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Ladies and gentlemen, greetings and welcome to the Longeveron 2026 first quarter financial results and business update call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference call, please signal the operator by pressing star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole from Investor Relations at Y three Solutions. Please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us today to review Longeveron's 2026 first quarter financial results and business update. After the U.S. markets today, we issued a press release with financial results for the first quarter, which can be found under the investor section of the longeveron website. On the call today are Stephen Willard, Chief Executive Officer, Joshua Hare, Co-founder, Chief Science Officer, and Executive Chairman of the Board, Nataliya Agafonova, Chief Medical Officer, and Lisa Locklear, Chief Financial Officer. 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 covering research analysts. With that, let me hand over the call to Stephen Willard, Chief Executive Officer. Steve?

Thank you, Derek, and thank you all for joining us today. We have had an extremely productive start to this year. After I took on the role as CEO in February, we embarked on two immediate critical tasks: a comprehensive review of the company's assets, development, and strategic plan, and attracting new investment capital. Following this review, we have taken decisive steps to reposition the company for long-term value creation, sharpen our strategic focus, and align our development and capital strategy with the most impactful near-term catalysts. With this reorientation, we were able to successfully attract new investment capital from several of the premier investment funds in the life sciences space, including Coastlands Capital, Janus Henderson Investors, Logos Capital, and Kalehua Capital. Our strategic repositioning is designed to maximize shareholder value while maintaining disciplined capital allocation.

We are transitioning toward a more capital-efficient, asset-light operating model with an increasing focus on securing strategic licensing partnerships for our stem cell product, laromestrocel, across all our development programs, hypoplastic left heart syndrome, or HLHS, Alzheimer's disease, pediatric dilated cardiomyopathy, or PDCM, and aging-related frailty. This evolution reflects both the strength of our client data and clinical data and the growing external validation of our programs. We believe that leveraging the commercial infrastructure, capital resources, and global reach of established pharmaceutical partners represents the most efficient pathway to unlock the full value of our assets. Longeveron will be participating in the BIO International Convention taking place June 22nd through 25th of 2026 at the San Diego Convention Center. We will be hosting meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the company's four stem cell development programs.

We are focused on our development activities to prioritize our most important near-term catalyst, the data readout of ELPIS II, our phase II-B clinical trial evaluating laromestrocel in HLHS expected in August. This disciplined prioritization has enabled us to extend our operating runway while maintaining focus on value-driven milestones. In 2026, we believe we are approaching a series of potentially transformative milestones that have the potential to redefine the trajectory of our business. It is an exciting time for laromestrocel, the patients we serve, Longeveron, and our shareholders. With that, I will turn the call over to Dr. Agafonova, our Chief Medical Officer, to touch on our clinical development programs. Nataliya?

Thank you, Steve, and good afternoon, everyone. As Steve mentioned, our HLHS program is the primary focus for us, addressing an area of clear unmet medical need. ELPIS II, our phase II clinical trial evaluating the potential of laromestrocel in infants with HLHS, is nearing completion. Enrollment of 40 patients was completed in June of last year. Top-line results from the ELPIS II trial are anticipated in August 2026. We recently completed a constructive Type C meeting with the FDA on the laromestrocel development program in HLHS. In the meeting, the FDA acknowledged that HLHS is a rare disease associated with significant morbidity and mortality with a high unmet medical need for safe and effective therapies. Also asserted that the primary endpoint of right ventricle ejection fraction in the ELPIS II trial is not an appropriate endpoint to demonstrate efficacy.

While Longeveron agreed with the FDA regarding the insufficiency of RVEF as the primary endpoint and was prepared to discuss other potentially appropriate endpoints sufficient to demonstrate efficacy, the FDA indicated that given the interim analysis mandated and conducted by the National Institutes of Health, NIH, during the trial, to which the company was and remain blinded, a new primary endpoint could not be agreed to while the trial is still ongoing. Without an agreed-upon primary endpoint sufficient for efficacy, the FDA no longer refers to the ELPIS II trial as pivotal, as had been specifically discussed with the FDA in the company's Type C meeting in 2024. Nevertheless, the FDA expressly agreed that it is willing to meet with Longeveron again when the ongoing ELPIS II study is completed to discuss the study results and align on a potential path forward.

The FDA further indicated that only the most objective measures, including all-cause mortality, cardiac transplant-free survival, event of cardiac transplantation, and well-defined major adverse cardiac events, MACE, could be informative of efficacy in LP 2. In that regard, the company is capturing all of these measures in LP 2, along with some additional key measures to support an efficacy determination. The company intends to submit to the FDA a sponsor statistical analysis plan, or SAP, for LP 2 for the FDA's review and approval and remain optimistic that the trial results and other available evidence will be sufficient to support filing a Biologics License Application, BLA, following the readout of top-line results of the LP 2 data, which, as I mentioned earlier, are anticipated in August of this year. We look forward for sharing the results of the LP 2 clinical trial when they are available.

