Earnings call transcript: Longeveron Q4 2024 sees revenue surge, stock gains

Longeveron LLC (LGVN) reported a significant increase in revenue for the year 2024, driven by its innovative cellular therapies, leading to a notable stock price increase in aftermarket trading. The company’s revenue reached $2.4 million, a 237% rise from the previous year, while operating expenses decreased, contributing to a reduced net loss. The stock price rose by 22.37% in aftermarket trading, reflecting positive investor sentiment. According to InvestingPro data, this performance continues the company’s strong revenue growth trajectory, with a 141.46% increase in the last twelve months. The company currently maintains a market capitalization of $22.85 million.

Key Takeaways

• Longeveron’s 2024 revenue increased by 237% compared to 2023.
• Operating expenses declined, resulting in a reduced net loss of $16 million.
• Stock price surged 22.37% in aftermarket trading following the earnings report.
• The company is preparing for significant advancements in its Alzheimer’s and HLHS programs.

Company Performance

Longeveron demonstrated impressive growth in 2024, with revenues soaring to $2.4 million, a 237% increase from the previous year. This growth was largely attributed to contract manufacturing revenue, which contributed $1 million. The company’s focus on cost management led to a 13% reduction in total operating expenses, helping to decrease its net loss by 25% to approximately $16 million. These results highlight Longeveron’s strategic focus on efficiency and innovation in the cellular therapy market.

Financial Highlights

• Revenue: $2.4 million, up 237% from 2023.
• Contract manufacturing revenue: $1 million.
• Operating expenses: down 13% year-over-year.
• G&A expenses: reduced to $10.3 million from $12.2 million in 2023.
• R&D expenses: decreased to $8.1 million.
• Net loss: decreased by 25% to approximately $16 million.
• Cash and cash equivalents: $19.2 million as of December 31, 2024.

Market Reaction

Following the release of the earnings report, Longeveron’s stock price experienced a significant increase of 22.37% in aftermarket trading, reaching $1.86. This surge reflects investor optimism about the company’s financial performance and future prospects, particularly in the promising fields of Alzheimer’s and HLHS therapies. InvestingPro analysis reveals two important insights: the company holds more cash than debt on its balance sheet, and its liquid assets exceed short term obligations with a strong current ratio of 7.67. Subscribers can access 5 additional ProTips and comprehensive financial analysis in the Pro Research Report.

Outlook & Guidance

Longeveron is poised for further growth, with plans to complete enrollment for its HLHS Phase 2b trial by Q2 2025 and anticipate top-line results by summer 2026. The company is also preparing for a Biologics License Application (BLA) submission in 2026 for its Alzheimer’s program, which has received RMAT and Fast Track designations. These initiatives underscore Longeveron’s commitment to advancing its cellular therapy pipeline.

Executive Commentary

CEO Wael Hochad emphasized the potential of LomaSIL B, stating, "We believe LAMASA B has the potential to be an important cellular therapy option for multiple chronic and life-threatening conditions." Chief Medical (TASE:BLWV) Officer Natalia Agafanova highlighted the impact of Alzheimer’s disease, noting, "Nearly seven million Americans are living with Alzheimer’s disease. It kills more people than breast cancer and prostate cancer combined."

Risks and Challenges

• Regulatory hurdles: The company’s future success hinges on obtaining necessary approvals from regulatory bodies.
• Market competition: The cellular therapy market is competitive, with numerous players vying for market share.
• Financial sustainability: While cash reserves are expected to fund operations into Q4 2025, ongoing financial management will be crucial.
• Enrollment challenges: Completing trial enrollments on time remains a logistical challenge.

Overall, Longeveron’s strong financial performance and strategic initiatives have positioned the company well for future growth, with investors responding positively to its latest earnings report.

Full transcript - Longeveron LLC (LGVN) Q4 2024:

Paul, Conference Operator: Good day, and welcome to the Longeveron twenty twenty four Full Year Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions.

Please go ahead.

Derek Cole, Investor Relations Advisory Solutions, Longeveron: Thank you, Paul. Good afternoon, everyone, and thank you for joining us today to review Longuveron’s twenty twenty four full year financial results and our business update. After The U. S. Markets closed today, we issued a press release with financial results for 2024, which can be found under the Investors section of the Lungevoron website.

