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Will Longeveron Gain Strength From Aging Frailty Trial Data?

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Shares of Longeveron Inc. (LGVN), which recently debuted on the NASDAQ, have halved in value over the past three months to trade around $5.

Longeveron is a clinical stage biotechnology company developing cellular therapies for chronic, 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.

A US phase I/II clinical study of Lomecel-B to improve immune response to influenza vaccine in subjects with Aging Frailty and a phase IIb study to assess Lomecel-B's effect on physical function, mobility, strength, balance, endurance, fear and risk of falling, inflammatory biomarkers and clinical outcomes in Aging Frailty subjects have been completed.

The top line safety and efficacy results from both the above studies are anticipated next quarter (Q3, 2021).

The company plans to initiate a phase II Japanese Aging Frailty trial in the second half of 2021.

What is Aging Frailty?

Aging Frailty is a life-threatening geriatric condition characterized by weakness, weight loss, and low activity that is associated with adverse health outcomes. About 15% of Americans over the age of 65, or 8.1 million individuals are affected by Aging Frailty.

There are no FDA-approved therapies that can slow down, reverse, or prevent Aging Frailty.

Other indications being explored for Lomecel-B

Longeveron plans to initiate a phase II trial of Lomecel-B infusion in mild Alzheimer's disease subjects in the second half of 2021. The study is expected to be a randomized, placebo-controlled, multidose trial designed to further evaluate biomarkers, change in cognitive function, and other disease-specific endpoints.

The company reported positive results from its phase I study of Lomecel-B for Alzheimer's disease last month. In patients who received low-dose Lomecel-B, the decline in cognitive function was slower and the quality of life metrics improved compared with placebo in the phase I trial.

Lomecel-B is also being testing in the indications of Hypoplastic Left Heart Syndrome (HLHS) and acute respiratory distress syndrome (ARDS).

The company plans to report the final results of the phase I HLHS trial in the second quarter of 2021. The phase II trial is expected to be initiated in the third quarter of 2021.

In March of this year, the FDA granted expanded access approval for the administration of Lomecel-B to a child with Hypoplastic Left Heart Syndrome. The FDA's Expanded Access program, also called "compassionate use," allows companies to provide their investigational drugs to patients outside of clinical trials in certain conditions when no comparable or satisfactory therapy options are available.

HLHS is a severe congenital birth defect in which the left ventricle of the heart is either severely underdeveloped or missing. As a result, babies born with this syndrome have substantially reduced systemic blood flow, necessitating a difficult, three-stage heart reconstruction surgery procedure over the course of the first 5 years of their lives.

A phase I trial of Lomecel-B for Acute Respiratory Distress Syndrome due to COVID 19 Infections is underway.

ARDS is a life-threatening lung condition that prevents enough oxygen from getting to the lungs and into the blood. Symptoms associated with this condition include difficulty breathing, low blood pressure and organ failure, rapid breathing and shortness of breath.

Financial Numbers

The company has incurred losses since its inception, and as of March 31, 2021, had an accumulated deficit of $30.0 million. Being a clinical stage company, no product revenue has been generated to date.

As of March 31, 2021, the company had cash, and cash equivalents of $24.5 million.

Founded in 2014, Longeveron went public on the Nasdaq Capital Market under the symbol "LGVN", on February 12, 2021, offering its shares at a price of $10 each.

LGVN has thus far hit a low of $5.15 and a high of $12.48. The stock closed yesterday's (May 18, 2021) trading at $5.68, up 7.37%.

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