Longeveron Inc - Ordinary Shares - Class A Aktie

[indiscernible] to the Longeveron 2026 Second Quarter Financial Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions. Please go ahead, sir.

Thank you, Richelle. Good afternoon, everyone, and thank you for joining us today to review Longeveron's 2026 Second Quarter Financial Results and Business Update. After the U.S. markets closed today, we issued a press release with financial results for the second quarter, which can be found under the Investors section of the Longeveron website. On the call today are Steven Willard, Chief Executive Officer, Dr. Joshua Hare, Co-Founder, Chief Science Officer, and Executive Chairman of the Board, Dr. Nataliya Agafonova, Chief Medical Officer, Devin Blass, Chief Technology Officer, and Marie Washburn, Chief Financial Officer. As a reminder, during this call we will 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 Steven Willard, Chief Executive Officer.

Thank you, Derek, and thank you all for joining us today. This is an incredibly important and exciting time for the company. Longeveron is approaching a series of potentially transformative milestones across our 4 stem cell therapy development programs that have the potential to redefine the trajectory of our business. As a reminder, we are developing laromestrocel in 4 indications with high unmet medical needs: Hypoplastic Left Heart Syndrome, Alzheimer's disease, pediatric dilated cardiomyopathy, and Aging Frailty. We have focused on our development activities to prioritize our most important near-term catalyst, the data readout from ELPIS II, our Phase 2b clinical trial evaluating laromestrocel in HLHS. We expect to report that data readout in mid-September.

Our approach to stem cell therapy development has garnered external recognition and validation with encouraging data from our clinical trials having been published in Nature Medicine and Cell Stem Cell. Additionally, as you hopefully saw in our announcement yesterday, published clinical trial results which indicate laromestrocel increases six-minute walk distance in patients with Aging Frailty were the basis for our selection as a finalist for the XPRIZE HealthSpan competition. XPRIZE HealthSpan is a 7-year, $101 million global competition to revolutionize the way we approach human aging. We are extremely humbled and appreciate to have our stem cell therapy laromestrocel recognized in this manner. We believe that we are the company to receive this honor. XPRIZE team applications were rigorously evaluated for scientific merit and clinical readiness to identify the best, most feasible, and safe approaches to increase human healthspan. The Milestone 2 awardees, out of more than 600 applicants across 58 countries, were selected to receive the [indiscernible] as finalist awardees.

The XPRIZE criteria was that finalist awardees must present a single or combination therapeutic approach that demonstrates feasibility and potential to restore or preserve muscular, cognitive, and immune function lost to age-related degradation by a patient at least [indiscernible] years with the ambitious goal of 20 years and deliver their therapy in 1 year or less in adults age 50 to 90 who are free of major or life-threatening disease and disability. The top Milestone 2 award-winning teams each receive $1 million to advance their therapeutic approach into the final phase of the competition, where teams will conduct coordinated clinical trials through 2029. The grand prize will award up to $81 million to the winning team. We look forward to the next chapter of the competition as we continue to develop our stem cell therapy that we believe has the potential to have a significant impact for patients and their families and extend healthy life. We believe the strength of our historical clinical data, external validation of our programs, and hopefully the ELPIS II data provide Longeveron with ideal timing to explore potential development and commercialization partnerships. 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. And it's been a very 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.

Thank you, Steve. Good afternoon, everyone. As Steve mentioned, our HLHS program is the primary focus for us. The top-line results from the ELPIS II trial anticipated over the next month. We look forward to sharing those results when they're available. ELPIS II is evaluating laromestrocel as a potential adjunct treatment for Hypoplastic Left Heart Syndrome, or HLHS. HLHS is a rare pediatric congenital heart defect in which the left ventricle, one of the pumping chamber of the heart is either severely underdeveloped or missing. We agree with the FDA 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 be informative of efficacy of ELPIS II.

We have captured all of these measures in ELPIS II, along with some additional key measures to support an efficacy determination. We are also continued with planning and preparation this year for a potential initiation in 2027 of a Phase 2 clinical trial in pediatric dilated cardiomyopathy, or PDCM. This is a rare pediatric cardiovascular disease in which one or more of the heart chambers become enlarged or stretched or 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 for potential treatment of pediatric dilated cardiomyopathy became effective in July 2025. This IND allows advancement directly into a single Phase 2 registrational clinical trial, reflecting the serious nature of this rare pediatric disease and the significant unmet medical need. I will hand the call over to Marie Washburn, our Chief Financial Officer. Marie?

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 are financial results in detail. So I will touch on some highlights. Revenues for the three-month periods ended June 30, 2026, and June 30, 2025, were $0.3 million. 2026 revenues decreased by $29,000, or 10%, when compared to 2025, primarily due to the absence of contract manufacturing revenue. General and administrative expenses for the three months ended June 30, 2026, were $3.2 million compared to $2.6 million for the same period in 2025. The increase of $0.6 million, or 23%, was primarily due to a $0.4 million increase in legal spend, and a $0.2 million increase in personnel costs. Research and development expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.0 million for the same period in 2025.

The increase of $0.2 million, or 7%, was due to higher clinical trial expenses to support the ELPIS II top-line results expected in September. Net loss was $6.1 million for the three months ended June 30, 2026, compared to $5.0 million for the three months ended June 30, 2025. The increase of $1.1 million, or 22%, was due to the factors outlined above. Our cash and cash equivalents as of June 30, 2026, was $10.1 million. We currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditures into the fourth quarter of 2026 based on our current operating budget. I'll hand over the call to Josh Hare, Co-Founder and CSO. Josh?

Thank you, Marie. Good afternoon, everyone. As we rapidly approach the availability of top-line data from the ELPIS II Phase 2b trial in HLHS, I want to highlight some of the progress and accomplishments that underpin our belief in our allogeneic mesenchymal stem cell therapy, laromestrocel, and support its potential application across multiple high-value indications. First, strong foundational science. Laromestrocel has multiple potential mechanisms of action that include anti-inflammatory, provascular, and pro-regenerative effects. Laromestrocel is supported by a portfolio of 52 issued patents with over 60 pending patents worldwide. We have 5 FDA expedited designations, including Regenerative Medicine Advanced Therapy, or RMAT, Fast Track, Orphan Drug, and Rare Pediatric Disease. Longeveron has completed and has encouraging initial results warranting further investigation across 5 clinical trials and 3 separate indications. We have promising data from our clinical trials that have been published in prestigious journals such as Nature Medicine and Cell Stem Cell.

We have favorable clinical trial results in Aging Frailty, supporting selection as a finalist out of over 600 development projects submitted worldwide for the XPRIZE HealthSpan competition, which also comes with a $1 million award. We continue to make progress across our entire development pipeline and look forward to sharing the results of ELPIS II shortly. I'll now turn the call back to Steven.

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 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 we'll hear from Ram Selvaraju with H.C. Wainwright.

Congratulations on all the recent progress, definitely coming up on exciting times here. I wanted to see if you could elaborate on the updated outlook for laromestrocel in HLHS specifically as this pertains to the following 3 items. Firstly, the timeline with which you anticipate a regulatory submission could be completed for filing upon generation of positive data from ELPIS II. Secondly, where you are with respect to commercial scale-up and how that dovetails with the underlying market demand that you anticipate for laromestrocel upon potential approval in HLHS. And lastly, any updated thoughts or feedback with respect to potential pricing discussions or the relative value proposition that you anticipate laromestrocel would be associated with from the payer standpoint. And then just a very quick question on the Aging Frailty aspect in the event that laromestrocel ultimately received the top prize in the XPRIZE competition. How would this affect the company's strategic planning for future development of the drug in the Aging Frailty indication?

