Q1 2026 Longeveron Inc Earnings Call

May 13, 2026

Operator 2: Ladies and gentlemen, greetings and welcome to the Longeveron 2026 Q1 Financial Results and Business Update Call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference call, please signal the operator by pressing star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole from Investor Relations at Y-three Solutions. Please go ahead.

Operator: Ladies and gentlemen, greetings and welcome to the Longeveron 2026 Q1 Financial Results and Business Update Call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference call, please signal the operator by pressing star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole from Investor Relations at Y-three Solutions. Please go ahead.

Speaker #2: A brief question-and-answer session will follow the formal presentation. If anyone requires operator assistance during the conference call, please signal the operator by pressing star and zero on your telephone keypad.

Speaker #2: 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.

Speaker #2: Thank you, operator. Good afternoon, everyone, and thank you for joining us today to review Longevron's 2026 first quarter financial results and business update. After the U.S.

Derek Cole: Thank you, operator. Good afternoon, everyone, and thank you for joining us today to review Longeveron's 2026 Q1 financial results and business update. After the US markets today, we issued a press release with financial results for the Q1, which can be found under the investor section of the Longeveron website. On the call today are Stephen Willard, Chief Executive Officer, Joshua Hare, Co-founder, Chief Science Officer, and Executive Chairman of the Board, Nataliya Agafonova, Chief Medical Officer, and Lisa Locklear, Chief Financial Officer. As a reminder, during this call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements.

Speaker #2: Markets today, we should have a press release with financial results for the first quarter, which can be found under the Investor section of the Longeveron website.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Derek Cole: 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?

Speaker #2: 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.

Speaker #2: Steve?

Speaker #3: Thank you, Derek, and thank you all for joining us today. We have had an extremely productive start to this year. After I took on the role as CEO in February, we embarked on two immediate critical tasks.

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

Speaker #3: 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.

Speaker #3: 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 Kalahua Capital.

Speaker #3: 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, Laramestra Cell.

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

Speaker #3: 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 strengths of our client data and clinical data, and the growing external validation of our programs.

Speaker #3: 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.

Speaker #3: Longevron will be participating in the biointernational convention taking place June 22nd through 25th of 2026 at the San Diego Convention Center. We will be hosting meetings with global pharmaceutical company executives, to explore potential partnership and strategic opportunities for the company's four stem cell development programs.

Speaker #3: 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 Laramestra Cell and HLHS expected in August.

Stephen Willard: 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. Nataliya Agafonova, our Chief Medical Officer, to touch on our clinical development programs. Nataliya?

Speaker #3: 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.

Speaker #3: It is an exciting time for Lomecel-B, 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.

Speaker #3: Nataliya?

Speaker #4: Thank you, Steven. Good afternoon, everyone. As Steve mentioned, our HLHS program is the primary focus for us, addressing an area of clear unmet medical need.

Nataliya Agafonova: Thank you, Steve. 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 2023. Top-line results from the ELPIS-II trial are anticipated in August 2026. We recently completed a constructive Type C meeting with the FDA on the laromestrocel development program in HLHS. In the meeting, the FDA acknowledged that HLHS is a rare disease associated with significant morbidity and mortality with a high unmet medical need for safe and effective therapies. Also asserted that the primary endpoint of right ventricle ejection fraction in the ELPIS-II trial is not an appropriate endpoint to demonstrate efficacy.

Speaker #4: ELPIS II, our Phase II clinical trial evaluating the potential of Laramestra Cell in infants with HLHS, is nearing completion. Enrollment of 40 patients was completed in June of last year.

Speaker #4: 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 Laramestra Cell development program in HLHS.

Speaker #4: 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.

Speaker #4: But also, asserted that the primary endpoint of right ventricle ejection fraction in the ELPIS II trial is not an appropriate endpoint to demonstrate efficacy.

Speaker #4: While Longeveron agreed with the FDA regarding the insufficiency of RVAF as the primary endpoint, and was prepared to discuss other potentially appropriate endpoints sufficient to demonstrate efficacy, the FDA indicated that given the interim analysis—mandated and conducted by the National Institutes of Health (NIH) during the trial, to which the company was and remains blinded—a new primary endpoint could not be agreed to while the trial is still ongoing.

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

Speaker #4: 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 a company's Type C meeting in 2024.

Speaker #4: 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.