On the call with me today are Wael Hochad, Chief Executive Officer Natalia Agafanova, Chief Medical Officer Lisa Locklear, Chief Financial Officer and Doctor. Joshua Hare, Co Founder, Chief Science Officer and Chairman of the Board. As a reminder, during this call, we will be making forward looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in the company’s filings with the Securities and Exchange Commission, which we encourage you to review.

Following the company’s prepared remarks, we will open the call to questions from our covering analysts. With that, let me hand the call over to Wael Harshad, Chief Executive Officer. Wael?

Wael Hochad, Chief Executive Officer, Longeveron: Thank you, Derek. Good afternoon, everyone, and thank you very much for joining us today. We are very pleased to update you on highly productive year in 2024 and provide an overview of what to expect in potentially transformational 2025 for LongoverONE. As a reminder for those of you newer to our story, Longeverone is a regenerative medicine company developing cutting edge cellular therapies. Our stem cell therapy LAMA Cell B or Laramestrocell represents a pipeline and a product opportunity that has delivered several positive initial results across five clinical trials in three indications.

Phase one and two in Alzheimer disease, Phase one and two in aging related frailty and Phase one in HLHS or hypoplastic left heart syndrome, a rare pediatric disease condition. The company development program for these three initial indications address U. S. Market opportunity of approximately $5 plus billion, approximately $4 plus billion and up to $1,000,000,000 respectively. Longivarone continued to make progress in 2024 with both the LAMATILL B and HLHS and Alzheimer disease programs.

Hypoplastic left heart syndrome or HLHS is a key strategic priority for us. We believe the HLHS program has high probability of success and the shortest path to potential regulatory approval and commercialization across our pipeline. In 2024, we continue to advance enrollments in our ongoing Phase 2b study, ALPHIS2, which is evaluating glomacell B as a potential adjunct treatment for HLHS. APIS2 has now achieved more than ninety percent enrollment and we expect to complete enrollment in the second quarter of this year. Also importantly, last year we completed a meeting with the U.

S. Food and Drug Administration, the FDA, which confirmed that ELFIS2 is a pivotal and if positive acceptable for biological license application or BLA submission for full traditional approval. This significantly accelerate the potential regulatory path for LomaCell B and if supported by clinical data from ALPIS2 would allow us to initiate a rolling submission of a BLA with the FDA in 2026. We also continue to advance the Alzheimer disease program. Results from our CLEAR MIND Phase 2a clinical trial was presented in a featured research oral presentation at the twenty twenty four Alzheimer’s Association International Conference, AAIC.

Based on the ClearMinds Phase 2a clinical data and prior Phase one data, the FDA granted LAMASIL B both regenerative medicine advanced therapy designation also known as RMAT and fast track designation for the treatment of mild Alzheimer disease. Lomacil B appeared to be the first cellular therapy candidate to receive RMAD designation for Alzheimer disease. With this data in hand, we anticipate meeting with the FDA later this quarter to review future clinical and regulatory strategy for continuing this important program. 2025 has the potential to be a transformative year for longevron with achieving clarity on Alzheimer’s development pathway, completing enrollment for the HLHS Phase two trial, which would establish a potential timeline for our first BLA submission in 2026. Starting the year off well, in February, Latin Master Cell for the non proprietary name of the company’s cellular therapy LomaCell B.

This naming approval is an important step in the development and the potential commercialization of LomaCell B. I am thoroughly excited by the opportunity for LomaCell B, Longaberone, patients and our stockholders. With that, I will turn the call to Doctor. Agafinova to provide update on our clinical development program. Natalia?

Natalia Agafanova, Chief Medical Officer, Longeveron: Thank you, Wael, and good afternoon, everyone. Our stem cell therapy, Lonicil B, has multiple models of action that include pro vascular, pro regenerative and anti inflammatory mechanism promoting tissue repair and healing, both broad potential applications across the spectrum of disease areas. Based on positive initial data, LomiCell B development programs have received five FDA designations. For the HLHS program, orphan drug designation, fast drug designation and rare pediatric disease designation. And for the Alzheimer’s disease program, regenerative medicine, advanced therapy, RMAD designation and Fast Track designation, each of which offers benefit for the program’s development and regulatory process.