Wow, that's quite a list of questions. Let me see if I can get to them in the order you provided. First of all, the timetable is, we are eagerly looking forward to having an auction for among partners of choice in the event of good HLHS data. And a partnership will determine some of the things like pricing and that sort of thing. We anticipate, we've already had conversations with major potential partners, and we think they are expert at pricing and timetable and that sort of thing. We don't see any blockers if we get good HLHS data to going to a BLA with, I would remind you, a priority review voucher, which just recently sold for $215 million. There's also a potential priority review voucher with regard to our PDCM, which will be starting next year.

I've discussed the timetable, the manufacturing, the pricing discussions, and then with regard to this XPRIZE, I think it's extraordinary to have a company known as a company despite 12 years in the longevity space as experts in rare pediatric orphan drugs. And that is part of our mandate. But we really have extraordinary data with regard to longevity. We will very much seek to partner in longevity prior to winning the XPRIZE and the $81 million. And I think it's a very fertile area that a lot of people are appreciating. And as I noted of the XPRIZE winners, I believe we are the only public company, the only one that people can invest in, in terms of the cutting edge of longevity research today. Did I hit your questions, Ram?

Yes, thank you very much.

Our next question we'll hear from Boobalan Pachaiyappan with Roth Capital Partners.

So we have 3 or 4, maybe. I wanted to start off our discussion with a focus on statistical analysis plan, or SAP, to say it in short form. Because this is a hot button issue, they say, with all the AdCom stuff that we witnessed a couple of weeks ago. So I'm compelled to ask a few questions based on this topic, and some of them we might have discussed in the past. Where are you in terms of SAP alignment with the FDA? Are there any last minute changes that needed to be made to the SAP protocol prior to database unblinding? And also a sub question again on the SAP is the lack SAP alignment with the FDA, the reason for pushing the deadline from August to September.

I can tell you, actually, Nataliya, would you answer that question?

Yes, absolutely. Thank you, Boobalan, for your questions. Just to clarify that we have already substantive discussions with the FDA in alignment regarding the endpoint strategy, which include both NIH-defined and we have incorporated all the agency feedback into our statistical plan, statistical approach. So we subsequently submitted the SAP to FDA for review and we're still waiting for their feedback. If we don't receive additional comments before database lock, we currently intend to proceed with the planned database lock, conduct analysis, [indiscernible], the finalized SAP. So I don't think there's anything unresolved.

We so far resolved all the FDA agencies questions, incorporated them to statistical analysis plan and of course, if we get them prior to database lock, we're happy to, you know, just to clarify some and incorporate their details about the SAP. And second question you asking about August versus September is not going to affect anything, so we were waiting for the last patient, last visit. There were a few delays in MRI month 12, and last patient, last visit, that was the reason why we slightly delay our database lock, but so far it's planned on August 31st with the top-line results data available in September.

All right. So, moving on. Let's say your former primary endpoint, which is RVEF, let's say the RVEF was not met in your ELPIS II, but you're seeing improvement in, let's say, the length of hospitalization, the transplant-free survival, and adverse events? And let's say you're hitting statistical significance in all of this. Can you regain the pivotal status and file a BLA based off of that? Or put it differently, what would be the minimum efficacy package that would justify a BLA submission?

Well, that's a lot to... And there are... Sorry. No, go ahead, Nataliya.

So there are a lot of precedences when sponsors approved biologics having exploratory endpoint, with exploratory endpoint. So we already know that FDA expressed opinion that the most clinically significant endpoints which we already incorporated in our analysis, such as all-cause mortality, hospitalization, et cetera. So, they will consider this as exploratory. However, they are happy to exercise regulatory flexibility and they requested to share results of our trial with them. See for potential, you know, potential, as potential approval. So absolutely, if in case if you, the option you described in case of right ventricular ejection fraction doesn't hit statistical significance, but the sponsor defined criteria, we absolutely do everything possible to regain BLA status quo.

Yes, and then there, remember here this is a very devastating disease for which there is not alternative medicines available. And the FDA has been quite positive in saying they want to work with us despite the challenges we've had. And I think that we're collecting the data which if successful, could encourage the FDA to give us the pivotal and BLA status.

Okay, maybe one last question. Let's say ELPIS II supports a BLA path. What are the remaining CMC items that need for a BLA filing sometime in 2027?

Devin, I'll take this one. We have made excellent progress with our CMC. A provider that we are working actively with to transfer the manufacturing. I think everything looks to be a go. We'll be able to fine tune our program once we have a partner. But I think the partner was probably going to allow us and agree with us that we are best at handling the manufacturing of this key product. So I don't see any blockers or impediments with a positive signal from the FDA to getting that BLA.

All right. Congratulations again. Thank you.

Our next question we'll hear from Michael Okunewitch with Maxim Group.

Thank you, Michael.

I just wanted to ask a little bit about how you're going to be collecting the events-based data, because it's only a 12-month endpoint for LVEF, for RVEF. So, is this something that you're expecting to collect over time and we're planning to do as part of some longer-term follow-up, or will you have sufficient data to actually see any sort of difference on an events-based outcome at the upcoming September readout?

Thank you, Michael. See if I might address this. Is it okay?

Please.

So Michael, great question. One of the long-term effects on patient outcome, we are collecting right before the database each patient. Some of the patients initiated the trials 5 years ago, and we have 5 years data. We are collecting survival status, we are collecting transplant status. This is going to have for all patients with different duration, depending on when patient initiated the treatment. This is something we will collect at the end of the trial.

In addition, we are planning long-term extension trial up to the patients of age of 10. And we already share this plan with FDA. They already submitted their questions. We are addressing them, and we already doing feasibility, et cetera. And our goal is to initiate this trial and continue following up these patients for the long-term outcome up to the patient's adoption at 10 years old. With that information, it's a long-term extension study for the survival status. With that information, there are a lot of, we kind of open a lot of regulatory options for us. Or we can go for accelerated approval, waiting for the long-term extension results. Or we can just go for traditional approval, still waiting for the results of the long-term extension, which always reassuring. Because the most important, clinically important, effect is a long-term survival, transplant-free survival for this patient population.

Certainly. Thank you for that additional color on it. Are we expecting that you will have sufficient survival data to go back to FDA and potentially file for an FDA this September or BLA this September, or is this something where we really need to wait and see how the data is before we can determine whether or not it'll be able to serve for approval in the near term?

So for now, I think we have sufficient data. Yes, we do have sufficient data to demonstrate long-term outcome. And at the time of the BLA, we might have even the, you know, additional survival data. So as we continue to collect them, we might have additional data. But at the end of this trial, like at the end of the, in September, we will have already sufficient data to demonstrate 5-year survival for some patients.

Thank you. And then one last one. I know this is an exploratory endpoint, but do you have... patient in the study that you could get some sort of statistical power on that on the events based endpoints?

Yes, even with missing data and we do have sufficient data, if our assumptions are correct, it's still blinded, but we do have sufficient data to demonstrate significance.

All right. Thank you. I really appreciate your additional clarity. Congrats on all the progress.

Thank you for getting involved.

