Q2 2024 Longeveron Inc Earnings Call

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Unknown Executive: Good day and welcome to the Longeveron's 2024 second quarter financial results conference of all. At this time, all participants are in a listen-only mode.

Unknown Executive: Raghuram Selvaraju, Raghuram Selvaraju Good day and welcome to Longeveron's 2024 second quarter financial results conference call. At this time, all participants are in a listen-only mode.

Speaker Change: Good day and welcome to the long Jeff runs 2024 second quarter financial results Conference call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.

Unknown Executive: A brief 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 is being recorded. It is now my pleasure to introduce your host, Derek Cole, Investor Relations and Advisory Solutions. Thank you, sir.

Unknown Executive: A brief question-and-answer session will follow the formal presentation.

Unknown Executive: If anyone should require operator assistance during the conference, please press star zero on your telephone chat. As a reminder, this conference is being recorded.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

Speaker Change: As a reminder, this conference is being recorded it is now my pleasure to introduce your host Darko Industrial Relations Advisory solutions. Thank you Sir you may begin.

Derek Cole: It is now my pleasure to introduce your host, Derek Cole, Vester Relations at Advisory Solutions. Thank you, sir.

Unknown Executive: You may begin. Thank you, Maria.

Derek Cole: You may begin. Thank you, Maria. Good afternoon, everyone, and thank you for joining us today to review Longeveron's second quarter 2024 financial results and business update. After the U.S. markets closed today, we issued a press release with financial results for the second quarter, which can be found under the investor relations section of the Longeveron website. On the call today are Wael Hashad, Chief Executive Officer, Dr. Nataliya Agafonova, Chief Medical Officer, Lisa Locklear, Chief Financial Officer, and Joshua Hare, Co-Founder, Chief Science Officer, and Chairman of the Board. As a reminder, during this call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected.

Speaker Change: Thank you Maria good afternoon, everyone and thank you for joining us today to review longevity on second quarter 2024 financial results and business update.

Mohamed Hashad: Good afternoon, everyone. And thank you for joining us today to review Longeveron's second quarter 2024 financial results and business update. After the US markets closed today, we should have pressed release with financial results of the second quarter, which can be found under the Investor Relations section of the Longeveron website.

Speaker Change: In the U S markets closed today, we issued a press release with financial results for the second quarter, which can be found under the Investor Relations section of our long jumper on web site.

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

Speaker Change: On the call today are while <unk> Shah Chief Executive Officer, Dr. <unk>, <unk>, Chief Medical Officer, Lisa Likelier, Chief Financial Officer, and Joshua Hair Co founder Chief Science Officer, and chairman of the board.

As a reminder, during this call we will be making forward looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements.

Speaker Change: 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 Securities Exchange Commission, which we encourage you to refer to you Paul.

Unknown Executive: Following the company's prepared remarks, we will open the call to questions from covering analysts.

Paul: Following the Companys prepared remarks, we will open the call to questions from covering analysts.

Mohamed Hashad: With that, let me hand the call over to Hashad, Chief Executive Officer, while. Thank you, Derek. Good afternoon, everyone, and thank you very much for joining us today.

Wael Hashad: 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 Security 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 Wael Hashad, Chief Executive Officer. Wael?

<unk> Shah: With that let me hand, the call over to <unk> Shah Chief Executive Officer.

<unk> Shah: Okay.

Wael Hashad: Thank you, Derek. Good afternoon, everyone. And thank you very much for joining us today. Earlier this year in our letter to the shareholders, we laid out our vision for Longeveron and the strategy we would implement in pursuit of this vision. On our last quarterly call, I detailed the four reasons that drive my confidence in our ability to execute well and make an impact. One, our foundation is strong science.

<unk> Shah: Thank you Derek good afternoon, everyone and thank you very much for joining us today.

Mohamed Hashad: Earlier this year, in our letter to the shareholders, we laid out our vision for Longeveron and the strategy we would implement in pursuit of this vision. On our last quarterly call, I detailed the four reasons that drive my confidence in our ability to execute well and make an impact. One, our foundation in a strong sign. The experience and expertise of the Longeveron team and the team dedication and commitment to advance this research, and fourth, and the most important, is a concerted focus on patients impacted by the diseases for which we are attempting to develop treatment.

Speaker Change: This year in our letter to the shareholders.

Speaker Change: Laid out our vision for long to grow on the strategy, we would implement and pursue it.

Speaker Change: Yeah.

Speaker Change: On our last quarterly call I detailed before.

Speaker Change: That drives my confidence in our ability to execute well.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Our foundation is strong.

Speaker Change: Okay very good.

Speaker Change: And the expertise that long long as youre growing team.

Speaker Change: And the team's dedication and commitment right Dan.

Dan: And fourth and most important is a concerted focus on patients who are impacted by the diseases for which we are attempting to develop treatment.

Mohamed Hashad: Now, I'm very pleased to update you on our progress and accomplishments since the end of the first quarter, which I can sum up as continued strong execution across all aspects of the organization.

Wael Hashad: The experience and expertise of the Longeveron team, and the Team Dedication and Commitment Advanced, Felicia, and Ford, and, most importantly, a concerted focus on patients impacted by the diseases for which we are attempting to develop trees. Now, I'm very pleased to update you on our progress and accomplishments since the end of the first quarter, which I can sum up as continued strong execution across all aspects of the organization.

Dan: Now I'm very pleased to update you on our progress on our accomplishments.

Dan: The first quarter.

Speaker Change: Which items.

Speaker Change: Kingwood.

Speaker Change: Execution across all aspects.

Speaker Change: Of the organization.

Mohamed Hashad: As I remind them, for those of you who are new to our story, Longeveron is a regenerative medicine company, developing cutting-edge cellular therapy. Our lease development compound, Longevity, represents a pipeline and a product opportunity that is being evaluated across the three important treatment areas, addressing numerous medical needs with US market potential opportunities of approximately 10 to 18 billion US dollars. Lomeco B is a proprietary, scalable, allergenic cellular therapy that has delivered positive initial results across five clinical trials in three indications. Phase one and two trials in op-ironic disease, phase one and two trials in aging-related frailty, and phase one in hypoplastic left part syndrome also known as HLHS.

Wael Hashad: As I remind them, for those of you who are new to our story, Longeveron is a regenerative medicine company developing cutting-edge cellular therapy, Our Leaves Development Compound, Longeford B, that presents a pipeline and a product opportunity that is being evaluated across three important treatment areas, addressing numerous unmet medical needs with U.S. market potential opportunities of approximately 10 to 18 billion U.S. dollars. Lumix OB is a proprietary, scalable, allergenic cellular therapy that has delivered positive initial results across five clinical trials in three indications.

Speaker Change: I've got a reminder, for those of you who are newer to our story long deeper on.

Speaker Change: Madison developing cutting edge cellular therapy.

Speaker Change: Our lead development compounds monotherapy.

Speaker Change: Presents a pipeline in a product opportunity that is being evaluated across three important treatment area.

Speaker Change: Directing numerous unmet medical need with you.

Speaker Change: The market opportunity.

Speaker Change: Let me turn to $18 billion.

Speaker Change: Wonderful.

Speaker Change: Reactor scalable allogeneic cellular therapy.

Speaker Change: <unk> delivered positive initial results across five clinical trials.

Speaker Change: Three indications.

Wael Hashad: Case 1 and 2, Trials and Apartment Divis, Phase 1 and 2 trials in aging-related frailty, and Phase 1 in hypoplastic left heart syndrome, also known as HLHS. HLHS is a key strategic priority for us this year. The positive results of our Phase I study, ALPHAGE I, were the basis for our ongoing Phase II study, ALPHAGE II, which is evaluating Lomital B as a potential adjunct treatment for HLHS. The study continues to make progress, enrolling patients with enrollment completion targeted for the end of 2024. In June, we hosted a successful Alpha 2 Investigator meeting. Dr. Agafonova will provide more details on that meeting shortly. But I will share that the participation and the level of excitement and enthusiasm were incredible.

Speaker Change: Phase one and two trials in Alzheimer's disease.

Speaker Change: Phase, one and two trials and aging related gravity.

Speaker Change: And phase one and Hyperplastic heart syndrome also known as edge out Jack.

Speaker Change: Hi, Joe and John.

Mohamed Hashad: HLHS is a key strategic priority for us this year. The positive result of our phase one study, phase one, was the basis for our own ongoing phase two study of this two, which is evaluating long-to-be as a potential adjunct treatment for HLHS. The trial continues to make progress involving patients, with the enrollment completion targeted for the end of 2024.

Speaker Change: Key strategic priority for us this year.

Speaker Change: The positive results of our Phase one study operates one what is the basis for our ongoing phase two study it's too well.

Speaker Change: We're just evaluating monotherapy.

Chad: And the potential of Johns Creek for edge I'll, let Chad.

Speaker Change: We're proud to continue to make progress enrolling patients with enrollment completion targeted for the end of 'twenty 'twenty four.

Mohamed Hashad: In June, we hosted successful outfits two in the theater meeting. Dr. Agafonova will provide more details on their meeting shortly, but I will share that the participation in the level of excitement and enthusiasm was incredible. We believe the HLHS program has a high probability of success and the shortest path to potential regulatory approval across our pipeline. This belief is enhanced with Opage One data serving at the basis for the U.S. FDA awarding the HLHS program with three distinct and important designations: orphan drug disease designations, fast-track designations, and rare pediatric disease designations.

Chad: Okay.

Chad: In June we hosted platform operates two investigator meeting.

Chad: Dr.

Chad: Well provide more detail on that meeting shortly.

Speaker Change: I will share that with our participation in the level of excitement and enthusiasm was incredible.

Wael Hashad: We believe the HLHF program has a high probability of success and the shortest path to potential regulatory approval across our pipeline. This belief is enhanced by LPH-1 data, serving as the basis for the U.S. FDA awarding the HLHS program three distinct and important designations. Four friends rush to visit the nation.

Speaker Change: We believe.

Speaker Change: The program has a high probability of success and the shortest path to potential regulatory approval across our pipeline.

Speaker Change: This belief is enhanced with Opex, one data surfing the basin towards the upbeat for the U S. FDA awarding the extra lift jet program.

Speaker Change: Three distinct and important measure.

Speaker Change: Orphan drug designation.

Wael Hashad: Trans Tract Designation and Rare Pediatric Disease Designation. While we are very focused on HLHS, we also continue to advance our Alzheimer's disease program, as you hopefully have seen in three important weeks in the event. Based on the Phase I and the ClearMind Phase IIa clinical data, the FDA has granted Lomisol-B, Both Regenerative Medicine Advanced Therapies are NAT designations, and transstrang designation for the treatment of mild Alzheimer's disease. Lamaselvi appears to be the first singular therapy, candidates to receive our MAD designation for Alzheimer's disease.

Speaker Change: Brad Frack designation and granted pediatric disease designation.

Mohamed Hashad: While we are very focused on HLHS, we also continue to advance our op-ironic disease program. As you hopefully have seen in three important recent events, based on the phase one and the clear mind phase two A clinical data, the FDA has granted long-to-be both regenerative medicine, advanced therapy, R-NAT designation, and fast-track designation for the treatment of mild Alzheimer's disease. Lomato B appears to be the first cellular therapy candidate to receive our NAT designation for Alzheimer's disease. We are honored to have received these designations and look forward to continue to work with the FDA on the next steps.

Speaker Change: Why we are very focused on Petrobras right. We also continued to advance our Alzheimer's disease program.

Speaker Change: Hopefully you have seen.

Speaker Change: Of course, the reason there Brad.

Speaker Change: Based on the phase, one and a clear mind space.

Speaker Change: Clinical data the FDA has granted <unk>.

Speaker Change: <unk>.

Speaker Change: Both for regenerative medicine advanced therapy arm that designation.

Speaker Change: And fast track designation for the treatment of mild Alzheimer's disease.

Speaker Change: Hello, Ms there'll be appears to be the first cellular therapy.

Speaker Change: Candidates to receive or not does it make.

Speaker Change: For Alzheimer's disease.

Wael Hashad: We are honored to have received these designations and look forward to continue to work with the FDA on the next step. Four results from that clear mind-based to a clinical trials were presented in a featured research oral presentation, at the 2024 Alzheimer Association International Conference, AAIC, that was just held in Philadelphia. Dr. Agafonova will review the results. But I think it is important starting highlight is that the clinical trial, In the clinical trial of Lomacell VE treated, an important treated patient showed an overall slowing or prevention of disease worsening compared to placebo. We understand Alzheimer's disease has historically been a very difficult area for development.

Speaker Change: We are honored to have received designation I look forward to continue to work with the FDA on the next steps.

