Q4 2025 Longeveron Inc Earnings Call

Operator: Greetings, welcome to Longeveron 2025 Full Year Financial Results and Business Update. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. I would now like to introduce your host, Jenny Coven. Thank you. You may begin.

Speaker #5: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded.

Speaker #5: I would now like to introduce your host, Jenny Koben. Thank you. You may begin.

Speaker #2: 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.

Jenny Coven: Good afternoon, everyone, and thank you for joining us today to review Longeveron's 2025 full year financial results and business updates. After the US 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, 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.

Operator: Good afternoon, everyone, and thank you for joining us today to review Longeveron's 2025 full year financial results and business updates. After the US 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, 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: On the call today are Stephen Willard, Chief Executive Officer; Joshua Hare, Co-founder and Chief Science Officer; Nataliya Agafonova, Executive Chairman of the Board and 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.

Jenny Coven: 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?

Operator: 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?

Speaker #2: 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.

Speaker #2: Steve?

Speaker #3: 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.

Stephen H. Willard: 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 three 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 two of the premier fundamental institutional investors in bio pharma, Coastlands Capital LP, that's Matthew D. Perry, and Janus Henderson Investors. We also have the potential to close a second tranche of an additional $15 million upon meeting certain milestones.

Stephen Willard: 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 three 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 two of the premier fundamental institutional investors in bio pharma, Coastlands Capital LP, that's Matthew D. Perry, and Janus Henderson Investors. We also have the potential to close a second tranche of an additional $15 million upon meeting certain milestones.

Speaker #3: 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.

Speaker #3: Upon assuming the role of CEO, I have had an immediate focus on three 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 two of the premier fundamental institutional investors in biopharma: Coastlands Capital—that's Matthew Perry—and Janus Henderson Investments.

Speaker #3: 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.

Stephen H. Willard: 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 Q4 2026. Second, this capital enables us to complete and deliver the results of the ELPIS II, our anticipated pivotal Phase 2b study in HLHS, and potentially, if supported by the data, begin preparation of the company's first BLA with the US FDA. Enrollment of the clinical trial was completed in June of last year, and we remain on track for reporting results in Q3 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.

Stephen Willard: 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 Q4 2026. Second, this capital enables us to complete and deliver the results of the ELPIS II, our anticipated pivotal Phase 2b study in HLHS, and potentially, if supported by the data, begin preparation of the company's first BLA with the US FDA. Enrollment of the clinical trial was completed in June of last year, and we remain on track for reporting results in Q3 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.

Speaker #3: 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 US FDA.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Stephen H. Willard: 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 Q3 of this year. For Alzheimer's disease, we plan to leverage the strength of our Phase 2 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 2 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.

Stephen Willard: 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 Q3 of this year. For Alzheimer's disease, we plan to leverage the strength of our Phase 2 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 2 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Finally, and potentially very significantly, are our opportunities for priority review vouchers. 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.

Stephen H. Willard: 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 a 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 2024, vouchers have been sold for between $150 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.

Stephen Willard: 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 a 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 2024, vouchers have been sold for between $150 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.

Speaker #3: And the same opportunity may exist for our PDCM program to also be eligible for a PRV. Companies can either use the PRV to secure a speedier FDA review of a future therapy, or sell it to another company.

Speaker #3: Since August of 2024, vouchers have been sold for between $150 and $205 million each. Securing one or more PRVs would obviously be a tremendous financial outcome for the company and shareholders.

Speaker #3: In our recent private placement, we agreed to

Speaker #1: To pursue a sale of a PRV received for health . If granted , and that the investors would be entitled to 50% of the proceeds received from the potential future sale of the H .

Speaker #1: L , h PRV . It is an exciting time for Lara . All the patients we serve Longeveron Inc. our shareholders . With that , I will turn the call over to Doctor Agafonova , our chief Medical Officer , to touch on the clinical development programs Natalia .

Stephen H. Willard: 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 the clinical development programs. Natalia?