As Vael mentioned, our HLHS program is a primary focus for us with a near term pathway to potential approval in a rare area of unclear unmet medical needs. We are currently conducting a Phase 2b clinical trial, LPISS2, evaluating the potential of LUNISIL B to improve right ventricular function and long term outcomes in pediatric patients with HLHS. LPS II is being conducted in collaboration with the National Heart, Lung and Blood Institute through grants from the National Institute of Health. We are very pleased to share that LPS II has now achieved over ninety percent enrollment. We expect to complete enrollment of this trial before the end of the second quarter and then we will follow the patients for twelve months.

If results from LPS II are positive, we would be positioned to initiate a rolling BLA submission with the FDA in 2026. Turning now to our Alzheimer disease program. This is also an area of significant unmet need. Nearly seven million Americans are living with Alzheimer disease. It kills more people than breast cancer and prostate cancer combined.

And there has not been great progress in this area. Between 2021, death from heart disease decreased two point one percent, while death from Alzheimer disease increased one hundred and forty one percent. Potentially helping provide a new option for these patients and their families is our mission. And we are optimistic given the Lonisol B data to date. In 2024, data from CLEARMind Phase IIa clinical trial evaluating Lonisel B in Alzheimer disease were selected for a future research oral presentation at the twenty twenty four Isiner Association International Conference held at the July.

We are very excited about the trial positive results, which we have reviewed previously. The trial achieved the primary safety and secondary efficacy endpoints and the clinical trial LamiCell B treated patients showed an overall slowing prevention of disease worsening compared to placebo. We believe the results from ClearMind supports the therapeutic potential of Lomicel B in the treatment of mild Alzheimer disease and provided evidence based support of further clinical development. Based on the data generated in our Phase I and Phase II Alzheimer clinical trials, in July, the FDA has granted Lonisil B board Regenerative Medicine Advanced Therapy, RMAT designation and Fast Track designation for the treatment of mild IVIONER disease. We plan to meet with the FDA in March to review the future clinical and regulatory strategy for the Alzheimer program to continue advancing this potentially important therapeutic option for patients living with Alzheimer’s disease.

I will hand the call over to Lisa LaClair, our Chief Financial Officer, to discuss our financial results for the year. Lisa?

Lisa Locklear, Chief Financial Officer, Longeveron: Thank you, Natalia, and good afternoon, everyone. This afternoon, we issued a press release and filed our annual report on Form 10 ks, both of which present our financial results in detail. So I will touch on some highlights. Revenues for 2024 were $2,400,000 up $1,700,000 or 237% when compared to 2023, mainly as a result of increased participant demand for our frailty and cognitive impairment registry trial in The Bahamas and new contract manufacturing revenue. Contract manufacturing revenue for 2024 was $1,000,000 consisting of $500,000 from our manufacturing lease services and another $500,000 from our manufacturing services contract.

This year, we have focused on prioritizing investments in our programs and expense management and we have successfully executed in both areas. Total (EPA:TTEF) operating expenses for the year declined 13% year over year with G and A expenses decreasing to approximately $10,300,000 from $12,200,000 in 2023. This G and A expense decrease of approximately $1,900,000 or 16% was primarily due to lower personnel expenses as a result of reduced severance in 2024 and lower legal and other administrative expenses. R and D expenses for 2024 also decreased approximately $1,000,000 or 10% to approximately $8,100,000 The decrease was primarily due to a reduction of $2,300,000 in expenses related to the completed CLEAR MIND Alzheimer’s disease clinical trial, reduced costs for the aging related frailty clinical trial following our decision earlier this year to discontinue trial activities in Japan and a $900,000 decrease in supply costs. These reductions were partially offset by $1,700,000 in higher compensation and benefit costs in R and D and another $300,000 increase in equity based compensation for that team.