There are no further questions at this time. I would like to turn the floor back to Steven Willard for closing remarks.

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 in the coming weeks. Thank you. Operator, you may end the call.

This does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time.

Good morning, everybody. Will the meeting please come to order. I'm Dr. Joshua Hare, Executive Chairman of the Board of Longeveron, Inc. I will be presiding at this meeting. Along with my fellow directors and executive officers of the company, I would like to welcome you to our Fifth Annual Meeting of Stockholders, which is being held virtually as we aim to establish robust participation.

We appreciate your attendance, your interest and most importantly, your support of Longeveron. This Annual Meeting of Stockholders is held pursuant to the bylaws of the company and written notice to all stockholders. [Operator Instructions] Questions submitted by stockholders should pertain to the proposals being considered at this time. Questions that are properly submitted using the chat function will be gathered and posted with responses on the company's website.

After introducing our executive officers in attendance and dealing with a few procedural matters, we will take up the items to be acted upon.

We would like to introduce the Longeveron executives who are in attendance. Lisa Locklear, our Chief Financial Officer; and myself, Stephen Willard, Chief Executive Officer and Acting Corporate Secretary. Our company Vice President and Controller, Marie Washburn is also in attendance.

Also attending this meeting are representatives from CBIZ, our independent auditors. Although CBIZ has indicated that it does not wish to make a statement, representatives are available to respond to appropriate questions submitted during the meeting. Josh?

The Board of Directors has appointed Colonial Stock Transfer to serve as the independent Inspector of Election for this meeting. I request that they file their oath of office with the acting Secretary of the meeting for inclusion in the meetings of this minute. Will the acting Secretary please report on the proof of notice of meeting.

I have an affidavit of mailing from Colonial Stock Transfer certifying as to the giving of notice of this meeting and the sending to stockholders of record as of May 11, 2026, the notice of Internet availability of proxy materials, all of which Colonial commenced distributing to stockholders on May 20, 2026.

I also have a copy of the 2025 annual report on Form 10-K, which includes financial statements certified by CBIZ. A copy of this annual report was sent or made available to each stockholder entitled to vote at this meeting and an electronic copy of the annual report is available on the website used to access this meeting.

The notice of meeting and the affidavit of mailing, together with the attachments thereto and the 2025 annual report will be filed with the minutes of this meeting.

Thank you, Steve. The Acting Secretary has the list of the holders of record of Class A common stock and Class B common stock of the company at the close of business on May 11, 2026.

This list of stockholders has been open for examination at the company for any purpose relevant to this meeting during ordinary business hours for the past 10 days in accordance with Delaware Law. This list is available for inspection during this meeting by any stockholder on the website used to access this meeting. The Acting Secretary will please file a copy of the list of stockholders with the records of the company.

Mr. Willard, will you please present your report of attendance at this meeting so that we can determine whether a quorum is present.

Yes. On May 11, 2026, the record date for this annual meeting, there were outstanding and entitled to vote 30,148,947 shares of Class A common stock, representing the same number of votes and 1,449,005 shares of Class B common stock representing 7,245,025 votes.

I have been informed by the Inspector of Elections that shares of stock representing at least 10,532,651 shares and greater than 18,696,987 votes are represented by proxy and entitled to vote at this annual meeting. The shares so represented exceed 50% of the total votes entitled to vote at this meeting and at least 1/3 of the total number of shares entitled to vote and thus constitutes a quorum.

Thank you, Mr. Willard. On the basis of the report of the acting Secretary and Inspector of Election, I find that proper notice has been given and that a quorum is present. Accordingly, this meeting has been properly convened.

The next order of business is a description of the matters to be acted upon at today's meeting. Mr. Willard, will you please proceed.

Thank you, Dr. Hare. The first proposal to come before the meeting is the election of directors. At this meeting, we will be electing three Class II directors for a 3-year term expiring at the 2029 Annual Meeting of Stockholders or until their successor has been elected and qualified.

The nominees are Stephen Willard, Leah Rush Cann and Deborah Ascheim. Information concerning the nominees' principal occupation, skills and qualifications and other matters which may be of interest are contained in the proxy statement. Dr. Hare, were there any other nominations received?

Mr. Willard, no other nominations were received prior to the deadline established in the company's bylaws. Therefore, no additional nominations may be made at this meeting, and I declare that the nominations to be closed.

Thank you, Dr. Hare. The second matter to come before the meeting is a resolution for approval of an amendment to the company's certificate of incorporation as amended to increase the number of shares of Class A common stock authorized to 175 million shares.

The third matter to come before the meeting is a resolution for approval of an amendment to the company's certificate of incorporation as amended, to effect a reverse stock split of common stock at a ratio of 1:2 to 1:20 with the exact ratio within a range -- within that range. to be determined by the Board of Directors of the company at their discretion.

The fourth matter to come before the meeting is a resolution for approval of an amendment to the company's third amended and restated 2021 incentive award plan to increase the maximum number of shares authorized and available for issuance under the plan by 5 million shares and to make commensurate changes to the plan.

The fifth matter to come before the meeting is the ratification of the appointment of CBIZ as the company's independent registered public accounting firm. The Board of Directors recommends the ratification of the appointment of CBIZ to serve as the company's independent registered public accounting firm and to audit the company's financial statements for the fiscal year ending December 31, 2026.

And the last matter to come before the meeting is a resolution for approval of a proposal to adjourn the meeting to a later date, if necessary or appropriate, to permit further solicitation and vote of the proxies in the event that there are insufficient votes for or otherwise in connection with the approval of proposals 2 and 3, the share increased amendment and the reverse stock split proposal.

Are there any questions or comments with respect to any of the six proposals?

Seeing none, Dr. Executive Chairman, will you please proceed with the opening of the polls for voting?

Thank you, Mr. Willard. It is 11:09 a.m. on July 1, 2026, and the polls for voting on all matters are open. All Longeveron shareholders entitled to vote at this meeting have the ability to do so online. If you are a stockholder entitled to vote and have not yet voted or if you want to change your previously cast vote, please do so by clicking on the Longeveron button located on the website used to access this meeting.

Please remember that if you have already voted by proxy, it is not necessary to vote again. After voting has been completed on all matters on the agenda, we will close the polls and provide a preliminary report.

Thank you. The polls are about to close. If you have not voted, please do so.

[Voting]

Since everyone has had the opportunity to vote, it is now 11:10 a.m. and the polls are closed. The Inspector of Elections has delivered their preliminary report and I will now announce the preliminary results.

Based on the Inspector of Election's preliminary report, the three nominees for director receiving a sufficient number of votes cast in favor of their election and have been elected as a director of the company to serve for a 3-year term that will expire at the 2029 Annual Meeting of Stockholders or until their successor has been elected and qualified.

B, the amendment to the company's certificate of incorporation as amended to increase the number of shares of Class A common stock authorized to 175 million shares has been approved by the affirmative votes of the majority of the votes of our common stock outstanding and entitled to vote on the proposal.

C, the amendment to the company's certificate of incorporation to effect a reverse stock split of common stock at the ratio of 1:2 to 1:20 and has been approved by the affirmative vote of a majority of the votes of our common stock outstanding and entitled to vote on the proposal.

D, the fourth amendment and restatement of the company's 2021 incentive award plan to increase the maximum number of shares authorized and available for issuance under the plan by 5 million shares and to make commensurate changes to the plan has been approved by more than a majority of the votes cast in favor of the proposal.