Stephen Willard: 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 the clinical development programs. Natalia?

Speaker #2: Thank you , Steve , and good afternoon , everyone As Steve mentioned , our health program is the primary focus for us with the near-term pathway to potential approval in an area of clear unmet medical need The phase two B clinical trial evaluating the potential of Laramie Cell to improve right ventricular function and long term clinical outcomes in infants with HIV is nearing completion Enrollment of 40 patients was completed in June of last year .

Nataliya Agafonova: 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 2b 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 Q3 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.

Nataliya Agafonova: 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 2b 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 Q3 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.

Speaker #2: Top-line results from the LP2 trial are anticipated in the third quarter of 2026, based on FDA feedback. The meeting is scheduled for August 2024.

Speaker #2: LP 2nd may be considered a pivotal study, subject to the trial results, which could potentially accelerate the regulatory pathway for Laramie, Extracell.

Speaker #2: If supported by the data, we plan to initiate preparation for a potential Biologic License Application. By the way, this would represent our first BLA submission and targets a serious pediatric condition with significant unmet medical need.

Nataliya Agafonova: 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 1 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 Q3. Pediatric dilated cardiomyopathy is a rare pediatric cardiovascular disease in which the muscles in one or 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: 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 1 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 Q3. Pediatric dilated cardiomyopathy is a rare pediatric cardiovascular disease in which the muscles in one or 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.

Speaker #2: Our master cell programs in HLS are designed to improve cardiac function in these children, with the goal of potentially improving long-term clinical outcomes. The earlier Phase 1 LPS1 study established the safety and feasibility of LARA.

Speaker #2: Mr. . Administration and provided supportive clinical observations that informed the design of the ongoing pivotal LP two trial . Due to its small size and single arm design , LP one was not intended to evaluate efficacy outcomes .

Speaker #2: We look forward to sharing the results of the LP2 clinical trial in the third quarter. Pediatric dilated cardiomyopathy is a rare pediatric cardiovascular disease in which the muscles in one or more of the heart chambers become enlarged or stretched, or dilated.

Speaker #2: With nearly 40% of children with PDC requiring a heart transplant or dying within two years of diagnosis, our Investigational New Drug (IND) application for Laramie Extracell, as a potential treatment for PDC, became effective in July 2025.

Nataliya Agafonova: Our investigational new drug, IND, application for laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND allows Anvaye's advancement directly into a single pivotal phase 2 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?

Nataliya Agafonova: Our investigational new drug, IND, application for laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND allows Anvaye's advancement directly into a single pivotal phase 2 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?

Speaker #2: This IND allows unbiased advancement directly into single pivotal Phase 2 registrational clinical trials. Reflecting the serious nature of this rare pediatric disease and the significant unmet medical need, we currently anticipate.

Speaker #2: 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.

Speaker #2: Our Chief Financial Officer, Lisa.

Speaker #3: Thank you , Natalia , 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 and detail .

Lisa Locklear: 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.

Lisa Locklear: 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.

Speaker #3: So I will touch on some highlights . Revenues for the year ended December 31st , 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 31st , 2024 , were $2.4 million and consisted of $1.4 million of clinical trial revenue .

Lisa Locklear: 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.

Lisa Locklear: 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.

Speaker #3: $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 2020 .

Speaker #3: Four . 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 31st , 2025 increased to approximately $12 million , compared to $10.3 million for the same period in 2024 .

Speaker #3: 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 one time accrued severance costs for our former CEO Research and development expenses for the year ended December 31st , 2025 increased to approximately $12 million from $8.1 million for the same period in 2024 .

Lisa Locklear: The increase of approximately $1 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 one-time 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 $2.2 million dollar increase in personnel and related costs, including equity-based compensation, $1.4 million dollar increase in CMC costs associated with technology transfer, including non-clinical manufacturing batches that advance our readiness for future commercial production as part of our BLA-enabling efforts, and $0.2 million dollar increase in amortization expense related to patent costs.

