital coronary heart situation with no accredited drug therapies and important mortality regardless of surgical intervention.
Final yr, we accomplished enrollment in our Part 2b scientific trial (ELPIS II), a randomized, managed research evaluating laromestrocel as an adjunct remedy to customary surgical care. We anticipate top-line 12-month knowledge in August 2026.
We imagine ELPIS II represents an necessary and doubtlessly transformative catalyst for the Firm. We’re optimistic that optimistic outcomes may doubtlessly assist a path towards a Biologics License Utility (BLA) following FDA assessment of all the accessible knowledge, and place HLHS as a first-in-class therapeutic possibility on this underserved inhabitants.
Importantly, the HLHS program is eligible for a Precedence Evaluate Voucher (PRV) upon BLA approval. Based mostly on current transactions, PRVs have achieved market values of roughly $150 million to $200 million, representing a big potential non-dilutive asset. In our March 2026 Personal Placement financing, the Firm agreed to promote to the collaborating buyers an curiosity in 50% of proceeds obtained from the potential future sale of a Uncommon Pediatric Illness PRV, to the extent obtained from the FDA in reference to the Firm’s laromestrocel program for HLHS.
Pediatric Dilated Cardiomyopathy (PDCM): Strategic Growth Alternative
Constructing on the cardiac sign noticed in HLHS, we have now expanded our pipeline into Pediatric Dilated Cardiomyopathy (PDCM), a uncommon and extreme pediatric cardiovascular situation with excessive mortality and restricted remedy choices.
The FDA has accepted our Investigational New Drug (IND) software, permitting us to proceed straight right into a single, Part 2 registrational scientific trial. We imagine this program represents a compelling follow-on asset with important licensing potential, and we anticipate initiating this scientific trial in 2027, topic to receipt of financing or partnership assist.
We imagine PDCM offers a pretty alternative to prolong the worth of our cardiac platform whereas creating a further pathway for monetization.
Alzheimer’s Illness: Partnership-Targeted Growth
Our improvement program in delicate Alzheimer’s illness has generated encouraging scientific knowledge. Outcomes from our Part 2a scientific trial (CLEAR MIND) demonstrated a good security profile and confirmed promising alerts, together with statistically important reductions in mind quantity loss and enhancements in key scientific and biomarker endpoints.
These findings had been revealed in Nature Medication and offered at main scientific conferences, reinforcing the credibility of our knowledge inside the scientific and medical communities.
We’ve got achieved alignment with the FDA on a single, Part 2/3 adaptive scientific trial design that, if profitable, may doubtlessly assist a BLA submission. Notably, to our information, laromestrocel stays the one mobile remedy with RMAT designation in Alzheimer’s illness.
Given the size and price of late-stage scientific trials for Alzheimer’s illness, we’re actively pursuing strategic partnerships and non-dilutive funding to advance this program.
Growing older-related Frailty
Sufferers with Growing older-related Frailty are disproportionately compromised of their capacity to deal with day-after-day and acute stressors, are at excessive vulnerability to illness and damage, and are at elevated threat for poor outcomes and loss of life after surgical procedure. Outcomes from our Part 2b scientific trial demonstrated that intravenous laromestrocel improved the bodily situation of sufferers with age-related scientific frailty after 9 months, in contrast to placebo.
These outcomes had been revealed in Cell Stem Cell, additional validating laromestrocel’s scientific knowledge units and offering an engagement level for discussions with potential strategic companions to advance this necessary however underserved improvement space.
Mental Property and Strategic Worth
Our mental property portfolio stays a core pillar of our long-term worth proposition. With over 52 international patent property spanning composition of matter, strategies of use, and manufacturing processes, we imagine we have now established a sturdy aggressive moat round laromestrocel.
Mixed with regulatory exclusivity pathways, together with potential 12-year biologic exclusivity, our IP place enhances the attractiveness of our platform for international licensing partnerships.
Monetary Technique and Capital Allocation
We’ve got taken significant steps to cut back money burn and align our price construction with our strategic priorities. Our transition to a extra capital-light mannequin, mixed with a concentrate on licensing and partnerships, is designed to prolong our runway whereas minimizing stockholder dilution.
As talked about earlier, with our repositioned strategic method, we had been ready full a financing transaction in March of this yr with institutional buyers for up to roughly $30 million in gross proceeds, with $15 million already obtained upfront and up to a further roughly $15 million in gross proceeds, topic to attaining sure milestone-driven situations associated to the outcomes of the Firm’s Part 2b scientific trial (ELPIS II) in HLHS and share worth.
We proceed to consider a number of sources of capital, together with strategic partnerships, non-dilutive funding, and selective financing alternatives, to assist our improvement applications and maximize flexibility.
Close to-Time period Milestones and Outlook
We’re getting into a interval outlined by clear, high-impact catalysts:
• High-line knowledge from the ELPIS II HLHS trial (Q3 2026)
• Continued FDA engagement concerning HLHS improvement and regulatory pathway
• Development of the PDCM program towards initiation of a Part 2 scientific trial (2027)
• Strategic partnership progress in Alzheimer’s illness and Growing older-related Frailty
We imagine these milestones, mixed with our repositioned technique, create a compelling alternative for worth recognition, notably in gentle of public market precedents for corporations with comparable scientific profiles and regulatory positioning.