The ratification of the appointment of CBIZ as the company's independent registered public accounting firm for the year ending December 31, 2026, received more than a majority of votes cast in favor of the proposal and the appointment has been ratified.

And the proposal to adjourn the meeting to a later date, if necessary or appropriate, received more than a majority of the votes cast in favor of the proposal.

We will file the final report of the Inspector of Elections with records of this meeting. We expect to report the results of the voting on a Form 8-K to be filed with the SEC within 4 business days of this meeting.

Thank you. That concludes the business for this meeting. The meeting is now adjourned.

Any questions that have been properly submitted regarding the company and its business will be posted promptly on the company's website for review.

Ladies and gentlemen, thank you for attending today's meeting.

Ladies and gentlemen, greetings, and welcome to the Longeveron 2026 First Quarter Financial Results and Business Update Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole from Investor Relations Advisory 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 Investors 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 2 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 22-25, 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 IIb 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, but also asserted that the primary endpoint of right ventricular 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 Institute of Health, NIH, during the trial, to which the company was and remain blinded, a new primary endpoint could not be agreed 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 ELPIS II. And in that regard, the company is capturing all of these measures in ELPIS II along with some additional key measures to support an efficacy determination.

The company intends to submit to the FDA a sponsored statistical analysis plan, or SAP, for ELPIS II 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 biological license application, BLA, following the readout of top line results of the ELPIS II data, which, as I mentioned earlier, are anticipated in August of this year. We look forward for sharing the results of the ELPIS II 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 and 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 31, 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 31, 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 31, 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 31, 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 31, 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 nonrecurring 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 3 months ended March 31, 2026, compared to $5 million for the 3 months ended March 31, 2025. The decrease of $0.3 million or 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 Josh Hare, our Co-Founder, Chief Science Officer and Executive Chairman. Josh?

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-plus 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.

[Operator Instructions] We take the first question from the line of [ Raj ] Selvaraju from H.C. Wainwright.

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, within what time frame would you request a potential meeting with the agency to discuss the ELPIS II results? And what type -- 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 Nataliya because if it's an end of Phase II, it could be a Type B meeting. But 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. And if the -- so it depends on the results, if the results are really overwhelmingly positive, we would like to come back probably at a Type B meeting to discuss all the potentials for the future potential BLA filing. And of course, we will follow up with the full clinical study report. And then definitely, we will plan a pre-BLA meeting later on probably by the end of the year to discuss all the points of our path forward for the BLA. And actually, pre-BLA meeting should be done sometime in 2027 because it should be a meeting where we can discuss all our readiness for the BLA from -- not just from the stand of clinical results, but also CMC, et cetera. So yes.

And then with respect to what could conceivably be the post-marketing requirements for laromestrocel if granted approval in HLHS. So 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, and we proposed long-term extension study. Basically, every patient who went through ELPIS I and ELPIS II study, we wanted to see long-term data, long-term transplant-free survival. So we proposed this design to FDA. They accepted it, they like it.

So most likely, that would be the requirement in case if we approve them to demonstrate efficacy on transplant-free survival and some other endpoints from 10 years, let's say, from -- when the patient reached 10 years old later on. So that would be probably one of the requirements, and we are preparing for that. We have designed, and we are implementing it operationally as we speak, we think about it.

And 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. But I just wanted to see if from your perspective, there is any read-through to the PDCM program and 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.

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

Yes, please go ahead.

Okay. So 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 are completely different. And I would say the results of HLHS trial will definitely in some way, inform a message, we can develop some key messages, clinical messages for PDCM.

But they are 2 independent diseases and the route of administration is completely different, patient population is different. So even though we will learn from it and we even might apply some data to PDCM, it's completely 2 different entities, 2 different diseases.

And Steve, maybe you can provide your perspective from a business point of view, what happened as to results of HLHS.

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

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

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 need approvability criteria if met. So while there certainly will be opportunities for refinements, we don't anticipate -- we -- rather, let me restate, 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.

Sure. So Josh, so would you like me to just mention what was -- sorry, I missed it.

Yes. No, no. I think I just indicated, Nataliya, that we already have the chosen clinical endpoint agreed upon with the agency for the PDCM trial.

Yes.

We take the next question from the line of Boobalan Pachaiyappan from ROTH Capital Partners.

This is Maanasa dialing in for Boobalan, and we have a couple of questions. So yes, the first question is, given that RVEF is out of the question, let's assume a composite endpoint that comprises of 12 months transplant-free survival rate, the length of hospitalization and MACE. So what level of benefits do you need to show in each category to convince the FDA?

Josh, do you want to take that?

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

Sure. Yes. So specifically, as you know, when we plan the trial and now as we prepare to submit statistical analysis plan, and we just received the blinded data. So we are looking at all the assumptions. And -- but we know even as blinded, we know that as of today, we have 2 deaths on the trial. One death happened prior to Glenn procedure and another death happened after Glenn procedure. So we have these 2 events.

And because it's a composite endpoint, the whole weight of the composite endpoint is -- the weighting is going to be on hospitalization based on the hospital. Our assumptions based on literature, as you know, we are pioneering in this indication, and there are not many precedents available and they are using SVR data, they are using single institution data on literature. So based on all the literature evidence, currently, patients with HLHS spent about 30 days in the hospital, 12 months after Glenn, and that's our base assumption.

So of course, on our trial, we would like to do better, and we would like to demonstrate that the very clinically meaningful endpoints such as how many patients spend in the hospital, it's shorter than 30 days. And we have different assumptions, 15 days, et cetera. For now, we are powering for 15 days.

And then as far as MACE, we know what potentially we have, how many events we have, but we have to adjudicate these events and -- but we have enough events to demonstrate some difference between standard of care and laromestrocel at this point. And MACE is our -- which is another composite endpoint and which consists of cardiovascular mortality, hospitalization due to heart failure, thromboembolic events and arrhythmia. So we adjudicating this event, and we have enough sufficient events to demonstrate the difference.

So did I address your question?

Yes. So I have a couple more. So the next thing is, so are there any specific learnings from the recently published trial study that could provide a read-through for the ELPIS II study?

Josh, maybe you can answer this question because you're involved in the study and you know it better.

Yes. Thank you, and thank you for that question. We're excited about the trial 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 where the SVR data is somewhat dated. So the trial study was concurrently enrolled at the same centers with the ELPIS II patients. And it did also involve standard -- we also had a randomization between active treatment and standard of care. So we have a standard of care reference, although it's a small study.

Now what was quite intriguing in the trial 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 trial study. So again, concurrently enrolled with ELPIS II, so at the same time in -- same point in time, at the same centers with the same surgeons. And although it was a much smaller study, we did -- we were able to detect meaningful differences between treated patients and standard of care patients.

So 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. And we are hopeful that the [indiscernible] rate in trial will be -- that we saw in trial will be similar in the ELPIS II study.

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

I would say clinically relevant 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. And then 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. And I think these two are very, very important. And of course, heart failure hospitalization also, so which is kind of indicator how the right ventricle is performing, et cetera. So I think those are the most significant endpoints.

And in addition, I would like to say, even though FDA did not accept right ventricular 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. And 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.

So -- 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 ventricular ejection fraction to surrogate endpoint.

Nataliya. And one last question from me. So after the release of ELPIS II and assuming positive data, do placebo patients have an opportunity to try out Lomecel-B on a compassionate basis?