Switching over to pediatric dilated cardiomyopathy, or PDCM. This is a rare pediatric cardiovascular disease in which the muscles in one of the more of the heart chambers become enlarged or stretched, dilated, with nearly 40% of children with PDCM requiring a heart transplant or dying within 2 years of diagnosis. Our investigational new drug, IND, application for laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND allows advancement directly into a single phase II registrational clinical trial, reflecting the serious nature of this rare pediatric disease and the significant unmet medical need. We currently anticipate planning and preparation for the study in 2026, with potential initiation of the study in 2027. I will hand the call over to Lisa Locklear, our chief financial officer. Lisa.

Thank you, Nataliya, and good afternoon, everyone. This afternoon, we issued a press release and filed our quarterly report on Form 10-Q, both of which present our financial results in detail, so I will touch on some highlights. Revenues for the 3 months ended March 31st, 2026 were $0.4 million and consisted of $0.4 million of clinical trial revenue and $20,000 of contract manufacturing revenues. Revenues for the 3 months ended March 31st, 2025 were $0.4 million and consisted of $0.3 million of clinical trial revenues and $0.1 million of contract manufacturing revenues.

Clinical trial revenues for the 3 months ended March 31st, 2026 increased $0.1 million or 46% when compared to the same period in 2025 as a result of greater participant demand for our Bahamas Registry Trial. Contract manufacturing revenues for the 3 months ended March 31st, 2026 decreased $0.1 million or 84% when compared to the same period in 2025, driven by reduced demand for these services from our third-party clients. General and administrative expenses for the 3 months ended March 31st, 2026 were $2.7 million, compared with $2.9 million for the same period in 2025.

The $0.2 million or 7% decrease was primarily due to a $0.4 million reduction in personnel and related costs, reflecting lower performance achievement for the 2025 annual cash incentive bonuses, partially offset by higher legal, accounting, and consulting fees. Research and development expenses were $2.3 million for the 3 months ended March 31, 2026, compared to $2.5 million for the same period in 2025. The $0.2 million or 8% decrease was due to lower performance achievement related to the 2025 annual cash incentive bonuses and a $2 million non-recurring charge for amortization expense.

Related to patent costs recorded in the 2025 period. These were partially offset by a year-over-year increase in personnel and higher clinical spend as we prepare for the ELPIS II study results in August. Our net loss was $4.7 million for the three months ended March 31, 2026, compared to $5 million for the three months ended March 31, 2025. The decrease of $0.3 million to 6% was due to the factors outlined before. Our cash and cash equivalents as of March 31, 2026 were $15.8 million. We currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026 based on our current operating budget and cash flow forecast.

I will hand the call over to Joshua Hare, our Co-founder, Chief Science Officer, and Executive Chairman. Joshua?

Thank you, Lisa. Good afternoon, everyone. Laromestrocel is an allogeneic mesenchymal stem cell therapy supported by a robust intellectual property portfolio of 52 issued patents and over 60 pending patents worldwide. Its potential mechanism of action, including anti-inflammatory, pro-vascular, and pro-regenerative effects, support its potential application across multiple high-value indications. Laromestrocel benefits from having received 5 FDA expedited designations, including Regenerative Medicine Advanced Therapy, or RMAT, Fast Track, Orphan Drug, and Rare Pediatric Disease designations, reinforcing both the clinical promise and regulatory positioning of our programs. We continue to advance a pipeline and a product strategy with multiple indications that can be independently developed, partnered, or licensed, creating multiple pathways for value creation. Our stem cell therapy development programs address life-threatening conditions in the most vulnerable populations, children and the elderly.

Our four initial indications address market opportunities of what we estimate to be approximately $1 billion, $5+ billion, and up to $1 billion and $4 billion, respectively. We plan to pursue a robust partnering strategy across our development programs to accelerate potential time to market, increase capital use efficiency, and leverage the greater resources of larger organizations. I will now turn the call back to Stephen.

Thank you, Josh. The anticipated near-term clinical data for HLHS, the strengthening of our balance sheet, the support of high-quality fundamental investors, and the potential for partnerships across our development programs make this an extraordinary exciting time for Longeveron. We deeply appreciate the support of all our stakeholders and look forward to continued collaborations and progress in the future. Operator, we would now like to open the call for questions from our covering analysts.

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Ladies and gentlemen, we will wait for a moment while we poll for questions. We take the first question from the line of Raghuram Selvaraju from H.C. Wainwright & Co. Please go ahead.