Lisa Locklear: The increase of approximately $1 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 one-time 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 $2.2 million dollar increase in personnel and related costs, including equity-based compensation, $1.4 million dollar increase in CMC costs associated with technology transfer, including non-clinical manufacturing batches that advance our readiness for future commercial production as part of our BLA-enabling efforts, and $0.2 million dollar increase in amortization expense related to patent costs.

Speaker #3: This increase of $3.9 million from 48% was primarily driven by a $2.2 million increase in personnel and related costs, including equity-based compensation.

Speaker #3: $1.4 million increase in CMC costs associated with technology transfer , including non-clinical 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 .

Speaker #3: 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.

Lisa Locklear: 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 Coastlands Capital and Janus Henderson Investors as key shareholders.

Lisa Locklear: 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 Coastlands Capital and Janus Henderson Investors as key shareholders.

Speaker #3: 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 31st , 2025 , were $4.7 million , with approximately 1.4 million in working capital .

Speaker #3: On March 11th , we completed a private placement that raised gross proceeds of approximately $15.9 million . We are delighted to Coastlands 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 .

Lisa Locklear: 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 Q4 of 2026, based on our current operating budget and cash flow forecast. I will now hand the call over to Joshua Hare, our Founder and Chief Science Officer. Josh?

Lisa Locklear: 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 Q4 of 2026, based on our current operating budget and cash flow forecast. I will now hand the call over to Joshua Hare, our Founder and Chief Science Officer. Josh?

Speaker #3: I will now hand the call over to Joshua Hare, our Founder and Chief Science Officer. Josh.

Speaker #4: Thank you , Lisa . Good afternoon everyone . As you've heard from the previous speakers , we believe we are on the cusp of pivotal data and health , 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 Inc. reflects not only the continued advancement of lateral master cell , but also the significant progress occurring across the broader field of stem cell research .

Joshua M. Hare: 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 needs.

Joshua Hare: 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 needs.

Speaker #4: Clinical application and commercialization—in recent years, we've seen increasing validation of therapy's role in regenerative medicine and its potential to address a wide range of serious conditions, reinforcing the promise of this rapidly growing area of medicine.

Speaker #4: We believe these advances are helping to establish cell therapy as a potentially transformative approach for treating serious diseases with significant unmet medical need .

Speaker #4: Longevity has been an active participation in 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 .

Joshua M. Hare: Longeveron has been 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 patient populations represents 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.

Joshua Hare: Longeveron has been 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 patient populations represents 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.

Speaker #4: 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 .

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

Speaker #1: Thank you . Josh The anticipated near-term pivotal clinical data for health , 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 Inc. .

Stephen H. Willard: Thank you, Joshua Hare. 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.

Stephen Willard: Thank you, Joshua Hare. 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.

Speaker #1: 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.

Speaker #5: Thank you . At this time , we'll be conducting a question and answer session . If you'd like to ask a question , please press star one on your telephone keypad .

Operator: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for questions. Our first question comes from Raghuram Selvaraju with H.C. Wainwright. Your line is now live.

Operator: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for questions. Our first question comes from Raghuram Selvaraju with H.C. Wainwright. Your line is now live.

Speaker #5: A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue.

Speaker #5: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for questions. Our first question comes from Ron Carvalho with H.

Speaker #5: C. Wainwright, your line is now live.

Speaker #6: Thanks so much for taking my questions and 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 cell .

Raghuram Selvaraju: Thanks so much for taking my questions and congratulations on all the recent progress. Very exciting. 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. 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?

Raghuram Selvaraju: Thanks so much for taking my questions and congratulations on all the recent progress. Very exciting. 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. 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?

Speaker #6: Were it to be approved in the HLS indication. And also, I wanted to see if you could just enumerate for us again which potential areas of inquiry for SSL could conceivably be eligible for PRVs in the future.

Speaker #6: Beyond HLS

Speaker #1: Sure , this is Steve I'll take the second question . We could have a separate PRV for PDC . In fact , we'll be seeking that very shortly .