Mohamed Hashad: Four results from that clear mind phase two A clinical trials were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference, AAIC, that was just held in Philadelphia. Dr. Agaphanil will review the results, but I think it is important starting highlight is that the clinical trial In the clinical trial of Longeveron Selvaraju treated an important treatitation showed an overall slowing or prevention of disease worsening compared to placebo. We understand Alzheimer's disease has historically been a very difficult area for development. So we are only more encouraged to, as a result, we have seen today with Longever Selvaraju.

Speaker Change: Full results from that.

Speaker Change: Clinical trials were presented and it featured research oral presentation.

Speaker Change: The 'twenty 'twenty four apartment Association International Conference.

Speaker Change: I see that was held in Philadelphia.

Speaker Change: After I got somehow got well with your the resolved.

Speaker Change: But I think it is important starting highlight is that the clinical trial.

Speaker Change: The clinical trials.

Speaker Change: Created in.

Speaker Change: Unimportant.

Speaker Change: Treated patients showed an overall slowing.

Speaker Change: Sure.

Speaker Change: Prevention of disease worsening compared to placebo.

Speaker Change: We understand Alzheimer's disease.

Speaker Change: Correctly, then it's very difficult to area for development.

Wael Hashad: So we are only more encouraged by the results we have seen to date with Lama Salvi. With this data in hand, we anticipate meeting with the FDA before year-end to review future clinical and regulatory strategies for continuing this important program. As I mentioned on our last call, we are expanding our contract manufacturing operation, and as part of the overall resource optimization strategy, we have assembled a team of experts and proprietary technologies that enable us to take a systematic approach to rapidly develop improved cell therapy.

Speaker Change: So we are only more encouraged with the results we have seen to date with monotherapy.

Mohamed Hashad: With this data in hand, we anticipate meeting with the FDA before year-end to review future clinical and regulatory strategy for continuing this important program.

With this data in hand, we anticipate meeting with the FDA before year end to review future clinical and regulatory strategy.

Speaker Change: Continuing this quarter.

Speaker Change: Program.

Mohamed Hashad: As I mentioned on our last call, we are expanding our contract manufacturing operation as part of the overall resource optimization strategy. We have assembled a team of experts and proprietary technologies that enable us to take a systematic approach to rapidly develop improved cell therapy. Our state of the art, GME facility in Miami, at Life Science and Technology Park, consists of 3,000 square feet of clean room space containing eight ISO study and clean room and entry areas, as well as 1,100 60 square feet of process development quality control and warehousing space. While this facility gives us capacity to manufacture one of the four clinical trial use and potentially, if approved for commercial scale, we are not currently using the facility's whole capacity.

Speaker Change: As I mentioned on our last call.

Speaker Change: We are expanding our contract manufacturing operation as part of the overall resource optimization strategy.

Speaker Change: We have assembled a team of experts and property after each technology that enable us to take a systematic approach to rapidly develop.

Speaker Change: Improved cell therapy.

Wael Hashad: Our state-of-the-art GMT facility in Miami at Life Science and Technology Park consists of 3,000 square feet of clean room space containing eight ISO 7 clean rooms and ancillary areas as well as 1,150 square feet of process development, quality control, and warehousing space.

Speaker Change: Our state of the art GMP facility in Miami at Life Science and Technology Park.

Speaker Change: Great.

Speaker Change: 3000 square feet.

Speaker Change: Clean room space for <unk>.

Speaker Change: Aid I, suppose clean room, and ancillary areas as well as 1168 square feet.

Unknown Executive: Good day and welcome to the Longeveron's 2024 Second Quarter Financial Results Conference of All. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.

Speaker Change: Process development and quality control and warehousing space.

Wael Hashad: While this facility gives us capacity to manufacture long-nailed beads for clinical trial use and potentially, if approved for commercial scale, We are not currently using the facility's full capacity. This presents an additional opportunity for us as the company's manufacturing expertise and capabilities, and the facility are in demand from other pharmaceutical organizations. We are performing work under the first contract, and we have already generated over $200,000 in revenue. We believe the contract manufacturing business has the potential to expand our team and generate approximately $4 to $5 million in annual revenue once it's up and running fully, helping offset our clinical development costs and reducing, but not eliminating, our additional capital needs. Good night. Good night. Good night.

Speaker Change: While this facility give us.

Speaker Change: <unk> is a manufacturer of monotherapy for clinical trial use potentially if approved for commercial scale.

Unknown Executive: If anyone should require operator assistance during the conference, please press star zero on your telephone chat. As a reminder, this conference is being recorded.

Speaker Change: Our non policy using debt facilities.

Speaker Change: Got it.

Mohamed Hashad: This presents an additional opportunity for us as the company's manufacturing expertise and capabilities, and the facility, are in demand from other pharmaceutical organizations. We are performing work under the first contract, and we have already generated over $200,000 in revenue. We believe the contract manufacturing business has the potential to expand our team experience and generate approximately 4 to 5 million in annual revenue once it's up and running fully.

Speaker Change: This presents an additional opportunity for us.

Derek Cole: It is now my pleasure to introduce your host, Derek Cole, Vester Relations at Advisory Solutions. Thank you, sir. You may begin. Thank you, Maria. Good afternoon, everyone. And thank you for joining us today to review Longeveron's second quarter 2024 financial results and business update. After the US markets closed today, we should have pressed release with financial results of the second quarter, which can be found under the investor relations section of the Longeveron website.

Speaker Change: Company's manufacturing expertise and capabilities and the facility are in demand from other sort of organization.

Speaker Change: We are performing work under the first contract and we have already been migrated over $200000 in Rabbit Hill.

Speaker Change: We believe the contract manufacturing business has the potential to expand our <unk> experience and.

Speaker Change: <unk> generates approximately $4 million to $5 million annual revenue once it's up and running fully.

Derek Cole: On the call today are while Hashad, Chief Executive Officer, Dr. Nataliya Agafonova, Chief Medical Officer, Lisa Locklear, Chief Financial Officer, and Joshua Hare, Co-Founder, Chief Science Officer, and Chairman of the Board. As a reminder, during this call, we will be making forward-looking statements. These statements are subjects of certain risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in the company's filings with the Securities Exchange Commission, which we encourage you to review.

Mohamed Hashad: Helping offset our clinical development costs and reducing, but not eliminating, our additional capital needs. Lastly, we remain tightly focused on optimizing our resources and being good stewards of shareholders' capital, which focus on expense control and program prioritization. Our total operating expenses through the first half of the year are down 22% year over year.

Speaker Change: Okay.

Speaker Change: Helping offset our clinical development costs.

Speaker Change: Reducing but not eliminating our additional captisol with me.

Speaker Change: Lastly.

Wael Hashad: We remain tightly focused on optimizing our resources and being good stewards of shareholders capital, which focused on expense control and program prioritizing, our total operating expenses through the first half of the year, are down 22% year over year. Following a successful capital raises and warrant exercises in the second quarter and in July, our existing cash and cash equivalents are expected to be sufficient to fund the company through the fourth quarter of 2025. With that, I will turn the call to Dr. Agafonova to provide updates on our clinical development program. Natalia?

Speaker Change: We remain tightly focused on optimizing our resources and being good stewards of shareholders' capital.

Speaker Change: Focus on expense control on program prioritization.

Our total operating expenses through the first half of the year are down 22% year over year.

Unknown Executive: Following the company's prepared remarks, we will open the call to questions from covering analysts.

Mohamed Hashad: Following a successful transfer, raises and warrant exercises in the second quarter and in July, we are experiencing cash and cash equivalents are expected to be sufficient to fund the through the fourth quarter of 2025.

Speaker Change: Growing our successful capital raises and warrant exercises in the second quarter and in July we.

Mohamed Hashad: With that, let me hand the call over to while Hashad, Chief Executive Officer, while. Thank you, Derek. Good afternoon, everyone, and thank you very much for joining us today.

Speaker Change: <unk>.

Speaker Change: Our existing cash and cash equivalents are expected to be sufficient to fund the company through the fourth quarter of 2025.

Mohamed Hashad: Earlier this year in our letter to the shareholders, we laid out our vision for Longeveron and the strategy we would implement in pursuit of this vision. On our last quarterly call, I detailed the four reasons that drive my confidence in our ability to execute well and make an impact. One, our foundation in a strong sign. The experience and expertise of the Longeveron team and the team dedication and commitment to advance this research and fourth, and the most important, is a concerted focus on patients impacted by the diseases for which we are attempting to develop treatment.

Nataliya Agafonova: With that, I will turn the call to Dr. Agafonova to provide updates on our clinical development program, Raghuram Selvaraju. Thank you, Vagiyal, and good afternoon, everyone. As Vagiyal mentioned, our HLH program is a primary focus for us. As we believe it is the program with the highest probability of success, and nearly 10% possible to potential approval. HLHH, or hyperplastic-less heart syndrome, is a rare pediatric congenital heart-dark defect in which the last ventricle of the heart is either severely underdeveloped or missing. The heart treatment requires infants to undergo complex three-stage heart reconstruction surgery process over the first five years of their lives.

Speaker Change: With that I will.

Speaker Change: I'll turn the call as the Doctor I guess at Nova.

Speaker Change: Based on our clinical development program.

Speaker Change: Tayo.

Nataliya Agafonova: Thank you, Vael, and good afternoon, everyone. As Vael mentioned, our HLHF program is a primary focus for us, as we believe it is the program with the highest probability of success and nearly 10 pathways to potential approval. HLHF, or hypoplastic left heart syndrome, is a rare pediatric congenital heart birth defect in which the left ventricle of the heart is either severely underdeveloped or missing.

Tayo: Thank you Bob and good afternoon, everyone.

Speaker Change: Well you mentioned, our HLA Chip program is a primary focus for us as we believe it is the program with the highest probability of success and nearly 10, possibly to potential approval.

Speaker Change: HMH has a hyperplastic left heart syndrome is a rare pediatric congenital heart defect in each of the last week in Chicago. The harvest is a severely under developed.

Nataliya Agafonova: The current treatment requires infants to undergo a complex three-stage heart reconstruction surgery process over the first five years of their life. Even with this comprehensive treatment, only 60% to 60% of infants survive to other lessons due to, There is a clear and important unmet medical need to improve right ventricular function in this infant to positively impact both short and long-term patient outcomes. Our LPS1 Phase 1 study of Lomicell B in infants with HLHS demonstrated that infants in the trial experienced 100% transplant-free survival up to 5 years of age after receiving Lomicell B during stage 2 surgery, compared to approximately 20% mortality rate observed from historical control data.

Speaker Change: They call them Kietzman requires in France to undergoing complex can you stay charts reconstruction soldier a process over the first five years of their lives.

Mohamed Hashad: Now, I'm very pleased to update you on our progress and accomplishments since the end of the first quarter, which I can sum up as continued strong execution across all aspects of the organization. As I remind them, for those of you who are new to our story, Longeveron is a regenerative medicine company, developing cutting-edge cellular therapy. Our lease development compound, Longevity, represents a pipeline and a product opportunity that is being evaluated across the three important treatment areas, addressing numerous medical needs with US market potential opportunities of approximately 10 to 18 billion US dollars.

Nataliya Agafonova: Even with this comprehensive treatment, only 60% to 60% of infants survive to other lessons due to right ventricular failure. There is clear and important unmet medical needs to improve right ventricular function in this infant to positively impact both short and long-term patient outcomes. Our L.P.1-3, one study of L.P.1-3 in infants, is HLHS, demonstrated that infants in the trial experience 100% from explanatory survival up to five years of age after receiving L.P.1-3 during their stage two surgery, compared to approximately 20% mortality rate observed from historical control data. The L.P.1 data were highly encouraging and served as a basis for L.P.2.

Speaker Change: Even in this comprehensive treatment only 50% to 60% of infants survived adolescence due to BMS equal a premium.

Speaker Change: There is clear and important unmet medical need to improve our I think equal a function in these infants to positively impact both short and long term patient outcomes.

Speaker Change: Our L Y N C. One bad deal flow mix there'll be in infants is equally true demonstrated that in funds in the trial experienced hundreds per cent transplant free survival. After five years of age after receiving only so be during this stage to surgery compared to approximately.

Mohamed Hashad: Lomeco B is a proprietary, scalable, allergenic cellular therapy that has delivered positive initial results across five clinical trials in three indications. Phase one and two trials in op-ironic disease, phase one and two trials in aging-related frailty, and phase one in hypoplastics left part syndrome also known as HLHS. HLHS is a key strategic priority for us this year. The positive result of our phase one study, phase one, where the basis for our own ongoing phase two study of this two, which is the evaluating long-to-be as a potential adjunct treatment for HLHS. The trial continues to make progress involving patients with the enrollment completion targeted for the end of 2024.

