Form 8-K

8-K — Longeveron Inc.

Accession: 0001213900-26-102611

Filed: 2026-09-23

Period: 2026-09-16

CIK: 0001721484

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0306147-8k_longeveron.htm (Primary)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities

Exchange Act of 1934

Date of Report (Date of earliest event reported):

September 16, 2026

LONGEVERON INC.

(Exact name of registrant as specified in its

charter)

Delaware

001-40060

47-2174146

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

1951 NW 7th Avenue, Suite 520

Miami, Florida 33136

(Address of principal executive offices) (Zip

Code)

Registrant’s telephone number, including

area code: (305) 909-0840

Not Applicable

(Former name or former address, if changed since

last report)

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities

Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange

Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under

the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under

the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A Common Stock, $0.001 par value per share

LGVN

The Nasdaq Capital Market

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the

Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check

mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting

standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01. Other Events.

On September 16, 2026, Longeveron Inc. (the “Company”)

a clinical-stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions,

issued a press release announcing topline results from ELPIS II, its Phase 2b clinical trial evaluating the Company’s investigational

stem cell therapy, laromestrocel, as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome (“HLHS”).

The ELPIS II trial did not meet the primary efficacy

endpoint of change from baseline in right ventricular ejection fraction (“RVEF”) at Month 12. In the intent-to-treat population,

the least-squares mean difference between treatment groups was −0.7 percentage points (95% confidence interval: −7.3 to 5.9;

p=0.8336).

A copy of the press release is attached hereto

as Exhibit 99.1 and is incorporated herein by reference. The information included pursuant to this Item 8.01, including Exhibit 99.1,

shall not be deemed an admission as to the materiality of any information contained herein or therein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release of Longeveron Inc., dated September 16, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities

Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

LONGEVERON INC.

Date: September 23, 2026

By:

/s/ Stephen H. Willard

Name:

Stephen H. Willard

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE OF LONGEVERON INC., DATED SEPTEMBER 16, 2026

EX-99.1

Filename: ea030614701ex99-1.htm · Sequence: 2

Exhibit 99.1

Longeveron Announces Topline Results

from ELPIS II Phase 2b Clinical Trial Evaluating Laromestrocel as a Potential Treatment for Hypoplastic Left Heart Syndrome (HLHS)

-------------------

Company Announces Exploration

of All Options to Maximize Shareholder Value

● The top line results showed that the ELPIS II trial did

not meet its primary endpoint of improvement in right ventricular ejection fraction (RVEF) at month 12, but there were exploratory clinical

endpoints that the Company is continuing to analyze and plans to discuss with the FDA to determine a potential path forward in HLHS

● Laromestrocel has maintained what Longeveron believes

is a favorable safety and tolerability profile consistent with prior clinical trials, now with 644 patients treated across Longeveron's

multiple clinical programs, and has shown potential efficacy in clinical studies across multiple indications and has received 5 designations

from FDA

● Laromestrocel has shown positive initial results in Aging-related

Frailty, including publication of clinical trial results in Cell Stem Cell and selection as a Finalist awardee in the XPRIZE Healthspan

global competition

● The Company has initiated a process of optimizing cost

containment and will explore all options with the goal of maximizing shareholder value

MIAMI, Fla., September 16, 2026 --

Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for life-threatening, rare pediatric

and chronic aging-related conditions, today announced topline results from ELPIS II, its Phase 2b clinical trial evaluating its investigational

stem cell therapy laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome (HLHS).

The ELPIS II trial did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at

Month 12. In the intent-to-treat (ITT) population, the least-squares mean difference between treatment groups was −0.7 percentage

points (95% CI: −7.3 to 5.9; p=0.8336).

Initial exploratory clinical outcomes in the as-treated

analyses include:

● Over a 12-month period, there were no deaths in patients

that received laromestrocel, compared to one patient in the control group, in the as-treated group

● Over a long-term follow up of transplant-free survival (up

to five years across all patients), the laromestrocel arm had one event (out of 17 patients) vs. two events (out of 21 patients) in the

standard-of-care arm

● Hospitalization burden was similar between arms

● Adjudicated Major Adverse Cardiovascular Events (MACE) were

approximately 31% fewer in the laromestrocel arm (12 events in the treated arm vs. 19 events in the untreated arm, respectively). However,

the negative binomial analysis was not statistically significant.

A sponsor-defined exploratory

hierarchical composite endpoint consisting of all-cause mortality and duration of inpatient hospitalization was not statistically significant

in the ITT population.

Laromestrocel demonstrated a safety

profile generally consistent with prior clinical trials, and no new safety signals were identified in the study.

The Company is conducting additional

analyses of the complete dataset and intends to discuss the results with the U.S. Food and Drug Administration (FDA) to determine potential

next steps for the HLHS development program. FDA previously indicated its willingness to meet with the Company following completion of

the study to discuss the results and potential paths forward.

Sunjay Kaushal, M.D., Ph.D., Professor

of Surgery, Cardiovascular and Thoracic Surgery at University of Nevada, Las Vegas commented: “There remains a significant unmet

medical need to boost the survival of the babies undergoing standard of care surgeries that still have only a 50-60% survival rate to

adolescence with approximately 20% requiring heart transplant. ELPIS II provides evidence of the safety of using stem cells to address

this unmet need.”

Laromestrocel demonstrated a favorable

safety and tolerability profile in ELPIS II, consistent with the safety experience observed across Longeveron’s clinical development

programs, in which 644 participants have been treated to date. Treatment-emergent adverse events (TEAEs) and treatment-emergent serious

adverse events (TE-SAEs) were reported in 94.1% and 64.7% of laromestrocel-treated participants, respectively, compared with 100% and

71.4% of control participants. No new safety signals were identified, and no TEAEs or TE-SAEs were assessed by investigators as related

to laromestrocel.

