Longeveron Reports Third Quarter 2023 Results and Provides Corporate Update

Top Line Results from CLEAR MIND Alzheimer’s disease Trial Affirm Safety Profile of Lomecel-B™ and Provide Efficacy Signal; Full Study Data Remains on Track to Share in Coming Weeks

Long-term Survival Data from ELPIS 1 Trial to be Presented at the 2023 Scientific Sessions of the American Heart Association

$4 Million in Equity Financing Secured in Registered Direct Offering

ELPIS II Phase 2 Trial of Lomecel-B™ in HLHS Continues Enrollment; Completion of Study Enrollment Anticipated in 2024

Company to Hold Conference Call and Webcast Today, November 10, 2023 at 8:30am Eastern Time

MIAMI, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, announced today its results for the quarter ended September 30, 2023 and provided a corporate update.

“During our third quarter and in recent weeks, we continued to advance our Lomecel-B™ clinical programs, highlighted by postive top-line results from our CLEAR MIND clinical trial of Lomecel-B™ in the treatment of mild Alzheimer’s disease and acceptance of ELPIS I long-term survival data for presentation at the American Heart Association annual meeting,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We also took steps to strengthen our balance sheet, securing $4 million of gross proceeds from an equity financing to support our continued advancement of these critical programs.”

“As we announced in October, the results from our CLEAR MIND trial provide important validation of both the safety and therapeutic potential of Lomecel-B™ in the treatment of mild Alzheimer’s disease. In addition to achieving the study’s safety endpoints, the study provided statistically significant evidence of slowing disease progression as compared to placebo. We believe these results provide a robust foundation for additional clinical programs with Lomecel-B™ in Alzheimer’s disease as well as other indications, and look forward to reporting the full study data from this trial in the coming weeks once the remaining data is received and analyzed.

“We are also pleased to see our poster, which details the five-year long-term survival data from our ELPIS I trial in hypoplastic left heart syndrome (HLHS), accepted for presentation at the upcoming American Heart Association (AHA) meeting. HLHS patients are in critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication. To that end, enrollment in our follow-on ELPIS II study has exceeded the 50% threshold, and we anticipate completing study enrollment in 2024,” concluded Mr. Hashad.

Recent Highlights

Postive Topline Data Announced from CLEAR MIND Trial

• In October 2023, Longeveron announced topline results from the CLEAR MIND trial— a Phase 2a trial of Lomecel-B™ for the treatment of mild Alzheimer’s disease (AD). CLEAR MIND is a 48 patient, 4-arm, parallel design, randomized (1:1:1:1) clinical trial of Lomecel-B™ intended to evaluate the safety of a single and multiple infusions of two different dose levels compared to placebo in patients with mild AD.
• The primary endpoint of safety was met based on statistical and medical assessment. There was one Serious Adverse Event (SAE) reported on each Lomecel-B™ treatment group and none on placebo. Each SAE was reviewed and assessed by the Data and Safety Monitoring Board (DSMB) with no safety issues raised.
• The secondary endpoint of change from baseline to week 39 in CADS demonstrated positive results at the prespecified statistical level of p