Stephen H. Willard: Sure. This is Steve. I'll take the second question. We could have a separate PRV for PDCM. In fact, we'll be seeking that very shortly. There are two different PRVs, that one of which has we sold half of to our investors and the other half is for us. 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 with 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?

Stephen Willard: Sure. This is Steve. I'll take the second question. We could have a separate PRV for PDCM. In fact, we'll be seeking that very shortly. There are two different PRVs, that one of which has we sold half of to our investors and the other half is for us. 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 with 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?

Speaker #1: So there are two different PRVs, one of which has— We sold half of it to our investors, and the other half is for us.

Speaker #1: And then the PDC is entirely for us with regard to the manufacturing and CMC , that is a priority for us Going forward .

Speaker #1: 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 .

Speaker #1: Give a follow on question ROM

Speaker #6: Yes, with respect to indications like, for example, Alzheimer's disease and age-related frailty, what potential non-dilutive sources of capital are there to fund those initiatives?

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

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

Speaker #6: Could you access beyond the prvs that you just enumerated

Stephen H. Willard: Great question. 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. Age-related frailty, we have a wonderful paper in Cell Stem Cell that just came out. I recommend it to you highly. We already had incoming interest with regard to licensing that technology. Those two things will be on the priority list for 2026.

Speaker #1: 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.

Stephen Willard: Great question. 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. Age-related frailty, we have a wonderful paper in Cell Stem Cell that just came out. I recommend it to you highly. We already had incoming interest with regard to licensing that technology. Those two things will be on the priority list for 2026.

Speaker #1: I have a background in licensing I run a company called Flamel Technologies Ticker symbol f l m l , based in Lyon , France .

Speaker #1: 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 related frailty .

Speaker #1: 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.

Speaker #1: So, those two things will be on the priority list for 2026.

Speaker #6: Thank you so much

Raghuram Selvaraju: Thank you so much.

Raghuram Selvaraju: Thank you so much.

Speaker #1: Thank you Rob .

Stephen H. Willard: Thank you, Ram.

Stephen Willard: Thank you, Ram.

Speaker #5: Our next question comes from Babylon Patrick with Roth Capital Partners. Your line is now live.

Operator: Our next question comes from Boobalan Pachaiyappan with Roth Capital Partners. Your line is now live.

Operator: Our next question comes from Boobalan Pachaiyappan with Roth Capital Partners. Your line is now live.

Speaker #7: Hi . Good afternoon , and thanks for taking our questions . Of course . Congratulations on your new role . So firstly , with respect to the program Assuming the data is positive in three quarter .

Boobalan Pachaiyappan: Hi. Good afternoon, and thanks for taking our questions. Of course, congratulations on your new role. So firstly, with respect to the HLHS program, assuming the data is positive in Q3 2026, how soon can you 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.

Boobalan Pachaiyappan: Hi. Good afternoon, and thanks for taking our questions. Of course, congratulations on your new role. So firstly, with respect to the HLHS program, assuming the data is positive in Q3 2026, how soon can you 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.

Speaker #7: Third quarter '26. How soon are you—can you file for BLA for the program? And also, if you can provide some granularity in terms of whether you will be filing your BLA on a rolling basis, and also if you're expecting a priority review.

Speaker #1: 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 HLS Yeah .

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

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

Speaker #1: Thank you. Thank you, Steve. Hi.

Joshua M. Hare: Yeah. Thank you. Thank you, Steve. Hi, Bhupalan. 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.

Joshua Hare: Yeah. Thank you. Thank you, Steve. Hi, Bhupalan. 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.

Speaker #4: Thank you for the question .

Speaker #1: Yes , we we are potentially eligible for for rolling submission , which we would take advantage of if allowed by the FDA at this stage .

Speaker #1: Our our next big milestone is , of course , the the data readout , which will then trigger end of phase meeting with the FDA to help .

