Q1 2024 Longeveron Inc Earnings Call
Operator: Good morning, ladies and gentlemen, and welcome to Longeveron's 2024 First Quarter Financial Results Earnings Call. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require the operator's assistance during the conference, please press star zero on your telephone keypad. Please note that this conference call is being recorded. I would now like to turn the conference over to Derek Cole of Industrial Relations Advisory Solutions. You may begin, sir.
Good day, ladies and gentlemen, and won't come cheap on Jupiter, one 'twenty 'twenty four first quarter financial results earnings call.
Speaker Change: At this time, all participants are in listen only mode.
Speaker Change: A question and answer all fishing will follow the formal presentation.
Speaker Change: If anyone should require operator assistance during the conference. Please press star zero and he's trying to fund key pad.
Speaker Change: Please note that this conference call is being recorded.
Speaker Change: I would not have to turn the conference over to Jerry Coke oven guest relations Advisory citizens you may begin sir.
Judith: Thank you Judith.
Derek Cole: Thank you, Judith. Good afternoon, everyone, and thank you for joining us today to review Longeveron's first quarter 2024 financial results and business update. After the U.S. markets closed today, we issued a press release with financial results from the first quarter, which can be found in the investor section of the Longeveron website. On the call today are Wael Hashad, Chief Executive Officer, Dr. Natalia Agapitova, Chief Medical Officer, Lisa Locklear, Chief Financial Officer, and Joshua Hare, Co-Founder, Chief Science Officer, and Chairman of the Board.
Speaker Change: Turning to everyone and thank you for joining us today to review longevity Islands first quarter 2024 financial results and business update.
Speaker Change: After the U S market closed today, we issued a press release with financial results for the first quarter, which can be found under the investors section of our longevity on the website.
Speaker Change: On the call today are while a Shah Chief Executive Officer, Dr. <unk> Italia off over Chief Medical Officer.
Speaker Change: So Luckily, our chief financial Officer, and Joshua Here Co founder Chief Science Officer, and Chairman of the board.
Derek Cole: As a reminder, during this call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in the company's filings with the Securities and Exchange Commission, which we encourage you to review. Following the company's prepared remarks, we will open the call to questions from covering analysts. With that, let me hand the call over to Wael Hashad, Chief Executive Officer. Wael?
Speaker Change: As a reminder, during this call you'll 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 the Securities and Exchange Commission, which we encourage you to review.
Speaker Change: 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 wildly Schott Chief Executive Officer well.
Speaker Change: Thank you Derek good afternoon, everyone.
Mohamed Wa'el Ahmed Hashad: Thank you, Derek. Good afternoon, everyone.
Mohamed Wa'el Ahmed Hashad: We are pleased to update you on our progress and to share why we're confident in Longeveron's opportunity and its future. As a reminder, for those of you who are new to our story, Longeveron is a regenerative medicine company developing cutting-edge cellular therapy. Our lead development compound, a cellular therapy candidate called Lomasol-B, represents a pipeline and a product opportunity that is being evaluated across three important treatment areas, addressing numerous unmet medical needs with a U.S. market potential opportunity of approximately $10 to $18 billion. There are four main reasons that give me confidence in our ability to achieve the potential of Long SLB. The first is Longeveron's Foundation for Strong Science.
wildly Schott: We are pleased to update you on our progress and to share why we're confident in lanzhou crohn's opportunity and its future.
Mohamed Wa'el Ahmed Hashad: Lomicil B is a proprietary, scalable, allogenic cellular therapy that has delivered positive initial results across five clinical trials, including phase 1 and 2 trials in Alzheimer's disease, phase 1 and 2 trials in aging-related frailty, and phase 1 in hypoplastic left heart syndrome, or HLHS. Second, is the experience and expertise of the Longeveron team, which makes advancing this research possible across clinical development, regulatory, and manufacturing. Finally, it's the team's dedication and commitment to advance this research for the fourth and most important reason, the patient.
wildly Schott: As a reminder for those of you newer to our story launch of Arone regenerative Medicine company developing cutting edge cellular.
Mohamed Wa'el Ahmed Hashad: Hypoblastic left heart syndrome, Alzheimer's disease, aging, frailty, these words convey a lot of information to scientists and doctors, but they can't fully express the devastating impact these diseases and conditions have on the patients and their families. It is heartbreaking to see an infant after heart surgery so early in their young life, for the loss of memory and cognition associated with Alzheimer's.
Speaker Change: Therapy.
Speaker Change: Our lead development compound.
Speaker Change: Therapy candidate called love it so be it.
Speaker Change: It presents a pipeline in a product opportunity that is being evaluated across three important treatment area.
Speaker Change: Addressing numerous unmet medical needs with U S market potential opportunity of approximately 10 to 18 billion U S dollars.
Mohamed Wa'el Ahmed Hashad: What really drives everyone here at Longeveron, day in and day out, is their patience and the opportunity to have a positive impact on them. They are why we are working every day to hopefully develop therapeutic solutions for these unmet needs. These four reasons drive my confidence in our ability to make an impact. And that impact starts with HLHF, our strategic priority for this year. As you know, we completed a phase one study known as ALPES-1, which produced positive results that were the basis for initiating our ongoing phase two study.
Speaker Change: There are four main reasons that give me confidence in our ability to achieve the opportunity laminates L. B.
Speaker Change: The first is long longer grown foundation, a strong site.
Speaker Change: As long as they'll be inappropriate I agree scalable allogeneic cellular therapy that has delivered positive initial results across five clinical trial.
Mohamed Wa'el Ahmed Hashad: Outfit 2, which is evaluating glomus LB as a potential adjunct treatment for HLHS. Completing enrollment in this trial by the end of this year is our primary focus with this program. HLHS is our top priority program, as we believe it is the program with the highest probability of success and the shortest path to potential regulatory approval. The ALPIS-1 data were also the basis for the U.S. FDA awarding the HLHS program three distinct and important designations, including forefront drug designation.