Speaker Change: 2% mortality rate observed from historical control data.

Nataliya Agafonova: The LPS-1 data were highly encouraging and served as a basis for LPS-2, our ongoing Phase 2B clinical trial designed to assess the potential of women's LB to improve right ventricular function and long-term outcomes. LPIST-2 is being conducted in collaboration with National Heart, Lung, and Blood Institute through the grants from the National Institute of Health. As Vahiel mentioned, in June, we hosted an investigator meeting for LPS-2 clinical trials, bringing together principal investigators and side staff from premier infant and children's treatment institutions across the country.

Speaker Change: The Elk. This one data were highly encouraging and serve as the basis for LTE stool, Oh boy phase two b clinical trial design.

Nataliya Agafonova: Our ongoing phase-to-be clinical trial designed to assess the potential of women's L.P.2 to improve right ventricular function and long-term outcomes. L.P.2 is being conducted in collaboration with the National Heart, Lung, and Blood Institute through the grants from the National Institutes of Health. As we all mentioned in June, we hosted an investigator meeting for L.P.2 clinical trial, bringing together principal investigators and sites starting from premier, infant and children treatment institutions across the country. Participating organizations included Children Hospital of Los Angeles, Children Health Care of Atlanta, and enrolled more Children Hospital of Chicago, Boston Children Hospital, Children's Nebraska, John and Catching Magover Medical School of University of Texas Health, Primary Children Hospital at University of Utah.

Speaker Change: The potential of one is don't be too improve right for them to call a function and long term outcomes.

Speaker Change: This tool is being conducted in collaboration with National Heart lung and blocked Institute told the grants from the National Institute of Health.

Speaker Change: As I have mentioned in June.

Speaker Change: The cost cuts and investigate our meeting for Lp's, two clinical trials linking together principal investigators and site staff homes premier infant and children's cheeseman institutions across the country.

Nataliya Agafonova: Participating organizations included Children's Hospital of Los Angeles, Children's Health Care of Atlanta, Ann and Robert Lurie Children's Hospital of Chicago, Boston Children's Hospital, Children's Nebraska, John and Catherine McGovern Medical School of University of Texas Health, Primary Children's Hospital at University of Utah.

Speaker Change: Participating urbanization include that children constantly to look for some jealous.

Sheowns: She owns in health care of Atlanta.

Mohamed Hashad: In June, we hosted successful outfits two in the theater meeting. Dr. Agafonova will provide more details on their meeting shortly, but I will share that the participation in the level of excitement and enthusiasm was incredible. We believe the HLHS program has high probability of success and the shortest path to potential regulatory approval across our pipeline. This belief is enhanced with Opage One data serving at the basis for the U.S. FDA awarding the HLHS program with three distinct and important designations, orphan drug disease designations, fast-track designations, and rare pediatric disease designations.

Sheowns: And Robert more children hospitals, Chicago, Boston Children's Hospital children's Nebraska Com.

Sheowns: And catching Montgomery Medical school of University of Texas Health primary children's Hospital at University of Utah.

Nataliya Agafonova: Three additional nationally recognized pediatric or pediatric institutions participated in the investigator meeting as a part of their preparation for participation as investigators in L.P.2. Since then, Children Hospital of Colorado has officially became an active clinical trial site. We could not be more pleased with participation group and their enthusiasm for LPG2 and thank them for all their work they do for their patients and patient families. With this support, we have now reached 70% enrollment in the trial and are targeting completion enrollment of the trial by the end of this year. We believe that pediatric or pediatric community recognizes that there is an important and mathematical need to improve writing to call a function in this infant to positively impact both short and long-term patient outcomes.

Nataliya Agafonova: Three additional nationally recognized pediatric cardiothoracic institutions participated in the investigator meeting as a part of their preparation for participating as investigators in LPS2. Since then, Children's Hospital of Colorado has officially become an active clinical trial site. We could not be more pleased with the participating groups and their enthusiasm for LPS2 and thank them for all their work they do for their patients and their patients' families. With their support, we have now reached 70% enrollment in the trial and are targeting completing enrollment of the trial by the end of this year.

Sheowns: See I used to know nationally recognized pediatric cardio thoracic institution, but dissipated in the investigator meeting as a part of their preparation for participation in this the Gators in Lp's tool. Since then children's hospital of Colorado has officially became.

Sheowns: Active clinical trial sites.

Speaker Change: We could not be more pleased to participate in group and their enthusiasm for L. P store and thank them for all their work they do for their patients and patient families.

Speaker Change: This supports we have now reached 70% enrollment in the trial and are targeting completion of enrollment of the trial by the end of this year.

Mohamed Hashad: While we are very focused on HLHS, we also continue to advance our op-ironic disease program. As you hopefully have seen in three important recent events, based on the phase one and the clear mind phase two A clinical data, the FDA has granted long-to-be both regenerative medicine, advanced therapy, R-NAT, designation, and fast-track designation for the treatment of mild Alzheimer's disease. Lomato B appears to be the first cellular therapy candidate to receive our NAT designation for Alzheimer's disease. We are honored to have received these designations and look forward to continue to work with the FDA on the next steps.

Nataliya Agafonova: We believe that the pediatric cardiothoracic community recognizes, that there is an important unmet medical need to improve right ventricular function in this infant to positively impact both short and long-term patient outcomes. For the advance of this program, we anticipate feedback from a type C meeting with the FDA before end of year on development strategy for HLHS and expectations for the potential biologic license application. BOE Apollo.

Speaker Change: Because he believes that pediatric Congress the artist community recognizes that there is an important unmet medical need to improve pricing to call a function in the implants to positively impact both short and long term patient outcome.

Nataliya Agafonova: Some of the advanced events of this program we anticipate feedback from a Type C meeting with the FDA before and year on development strategy for HLHS and expectations for the potential Biologics License Application, BLA approval.

Speaker Change: Turning to advance this program.

Anticipate he's back home a type C meeting with the M D before and the year on development charter for a chilly checks and expectations for the potential biologics license application BLA alcohol.

Nataliya Agafonova: Lastly, for HLHS, we anticipate LPG1 five-year post-treatment completion data in the third quarter of this year and look forward to sharing that important information.

Nataliya Agafonova: Lastly, for HLHS, we anticipate LPS1 five-year post-treatment completion data in the third quarter of this year and look forward to sharing that important information. Turning now to Alzheimer's Disease Call. We have multiple exciting things to discuss. Data from ClearMinds leads to a clinical trial. We've been selected for a future pre-search oral presentation at the 2024 Alzheimer's Association International Conference held at the end of July. We are very excited about the positive results.

Speaker Change: Lastly for HMH, Yes, we anticipate Elk. This one five year fourth treatment completion date in the third quarter of this year and look forward to sharing that important information.

Mohamed Hashad: Four results from that clear mind phase two A clinical trials were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference, AAIC, that was just held in Philadelphia. Dr. Agaphanil will review the results, but I think it is important starting highlight is that the clinical trial In the clinical trial of Longeveron Selvaraju treated an important treatitation showed an overall slowing or prevention of disease worsening compared to placebo. We understand Alzheimer's disease has historically been a very difficult area for development. So we are only more encouraged to as a result we have seen today with Longever Selvaraju.

Nataliya Agafonova: Storming now to Alzheimer's Disease program. We have multiple exciting things to discuss. Data form from the clear mind leads to a clinical trial where it's selected for a future pre-judge oral presentation at the 2034 Alzheimer's Association International Conference held at the end of July. We are very excited about the positive results. In the clinical trial, Loni-Celby treated patients showing overall clothing prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy end point and showed statistically significant improvements in pre-specified clinical and biomarker end point. In specific, Loni-Celby goal compared to placebo.

Speaker Change: During the downturn Dennis can you just call me.

Speaker Change: We have multiple exciting things to discuss.

Speaker Change: Data from our from the clear mind since two eight clinical trials, we're still at this point, our future pretty huge oral presentation at the range of three to four assignment Association International Conference held at the end of July.

Speaker Change: We are very excited about the positive results.

Nataliya Agafonova: In the clinical trial, LOMI cell B detected patients showing overall slowing prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoint, and showed statistically significant improvements in pre-specified clinical and biomarker endpoints, in specific Lomicell B group compared to placebo. The Established Safety Profile of Lomicelle B for Single and Multiple Dose Regimen, was demonstrated in study data that showed no incidence of hypersensitivity in fusion-related reactions and no cases of amyloid-related imaging abnormality. Arya.

Speaker Change: In the clinical trial known as Toby Keith the patients showing overall slowing prevention of disease worsening compared to placebo.

Speaker Change: The trial achieved the primary safety and secondary efficacy endpoints.

Speaker Change: And so that he can be significant improvements increase basically five clinical and biomarker endpoints into ctrip luminous there'll be equal compared to placebo.

Mohamed Hashad: With this data in hand, we anticipate meeting with the FDA before year end to review future clinical and regulatory strategy for continuing this important program.

Nataliya Agafonova: The established safety profile of Loni-Celby for CMGO and multiple dose in regimen was demonstrated in study data that showed no incidence of hypersensitivity in fusion related reactions and no cases of annually related imaging abnormalities. Earlier, administration of Loni-Celby was associated with slowing cognitive and functional decline and demonstrated by statistically significant results in the Montreal Cognitive Assessment and statistical training and improvement compared to placebo and CDR at B and MMSE. There was a statistically significant improvement relative to placebo observed in Alzheimer's disease, Cooperative Study Activities of Daily Living. Brain MRI results demonstrated a 49% reduction in brain, body, and loss and improvement in cerebral blood flow.

Speaker Change: The established safety profile, Oklahoma's there'll be for single and multiple dose regimen.

Speaker Change: But what is demonstrated in study to date that that show no incidents of hypersensitivity to infusion related reactions and no cases of I remember regionally related imaging abnormality.

Mohamed Hashad: As I mentioned on our last call, we are expanding our contract manufacturing operation as part of the overall resource optimization strategy. We have assembled a team of experts and proprietary technologies that enable us to take a systematic approach to rapidly develop improved cell therapy. Our state of the art, GME facility in Miami, at Life Science and Technology Park consists of 3000 square feet of clean room space containing eight ISO study and clean room and entry areas as well as 1,100 60 square feet of process development quality control and warehousing space.

Speaker Change: Yeah.

Lisa Locklear: Administration of oneself was associated with slow and cognitive and functional decline and demonstrated by statistically significant results in the Montreal cognitive assessment and statistical training and improvement compared to placebo and CDR at B and MMS. There was a statistically significant improvement relative to placebo observed in Alzheimer's disease cooperative study activities of daily living. Brain MRI results demonstrated a 49% reduction in brain volume loss, and Improvement in Cerebral Block Tumor. Based on the data generated on our Phase 1 and Phase 2 Alzheimer's clinical trials in July, the FDA has granted Longe-Cell-B both Regenerative Medicine Advanced Therapy, RMAT designation, and FAST-TRAX designation for the treatment of mild Alzheimer's disease.

Speaker Change: Administration of <unk> associated with slowly in cognitive and functional decline as demonstrated by statistically significant results in the Montreal cognitive assessment and statistical train him improvement compared to placebo and C. D. R B and M. M S.

Speaker Change: Yeah.

Speaker Change: There was a statistically significant improvement relative to placebo observed Xander disease courtyard, just diving activities from D. D D.

Speaker Change: Brain MRI results demonstrated a 49% reduction in brain volume loss and improvement in Caribbean block Sone.

Mohamed Hashad: While this facility gives us capacity to manufacture one of the four clinical trial use and potentially if approved for commercial scale, we are not currently using the facility's whole capacity. This presents an additional opportunity for us as the company's manufacturing expertise and capabilities and the facility are in demand from other pharmaceutical organizations. We are performing work under the first contract and we have already generated over $200,000 in revenue. We believe the contract manufacturing business has the potential to expand our team experience and generate approximately 4 to 5 million in annual revenue once it's up and running fully. Helping offset our clinical development costs and reducing but not eliminating our additional capital needs.

Nataliya Agafonova: Based on the data generated to now, phase 1 and phase 2 Alzheimer clinical trials, in July, the FDA has granted Loni-Celby both for generative medicine, advanced therapy, R-MAT designation, and 5th truck designation for the treatment of mild Alzheimer's disease. D. This plan to meet with the FDA before year end, to review future clinical and regulatory strategy for Alzheimer's program. We are currently seeking partnership and non-religious functioning to find them to support further development of Lone Cell B in Alzheimer's disease. We believe that results from clear minds support the therapeutic potential of Lone Cell B in the treatment of mild Alzheimer's disease and provide evidence-based support for further clinical development.

