LGVN · Longeveron Inc. · Documents
Substantial doubt about the company's ability to continue as a going concern.
“We have prepared a cash flow forecast which indicates that we do not have sufficient cash to meet our minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore we need to raise additional funds to continue as a going concern. As a result, there is substantial doubt about our ability to continue as a going concern.”View the 10-Q filed Aug 12, 2026
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Longeveron Inc. reported that laromestrocel did not meet ELPIS II’s primary efficacy endpoint, but achieved statistically significant MACE results of 8 events with standard of care versus 1 with laromestrocel (P=0.043); the company plans an FDA meeting.
Longeveron Inc. announced that Dr. Nataliya Agafonova decided to step down as Chief Medical Officer, effective October 14, 2026, after notifying management on October 7, 2026.
Longeveron said ELPIS II in 40 infants with HLHS missed its primary efficacy endpoint: the intent-to-treat RVEF difference was −0.7 percentage points at Month 12 (95% CI: −7.3 to 5.9; p=0.8336). It began reviewing all options to maximize shareholder value.