Mohamed Wa'el Ahmed Hashad: Fast Track designation and Rare Pediatric Disease designation, which upon approval may lead to the granting of a priority review voucher, a very valuable additional asset, which if granted, would enable us to speed up FDA review of another Longeveron NDA or BLA or to potentially sell the voucher to another company. The selling price of these priority review vouchers has generally been in excess of $100 million.
Mohamed Wa'el Ahmed Hashad: My earlier point about the strengths of our science is further evidenced by the positive data from CLEARMIND Phase 2a clinical trial in mild Alzheimer's disease. We anticipate meeting with the FDA late this year to review future clinical and regulatory strategies for continuing this important program. Our Chief Medical Officer, Dr. Natalia Agafonova, will provide some additional details on both HLHS and the Alzheimer's disease program later in this call. But I want to take a moment to highlight two other areas of the company where we are optimizing our resources, and that reinforces the reason I just mentioned for our company.
Speaker Change: Phase one and two trials in Alzheimer disease phase, one and two trials in aging related frailty and phase, one and hypoplastic syndrome or HLA chats.
Mohamed Wa'el Ahmed Hashad: Given our preliminary phase 2 clinical data suggesting that Lomacell B may potentially address the problem associated with aging-related frailty, we are gaining additional real-world evidence from our currently enrolling investigational frailty and cognitive impairment registry trial in the Bahamas. Eligible participants may receive Lomasol B for aging-related frailty, Alzheimer's disease, or other indications at their own expense and are then followed for safety and Why is this important?
Speaker Change: Okay.
Speaker Change: Is the experience and expertise of the launch of her own which meet advancing this research possible across clinical development regulatory and manufacturing.
Speaker Change: Sure.
Speaker Change: The team's dedication and commitment to advance the research port the port and most importantly thing there.
Speaker Change: The patients.
Speaker Change: Hyperplastic left heart syndrome, all the time.
Speaker Change: Or does the aging frailty. These words convey a lot of information the scientists and doctors.
Speaker Change: But they can fully express the devastating impact that these conditions have on the patient and their family.
Speaker Change: It is heartbreaking to see an infant after a heart surgery too early in their young lives.
Speaker Change: Or the lockup on memory and cognition associated with Alzheimer's.
Speaker Change: What really drives everyone here at launch of Arone day in and day out if the patient.
Speaker Change: And the opportunity to have a positive impact for them.
Speaker Change: They are why we are working every day to hopefully develop therapeutic solutions for these unmet needs.
Speaker Change: These four reasons grabbed my confidence in our ability to make an impact.
Speaker Change: And that impact starts with HLA Chad <unk>.
Speaker Change: Our strategic priority for this year.
Speaker Change: You know we completed phase one study known as I'll bet one.
Speaker Change: Which produced positive results that were the basis for initiating our ongoing phase two study.
Speaker Change: Help us too.
Speaker Change: Which is evaluating walnuts there'll be potential adjunct treatment for etch I'll, let Chad.
Speaker Change: Completing enrollment in this trial by the end of this year is our primary focus with this program.
Speaker Change: Actually Chad, it's our top priority program as we believe it is a program with the highest probability of success.
Speaker Change: The shortest path to.
Speaker Change: Two potential regulatory approval.
Speaker Change: The Opus one data where also the basis for the U F D. A awarding the HLA chats program with three distinct and important designation.
Speaker Change: Orphan drug designation.
Speaker Change: Track designation rare pediatric disease designation, which upon approval maybe at the granting of a priority review voucher and very valuable additional assay, which if granted enable us to speed up the FDA review of another larger barone N V a or B L. A.
Speaker Change: Or to potentially sell the voucher to another company.
Speaker Change: The selling price of these priority review vouchers has generally been in excess of 100 million U S dollars.
Speaker Change: My earlier point about the trends.
Speaker Change: All our science is further evidenced by the positive data from clear mind phase Iia clinical trial in mild Alzheimer's disease.
Speaker Change: We anticipate meeting with the FDA this year to review future clinical and regulatory.
Speaker Change: Our strategy for continuing this important program.
Speaker Change: Our Chief Medical Officer, Doctor and Italia, I guess that yoga will provide some additional details on both actually Chad and Alzheimer disease program later in this call.
Speaker Change: I wanted to take a moment to highlight two other areas of the company, where we are optimizing our resources and that reinforces the reason I just mentioned for our confidence.
Speaker Change: Given our preliminary phase II clinical data, suggesting that not myself b.
Speaker Change: Maybe potentially address the problems associated with aging related cryo theme, we are gaining additional real world evidence from our currency and Golding litigation, all frailty and cognitive impairment graduate shape trials in the Bahamas.
Eligible participants: Eligible participants may receive lummus there'll be four aging related crafty.
Eligible participants: At the time of disease or other indications at their own expense.
Eligible participants: And are then followed for safety and clinical efficacy.
Mohamed Wa'el Ahmed Hashad: First, it's indicative of the strength of our initial data that supports the authorization for this investigational program in the first place. Second, though, in this investigational registry trial, we are able to collect real-world treatment data to better understand Lomatho-B activity. Safety Profile, and Potential Applicants. LumSLB has been safely administered in over 500 patients to date across clinical trials and death registry trials. We believe this data will be important in guiding the clinical development program for low-risk obesity. Finally, and importantly, we are able to generate this data in a cost-neutral manner as participants do so at their own expense.
Eligible participants: Why this is important first then.
Eligible participants: And indicative of the strength of our initial data that supports the authorization for this investigational program in the first place.