Conclusion
Longeveron at the moment is a extra centered, capital-efficient, and strategically aligned group. With a differentiated platform, a number of photographs on objective, and a transparent path to near-term worth inflection, we imagine we’re well-positioned to unlock important stockholder worth.
We stay deeply dedicated to advancing therapies for life-threatening and continual situations affecting a few of the most weak populations—youngsters and the aged—whereas delivering on our duty to our stockholders.
We respect your continued assist and look ahead to updating you on our progress within the months forward.
Sincerely,
Steve Willard
Chief Government Officer, Longeveron Inc.
Ahead-Trying Statements
Sure statements on this press launch that aren’t historic information are forward-looking statements made pursuant to the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995, which mirror administration’s present expectations, assumptions, and estimates of future operations, efficiency and financial situations, and contain recognized and unknown dangers, uncertainties, and different necessary elements that might trigger precise outcomes, efficiency, or achievements to differ materially from these anticipated, expressed, or implied by the statements made herein. Ahead-looking statements are usually identifiable by means of forward-looking terminology resembling “anticipate,” “imagine,” “ponder,” “proceed,” “may,” “estimate,” “expects,” “intend,” “appears to be like to,” “could,” “on situation,” “plan,” “potential,” “predict,” “preliminary,” “mission,” “see,” “ought to,” “goal,” “will,” “would,” or the damaging thereof or comparable terminology, though not all forward-looking statements comprise these phrases, or by dialogue of technique or targets or different future occasions, circumstances, or results. Elements that might trigger precise outcomes to differ materially from these expressed or implied in any forward-looking statements on this launch embrace, however should not restricted to, the power of our scientific trials to exhibit security and efficacy of our product candidates, and different optimistic outcomes; our capacity to efficiently transition towards a extra capital-efficient, asset-light working mannequin; our capacity to safe a number of strategic licensing partnerships for our stem cell remedy laromestrocel in our improvement applications; the power to attain alignment with the FDA on a possible path towards regulatory approval; receipt of trial outcomes and different accessible proof adequate to assist the Firm submitting a BLA following the readout of top-line outcomes of the ELPIS II knowledge; the timing and focus of our ongoing and future preclinical research and scientific trials, and the reporting of information from these research and trials; market and different situations, our money place and want to elevate further capital, the difficulties we could face in acquiring entry to capital, and the dilutive affect it might have on our buyers; our monetary efficiency, and capacity to proceed as a going concern; the interval over which we estimate our current money and money equivalents will probably be adequate to fund our future working bills and capital expenditure necessities; the power of our scientific trials to exhibit security and efficacy of our investigational product candidates, and different optimistic outcomes; the timing and focus of our ongoing and future preclinical research and scientific trials, and the reporting of information from these research and trials; the dimensions of the market alternative for sure of our investigational product candidates, together with our estimates of the variety of sufferers who are suffering from the ailments we’re concentrating on; our capacity to scale manufacturing and commercialize the investigational product candidate for sure indications; the success of competing therapies which are or could develop into accessible; the useful traits, security, efficacy and therapeutic results of our investigational product candidates; our capacity to get hold of and keep regulatory approval of our investigational product candidates within the U.S. and different jurisdictions; our plans relating to the additional improvement of our investigational product candidates, together with further illness states or indications we could pursue; our plans and capacity to get hold of or shield mental property rights, together with extensions of current patent phrases the place accessible and our capacity to keep away from infringing the mental property rights of others; the necessity to rent further personnel and our capacity to appeal to and retain such personnel; and our estimates concerning bills, future income, capital necessities and wants for added financing.
Additional info relating to elements that will affect the Firm’s outcomes and forward-looking statements are disclosed within the Firm’s filings with the Securities and Trade Fee, together with Longeveron’s Annual Report on Kind 10-Ok for the yr ended December 31, 2025, filed with the Securities and Trade Fee on March 17, 2026, its Quarterly Studies on Kind 10-Q, and its Present Studies on Kind 8-Ok. The Firm operates in extremely aggressive and quickly altering surroundings; subsequently, new elements could come up, and it isn’t potential for the Firm’s administration to predict all such elements that will come up nor assess the affect of such elements or the extent to which any particular person issue or mixture thereof, could trigger outcomes to differ materially from these contained in any forward-looking statements. The forward-looking statements contained on this press launch are made as of the date of this press launch primarily based on info accessible as of the date of this press launch, are inherently unsure, and the Firm disclaims any intention or obligation, aside from imposed by legislation, to replace or revise any forward-looking statements, whether or not because of new info, future occasions, or in any other case.
Investor and Media Contact:
Derek Cole
Investor Relations Advisory Options
derek.cole@iradvisory.com
A photograph accompanying this announcement is accessible at https://www.globenewswire.com/NewsRoom/AttachmentNg/cde71c09-a5f1-424d-837b-80f8786d82a5
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