Speaker #4: 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 measure 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.

Nataliya Agafonova: 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. 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 Sponsor 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 Biologics 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.

Speaker #4: 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.

Speaker #4: Which, as I mentioned earlier, are anticipated in August of this year. We look forward to sharing the results of the ELPIS II clinical trial when they are available.

Speaker #4: Switching over to pediatric dilated cardiomyopathy, or PDCM. This is a rare pediatric cardiovascular disease in which the muscles in one of the more of the heart chambers become enlarged or stretched, dilated, with nearly 40% of children with PDCM requiring a heart transplant or dying within two years of diagnosis.

Nataliya Agafonova: Switching over to pediatric dilated cardiomyopathy, or PDCM. This is a rare pediatric cardiovascular disease in which the muscles in one of the more of the heart chambers become enlarged or stretched, dilated, with nearly 40% of children with PDCM requiring a heart transplant or dying within 2 years of diagnosis. Our Investigational New Drug, IND, application for laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND allows advancement directly into a single phase II registrational clinical trial, reflecting the serious nature of this rare pediatric disease. 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.

Speaker #4: Our investigational new drug, IND application for Laramestra Cell, has the 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.

Speaker #4: 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.

Speaker #4: 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 10Q, both of which present our financial results in detail, so I will touch on some highlights.

Lisa Locklear: Thank you, Natalia, 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. I will touch on some highlights. Revenues for the 3 months ended 31 March 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 31 March 2025 were $0.4 million and consisted of $0.3 million of clinical trial revenues and $0.1 million of contract manufacturing revenues.

Speaker #4: Revenues for the three 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.

Speaker #4: Revenues for the three 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.

Speaker #4: Clinical trial revenues for the three 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.

Lisa Locklear: Clinical trial revenues for the 3 months ended 31 March 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 31 March 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 31 March 2026 were $2.7 million, compared with $2.9 million for the same period in 2025.

Speaker #4: Contract manufacturing revenues for the three 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 client.

Speaker #4: General and administrative expenses for the three months ended March 31, 2026, were $2.7 million compared with $2.9 million for the same period in 2025.

Speaker #4: 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.

Lisa Locklear: 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 31 March 2026, compared to $2.5 million for the same period in 2025. The $0.2 million or 8% decrease was due to lower performance achievement related to the 2025 annual cash incentive bonuses and a $2 million non-recurring charge for amortization expense related to patent costs recorded in the 2025 period. These were partially offset by a year-over-year increase in personnel and higher clinical spend as we prepare for the ELPIS-II study results in August.

Speaker #4: Research and development expenses were $2.3 million for the three months ended March 31, 2026, compared to $2.5 million for the same period in 2025.

Speaker #4: The $0.2 million or 8% decrease was due to lower performance achievement related to the 2025 annual cash incentive bonuses, and a $2 million non-recurring charge for amortization expense related to patent costs recorded in the 2025 period.

Speaker #4: 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.

Speaker #4: Our net loss was $4.7 million for the three months ended March 31, 2026, compared to $5 million for the three months ended March 31, 2025.

Lisa Locklear: Our net loss was $4.7 million for the 3 months ended 31 March 2026, compared to $5 million for the 3 months ended 31 March 2025. The decrease of $0.3 million to 6% was due to the factors outlined before. Our cash and cash equivalents as of 31 March 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 Q4 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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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. Laramestra Cell is an allogeneic mesenchymal stem cell therapy supported by a robust intellectual property portfolio of 52 issued patents and over 60 pending patents worldwide.

Joshua Hare: 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.

Speaker #4: Its potential mechanism of action, including anti-inflammatory, pro-vascular, and pre-regenerative effects, supports its potential application across multiple high-value indications. Laramestra Cell benefits from having received five FDA-expedited designations, including regenerative medicine advanced therapy, or RMAT, fast track, orphan drug, and rare pediatric disease designations.

Speaker #4: Reinforcing both the clinical promise and regulatory positioning of our programs, we continue to advance a pipeline in a product strategy with multiple indications that can be independently developed, partnered, or licensed, creating multiple pathways for value creation.

Speaker #4: 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, five-plus billion, and up to $1 billion and $4 billion.

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

Speaker #4: 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.

Speaker #4: I will now turn the call back to Stephen.

Speaker #1: 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.

Stephen Willard: 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.