So we don't have any long term or -- we do have compassionate program, but we didn't have any long-term extension study where a patient can switch or cross over anything like this. But 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 the whole purpose of Dr. Hare creating this company over 10 years ago was to save lives, particularly in children and the elderly and 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...

Any other questions?

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. But please remember that we have four shots on goal here, not just one. And that you can expect, we hope, very interesting progress with regard to Alzheimer's Disease and Aging Frailty 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.

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.

Greetings, and welcome to the Longeveron 2025 Q3 Financial Results and Business Update Call. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Derek Cole, Investor Relations. Thank you. You may begin.

Thank you, operator. Good afternoon, everyone, and thank you for joining us today to review Longeveron's 2025 Third Quarter Financial Results and Business Update. After the U.S. markets closed today, we issued a press release with financial results for Q3 2025, which can be found under the Investors section of the Longeveron website.

On the call today with me are Than Powell, Interim Chief Executive Officer; Dr. Joshua Hare, Co-Founder, Chief Science Officer and Executive Chairman of the Board; Dr. Nataliya Agafonova, Chief Medical Officer; Lisa Locklear, Chief Financial Officer; and Devin Blass, Chief Technology 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 our covering analysts.

With that, let me hand the call over to Than Powell, Interim Chief Executive Officer. Than?

Thank you, Derek, and thank you all for joining us today. I'm excited to be here with our leadership team to provide an update on our progress over the previous quarter and to share some thoughts about what is ahead. This is an incredibly important period for Longeveron and our stem cell therapy, laromestrocel and most importantly, for the patients that we hope to treat. I am honored to step in to lead the company and feel a deep sense of responsibility to our patients and their families to continue the progress on our medicines through clinical development and ultimately to approval.

Through the first month in this role with the leadership team, the company and I, we have focused on disciplined execution, making decisions to further bolster our cash runway and still deliver on our corporate priorities and to bring the needs and expectations of our patients into everything that we do. Our time this afternoon will provide critical updates in these areas.

But first, a brief comment on why I joined Longeveron this summer and why I'm committed to ensuring our success. Longeveron is focused on indications with significant unmet medical need and ones that have directly impacted my family. I know firsthand the need for new treatment modalities, and I am personally invested in advancing the company's development programs with a high degree of rigor and clinical relevance to prove their worth. That scientific rigor and groundbreaking innovation at the heart of Longeveron's stem cell research was critical in my decision to join this company.

In our area of research, establishing safety and efficacy through FDA-supported clinical studies is table stakes for building the belief in the potential life-saving qualities of these therapies. And I've had the good fortune to work in the pharmaceutical and biotech industry for over 25 years, ranging from leadership positions with large organizations like GSK and Eli Lilly to being Co-Founder and CEO at a venture-backed start-up. And in every company, large or small, establishing the foundation of high-quality and clinical data has been at the heart of long-term success, and I'm excited about the opportunity to continue to deliver that here with Longeveron.

Maybe most importantly, for my reason to join this company are all of the individuals that make up this great team. The leadership team is loaded with experts in their fields who are committed to delivering success for our patients and their families and who happen to be good people as well. Their expertise, their industry experience and their day in, day out effort to make a difference is inspiring, and I'm looking forward to continue to work with them. But enough about me, on to why we're here today.

Longeveron has made significant progress advancing 3 programs, building on positive initial results across 5 clinical trials. We have a robust pipeline addressing rare pediatric cardiovascular indications of hypoplastic left heart syndrome and pediatric dilated cardiomyopathy as well as chronic age-related indications, Alzheimer's disease and aging-related frailty. The progress made so far by a small organization is remarkable, in my opinion.

In the near-term, we will have unwavering focus on 3 things: first, delivering clinical trial results from ELPIS II, our pivotal Phase IIb study in HLHS. We completed enrollment of the clinical trial in June and remain on track for reporting results in the third quarter of next year. HLHS is a key strategic priority for us. We believe the HLHS clinical trial program developed in conjunction with the National Heart, Lung and Blood Institute represents the largest placebo-controlled study to date in this critical rare disease patient population. Pending the clinical trial results in Q3 of next year, based on discussions with the FDA, we have a clear path to potential regulatory approval and to future commercialization.

Our second unwavering focus is on securing necessary financial resources. Now stem cell therapy development, seeking regulatory approval and preparing for potential commercialization all require a significant amount of capital. We've been successful throughout the history of this company in obtaining the capital we need and believe we'll be able to continue to do so, given what we see as a very attractive return on investment with our pipeline and near-term milestones. We recognize that future financing opportunities are not guaranteed and acknowledge there is risk in our current financial situation.

Through the operational decisions we have made over the past month, we have extended our runway into late Q1, and we'll continue to stay focused on making cash-conscious decisions. While we do have an at-the-market financing facility in place that provides the potential to raise up to $10.7 million, if needed, we will continue to seek additional financing through capital raises and nondilutive funding options, including grants and strategic collaborations to advance our development programs. We firmly believe that with the intrinsic properties of laromestrocel, there is significant opportunity to attract partners for the continued development and potential commercialization of medicine. We will seek and are evaluating partnering opportunities across all indications, inclusive of HLHS.

Our third unwavering focus will be on HLHS BLA preparedness. We remain focused on delivering key activity to support BLA readiness ahead of the ELPIS II data readout and beyond. We are also cognizant of our current financial situation and have now structured our spending to sequentially deliver critical CMC and manufacturing milestones to derisk our spend and appropriately optimize towards delivery of the ELPIS II study results. These actions have extended our cash runway, as I mentioned, though they will push our potential full BLA filing from late 2026 into 2027.

The next 9 months are a transformational period for Longeveron with multiple critical milestones. It is an exciting time for laromestrocel, for Longeveron, for our shareholders and most importantly, for our patients.

With that, I will turn the call over to Dr. Agafonova, our Chief Medical Officer, to provide an update on our clinical development programs. Nataliya?

Thank you, Than, and good afternoon, everyone. As Than mentioned, our HLHS program is a primary focus for us with a near-term pathway to potential approval in an area of clear unmet medical need. We are currently conducting 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.

We completed enrollment of the trial in June, enrolling 40 patients at 12 well-regarded infant and children's treatment institutions across the country. We remain solidly on track for top-line trial results in the third quarter of 2026 based on the 12-month follow-up period. The determination by the FDA at our meeting in August of last year that ELPIS II is pivotal significantly accelerates the potential regulatory path for laromestrocel. And if supported by data from clinical trial, this would allow us to initiate a BLA submission. This would be our first BLA submission, and it would be far an important indication with large unmet medical need and significant market opportunity.

We can't overemphasize the unmet need our HLHS program is attempting to address. The current standard of care for HLHS involves a complicated 3-stage heart reconstruction surgery over the course of the first 4 to 5 years of patient's life. Despite this surgical reconstruction, only 50% of the affected children survived to age 15 without heart transplantation.

Last month, we attended 2025 Single Ventricle Outcome Network Conference in Indianapolis. Hearing the stories of survival and their families was incredibly moving and a powerful motivator to continue advancing our stem cell therapy as a potential additional tool to help.

Our laromestrocel program in HLHS is designed to boost or improve the heart function in these children with the goal of potentially enhancing their survival. In ELPIS I, our Phase I clinical study evaluating laromestrocel in infant with HLHS, we observed 100% transplant-free survival for 5 years in all patients following treatment. This contrasts with an approximately 20% death and heart transplant observed in historical control data over a 5-year period.

