Form 8-K

8-K — Longeveron Inc.

Accession: 0001213900-26-053902

Filed: 2026-05-08

Period: 2026-05-08

CIK: 0001721484

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0289853-8k_longeveron.htm (Primary)

EX-99.1 — PRESS RELEASE ISSUED BY THE COMPANY ON MAY 8, 2026 (ea028985301ex99-1.htm)

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8-K — CURRENT REPORT

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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):

May 8, 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

3313

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including

Area Code: (305) 909-0840

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 May 8, 2026, Longeveron Inc. (the Company) issued a press release

announcing that a constructive Type C meeting with the U.S. Food and Drug Administration (FDA or Agency) was held in late March, with

the FDA providing their meeting summary in late April, to discuss the ongoing development of laromestrocel (LOMECEL-B®), a proprietary,

scalable, allogeneic, investigational cellular therapy currently being evaluated in a Phase 2b clinical trial (ELPIS II) for hypoplastic

left heart syndrome (HLHS). Top-line results from the randomized, controlled Phase 2b ELPIS II clinical trial are anticipated in August

2026.

In the Type C meeting, the FDA acknowledged that HLHS is a rare disease

associated with significant morbidity and mortality with a high unmet medical need for safe and effective therapies, but also asserted

that the primary endpoint of right ventricle ejection fraction (RVEF) in the ELPIS II trial is not an appropriate endpoint to demonstrate

efficacy. While Longeveron agreed with the FDA regarding the insufficiency of RVEF as the primary endpoint, and was prepared to discuss

other potentially appropriate endpoints sufficient to demonstrate efficacy, the FDA indicated that given the interim analysis

mandated and conducted by the National Institute of Health (NIH) during the trial (to which the Company was and remains blinded), a new

primary endpoint could not be agreed to while the trial is still ongoing. Without an agreed upon primary endpoint sufficient for efficacy,

the FDA no longer refers to the ELPIS II trial as pivotal, as had been specifically discussed in the Company’s Type C meeting in

2024.

Nevertheless, the FDA expressly agreed that it is willing to meet with

Longeveron again when the ongoing ELPIS II study is completed to discuss the study results and align on a potential path forward. The

FDA further indicated that only the most objective measures, including, all-cause mortality, cardiac transplant-free survival, event of

cardiac transplantation, and well-defined major adverse cardiac events (MACE), could be informative of efficacy in ELPIS II, and in that

regard, the Company is capturing all of these measures in ELPIS II along with some additional key measures to support an efficacy determination.

The Company intends to submit to the FDA a Sponsor Statistical Analysis Plan (SAP) for ELPIS II with a composite primary endpoint and

secondary endpoints for the FDA’s review and approval, and remains optimistic that the trial results and other available evidence

will be sufficient to support filing a Biologics License Application (BLA) following the readout of top-line results of the ELPIS II data.

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 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. 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, including our ELPIS II trial for HLHS, to demonstrate safety and efficacy of our product candidates,

and other positive results; the willingness of the FDA to deem the ELPIS II trial as pivotal following-completion of the ELPIS II trial

or to otherwise reach alignment with the Company on a potential path toward regulatory approval; receipt of FDA approval, following review,

of the Company’s Sponsor Statistical Analysis Plan (SAP) for ELPIS II; 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; 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 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.

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 Securities and Exchange Commission

on March 17, 2026, its Quarterly Reports on Form 10-Q, and other filings with the Securities and Exchange Commission. 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 issued by the Company on May 8, 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: May 8, 2026

/s/ Stephen H. Willard

Name:

Stephen H. Willard

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE ISSUED BY THE COMPANY ON MAY 8, 2026

EX-99.1

Filename: ea028985301ex99-1.htm · Sequence: 2

Exhibit 99.1

Longeveron Announces Constructive Type C Meeting

with U.S. FDA Ahead of Data Readout for

ELPIS II Phase 2b Clinical Trial Evaluating Treatment for Hypoplastic Left Heart Syndrome

(HLHS)