Net loss decreased 25% to approximately $16,000,000 for 2024 from a net loss of $21,400,000 for 2023. Cash and cash equivalents as of 12/31/2024 were $19,200,000 The company believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of twenty twenty five based on our current operating budget and cash flow forecast. It is important to note, however, that as a result of our Type C meeting with the U. S. FDA in August 2024, with respect to the HLHS regulatory pathway, we have started to ramp up Biologics License Application, BLA enabling activities as we currently anticipate a potential filing with the FDA in 2026 if the current ELPIS II trial is successful.

Our operating expenses and capital expenditure requirements are expected to accelerate in calendar 2025 as a result of these activities, including CMC chemistry manufacturing controls and manufacturing readiness spend as we prepare for the BLA. And there will be a need to increase our current proposed spend and further increase our capital investments as a result. We intend to seek additional financing and non dilutive funding options to support these activities and the current cash projections will be impacted by these ramped up activities and any financing transactions entered into. I will now hand the call back to Yael.

Wael Hochad, Chief Executive Officer, Longeveron: Thank you, Lisa. Over the past decade, stem cell therapy has made tremendous progress, transforming from promising field into one delivering tangible clinical outcome. We have seen the solidification of cell therapies role in regenerative medicine and its potential to treat wide range of conditions, signaling an exciting future for both scientific innovation and patient care. We believe LAMASA B has the potential to be important cellular therapy option for multiple chronic and life threatening conditions. The data generated to date in HLHS, Alzheimer disease support that belief.

The strength of our clinical data, our experience and committed team and unwavering focus on patients give me confidence in the future of LAMASIL B and Longivarone. Operator, now we would like to open the call for questions from covering analysts.

Paul, Conference Operator: Thank you. We’ll now be conducting a question and answer session. Thank you. Our first question is from Bhubilan Pacharyupan with Roth Capital Partners (WA:CPAP). Please proceed with your question.

Bob Allen, Analyst, Roth Capital Partners: Good afternoon, Tim. Can you hear me okay?

Wael Hochad, Chief Executive Officer, Longeveron: Yes. Bob Allen, hi.

Bob Allen, Analyst, Roth Capital Partners: Hi. Thank you so much. Thanks for taking our questions. So we have a couple of them. So firstly, with respect to LPs2 enrollment delay, I was wondering maybe if you could provide some additional color, so what’s causing the enrollment delay?

Because I mean, I’m following up your story for quite some time. So initially, we were planning I mean, I wanted to see the enrollment wrap up sometime in fourth quarter of last year and then after that he said it will be first quarter. So I’m curious what’s causing the delay. I understand you have no control in terms of setting the surgery date, which I feel is a key factor. But other than the surgery date, are there any other factors that are causing the enrollment delays?

Wael Hochad, Chief Executive Officer, Longeveron: Yes. Bob Allen, I’ll take that question and Natalia can add color. Of course, as you know, ETS is a rare disease and actually goes into the border of ultra rare disease. And it is very hard sometimes to predict it with a great details of accuracy. The team is pushing to finish enrollment as fast as possible, But sometimes delays of the surgery itself can happen, things like that.

The great news is we continue to make progress as you can see from one quarter to another or from one call to another. And right now we’re sending above ninety percent enrolled. Actually that means that we have 35 patients enrolled. So we are talking about honestly the last couple of patients left in the trial and we now with absolute full confidence we believe that we can finish that enrollment in the next couple of months.

Bob Allen, Analyst, Roth Capital Partners: Great. And then moving on, so I have a question sorry, go

Wael Hochad, Chief Executive Officer, Longeveron: ahead. Yes. I was going to say, if Natalia want to add any comments, feel free as well if you have any last one.

Natalia Agafanova, Chief Medical Officer, Longeveron: Yes. Thank you, Bhavan. That’s a great question. And as Raul said, we are definitely making a very, very good progress. And the nature of disease sometimes have surprises.

And as you mentioned, the Glenn surgery, sometimes the patient goes to the surgery, seems promising and during the surgery, unfortunately, some patients are not eligible based on intraoperative decision. So again, it’s a very complicated indication and we are so far been very successful. So because of that, sometimes we have promising patients, but they are not eligible at the end of this. So it’s a definitely decision, but we keep track of every single patient who are potentially eligible. We approach them and we are making great progress on that.