Thanks so much for taking my questions. Firstly, on the regulatory front, could you maybe provide us with some sense of your expectations post-reporting of top-line results from ELPIS II, and what you think are likely to be the most logical follow-up steps that you would take with the agency? In other words, you know, within what timeframe would you request a potential meeting with the agency to discuss the ELPIS II results, and what classification of meeting would that be?

I would say that we would do that immediately, and it would be a Type C meeting. Josh, do you have any correction to that?

I'm not sure. I'd like to hear from Natalia because if it's an end of phase II, it could be a Type B meeting.

Okay.

Our plan is to immediately provide the top-line results to the agency and to solicit a meeting with them as soon as possible.

Nataliya, any?

Sure. Sure. I agree with that. It depends on the results. If the results are really overwhelmingly positive, we would like to come back probably the Type B meeting to discuss all the potentials for the future potential BLA filing. Of course, we will follow up with the full clinical study report. Definitely we will plan a pre-BLA meeting later on, probably by the end of the year, to discuss all the, you know, all the points of our path forward for the BLA.

Actually, pre-BLA meeting should be done sometimes in 2027 because it should be meeting where we can discuss all our readiness for the BLA from not just from the standpoint of clinical results, but also CMC, et cetera. Yeah.

With respect to what could conceivably be the post-marketing requirements for laromestrocel if granted approval in HLHS. This is a hypothetical scenario. Can you give us a sense of whether you think the overall regulatory positioning on what the requirements might be for post-approval assessment of laromestrocel have changed in the wake of the most recent feedback from the FDA regarding the primary efficacy endpoint in ELPIS II, or if that is really a completely separate subject and has not been impacted in any way by the change in the agency's view of ELPIS II?

Sure. It's a fantastic question. Thank you for that question. We actually thought through even in 2024 about potential post-marketing requirements, we proposed long-term extension study. Basically, every patient who went through ELPIS I and ELPIS II study, we want to see long-term data, long-term transplant-free survival. We proposed this design to FDA. They accepted it. They like it. Most likely, that would be the requirement in case if we approve them to demonstrate efficacy on transplant-free survival and some other endpoints, 10 years, let's say, from when the patient reached 10 years old later on. That would be probably one of the requirements, we are preparing for that. We have design, we are implementing it operationally as we speak. We are thinking through about it.

At the risk of sounding iterative, I also wanted to ask about whether you feel that there is any read-through or impact on your plans in PDCM based on the recent regulatory feedback that you have received. Obviously, there are noteworthy differences between HLHS and PDCM.

Yeah.

I just wanted to see if from your perspective, there is any read-through to the PDCM program and, you know, any additional considerations that may now be introduced as you look to design the path forward for laromestrocel in PDCM in the wake of the most recent FDA feedback on the ELPIS II study.

May I just answer from clinical development perspective? Maybe you can give business perspective. Is it okay?

Yes, please. Go ahead.

Okay. You're absolutely right. When we look at the whole life cycle management, we always have to look at each indication for the same compound investigational product, even though they can be not connected, and they're completely different. I would say, the results of our HLHS trial will definitely in some way inform a message. We can develop some key messages, clinical messages for PDCM. They are two independent diseases, and their route of administration is completely different. Patient population is different. Even though we will learn from it, and we even might apply some data to PDCM, it's completely two different, two different entity, two different diseases. Steve, maybe you can provide your perspective from business point of view.

Sure.

-after results of HLHS. Mm-hmm.

Sure. From a business point of view, I think this was a surprise that we had this issue with the FDA. I think it's one that we will be able to overcome quite well because it all comes down to the data. The FDA has been quite clear that this is a very rare Orphan Drug disease that is an unmet medical need. The same is true of PDCM. I think we will just be careful with the FDA in terms of making sure that they are completely comfortable with our endpoints. I think we should be in a good shape for both products.

Thank you.

I would like to add that we in 2026 are planning operationally to initiate PDCM. We are going to do feasibility, et cetera. We are preparing for initiation of PDCM.

Thank you.

Nataliya, it might be worth mentioning what the PDCM endpoint is that we already designed for the approved IND. It is already a clinical endpoint that we anticipate would meet approvability criteria if met. While there certainly will be opportunities for refinement, We do anticipate that the endpoint already agreed upon with the FDA will ultimately be the endpoint if met that will result in approval for PDCM.

Right.

Sure, sure. Josh, would you like me to just mention what's? Sorry, I missed it.

I just indicated, Nataliya, that we already have the chosen clinical endpoint agreed upon.

Okay. Yes.

with the agency for the PDCM trial.

Yep. Thank you. Yes.

Thank you.

Thank you very much.

