Shares of Longeveron Inc. (LGVN) are down nearly 85% from their 52-week high of $45, recorded last November, and trade around $6.
It was on Feb.12, 2021, that the company listed its shares on the Nasdaq Capital Market at an offer price of $10 each.
Longeveron is a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions. The lead investigational product is Lomecel-B, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors.
The following clinical trials with Lomecel-B are underway…
— A phase IIa clinical trial evaluating Lomecel-B as a treatment for Alzheimer’s disease initiated in January of this year. The study is designed to enroll 48 patients and will measure brain anatomy using MRI, and include detailed assessments of the inflammatory and vascular systems thought to contribute to the worsening of Alzheimer’s disease.
— A phase II clinical trial evaluating Lomecel-B intraventricular injection in infants with Hypoplastic Left Heart Syndrome, dubbed ELPISII. Initiated last July, this trial is designed to enroll 38 infants with Hypoplastic Left Heart Syndrome, a rare and life-threatening congenital heart defect.
— A phase IIb trial evaluating the safety and efficacy of Lomecel-B in older adults with frailty in the U.S. was recently completed. The trial showed mixed results.
Aging Frailty is a clinically-defined and extreme form of unsuccessful aging, recognized by the hallmark signs of weakness, slowness, fatigue, unintentional weight loss, and low activity.
According to the results reported last August, there were statistically significant increases in six-minute walk test (6MWT) compared to placebo at Day 180 in the highest 3 doses namely, 50 million, 100 million and 200 million Lomecel-B cohorts. However, there was no significant change in the lowest dose of Lomecel-B.
The company is evaluating the next step in the aging frailty program.
— A phase I/II study exploring the effect of Lomecel-B on the frail immune system and other frailty endpoints, in subjects receiving the influenza vaccine dubbed HERA. Topline data from this study are anticipated in Q1/Q2, 2022.
Planned trial with Lomecel-B:
A phase II trial of Lomecel-B in older adults with frailty in Japan is expected to be initiated this quarter.
Being a clinical-stage company, Longeveron has no marketed products. Revenue has been generated from grants, clinical trials and contract manufacturing.
Since inception, the company has incurred losses, and as of September 30, 2021, had an accumulated deficit of $39.9 million.
Longeveron, which had cash and short term investments of $19.0 million at Sep.30, 2021, raised $20.5 million in a private placement in Dec.2021, by selling about 1.17 million shares of its common stock and 1.17 million warrants to purchase 1.17 million shares of common stock. The purchase price for one share of common stock and one corresponding warrant will be $17.50.
LGVN has traded in a range of $2.84 to $45.00 in the last 1 year. The stock closed Friday’s trading at $6.97, down 2.79%.
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