So hopefully within one, two months, we will be able to complete enrollment.

Bob Allen, Analyst, Roth Capital Partners: That’s very helpful. Thanks for that. And then staying on LPS II lane, so I was wondering, I mean, I understand the primary endpoint is RVEF and you’re tracking this for twelve months. So I was wondering if the FDA would be open to the possibility of considering a composite endpoint, because I’m not very sure whether a clinically meaningful difference could be recognized in that twelve months timeframe. So assuming, I mean, in addition to RVEF, is it possible, you can get some data about the other factors such as prolonged hospitalization and MACI’s such as reoperation and percutaneous interventions and all other events that could potentially all these HLHS patients would normally go through, whether that would be embedded in your composite endpoint?

That was my question.

Natalia Agafanova, Chief Medical Officer, Longeveron: Raul, would you like me to

Wael Hochad, Chief Executive Officer, Longeveron: Yes, you can respond and I can ask you a question. Okay. Thank

Natalia Agafanova, Chief Medical Officer, Longeveron: you. Thank you so much. So it’s a great question and you’re reading our mind. So we definitely thinking in the line that just to have right ventricular ejection fraction, it would be not sufficient. So we did have conversation with FDA and currently, as we mentioned, FDA accepted LPIS2 clinical trial as pivotal and also they were willing to see more thoughts around primary endpoint and we currently working with our data, we are working to prepare response to FDA, to compile convincing evidence that composite endpoint would be the way to go.

So we are thinking exactly what you mentioned. We are thinking about composite endpoint, we are thinking about different type of endpoint and hospitalization maybe something else. So definitely and we are our plan is to get an alignment with FDA this year that we are analyzing the data based on this composite endpoint.

Wael Hochad, Chief Executive Officer, Longeveron: Yes. So thank you, Natalia. Bob Allen, I will add just one thing is, it’s not just our thoughts. We have actually had that discussion with the FDA, as you said. So the agreement is, yes, they will accept the composite endpoints.

We want to make sure that these composite endpoints happen in a frequency that allow us to detect the difference and success of the trial. And the FDA was open to several suggestions from our side and including hospitalization, survival and other endpoints. And we are in the process of preparing an SAP and sharing it back. And they said they will be happy to discuss that further once they receive the SAP from us. Great.

Bob Allen, Analyst, Roth Capital Partners: Switching gears and talking about the Alzheimer’s program. So you mentioned that you’ll be speaking with the agency sometime this quarter. So I’m curious, what are some of the key items that you wanted clarifications from the agency? Because you have this ARMED designation and this is it’s a very long program. Ozemers, it’s not for the faint of heart, just to tell you that.

So do you plan to sort of propose a plan such that you will have to do a Phase 2b prior to Phase three or is there a way you could sort of bypass 2b and directly go to Phase three? Is there a possibility to do that for that?

Wael Hochad, Chief Executive Officer, Longeveron: So that’s a great question. I will tell you that’s the reason why we’re meeting. We are proposing and we’ll get into the details after the meeting, but we are proposing a very accelerated path to the commercialization and regulatory approval course, but at the same time providing the agency an opportunity to ensure that the safety and the efficacy of the product is fully demonstrated as well. And that path for approval, if the FDA agree with our proposal, will definitely presents a great differential opportunity over existing path and that would be one of the values that we can. And by the way, this is part of the RMAT because the RMAT give you an opportunity for an accelerated path for approval.

So that’s what we’re asking for and that’s what we’re hoping the FDA will agree with our plans for that as well. But we have to wait and see what happened at the meeting.

Bob Allen, Analyst, Roth Capital Partners: Great. Maybe one last question. Sorry, this is the last question from me. So after 09/30/2026, so the agency may not award any pediatric disease priority review voucher and these have been around for quite some time. So I’m curious, what are the prospects for in your case for the LMSL B in terms of receiving a PRV, should this agent be approved, say either late twenty six or first half of twenty seven for HLHs?