Speaker Change: Based on the data generated till now phase one and phase two a designer clinical trials in July. The FDA has granted money can be bought regenerative medicine advanced therapy, Armani, Dziedzic nation, and fast track designation for the treatment of mild.

Speaker Change: On assignment.

Lisa Locklear: We plan to meet with the FDA before year-end to review future clinical and regulatory strategies for the Alzheimer's program. We are currently seeking partnership and non-dilutive funding to support further development of Lomis-LB in Alzheimer's. We believe that results from CLEARmind support the therapeutic potential of Lonicel B in the treatment of mild Alzheimer's disease and provide evidence-based support for further clinical development. I will hand the call over to Lisa Locklear, our Chief Financial Officer, to discuss our financial results for the second quarter. Lisa?

Speaker Change: We plan to meet to get the empty before year end.

To review future clinical and regulatory strategy for a designer program.

Speaker Change: We are currently seeking partnerships and non diluted function into some funding to support further.

Speaker Change: Further development of money so be in Alzheimers disease.

Speaker Change: We believe that results from clear mind support the therapeutic potential of money still be in the achievement of milestones down there.

Speaker Change: And provided evidence based support for further clinical development.

Lisa Locklear: I will hand the call over to Lisa Locklear.

Lisa Lafleur: I will hand, the call over Lisa Lafleur, our Chief financial Officer to discuss our financial results for the second quarter Lisa.

Mohamed Hashad: Lastly, we remain tightly focused on optimizing our resources and being good stewards of shareholders capital which focus on expense control and program prioritization. Our total operating expenses through the first half of the year are down 22% year over year. Following a successful transfer raises and warrant exercises in the second quarter and in July, we are experiencing cash and cash equivalent are expected to be sufficient to fund the through the fourth quarter of 2025.

Lisa Locklear: I will keep financial officer to discuss our financial results for the second quarter. Lisa? Thank you, Nataliya, and good afternoon, everyone. This afternoon, we issued a press release and filed our quarterly report on Form 10-Q, both of which present our financial results in detail. I will touch on some highlights, including our expense management, contract manufacturing business, and successful capital raising. Revenues for the first half of 2024 were $1 million, up $0.5 million or 105% when compared to the first half of 2023. Mainly as a result of increased participant demand for our frailty and cognitive impairment registry trial in the Bahamas and new contract manufacturing revenue.

Lisa Locklear: Thank you, Nataliya, and good afternoon, everyone. This afternoon, we issued a press release and filed our quarterly report on Form 10-Q, both of which present our financial results in detail. So I will touch on some highlights, including our expense management, contract manufacturing business, and successful capital raising. Revenues for the first half of 2024 were $1 million, up $0.5 million or 105% when compared to the first half of 2023, mainly as a result of increased participant demand for our frailty and cognitive impairment registry trial in the Bahamas and new contract manufacturing revenue.

Lisa Lafleur: Thank you Natalia and good afternoon, everyone.

Lisa Locklear: Contract manufacturing revenue for the six months ended June 30, 2024 was $0.2 million from our first manufacturing services contract with Secretome Therapeutics. As while indicated, we believe that there is opportunity to expand this area of business to make use of our team's significant expertise and our state-of-the-art GNP facility to potentially generate up to $4 to $5 million in revenue annually. Earlier this year, we discussed our plan for program prioritization and focused expense management, and we have successfully executed in both areas. First half total operating expenses declined 22% year over year.

Lisa Lafleur: 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, but I will touch on some highlights, including our expense management contract manufacturing business and successful capital raising.

Lisa Locklear: GNA expenses for the six-month period ending June 30, 2024, decreasing to approximately $4.3 million, compared to $5.5 million for the same period in 2023. R&D expenses for the six months ended June 30, 2024 also decreased approximately $1.2 million or 22% to approximately $3.9 million. The decrease was primarily due to a reduced expenses associated with the completed Clear Mind Alzheimer's Disease clinical trial and reduced costs for the aging-related frailty clinical trial following our decision to discontinue trial activities in Japan.

Speaker Change: Revenues for the first half of 2024 $1 million.

Speaker Change: <unk> $5 million or 105% when compared to the first half of 2023.

Nataliya Agafonova: With that, I will turn the call to Dr Agafonova to provide updates on our clinical development program, Raghuram Selvaraju. Thank you, Vagiyal and good afternoon, everyone. As Vagiyal mentioned, our HLH program is a primary focus for us. As we believe it is the program with the highest probability of success, and nearly 10% possible to potential approval.

Speaker Change: Mainly as a result of increased participant demand for our frailty and cognitive impairment registry trial in the Bahamas, and new contract manufacturing revenue.

Lisa Locklear: Contract manufacturing revenue for the six months ended June 30, 2024, was $0.2 million from our first manufacturing services contract with Secretome Therapeutics. As while indicated, we believe that there is opportunity to expand this area of business to make use of our team's significant expertise and our state-of-the-art GNP facility to potentially generate up to $4 to $5 million in revenue annually.

Speaker Change: Contract manufacturing revenue for the six months ended June 30th 'twenty 'twenty four.

Speaker Change: Zero point $2 million from our first manufacturing services contract with secret Tom Therapeutics.

Speaker Change: That's why I indicated we believe that there's opportunity to expand this area of business to make use of our team's significant expertise and our state of the art GMP facility to potentially generate up to $4 million to $5 million in revenue annually.

Nataliya Agafonova: HLHH, or hyperplastic-less heart syndrome, is a rare pediatric congenital heart-dark defect, in which the last ventricle of the heart is either severely underdeveloped or missing. The heart treatment requires infants to undergo complex three-stage heart reconstruction surgery process over the first five years of their lives. Even with this comprehensive treatment, only 60% to 60% of infants survive to other lessons due to right ventricular failure. There is clear and important unmet medical needs to improve right ventricular function in this infant to positively impact both short and long-term patient outcomes.

Lisa Locklear: Earlier this year, we discussed our plan for program prioritization and focused expense management, and we have successfully executed in both areas. First half total operating expenses declined 22% year-over-year, with GNA expenses for the six-month period ending June 30, 2024, decreasing to approximately $4.3 million compared to $5.5 million for the same period in 2023. R&D expenses for the six-months ended June 30, 2024 also decreased approximately 1.2 million or 22% to approximately $3.9 million. The due increase was primarily due to a reduced expenses associated with the completed clear-mind Alzheimer's disease clinical trial and reduced costs for the aging-related frailty clinical trial following our decision to discontinue trial activities in Japan.

Speaker Change: Earlier this year, we discussed our plan for program prioritization and focused expense management and we have successfully executed in both areas.

Speaker Change: First half total operating expenses declined 22% year over year.

Speaker Change: G&A expenses for the six month period, ending June 32024, decreasing to approximately $4 $3 million compared to $5 5 million for the same period in 2023.

Speaker Change: R&D expenses for the six months ended June 30th 2024 also decreased approximately $1 2 million or 22% to approximately $3 9 million.

Nataliya Agafonova: Our L.P.1-3, one study of L.P.1-3 in infants is HLHS, demonstrated that infants in the trial experience 100% from explanatory survival up to five years of age after receiving L.P.1-3 during their stage two surgery, compared to approximately 20% mortality rate observed from historical control data. The L.P.1 data were highly encouraging and served as a basis for L.P.2. Our ongoing phase-to-be clinical trial designed to assess the potential of women's L.P.2 to improve right ventricular function and long-term outcomes.

Speaker Change: The decrease was.

Speaker Change: Primarily due to a reduced expenses associated with the completed clear mind, Alzheimers disease clinical trials and reduce costs for the aging related frailty clinical trial following our decision to discontinue trial activities in Japan.

Lisa Locklear: Our net loss decreased to approximately $7.5 million for the six-month ended June 30, 2024, from a net loss of $10.3 million for the same period in 2023. Cash and cash equivalents as of June 30, 2024, were $12.4 million. Williams. Following capital raises and warrant exercises in April and June 2024, resulting in gross proceeds of 17.6 million. In July 2024, we completed a registered direct offering, which resulted in gross proceeds of $9 million. Additionally, certain warrant holders exercised their existing warrant in July, generating gross proceeds of another $6.3 million. We believe our existing cash and cash equivalents will fund our operating expenses and capital expenditure requirements through the fourth quarter of 2025 based on our current spending estimates.

Lisa Locklear: Our net loss decreased to approximately $7.5 million for the six months ended June 30, 2024, from a net loss of $10.3 million for the same period in 2023. Cash and cash equivalents as of June 30, 2024 were $12.4 million. Following capital raises and warrant exercises in April and June 2024, resulting in gross proceeds of $17.6 million. In July 2024, we completed a registered direct offering which resulted in gross proceeds of $9 million. Additionally, certain warrant holders exercised their existing warrants in July, generating gross proceeds of another $6.3 million.

Speaker Change: Our net loss decreased to approximately $7 5 million for the six months ended June 32024 from a net loss of $10 3 million for the same period in 2023.

Speaker Change: Cash and cash equivalents as of.

Speaker Change: At June 32024 were $12 $4 million.

Speaker Change: Following capital races, and more exercises in April and June 2024, resulting in gross proceeds of $17 6 million.

Nataliya Agafonova: L.P.2 is being conducted in collaboration with National Heart Lands and Blood Institute through the grants from the National Institute of Health. As we all mentioned in June, we hosted an investigator meeting for L.P.2 clinical trial, rinking together principal investigators and sites start from premier, infant and children treatment institutions across the country. Participating organizations included children hospital of Los Angeles, children health care of Atlanta, and enrolled more children hospital of Chicago, Boston Children Hospital, Children's Nebraska, John and Catching Magover Medical School of University of Texas Health, primary children hospital at University of Utah.

Speaker Change: In July 2024, we completed a registered direct offering which resulted in gross proceeds of $9 million. Additionally, certain warrant holders exercise their existing warrants in July generating gross proceeds of another $6 $3 million.

Joshua Hare: We believe our existing cash and cash equivalents will fund our operating expenses and capital expenditure requirements through the fourth quarter of 2025, based on our current spending S. I will now hand the call over to Dr. Joshua Hare, our co-founder, chief science officer, and chairman of the board.

Speaker Change: We believe our existing cash and cash equivalents will fund, our operating expenses and capital expenditure requirements through the fourth quarter of 2025 based on our current spending estimates.

Joshua Hare: I will now hand the call over to Dr. Joshua Hare, our co-founder, Chief Science Officer, and Chairman of the Board. Joshua? Thank you, Lisa, and good afternoon, everyone. As you've heard from the team, we are making great progress advancing cellular therapy research and our lead product candidate, Lomas LB.

Speaker Change: I will now hand, the call over to Dr. Joshua hair, our cofounder, Chief Science Officer, and chairman of the board.

Speaker Change: Gotcha.

Speaker Change: Yeah.

Joshua Hare: Thank you, Lisa, and good afternoon, everyone. As you've heard from the team, we are making great progress advancing cellular therapy research and our lead product candidate, Lomacell B. In recognition of Longeveron's continued growth and evolution, we are fortunate to have recently added three industry veterans to our Board of Directors. First, Dr. Raja Hajjar brings incredible experience as a scientist, academic, and operational executive. He's an internationally recognized scientist whose cardiac gene therapy discoveries have spurred clinical trials for heart failure, and whose methodologies for cardiac directed gene transfer are currently utilized by investigators around the world.

Speaker Change: Thank you Lisa and good afternoon, everyone. As you heard from the team we are making great progress advancing cellular therapy research and our lead product candidates Loomis L. B.

Nataliya Agafonova: Three additional nationally recognized pediatric or pediatric institutions participated in the investigator meeting as a part of their preparation for participation as investigators in L.P.2. Since then, children hospital of Colorado has officially became an active clinical trial site. We could not be more pleased with participation group and their enthusiasm for LPG2 and thanks them for all their work they do for their patients and patient families. With this support, we have now reached 70% enrollment in the trial and are targeting completion enrollment of the trial by the end of this year.

Joshua Hare: So he knows quite a lot about what we're doing here at Longeveron, He was recently head of RRD at Ring Therapeutics and was appointed as the inaugural director of the Gene and Cell Therapy Institute at Mass General Brigham. Our second new director is Rich Kinder, who is a retired Senior Vice President of Business Development and Corporate Licensing at Merck and Company Incorporated. He spent his entire professional career at Merck in various corporate roles of increasing responsibility and was involved in more than 100 business development and licensing transactions.