Eligible participants: Second, though that this investigational graduate to the trial, we are able to collect real world treatment data.
Eligible participants: To better understand now microbial activity.
Eligible participants: Safety profile and potential efficacy.
Eligible participants: No Michael B has been safely administered being over 500 patients to date across clinical trials and registry trial.
Eligible participants: We believe this data will be important in guiding clinical development program for <unk>.
Eligible participants: Finally, and importantly, we are able to generate that data in a cost neutral manner as participants do so at their own money spent.
Mohamed Wa'el Ahmed Hashad: Building on the success of this registry trial so far, we plan to launch an investigational osteoarthritis registry trial in the Bahamas in the fourth quarter of this year. The second area is in regard to Longeveron's manufacturing expertise and capabilities. We have assembled a team of experts in proprietary technology that enable us to take a systematic approach to rapidly develop improved cell therapy. Our state-of-the-art GMP facility in Miami at Life Science and Technology Park consists of 3,000 square feet of clean room space containing eight ISOO 7 clean rooms, an ancillary area as well as 1150 square feet of process development, quality control, and warehouse space. All products are manufactured and released based on FDA guidance.
Eligible participants: Building on the success of this registry trial, so far we plan to launch an investigational osteoarthritis registry trial at the Bahamas in the fourth quarter of this year.
Eligible participants: The second area is intra garden laundry bronze manufacturing expertise and capability.
Eligible participants: We have assembled a team of expert and Cook reactivate technology.
Eligible participants: That enable us to take systematic approach to rapidly develop improved cell therapy.
Speaker Change: Our state of the art GMP facility in Miami at Life Science, and Technology Park consist of 3000 square feet of clean room space containing eight.
Eligible participants: I saw seven clean room, and ancillary area as well as 1100 50 square feet of.
Eligible participants: Process development quality control and warehouse space.
Eligible participants: All products are manufactured and released based on FDA guidance.
Mohamed Wa'el Ahmed Hashad: While this facility gives us the capacity to manufacture Lomacell-B for clinical trial use and potentially, if approved for commercial scale, we do not currently need the facility's full capacity. This presents an additional opportunity for us as a company. The company's manufacturing expertise, capabilities, and facility are in demand from other pharmaceutical organizations. We plan to expand contract manufacturing operations as part of our overall resource optimization strategy. We have already secured the first contract under this initiative and started preliminary work with the client.
Speaker Change: While this facility give us the capacity to manufacture alumnus there'll be for clinical trial use and potentially if approved for commercial scale. We do not currently need that facility at full capacity.
Speaker Change: This presents an additional opportunity for us as a company.
Eligible participants: At the company's manufacturing expertise capabilities that facility are in demand from other pharmaceutical organizations.
Eligible participants: We plan to expand the contract manufacturing operation as part of our overall resource optimization strategy.
Eligible participants: We have already secured our first contract under this initiative.
Eligible participants: And it started preliminary work with the client.
Mohamed Wa'el Ahmed Hashad: We believe this contract manufacturing has the potential to expand the 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. Which leads me to the final area of comment, capital allocation and expansion. As I hope you can see from my prior comments, we are tightly focused on optimizing our resources and being good stewards of shareholders' capital.
Eligible participants: We believe this contract manufacturing has the potential to expand the team experience and generate approximately $4 million to $5 million in annual revenue once it's up and running fully.
Speaker Change: Hopping upset our clinical development cost and reducing but not eliminating our additional capital need.
Speaker Change: Which leads me to the final area of common capital allocation and it's been.
Speaker Change: As I hope you can see from my prior comment we are tightly focused on optimizing our resources.
Speaker Change: And being good stewards of shareholders' capital.
Mohamed Wa'el Ahmed Hashad: With a focus on expense control, our total operating expenses are down 8% year over year. In April, we raised $11.4 million, which combined with our existing balance sheet will help us fund continued development of the HLHS program and regulatory discussions for Alzheimer's disease into the fourth quarter. The data generated to date in HLHS and Alzheimer's disease all support broad potential for Lama cell B as a regenerative medical therapy across multiple indications.
Speaker Change: With focus on expense control, our total operating expenses are down 8% year over year.
Speaker Change: In April we raised $11 4 million dollar.
Speaker Change: Which combined with our existing balance sheet will help us fund.
Speaker Change: Continued development of the HLA Church program and regulatory discussions for Alzheimer's disease program into the fourth quarter.
Speaker Change: The data generated to date and actually their chests and Alzheimers disease, all support the broad potential for Lamar L. B.
Speaker Change: Generative medical therapy across multiple indications.
Mohamed Wa'el Ahmed Hashad: The strength of that data, our experienced and committed team, and the unwavering focus on patients give me confidence in the future of Lomas LB and Longeveron. With that, I will turn the call to Dr. Agafonova to provide an update on the clinical development program. Natalia
Speaker Change: That's the trend.
Speaker Change: That data, our experienced and committed team and unwavering focus on patients give me confidence in the future of lummus there'll be and launch it alone.
Speaker Change: With that I will turn the call to Doctor I got to know about to provide.
Speaker Change: An update on the clinical development program.
Speaker Change: Tayo.
Speaker Change: Thank you, Mike and good afternoon, everyone.
Natalia Agapitova: Thank you, Vaheo, and good afternoon, everyone. As Lael mentioned, our HLHS program is a primary focus for us, as we believe it is the program with the highest probability of success and the nearest term pathway to potential approval. As a reminder for those who might not know, HLHS 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: As Michael mentioned, our HLA Chess program is a primary focus for us as we believe it is the program with the highest probability of success and nearly stern partially to potential approval.
Speaker Change: As a reminder, for those who might not know HLA Chastel Hyperplastic left heart syndrome.
Speaker Change: Is a rare pediatric congenital heart dark except in which the left ventricle of the harvest either severely under developed or niche in the.
