Longeveron Announces Second Quarter 2025 Financial Results and Provides Business Update Full enrollment achieved for pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment fo

Announces Second Quarter 2025 Financial Results and Provides Business Update

August 13, 2025 -- 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 reported financial

results for the quarter ended June 30, 2025 and provided a business update.

differentiated approach to stem cell therapy continues to yield positive results," said Wa'el

Hashad, Chief Executive Officer of Longeveron. "Laromestrocel has demonstrated positive initial outcomes in five clinical trials

across three indications. Based on the strength of our initial clinical data and regulatory approach, we have had positive, pathway clarifying

meetings with the FDA for our HLHS and Alzheimer's development programs and received approval for our pediatric dilated cardiomyopathy

IND to move directly to its pivotal clinical trial. With our pivotal Phase 2b clinical trial evaluating laromestrocel as a potential

treatment for HLHS having achieved full enrollment, we are now looking forward to top-line trial results in 2026. We are focused on organizational

readiness for a potential BLA filing for HLHS in late 2026. Our goal is to substantially advance our BLA readiness this year ahead of

data readout to potentially shorten the timeline to BLA submission and potential commercialization."

investigational therapeutic candidate is laromestrocel (Lomecel-BTM), a proprietary,

scalable, allogeneic cellular therapy being evaluated in multiple indications.

Left Heart Syndrome (HLHS) - a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping

chambers of the heart) is either severely underdeveloped or missing.

disease (AD) - a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited

therapeutic options.

Dilated Cardiomyopathy (DCM) - a rare pediatric cardiovascular disease in which the muscles in one of more of the heart chambers

become enlarged or stretched (dilated), with nearly 40% of children with DCM requiring a heart transplant or dying within two years of

Quarter 2025 Summary Financial Results

Call and Webcast Details:

archived replay of the webcast will be available on the "Events

& Presentations" section of the Company's website following the conference.

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,

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.

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 Relations Advisory Solutions

thousands, except share and per share data)

accompanying notes to unaudited condensed financial statements.

Statements of Operations

thousands, except per share data)

accompanying notes to unaudited condensed financial statements.