Joshua Hare: Recognizing Longeveron's continued growth and evolution, we are fortunate to have recently added three industry veterans to our Board of Directors. First, Dr. Raja Hajjar brings incredible experiences of scientists, academic, and operational executives. He's an internationally recognized scientist whose cardiac gene therapy discoveries have spurred clinical trials for heart failure and whose methodologies for cardiac-directed gene transfer are currently utilized by investigators around the world. So he knows quite a lot about what we're doing here at Longeveron. He was recently head of RID at Ring Therapeutics and was appointed as the inaugural director of the Gene and Cell Therapy Institute at Mass General Brigham.

Speaker Change: Recognizing longevity and its continued growth and evolution. We are fortunate to have recently added three industry veterans to our board of directors.

Speaker Change: First Doctor Roger Jar brings incredible experience as a scientist academic and operational executive.

He is an internationally recognized scientists, whose cardiac gene therapy discoveries have spurred clinical trials for heart failure, and whose methodologies for cardiac directed gene transfer are currently utilized by investigators around the world.

So he knows quite a lot about what we're doing here at longevity on.

Speaker Change: He was recently head of R&D at ring Therapeutics and was appointed as the inaugural director of the gene and cell therapy Institute at mass General Brigham.

Nataliya Agafonova: We believe that pediatric or pediatric community recognizes that there is an important and mathematical need to improve writing to call a function in this infant to positively impact both short and long-term patient outcomes. Some of the advanced events of this program we anticipate feedback from a type C meeting with the FDA before and year on development strategy for HLHS and expectations for the potential biologist license application, BLA approval.

Joshua Hare: Our second new director is Rich Kinder, who is a retired senior vice president of business development and corporate licensing at Merck & Company Incorporated. He spent his entire professional career at Merck in various corporate roles of increasing responsibility and was involved in more than a hundred business development and licensing transactions.

Speaker Change: Our second new directors Rich Kinder, who is a retired senior vice president of business development and corporate licensing at Merck and cut and company incorporated.

Rich Kinder: He spent his entire professional career at Merck in various corporate roles of increasing responsibility and was involved more than 100 business development and licensing transactions.

Joshua Hare: Finally, Neha Matwani has over 25 years of healthcare investment banking experience. Most recently having served as Managing Director of healthcare investment banking at William Blair. She previously held investment banking roles of increasing responsibility with Truest Securities, Off-and-Himer and Company, Steeple Financial and Cowon and Company. We're collectively should completed transactions raising over $6.8 billion US dollars. I believe all three of these individuals will add tremendous value to the board and to Longeveron, and look forward to collaborating with them.

Joshua Hare: Finally, Neha Martwani has over 25 years of healthcare investment banking experience, most recently having served as Managing Director of Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer & Co., Stiefel Financial, and Cowan & Company, where collectively she completed transactions raising over $6.8 billion.

Speaker Change: Leanne ne Huh Motwani has over 25 years of health care investment banking experience. Most recently, having served as managing director health care investment banking at William Blair sheep.

Nataliya Agafonova: Lastly, for HLHS, we anticipate LPG1 five-year post-cheatment completion data in the third quarter of this year and look forward to sharing that important information.

Speaker Change: She previously held investment banking roles of increasing responsibility with truest Securities Oppenheimer and company.

Speaker Change: Stifel financial and Cowen and company, where collectively should completed transactions raising over 6.8 billion U S dollars.

Nataliya Agafonova: Storming now to Alzheimer's disease program. We have multiple exciting things to discuss. Data form from the clear mind leads to a clinical trial where it's selected for a future pre-judge oral presentation at the 2034 Alzheimer's Association International Conference held at the end of July.

Wael Hashad: I believe all three of these individuals will add tremendous value to the board and to Longeveron and look forward to collaborating with them. Thank you, and I will turn the call back over to Wael at this time. Thank you, Dr. Hare. The data generated today, the natural chest, And Alzheimer's disease supports a broad potential for wellness of the as a regenerative medicine medicinal therapy across multiple indicators.

Speaker Change: I believe all three of these individuals will add tremendous value to the board and so longevity are on and look forward to collaborating with them.

Joshua Hare: Thank you, and I will turn the call back over to you while at this time.

Speaker Change: Thank you.

Speaker Change: And I will turn the call back over to while at this time.

Nataliya Agafonova: We are very excited about the positive results. In the clinical trial, Loni-Celby treated patients showing overall clothing prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy end point and showed statistically significant improvements in pre-specified clinical and biomarker end point. In specific, Loni-Celby goal compared to placebo. The established safety profile of Loni-Celby for CMGO and multiple dose in regimen was demonstrated in study data that showed no incidence of hypersensitivity in fusion related reactions and no cases of annually related imaging abnormalities.

Speaker Change: Okay.

Mohamed Hashad: Thank you, Dr. Haer. The data is generated today's financial chest and Alzheimer's disease support the broad potential for wellness of the as a regenerative, medicinal therapy across multiple indicators. The trends of the data, our experience and committed scenes, and unwavering focus on patients, give me confidence in the future of Longeveron. What really drives everyone here at Longeveron day in and day out is the patience and the opportunities to have a positive impact for them. They are why we are working every day to hopefully develop a bit of solution for these unmet needs.

Speaker Change: Thank you Doctor hair.

Chad: The data generated to date naturally Chad.

Speaker Change: All timer Dizzy support the broad potential football myself as a regenerative.

Speaker Change: Medicinal therapy across multiple indications.

Speaker Change: The strength of the data.

Wael Hashad: The Trends of the Data, our experienced and committed team, and unwavering focus on patients, gave me confidence in the future of Long LLB and Longeveron. What really drives everyone here at Longeveron day in and day out, is the patient, and the opportunity to have a positive impact for them. They are why we are working every day to hopefully develop a bit of solutions for these on next.

Speaker Change: Our experienced and committed team and unwavering focus on patients.

London: Give me confidence in the future of London there'll be on long deferral.

Speaker Change: What really drives everyone here that the launch of her on day in and day out.

Speaker Change: The patients.

Speaker Change: The opportunity to have a positive impact for them.

Speaker Change: They are why we are working every day to hopefully develop therapeutic solution for this unmet need.

Nataliya Agafonova: Earlier, administration of Loni-Celby was associated with slowing cognitive and functional decline and demonstrated by statistically significant results in the Montreal cognitive assessment and statistical training and improvement compared to placebo and CDR at B and MMSC. There was a statistically significant improvement relative to placebo observed in Alzheimer's disease, cooperative study activities of daily living. Brain MRI results demonstrated a 49% reduction in brain, body, and loss and improvement in cerebral blood flow. Based on the data generated to now phase 1 and phase 2 Alzheimer clinical trials, in July, the FDA has granted Loni-Celby both for generative medicine, advanced therapy, R-MAT, designation, and 5th truck designation for the treatment of mild Alzheimer's disease.

Speaker Change: Okay.

Unknown Executive: Operator, [inaudible] We would now like to open the call for questions from our covering analyst. Thank you.

Speaker Change: Operator.

Unknown Executive: Operator, we would now like to open the call for questions from our covering analyst. Thank you. When I'll be conducting a question and answer session, if you would 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 would 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.

Speaker Change: Wed now like to open the call for questions from our covering analysts.

Speaker Change: Thank you.

Unknown Executive: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Speaker Change: Thank you.

Speaker Change: Ill be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad.

Raghuram Selvaraju: You may press star 2 if you would 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 key. One moment, please, while we poll for questions. Our first question comes from Raghuram Selvaraju, H.C. Wainwright. Please proceed with your question. Hello, thank you very much for taking my questions and congratulations on all this important progress. Firstly, with respect to Lomis-LB in the LPIS-2 study, can you give us some more granularity around how close you are to completion of enrollment, how long you expect the enrollment of the remaining patients to take, and assuming completion of enrollment in accordance with your previously reported guidance, when could we see top-line data from this trial? Is it potentially disclosable before the end of 2025? Sure. Hi, this is Wael Hashad.

Speaker Change: Confirmation tone will indicate your line is in the question queue.

Speaker Change: Press Star two if he would like to remove your question from the queue.

Speaker Change: It just depends using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Unknown Executive: One moment, please. Will we pull for questions?

Speaker Change: One moment, please while we poll for questions.

Raghuram Selvaraju: Our first question comes from Raj Selvaraju, A.C. Wainwright. Please proceed with your question.

Speaker Change: Our first question comes from Raj Silvershoe H C. Wainwright. Please proceed with your question.

Mohamed Hashad: Hello, thank you very much for taking my questions, and congratulations on all this important progress. Firstly, with respect to Lomas L.B. In the Elkis II study, can you give us some more granularity around how close you are to completion of enrollment? How long do you expect the enrollment of the remaining patients to take, and assuming completion of enrollment in accordance with your previously reported guidance? When could we see top-line data from this trial? Is it potentially disposable before the end of 2025? Thank you. Sure. Hi, this is Wailha Shad. First, I want to remind you on everyone.

Raj Silvershoe: Hello, Thanks, very much for taking my questions and congratulations on all of this important progress.

Speaker Change: Firstly with respect to lamar's they'll be in the Opus. Two study can you give us some more granularity around how close you are to completion of enrollment how long you expect the enrollment of the remaining patients to take and assuming completion of enrollment in our <unk>.

Nataliya Agafonova: D. This plan to meet with the FDA before year end, to review future clinical and regulatory strategy for Alzheimer's program. We are currently seeking partnership and non-religious functioning to find them to support further development of Lone Cell B in Alzheimer's disease. We believe that results from clear minds support the therapeutic potential of Lone Cell B in the treatment of mild Alzheimer's disease and provided evidence-based support for further clinical development.

Speaker Change: With your previously reported guidance when could we see top line data from this trial is it potentially disclose about before the end of 2025. Thank you.

Speaker Change: Sure.

Waller: Hi, this is while a shot.

Wael Hashad: So, first, I want to remind you and everyone, our projection is the best of our ability. Of course, as you know, with rare diseases, there is no easy way to predict exact timing to close. So, we're still targeting the end of this year. We're hoping that the addition of the new sites will accelerate the enrollment. But definitely, things can also vary a little bit.

Speaker Change: So first I wanted to remind you and everyone.

Nataliya Agafonova: Our projection is the best of our ability. Of course, as you know, with rare diseases, there is no easy way to predict exact timing to close. We're still targeting the end of this year. We're hoping that the addition of the new sites will accelerate the enrollment, but definitely, things can also vary a little bit. But we are not that far, as you hear from Nataya that we are starting to present enrollment. Nataya can give you more specificity around the exact number of patients being recruited. And then the second thing is I just want to remind you that our follow-on to the closure of the trial is one year from the last patient in, and that has not changed.

Speaker Change: Our projection is the basketball or ability of course as you know it was rare diseases. There is no easy way to predict the exact timing for close we're still targeting the end of this year. We're hoping that the addition of the new sites will accelerate the enrollment.

Lisa Locklear: I will hand the call over Lisa Locklear. I will keep financial officer to discuss our financial results for the second quarter. Lisa?

Lisa Locklear: 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. I will touch on some highlights, including our expense management, contract manufacturing business, and successful capital raising. Revenues for the first half of 2024 were $1 million, up $0.5 million or 105% when compared to the first half of 2023. Mainly as a result of increased participant demand for our frailty and cognitive impairment registry trial in the Bahamas and new contract manufacturing revenue.

Speaker Change: But definitely things can also vary a little bit, but we are not that far out as you heard from Natalia.

Wael Hashad: But we are not that far, as you heard from Nataliya, that we are 70% enrolled, and Nataliya can give you more specificity around the exact number of patients being recruited. And then the second thing is, I just want to remind you that our follow-on to the closure of the trial is one year from the last patient, and that has not changed. And with that, I will give it to Nataliya to give you more specificity on your question. Thank you very much, Vael. As Vael mentioned, and thank you, Raj, for your question. As Vael mentioned, currently, we have enrolled 27 out of 38 patients.

Natalia: That we are at 70% and Golden Chicken out that's how you can give you more specificity around what the exact number of patients being recruited.

Natalia: And then the second thing is I just wanted to remind you that our.

Natalia: Follow on to the closer of the closure of the trial is one year from the last patient in and that has not changed and with that I will give it to Nick I hate to give you more specificity around your question.

Nataliya Agafonova: And with that, I will give it to Nataya to give you more specificity around your question. Thank you very much, Wailha. As Wailha mentioned, and thank you, Raj, for your question. As Wailha mentioned, currently, we enroll 37 out of 38 patients. So we have 11 patients remaining to enroll. We are absolutely hopeful that the new sites, we just currently... in role to the clinical trial, will help us to expedite enrollment. So, at 12th, the primary end point design that way that we evaluate the effect of their function 12 months after the last patient enrolled. So, approximately, they are looking for filing in probably first quarter of 2026 as a best scenario.

