LGVN

EX-99.1

2 ea030175701ex99-1.htm

PRESS RELEASE ISSUED BY THE COMPANY ON AUGUST 12, 2026

Exhibit 99.1

Longeveron Announces 2026 Second Quarter Financial Results and Provides Business Update

●On track for September 2026 top-line results from Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for hypoplastic left heart syndrome (HLHS), a rare pediatric disease and orphan-designated indication

●Longeveron selected as a Finalist and Milestone 2 Awardee for the XPRIZE Healthspan competition based on published clinical trial results which indicated laromestrocel increased 6-minute walk distance in patients with aging frailty

●Three new independent Directors join Longeveron’s Board of Directors

●Company to host conference call and webcast today at 4:30 p.m. ET

MIAMI,

Fla., August 12, 2026 -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today reported financial results for the quarter ended June 30, 2026 and provided a business update.

“Longeveron is approaching a series of potentially transformative milestones across our four stem cell therapy development programs that have the potential to redefine the trajectory of our business,” said Stephen H. Willard, Chief Executive Officer of Longeveron. “Our approach to stem cell therapy development has garnered external recognition and validation with positive clinical data having been published in Nature Medicine and Cell Stem Cell and also serving as the foundation for our selection as a Finalist for the XPRIZE Healthspan competition out of over 600 projects submitted worldwide. We are rapidly approaching the September top line data readout of our ELPIS II Phase 2b clinical trial evaluating laromestrocel in HLHS and look forward to sharing those results.”

Development Programs

Longeveron’s investigational therapeutic candidate laromestrocel (Lomecel-B®) is a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications.

Hypoplastic 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.

●Topline results from the Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS are anticipated in September 2026.

●In May, the Company announced that the U.S. Food and Drug Administration (FDA) held a Type C meeting in late March 2026 focused on the ELPIS II Phase 2b clinical trial and upcoming data readout.

●Also in May, the Company announced that the independent Data Monitoring Committee (DMC) completed its final prespecified data review for ELPIS II Phase 2b clinical trial (ELPIS II). The DMC performed a risk-benefit assessment, indicated no safety concerns, and approved the study to continue as designed to completion.

●ELPIS

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

●The FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS.

Pediatric Dilated Cardiomyopathy (PDCM) – a rare pediatric cardiovascular disease in which the muscles in one or more of the heart chambers become enlarged or stretched (dilated), with nearly 40% of children with PDCM requiring a heart transplant or dying within two years of diagnosis.

●Longeveron’s Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND provides for moving directly to a single Phase 2 registrational clinical trial.

●The Company currently anticipates initiation of the Phase 2 clinical trial in 2027, with planning and preparation beginning in 2026.

Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options.

●In July, additional analysis of data from the Phase 2a clinical trial evaluating laromestrocel in mild AD was presented in a Poster Presentation at the 2026 Alzheimer’s Association International Conference® (AAIC®). The data indicated that laromestrocel reduced neuroinflammation in patients with mild Alzheimer’s disease.

●Results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development, were published in the peer-reviewed journal Nature Medicine in March 2025.

●Positive Type B meeting with FDA regarding pathway to potential BLA submission for laromestrocel in Alzheimer’s disease held in March 2025 with tentative alignment reached on proposed trial study design, population and endpoints for a s

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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): November 4, 2025

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)

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 2.02. Results of Operations and Financial Condition

On November 4, 2025, Longeveron Inc. (the “Company”) issued a press release announcing its financial and operating results for the three and nine months ended September 30, 2025 and certain other business updates and information. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.

The information provided under this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for any purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The exhibits listed in the following Exhibit Index are being furnished as part of this Current Report on Form 8-K.

Exhibit No.

Description

99.1

Press Release issued by the Company on November 4, 2025

104

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

1

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: November 4, 2025 /s/ J. Nathaniel Powell

Name: J. Nathaniel Powell

Title: Chief Executive Officer

2