As we mentioned on our last call, with the positive results from Phase IIa CLEAR MIND clinical trial in Alzheimer's disease, the publication of that data in Nature Medicine and the positive Type B meeting with FDA regarding pathway to BLA submission in Alzheimer's disease that yielded alignment on the proposed trial study design, population and endpoints for a single pivotal Phase II/III clinical trial that, if positive, could be acceptable for BLA submission for Alzheimer's disease, we believe we have a strong opportunity to forge collaborations and/or partnership for the advancement of laromestrocel in addressing of Alzheimer's disease.

The need here is great as well and unfortunately growing. Between 2000 and 2021, death from Alzheimer's disease have increased 141%. 1 in 3 older adults dies with Alzheimer's or another dementia. We believe stem cells, particularly mesenchymal stem cells may have the potential to have a significant impact given their mechanism of action.

I will hand the call over to Devin Blass, our Chief Technology Officer. Devin?

Thank you, Nataliya, and good afternoon, everyone. As we mentioned in our last call, a key area of focus this year is organizational readiness in chemistry, manufacturing and controls, or CMC, as we prepare for a potential BLA submission for HLHS in 2027. We are working diligently to ensure that our manufacturing infrastructure and operations are positioned to support both regulatory expectations and future commercial demand.

After a disciplined evaluation, we made a strategic decision to pursue commercial manufacturing through a third-party CMO. This approach allows us to leverage the scale, experience and compliance infrastructure of a dedicated commercial manufacturer while maintaining flexibility and oversight. Under a limited statement of work, we have initiated technology transfer activities and successfully completed proof-of-concept manufacturing runs, demonstrating reproducibility of our process at an external site.

We expect to finalize a master services agreement in the near-term, after which we plan to begin larger-scale manufacturing campaigns to confirm the process, analytics and prepare for commercial production. We anticipate announcing our selected commercial manufacturing partner later this quarter.

Our goal is to continue to advance BLA readiness ahead of ELPIS II data readout so that we can move efficiently towards the BLA submission should data support it. Current priorities include technology transfer, planning and preparations for process and analytical method validation.

Our Miami cGMP facility continues to support our early phase clinical manufacturing, process development and research activities. Additionally, with the existing capacity in our cGMP facility, we have the opportunity to provide selective contract manufacturing services for third parties.

Our first contract manufacturing agreement has been mutually successful. While work under this initial contract is winding down, we believe there is opportunity for us to enter into new contract manufacturing and testing agreements that could generate additional revenue for Longeveron, helping offset our clinical development costs and reducing but not eliminating our additional capital need.

I will hand the call over to Lisa Locklear, our Chief Financial Officer. Lisa?

Thank you, Devin, 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 9 months ended September 30, 2025 and 2024 were $0.8 million and $1.8 million, respectively. This represents a decrease of $1.0 million, or 53% in 2025 compared to 2024, driven primarily by a decreased participant demand for our Bahamas Registry Trial and reduced demand for contract manufacturing services from our third-party client. As Devin mentioned, we continue to explore opportunities to bring in new contract manufacturing services clients to utilize the excess capacity in our Miami cGMP facility. We also see the potential for increased demand in the Bahamas.

Clinical trial revenue, which is derived from the Bahamas Registry Trial for the 9 months ended September 30, 2025 and 2024, was $0.7 million and $1.0 million, respectively. The $0.3 million or 36% decrease in clinical trial revenue when compared to the same period in 2024 was a result of decreased participant demand.

Contract manufacturing revenue for the 9 months ended September 30, 2025, was $0.2 million from our manufacturing services contract, which is a decrease of $0.6 million or 76% when compared to the $0.8 million in contract manufacturing revenue for the 9 months ended September 30, 2024. This decrease was driven by reduced demand for contract manufacturing services from our third-party client.

General and administrative expenses for the 9 months ended September 30, 2025, increased to approximately $9.1 million compared to $7.4 million for the same period in 2024. The increase of approximately $1.7 million or 22% was primarily related to an increase in personnel and related costs in 2025, including increased severance and equity-based compensation.

Research and development expenses for the 9 months ended September 30, 2025, increased to approximately $9.3 million from approximately $6.1 million for the same period in 2024. The increase of $3.2 million or 52% was primarily driven by a $1.8 million increase in personnel and related costs, including equity-based compensation, a $1.2 million increase in supplies and costs associated with our technology transfer, including nonclinical manufacturing batches that advance our readiness for future commercial production as part of our BLA-enabling efforts; and finally, a $0.2 million increase in amortization expense related to patent costs.

Our net loss increased to approximately $17.3 million for the 9 months ended September 30, 2025, from a net loss of $11.9 million for the same period in 2024. The increase in the net loss of $5.4 million or 45% was for the reasons outlined previously.

Our cash and cash equivalents as of September 30, 2025, were $9.2 million. As a result of the recently completed financing in August of 2025 and a continued focus on disciplined and efficient capital allocation focused on first-to-market indications, the company currently anticipates its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements late into the first quarter of 2026 based on its current operating budget and cash flow forecast.

As Than mentioned, the company also has access to an at-the-market ATM equity financing vehicle for the possible sale of up to $10.7 million aggregate market value of shares of the company's Class A stock. We are focused on managing our spend levels to optimize spend towards delivery of the ELPIS II study results. These actions have extended our cash runway into late Q1 2026 and will push our full BLA filing from late 2026 into 2027 if the current ELPIS II trial in HLHS is successful.

The company intends to seek additional financing through capital raises, nondilutive funding options, including grants and strategic partnerships across all indications to continue to support our operations. There can be no assurance that the company will be able to obtain future financing at terms favorable to the company or at all. In the event the company is unable to attain the financing needed, we will need to materially revise our current operational plan.

The relatively near-term potential for pivotal clinical data for HLHS and possibly our first BLA submission make this an extraordinarily exciting time for Longeveron.

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're on the cusp of pivotal data in HLHS and hopefully our first BLA filing, which 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 our progress with laromestrocel, but the remarkable strides in stem cell research, application and commercialization.

We've seen the solidification of cell therapy's role in regenerative medicine and its potential to treat a wide range of conditions, signaling an exciting future for both scientific innovation and patient care. Longeveron has been at the forefront of this evolution in medicine. Laromestrocel has delivered positive initial results across 5 clinical trials and 3 indications, and laromestrocel development programs have received 5 distinct and important U.S. FDA designations.

For the HLHS program, Orphan Drug designation, Fast Track designation and Rare Pediatric Disease designation and for the Alzheimer's disease program, Regenerative Medicine Advanced Therapy designation and Fast Track designation. We believe stem cell therapy has the potential to become a mainstream treatment for many conditions with significant unmet medical needs. The outlook for future breakthroughs is promising, and we will continue to work towards our mission and hopefully support patients battling a range of diseases and conditions. As we do, we look forward to continuing to share advancements in our research, clinical programs and regulatory progress.

I will now turn the call back to Than.

Thank you, Josh. As you've heard, Longeveron has made tremendous progress advancing stem cell research for important development programs. We have 3 programs either currently in or with potential to start potentially pivotal clinical trials. HLHS, Alzheimer's disease and pediatric dilated cardiomyopathy. We are now approaching multiple potentially transformational milestones, including completion of a pivotal Phase IIb clinical trial in HLHS, our first potential BLA submission for HLHS and based on the strength of Phase IIa clinical data, potential partnering for the Alzheimer's disease program. We deeply appreciate the support of all of our stakeholders and look forward to continued collaboration and progress in the future.