Nataliya Agafonova: So we have 11 patients remaining to enroll. We are absolutely hopeful that the new site, which we just currently, So, the primary endpoint design, that way that we evaluate the effect cardiac function 12 months after the last patient enrolled. So approximately, we are looking for filing in probably first quarter of 2026 as the best scenario.

Nick: Thank you very much rail.

Nick: It's why young man shouldn't thank you Raj for your question as Mario mentioned currently.

Lisa Locklear: Contract manufacturing revenue for the six months ended June 30, 2024 was $0.2 million from our first manufacturing services contract with secretome therapeutics. As while indicated, we believe that there is opportunity to expand this area of business to make use of our team's significant expertise and our state-of-the-art GNP facility to potentially generate up to $4 to $5 million in revenue annually.

Nick: We enrolled 27 out of 38 patients because we have 11 patients remaining to enroll yeah, absolutely I'm hopeful that.

Speaker Change: New sites be cheap, we just no currently.

Speaker Change: <unk> enrolled to the clinical trial will help us to expedite enrollment.

Speaker Change: So well.

Speaker Change: The primary endpoint designed that way that we evaluate in France, partly a function of 12 months. After the last patient enrolled so approximately they are looking for filing our IND, probably first quarter of 'twenty think speaks as if that's the scenario.

Lisa Locklear: Earlier this year, we discussed our plan for program prioritization and focused expense management, and we have successfully executed in both areas. First half total operating expenses declined 22% year-over-year, with GNA expenses for the six-month period ending June 30, 2024, decreasing to approximately $4.3 million compared to $5.5 million for the same period in 2023. R&D expenses for the six-month-sended June 30, 2024 also decreased approximately 1.2 million or 22% to approximately $3.9 million.

Nataliya Agafonova: And with respect to the LPS1 study, can you just remind us about what additional data you expect to generate from long-term follow-up of the patients who are enrolled and followed as part of that study? And what do you expect to be the key amount of follow-up necessary to secure regulatory approval of LMSLB in HLHS? I would understand and imagine that it would be the 12-month follow-up end point, but you certainly would be able to obtain longer-term follow-up data from the LPS1 patient. So, just wanted to get some additional color there. Thank you. Thank you so much.

Nataliya Agafonova: And with respect to the ELPIS-1 study, can you just remind us about what additional data you expect to generate from long-term follow-up of the patients who are enrolled and followed as part of that study? And what do you expect to be the key amount of follow-up necessary to secure regulatory approval for Lomis-LB in HLHS? I would understand and imagine that it would be the 12-month follow-up endpoint, but you certainly would be able to obtain longer-term follow-up data from the ELPIS-1 patients, so just wanted to get some additional color there.

Speaker Change: And with respect to the Opus one study.

Speaker Change: Can you just remind us about what additional data you expect to generate from a long term follow up of the patients who are enrolled and followed as part of that study and what do you expect to be the key amount of follow up necessary to secure regulatory approval for myself.

Lisa Locklear: The due increase was primarily due to a reduced expenses associated with the completed clear-mind Alzheimer's disease clinical trial and reduced costs for the aging-related frailty clinical trial following our decision to discontinue trial activities in Japan. Our net loss decreased to approximately $7.5 million for the six-month ended June 30, 2024 from a net loss of $10.3 million for the same period in 2023. Cash and cash equivalents as of June 30, 2024 were $12.4 million.

Speaker Change: <unk> and HLA, so I I would understand and imagine that it would be the 12 month follow up end point, but you certainly would be able to obtain longer term follow up data from the alpha one patients. So just wanted to get some additional color there. Thank you.

Nataliya Agafonova: Thank you so much. It's a very great question. You're absolutely right. We are collecting loan-term data and from our temptations in L.K. Swat.

Speaker Change: Thank you so much it's a very great question.

Nataliya Agafonova: It's a very great question. You're absolutely right. We are collecting long-term data from our 10 patients on LPS1. In August, end of August this year, we will have school five year follow-up after the patient completed Glenn procedure, stage two procedure. So, the type of data we are looking for is transplants, it's survival and transplants, three survival data. That can definitely be included in our VLA submission to support not only safety, but also actually the most important end point, such as long-term transplants, three survival and can support the rest of the data for the rest of the patients.

Speaker Change: You're absolutely right E. R collection launched Vito and some temptations and L. P Swan.

Nataliya Agafonova: In August, the end of August this year, we will have school five-year follow-up after the patient has completed the Glenn procedure, stage two procedure. So the type of data we are looking for is transplanted survival and transplant-free survival data that can definitely be included in our BLA submission to support not only safety but actually the most important endpoints such as long-term transplant-free survival and can support the rest of the data for the rest of the patients.

Speaker Change: In August end of August this year diesel have school five year fall off after the patient completed Glenn procedure speech to procedure. So the type of data. We are looking for is a transplant its survival and transplant free survival data that.

Lisa Locklear: Williams. Following capital raises and warrant exercises in April and June 2024, resulting in gross proceeds of 17.6 million. In July 2024, we completed a registered direct offering which resulted in gross proceeds of $9 million. Additionally, certain warrant holders exercised their existing warrant in July, generating gross proceeds of another $6.3 million. We believe our existing cash and cash equivalent will fund our operating expenses and capital expenditure requirements through the fourth quarter of 2025 based on our current spending estimates.

Speaker Change: Definitely be included in our BLA submission to support not only safety, but also actually the most important.

Speaker Change: Endpoints, such as long term, a transplant free survival and can't support the rest of the data for for the rest of the patients and these present four year survival last year is now American Heart Association.

Nataliya Agafonova: We did present four year survival last year in the American Heart Association, and hopefully once we have more data this year, you might see this information on future scientific presentation.

Nataliya Agafonova: And we did present four-year survival last year in the American Heart Association. And hopefully, once we have more data this year, you might see this information on future scientific presentation. Great, and then shifting to Lomacell B on the regulatory front, I just wanted to confirm what the outlook was there with respect to the type B meeting that you originally indicated you would seek on Lomacell B. And then with respect to Alzheimer's disease, maybe you can comment a little bit on, you know, the changing state of the field.

Joshua Hare: I will now hand the call over to Dr. Joshua Hare, our co-founder, chief science officer, and chairman of the board. Joshua? Thank you, Lisa, and good afternoon, everyone. As you've heard from the team, we are making great progress advancing cellular therapy research and our lead product candidate, Lomas LB.

Speaker Change: And hopefully once we have more data this year you might see this information on future. Thank you for your presentation.

Speaker Change: Okay.

Raghuram Selvaraju: Great.

Great and then shifting to low myself would be on the regulatory front I just wanted to confirm what the outlook was there with respect to the type of thing that you. Originally indicated you would think on low myself would be and then with respect to Alzheimer's disease, maybe you can comment a little bit.

Raghuram Selvaraju: And then shifting to LMSLB on the regulatory front. I just wanted to confirm what the outlook was there with respect to the type B meeting that you originally indicated you would seek on LMSLB. And then, with respect to Alzheimer's disease, maybe you can comment a little bit on the changing state of the field. You mentioned earlier the lack of ARIA abnormalities in patients treated with LMSLB and how important that is from a competitive positioning perspective. But I also wanted to better understand how you are thinking about the timing with which you may advance LMSLB into further clinical development within the Alzheimer's context.

Joshua Hare: Recognizing Longeveron's continued growth and evolution, we are fortunate to have recently added three industry veterans to our board of directors. First, Dr. Raja Hajjar brings incredible experiences of scientists, academic, and operational executives. He's an internationally recognized scientist whose cardiac gene therapy discoveries have spurred clinical trials for heart failure and whose methodologies for cardiac directed gene transfer are currently utilized by investigators around the world. So he knows quite a lot about what we're doing here at Longeveron. He was recently head of RID at Ring Therapeutics and was appointed as the inaugural director of the gene and cell therapy institute at Mass General Brigham.

Speaker Change: On you know the changing state of the field you mentioned earlier, the lack of ARIA abnormalities in patients treated with low myself b and how important that is from a competitive positioning perspective, but I also wanted to better understand how you are thinking about the timing with which you may advanced wellness.

Nataliya Agafonova: You mentioned earlier the lack of ARIA abnormalities in patients treated with Lomacell B and how important that is from a competitive positioning perspective. But I also wanted to better understand how you're thinking about the timing with which you may advance Lomacell B into further clinical development within the Alzheimer's context. And if you are contemplating the possibility of doing that before we actually see final data from the HLHS study, and if you are pursuing any potential non-dilutive routes of funding to advance that initiative, like for example from NIH and so on. Royel, would you like to take the first part of the question? Yes.

Speaker Change #100: They'll be into further clinical development within the Alzheimers context, and if you are contemplating the possibility of doing that before we actually see final data from the HLA test study and if you are pursuing any potential non dilutive route for funding to advance that initiatives like for example.

Raghuram Selvaraju: And if you are contemplating the possibility of doing that, before we actually see final data from the HLHS study and if you are pursuing any potential non-dilutive routes of funding to advance that initiative, like for example from NIH and France.

Joshua Hare: Our second new director is Rich Kinder, who is a retired senior vice president of business development and corporate licensing at Merck and company incorporated. He spent his entire professional career at Merck in various corporate roles of increasing responsibility and was involved more than a hundred business development and licensing transactions.

Speaker Change #100: From NIH in France.

Nataliya Agafonova: Michael, would you like to take the first part of the question? Yes, so there is multiple questions here. Raghuram, I will try to address, and if I forget any of the parts of the question, you can remind me. But first, you're getting the regulatory process. We're actually meeting with the CEPAR division or planning to meet with the CEPAR division on both Echolichets as well as the Alzheimer program, and those will be separate meetings. And while both of them are reviewed by the same division, sometimes the reviewers could be different depending on the indication as well.

Speaker Change #101: Well you would you like to take the first part of the question. Yeah. So there is multiple questions here Raj on I'll try to address it and if I forget.

Wael Hashad: So, there is multiple questions here, Raj, and I will try to address them. If I forget any of the parts of the question, you can remind me. But first, regarding the regulatory process, we're actually meeting with the CBER division, or we're planning to meet with the CBER division on both HLHS as well as the Alzheimer program, and those will be separate meetings. And while both of them are reviewed by the same division, sometimes the reviewers could be different depending on the indication as well.

Speaker Change #102: The a part of the question you can remind me, but first regarding the regulatory process, we're actually meeting with the cheaper division or we're planning to meet with the seafood division on both actually Chad as well as Ah got all time of program and those will be separate meetings.

Joshua Hare: Finally, Neha Matwani has over 25 years of healthcare investment banking experience. Most recently having served as managing director of healthcare investment banking at William Blair. She previously held investment banking roles of increasing responsibility with truest securities, off-and-himer and company, steeple financial and cowon and company. We're collectively should completed transactions raising over $6.8 billion US dollars. I believe all three of these individuals will add tremendous value to the board and to Longeveron and look forward to collaborating with them.

Speaker Change #102: Hum and while both of them are quite the same division, sometimes you gotta get worse could be different depending on the indication as well.

Wael Hashad: We, as you know, part of the RMAT designation that we have received, the FDA has requested us to prepare for type B meeting, as Nataliya has mentioned, which we plan to have before the end of the year. That Tap B meeting, as you know, it takes time to prepare for from a briefing book and timing from the agency, but we're hopeful that we can get this one done by the end of the year.

Speaker Change #102:

Mohamed Hashad: As you know, part of the R-MAT designation that we have received, the FDA has requested us to prepare for a type B meeting, as Nataliya has mentioned, which we plan to have before the end of the year. That type B meeting, as you know, takes time to prepare for from a briefing book and timing from the agency, but we're hopeful that we can get this one done by the end of the year. With same thing, with happening also with the Echolichets, I will update you once the meeting takes place and the minute comes in. So that's regarding our regulatory process, and both of them are very important because both are going to outlay what is the path for BLA on the Echolichets front.

Speaker Change #102: And as you know part of the arm at a designation that we have received the FDA has requested us to to.

Speaker Change #102: Prepare for type B meeting.

Speaker Change #102: Probably I was mentioned, which we plan to have before the end of the year.

Speaker Change #102: That type B meeting as you know it takes time to prepare for from a briefing book and timing from the agency, but we're hopeful that we can get this one done by the end of the year with same thing what's happening also with the HLA chats and well update you once the meeting takes place and that the minutes comes in.

Mohamed Hashad: Thank you and I will turn the call back over to you while at this time. Thank you Dr. Haer.