Thank you. We take the next question from the line of Boobalan Pachaiyappan from ROTH Capital Partners. Please go ahead.

Hi, team. This is Manasa dialing in for Bubalan. We have a couple of questions.

Yes.

So- Yeah. The first question is, given that RVEF is out of the question, let's assume a composite endpoint, you know, that comprises of 12 months transplant-free survival rate, the length of hospitalization, and MACE. What level of benefits do you need to show in each category to convince the FDA?

Josh, you wanna take that?

I think it's better if we have Natalia answer that because she's completed the power analysis. Natalia, would you like to take that question?

Sure. Yeah. Specifically, as you know, when we planned the trial, and now as we prepare to submit statistical analysis plan, and we just received the blinded data. We are looking at all the assumptions. We know, even it's blinded, we know that as of today, we have 2 deaths on the trial. 1 death happened prior to Glenn procedure, and another death happened after Glenn procedure. We have these 2 events. Because it's a composite endpoint, the whole weight of the composite endpoint is the weighting is going to be on hospitalizations, days in the hospital. Our assumptions based on literature. As you know, we are pioneering this indication, there are not many precedents available, and we are using SVR data. We are using a single institution data on literature.

Based on all the literature evidence, currently, patients with HLHS just spent about 30 days in a hospital 12 months after Glenn, and that's our base assumptions. Of course, on our trial, we would like to do better, and we would like to demonstrate that these are very clinically meaningful endpoints, such as how many patients spend in the hospital. It's shorter than 30 days. We have different assumptions, 15 days, et cetera. For now, we are powering for 15 days. As far as MACE, we know what potentially we have, how many events we have, but we have to adjudicate these events. We have enough events to demonstrate some difference between standard of care and laromestrocel at this point.

MACE is our, which is another composite endpoint, and which consists of cardiovascular mortality, hospitalization due to heart failure, thromboembolic events and arrhythmia. We're adjudicating these events, and we have enough sufficient events to demonstrate the difference. So, did I address your question?

Yeah. I have a couple more. The next thing is, are there any specific learnings from the recently published CHILD Study that, you know, could provide a read-through for the ELPIS II study?

Josh, maybe you can answer this question because you were involved in the study.

Yes

You know it better.

Yes. Thank you, and thank you for that question. We're excited about the CHILD Study results, and they did inform our thinking for the endpoint of ELPIS II. The reason why it's so attractive is, first of all, it is current data, whereas the SVR data is somewhat dated. The CHILD Study was concurrently enrolled at the same centers with the ELPIS II patients, and it did also involve We also had a randomization between active treatment and standard of care. We have a standard of care reference, although it's a small study. What was quite intriguing in the CHILD Study was that the rate of events was quite high in the standard of care group, and all of the events that we are looking at in the ELPIS II were seen in the CHILD Study.

Again, concurrently enrolled with ELPIS II, at the same time in same point in time, at the same centers with the same surgeons. Although it was a much smaller study, we were able to detect meaningful differences between treated patients and standard of care patients. We did use that as a guide in our thinking of what the endpoint for ELPIS II should be, as well as what the constituents of MACE should be. We are hopeful that the event rate that we saw in CHILD will be similar in the ELPIS II study.

Thank you, Josh. Another question. From a payer standpoint, what would be the greatest predictor of drug efficacy, you know, that would influence them to cover Lomecel-B, you know, if it is approved on an accelerated basis?

I would say, you know, clinically relevant and outcome measures as we spoke, transplant-free survival, it's very important. There are not too many hearts available, and we would love this transplant-free survival to be as long as possible. Days in the hospital, it's also very important to demonstrate. On the composite endpoint, even though we can demonstrate composite, we have to demonstrate significance on each endpoint anyway. I think these two are very, very important. Of course, heart failure hospitalization also. Which is, kind of indicator how is the right ventricle is, you know, performing, et cetera. I think those are the most significant endpoints.

In addition, I would like to say, even though FDA did not accept right ventricle ejection fraction because they believe it's not enough evidence to consider this a surrogate endpoint, we're still including it as our secondary endpoint, and we would like to do more work. Once we have more long-term data available, we would like to perform this analysis of correlation with ejection fraction and clinical outcome and survival. It is not surrogate endpoint today, but I hope this study can inform us, and maybe it is a potential for us to elevate right ventricle ejection fraction to surrogate endpoint.

Thanks, Nataliya. One last question from me. After the release of ELPIS II and, you know, assuming positive data, do placebo patients have an opportunity to try out Lomecel-B on a compassionate basis?

We do have compassionate program, but we don't have any long-term extension study where a patient can switch or crossover, anything like this. We haven't discussed it yet, but I think we should. If the data are positive, I think it should be a discussion how to make it available for patients. Absolutely. Steve, would you like to add anything for compassionate use?