Speaker #1: 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.

Speaker #3: Thank you. Ladies, and gentlemen, we will now begin the question-and-answer session. If you would like to ask a question, please press star and one on your telephone keypad.

Operator 2: Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you'd like to remove your question from the queue.

Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you'd like to remove your question from the queue.

Speaker #3: A confirmation tone will indicate your line is in the question queue. You may press star and two if you'd like to remove your question from the queue.

Speaker #3: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions.

Operator 2: Ladies and gentlemen, we will wait for a moment while we poll for questions. We take the first question from the line of Raghuram Selvaraju from H.C. Wainwright. Please go ahead.

Operator: Ladies and gentlemen, we will wait for a moment while we poll for questions. We take the first question from the line of Raghuram Selvaraju from H.C. Wainwright. Please go ahead.

Speaker #3: We take the first question from the line of Raj Salvaraju from HC Wainwright. Please go ahead.

Speaker #4: Thanks very much for taking my questions. Firstly, on the regulatory front, could you maybe provide us with some sense of your expectations post-reporting of top-line results from ELPIS II, and what you think are likely to be the most logical follow-up steps that you would take with the agency?

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

Speaker #4: In other words, within what timeframe would you request a potential meeting with the agency to discuss the ELPIS II results? And what classification of meeting would that be?

Stephen Willard: 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?

Speaker #5: 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?

Stephen Willard: 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?

Joshua Hare: 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.

Speaker #4: I'm not sure. I'd like to hear from Nataliya because if it's an end-of-phase two, it could be a type B meeting. But after then, is to immediately provide the top-line results to the agency and to solicit a meeting with them as soon as possible.

Joshua Hare: 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.

Stephen Willard: Okay.

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

Stephen Willard: Okay.

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

Speaker #5: Nataliya, any?

David Brown: Nataliya, any.

Stephen Willard: Nataliya, any.

Speaker #6: Sure. Sure. I agree with that. And if there so it depends on the results. If the results are really overwhelmingly positive, we would like to come back probably as a type B meeting to discuss all the potentials for the future potential BLA filing.

Raghuram Selvaraju: And then with-

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

Speaker #6: 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, etc.

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

Speaker #6: So yeah.

Speaker #4: And then, with respect to what could conceivably be the post-marketing requirements for Laramestra Cell if granted approval in HLHS? So, this is a hypothetical scenario.

Raghuram Selvaraju: With respect to what could conceivably be the post-marketing requirements for laromestrocel.

Nataliya Agafonova: Yeah.

Raghuram Selvaraju: if granted approval in HLHS. This is a hypothetical scenario.

Speaker #4: 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 Laramestra Cell 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?

Nataliya Agafonova: Sure.

Raghuram Selvaraju: Can you give us a sense of whether you think the overall regulatory positioning on what the requirements might be for pro-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 an, a completely separate subject and has not been impacted in any way by the change in the agency's view of ELPIS-II?

Speaker #6: 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 want to see long-term data, long-term transplant-free survival.

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

Speaker #6: So we proposed this design to FDA. They accepted it. They like it. So most likely, that would be the requirement in cases we approve them to demonstrate efficacy on transplant-free survival and some other endpoints 10 years, let's say, from when the patient reached 10 years old later on.

Speaker #6: 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.

Speaker #6: We're thinking through about it.

Speaker #4: 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.

Raghuram Selvaraju: 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.

Speaker #4: 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.

Nataliya Agafonova: Yeah.

Raghuram Selvaraju: I just wanted to see if, from your perspective, there is any read-through to the PDCM program and, you know, any additional considerations that may now be introduced as you look to design the path forward for laromestrocel and PDCM.

Speaker #4: And any additional considerations that may now be introduced as you look to design the path forward for Laramestra Cell in PDCM in the wake of the most recent FDA feedback on the ELPIS II study.

Raghuram Selvaraju: in the wake of the most recent FDA feedback on the ELPIS II study.

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

Speaker #6: May I just answer from a clinical development perspective? Maybe you can give the business perspective? Is that okay?

Speaker #5: Yes, please. Go ahead.

Stephen Willard: Yes, please. Go ahead.

Speaker #6: 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 may not be connected.

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

Speaker #6: And they're completely different. And I would say the results of HLHS trial will definitely inform in some way inform and message we can develop some key messages, clinical messages for PDCM.