Wael Hashad: With same thing with happening also with HLHS, I will update you once the meeting takes place and the minutes comes in. So that's regarding our regulatory process. And both of them are very important because both are going to outlay what is the path for BLA on the HLHS front. And the other one is a very important because as you know, with the RMAT designation, it's an equivalent of breakthrough. And therefore there could be a streamlined approach to approval as well with Alzheimer's disease.

Mohamed Hashad: The data is generated today's financial chest and Alzheimer's disease support the broad potential for wellness of the as a regenerative, medicinal therapy across multiple indicators. The trends of the data, our experience and committed scenes, and unwavering focus on patients, give me confidence in the future of Longeveron. What really drives everyone here at Longeveron day in and day out is the patience and the opportunities to have a positive impact for them. They are why we are working every day to hopefully develop a bit of solution for these unmet needs.

Speaker Change #102: So that's regarding our regulatory process on both of them are very important.

Speaker Change #103: Both are going to outline what is the path for BLA out on the edge I'll, let Jos front and the other one is a very important to be cod.

Mohamed Hashad: And the other one is very important because, as you know, with the R-MAT designation, it's an equivalent of breakthrough, and therefore there could be a streamlined approach to approval as well with Alzheimer's disease. And we want to discuss that first with the FDA before we finalize our plan moving forward because we believe that this could be a streamlined and the cost needed could be significant introduced. Now, we will not know that until we meet with the FDA and agree on that plan. In terms of our needs, yes, we are pursuing non-diluted funding that is looking at grants all the time.

Speaker Change #103: As you know with the arm that designation is an equivalent of breakthrough and and therefore, there could be a streamlined approach to the to.

Speaker Change #103: <unk> approval as well with Alzheimer disease, and what do you want to discuss that first would be yet that with the FDA before we finalize our plan moving forward because we believe that this could be a streamlined and cockney could be significantly.

Wael Hashad: And we want to discuss that first with the FDA before we finalize our plan moving forward because we believe that this could be streamlined and the cost needed could be significantly reduced. However, we will not know that until we meet with the FDA and agree on that plan. In terms of our needs, yes, we are pursuing non-dilutive funding and looking at grants all the time. NIA is one of them, and others as well.

Speaker Change #103: Significantly reduced now we will not know that until we meet with the FDA and agree on that plan.

Unknown Executive: Operator, we would now like to open the call for questions from our covering analyst. Thank you. When I'll be conducting a question and answer session, if you would 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 would 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, will we pull for questions?

Speaker Change #104: In terms of our need yes, we are pursuing non dilutive funding that is looking at grants all the time and I E. It's one of them with others as well.

Raghuram Selvaraju: Our first question comes from Raj Selvaraju, A.C. Wainwright. Please proceed with your question.

Mohamed Hashad: NIA is one of them, with others as well. And we're also pursuing, as you have heard from multiple, also the possibility of partnerships and non-also private funding as well from other sources as well. So we're exploring multiple avenues when it comes to funding related to Alzheimer's research. So that's regarding the funding; that's regarding the regulatory path. Do we have a final plan yet for the FDA for the Alzheimer's past forward? As I said, we will not be able to specifically communicate anything until we meet with the FDA. I hope I answered all your questions. Natalia, if I missed anything, feel free to add.

Wael Hashad: And we're also pursuing, as you have heard from multiple, also possibility of partnerships, and non-, also private funding as well from other sources as well. So we're exploring multiple avenues when it comes, to funding related to Alzheimer research. So that's regarding the funding. That's regarding the regulatory path.

Speaker Change #104: And we're also pursuing.

You have heard from multiple well so possibility of partnerships and non also private funding as well from AGA.

Speaker Change #104: Other sources as well so we're exploring multiple avenues when it comes.

Speaker Change #104: To Doe funding related to Alzheimer.

Speaker Change #104: Research so that's regarding the funding that's regarding the irregular.

Mohamed Hashad: Hello, thank you very much for taking my questions and congratulations on all this important progress. Firstly, with respect to Lomas L.B, in the Elkis II study, can you give us some more granularity around how close you are to completion of enrollment? How long you expect the enrollment of the remaining patients to take and assuming completion of enrollment in accordance with your previously reported guidance? When could we see top-line data from this trial? Is it potentially disposable before the end of 2025? Thank you. Sure.

Speaker Change #104: Our regulatory path as do we have a final plan yet for the FDA for <unk> for the Alzheimer our path forward as I said, we will not be able to.

Wael Hashad: As we have not yet had a final plan yet for the FDA for the Alzheimer's path forward, as I said, we will not be able to specifically communicate anything until we meet with the FDA. I hope I answered all your questions.

Speaker Change #104: Specifically communicate anything until we meet with the FDA.

Wael Hashad: Nataliya, if I missed anything, feel free to add. And if I missed any part of your question, happy to answer it as well. No, I think that was very helpful.

Speaker Change #104: I answered all your questions Natalya, if I Miss anything feel free to.

Speaker Change #104: So AD and Ah if I Miss any part of your question I'm happy to answer if there's wild wash.

Raghuram Selvaraju: And if I missed any part of your question, happy to answer as well.

Raghuram Selvaraju: No, I think that was very helpful.

Speaker Change #104: Yeah.

Wael Hashad: And then the last question I had was in relation to the contract services business. And there are really two parts here. The first is wanted to understand better, you know, you mentioned that there may be the possibility to generate as much as 4.5 million in annualized revenue from contract services. I just wanted to get a sense of what the timeline might be to get to that level of revenue generation. Would it be a year from now, two years from now?

Natalya: No I think that was very helpful. And then the last question I had was in relation to the contract services business and there are really two parts here.

Raghuram Selvaraju: And then the last question I had was in relation to the contract services business. And there are really two parts here. The first is, wanted to understand better, you know, you mentioned that there may be the possibility to generate as much as 4.5 million in annualized revenue from contract services. I just wanted to get a sense of what the timeline might be to get to that level of revenue generation. Would it be a year from now, two years from now? How are you thinking about that?

Speaker Change #105: First is wanted to understand better.

Nataliya Agafonova: Hi, this is Wailha Shad. First, I want to remind you on everyone. Our projection is the best of our ability. Of course, as you know, with rare diseases, there is no easy way to predict exact timing to close. We're still targeting the end of this year. We're hoping that the addition of the new sites will accelerate the enrollment, but definitely things can also vary a little bit. But we are not that far as you hear from Nataya that we are starting to present enrollment.

Speaker Change #107: And that there may be the possibility for generate as much as $4 5 million in annualized revenue from contract services I just wanted to get a sense of what the timeline might be to get to that level of revenue generation, whether it be a year from now two years from now how are you thinking about that and then the <unk>.

Wael Hashad: How are you thinking about that? And then the second question is specifically about one of your contract manufacturing clients, Secretome Therapeutics. It would be interesting to learn a bit more about this company, what they do, what the nature of Longeveron's relationship is to Secretome, and if there might ultimately be the possibility of Longeveron collaborating with Secretome on programs from Secretome's proprietary platform. Because, as I understand it, this is a technology platform company, and its approach may be viewed as complementary to that of Longeveron and could potentially broaden its own pipeline.

Mohamed Hashad: And then the second question is specifically around one of your contract manufacturing clients, the CRETE on therapeutics. It would be interesting to learn a bit more about this company, what they do, and what the nature of Langevaran's relationship is to the CRETE home. And if there might ultimately be the possibility of Langevaran collaborating with the CRETE home on programs from the CRETE home proprietary platform. Because, as I understand it, this is a technology platform company. And its approach may be viewed as complementary to that of Langevaran and could potentially broaden Langevaran's own pipeline. So I was just hoping maybe you could comment a little bit on that and how you see the relationship between yourselves and the CRETE home developing over.

Speaker Change #108: Second question is specifically around one of your contract manufacturing clients. The creek on therapeutics them. It would be interesting to learn a bit more about this company what they do what the nature of longevity runs relationship is just the greektown and if there might ultimately be the possibility of lunch ever on call.

Nataliya Agafonova: Nataya can give you more specificity around the exact number of patients being recruited. And then the second thing is I just want to remind you that our follow-on to the closure of the trial is one year from the last patient in and that has not changed. And with that, I will give it to Nataya to give you more specificity around your question.

Speaker Change #109: Library thing with the creep to them on our programs from secrete Tom's proprietary platform because as I understand it. This is a technology platform company.

Wael Hashad: So I was just hoping maybe you could comment a little bit on that and how you see the relationship between yourselves and Secretome developing over time. Sure. So, first, I can tell you that I will start with the second part of your question, which is the relationship with Secretome. And I can tell you at this time that our relationship is purely related to us helping them with the manufacturing capabilities of their product. We are not collaborating with Secretome on any other fronts.

Speaker Change #110: And its approach may be viewed as complementary to that of longevity or on that potential.

Speaker Change #111: Potentially broaden longevity runs on pipeline. So I was just hoping maybe you could comment a little bit on that and how you see the relationship between yourselves and so creek them developing over time.

Nataliya Agafonova: Thank you very much, Wailha. As Wailha mentioned, and thank you, Raj, for your question. As Wailha mentioned, currently, we enroll 37 out of 38 patients. So we have 11 patients remaining to enroll. We are absolutely hopeful that the new sites, we just currently.., in role to the clinical trial, will help us to expedite enrollment. So, at 12th, the primary end point design that way that we evaluate the effect of their function 12 months after the last patient enrolled. So, approximately, they are looking for filing in probably first quarter of 2026 as a best scenario.

Speaker Change #112: Sure. So first I can tell you that I will talk about the second part of your question, which is the relationship with sector to them and I can tell you at this time our relationship it's purely.

Mohamed Hashad: Sure, so first I can tell you that I will start with the second part of your question, which is the relationship with Secretary Dome, and I can tell you at this time our relationship is purely related to us helping them with the manufacturing capabilities of their product. But we are not collaborating with Secretary Dome and any other fronts; we have not been engaged in any other discussions or anything outside of that scope of the manufacturing at this time. We are always open to new technologies and new areas that we can expand our science and research and to get a good area.

Speaker Change #112: Related to us helping them with their manufacturing.

Speaker Change #112: Capabilities of their product.

Wael Hashad: We have not been engaged in any other discussions or anything outside of the scope of the manufacturing at this time. We're always open to new technologies and new areas where we can expand our science and research and therapeutic areas. But in that avenue, we're going to pursue much broader opportunities. And you'll hear from Dr. Hare. We brought several experts on our board that can help us formulate that strategy of how we can go and move forward.

Speaker Change #112: Not collaborating with sector German any other fronts, we have not been engaged in any other discussions or anything that are outside of that scope of the manufacturing at this time.

Speaker Change #112: We're always open to new technologies, and the new areas that we can expand or.

Speaker Change #112: Science and research and therapeutic area.

Mohamed Hashad: But in that avenue, we are going to pursue much more broader opportunities. And you will hear from Dr. Hare; we brought several experts on our board that can help us formulate that strategy of how we can go and move forward. And we will be communicating some of that also in the future. Is one of the Longeveron 2.0 how we can go beyond almost the end of the future. And those things are always going to be in our plan and the strategy. And definitely there will be a time and place when we are ready to communicate around this, but would be much more broader than Secretary Dome.

Speaker Change #112: We were all in in that Avenue, we're going to pursue much more broader opportunities and you'll hear from Dr. Harry you know we brought several experts on our board.

Nataliya Agafonova: And with respect to the LPS1 study, can you just remind us about what additional data you expect to generate from long-term follow-up of the patients who are enrolled and followed as part of that study? And what do you expect to be the key amount of follow-up necessary to secure regulatory approval of LMSLB in HLHS? I would understand and imagine that it would be the 12 month follow-up end point, but you certainly would be able to obtain longer-term follow-up data from the LPS1 patient.

Dr. Harry: Can help us formulate that strategy of how we can go and move forward and we'll be communicating that also in the future is what I would say longer belonged to point out how we can go beyond on the therapy and the future and those things as it is always going to be and our plan and our strategy.

Wael Hashad: And we'll be communicating some of that also in the future, what I would call Longeveron 2.0, how we can go beyond Velma Cell B in the future. And those things are always going to be in our plan and strategy. And definitely, there will be a time and place when we are ready to communicate around this, but it would be much broader than Secretome. Regarding the potential and when we can see that $4 to $5 million, we are working at full scale, full speed; I'm full steam ahead to try to get everything ready. We are doing a full assessment of what additional equipment we need because we don't want to limit ourselves to just stem cell manufacturing.

Dr. Harry: Definitely there will be a time and place one when we are ready to communicate around that but it would be much more broader than cyclical.