Natalia Agapitova: The current treatment requires infants to undergo a complex three-stage heart reconstruction surgery process over the first five years of their lives. Even with this comprehensive treatment, only 50 to 60 percent of infants survive to adolescence due to right ventricular failure. There is clearly an important medical need to improve right ventricular function in these infants to positively impact both short- and long-term patient outcomes.
Speaker Change: The current treatment requires infinite still undergoing complex three stage hark reconstruction, so Jerry protests.
Speaker Change: Over the first five years of their lives.
Speaker Change: Even get the comprehensive treatment only 50% to 60% of infants survived adolescence due to rise in Chico Australia.
Speaker Change: There is a clearly an important unmet medical needs to improve pricing and chick Fil a function of the same funds to partly positively impact both short and long term patient outcomes.
Natalia Agapitova: Our LPS-1 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. The LPS-1 data were highly encouraging and served as the basis for LPS-2, our ongoing Phase 2b clinical trial designed to assess the potential of Lomis-LB to improve right ventricular function and long-term outcomes. LPIST-2 is being conducted in collaboration with the National Heart, Lung, and Blood Institute through grants from the National Institutes of Health. LPS II remains on track to complete enrollment by the end of this year.
Speaker Change: Our eldest one phase one study of felonious there'll be an infant with HLA chess demonstrated that infants in the trial experience hundred percent transplant free survival. After five years of age after receipt and learning shall be during this stage two so dream.
Speaker Change: <unk> to approximately 22% mortality rate.
Speaker Change: Derek from historical control data.
Speaker Change: This one data were highly encouraging and serve as the basis for L. P to our ongoing phase two b clinical trial designed to assess the potential upon its L. B to improve right into college function and long term outcome.
Speaker Change: This too is being conducted in collaboration with National Heart lung and Blood Institute grants from the National Institutes of health.
Speaker Change: It will be still remains on track to complete enrollment by the end of this year.
Natalia Agapitova: We intend to request a Type 2 or Type B meeting with the FDA to discuss the development strategy for HLHS and expectations for the potential biologic license application or BLA approval. Moving on to our Alzheimer's disease program. As we mentioned on our last call, in our Phase 2a clinical trial, clear-minded, long-SLD-treated patients showed overall slowing of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific longicell B groups compared to placebo.
Speaker Change: The intent to request a type two type B meeting did the FDA to discuss development strategy for HLA chess and expectations for the potential biologic license application or BLA approval.
Speaker Change: Moving onto all Zeiner disease program.
Speaker Change: As we mentioned on our last call in our phase two <unk> clinical trial.
Speaker Change: We are mindful of Michelle D treated patients.
Speaker Change: So then overall slowly in prevention of disease, morphing and compare to placebo.
Speaker Change: The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in prespecified clinical and biomarker endpoints in specific let me fill be groups compared to placebo for results from the clear mine Skyjack has been selected for.
Natalia Agapitova: Full results from the ClearMind study have been selected for a future research oral presentation at the 2024 Alzheimer Association International Conference, and Longeveron was invited to chair this session. We believe the results from ClearMind support the therapeutic potential of Lomicel B in the treatment of mild Alzheimer's disease and provide evidence-based support for further clinical development. We plan to meet with the FDA to review future clinical and regulatory strategies for the Alzheimer's program.
Speaker Change: Future research oral presentation at trying to thank you for a designer Association International Conference Inland General was invited to chair this session.
Speaker Change: He believes the resolve come clear mind support the therapeutic potential of flowing in Shelby in the treatment of mild Alzheimer's disease and provide that evidence based support for further clinical development.
Speaker Change: We plan to meet with the FDA to review future clinical and regulatory strategy for the <unk> program.
Natalia Agapitova: We are seeking partnership and non-dilutive funding to support further development of LomSLB in Alzheimer's disease. Finally, as previously announced as part of our strategic prioritization on HLHS, in the first quarter, we discontinued our aging-related frailty clinical trial in Japan. Cost savings from the discontinuation will support HLHS development and reduce but not eliminate our additional capital needs. We continue to believe in the potential of Lomacell B in this diseased state, and we will evaluate. Option for continued development at a future date. I will hand the call over to Lisa Locklear, our Chief Financial Officer, to discuss our financial results for the first quarter. Lisa?
Speaker Change: Now she can partnership and non dilutive funding to support further development of blood Michel D dimer.
Speaker Change: Behind her disease.
Speaker Change: Finally, as previously announced as part of our strategic prioritization on HLA chess in the first quarter.
Speaker Change: Just continue our aging related frailty clinical trial in Japan.
Speaker Change: Cost savings from the discontinuation, you'll support H L a chance development and reduce but not eliminate our additional kept adult meek.
Speaker Change: We continue to believe in the potential of long as they'll be in these disease states and D they'll evaluate.
Speaker Change: Options for continued development at <unk>.
Speaker Change: A future date.
Speaker Change: I will hand, the call over to Lisa Leclair, our Chief financial Officer to discuss our financial results for the first quarter Lisa.
Lisa Locklear: Thank you, Natalia, and good afternoon, everyone. This afternoon, we issued a press release and filed our quarterly report on Form 10-Q, both of which present our financial results in detail, so I will now touch on some highlights. Revenues for the first quarter of 2024 were $0.5 million, up $0.2 million, or 96% when compared to the first quarter of 2023, mainly as a result of increased participant demand for our Frailty and Cognitive Impairment Registry trial in the Bahamas.
Lisa Locklear: I can tell you and good afternoon, everyone.
Lisa Locklear: This afternoon, we issued a press release and filed our quarterly report on Form 10-Q.
Lisa Locklear: Of which presents our financial results in detail. So I will now touch on some highlights.