Speaker #6: But there are two independent diseases. And their 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 two different entities, two different diseases.

Speaker #6: And Steve, maybe you can provide your perspective from business point of view what happened after results of HLHS.

Speaker #5: 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.

Stephen Willard: 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. The FDA has been quite clear that this is a very rare Orphan Drug disease that is an unmet medical need. The same is true of PDCM. I think we will just be careful with the FDA in terms of making sure that they are completely comfortable with our endpoints. I think we should be in a good shape for both products.

Speaker #5: And the FDA has been quite clear that this is a very rare orphan drug disease that is an unmet medical need. And the same is true of PDCM.

Speaker #5: 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.

Speaker #5: But I think we should be in a good shape for both products.

Speaker #6: And I would like to add that we in 2026, we are planning operationally to initiate PDCM. We are going to do feasibility, etc. So we are preparing for initiation of PDCM.

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

Speaker #4: Thank you.

Stephen Willard: Thank you.

Raghuram Selvaraju: Thank you.

Speaker #7: Nataliya, it might be worth mentioning what the PDCM endpoint is that we already designed for the approved IND. It is already a clinical endpoint that we anticipate would meet approveability criteria if met.

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

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

Speaker #7: So, while there certainly will be opportunities for refinement, we don't anticipate—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.

Speaker #5: Right.

Stephen Willard: Right.

Nataliya Agafonova: Sure. Josh, would you like me to just mention what was? Sorry, I missed it.

Speaker #6: Sure. So Josh, so would you like me to just mention what's sorry, I missed it.

Speaker #7: Oh, yeah. No, no. I think I was just saying—I just indicated, Nataliya—that we already have the chosen clinical endpoint agreed upon with the agency for the PDCM trial.

Joshua Hare: Oh, yeah. No, no. I think I just indicated, Nataliya, that we already have the chosen clinical endpoint agreed upon.

Nataliya Agafonova: Okay. Yes.

Joshua Hare: -with the agency for the PDCM trial.

Speaker #6: Yep. Thank you. Yes.

Nataliya Agafonova: Yep. Thank you. Yes.

Speaker #4: Thank you.

Stephen Willard: Thank you.

Raghuram Selvaraju: Thank you.

Speaker #5: Thank you very much.

Stephen Willard: Thank you very much.

Speaker #4: Thank you. We take the next question from the line of Avul Balan Pachayapan from Roth Capital Partners. Please go ahead.

Operator 2: Thank you. We take the next question from the line of Bubalan Pacharapan from Northland Capital Markets. Please go ahead.

Operator: Thank you. We take the next question from the line of Bubalan Pacharapan from Northland Capital Markets. Please go ahead.

Speaker #8: Hi, team. This is Manisa dialing in for Avul Balan. And we have a couple of questions. So, yeah, the first question is, given that RVEF is out of the question, let's assume a composite endpoint that comprises the 12-month transplant-free survival rate, the length of hospitalization, and MACE.

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

Maanasa Ramesh Sangeetha: Hi, team. This is Manasa dialing in for Bubalan, and we have a couple of questions.

Stephen Willard: Yes.

Manasa: So-

Maanasa Ramesh Sangeetha: So-

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

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

Speaker #8: So, what level of benefits do you need to show in each category to convince the FDA?

Speaker #4: Josh, you want to take that?

Stephen Willard: Josh, you wanna take that?

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

Speaker #7: 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?

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

Speaker #6: Sure. Yeah. So specifically, as you know, when we planned the trial and now, as we prepare to submit the statistical analysis plan, and we just received the blinded data, so we are looking at all the assumptions.

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

Speaker #6: And, but we know, even though it's blinded, we know that as of today we have two deaths on the trial: one death happened prior to the GLAM procedure, and another death happened after the GLAM procedure.

Speaker #6: So we have these two events. And because it's a composite endpoint, the whole weight of the composite endpoint is the weighting is going to be on hospitalization, days in a hospital.

Speaker #6: Our assumptions, based on literature—as you know, we are pioneering this indication, and there are not many precedents available. And we are using SVR data.

Speaker #6: We are using single institution data on literature. So based on all the literature, evidence, currently, patients with HLHS spend about 30 days in a hospital, 12 months after GLAM.

