Full Year 2024 Longeveron Inc Earnings Call
Unknown Executive: Good day and welcome to the Longeveron 2024 Full Year Financial Results Conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation.
Good day and welcome to the longevity around 'twenty 'twenty, four and full year financial results Conference call.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
Unknown Executive: If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
If anyone should require operator assistance. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.
Derek Cole: I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions. Please go ahead. Thank you, Paul. Good afternoon, everyone. And thank you for joining us today to review Longeveron's 2024 full-year financial results and our business update. After the US markets closed today, we issued a press release with financial results for 2024, which can be found under the investor section of the Longeveron website.
Speaker Change: I'd now like to hand, the call over to Derek Cole of Investor Relations Advisory solution. Please go ahead.
Speaker Change: Thank you Paul Good afternoon, everyone and thank you for joining us today to review longevity, <unk> 'twenty 'twenty, four or full year financial results and business update.
Speaker Change: The U S markets closed today, we issued a press release with financial results for 2024, which can be found under the investors section of the longevity on website.
Derek Cole: On the call with me today are Wael Hashad, Chief Executive Officer, Nataliya Agafonova, Chief Medical Officer, Lisa Locklear, Chief Financial Officer, and Dr. 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 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 Security Exchange Commission, which we encourage you to review.
Speaker Change: On the call with me today are while <unk>, Chief Executive Officer, and Italia, AGA Vanilla box, Chief Medical Officer, Lisa lot clearer Chief Financial Officer and Dr. Joshua Here Co founder Chief Science Officer, and Chairman of the board.
Speaker Change: 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 Exchange Commission, which we encourage you to review.
Derek Cole: Following the company's prepared remarks, we will open the call to questions from our covering analysts.
Speaker Change: Following the company's Premier prepared remarks, we will open the call to questions from our covering analysts with that let me hand, the call over to Wild Horse Shah Chief Executive Officer, while.
Wael Hashad: With that, let me hand the call over to Wael Hashad, Chief Executive Officer. Wael? Thank you, Derek. Good afternoon, everyone. And thank you very much for joining us today.
Speaker Change: Thank you Derek good afternoon, everyone and thank you very much for joining us today.
Wael Hashad: We are very pleased to update you on a highly productive year in 2024 and provide an overview of what to expect and potentially transformational 2025 for Longeveron. 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 stem cell therapy, Lomacell B, or Larimestral Cell, represents a pipeline and a product opportunity that has delivered several positive initial results across five clinical trials and three indications. Phase 1 and 2 in Alzheimer's disease, Phase 1 and 2 in aging-related frailty, and Phase 1 in HLHS or hypoplastic left heart syndrome, a rare pediatric disease condition.
Speaker Change: We are very pleased to update you on highly productive year in 2024 and provide an overview of what to expect and potentially transformational 2025 for lunch I got wrong.
Speaker Change: As a reminder for those of you and you went to our story.
Speaker Change: Launch of alone is that a regenerative medicine company developing cutting edge cellular therapies.
Speaker Change: Our stem cell therapy, Lamassoure, b or latter metro cell represents a pipeline in a product opportunity that has delivered several positive initial results across five clinical trials and three indications.
Speaker Change: Phase, one and two and now assignment disease phase.
Speaker Change: Phase, one and two and aging related frailty and phase, one and SMA chest or hypoplastic left heart syndrome, a rare pediatric disease condition.
Wael Hashad: The company development program for these three initial indications address U.S. market opportunity of approximately five plus billion, approximately four plus billion, and up to one billion dollar risk factor. Longeveron continued to make progress in 2024 with both the LAMSLB and HLHS and Alzheimer's disease program. Hypoplastic left heart syndrome, or HLHS, is a key strategic priority for us. We believe the HLHS program has high probability of success and the shortest path to potential regulatory approval and commercialization across our pipeline. In 2024, we continue to advance enrollments in our ongoing Phase 2B study, Office 2. which is evaluating glomus LB as a potential adjunct treatment for HLHS.
Speaker Change: Company Development program for these three initial indications at the dress U S market opportunity about approximately five plus billion approximately four plus billion and up to $1 billion respectively.