Nataliya Agafonova: So, just wanted to get some additional color there. Thank you. Thank you so much. It's a very great question. You're absolutely right. We are collecting long-term data and from our 10 patients on LPS1. In August, end of August this year, we will have school five year follow-up after the patient completed Glenn procedure, stage two procedure. So, the type of data we are looking for is transplants, it's survival and transplants, three survival data.

Mohamed Hashad: Regarding the potential and when can we see the $4 to $5 million, we are working on full scale, full speed. I'm full steam ahead to try to get everything ready. We are doing a full assessment of what additional equipment because we don't want to limit ourselves to just the stem cell manufacturing. We want to go broader for cell therapy. We have the capabilities and expertise to cover broader, you know, other types of cell therapies that we can manufacture in our facility. And we don't want to limit ourselves on to one type of manufacturing. And therefore we are right now in the middle of assessing what additional needs that we need to do and make sure that we're ready from both human capital and human resource standpoint, as well as any other needs.

Speaker Change #114: Regarding the potential and when when can we see that $4 million to $5 million we are working.

Speaker Change #115: On a full scale full speed that down.

Speaker Change #115: Full steam ahead to try to get everything ready.

Speaker Change #115: We are doing a full assessment of what additional equipment, because we don't want to limit ourselves to just the stem cell manufacturing, we want to go broader for cell therapy, we have the capabilities and expertise to cover a broader set up that you know other.

Wael Hashad: We want to go broader for cell therapy. We have the capabilities and expertise to cover a broader range of cell therapies that we can manufacture in our facility. And we don't want to limit ourselves to one type of manufacturing.

Speaker Change #115: Other types of cell therapies that we can manufacture in our facility and we don't want to limit ourselves to one type of manufacturing.

Nataliya Agafonova: That can definitely be included in our VLA submission to support not only safety, but also actually the most important end point, such as long-term transplants, three survival and can support the rest of the data for the rest of the patients. We did present four year survival last year in the American Heart Association and hopefully once we have more data this year, you might see this information on future scientific presentation. Great.

Speaker Change #115: Manufacturing and therefore, we are right now in the middle of the.

Wael Hashad: And therefore, we are right now in the middle of assessing what additional needs we need to do and making sure that we're ready from both a human capital and human resource standpoint, as well as any other needs. And we are already engaging in, and we are present at, many of the meetings of cell therapies and gene therapies. And we're speaking with potential customers and looking forward to building it up. How specifically, I don't know, but we anticipate that within a year or two, we'll be able to get to the full potential with four to five million.

Speaker Change #115: That saying what additional needs that we need to do and make sure that we're ready from both a.

Wael Hashad: Thank you very much. It was very helpful. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. There are no further questions at this time. I would now like to turn the floor back over to Leo and Hashad for closing comments. Thank you, Maria. And thank you all for attending our call today. We greatly appreciate your interest and support and look forward to updating you on our progress throughout the remainder of the year. Thank you. Operator, you may end the call now. This concludes today's teleconference. You may disconnect your lines at this time.

Speaker Change #115: Human capital and human resource standpoint, as well as any other needs.

Speaker Change #115: And we are already engaging we are present in many of the meetings of the cell therapies and gene therapies, and we're speaking with potential customers and are looking forward to build it up.

Mohamed Hashad: And we are already engaging that we are present in many of the meetings of the cell therapies and gene therapies. And we're speaking with potential customers and looking forward to build it up. How is specifically, I don't know, but we anticipate a year or two will be able to get to the full potential with the $4 to $5.

Speaker Change #115: How it specifically I don't know, but we anticipate a year or two we'll be able to get to their full potential with a $4 million to $5 million.

Mohamed Hashad: And then shifting to LMSLB on the regulatory front. I just wanted to confirm what the outlook was there with respect to the type B meeting that you originally indicated you would seek on LMSLB. And then with respect to Alzheimer's disease, maybe you can comment a little bit on the changing state of the field. You mentioned earlier the lack of ARIA abnormalities in patients treated with LMSLB and how important that is from a competitive positioning perspective.

Raghuram Selvaraju: Thank you very much. Very helpful.

Speaker Change #116: Thank you very much very helpful.

Speaker Change #115: Okay.

Unknown Executive: As a reminder, if you would like to ask a question, please press star one on your telephone e-pad.

Speaker Change #117: As a reminder, if he would like to ask a question. Please press star one on your telephone keypad.

Speaker Change #117: Okay.

Speaker Change #117: Okay.

Speaker Change #117: Okay.

Speaker Change #117: Yeah.

Unknown Executive: There are no further questions at this time.

Speaker Change #117: There are no further questions at this time I would now like to turn the floor back over to Neil.

Mohamed Hashad: I would now like to turn the floor back over to you for closing comments. Thank you, Maria. And thank you all for attending our today's call. We greatly appreciate your interest and support and look forward to updating you on our progress throughout the remainder of the year.

Neil Chavez: Chavez for closing comments.

Mohamed Hashad: But I also wanted to better understand how you are thinking about the timing with which you may advance LMSLB into further clinical development within the Alzheimer's context. And if you are contemplating the possibility of doing that, before we actually see final data from the HLHS study and if you are pursuing any potential non-dilutive routes of funding to advance that initiative, like for example from NIH and France. Michael, would you like to take the first part of the question?

Neil Chavez: Okay.

Neil Chavez: Thank you Maria and thank you all for attending our today's call.

Neil Chavez: We greatly appreciate your interest and support and look forward to updating you on our progress throughout the remainder of the year.

Unknown Executive: Thank you, Operator. You may end the call now. This includes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Speaker Change #119: Thank you operator, you may end the call now.

Speaker Change #119: Okay.

Speaker Change #120: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Speaker Change #120: Hum.

Unknown Executive: Thank you for your participation, and Lopez Ramos. Thank you for watching, and uh... V. Hope you enjoyed it! and Liza Kudrow.

Speaker Change #120: [music].

Mohamed Hashad: Yes, so there is multiple questions here. Raghuram, I will try to address and if I forget any of the parts of the question you can remind me. But first you're getting the regulatory process. We're actually meeting with the CEPAR division or planning to meet with the CEPAR division on both Echolichets as well as the Alzheimer program and those will be separate meetings. And while both of them are reviewed by the same division, sometimes the reviewers could be different depending on the indication as well.

Speaker Change #120: Hum.

Speaker Change #120: [music].

Unknown Executive: Thank you for watching. I hope you enjoyed this video. If you did, please like, comment, and subscribe. I'll see you next time. Vinny Chitluri and Fred Kline For More Information Vinny Chitluri, Raghuram Selvaraju, Raghuram Selvaraju, .., and others. Please see the complete disclaimer at https://sites.google.com If you have any questions or other problems, please post them in the comments.

Mohamed Hashad: As you know, part of the R-MAT designation that we have received, the FDA has requested us to prepare for type B meeting, as Nataliya has mentioned, which we plan to have before the end of the year. That type B meeting, as you know, takes time to prepare for from a briefing book and timing from the agency, but we're hopeful that we can get this one done by the end of the year.

Speaker Change #120: Hum.

Speaker Change #120: [noise].

Mohamed Hashad: With same thing, with happening also with the Echolichets, I will update you once the meeting takes place and the minute comes in. So that's regarding our regulatory process, and both of them are very important because both are going to outlay what is the path for BLA on the Echolichets front. And the other one is a very important because, as you know, with the R-MAT designation, it's an equivalent of breakthrough and therefore there could be a streamlined approach to approval as well with Alzheimer's disease.

Speaker Change #120:

Speaker Change #120: Yeah.

Speaker Change #120: Yeah.

Speaker Change #120: [noise].

Unknown Executive: Thank you for watching and I will see you in the next video. Bye bye, and many more. Thank you for watching. I'm Mike Moyer. Thank you for tuning in. Meanwhile... [inaudible] along with most of the recordings will be available on our Chinese channels which are ediable back on our YouTube Channel.

Speaker Change #120: Mhm.

Mohamed Hashad: And we want to discuss that first with the FDA before we finalize our plan moving forward because we believe that this could be a streamlined and the cost needed could be significant introduced. Now, we will not know that until we meet with the FDA and agree on that plan. In terms of our needs, yes, we are pursuing non-dalued funding that is looking at grants all the time. NIA is one of them, with others as well.

Speaker Change #120: [music] mhm.

Speaker Change #120: Hum.

Hmm.

Speaker Change #120: Okay.

Speaker Change #120: [music].

Unknown Executive: Then we will continue broadcasting the records for our television program. Music, 2nd Amendment Statement. S1,.

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Mohamed Hashad: And we're also pursuing, as you have heard from multiple, also possibility of partnerships and non-also private funding as well from other sources as well. So we're exploring multiple avenues when it comes to funding related to Alzheimer's research. So that's regarding the funding, that's regarding the regulatory path. Do we have a final plan yet for the FDA for the Alzheimer's past forward? As I said, we will not be able to specifically communicate anything until we meet with the FDA. I hope I answered all your questions. Natalia, if I missed anything, feel free to add. And if I missed any part of your question, happy to answer as well.

Speaker Change #120: Hum.

Speaker Change #120: [music].

Speaker Change #120: Hum.

Speaker Change #120: Hum.

[music].

Raghuram Selvaraju: No, I think that was very helpful.

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Raghuram Selvaraju: And then the last question I had was in relation to the contract services business. And there are really two parts here. The first is, wanted to understand better, you know, you mentioned that there may be the possibility to generate as much as 4.5 million in annualized revenue from contract services.

Raghuram Selvaraju: I just wanted to get a sense of what the timeline might be to get to that level of revenue generation. Would it be a year from now, two years from now? How are you thinking about that?

Mohamed Hashad: And then the second question is specifically around one of your contract manufacturing clients, the CRETE on therapeutics. It would be interesting to learn a bit more about this company, what they do, what the nature of Langevaran's relationship is to the CRETE home. And if there might ultimately be the possibility of Langevaran collaborating with the CRETE home on programs from the CRETE home proprietary platform. Because as I understand it, this is a technology platform company.

Mohamed Hashad: And its approach may be viewed as complementary to that of Langevaran and could potentially broaden Langevaran's own pipeline. So I was just hoping maybe you could comment a little bit on that and how you see the relationship between yourselves and the CRETE home developing over. Sure, so first I can tell you that I will start with the second part of your question, which is the relationship with Secretary Dome and I can tell you at this time our relationship is purely related to us helping them with the manufacturing capabilities of their product.

Michael Okunewitch: Michael Okunewitch, Raghuram Selvaraju, Michael Okunewitch Michael Okunewitch, Raghuram Selvaraju,

Speaker Change #120: Hmm.

Speaker Change #120: Mhm.

Speaker Change #120: Hum.

Speaker Change #120: Hum.

Speaker Change #120: [music].

Mohamed Hashad: But we are not collaborating with Secretary Dome and any other fronts, we have not been engaged in any other discussions or anything outside of that scope of the manufacturing at this time. We are always open to new technologies and new areas that we can expand our science and research and to get a good area. But in that avenue we are going to pursue much more broader opportunities. And you will hear from Dr. Hare, we brought several experts on our board that can help us formulate that strategy of how we can go and move forward.

Mohamed Hashad: And we will be communicating some of that also in the future is one of the Longeveron 2.0, how we can go beyond almost the end of the future. And those things is always going to be in our plan and the strategy. And definitely there will be a time and place when we are ready to communicate around this but would be much more broader than Secretary Dome. Regarding the potential and when can we see the $4 to $5 million, we are working on full scale, full speed.

Mohamed Hashad: I'm full steam ahead to try to get everything ready. We are doing a full assessment of what additional equipment because we don't want to limit ourselves to just the stem cell manufacturing. We want to go broader for cell therapy. We have the capabilities and expertise to cover broader, you know, other types of cell therapies that we can manufacture in our facility. And we don't want to limit ourselves on to one type of manufacturing.

Mohamed Hashad: And therefore we are right now in the middle of assessing what additional needs that we need to do and make sure that we're ready from both human capital and human resource standpoint, as well as any other needs. And we are already engaging that we are present in many of the meetings of the cell therapies and gene therapies. And we're speaking with potential customers and looking forward to build it up. How is specifically, I don't know, but we anticipate a year or two will be able to get to the full potential with the $4 to $5. Thank you very much very helpful. As a reminder, if you would like to ask a question, please press star one on your telephone e-pad. There are no further questions at this time.

Unknown Executive: I would now like to turn the floor back over to you for closing comments. Thank you, Maria. And thank you all for attending our today's call. We greatly appreciate your interest and support and look forward to updating you on our progress throughout the remainder of the year. Thank you, Operator. You may end the call now. This includes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Michael Okunewitch, Raghuram Selvaraju, Michael Okunewitch Michael Okunewitch, Raghuram Selvaraju,