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

Speaker #6: And that's our base assumption. So of course, on our trial, we would like to be do better and we would like to demonstrate that this very clinically meaningful endpoint such as how many patients spend in the hospital is shorter than 30 days.

Speaker #6: And we have different assumptions, 15 days, etc. 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.

Speaker #6: And—but we have enough events to demonstrate some difference between standard of care and LARO mistress cell at this point. And MACE is our—which is another composite endpoint.

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

Speaker #6: And which consists of cardiovascular mortality, hospitalization due to heart failure, thromboembolic events, and arrhythmias. So we adjudicate in these events. And we have enough sufficient events to demonstrate the difference.

Speaker #6: So, to address your question—yeah. So, I have a couple more. The next thing is: are there any specific learnings from the recently published child study that could provide a read-through for the ELPIS 2 study?

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

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

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

Speaker #6: Josh, maybe you can answer this question because you were involved in the study and you know it better.

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

Joshua Hare: Yes.

Nataliya Agafonova: You know it better.

Speaker #7: Yes, thank you. And thank you for that question. We're excited about the child results, and they did inform our thinking for the endpoint of ELPIS 2.

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

Speaker #7: The reason why it's so attractive, first of all, is that it is current data, whereas the SVR data is somewhat dated. So the CHILD study was concurrently enrolled at the same centers with the ELPIS 2 patients.

Speaker #7: And it did also involve standard we also had randomization between active treatment and standard of care. So we have a standard of care reference, although it's a small study.

Speaker #7: Now, what was quite intriguing in the child study was that the rate of events was quite high in the standard of care group. And all of the events that we are looking at in the ELPIS 2 were seen in the child study.

Speaker #7: So again, concurrently enrolled with ELPIS 2. So at the same time in same point in time, at the same centers with the same surgeons.

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

Speaker #7: And although it was a much smaller study, 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 2 should be, as well as what the constituents of MACE should be.

Speaker #7: And we are hopeful that the event rate in child will be that we saw in child will be similar in the ELPIS 2 study.

Speaker #8: 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 LARMS-LB if it is approved on an accelerated basis?

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

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

Speaker #6: I would say clinically, relevant and outcome measures as we spoke, transplant-free survival, it's very important. There are not too many hearts available. And we would love this transplant-free survival to be as long as possible.

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

Speaker #6: And then days in a 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.

Speaker #6: And I think these two are very, very important. And of course, heart failure hospitalization also. So which is kind of indicator how is the right ventricle is performing, etc.

Speaker #6: 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 as surrogate endpoint, we still including it as our secondary endpoint.

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

Speaker #6: 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.

Speaker #6: So, it is not a 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 a surrogate endpoint.

Speaker #8: Thanks, Nataliya. And one last question from me. So after the release of ELPIS 2 and assuming positive data, do placebo patients have an opportunity to try out LARMS-LB on a compassionate basis?

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

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

Speaker #6: So we don't have any long-term or we do have compassionate program, but we don't have any long-term extension study where a patient can switch or crossover anything like this.

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

Speaker #6: 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.

Speaker #6: Steve, would you like to add anything for compassionate use?

Speaker #9: 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.

Stephen Willard: 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. 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?

Speaker #9: 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?

Speaker #6: Thank you for the question.

Speaker #10: Thank you. Ladies and gentlemen, have there are no further questions from the participants, I would now hand the conference over to Stephen Willard for his closing comments.

Manasa: Thank you for the question.

Maanasa Ramesh Sangeetha: Thank you for the question.

Operator 2: Thank you. Ladies and gentlemen, as there are no further questions from the participants, I will now hand the conference over to Stephen Willard for his closing comments.

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

Speaker #9: 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.

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

Speaker #9: It is a fundamental time for our company. But please remember that we have four shots on goal here, not just the one. And that you can expect, we hope, very interesting progress with regard to Alzheimer's disease and aging frailty.

Speaker #9: As a supplement to and as a very strong carrier of the company together with our HLHS and PBCM products. Thank you once again for your time.

Speaker #9: And we look forward to updating you shortly again. Thank you.

Speaker #10: Thank you. Ladies and gentlemen, the conference of long everyone has now concluded. Thank you for your participation. You may now disconnect your lines.

Operator 2: Thank you. Ladies and gentlemen, the conference of Longeveron has now concluded. Thank you for your participation. You may now disconnect your lines.

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

Nataliya Agafonova: Thank you.