Yes. I mean, this whole, the whole purpose of Dr. Hare creating this company over 10 years ago was to save lives, particularly in children and the elderly. Making our drugs available for compassionate use is a priority for us. We will do everything we can to make that possible. Were there any other questions?

Thank you for the question.

Thank you. Ladies and gentlemen, as there are no further questions from the participants, I would now hand the conference over to Stephen Willard for his closing comments.

Thank you all very much for participating in this conference call and for listening to our progress. We have focused today tremendously on the data that we expect in August. It is a fundamental time for our company. Please remember that we have 4 shots on goal here, not just the 1. That you can expect, we hope, very interesting progress with regard to Alzheimer's disease and aging frailty, as a, as a supplement to, and as a very strong carrier of the company together with our HLHS and PDCM products. Thank you once again for your time, and we look forward to updating you shortly again. Thank you.

Thank you. Ladies and gentlemen, the conference of Longeveron has now concluded. Thank you for your participation. You may now disconnect your lines.

Thank you.

Greetings, and welcome to Longeveron 2025 Full Year Financial Results and Business Update. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host, Jenny Kobin. Thank you. You may begin.

Good afternoon, everyone, and thank you for joining us today to review Longeveron's 2025 Full Year Financial Results and Business update. After the U.S. markets closed today, we issued a press release with the financial results for 2025, which can be found under the Investors section of the Longeveron website. On the call today are Stephen Willard, Chief Executive Officer; Joshua Hare here, Co-Founder, Chief Science Officer and Executive Chairman of the Board; Nataliya Agafonova, Chief Medical Officer; and Lisa Locklear, Chief Financial Officer. 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 covering analysts. With that, let me hand the call over to Stephen Willard, CEO. Steve?

Thank you, Jenny, and thank you all for joining us today. I am excited and honored to join Longeveron at this pivotal moment for the company. The strength of the company's stem cell science and success in multiple clinical trials across several indications positions Longeveron to be a leader in the stem cell field. Upon assuming the role of CEO, I have had an immediate focus on 3 critical areas: first, securing necessary financial resources and planning efficient capital allocation. I'm delighted to report, as you have hopefully seen from our prior press releases, that we have secured $15 million in new capital from, among others, what I believe are 2 of the premier fundamental institutional investors in biopharma, Coastland Capital, that's Matthew Perry; and Janus Henderson Investments. We also have the potential to close a second tranche of an additional $15 million upon meeting certain milestones. We are grateful for their investment, support and shared vision of advancing stem cell therapies for the benefit of patients and their families. The initial capital from the financing provides runway comfortably into the fourth quarter of 2026. Second, this capital enables us to complete and deliver the results of the ELPIS II, our anticipated pivotal Phase IIb study in HLHS and potentially, if supported by the data, begin preparation of the company's first BLA with the U.S. FDA. Enrollment of the clinical trial was completed in June of last year, and we remain on track for reporting results in the third quarter of this year. Third, strategic partnering. We plan to pursue a robust partnering strategy across all of our development programs to accelerate potential time to market, increase capital use efficiency and leverage the greater resources of larger organizations. For HLHS, we believe that the optimal timing to secure a potential BLA and commercialization partner will be following the readout of the ELPIS II clinical trial results in the third quarter of this year. For Alzheimer's disease, we plan to leverage the strength of our Phase II data and clarity on the clinical pathway to a potential BLA for Alzheimer's disease to engage with potential funding commercialization partners. For pediatric dilated cardiomyopathy or PDCM, we intend to execute a single pivotal Phase II registrational study under our active FDA IND, leveraging an efficient development strategy appropriate for a rare pediatric disease. If successful, this study could form the basis of a potential BLA submission pending FDA alignment. Upon successful completion, we intend to pursue strategic partnership opportunities to support regulatory approval and commercialization. Finally, and potentially very significantly, are our opportunities for Priority Review Vouchers or PRVs. Our HLHS program has been granted rare pediatric disease designation by the FDA, which makes it eligible to receive a PRV upon approval of a BLA. And the same opportunity may exist for our PDCM program to also be eligible for PRV. Companies can either use the PRV to secure a speedier FDA review of a future therapy or sell it to another company. Since August of 2024, vouchers have been sold for between $150 million and $205 million each. Securing one or more PRVs would obviously be a tremendous financial outcome for the company and shareholders. In our recent private placement, we agreed to pursue a sale of a PRV received for HLHS if granted and that the investors would be entitled to 50% of the proceeds received from the potential future sale of the HLHS PRV. It is an exciting time for laromestrocel, the patients we serve, Longeveron and our shareholders. With that, I will turn the call over to Dr. Agafonova, our Chief Medical Officer, to touch on the clinical development programs. Nataliya?

