LGVN: Alzheimer’s Study Gains Traction as CEO Search Continues

By Brad Sorensen, CFA

NASDAQ:LGVN

READ THE FULL LGVN RESEARCH REPORT

Longeveron (NASDAQ:LGVN) is a clinical stage biotech company that is using cutting edge cellular technology to treat a rare heart disease and the impacts of aging. We are pleased that the company recently announced a further positive development for the company’s flagship treatment for Alzheimer’s Disease—Lomecel-B. An abstract regarding the Lomecel-B Phase 2a trial in Alzheimer’s Disease was accepted for a poster presentation at the Alzheimer’s Association International Conference (AAIC)—held July 31-August 4, 2022.

• Interim CEO Chris Minn noted the enrollment in the Phase 2a trial is ongoing and the company remains “excited about the potential of Lomecel-B as a treatment for this important unmet medical need.”

• The AAIC is an important event in the Alzheimer’s universe and being accepted to present possible treatments at the conference should be viewed as another positive event for Longeveron and further helps to validate our confidence, in our view, of Lomecel-B.

The company is also continuing its search for a new CEO after the company’s previous leader resigned effective June 1, 2022. We haven’t received any updates on the search but don’t view that as a negative and are pleased that LGVN’s board appears to be taking the time and consideration needed for such an important decision. We are also very pleased that the company is continuing on the path set by the previous CEO and that positive developments for Lomecel-B continue to pile up.

Lomecel-B

Lomecel-B is made from living cells called Medicinal Signaling Cells (MSCs) that are isolated from fresh bone marrow tissue donated by adult donors, alleviating some of the ethical concerns that can surround some forms of cell research and their sources. Once these MSCs are isolated, the cells are culture expanded (allowed to replicate under controlled laboratory conditions) into billions of living cells. After a specific number of expansion cycles, the cells are harvested and separated into specific doses. This method of harvesting and replicating cells has several inherent advantages, including:

• Cells harvested from living human donors have characteristics that allow them to be transplanted from donor to host without triggering a harmful immune response.

• Therapies using these cells can be administered on an out-patient basis in as little as 40 minutes after thawing.

• This has an advantage over a patient using their own cells and then reintroducing them back into the same person—which requires a surgical procedure and can take weeks or months and can only be used on one patient.

• Therapies using these cells are considered an “off-the-shelf” product, which means they are stored frozen and available for on-demand use.

• Data from clinical studies suggest the effects of a single dose may last over 6 months.

• The source for the starting raw material is young healthy adult donors.

Now that we know where it comes from, how does it work? Here it gets a bit more complicated but also makes some intuitive sense. Although the research is ongoing, the researchers at Longeveron currently believe that there are several mechanisms of action believed to mediate therapeutic benefits. First, there is the release of growth factors and other proteins, such as anti-inflammatory cytokines, which are a type of protein that have an effect on the immune system. These cytokines have the potential to reduce inflammation and stimulate nearby stem cells to promote regenerative and repair responses. Further, the Lomecel-B cells engage in direct cell-to-cell interaction to induce positive pathways in contacted cells. Lomecel-B cells can also release exosomes, which are the functional part of the genome and carry RNA, proteins, and other molecules that can be taken up by other cells to provide beneficial effects and have the potential to form nanotube bridges, which can allow the exchange of mitochondria and other cellular contents between cells. For those that want a pictorial representation of the process:

Alzheimer’s Disease

One of the most feared aspects of aging among many is the prospect of not being able to recognize those who have been known for years nor remember crucial and beloved memories of a life lived—in short—the prospect of being diagnosed with Alzheimer’s Disease. We don’t need to go into too many details of the dreaded disease as most are all too familiar with it, but it is the most common cause of dementia, accounting for between 60-80% of cases and afflicting as many as 5.8 million Americans according to the CDC—projected to grow to 14 million by 2060. There is no cure and currently, according to the Alzheimer’s Association, there is only one treatment—aducanumab (brand name Aduhelm produced by Biogen and Neurimmune)—which removed amyloid, one of the hallmarks of Alzheimer’s Disease.

According to the CDC, Alzheimer’s Disease is the 6th leading cause of death among US adults and the 5th leading cause for adults aged 65 or older. And the costs to society are almost immeasurable in certain terms but in monetary terms, a paper by Winston Wong, who is a Scholar in Resident at the UCLA Kaiser Permanente Center for Health Equity, estimated the cost is 2020 at $305 billion, and estimated by the CDC to growth to more than $500 billion by 2040.

It is these tragic facts that Longeveron is attempting to mitigate with Lomecel-B. The company is testing Lomecel-B as a treatment for Alzheimer’s based on the hypothesis that multiple possible mechanisms of action (MOAs) can simultaneously address multiple features of Alzheimer’s. Preclinical studies show that MSCs (Medicinal Signaling Cells) can potentially reduce Alzheimer’s-associated brain inflammation, improve the function of blood vessels in the brain, and reduce brain damage due to Alzheimer’s Disease progression and promote regenerative responses. Longeveron has completed the Phase I safety study of subjects with mild Alzheimer’s disease and based on the success is now enrolling subjects for the Phase 2a clinical trial, which is designed to evaluate the safety of single and multiple administrations of two different doses of Lomecel-B. Additionally, the company was accepted to present a poster of the trial at the AAIC. The Phase I trial was supported by a Part the Cloud grant from the Alzheimer’s Association, which could result in payments from the company to the Association should a therapy reach commercialization status. Based on the preliminary results—seen below in the form of measuring memory with a Mini Mental State Exam (MMSE)—Longeveron is hopeful Lomecel-B may prove to be a disease-modifying therapy for Alzheimer’s Disease. Longeveron published the results from the Phase I trial in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, confirming the positive results.

Longeveron continues, in our view, to make solid progress toward very important goals of treating serious conditions that currently have no treatment. We are watching the CEO search carefully as we believe leadership is incredibly important, especially for a company at this stage of development. We have confidence that the board to taking the search process very seriously and are pleased with the continued forward progress Lomecel-B appears to be making. As such, we believe LGVN is worth a look by investors willing to take a higher risk and is looking to get in a company with the potential for changing people’s lives for the better.

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