Operator, we would now like to open the call for questions from our covering analysts.

[Operator Instructions] The first question we have is from Ram Selvaraju of H.C. Wainwright.

Just 2 quick ones. Firstly, I was wondering if it would be possible for you to elaborate on the sort of business advisability of identifying potential partners for commercialization in rare, ultra-rare conditions like, for example, HLHS or PCM. And in particular, what format such partnerships might take and how these might differ in structure or nature from partnerships that might be applicable in more mass market indications.

And in particular, if you could maybe just drill down on what might drive the decision to go that route via versus self-commercialization given how niche these indications are and the fact that they are not likely to require significant sales and marketing infrastructure to be penetrated efficiently?

Excellent question, Ram, and I will take that one myself. I appreciate the question and appreciate you being here today.

So yes, I do think in rare pediatric diseases, we've talked about before, our desire to seek partnerships outside of the U.S. And in today's announcements, we are talking about that having those conversations as well for partnerships in the U.S. I think our baseline expectation is that we will be prepared and can commercialize this product, as you mentioned, it is a relatively small footprint, and it is a customer base and surgeon base that we do know well from our clinical trials.

That said, we do know there's incredible value here in being this close to a pivotal study readout for those companies that are engaged and involved in similar markets and with similar customers. And the value of that is something that we want to make sure we understand and explore both for ability to realize some cost savings from the commercial footprint build as well as being able to maximize and ramp-up revenue through existing forces that those commercial organizations may have at potential partners.

It is an area that we're still exploring. This is certainly something that we will take under advisement based on our own expectations for how quickly we can grow ourselves, but wanted to ensure that we are looking at all options of value on the table. And again, it's based on the quality of the data we hope to see out of our ELPIS II study and knowing that being this close to a pivotal study is a rare and valuable asset, and we want to explore all ways to bring value into the company.

I think that has been true in the market. You've seen other deals that have some of that structure in place. And there is a wide range of potential structures from straight commercial partnerships to potential future development, inclusive of PDCM and other indications that we may look at in the future, all would be on the table and be dependent on what's best for certainly getting this medicine to patients and certainly for the value we see as a company.

That's very helpful. And I also wanted to ask if it would be possible perhaps to elaborate on dementia and in Lewy body dementia as a potential additional indication for laromestrocel?

Yes. I appreciate that and appreciate the conversation on Lewy body dementia. Right now, those patients, our clinical trial was focused on mild cognitive disease and didn't have a Lewy body dementia component to it in our Phase II study. I do think the need and certainly some of the development we've seen in the Alzheimer's space for Lewy body dementia and understanding the mechanisms that may look at that or may be able to affect treatment there compared to Alzheimer's is interesting. I think right now, our focus is being able to continue the study and the results that we currently have in MCI in Alzheimer's disease and seek partnerships and development expertise from other companies that have had experience in the space.

If there is reason to believe and if we have a scientific and development partner who also sees Lewy body dementia as a potential avenue to explore, we certainly know that the unmet need is significant there and would be happy to explore it based on good solid scientific rationale and any future conversations with the FDA on identifying those patient populations. Glad to see that there has been some more work in that space here from when we first started in Alzheimer's.

Nataliya, any additional comments there?

No. Thank you so much, Than. I think you described it very well.

Than, may I add a comment?

Please, Josh.

Yes. So terrific question. Thank you for that question. Just to reiterate what Than said, we have an RMAT designation and an aligned single adaptive design protocol with the FDA in place for our Phase II/III in Alzheimer's. So that clearly would be our next focus. However, Lewy body dementia, although distinct from Alzheimer's, does share a common pathophysiology of neuroinflammation. And we believe that, that is one of the key potential mechanisms by which laromestrocel is operative in Alzheimer's disease.

From that mechanism of action standpoint, it certainly makes sense to think about Lewy body dementia, and other disorders associated with neuroinflammation in the future. But because of the progress -- because the progress we've already made is with Alzheimer's, it seems logical that, that should be the next step in the development of laromestrocel in the neurocognitive space.

The next question we have is from Boobalan Pachaiyappan of ROTH Capital Partners.

So congratulations, Than, for taking your new role. So 3 questions from us. So first, I wanted to discuss a little bit about the primary endpoint. So obviously, you wanted to show superiority in the composite endpoint, specifically on survival, heart transplantation and rehospitalization. So I understand the totality of the evidence is more important to secure approval. But I was wondering if you could provide some thoughts on -- or maybe if you have any expectations for the placebo and the treatment groups for all these 3 sub sort of endpoints, if you will, in order to consider ELPIS II a success?

I can take this, Than.

Please go ahead, Nataliya.

Yes. Thank you so much. Boobalan, thank you so much. Great question. And we live this life right now to think about the best possible outcome, which is meaningful for parents, for patients and, of course, for the regulatory approval. And as you mentioned, we are thinking about the composite endpoint, which has some component of all cause mortality, transplant-free survival and overall hospitalization. And hospitalization currently is considered in this cardiovascular space is very, very clinically meaningful endpoint, not only how many of these patients stay in hospital, but how many patients stay out of hospital and alive. So we consider all this.

And when we are thinking about this endpoint, definitely, we take into consideration our ELPIS I clinical trial. As you know, we have completed ELPIS I trial. It's open label, but we are trying to be creative here and using real-world evidence and compared to real-world evidence. So I can assure you that we consider all prior developed positive data and the current space to design the best, most clinically meaningful endpoint.

Please let me know if I address your question or if you have more to ask.

No, this is clear. So moving on to the next question. Obviously, in your press release as well as in your remarks, you mentioned that the BLA is now anticipated in 2027 rather than late 2026. And obviously, you've given reasons, operational decision to extend the runway. So I wanted some clarity on that. So my understanding is that you can submit your BLA on a rolling basis, which means potentially you could start the -- I don't know, the components one by one as early as whenever possible or whenever the FDA says okay or whenever the package is ready. So -- and also from now until late 2026, you have plenty of opportunities to strengthen your cash runway.

So I'm curious why guidance is necessary at this juncture in terms of postponing the BLA? And also curious whether you'll be looking for fresh opportunities because you've got at least 4 or so quarters from now to strengthen your cash runway. So any additional thoughts would be helpful.

Thank you, Boobalan. Really appreciate that question and certainly worth having a further discussion. And so I'll provide some initial comments and happy to have both Nataliya and Josh provide comments as well. I do think in our previous guidance and in our conversations, we have commented on having a full submission complete by the end of '26. And I think that's really the change that we're signaling here today is that, that full submission by the end of '26 as we've made decisions based on really making sure that we are optimizing the spend in CMC and the way and timing of when we're spending that, that it likely will just not be able to be fully submitted by 2026.

Relative to a rolling submission and conversations on being able to start the conversations with the FDA earlier, certainly with the distinctions that we have for HLHS and our active conversations with the FDA, we do think conversations will be able to start earlier. The decision on rolling submissions and when that conversation takes place, we will have further conversations in Type C meetings to better understand that. But the primary component that we want to be able to communicate today was that a full submission based on the plans we have is likely not possible by the end of 2026.