Thank you, Steve, and good afternoon, everyone. As Steve mentioned, our HLHS program is the primary focus for us with a near-term pathway to potential approval in an area of clear unmet medical need. The Phase IIb clinical trial, ELPIS II, evaluating the potential of laromestrocel to improve right ventricular function and long-term clinical outcomes in infants with HLHS is nearing completion. Enrollment of 40 patients was completed in June of last year. Top line results from the ELPIS II trial are anticipated in the third quarter of 2026. Based on FDA feedback received in August 2024, ELPIS II may be considered a pivotal study subject to the trial results, which could potentially accelerate the regulatory pathway for laromestrocel. If supported by the data, we plan to initiate preparation for a potential biologic license application, BLA. This would represent our first BLA submission and targets a serious pediatric condition with significant unmet medical need. Our laromestrocel program in HLHS is designed to improve cardiac function in these children with the goal of potentially improving long-term clinical outcomes. The earlier Phase I ELPIS I study established the safety and feasibility of laromestrocel administration and provided supportive clinical observations that informed the design of the ongoing pivotal ELPIS II trial. Due to its small size and single-arm design, ELPIS I was not intended to evaluate efficacy outcomes. We look forward to sharing the results of the ELPIS II clinical trial in the third quarter. Pediatric dilated cardiomyopathy is a rare pediatric cardiovascular disease in which the muscles in one of the more of the heart chambers become enlarged or stretched dilated with nearly 40% of children with PDCM required the heart transplant or dying within 2 years of diagnosis. Our investigational new drug IND application for laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND allows unbased advancement directly into a single pivotal Phase II registrational clinical trial, reflecting the serious nature of this rare pediatric disease and the significant unmet medical need. We currently anticipate planning and preparation for the study in 2026 with potential initiation of the study in 2027. I will hand the call over to Lisa Locklear, our Chief Financial Officer. Lisa?

Thank you, Nataliya, and good afternoon, everyone. This afternoon, we issued a press release and filed our annual report on Form 10-K, both of which present our financial results in detail, so I will touch on some highlights. Revenues for the year ended December 31, 2025, were $1.2 million and consisted of $1 million of clinical trial revenue and $0.2 million of contract manufacturing revenue. Revenues for the year ended December 31, 2024, were $2.4 million and consisted of $1.4 million of clinical trial revenue, $0.5 million of contract manufacturing lease revenue and $0.5 million of contract manufacturing revenue. 2025 revenues decreased $1.2 million or 50% when compared to 2024 as a result of lower participant demand for our Bahamas registry trial and reduced demand for contract manufacturing services from our third-party clients. General and administrative expenses for the year ended December 31, 2025, increased to approximately $12 million compared to $10.3 million for the same period in 2024. The increase of approximately $1.8 million or 17% was primarily related to an increase in personnel and related costs in 2025 as we increased headcount year-over-year and a onetime accrued severance cost for our former CEO. Research and development expenses for the year ended December 31, 2025, increased to approximately $12 million from $8.1 million for the same period in 2024. This increase of $3.9 million or 48% was primarily driven by a $2.2 million increase in personnel and related costs, including equity-based compensation, 1.4 million increase in CMC costs associated with technology transfer, including nonclinical manufacturing batches that advance our readiness for future commercial production as part of our BLA-enabling efforts and $0.2 million increase in amortization expense related to patent costs. Our net loss increased to approximately $22.7 million for the year ended December 31, 2025, from a net loss of $16 million for the same period in 2024. The increase in the net loss of $6.7 million or 41% was for the reasons outlined previously. Our cash and cash equivalents as of December 31, 2025, were $4.7 million with approximately $1.4 million in working capital. On March 11, we completed a private placement that raised gross proceeds of approximately $15.9 million. We're delighted to welcome Coastland Capital and Janus Henderson investors as key shareholders. As a result of the financing, we currently anticipate our existing cash and cash equivalents will enable us to fund operating expenses and capital expenditure requirements into the fourth quarter of 2026 based on our current operating budget and cash flow forecast. I will now hand the call over to Josh Hare, our Founder and Chief Science Officer. Josh?

Thank you, Lisa. Good afternoon, everyone. As you've heard from the previous speakers, we believe we are on the cusp of pivotal data in HLHS which, if positive, would be an important step in our mission to help patients and families through the application of stem cell research. This important milestone for Longeveron reflects not only the continued advancement of laromestrocel, but also the significant progress occurring across the broader field of stem cell research, clinical application and commercialization. In recent years, we've seen increasing validation of cell therapy's role in regenerative medicine and its potential to address a wide range of serious conditions, reinforcing the promise of this rapidly evolving area of medicine. We believe these advances are helping to establish cell therapy as a potentially transformative approach for treating serious diseases with significant unmet medical need. Longeveron has been an active participation -- an active participant in this evolution. with multiple clinical stage programs, publications of clinical trial results in premier journals such as Nature Medicine and Cell stem cell and multiple stem cell therapy patents issued globally. The potential for stem cell therapies to address large and underserved patients -- underserved patient populations represent a significant opportunity, and we remain focused on executing our clinical, regulatory and strategic priorities to unlock the value of our platform. I will now turn the call back to Stephen.