Wael Hochad, Chief Executive Officer, Longeveron: That’s a great question, Bob Allen. First, as you know, the PRV is going for renewal next month. There is on the ballot that is a Give Kids a Chance Act five to extend the whole PRV. We believe if we are and that’s going to be part of the pre BLA because we have been acting in a very fast and judicious way. We believe that we will have an extension on this one, but we have to get agreement with the agency at the pre BLA meeting for this as well.

Bob Allen, Analyst, Roth Capital Partners: All right. Thank you, Tim. Congrats on the progress.

Natalia Agafanova, Chief Medical Officer, Longeveron: Thank you.

Wael Hochad, Chief Executive Officer, Longeveron: Thank you, Bhavan.

Paul, Conference Operator: Our next question is from Ram Selvaraju with H. C. Wainwright.

Ram Selvaraju, Analyst, H.C. Wainwright: Thanks so much for taking my questions and congratulations on all the recent progress. I was just wondering if you could confirm specifically how many patients remain to be enrolled in LPS II at this juncture?

Wael Hochad, Chief Executive Officer, Longeveron: So that trial is, as you know, it’s a 38 patients, we have enrolled 35. So we’re waiting on three more patients. But if there is one or two more patients are in the hopper and things like that, we may take them and we’re not declining them. But the goal is to enroll three, but we could end up enrolling a couple of more if they happen to be in the hopper and consented.

Ram Selvaraju, Analyst, H.C. Wainwright: Okay. So just to clarify, it’s possible that you could over enroll the study by one or two patients if during the process of screening to finish enrollment, you wind up having a couple extra. Is that correct?

Wael Hochad, Chief Executive Officer, Longeveron: Correct. Sometimes you have to be I don’t want to take a chance, Ram, on losing a patient as Natalia had mentioned in her answer to Bob Allen is sometimes you get surprises at that time of randomization and so on. So we keep the hopper or the feed pool full because I’m interested in finishing the trial and get done with it once and for all. In that process, we may end up finishing one or two more patients and that will be good thing, not a bad thing to have. But we’re not delaying it beyond 38 being enrolled.

I mean, not intentionally, but if we happen to enroll few more patients, we’ll enroll them.

Ram Selvaraju, Analyst, H.C. Wainwright: You can confirm, right, that at this juncture, you don’t see any issue with reaching full enrollment in the trial based on the current complement of sites that you have up and running. In other words, you would not need to open any new sites in order to complete enrollment. Is that correct?

Wael Hochad, Chief Executive Officer, Longeveron: Absolutely correct.

Ram Selvaraju, Analyst, H.C. Wainwright: Okay. Can you just remind us, let us assume that you complete the study in the second quarter or you sorry, you complete enrollment in the second quarter. When approximately would you expect to report top line results?

Wael Hochad, Chief Executive Officer, Longeveron: So let’s say I’m just hypothetical here, so we can get. If I finish enrollment in May, I will we need twelve months for a study to lock the database on last patient out and then within three, four weeks after that we’ll have that data announced and everything moving on. So within three weeks after the data base lock, which would happen twelve months from the last patient in.

Ram Selvaraju, Analyst, H.C. Wainwright: So just to confirm, that’s basically sort of like the summer of twenty twenty six timeframe. Is that correct?

Wael Hochad, Chief Executive Officer, Longeveron: Correct.

Ram Selvaraju, Analyst, H.C. Wainwright: Okay. Switching with respect to the potential future commercial scenario for LomaCell B in the HLHS context, maybe you can give us some sort of frame of reference regarding how the drug might be commercialized in that indication and what kind of commercial infrastructure would need to be put in place. Because I would expect given the nature of the epidemiology and how these patients are triaged, you would not really need significant sales and marketing infrastructure. And this is potentially an area in which Rolongeveron could handle commercialization independently. Is that correct?

Wael Hochad, Chief Executive Officer, Longeveron: You’re absolutely correct, Ram. I can tell you right now, the number of treating physicians is about 50 in The United States. So the surgeons would do doing this surgery. As you know, we are our treatment is adjunct to the surgery. So the surgeons are our target.