Speaker #1: Determine the speed and timing of the of the application process Because we have the the the rare pediatric disease designation , we are eligible for the rolling submission and I believe we're also eligible for property review based on the designations that we have .

Speaker #1: So of course , data , data permitting , our our objective would be to initiate that regulatory process as quickly as possible . And as allowed by the by the FDA .

Joshua M. Hare: Of course, data permitting, our objective would be to initiate that regulatory process as quickly as possible and as is allowed by the FDA. Perhaps I might also ask Natalia to comment on that since she's so involved in that process.

Joshua Hare: Of course, data permitting, our objective would be to initiate that regulatory process as quickly as possible and as is allowed by the FDA. Perhaps I might also ask Natalia to comment on that since she's so involved in that process.

Speaker #1: Perhaps I might also ask Nataliya to comment on that, since she's so involved in that process.

Speaker #2: Thank you so much . And thank you for your question . So assuming the data positive sort quarter of 2020 . Six . Definitely .

Nataliya Agafonova: Thank you so much, Josh, and thank you, Bhupalan, for your question. Assuming the data are positive in Q4 of 2026, definitely we would like to take advantage of rolling submission. As you know, it's not only the readiness of clinical data and all the modules related to clinical data, it's also CMC. We are going to take all the advantage and targeting BLA submission sometime in 2027.

Nataliya Agafonova: Thank you so much, Josh, and thank you, Bhupalan, for your question. Assuming the data are positive in Q4 of 2026, definitely we would like to take advantage of rolling submission. As you know, it's not only the readiness of clinical data and all the modules related to clinical data, it's also CMC. We are going to take all the advantage and targeting BLA submission sometime in 2027.

Speaker #2: We would like to take advantage of rolling submission . And as you know , it's not only the readiness of clinical data and all the modules related to clinical data , it's also CMC .

Speaker #2: But we are going to take all the advantage and targeting BLA submission sometime in 2027.

Speaker #7: Okay . That's very 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 .

Boobalan Pachaiyappan: Okay. That's very helpful. Then in terms of PRV, because that has been mentioned many times in today's call. Obviously the most recent PRV was sold for a very high price of $205 million. This is from Fortis Therapeutics, right? At the same time, we have a new sunset date for the PRV, which is September 2029, which is little more than three years from today. 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.

Boobalan Pachaiyappan: Okay. That's very helpful. Then in terms of PRV, because that has been mentioned many times in today's call. Obviously the most recent PRV was sold for a very high price of $205 million. This is from Fortis Therapeutics, right? At the same time, we have a new sunset date for the PRV, which is September 2029, which is little more than three years from today. 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.

Speaker #7: 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 three years from today So .

Speaker #7: 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 ?

Speaker #7: Just curious

Speaker #1: Yeah , that's a great question It's it's hard to predict out that far , but I don't I think prices the immediately prior to that 205 million was a 2 million , 200 million from jazz Pharmaceuticals .

Stephen H. Willard: Yeah, it's a great question. It's hard to predict out that far, but I think prices immediately prior to that $205 million was a $200 million from Jazz Pharmaceuticals. So the last two have been in the $200 million range. I would expect prices to remain strong for these as we approach 2029.

Stephen Willard: Yeah, it's a great question. It's hard to predict out that far, but I think prices immediately prior to that $205 million was a $200 million from Jazz Pharmaceuticals. So the last two have been in the $200 million range. I would expect prices to remain strong for these as we approach 2029.

Speaker #1: So the last two have been in the 200 million range . I would expect prices I would expect prices to remain strong for these as we approach 2029 .

Speaker #7: All right . And then with respect to PD , CM pediatric Dilated cardiomyopathy program , can you provide some context in terms of , you know , what would be the next step in this program ?

Boobalan Pachaiyappan: All right. Then with respect to PDCM, pediatric dilated cardiomyopathy program, can you provide some context in terms of, you know, what would be the next step in this program? How soon can you start your clinical study? I know your IND has been sort of cleared, so maybe provide some context in terms of the timeline, design and, potential endpoints you could possibly explore. 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?