Thank you, Josh. The anticipated near-term pivotal clinical data for HLHS, the strengthening of our balance sheet, the support of high-quality fundamental investors and possibly our first BLA submission as well as potential partnerships across our development programs make this an extraordinarily exciting time for Longeveron. We deeply appreciate the support of all of our stakeholders and look forward to continuing collaboration and progress in the future. Operator, we would now like to open the call for questions from our covering analysts.

[Operator Instructions] Our first question comes from Ram Selvaraju with H.C. Wainwright.

Congratulations on all the recent progress, very exciting. I wanted to ask about the commercial perspectives as these pertain to scaled up manufacturing and CMC for laromestrocel were it to be approved in the HLHS indication? And also wanted to see if you could just enumerate for us again which potential areas of inquiry for laromestrocel could conceivably be eligible for PRVs in the future beyond HLHS?

Sure. This is Steve. I'll take the second question. We could have a separate PRB for PDCM. In fact, we'll be seeking that very shortly. So there are 2 different PRVs that one of which has -- we sold half of to our investors and the other half is for us. And then the PDCM is entirely for us. With regard to the manufacturing in CMC, that is a priority for us going forward. It's a priority for us this year. We've made incredible strides with regard to it so far. We are engaged in a CDMO who will be able to do the manufacturing for us going forward, and it will free up our own laboratory space for other projects. Do you have a follow-on question, Ram?

Yes. With respect to indications like, for example, Alzheimer's disease and age-related frailty, what potential nondilutive sources of capital to fund those initiatives? Could you access beyond the PRVs that you just enumerated?

Great question. And the answer is it's going to be a real priority for us to seek licensing partners for both Alzheimer's disease and for age-related frailty. We've already got some preliminary conversations set up. I have a background in licensing. I ran a company called Flamel Technologies, ticker symbol FLML based in Lyon, France, and we had partnerships with 24 of the world's largest pharmaceutical companies. I have a pretty active Rolodex and Alzheimer's disease is a very attractive possibility for us now. and age-relating frailty, we have a wonderful paper in cell stem cell that just came out. I recommend it to you highly. And we already had incoming interest with regard to licensing that technology. So those 2 things will be on the priority list for 2026.

Our next question comes from Boobalan Patheon with ROTH Capital Partners.

Of course, congratulations on your new role. So firstly, with respect to the HLHS program, assuming the data is positive in 3 quarter -- third quarter '26, how sooner you can file for BLA for the HLHS program? And also, if you can provide some granularity in terms of whether you'll be filing your BLA on a rolling basis and also if you're expecting a priority review?

Thank you very much for those questions. Josh, would you care to answer with regard to the various attractive things that have granted to us by the FDA with regard to HLHS?

Yes. Thank you, Steve. Boobalan, thank you for the question. Yes, we are potentially eligible for rolling submission, which we would take advantage of if allowed by the FDA. At this stage, our next big milestone is, of course, the data readout, which will then trigger an end-of-phase meeting with the FDA to help determine the speed and timing of the application process because we have the rare pediatric disease designation, we are eligible for the rolling submission. And I believe we're also eligible for priority review based on the designations that we have. So of course, data permitting, our objective would be to initiate that regulatory process as quickly as possible and as allowed by the FDA. Perhaps I might also ask Nataliya to comment on that since she's so involved in that process.

Thank you so much, Josh, and thank you, Boobalan, for your question. So assuming the data are positive in third quarter of 2026, definitely, we would like to take advantage of following submission. And as you know, it's not only the readiness of clinical data and all the modules related to clinical data is also CMC, but we are going to take all the advantage and targeting BLA submission sometime in 2027.

Okay. That's really helpful. And then in terms of PRV because that has been mentioned many times in today's call. So obviously, the most recent PRV was sold for a very high price of $205 million. This is from Fortress Biotech, right? But at the same time, we have a new sunset date for the PRV, which is September 2029, which is a little more than 3 years from today. So because the sunset date is a little far, do you expect any challenges in terms of monetizing PRV for a heavy premium given this new sunset date? Just curious.