And actually more than seventy percent of these surgeries happen in the centers that we have conducted our clinical trial. So number one, we have a great opportunity that we know all the treatment position in the future because they have participated in the trial. And then the second thing is the number 50 of physician treating does not require a significant infrastructure from a sales organization. I mean, it’s actually at most you don’t need more than two or three individuals with the manager. The whole commercial organization can be less than 15 people, including payer, patient services, all of these type of things.

So very minimal infrastructure on the commercial organization side, which is one of the beauty of operating in an orphan disease. It’s you don’t have to make a massive investment. So you’re absolutely correct in your assumption.

Ram Selvaraju, Analyst, H.C. Wainwright: Okay. With respect to Alzheimer’s disease, I was wondering if you had had any recent interactions with non U. S. Regulatory authorities and if there appears to be any differentiated picture with respect to how regulators outside of The U. S.

Are thinking about potential approvability criteria for a drug like Lomicil B and if you are exploring the possibility of conducting any clinical exploration of LUMISEL B and Alzheimer’s disease outside The U. S. At this time and if so, what the format and scope of that might take?

Wael Hochad, Chief Executive Officer, Longeveron: Yes. Thank you so much for this great question. So I’ll answer the first part and explain what is our intention outside The U. S. So we have not had any interaction with any of the agencies outside The United States specifically regarding the development path for Alzheimer disease.

So that’s the answer to your first question. We are in the process of hiring a full time regulatory person now that we are heading into the BLA submission next year for this one and we have a lead candidate. And actually one of the most important tasks that this individual will do as soon as the full time joined the company is to have a discussion with both the EMEA, The UK MHRA, as well as Health Canada, Australia and Japan. Those are the priority international markets that we’re going to go after. And that is in our plan is to engage and start the discussion regarding the filing of the biological license application in this respective health authorities, but for Lomacil B and HLHS that is our top priority.

And then once we do that, we’ll get into the Alzheimer disease. Our Alzheimer disease focus moving on is going to be around partnership. We definitely don’t want to dilute our efforts, but we want to focus 100% on partnership globally, U. S. And outside The U.

S.

Ram Selvaraju, Analyst, H.C. Wainwright: Okay, great. And one more from me. With respect to the manufacturing revenue that you historically booked in 2024, can you give us some sense of what the perspectives are to potentially either emulate that level of business or grow it in 2025. As an example, I believe that you previously had a client called Secretome privately held company, which successfully raised capital. Not sure whether that is going to be a source of repeat business for you, but just wanted to get a sense of what you expect the level of manufacturing revenue to be in 2025.

Michael Okunovich, Analyst, Maxim Group: And if

Ram Selvaraju, Analyst, H.C. Wainwright: you think it could be the same or higher than what you saw in 2024. Thank you.

Wael Hochad, Chief Executive Officer, Longeveron: Yes. So Ram, that’s a great question. We continue to have a very good relationship with Secretome. Actually, we may have some small amount of work in 2025 for them. But, and I don’t know.

I mean, we’re happy if they have any additional needs that come throughout the year. We’ll definitely I think we establish a good relationship and expertise between the two companies. So So we continue to develop it depending on what their needs are. So they are better to speak up about their needs than me speaking it up. Regarding other opportunity, we remain open to other opportunities.

I cannot guarantee the same thing, because honestly the other thing that is going on parallel here is our CMC readiness process and that is going to require an extensive work on our side. As you know, shifting from a clinical development to a fully commercial CMC requirement is a major step upward. We have recently hired Devin Blass, which we are extremely excited about having him on board. He has been a tremendous addition to our team, making great progress in establishing what I would say is the CMC master plan that ensure that our pre approval and inspection for the facility as well as the whole product characterization will meet all the regulatory requirement at the time of the BLA filing. So we are full steam ahead on the CMC that will keep us busy, but definitely we’ll stay opportunistic on the CMC sorry, on the CDMO business.

And if there is an opportunity, we’ll definitely use it and deliver revenue for the company.

Ram Selvaraju, Analyst, H.C. Wainwright: Thank you very much. Congrats once again on all the progress.

Wael Hochad, Chief Executive Officer, Longeveron: Thank you.

Paul, Conference Operator: Our next question is from Michael Okunovich with Maxim Group. Please proceed with your question.