We do and will plan as we are able to find and secure additional funding to accelerate and bring forward as much as possible, both the stem and CMC and any opportunities that we have to get that full submission in and have those further conversations. So appreciate you making that distinction and giving us the chance to really further provide detail there. And as we have more information on when that timing could occur, we'll certainly look to provide that through these updates and any other updates that we have.

Nataliya, Josh, any additional comments there?

Thank you, Than. I would just like to add that despite of these time line changes, we are full speed working toward BLA and the database lock every day. So nothing changed from the conduction of clinical trial and database lock, which we are planning next year sometimes end of July, August.

Yes. Really good point, and I should have emphasized that. Yes, this is -- we are as confident as we ever have been on being able to complete the database lock. And this communication of this change has nothing to do with any findings certainly on any of the clinical trial results or anything on that's been produced on the CMC side. Devin and his team have done a fantastic job along with our conversations with the potential CDMO partners to really optimize spend there and all the results and examples or data that we have so far are on pace and on track to deliver. So we feel good about that side of it, too.

All right. Great. Maybe one last question from us. So I'm taking a 30,000-foot view here and looking at the broader landscape of rare diseases, focusing particularly on the M&A aspect. Obviously, the space is getting heated up. And most recently, Novartis acquired Avidity, the company that we cover for $12 billion. And one of the key focus areas is rare pediatric disease and which is also your focus. So I would like to sort of get your broader thoughts on maybe the steps you can take from now, I don't know, in the next 4 quarters or so to sort of increase the M&A appeal of Longeveron. If you can comment on that, that would be good.

Yes. Thank you. I appreciate that. And similar to the conversations on commercial structure for business development conversations, there are certainly M&A conversations that are possible in the rare disease space. And I do think for laromestrocel and both the opportunity it provides and the data that we have across the board, we would expect interested parties to want to have some of those conversations. For us, it will be critical that we are both seeing the value that we expect to see in any of those conversations.

And to your point, that we are making sure that we're emphasizing the value that we see with HLHS as the lead indication, but the pipeline that also follows for the company and that in any conversations about partnerships or M&A, that the full value of the company is part of those conversations and part of the types of deals we want to structure.

To your overarching 30,000-foot question, it's part of the reason I joined this company and part of the reason I am glad to be in this role. I do think the value proposition for our products and for the company are significant and to be able to have a top-line readout in rare pediatric cardiovascular indication with patients that have deep needs and additional treatments, plus a pipeline in a similar indication is a rare commodity to have in this space, and it is a great opportunity for us to make sure that, that value is both something that we're communicating and that we're having discussions about with potential partners.

And we are glad that the market is coming back in the space. And I think as Dr. Hare mentioned in an interview he had recently done with NPR, we believe that congenital heart defects do deserve as much attention and focus as some of the genetic defects have been getting attention as well as the treatment modalities. So we think there's some additional communication we need to have about the patient need here with congenital heart defects and where we can play a role in that space.

Josh, Lisa, anyone else?

No, I don't have anything to add, Than. Thank you.

Yes, nothing from me, Than. Thank you.

The next question we have is from Michael Okunewitch of Maxim Group.

I'd like to start off, just given the seeming early success that we've seen from Mesoblast in their GvHD indication, it's another rare pediatric disease with quite high pricing that seems to be gaining traction with the physicians. So does this impact at all how you're thinking about the value of laromestrocel in HLHS in particular? Is there more of an appetite than you would have expected for high-priced cell therapies in these rare indications?

Yes. Great question, Michael. Thank you. And I think we have always seen the HLHS program and with the conversation we've had on providing our SAP plan and thoughts on our primary endpoints. I mean we do see the value here of potential for survival, reduction in hospitalizations, transplant-free survival. The value proposition in HLHS is significant and does have value, most importantly, for patients and babies and their families. But certainly, as we think about the reality of those outcomes on the cost for treating those patients. So we do think there is significant value if and when this medicine is able to deliver as we hope it will in ELPIS II. And we do think that opens the door for conversations on making sure that, that value is recognized in the market.

We are pleased that Mesoblast has had the success they've had in cell therapy and being able to have success in getting that product to market. Certainly, we see our value proposition in HLHS as its own entity, but being able to have other examples of cell therapies that have been successful and are delivering value is a good case study for us to examine.

I would like to also touch on the -- how important you would consider the longer-term follow-up data from ELPIS I surrounding survival when you do end up going into those payer conversations. Do you think that will play a bigger role compared to with the FDA, where, obviously, the ELPIS II is the pivotal study. But I'd just like to see how important that 5-year long-term follow-up data you expect will be when you're justifying your reimbursement and payer conversations?

Yes. Thank you for the question. And in my career, I've had the chance to work pretty closely with the payer community and specifically on some clinical trial design conversations. And I won't try and predict what they will likely say once a product is approved and how they're looking at reimbursement. I do think being able to have a both the survival endpoints that we talked about and potential composite endpoints, including hospitalizations and others are great value propositions that they will understand and the types of hard outcomes that they would like to see.

And I think any data that speaks to its persistence and our ability to share that data. Obviously, ELPIS I is a Phase I study without a control arm, and we feel that data is incredibly important for the long-term success. And we do think payers and the FDA and patients will appreciate having that data. I just can't predict whether or not that will be an important piece of information for the payers or not, but certainly something that we will remind them of when we come to the reimbursement conversation.

And then just one last for me before I hop back into the queue. I'd like to follow up around some of the discussion that you've had around rolling BLAs and other potential ways that you could expedite this process of regulatory review. And given the seeming supportive stance from FDA around both cell therapies and rare disease, have you looked into any other ways to potentially expedite your BLA pathway such as the newly announced Commissioner's National Priority Voucher program from a couple of weeks back?

Yes, a good question. And I think the main thing I'll say on expediting our BLA path is we do have the designations across all of our programs that have allowed us to have very productive and open conversations with the FDA. I think ultimately, those conversations will be predicated on the data we get from ELPIS II and our ability to have those conversations both with our Type C meeting here going forward as well as the data from the trial, there will be lots of conversations that we will engage in about how to make sure if the trial is successful, we can get to patients as quickly as possible.

I think for the new approval process that is part of the voucher program that Dr. McCarty put in place, we did certainly see that announcement and the focus of those types of approvals really looked a little bit different to us than where we see HLHS as a rare pediatric disease with some of the criteria they had in place. We will certainly continue to look at that. I think our position and our belief is that the continued focus on being able to extend the priority review voucher system as it currently exists is critical for recognizing the innovation that's happening in rare diseases. And we are hoping and are glad for our partners at BIO and other places who continue to press that issue with Congress and hope that, that will be able to be continued as that is a designation that we've had for HLHS. And we think it's critical for really recognizing the value and the amount of time and effort it takes to produce the innovation needed in these rare disease spaces.

So the short version of the answer is we'll continue to look at any potential to bring our product to market as quickly as possible and just want to emphasize that extension of the priority review voucher is a critical priority for us in our conversations with Congress and anyone else who will listen.

Hello?

Operator, are there any other questions in the queue?

Hearing none, I will seek to close this meeting. If anyone does have a question, please do feel free to follow up with us. We might have lost the operator here, but happy to follow up and do just want to say thank you for being part of the call today. Really excited about this team and what they've been able to deliver. Really excited about what our future looks like and look forward to these conversations with you in the future. I appreciate you all being here today, and we'll talk soon.

Thank you very much.

Thank you.

Thank you.

Bye-bye.