Boobalan Pachaiyappan: All right. Then with respect to PDCM, pediatric dilated cardiomyopathy program, can you provide some context in terms of, you know, what would be the next step in this program? How soon can you start your clinical study? I know your IND has been sort of cleared, so maybe provide some context in terms of the timeline, design and, potential endpoints you could possibly explore. 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?

Speaker #7: How soon are you able to start your clinical study? I know your IND has been sort of cleared, so maybe provide some context in terms of the timeline, design, and potential endpoints.

Speaker #7: You could possibly explore . And also I'm trying to understand what is the unmet need you're trying to address here with , is it something that patients who would be treated with laromustine will not seek a hot transplantation ?

Speaker #7: Or is this an ambitious goal?

Speaker #1: Natalia, would you care to respond to that?

Stephen H. Willard: Nataliya, would you care to respond to that?

Stephen Willard: Nataliya, would you care to respond to that?

Speaker #2: Sure . Absolutely . So your first question about the timing of the PDC M our goal was to initiate the trial this , and due to funding , we were not able to achieve this .

Nataliya Agafonova: Sure. Absolutely. Boobalan, your first question about the timing of the PDCM. Our goal was to initiate the trial this year, and due to funding, we were not able to achieve this. However, it's our also priority. We're able to do feasibility assessments sometime this year and hopefully initiate the trial and start opening sites sometime in 2027.

Nataliya Agafonova: Sure. Absolutely. Boobalan, your first question about the timing of the PDCM. Our goal was to initiate the trial this year, and due to funding, we were not able to achieve this. However, it's our also priority. We're able to do feasibility assessments sometime this year and hopefully initiate the trial and start opening sites sometime in 2027.

Speaker #2: However, it's also a priority, and we are able to do feasibility assessment sometime this year and hopefully initiate the trial and start opening sites sometime in 2027.

Speaker #2: So, as far as the go-ahead,

Boobalan Pachaiyappan: Okay.

Boobalan Pachaiyappan: Okay.

Nataliya Agafonova: Uh-huh, go ahead.

Nataliya Agafonova: Uh-huh, go ahead.

Speaker #7: No, no. Go ahead. Sorry.

Boobalan Pachaiyappan: No, no, go ahead. Sorry.

Boobalan Pachaiyappan: No, no, go ahead. Sorry.

Speaker #2: Yeah . And you asked also about can you remind me . You asked about timing and then . Yeah .

Nataliya Agafonova: Yeah. You ask about timing and then,

Nataliya Agafonova: Yeah. You ask about timing and then,

Boobalan Pachaiyappan: Yeah. Design, sample size, and also is the goal here to, you know, to have patients not to seek heart transplantation?

Boobalan Pachaiyappan: Yeah. Design, sample size, and also is the goal here to, you know, to have patients not to seek heart transplantation?

Speaker #7: Design , sample size and also is the is goal here to , you know , to have patients not to seek heart transplantation

Nataliya Agafonova: Absolutely. We are planning to use hierarchical composite endpoint similar to the HLHS. We include listings for transplant because, you know, the left ventricle is failing, so we would like to see less heart transplant and the hospitalization. Those are very standard approach for heart failure patients, and we are utilizing that. FDA did accept that as a primary endpoint with few comments, which we are going to address as a protocol amendment once we are ready to initiate the trial. We are planning one-year study, every three months, administration with laromestrocel. Hopefully, the number of patients is 70 patients. Our goal was to do the trial globally, not just in the US, but in all geographic area.

Speaker #2: Absolutely . So we are planning to use a Iraqi , Iraqi composite endpoint similar to , to the hills . And we include listings for transplant because , you know , the left , left ventricle is failing .