Lisa Locklear: Revenues for the first quarter of 'twenty 'twenty, four, whereas they were up <unk> $5 million of zero point $2 million or 96% when compared to the first quarter of 2023, mainly as a result of increased participants demand for our frailty and cognitive impairment registry trial in the Bahamas.
Contract manufacturing revenue for the three months ended March 31, 2024 was less than 0.1 million. However, S. Y L indicated we believe that there is an opportunity to expand this area of business to make use of our team's significant expertise and our state of the art G. M T.
Lisa Locklear: Contract manufacturing revenue for the three months ended March 31st, 2024 was less than 0.1 million. However, as Yael indicated, we believe that there is an opportunity to expand this area of business to make use of our team's significant expertise and our state-of-the-art GMP manufacturing facility.
Lisa Locklear: <unk> manufacturing facility.
Lisa Locklear: Total operating expenses for the first quarter declined 8% year over year.
Lisa Locklear: Total operating expenses for the first quarter declined 8% year over year. GNA expenses for the quarter increased $0.2 million to $2.2 million, while R&D expenses decreased approximately $0.6 million to approximately $2.2 million, both amounts as compared to the same period in 2023. The decrease in R&D expenses was primarily due to reduced expenses related to Alzheimer's disease, clinical trials including, and the discontinuation of the aging-related GRAIL-T clinical trial in
Lisa Locklear: G&A expenses for the quarter increased zero point $2 million to $2 2 million well.
Lisa Locklear: R&D expenses decreased approximately zero point $6 million to approximately $2 2 million both amounts as compared to the same period in 2023.
Speaker Change: The decrease in R&D expenses was primarily due to reduced expenses related to alzheimers disease clinical trials, including and the discontinuation of the aging related frailty clinical trial in Japan.
Speaker Change: Our net loss decreased to approximately $4 $1 million for the three months ended March 31, 2024 from a net loss of $4 $6 million for the same period in 2023.
Lisa Locklear: Our net loss decreased to approximately $4.1 million for the three months ended March 31st, 2024 from a net loss of $4.6 million for the same period in 2023. Cash and cash equivalents, and marketable securities as of March 31st, 2024 were $2.3 million. In April 2024, the company completed two capital raises, which resulted in gross proceeds of $11.4 million. The company believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024. I will now hand the call over to Dr. Joshua Hare, our Chief Science Officer and Chairman of the Board, to update you on several exciting changes to our Board of Directors. Josh?
Speaker Change: Cash and cash equivalents and marketable securities as of March 31, 2024, or $2 $3 million.
Speaker Change: In April 2024, the company completed two capital raises which resulted in gross proceeds of $11 $4 million.
Speaker Change: The company believes its existing cash and cash equivalents equivalents will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024.
Speaker Change: I will now hand, the call over to Dr. Joshua here, our Chief Science Officer, and Chairman of the board to update you on several exciting changes to our board of directors Josh.
Joshua Michael Hare: Thank you Lisa and good afternoon, everyone.
Joshua Michael Hare: Thank you, Lisa, and good afternoon, everyone. Since the founding of this company, we have made tremendous clinical progress with Lomacell-B. That success in the clinic has not been without corporate challenges, challenges that we've been able to navigate with the assistance and guidance of a terrific Board of Directors. Recognizing Longeveron's continued growth and evolution, we implemented a planned board refreshment process with a focus on bringing in new, relevant, experienced leaders over time to add to the knowledge base and experience provided by current and departing board members. As part of this process, Jeffrey Pfeffer and Kathy Ross have left the board, and Dr. Doug Lasordo will not run for re-election at the end of his term at the upcoming annual shareholder meeting next month.
Josh: Since the founding of this company, we have made tremendous clinical progress with low Miss L. B.
Rec: That success in the clinic has not been without corporate challenges challenges have you been able to navigate with the assistance and guidance of a terrific board of directors Rec.
Speaker Change: Recognizing longevity lines continued growth and evolution, we've implemented a plan to board refreshment process with a focus on bringing in new relevant experience leaders overtime to add to the knowledge base and experience provided by current and departing board members.
Speaker Change: As part of this process, Jeffrey Pfeffer and Cathy Ross departed the board and Dr. Douglas sort of will not run for reelection at the end of his term at the upcoming annual shareholder meeting next month.
Joshua Michael Hare: On behalf of the board and company, I want to recognize and thank them for their leadership and many contributions. Their guidance and insights have been instrumental in Longeveron's success to this point, and we will miss their collaboration. We are delighted to have attracted several new experienced industry veterans that are interested in joining the Longeveron board. Richard Kender has been appointed to the board, filling the seat vacated by Jeffrey Pfeffer. Dr. Raja Hajjar and Neha Madhwani have been nominated as candidates for the board to replace Dr. Lasordo and Kathy Ross, subject to their election at our upcoming annual meeting of stockholders next month. I believe all three of these individuals will add tremendous value to the board and to Longeveron. Rich Kinder is a retired Senior Vice President of Business Development and Corporate Licensing at Merkin Company, Inc.
Speaker Change: On behalf of the board and company I want to recognize and thank them for their leadership and many contributions their guidance and insights were instrumental in longevity and success to this point and we will miss their collaboration.
Speaker Change: We are delighted to have attracted several new experienced industry veterans that are interested in joining the longevity onboard.
Speaker Change: Richard tender has been appointed to the board selling the seat vacated by Jeffrey Pfeffer.
Speaker Change: Dr. Roger a jar and do you have much Ronnie has been nominated as candidates for the board to replace Doctor Lasorda on Cathy Ross subject to their election at our upcoming annual meeting of stockholders next months.
unknown: I believe all three of these individuals will add tremendous value to the board and to longevity.
Speaker Change: Rich Kinder is a retired senior vice president of business development and corporate licensing of American Company incorporated.
