By Brad Sorensen, CFA

NASDAQ:LGVN

READ THE FULL LGVN RESEARCH REPORT

Longeveron (NASDAQ:LGVN) is a company that should be getting more attention from investors and the just released annual results again proved that point. LGVN has made substantial progress with its signature treatment, Lomecel-B, in treating both HLHS and Alzheimer's Disease and we suggest investors take a look at this stock before more good news comes out—such as what happened recently. The company announced that Lomecel-B has been granted an International Non-proprietary Name (INN) of “laromestrocel” on the INN List issued by the World Health Organization. This is an important step in the commercialization potential of Lomecel-B and follows the therapy being the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease.

Looking at the 2024 results, we also see the substantial progress the company has made. For 2024, revenues increased to $2.4 million in the year, well ahead of estimates and up 237% from the previous year, largely due to an increase in contract manufacturing revenue, an approach we have applauded before. Also, importantly, company management noted that the current cash the company has, approximately $19.2 million, is enough to fund the company’s operations through the 4^th quarter of 2025. We also want to highlight the 16% reduction y/y in operating expenses—another sign of the improved management we’ve seen in the company over the past year. 

Moving back to the test results, in order to understand how important these results are, investors need to understand how devastating HLHS can be. HLHS is a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. It is a devastating diagnosis for families with only 20-60% of babies with HLHS surviving their first year of life according to data compiled by the Cleveland Clinic.

Because of the rarity of the disease, designing studies can be difficult due to the limited number of potential patients. Additionally, part of how Lomecel-B’s effectiveness will be evaluated will be how the test subjects progress as time goes on. It’s those longer-term results that the company addressed at the Congenital Heart Surgeons’ Society meeting, with the five-year follow-on results available. ELPIS I, as the Phase 1 study was called, was an open-label clinical trial designed to evaluate the safety of Lomecel-B^TM in patients with HLHS. Patients underwent the Glenn Procedure (an open-heart surgery) at approximately 4-5 months of age. The results from the ELPIS I trial, which were previously reported, showed that the study met its primary safety endpoint and that all patients were alive, transplant-free, and maintained their expected rate of growth one year after treatment.

To assess long-term survival benefits, all ELPIS I patients (7 males, and 3 females) were followed for five years post-Glenn surgery and treatment with Lomecel-B to evaluate overall survival and transplant-free survival. Outcomes were compared with long-term historical data from patients in the Single Ventricle Reconstruction (SVR) Trial receiving the same shunt type at Stage I (Norwood) operation and underwent Glenn procedures. Key findings reported by the company include:

• 5-year post-Glenn procedure Kaplan-Meier survival was 100% in patients treated with Lomecel-B in ELPIS I, with none requiring heart transplant. This compared to 83% transplant-free survival in the SVR trial through 5 years post-Glenn surgery, and a 5.2% heart transplantation rate.
• No Major Adverse Cardiovascular Events (MACE) were reported during the study.
• No Lomecel-B related safety issues were reported.
• According to the company, these findings support the use of Lomecel-B as a potential adjunct to HLHS reconstruction surgery to improve transplant-free survival.

These results are very encouraging and support what we’ve been writing about—that LGVN is making great strides and has the potential to impact patients experiencing difficult diseases such as HLHS and Alzheimer’s Disease, which the company recently announced positive test results for at the Clinical Trials for Alzheimer’s Disease Conference.

We are looking forward to seeing results from the currently ongoing Phase 2 trial, known as ELPIS II. According to the company, ELPIS II has achieved more than 90% enrollment and company management noted it had a very positive Type C meeting with the FDA—both very encouraging developments for the patients that so desperately need hope.

We were also very excited to hear management note that they have a meeting scheduled with the FDA early in the year with the very real possibility of moving the timeline forward, as well as getting more guidance on its Alzheimer's program. We believe these conversations are very valuable and have great potential to be market moving events for the company’s stock.

As a reminder, FDA has granted Lomecel-B Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation, which allow greater access to the agency during Lomecel-B’s development for HLHS.

Summary

We continue to believe that Longeveron is an exciting clinical-stage company and investors aren’t appropriately appreciating the game-changing potential Lomecel-B may be able to have on multiple serious medical conditions. As a result of the prudent decisions made by management, we believe Lomecel-B will ultimately have a substantial impact on the health situations of thousands of patients. We believe the stock continues to be underpriced as investors aren’t appreciating the potential of Lomecel-B and encourage investors to take a look at LGVN. 

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