This little-known NASDAQ biotech is awaiting key results from an Alzheimer's Disease Phase 2a trial… data is expected by October!
Greetings Investors,
Devastating diseases. The world is filled with them, but what are we going to do about them? That's where the biotech arena plays a big role.
These companies are on a mission to revolutionize treatments and potential cures for horrible diseases such as Alzheimer's. The Alzheimer's disease treatment market is projected to reach $13 billion by 2030. Which stocks should be on investors' radar?
Perhaps one exciting clinical-stage company that has a lead candidate with game-changing potential for multiple serious medical conditions….
The company is called Longeveron and trades on the NASDAQ under the ticker symbol LGVN.
Priced at under $2.50 a share, Longeveron Inc. (NASDAQ: LGVN) has several compelling reasons why it could be undervalued.
This includes several new management members, and solid science that the company is consistently moving forward.
NASDAQ currently has a "STRONG BUY" rating on the stock with a $13.25 price target!
A $13.25 price target represents over 440% in upside potential!
It was not that long ago that LGVN announced earnings were roughly in line with estimates and noted cash balances remain solid.
The company also updated investors on the progress that has been made to this point in the year regarding its signature treatment—Lomecel-B.
Lomecel-B has the potential to be a breakthrough treatment and results from ongoing trials on various conditions are anxiously awaited!! Now is a pivotal time to have this underfollowed biotech company on your watch list!
https://longeveron.com/
Overview:
LGVN's lead investigational therapeutic candidate Lomecel-B will ultimately have a substantial impact on the health situations of thousands of patients – which could be a positive outcome for investors in LGVN.
Lomecel-B™ is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors.
The company believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, LGVN can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging.
"At Longeveron, we hypothesize that stem cells might reduce the difficulties associated with aging and offer improved quality of life for patients with life-threatening conditions." - Dr. Joshua Hare, Co-founder, Chief Science Officer and Chairman.
LGVN is currently conducting Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS), which is the current exception to our focus on aging.
LGVN announced that it expects to report results from its Phase 2a trial of Lomecel-B for the treatment of Alzheimer's in October 2023. This is around the corner!
Why is there a need for LGVN in healthcare?
One reason is that without surgical treatment, hypoplastic left heart syndrome (HLHS) is always fatal, and even with reconstructive surgical reconstruction, patients often die or require heart transplantation by 15 years of age. The company is hoping that Lomecel-B can improve these patients' outcomes.
LGVN is also testing Lomecel-B as a potential treatment for Alzheimer's Disease (AD) based on the hypothesis that its multiple possible MOAs can simultaneously address multiple features of AD.
Preclinical studies show that MSCs can potentially reduce AD-associated brain inflammation, improve the function of blood vessels in the brain, and reduce brain damage due to AD progression, and promoteregenerative responses!
MORE ABOUT LOMECEL-B™
LGVN's lead investigational therapeutic candidate is a cellular therapy called Lomecel-B™, which is being evaluated in multiple clinical trials for aging-related chronic diseases and other life-threatening conditions under US FDA-approved Investigational New Drug (IND) Applications.
This is proprietary, scalable, "off-the-shelf" cellular therapy.
Key advantages include:
- Superior efficacy for addressing inflammation
- Cells migrate to sites of tissue damage
- Enhanced safety as inherently Immuno-evasive
- Convenient off-the-shelf administration
HOW IS LOMECEL-B MADE?
Once the MSCs have been isolated from the fresh bone marrow through a careful selection process, the cells are culture-expanded (allowed to replicate under controlled laboratory conditions) into the billions using specialized techniques and processes in our GMP facility in Miami, Florida. After a specific number of expansion cycles called "passages", the cells are harvested, separated into specific doses (e.g. 50 million cells), and frozen until future use.
HOW DOES LOMECEL-B WORK?
It is becoming increasingly clear that the therapeutic effects of allogeneic MSCs occurs through secretion of bioactive molecules and direct cell-to-cell contact at the site of inflamed and damaged tissue. There are several potential mechanisms of action believed to mediate therapeutic benefits:
- Release of growth factors and other proteins, such as anti-inflammatory cytokines. These have the potential to reduce inflammation, and stimulate nearby stem cells and other cells (called paracrine activity) to promote regenerative and repair responses.
- Engage in direct cell-cell interactions to induce positive pathways in contacted cells.
- Release exosomes, which have cargo consisting of RNA, proteins, and other molecules that can be taken up by other cells to provide beneficial effects.
