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 pu…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
Longeveron Inc.
LGVNNASDAQEQUITYCurrent
Other Events
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 ad…
Company context
We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product candidate is laromestrocel, also referred to as Lomecel-B®.
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Disclosure sections
Item 8.01Item 8.01 - Other Events
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.