Michael Okunovich, Analyst, Maxim Group: Hey guys, thank you so much for taking my questions today. Congrats on a lot of really good progress here.

Wael Hochad, Chief Executive Officer, Longeveron: Thank you, Michael. Thank you.

Michael Okunovich, Analyst, Maxim Group: I guess to start off, I wanted to follow-up on one of the previous questions. Specifically in regards to you mentioned potential outcomes for that upcoming meeting are really focused on designing the pathway forward and potentially getting something more accelerated and streamlined to approval. So do you consider the results of that upcoming meeting to be somewhat of a dating item for these potential partnering discussions? And then especially if you have an accelerated pathway, do you think that could really open up these discussions?

Wael Hochad, Chief Executive Officer, Longeveron: Yes. So you’re reading my strategy, my friend. So as you know, Michael, there is over 140 clinical development program currently in the market place in various phases of development from Phase one to Phase three. Many of them are developed by small companies. And many of these programs are all hoping to get a partnership from one of the major players because the development costs when as you move toward the finish line Phase III, it becomes extensive both on the clinical development and the CMC front and the hundreds of millions of dollars.

So everybody is looking for the same partnership. I really believe we have our strategy is very simple. We have good clinical data and clinical outcome that we have demonstrated so far, which we have shared. We also are meeting with the FDA and hopefully the FDA agree with our approach and accelerated that also provides an economic opportunity for any partner to see a faster and more economical way to bring our product. And hopefully those two things, the clinical data combined with the accelerated path give us some competitive advantage over the other programs being developed in improving our chance of landing this partnership.

Michael Okunovich, Analyst, Maxim Group: Now just given that the increase in support from the FDA for cell therapy programs in particular around granting these more streamlined path to approval, do you think that could potentially de risk this outcome for these upcoming meetings?

Wael Hochad, Chief Executive Officer, Longeveron: I believe, yes, definitely I’m cautiously optimistic with your position, but I don’t like to make a statement I’m not in ownership of it. I would like to go through the meeting and hear the confirmation from the FDA with that principle.

Michael Okunovich, Analyst, Maxim Group: Certainly fair. And then just one last one for me and I’ll hop back into the queue. I’d like to see if you could just touch a little bit on your current manufacturing capabilities And then what else is needed on that front to become BLA ready? Just given the relatively small size of this market, I wouldn’t imagine you would need to scale all that much.

Wael Hochad, Chief Executive Officer, Longeveron: Yes, that’s a great thing, Michael. We definitely, as I said, I’m very, very happy and I think the next call we can bring Devin to join our earning call and also we’ll be in a position where we can answer a lot of more specific questions around CMC and have him answer those. But speaking on his behalf, I would tell you that moving from a clinical development to a fully commercial, it is a very major step up from a ramp up. And that includes many steps, both at the facility level, as well as the product level as well, including the stability studies and all of the final formulation and all of those type of things need to be done. And we have a plan, we have alignment from the FDA, but definitely that’s a major work that has to take place.

Also in addition, as you know, CMC, big portion of that is our quality system. They need to all be 100% into the commercialization level. Our supply chain need to be upgraded to the same level and many other areas within the CMC that all need to do this. It is a major focus for us this year. We believe we have a good plan to ramp up these activities.

It is going to be the largest portion of our investment this year is in the CMC. As I said, we have an agreement and alignment from the agency, but it’s going to be a lot, a lot of work this year and I’m happy in the future to bring Devin to answer any more specific questions related to CMC.

Michael Okunovich, Analyst, Maxim Group: All right. Thank you so much for taking my questions, Weil. Lots of work ahead, but lots of exciting progress as well.

Wael Hochad, Chief Executive Officer, Longeveron: Thank you, Michael.

Paul, Conference Operator: Thank you. There are no further questions at this time. I would like to hand the floor back over to Wael Hashed for any closing comments.

Wael Hochad, Chief Executive Officer, Longeveron: Thank you, Paul, and thank you all for attending today’s call. We greatly appreciate your interest and support and look forward to updating you on our progress soon. Thank you. Operator, you may end the call now.

Paul, Conference Operator: This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.

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