That's a great question. It's hard to predict out that part, but I don't I think prices immediately prior to that $205 million was a $2 million, $200 million from Jazz Pharmaceuticals. So the last 2 have been in the $200 million range. I would expect prices I would expect prices to remain strong for these as we approach 2029.

All right. And then with respect to PDCM, pediatric dilated cardiomyopathy program, can you provide some context in terms of what would be the next step in this program? How sooner you can start your clinical study? I know your IND has been sort of cleared. So maybe provide some context in terms of the time line design and potential endpoints you could possibly explore? And also, I'm trying to understand what is the unmet need you're trying to address here with laromestrocel? Is it something that patients who would be treated with laromestrocel not seek the heart transplantation? Or is this an ambitious goal?

Nataliya, would you care to respond to that?

Sure, absolutely. So Boobalan, on your first question about the timing of the PDCM, our goal was to initiate the trial this year. And due to finding, we were not able to achieve this. However, it's also a priority. And we are able to do feasibility assessment sometime this year and hopefully initiate the trial and open the -- start opening sites sometime in 2027. So -- as far as the -- go ahead.

No, no, go ahead, sorry.

Yes. And the -- you asked also about -- can you remind me, you asked about timing and then...

Design, sample size and also is the goal here to have patients not to seek transplantation?

Absolutely. So we are planning to use Hierarchical Composite Endpoint similar to the HLHS. And we include listings for transplant because the left ventricle is silent. So we would like to see less heart transplant and hospitalization. Those are very standard approach for heart failure patients, and we are utilizing that. FDA did accept that as a primary endpoint with a few comments, which we are going to do and address as a protocol amendment once they are ready to initiate the trial. And we are planning a 1-year study every 3 month administration with laromestrocel. And hopefully -- so the number of patients is 70 patients. And our goal was to do the trial globally, not just to U.S., but in all geographic area. But as I mentioned, we are planning to do feasibility this year, which is going to show us the high enrolling sites and the best geographic areas, et cetera. So hopefully, sometimes in our next call, we can give you an update on that.

Josh, do you have any comments on that?

Yes. Thank you, Steve. Yes, vis-a-vis the potential clinical outcome, laromestrocel in this population, we're very enthusiastic about the possibility for actually a meaningful disease modification effect here. This condition of dilated cardiomyopathy is something that affects both adults and children. In children, the clinical burden is much more severe than adults. It affects younger kids and the younger they are affected, more likely they are to have a poor outcome. So the death or transplant rate is extremely high in children in the first few years of life. And this is because it's a progressive illness. We don't have any disease -- we don't have any treatment modality to actually cure it, and it's treated with medications that are palliative medications. Laromestrocel has the potential to actually cure or reverse the disease. And evidence for that does come from studies done in the academic setting in adults that you can actually see a complete reversal and remission from the disease. So of course, we will only know that once the trial is done, but there is a reason -- there is some reasonable expectation here that the effect could be very substantial and could potentially be curative in these kids and prevent the need for heart transplant, not by prolonging the need for transplant potentially, but by actually completely reversing the need for it. So that at this point is a hypothesis. We can't say that, that is definitely going to happen, but the trial as designed will detect the ability to have the complete reversal of the disease and therefore, be one of the first true disease-modifying treatments for this condition.

That's wonderful.

Yes, maybe one last question, sorry. So obviously, you recently received a patent about Laro's used in sexual dysfunction in females. So this is a pretty interesting program. I'm trying to understand what's your strategy here? Is it -- do you envision this more of a partnered program rather than developing on your own? And also, do you expect this drug in this indication to be a short-term therapy or a long-term therapy?

Josh, you take that one as well, please.

Yes. Thank you. That's another great question. Yes. The finding of the improvement of female sexual dysfunction arose from our aging frailty work. And so this is an issue and the patent is related to older female individuals. This is a very important unmet need in this population as well. And there's a tremendous amount of interest in women's health in general that's emerging. It's particularly highlighted by the recent FDA decision to remove the black box warning on postmenopausal estrogen. And so I think we see a new era of focus on women's health in women in postmenopausal women. There's also the recognition in the field that sexual performance and sexual function at that stage of life is incredibly important for health and quality of life. And so we do see a big clinical need here and a physician community that's now very focused on this particular matter. In terms of development, I think this would be an indication that would be ripe for partnership as opposed to us going it alone. There would clearly be another study that would need to be done and a formal regulatory pathway with the FDA established. So in short, I do see this as addressing a very high unmet need and something that would be ripe for a partnership opportunity.

We have reached the end of the question-and-answer session. I'd now like to turn the call back to Stephen Willard for closing comments.

Thank you, operator, and thank you all for attending today's call. We greatly appreciate your interest and support and look forward to updating you on our continued progress. Thank you once again. Operator, you may end the call.

Thank you. This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.