Nataliya Agafonova: Absolutely. We are planning to use hierarchical composite endpoint similar to the HLHS. We include listings for transplant because, you know, the left ventricle is failing, so we would like to see less heart transplant and the hospitalization. Those are very standard approach for heart failure patients, and we are utilizing that. FDA did accept that as a primary endpoint with few comments, which we are going to address as a protocol amendment once we are ready to initiate the trial. We are planning one-year study, every three months, administration with laromestrocel. Hopefully, the number of patients is 70 patients. Our goal was to do the trial globally, not just in the US, but in all geographic area.

Speaker #2: So, we would like to see less heart transplant and less hospitalization. Those are very standard approaches for heart failure patients, and we are utilizing that.

Speaker #2: 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 we are ready to initiate the trial. We are planning a one-year study.

Speaker #2: Every three months , administration did And hopefully . So the the number of patients is 70 patients . And our goal was to do the trial globally , not just to us , 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 enroll sites , sites and the best geographic area , etc.

Nataliya Agafonova: 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 area, etc. Hopefully sometime in our next call we can give you an update on that.

Nataliya Agafonova: 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 area, etc. Hopefully sometime in our next call we can give you an update on that.

Speaker #2: So, hopefully sometime in our next call, we can give you an update on that.

Speaker #1: Thank you . Natalia . Josh , do you have any comments on that Yes . Thank you Steve Yeah . Vis-a-vis . The potential clinical outcome .

Stephen H. Willard: Thank you, Nataliya. Josh, do you have any comments on that?

Stephen Willard: Thank you, Nataliya. Josh, do you have any comments on that?

Joshua M. Hare: Yes. Thank you, Stephen. Yeah. Vis-à-vis the potential clinical outcome of laromestrocel in this population, we're very enthusiastic about the possibility for actually a meaningful disease modification effect here. This condition, 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. The death or transplant rate is extremely high in children in the first few years of life. This is because it's a progressive illness. We don't have any treatment or modality to actually cure it. It's treated with medications that are palliative medications.

Joshua Hare: Yes. Thank you, Stephen. Yeah. Vis-à-vis the potential clinical outcome of laromestrocel in this population, we're very enthusiastic about the possibility for actually a meaningful disease modification effect here. This condition, 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. The death or transplant rate is extremely high in children in the first few years of life. This is because it's a progressive illness. We don't have any treatment or modality to actually cure it. It's treated with medications that are palliative medications.

Speaker #1: Of SSL in this population . We're very enthusiastic about the possibility for actually a meaningful disease modification effect here . This this condition of dilated cardiomyopathy , something that affects both adults and children in children .

Speaker #1: The clinical burden is much more severe than in adults. It affects younger kids, and the younger they are affected, the more likely they are to have a poor outcome.

Speaker #1: So the 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 .

Speaker #1: 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.

Speaker #1: Lara has the potential to actually cure or reverse the disease . And evidence for that does come from studies done in the academic setting .

Joshua M. Hare: Laromestrocel has the potential to actually cure or reverse the disease. 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. Of course we will only know that once the trial is done. 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 transplants. Not by prolonging the need for heart transplant potentially, but by actually completely reversing the need for it. That at this point is a hypothesis. We can't say that is definitely going to happen.

Joshua Hare: Laromestrocel has the potential to actually cure or reverse the disease. 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. Of course we will only know that once the trial is done. 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 transplants. Not by prolonging the need for heart transplant potentially, but by actually completely reversing the need for it. That at this point is a hypothesis. We can't say that is definitely going to happen.

Speaker #1: In adults that you can actually see a complete reversal . And remission from the disease . So of course , we we will only know that once the trial is done .

Speaker #1: 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.

Speaker #1: 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 is a hypothesis .

Speaker #1: We can't say that that , that , that , that is definitely going to happen . But the trial as designed will detect 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 .

Joshua M. Hare: The trial as designed will detect ability to have the complete reversal of the disease and therefore be one of the first true disease modifying treatments for this condition.

Joshua Hare: The trial as designed will detect ability to have the complete reversal of the disease and therefore be one of the first true disease modifying treatments for this condition.

Stephen H. Willard: That's wonderful.

Stephen Willard: That's wonderful.

Boobalan Pachaiyappan: All right. Maybe one last question. I'm sorry. So obviously you recently received a patent about laromestrocel used in sexual dysfunction in females. This is pretty interesting program. I'm trying to understand what's your strategy here? Do you envision this more of a partnered program rather than, you know, developing on your own? Also, do you expect this drug in this indication to be a short-term therapy or a long-term therapy? Thank you very much.

Boobalan Pachaiyappan: All right. Maybe one last question. I'm sorry. So obviously you recently received a patent about laromestrocel used in sexual dysfunction in females. This is pretty interesting program. I'm trying to understand what's your strategy here? Do you envision this more of a partnered program rather than, you know, developing on your own? Also, do you expect this drug in this indication to be a short-term therapy or a long-term therapy? Thank you very much.

Speaker #7: Yeah. Maybe one last question. Sorry. So obviously you recently received a patent about LARA's use in sexual dysfunction in females.

Speaker #7: So this is pretty interesting program . I'm trying to understand what's your strategy here . Is it do you envision this more of a partner program rather than , you know , 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 ?

Speaker #7: Thank you very much .

Speaker #8: Josh, you take that one as well, please.

Stephen H. Willard: Josh, you take that one as well, please.

Stephen Willard: Josh, you take that one as well, please.

Speaker #1: Yeah . Thank you . That's another great question . Yes , the the , the finding of the improvement of female sexual dysfunction arose from our aging frailty work .

Joshua M. Hare: Yeah. Thank you. That's another great question. Yes. The finding of the improvement of female sexual dysfunction arose from our aging frailty work. 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. There's this 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 post-menopausal estrogen. I think we see a new era of focus on women's health in post-menopausal 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.

Joshua Hare: Yeah. Thank you. That's another great question. Yes. The finding of the improvement of female sexual dysfunction arose from our aging frailty work. 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. There's this 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 post-menopausal estrogen. I think we see a new era of focus on women's health in post-menopausal 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.

Speaker #1: And so this , this is an issue . And the patent is related to older end , older female individuals . This is a very important unmet need in this population as well .

Speaker #1: And there is a tremendous amount of interest in 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 .

Speaker #1: And so I think we see a new era of focus on women's health and 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, incredibly important for health and quality of life.

Speaker #1: And so we do see a , a big clinical need here . And a , a physician community that's now very focused on this particular matter in terms of development .

Joshua M. Hare: 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 at it alone. There would clearly be another study that would need to be done and a formal regulatory pathway with the FDA established. In short, I do see this as addressing a very high unmet need and something that would be ripe for a partnership opportunity.

Joshua Hare: 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 at it alone. There would clearly be another study that would need to be done and a formal regulatory pathway with the FDA established. In short, I do see this as addressing a very high unmet need and something that would be ripe for a partnership opportunity.

Speaker #1: I think this would be an indication that would be ripe for partnership, as opposed to us going it alone. That would clearly be another study that would need to be done.

Speaker #1: And for regulatory pathway with the F.D.A. established . So , so in short , I do see this as a addressing a very high unmet need and something that would be ripe for a partnership opportunity .

Speaker #7: All right. Thank you again.

Boobalan Pachaiyappan: All right. Thank you again.

Boobalan Pachaiyappan: All right. Thank you again.

Speaker #8: Thank you for the question

Stephen H. Willard: Thank you for the question.

Stephen Willard: Thank you for the question.

Speaker #5: 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 .

Operator: 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.

Operator: 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.

Speaker #8: 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 .

Stephen H. Willard: Thank you, operator. 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.

Stephen Willard: Thank you, operator. 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.

Speaker #8: Thank you once again . Operator . You may end the call .

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

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

Q4 2025 Longeveron Inc Earnings Call

Demo

Longeveron

Earnings

Q4 2025 Longeveron Inc Earnings Call

LGVN

Tuesday, March 17th, 2026 at 8:30 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

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