Speaker Change: <unk> continued to make progress in 2024 with both the lummus there'll be an SLA chats in alzheimer disease programs.
Speaker Change: Hypoplastic left heart syndrome, or <unk> is a key strategic priority for us.
Speaker Change: We believe that's how they test program has high probability of success and the shortest path to potential regulatory approval and commercialization across our pipeline.
Speaker Change: In 2024, we continued to advance enrollment in our ongoing phase II B study a phase II.
Speaker Change: Which is evaluating <unk> as a potential adjunctive treatment for HLA chess.
Wael Hashad: Office 2 has now achieved more than 90% enrollment, and we expect to complete enrollment in the second quarter of this year. Also importantly, last year we completed a meeting with the U.S. Food and Drug Administration, the FDA, which confirmed that LPIS-2 is a pivotal and, if positive, acceptable for biological license application or BLA submission for full traditional approval. This significantly accelerates the potential regulatory path for Lomacell B, and if supported by clinical data from ALPHA-2, would allow us to initiate a rolling submission of a BLA with the FDA in 2026.
Speaker Change: Up as to what has now achieved more than 90% enrollment.
Speaker Change: We expect to complete enrollment in the second quarter of this year.
Also importantly last year, we completed a meeting with the U S food and drug administration, the FDA, which confirmed that opus two is a pivotal and if positive acceptable for biological license application or BLA submission for full traditional approval.
Speaker Change: This significantly accelerates the potential regulatory path for <unk> B and if supported by clinical data from up as to what that allow us to initiate a rolling submission of a BLA with the FDA in 2026.
Wael Hashad: We also continue to advance the Alzheimer's disease program results from our ClearMind Phase 2A clinical trial was presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference, AAIC. Based on the ClearMind Phase 2a clinical data and prior Phase 1 data, the FDA granted Lomacell-B both regenerative medicine advanced therapy designation, also known as RMAT, and fast-track designation for the treatment of mild Alzheimer's disease. Lomacell B appeared to be the first cellular therapy candidate to receive our MAD designation for Alzheimer's. With this data in hand, we anticipate meeting with the FDA later this quarter to review future clinical and regulatory strategy for continuing this important program.
Speaker Change: We also continued to advance the Alzheimer disease program. The results from our clear mind Phase Iia clinical trial was presented and that featured research oral presentation at the 2020 for Alzheimer's Association International Conference.
Speaker Change: Yeah.
Speaker Change: Based on the clear mind phase Iia clinical data and prior phase one data the FDA granted wamus there'll be both regenerative medicine advanced therapy designation also known as our mat and fast track designation for the treatment of mild Alzheimer's disease.
Speaker Change: <unk> appear to be the first cellular therapy candidate.
Speaker Change: To receive our mad designation for Alzheimers disease.
With this data in hand, we anticipate meeting with the FDA later this quarter.
Speaker Change: To review future clinical and regulatory strategy for continuing this important program.
Wael Hashad: 2025 has the potential to be a transformative year for Longeveron, with achieving clarity on Alzheimer's development pathway, completing enrollment for the HLHS Phase 2 trial, which would establish a potential timeline for our first DLA submission in 2026. Starting the year off well, in February, the International Non-Proprietary Name INN Expert Committee of the World Health Organization approved Laramaster Cell for the non-proprietary name of the company's cellular therapy Lomacell-B. This naming approval is an important step in the development and the potential commercialization of Llamaselva.
Speaker Change: 2025 has the potential can be a transformative year for lingerie bra with achieving clarity on Alzheimer's development pathway completing enrollment for the <unk> phase III trial, which would establish a potential timeline for our first BLA submission in 2026.
Speaker Change: Starting the year off well in February the international non proprietary name <unk>.
And then expert committee of the <unk>.
Speaker Change: World Health organization approved lateral master cell for the non proprietary name of the company cellular therapy Lamassoure B.
Speaker Change: This naming approval is an important step in the development and potential commercialization of <unk>.
Wael Hashad: I am thoroughly excited by the opportunity for Lomacell B, Longeveron, patients and our stockholders.
Speaker Change: Hi, I'm thoroughly excited by the opportunity for Lamassoure b launch of their own patients and our stockholders.