MIAMI, Fla., May 8, 2026 -- Longeveron Inc. (NASDAQ:

LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related

conditions, today announced that a constructive Type C meeting with the U.S. Food and Drug Administration (FDA or Agency) was held in

late March, with the FDA providing their meeting summary in late April, to discuss the ongoing development of laromestrocel (LOMECEL-B®),

a proprietary, scalable, allogeneic, investigational cellular therapy currently being evaluated in a Phase 2b clinical trial (ELPIS II)

for hypoplastic left heart syndrome (HLHS). Top-line results from the randomized, controlled Phase 2b ELPIS II clinical trial are anticipated

in August 2026.

In the Type C meeting, the FDA acknowledged that

HLHS is a rare disease associated with significant morbidity and mortality with a high unmet medical need for safe and effective therapies,

but also asserted that the primary endpoint of right ventricle ejection fraction (RVEF) in the ELPIS II trial is not an appropriate endpoint

to demonstrate efficacy. While Longeveron agreed with the FDA regarding the insufficiency of RVEF as the primary endpoint, and was prepared

to discuss other potentially appropriate endpoints sufficient to demonstrate efficacy, the FDA indicated that given the interim

analysis mandated and conducted by the National Institute of Health (NIH) during the trial (to which the Company was and remains blinded),

a new primary endpoint could not be agreed to while the trial is still ongoing. Without an agreed upon primary endpoint sufficient for

efficacy, the FDA no longer refers to the ELPIS II trial as pivotal, as had been specifically discussed in the Company’s Type C

meeting in 2024. Nevertheless, the FDA expressly agreed that it is willing to meet with Longeveron again when the ongoing ELPIS II study

is completed to discuss the study results and align on a potential path forward. The FDA further indicated that only the most objective

measures, including, all-cause mortality, cardiac transplant-free survival, event of cardiac transplantation, and well-defined major adverse

cardiac events (MACE), could be informative of efficacy in ELPIS II, and in that regard, the Company is capturing all of these measures

in ELPIS II along with some additional key measures to support an efficacy determination. The Company intends to submit to the FDA a Sponsor

Statistical Analysis Plan (SAP) for ELPIS II with a composite primary endpoint and secondary endpoints for the FDA’s review and

approval, and remains optimistic that the trial results and other available evidence will be sufficient to support filing a Biologics

License Application (BLA) following the readout of top-line results of the ELPIS II data.

About ELPIS II

ELPIS II is a multicenter, randomized, controlled

Phase 2b clinical trial evaluating laromestrocel as a potential adjunct therapy in infants with HLHS undergoing Stage II surgical palliation.

The clinical trial enrolled 40 pediatric patients at twelve premiere infant and children’s treatment institutions across the country.

ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the NIH.

The laromestorcel HLHS program has received three

FDA designations: Orphan Drug designation, Fast Track designation and Rare Pediatric Disease designation. Under the Rare Pediatric Disease

designation, if Longeveron were to receive FDA marketing approval for laromestrocel for HLHS, the Company could be eligible to receive

a Priority Review Voucher.

About Hypoplastic Left Heart Syndrome (HLHS)

HLHS is a congenital birth defect in which the

left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, infants born

with this condition have severely diminished systemic blood flow, which requires them to undergo a complex, three stage heart reconstruction

surgery process over the course of the first 5 years of their lives. Although surgical advances have enabled survival into adulthood for

some patients, early mortality remains substantial in this population, due to right ventricular failure. As such, there remains an important

unmet medical need to improve right ventricular function in these patients in order to support both short-term and long-term outcomes.

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.

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. 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.

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, including our ELPIS II trial for HLHS, to demonstrate safety

and efficacy of our product candidates, and other positive results; the willingness of the FDA to deem the ELPIS II trial as pivotal following-completion

of the ELPIS II trial or to otherwise reach alignment with the Company on a potential path toward regulatory approval; receipt of FDA

approval, following review, of the Company’s Sponsor Statistical Analysis Plan (SAP) for ELPIS II; 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; 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 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.

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

###

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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.

+ References

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

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration