Longeveron (LGVN) Company Report

Longeveron (LGVN) supports the reauthorization of the Pediatric Priority Review Voucher (PPRV) Program, which encourages the development of treatments for rare pediatric diseases.
The company's laromestrocel program for Hypoplastic Left Heart Syndrome (HLHS) is eligible to receive a Priority Review Voucher if its Biological License Application (BLA) is approved by the FDA before September 2029.
Priority Review Vouchers have been sold for $150-200 million each since August 2024, representing a significant potential financial asset for Longeveron.
Top-line results from the Phase 2b clinical trial (ELPIS II) for laromestrocel in HLHS are anticipated in the third quarter of 2026.

1 day ago

Press Release

Longeveron Granted U.S. Patent for Female Sexual Dysfunction Treatment

LGVN

New Projects/Investments

Longeveron Inc. announced on December 17, 2025, that the United States Patent and Trademark Office (USPTO) granted U.S. Patent No. 12,496,316 for administering its proprietary mesenchymal stem cells (MSCs) to treat female sexual dysfunction.
This patent, titled "Treatment of Sexual Dysfunction and Improvement in Sexual Quality of Life," provides Longeveron with patent rights in the U.S. through 2038, with potential for further extensions.
The company anticipates entering into licensing or partnering agreements for the potential development and commercialization of this stem cell therapy, which addresses an unmet medical need affecting up to 46% of women.
The therapy utilizes laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell product.

Dec 17, 2025, 2:15 PM

Press Release

Longeveron Granted U.S. Patent for Aging-Related Frailty Treatment

LGVN

New Projects/Investments

Longeveron Inc. announced on November 12, 2025, that the U.S. Patent and Trademark Office (USPTO) granted a patent covering methods of administering its proprietary Mesenchymal Stem Cells (MSCs) for the treatment of aging-related frailty.
This patent, U.S. Patent No. 12,465,620, provides Longeveron with patent rights in the United States through 2038.
The company's lead MSC drug, laromestrocel, has delivered positive initial results across two clinical trials for aging-related frailty, a syndrome that currently has no approved treatments.

Nov 12, 2025, 2:05 PM

Press Release

Longeveron Reports Q3 2025 Financials, Updates on HLHS Trial, and Adjusts Regulatory Timeline

LGVN

Earnings

Guidance Update

New Projects/Investments

For the nine months ended September 30, 2025, Longeveron reported a 53% decrease in revenues to $0.8 million and a 45% increase in net loss to $17.3 million compared to the same period in 2024.
As of September 30, 2025, cash and cash equivalents were $9.2 million, with the company anticipating its existing cash to fund operations into late Q1 2026.
Longeveron has access to an at-the-market financing facility for up to $10.7 million and plans to seek additional financing through capital raises, grants, and strategic partnerships.
Enrollment for the pivotal phase 2b ELPASO-2 clinical trial in Hypoplastic Left Heart Syndrome (HLHS) was completed in June, with top-line results expected in Q3 2026.
Due to operational decisions to extend the cash runway, the potential full Biologics License Application (BLA) filing for HLHS has been pushed from late 2026 to 2027.

Nov 4, 2025, 9:30 PM

Transcript

Longeveron Reports Q3 2025 Financial Results and Business Updates

LGVN

Earnings

CEO Change

New Projects/Investments

For the nine months ended September 30, 2025, Longeveron reported a net loss of $17.3 million on revenues of $0.8 million, compared to a net loss of $11.9 million on revenues of $1.8 million for the same period in 2024.
As of September 30, 2025, cash and cash equivalents were $9.2 million, and the company anticipates this will fund operations late into the first quarter of 2026.
The pivotal Phase 2b clinical trial (ELPIS II) for Hypoplastic Left Heart Syndrome (HLHS) is fully enrolled, with top-line results expected in the third quarter of 2026 and a Biologics License Application (BLA) submission now anticipated in 2027.
The FDA approved an Investigational New Drug (IND) application in July 2025 for a Phase 2 pivotal registration clinical trial of laromestrocel for pediatric dilated cardiomyopathy (DCM), with trial initiation anticipated in 2026, subject to obtaining necessary financing.
Than Powell was appointed Interim Chief Executive Officer in September 2025, and the company completed a public offering in August, raising approximately $5.0 million.

Nov 4, 2025, 9:15 PM

8-K

Longeveron Announces Third Quarter 2025 Financial Results and Business Update

LGVN

Earnings

CEO Change

New Projects/Investments

Longeveron reported a net loss of approximately $17.3 million for the nine months ended September 30, 2025, a 45% increase from the prior year, with revenues decreasing by 53% to $0.8 million for the same period.
The company's cash and cash equivalents stood at $9.2 million as of September 30, 2025, anticipated to fund operations until late in the first quarter of 2026.
Key clinical trial updates include full enrollment in the pivotal Phase 2b trial for Hypoplastic Left Heart Syndrome (HLHS), with top-line results expected in the third quarter of 2026, and FDA approval of an Investigational New Drug (IND) application for Pediatric Dilated Cardiomyopathy (DCM), with a Phase 2 trial anticipated in 2026 subject to financing.
In corporate updates, Longeveron completed a public offering raising approximately $5.0 million in August and appointed Than Powell as Interim Chief Executive Officer in September 2025.

Nov 4, 2025, 9:05 PM

Press Release

Longeveron provides update on pivotal Phase 2b trial for HLHS therapy with results anticipated in Q3 2026

LGVN

New Projects/Investments

Longeveron's pivotal Phase 2b clinical trial (ELPIS II) for its stem cell therapy, laromestrocel, in hypoplastic left heart syndrome (HLHS) has achieved full enrollment.
Top-line results for the ELPIS II trial are anticipated in the third quarter of 2026.
The U.S. Food and Drug Administration (FDA) confirmed in August 2024 that ELPIS II is a pivotal trial, which, if it demonstrates sufficient efficacy, would be acceptable for a Biologics License Application (BLA) submission for full traditional approval for HLHS.
Laromestrocel has received Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation from the FDA for the treatment of HLHS.

Oct 27, 2025, 1:15 PM

Press Release

Longeveron Inc. Enters At The Market Offering Agreement

LGVN

New Projects/Investments

Longeveron Inc. (LGVN) entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC on September 19, 2025, to sell up to $10,700,000 of its Class A common stock.
H.C. Wainwright & Co., LLC will serve as the sales agent, earning a 3.0% commission on the gross sales price of the shares sold.
The net proceeds from the offering are designated for the clinical and regulatory development of laromestrocel, regulatory approvals, capital expenditures, working capital, and general corporate purposes.