Joshua Michael Hare: 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. Dr. Raja Hajjar brings incredible experience as a scientist, academic, and operational executive. He is 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 are doing here at Longeveron.
Unknown Executive: He spent his entire professional career at Merck and various corporate roles of increasing responsibility and was involved in more than 100 business development and licensing transactions.
Doctor Roger her jar brings incredible experience as a scientist academic and operational executive. He is an internationally recognized scientists, whose cardiac gene therapy discoveries has spurred clinical trials for heart failure, and whose methodologies for cardiac directed gene transfer are currently utilized by Investor investigator.
Unknown Executive: Around the world.
Speaker Change: So he knows quite a lot about what we are doing here at longevity.
Joshua Michael Hare: 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. Finally, the third board candidate, Neha Matwani, has over 25 years of healthcare investment and banking experience. Recently, she served as Managing Director, 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.
Doctor Roger: He was recently head of R&D at ring Therapeutics.
Speaker Change: Was appointed as the inaugural director of the gene and cell therapy Institute at Mass General Brigham.
Speaker Change: Finally, the third board candidates you have much one he has over 25 years of health care investment banking experience. Most recently, having served as managing director health care investment banking at William Blair.
Speaker Change: She previously held investment banking roles of increasing responsibility was truest securities Oppenheimer and company.
Speaker Change: Stifel financial and Cowen and company wide collectively should completed transactions raising over $6 $8 billion.
Joshua Michael Hare: I am delighted Rich has joined the board and enthusiastically support the election of Raja and Neha at the upcoming annual meeting of stockholders. I believe their experience, expertise, and insights will help guide Longeveron through its next stages of growth and opportunity. Thank you all very much, and I will now turn the call back to Weill.
Speaker Change: I'm delighted richest joined the board and enthusiastically supports the election of Roger in knee.
Speaker Change: At the upcoming annual meeting of stockholders I believe their experience expertise and insights will help guide longevity on through its next stage of growth and opportunity.
Speaker Change: Thank you all very much and I will now turn the call back to awhile.
Josh: Thank you Josh.
Speaker Change: We believe there are tremendous opportunity in our cellular therapy research and with Lance I'll be there.
Mohamed Wa'el Ahmed Hashad: We believe there are tremendous opportunities in our cellular therapy research and with Lomacell-B. The strength of initial clinical data from ALPIS-1 and CLEARMIND reinforces that belief. Our clinical development program in HLHS and Alzheimer's disease is designed to evaluate nominal B's potential in these indications in order to potentially provide new therapeutic options to patients impacted by these devastating diseases. With multiple upcoming important catalysts, we believe 2024 has the potential to be a transformational year for Longeveron. Operator, we would now like to open the call for questions from covering analysts.
Josh: Trends.
Speaker Change: Initial clinical data from Opus, one and clearer minds reinforces that belief.
Speaker Change: Our clinical development program and actually check in Alzheimer disease are designed to evaluate <unk> potential in these indications in order to potentially provide new therapeutic options to patients impacted by these devastating diseases.
Speaker Change: With multiple upcoming important catalysts, we believe 2024 has the potential to be a transformational year for lingerie bra.
Operator, we would now like to open the call for questions from covering analysts.
Speaker Change: Thank you Sir.
Operator: Ladies and gentlemen, if you'd like to ask a question, please press the star key followed by the number 1 on your touch-tone phone. A confirmation tone will indicate that your question is in the question queue. If you would like to withdraw your question, please press star, followed by the number two. If you are using speaker equipment, please lift the handset before making your selection. Our first question comes from Ram Solvaraju of H.C. Wainwright; please go ahead.
Speaker Change: Ladies Sanchez.
Speaker Change: About half the question please.
Speaker Change: All key photos bought the number one on a touchtone phone.
Speaker Change: Conservation 10 whole indicates epsilon is in the question queue.
Speaker Change: If you talk to the Troy Christian piece with stone.
Speaker Change: The stocky polypropylene number twos.
Speaker Change: If you like using speaker equipment piece.
Speaker Change: Please lift the handset before making affliction.
Speaker Change: Our first question comes from rent Silverado shoes of H C. Wainwright. Please go ahead.
Speaker Change: Thanks, very much for taking my questions are two regulatory items. Please firstly with respect to the applicability of Columbus L. B in HLA chats.
Ram Kumar Subramanyan: Thanks so much for taking my questions. Two regulatory items, please. Firstly, with respect to the applicability of Lomacel B in HLHS. If we look at the hypothetical scenario in which the ongoing study replicates the earlier clinical data, what perspectives can you provide to us regarding the regulatory receptivity to such a result and the potential for the drug to be the subject of accelerated approval? And what other parameters, if any, should be taken into consideration here?
Speaker Change: If we look at the hypothetical scenario in which the ongoing study replicate the earlier clinical data.
Speaker Change: What perspective can you provide to us regarding the regulatory receptivity to such a result, and the potential for the drug to be the subject of accelerated approval and what other parameters if any might be taking it and took into consideration here.
Speaker Change: Yeah.
Speaker Change: Alright, well granted thank you so much for that question.
Operator: Thank you.
Speaker Change: I will tell you that our intention is right now is that with the to finalize submitting the briefing book end and ask what they taught me meeting and our goal is to ask for actually the potential of getting full approval not just accelerator approval and our backup plan is accelerated approval.
Mohamed Wa'el Ahmed Hashad: All right. Well, Graham, thank you so much for that question.
Mohamed Wa'el Ahmed Hashad: I will tell you that our intention right now is to finalize the briefing book and ask for the TADME meeting. And our goal is to ask for the potential of getting full approval, not just accelerated approval. But our backup plan is accelerated approval.
Speaker Change: But our primary target is a full approval.