The Company thanks the patients, families,

investigators, and clinical sites who participated in the ELPIS II trial, as well as the NIH and the Data Coordinating and Clinical Coordinating

Centers for their partnership throughout the study.

“Since its founding, Longeveron

has advanced the stem cell therapy laromestrocel, completed multiple clinical trials and built a robust intellectual property portfolio,”

said Stephen H. Willard, Chief Executive Officer of Longeveron. “The ELPIS II results

continue to build our body of knowledge of laromestrocel for which we see significant promise across multiple indications, particularly

in longevity and Aging-related Frailty. We will work with our advisors to evaluate all options to maximize shareholder value.”

Review of All Options to Maximize Shareholder

Value

The Company announced that it has initiated

a process to review all options with the goal of maximizing shareholder value. The Company intends to engage an investment bank to act

as a strategic advisor for this process. In conjunction with that process, the Company will look to implement cash conservation measures

to optimize cost containment.

Longevity and Aging-Related Frailty

The Company intends to pursue funding

sources and other potential revenue opportunities to advance laromestrocel in longevity and Aging-related Frailty. Results from a 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 in February 2026. Further, based on these clinical trial results, Longeveron announced in August 2026 that it was selected

from over 600 worldwide applicants to advance to the final phase of the XPRIZE Healthspan

competition as a Milestone 2 Awardee team. Longeveron received the $1,000,000 Milestone 2 Award to be used towards the future competition

clinical trial in accordance with the XPRIZE competition rules, with the opportunity to compete for the XPRIZE Grand Prize of up to $81

million.

Longeveron has been invited to participate

in six upcoming longevity focused investor conferences in the fourth quarter of 2026.

About ELPIS II

ELPIS II is a Phase 2b, randomized,

double-blind, multicenter, two-arm trial conducted by Longeveron in collaboration with the National Heart, Lung, and Blood Institute (NHLBI)

through grants from the National Institutes of Health (NIH) (NCT04925024). A total of 40 infants with HLHS were randomized 1:1 to receive

a single intramyocardial dose of laromestrocel administered during Stage 2 palliative surgery (bidirectional Glenn or hemi-Fontan procedure)

or standard of care surgery alone, and were followed for 12 months. Long-term follow-up for transplant-free survival is planned for up

to 5 years.

The trial’s primary endpoint

was the difference between groups’ change from baseline in RVEF at 12 months, assessed by cardiac magnetic resonance (CMR). As previously

disclosed, FDA has advised Longeveron that RVEF alone would not be sufficient to demonstrate efficacy for regulatory approval. FDA also

previously expressed willingness to meet with Longeveron when the ongoing study is completed to discuss the study results and align on

a potential path forward.

Research reported in this press release

was supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number UH3HL148318. The

content is solely the responsibility of the Company and does not necessarily represent the official views of the National Institutes of

Health.

About Hypoplastic Left Heart Syndrome (HLHS)

HLHS is a rare congenital heart defect

that effects approximately 1,000 infants per year in the U.S. Infants with HLHS are born with an underdeveloped left ventricle, which

creates a life-threatening condition due to the heart’s inability to pump adequate amounts of blood throughout the body. The current

treatment requires infants to undergo a complex three-stage heart reconstruction surgery process over the first five years of their life.

Despite staged surgical palliation, long-term mortality and morbidity remain substantial, with progressive right ventricular dysfunction

representing a major contributor to adverse outcomes. There is clearly an important unmet medical need to improve right ventricular function

in these infants to positively impact both short- and long-term patient outcomes.

About laromestrocel (Lomecel-B®)

Laromestrocel is a living cell product

made from specialized cells isolated from the bone marrow of young, healthy adult donors. These specialized cells, known as mesenchymal

stem cells (MSCs), are essential to the human endogenous biological repair mechanism. MSCs have the potential to perform a number of complex

functions in the body and possibly support tissue repair and regenerative signaling pathways. They also may respond to sites of injury

or disease and may secrete bioactive factors that are immunomodulatory and regenerative. We believe laromestrocel MSCs may have multiple

potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application

for a range of rare and aging related 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. We believe 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 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. Further, certain forward-looking statements are based on assumptions as to future events that

may not prove to be accurate, including discussion of ELPIS II results with the FDA and the future of the HLHS development program;

our ability to pursue funding sources and potential revenue opportunities to advance laromestrocel in longevity and Aging-related

frailty; our expectations regarding the review and exploration of all options and their potential impact on shareholder value; our

ability to engage an investment bank or other strategic advisor; the continued listing of our Class A common stock on Nasdaq; our

expectations regarding the future of the company's operations, including our clinical, development and commercialization activities;

our plans to implement cash conservation measures to reduce operating expenses; and other statements regarding future events.

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. Additional 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 risk that the

exploration of strategic options may not result in any definitive transaction or enhance shareholder value or may create uncertainty

that may adversely affect our business, financial condition, results of operations, or shareholder and investor perception; the

ability of our clinical trials to demonstrate safety and efficacy of our investigational 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 laromestrocel in our development programs; our ability to reach alignment with the

FDA and other regulatory authorities on a potential path toward regulatory approval; the availability of evidence from our ongoing

and future preclinical studies and clinical trials sufficient to support the Company filing a BLA for the investigational product

candidate for one or more indications; 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 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 a 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 Inquiries:

investorrelations@longeveron.com

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

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dei_TradingSymbol

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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