- Potential to form nanotube bridges, which can allow the exchange of mitochondria and other cellular contents between cells.
THE OPPORTUNITY WITH ALZHEIMER'S DISEASE:
LGVN has completed a multicenter, randomized, placebo-controlled Phase 1 safety study of subjects with mild AD (n=33) designed to evaluate safety and tolerability, and to explore potential efficacy. This trial was supported by a Part the Cloud grant from the Alzheimer's Association. Based on preliminary results, the company intends to initiate a larger Phase 2 study. If successful in clinical studies, Lomecel-B may prove to be a disease-modifying therapy for AD!
Hypoplastic Left Heart Syndrome (HLHS) Research Program:
HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow, which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives.
While these children can now live into adulthood, early mortality is still extremely high in this population due to right ventricle failure, which is not meant for the increased load demanded for systemic circulation (blood circulation throughout the body). As such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term outcomes.
LGVN is testing Lomecel-B as a potential combinatorial therapy candidate to surgical intervention for HLHS. The scientific goal underlying this study builds on surgical advances of the past thirty years, and is intended to address remaining obstacles to improving transplant-free survival in HLHS patients.
Recent Highlights
Lomecel-B™ for Hypoplastic Left Heart Syndrome (HLHS):
- Announced achievement of exceeding 50% enrollment threshold for Phase 2 ELPIS II trial of Lomecel-B™ in HLHS.
- Announced new long-term survival data from ELPIS I Trial of Lomecel-B™ for HLHS.
- Children in the ELPIS I trial had 100% survival up to five years of age after receiving Lomecel-B™ compared to approximate 20% mortality rate observed from historical control data.
- Data reinforce potential survival benefit of Lomecel-B™ for patients in this indication.
Aging Frailty Research Program:
Aging Frailty is a common geriatric condition that disproportionately increases a patient's risk for poor clinical outcomes due to disease and injury, and is widely believed by geriatricians to ultimately be treatable.
LGVN's multinational interventional Aging Frailty clinical research program is one of the most advanced and extensive in the world for a pharmaceutical investigational product!
According to various studies by leading geriatricians, Aging Frailty affects approximately 15% of individuals 65 years and older, which translates to roughly 8.1 million people in the U.S. alone. Yet, no medical treatments for Aging Frailty have been approved by the FDA, or anywhere in the world…
This has presented LGVN with a remarkable opportunity here too.
U.S. Trials: Two U.S. clinical trials are ongoing in Aging Frailty subjects to assess whether Lomecel-B can improve physical function, reduce inflammation, and improve quality of life, among other endpoints, and to evaluate if Lomecel-B can be an effective vaccine adjuvant to improve immunity against influenza.
Japan Clinical Trial: The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved a Clinical Trial Notification (CTN), which is equivalent to a U.S. IND, allowing us to sponsor an investigator-initiated Phase 2 clinical study for Aging Frailty subjects in Japan.
The Bahamas Registry Trial: We sponsor a Registry Trial in Nassau, The Bahamas, where eligible participants may receive Lomecel-B for Aging Frailty and other indications, at their own expense.
Recent Highlights:
Enrollment continues in the Company's Phase 2 study evaluating Lomecel-B™ in patients with Aging-Related Frailty in Japan.
The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind infusion study of two different dose levels of Lomecel-B™. The trial is expected to enroll 45 patients and has a primary objective of evaluating the safety of Lomecel-B™ as a treatment for Aging-related Frailty.
The Phase 2 trial is being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG; Nagoya) and Juntendo University Hospital (Tokyo).
In Summary….
LGVN has made significant progress advancing its Lomecel-B™ clinical programs, exceeding the 50% enrollment threshold for its ELPIS II trial in hypoplastic left heart syndrome (HLHS) patients and announcing new long-term survival data from our ELPIS I study.
HLHS patients are in critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication. Investors can look forward to the company completing enrollment in the ELPIS II trial by mid-2024.
Additionally, LGVN is on track and expect to report top-line results from its CLEAR MIND Phase 2a trial of Lomecel-B™ treatment of Alzheimer's disease by October 2023!
The company continues to enroll patients in Phase 2 of Lomecel-B™ in patients with Aging-related Frailty at centers in Japan.
As LGVN advances Lomecel-B™ in areas of significant unmet medical needs, this could be a great time to keep an eye on the company. Especially with a price target of over $13!
Start your own research!
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