Mohamed Wa'el Ahmed Hashad: But our primary target is a full approval of LOMIS-LB and HLHS. The second point, I will probably have Natalia take this one, but I want to remind you that the Phase I program was not done as a head-to-head trial with only 10 patients. All of them have received Lomacell B. The Phase II program is done as a head-to-head program with 19 patients in each arm of the standard of care and the other 19 patients with adjunct therapy of Lomacell B. With that, I will have Natalia or Dr. Hare make comments related to the endpoints and the clinical outcomes that we can drive from Phase I into Phase II.
Speaker Change: Our numbers will be and I tell my chats.
Speaker Change: The second point I will have Natalia probably I take this one but I wanted to remind you that.
Speaker Change: The phase one program was not done.
Speaker Change: Had to had Ah trial was only 10 patients all of them have received enormous there'll be the.
The phase II program as Don has a head to head program with 19 patients in each arm of the standard of care and the other 19 patients with junk therapy lummus there'll be with that I will have Natalia or doctor here my comments related to the endpoint in the clinical.
Speaker Change: Outcome that we can drive from phase one into cruise too.
Natalia Agapitova: Absolutely. Thank you so much.
Absolutely. Thank you so much and grant I would like to Echo the same comments you get to where he held that they're current clinical trial L. P store.
Natalia Agapitova: And, Grant, I would like to echo the same comment with Vaheel that the current clinical trial, LPS-2, is a standard of care control trial, which, as you know, probably in rare disease indications is a big benefit for seeing results in a controlled fashion. Additionally, we are exploring all kinds of opportunities to design and design a good statistical methodology to show, increase the probability of success. As you know, this trial is a 12-month trial, and a lot of time based on the physiological changes and condition of these children, we would need a little bit longer.
Speaker Change: If its a standard of care controlled trial of each as you know.
Speaker Change: No probably in rare disease indication is a big being issued for C and.
Speaker Change: Out in a controlled fashion.
Speaker Change: I'm very we are exploring all kind of opportunities store.
Speaker Change: Design and design a good statistical methodology to the show.
Speaker Change: To increase probability of success as you know this trial is it 12 months Ah trial and a lot of time based on the physiological changes and Hum condition of these children do people do need a little bit longer time. However, there are parameters scar Jeff barometer.
Natalia Agapitova: However, there are parameters, cardiac parameters, and extracardiac parameters, which can be seen within 12 months after the injection of Lomicell directly into myocardium. And we are definitely going to have a conversation about it with FDA, again, to have this dialogue to make sure that the probability of success is there. Thank you.
Speaker Change: Truecar, Jeff behind it there, which can be seen it until months after their injection of Columbia, So directly into my car jump and then they send at least going to have a conversation about it gets for F. E. Again, they'll have this dialogue to make sure that their probability of successes.
Speaker Change: Thank you.
Speaker Change: Yeah.
Speaker Change: That's very helpful and with respect to the potential future.
Ram Kumar Subramanyan: That's very helpful. With respect to the potential future development of Lomacel B in Alzheimer's disease, I was wondering if you could comment on the regulatory guidance that appears to indicate that impact on a single clinical efficacy endpoint, notably the ADAS-COG scale, would be considered sufficient to entertain the possibility of approval of an investigational drug product in early Alzheimer's disease patients. And I was just wondering what implications this guidance may have for the future development of Lomacel B in the Alzheimer's disease context, along with the information that we already have indicating that Lomacel B may have safety advantages versus existing approved anti-Alzheimer's drugs, particularly with respect to the absence of ARIA seen so far in clinical development.
Speaker Change: Future development of almost they'll be in Alzheimers disease. I was wondering if you could comment on the regulatory guidance that appears to indicate that impact on a single clinical efficacy endpoint, notably the Adas cog scale would be considered sufficient for entertaining the possibility.
Speaker Change: Approval of an investigational drug product in early Alzheimers disease patients and I was just wondering what implications. This guidance may have for the future development of all myself be you'd be Alzheimer's to these contracts along with the information that we already have indicating that by myself.
Speaker Change: <unk> may have safety advantages versus existing approved anti Alzheimer's drugs, particularly with respect to the absence of E. R. I a theme so far in clinical development. Thank you.
Speaker Change: So I will take that Oh, Okay go ahead.
Mohamed Wa'el Ahmed Hashad: So, I will see you in a minute.
Operator: Thank you.
Mohamed Wa'el Ahmed Hashad: I will just add a couple of things, and I will have Natalia give you more details as well, Graham, on this one. As you know, there is a draft document that was circulated by the FDA looking also for inputs from all parties, including the industry, into potential surrogate endpoints as well as for Alzheimer's disease. I think the agency has definitely realized that current... I would say available endpoints to the industry are not enough, and there is room to change or modify some of these things to help companies bring more therapies into the marketplace in a much more streamlined fashion.
Speaker Change: I was going to say I'll I'll take just just to add a couple of things and I will have that and I tried to give you more details as well Graham on this one.
Speaker Change: As you know they are there is a draft document that was circulated by the M D.
Speaker Change: Looking also for inputs from.
Speaker Change: All parties, including the industry into potential surrogate endpoints as well related to.
Speaker Change: Two alzheimer disease I think the agency.
Speaker Change: Have definitely realize that that current.
Speaker Change: I would say.
Speaker Change: Available and points to the industry is not enough and there is a room to it.
Italia: The change or modify some of these things are to help companies, bringing more therapies into the marketplace in a much more streamlined fashion and of course, we are planning to provide our inputs as part of that and that process as well with that being said I will have and Italia I'd give you a little bit of why we still believe.
