Form 8-K

8-K — Longeveron Inc.

Accession: 0001213900-26-112508

Filed: 2026-10-26

Period: 2026-10-26

CIK: 0001721484

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0309208-8k_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):

October 26, 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 ☒

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 October 26, 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 updated 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 updated results follow planned additional analysis conducted by the Company and the National Institutes of Health (NIH) funded trial

investigators.

As previously disclosed, the ELPIS II trial did not

meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12. However, based on

the secondary endpoints, laromestrocel was associated with fewer adjudicated clinical and safety events than the standard of care arm.

Additional review of the pre-specified secondary endpoint major adverse cardiac events (MACE) showed statistical significance with eight

events in the standard of care (SOC) arm versus one in the laromestrocel treatment arm (P=0.043).

The Company believes the favorable pre-specified secondary

endpoint findings suggest that laromestrocel has the potential to meaningfully improve clinical outcomes of children with HLHS undergoing

Stage II surgical palliation. The Company intends to request a meeting with the U.S. Food and Drug Administration (FDA) to review the

results to determine potential next steps for the Company’s HLHS development program.

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.

Cautionary

Note Regarding Forward-Looking Statements

This Current Report on Form 8-K and certain of

the materials filed herewith contain forward-looking statements within the meaning 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. The forward-looking

statements in this Current Report on Form 8-K are made on the basis of the views and assumptions of management regarding future events

and business performance as of the date this Current Report on Form 8-K is filed with the Securities and Exchange Commission (“SEC”).

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in

which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects,

and these forward-looking statements are not guarantees of future performance or development. Forward-looking statements involve known

and unknown risks, uncertainties and other important factors that may cause actual events, results, performance or achievements to be

materially different from those expressed or implied by the forward-looking statements contained in this Current Report on Form 8-K or

the materials furnished or filed herewith.

These forward-looking statements are made as of

the date of this Current Report on Form 8-K and are subject to a number of risks, uncertainties and assumptions described in greater detail

in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026, its Quarterly

Reports on Form 10-Q, and other filings with the SEC. In addition, any forward-looking statements represent the Company’s views

only as of today and should not be relied upon as representing its views as of any subsequent date. These statements 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 occurring after the date this Current Report on Form 8-K is filed.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release of Longeveron Inc., dated October 26, 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: October 26, 2026

/s/ Stephen Willard

Name:

Stephen Willard

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE OF LONGEVERON INC., DATED OCTOBER 26, 2026

EX-99.1

Filename: ea030920801ex99-1.htm · Sequence: 2

Exhibit 99.1

Longeveron

Announces Updated Results from ELPIS II Phase 2b Clinical Trial Evaluating

Laromestrocel as a Potential Treatment for Hypoplastic Left

Heart Syndrome (HLHS)

Important

Secondary Clinical Outcome Endpoint MACE Achieved Statistical Significance

ELPIS

II 2 Data in HLHS Selected for Late-Breaking Science Program Podium Presentation in the

American Heart Association’s (AHA) 2026

Scientific Sessions

● As

previously reported, the ELPIS II trial did not meet the primary endpoint of increase in

right ventricular ejection fraction (RVEF) at month 12 and the Company planned to continue

analysis of additional data

● Additional

analysis demonstrates an important pre-specified secondary clinical outcome endpoint, major

adverse cardiac events (MACE), achieved statistical significance with 8 events in the standard

of care arm versus 1 in the laromestrocel treatment arm (P=0.043)

● Laromestrocel

was associated with fewer adjudicated clinical and safety events than the standard of care

arm

● The

Company believes the results suggest that laromestrocel may have the potential to meaningfully

improve clinical outcomes of children with HLHS undergoing Stage II surgical palliation

MIAMI,

Fla., October 26, 2026 -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening,

rare pediatric and chronic aging-related conditions, today announced updated results from ELPIS II following planned additional analysis

conducted by the Company and the National Institutes of Health (NIH) funded trial investigators. ELPIS II is the Company’s 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. Based on the secondary endpoints, laromestrocel was associated with fewer adjudicated clinical and safety events than the

standard of care (SOC) arm. Additional review of the pre-specified secondary endpoint major adverse cardiac events (MACE) showed

statistical significance with 8 events in the SOC arm versus 1 in the laromestrocel treatment arm (P=0.043).

Laromestrocel demonstrated a favorable safety and tolerability profile through 12 months, with no treatment-related serious adverse

events identified. The Company believes the favorable pre-specified secondary endpoint findings suggest that laromestrocel has the

potential to meaningfully improve clinical outcomes of children with HLHS undergoing Stage II surgical palliation. The Company

intends to request a meeting with the U.S. Food and Drug Administration (FDA) to review the results to determine potential next

steps for the HLHS development program.

Results

Among

the 40 randomized infants in the intention-to-treat (ITT) population, baseline and Month 12 cardiovascular magnetic resonance (CMR) were

available for 28 infants (15-S0C, 13- Laromestrocel group). Mean RVEF decreased by 2.6(SD=10.5) percentage points in the SoC group and

3.3 (SD=8.4) percentage points in the Laromestrocel group, with no statistically significant difference between 2 groups (baseline adjusted

difference=-1.36, 95% CI: -8.0 - 6.7, p=0.68).

Additional analysis for

prespecified secondary clinical outcome endpoints is presented as below.

Endpoint

SOC

Laromestrocel

Comparison

Infants with >= 1 major cardiac event, n

Total major cardiac events, n

Rate Ratio=0.16 (95%CI: 0.030-0.52); p<0.001

Major Cardiac event rate (per 100 person-days)

0.261

0.041

Total MACE, n

p=0.043

MACE rate (per 100 person-days)

0.095

0.014

TR events or Valve surgery

p=0.066

Death, n

Ventricular assist device implantation, n

Note: Event rates were calculated over

a total of 15757 person-days of follow-up. MACE - Major adverse cardiac events, TR - Tricuspid regurgitation

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.

American

Heart Association’s (AHA) 2026 Scientific Sessions

The

Phase 2 data from the ELPIS II trial have been selected for a Late-Breaking Science Program podium presentation at the American Heart

Association’s (AHA) 2026 Scientific Sessions which will take place in Chicago on November 6-9, 2026.

Presentation

Date:

Sunday, November 8, 2026

Time:

10:10am CDT

Session:

Featured Science, FS.07, Heart Failure Care for Novel Phenotypes

Title:

ELPIS II: A Phase 2b Randomized Clinical Trial to Evaluate the Efficacy and Safety of Laromestrocel as Adjunct

Therapy During Stage II Palliation for Hypoplastic Left Heart Syndrome

About

ELPIS II

ELPIS

II is an investigational 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) (ClinicalTrials.gov:

NCT04925024). A total of 40 infants with HLHS were randomized 1:1 to receive a single intramyocardial dose of an investigational drug

called laromestrocel that was 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.

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 affects 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 an investigational 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, anti-fibrotic, and/or

pro-vascular regenerative responses, and therefore may have broad applicability 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. 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 the occurrence of a meeting or 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 strategic 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:

Derek

Cole

Investor Relations Advisory Solutions

derek.cole@iradvisory.com

###

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Name of the Exchange on which a security is registered.

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

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-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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

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Trading symbol of an instrument as listed on an exchange.

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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.

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