Mohamed Wa'el Ahmed Hashad: And of course, we are planning to provide our inputs as part of that process as well. With that being said, I will have Natalia give you a little bit of why we still believe we are very confident about, even with the existing guidelines for approval. We're still very optimistic about our plan, and we want to move forward, of course. And Natalia, feel free to add to that. Absolutely. Thank you so much. Graham, you mentioned this.
Italia: We are very confident about our even with the existing guidelines are for approval. We're still very optimistic about our plan and that we want to move forward Golf course, and that's how you feel free to add to that.
Absolutely. Thank you so much rail grandmother, you mentioned this empty guidelines, which actually wasn't really a good and positive message for all of us and them as well as for the community and our designer disease and Ah our proof of concept phase two a study probably the stronger.
Natalia Agapitova: Graham, you mentioned the FDA guidelines, which actually were a really good and positive message for all of us, as well as for the community dealing with Alzheimer's disease. In our proof-of-concept Phase IIa study, probably the strongest result besides showing some improvement and stabilization in cognitive function, we've seen a lot of data points to show the slowing of brain volume decrease and deterioration. We also did a number of post hoc analyses, which shows that there is a connection between the slowing of brain volume and the cognitive and functional improvement, which is a great positive finding.
Italia: She's now decide are showing some improvement and stabilization in cognitive function. They see in a lot of a data point to show the slowing of brain volume decrease and decoration.
Speaker Change: We also did a number of post hoc analysis, which shows that there is a connection between the slowly in North Dakota, Brian brain volume.
Speaker Change: The cognitive and functional improvement, which is a great project to find games when do we find.
Natalia Agapitova: When we found out about these guidelines, actually, it gave us more opportunities to have dialogue with FDA, have dialogue with the experts in this field to design clinical trials, having in mind that imaging biomarkers, such as brain volume. We have a slightly different approach to Alzheimer's disease treatment.
Speaker Change: Find out about this guidelines actually gave us it gave us more opportunities to have dialogues with M. D have dialogues with the experts in the steel to design clinical trial.
Speaker Change: Having in mind that imaging biomarkers, such as the brain volume.
Speaker Change: If you have a slightly different approach for alzheimers disease treatment.
Natalia Agapitova: We're trying to target early Alzheimer's disease, MCI, and patients with Alzheimer's disease, mild dementia, where we can prevent not only cognitive function, not only brain volume changes, but also cognitive function by demonstrating and by designing a combination of imaging biomarkers and clinical biomarkers. So I think we have a great potential to have a next-stage, face-to-face study to implement all the brain imaging biomarkers, definitely with We do have some preliminary thoughts on our next design.
Speaker Change: You're trying to target early Alzheimers disease M. C. I end up you should see a designer.
Speaker Change: Disease mild dementia, where does he can prevent them not only cognitive function not only the brain volume changes, but also causing you to function.
Speaker Change: By demonstration and by design in a combination of imaging Biomarkers and clinical biomarker saw them I think we have a great potential to have a next stage phase two least idea to implement all the brain imaging biomarkers, yes. He is.
Speaker Change: So they cannot leave is a good a validated clinical scales. We do have some preliminary thoughts are on now next design they send Natalie.
Natalia Agapitova: Definitely, cognitive and functional measures will probably be up front. We are thinking maybe about CDRS-B, maybe a combination of outcomes that have been implemented before, followed by the great key secondary endpoints, which are imaging biomarkers and ADAS cognitive skills and MOCA skills, et cetera. So having results of our phase 2a study really helps us to navigate to the future of our design and development. And also, a vast majority of literature right now says that there is an opportunity to design Alzheimer's disease studies with imaging biomarkers with less financial burden and smaller sample size. And we are trying to be very creative but scientifically correct to explore that opportunity as well.
Speaker Change: Cognitive and functional measure so there'll be a probably upfront we I think it may be about.
Speaker Change: C J R as being maybe a combination outcomes.
Speaker Change: <unk> has been implemented before.
Speaker Change: Followed by a great a key secondary endpoint, which are imaging biomarkers from dusk cognitive scales.
Speaker Change: Smoker skills et cetera, so hadn't resolved or follow up phase two <unk> study really help us to navigate to the future of our design and development.
Speaker Change: And also there the vast majority of literature I tried now speaking that there is an opportunity to design.
Speaker Change #100: Assign their disease stadia August imaging Biomarkers this less a financial burden.
Speaker Change #100: And a smaller sample size and they are trying to be very creative but scientifically.
Correct.
Speaker Change #100: To explore that opportunity is at all.
Speaker Change #100: Yeah.
Speaker Change #101: Thank you very much.
Speaker Change #102: Thank you.
Speaker Change #101: Yeah.
Speaker Change #107: Ladies and gentlemen, we have reached the end of our question and answer session.
Operator: Ladies and gentlemen, we have reached the end of our question-and-answer session. I will now hand over to Ayub Hashad for closing.
Speaker Change #108: I'll now hand over to light a shot.
Speaker Change #101: Okay.
Speaker Change #103: Thank you and I wanted to thank you all for attending today's call.
Mohamed Wa'el Ahmed Hashad: Thank you. And I wanted to thank you all for attending today's call. We greatly appreciate your interest and support and look forward to updating you on our progress throughout the year.
Speaker Change #104: Greatly appreciate your interest and support and look forward to updating you on our progress throughout the year.
Operator: Thank you. Operator, you may end the call. Thank you. Ladies and gentlemen, that concludes today's event. Thank you for...
Speaker Change #106: Operator, you may end the call now.
Speaker Change #104: Thank you.
Operator: Ladies and gentlemen, that concludes today's event. Thank you for attending, and even I'll disconnect you now.
Speaker Change #105: Ladies and gentlemen that concludes today's event. Thank you for attending and even now disconnect your lines.
Speaker Change #104: Thank you.
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Speaker Change #104: Mhm.
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Speaker Change #104: Uh-huh.