Nataliya Agafonova: With that, I will turn the call to Dr. Agafonova to provide update on our clinical development program. Natalia. Thank you all and good afternoon, everyone. Our stem cell therapy, LoniCell-B, has multiple models of action that include provascular, pro-regenerative, and anti-inflammatory mechanisms, promoting tissue repair and healing both broad potential applications across the spectrum of disease areas. Based on positive initial data, LOMIS-LB development programs have received five FDA designations. For the HLHS program, Orphan Drug Designation, Fast Drug Designation, and Rare Pediatric Disease Designation. And for the Alzheimer's Disease Program, Regenerative Medicine Advanced Therapy, RMAD Designation, and Fast Drug Designation, each of which offers benefits for the program's development and regulatory process.
Speaker Change: With that I will turn the call to Doctor I got for Nova to provide update on our clinical development program.
Speaker Change: Yeah.
Doctor I: Thank you, Brian and good afternoon, everyone.
Speaker Change: Hello stem cell therapy, let me fill b has multiple models of action that conclude our vascular product January two.
Speaker Change: Anti inflammatory mechanism promoting tissue repair and healing bought brought potential applications across across the spectrum of disease areas.
Speaker Change: Based on positive initial data alone is there'll be development programs have received five M D designation.
For the HLA <unk> program orphan drug designation fast track designation and rare pediatric disease designation.
Speaker Change: And for the <unk> program for generators Medicine advanced therapy designation and fast track designation each of that each offers benefits for the program development and regulatory process.
Nataliya Agafonova: As Wael mentioned, our HLHS program is a primary focus. with a near-term pathway to potential approval in a rare area of unclear, unmet medical need. We are currently conducting a Phase IIb clinical trial, LPS-II, evaluating the potential of Lomicell B to improve right ventricular function and long-term outcomes in pediatric patients with HLHM. LPS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute through grants from the National Institute of Health. We are very pleased to share that LPS-2 has now achieved over 90% enrollment. We expect to complete enrollment of this trial before the end of the second quarter, and then we'll follow the patients for 12 months.
Speaker Change: It's why you mentioned our <unk> program is a primary focus for us with the New York their pathway to potential approval in that rare area.
Speaker Change: I'm clear I'm clear unmet medical need.
Speaker Change: We are currently conducting a phase two b clinical trial LP store.
Speaker Change: Evaluating the potential of <unk> to improve right and Chick Fil a function and long term outcomes in pediatric patients with HLA chess.
Speaker Change: <unk> is being conducted in collaboration with the National Heart lung and Blood Institute.
Speaker Change: Grants from the National Institute of Health.
Speaker Change: We are very pleased to share that <unk> has now achieved over 90% enrollment.
Speaker Change: First to complete enrollment of this trial before the end of the second quarter and then we'll follow the patients for 12 months.
Nataliya Agafonova: If results from LPS-2 are positive, we would be positioned to initiate a roll-in BLA submission with the FDA-incentive link.
Speaker Change: If results from <unk> to a positive, but it will be positioned to initiate their OLED BLA submission with the FDA basically just six.
Nataliya Agafonova: Turning now to our Alzheimer's disease program. This is also an area of significant unmet need. Nearly 7 million Americans are living with Alzheimer's disease. It kills more people than breast cancer and prostate cancer combined. And there has not been great progress in this area. Between 2000 and 2021, death from heart disease decreased 2.1%, while death from Alzheimer's disease increased 141%. Potentially helping provide a new option for these patients and their families is our mission. And we are optimistic given the longest of the data to date.
Speaker Change: Turning now to our examiner disease program.
This is also an area of significant unmet need.
Speaker Change: Nearly 7 million Americans are leading with Alzheimer's disease, it kills more than most people in breast cancer and prostate cancer combined.
Speaker Change: And there has not been great progress in this area between 2000 2021 deaths from heart disease decreased two 1% while death diagnose disease increased 141%.
Speaker Change: But then surely helping provide a new option for these patients and their families is our mission.
Speaker Change: And we are optimistic given the long as there'll be data to date.
Nataliya Agafonova: In 2024, data from CLEARMIND Phase 2a clinical trial evaluating Lomicell B in Alzheimer's disease were selected for a future research oral presentation at the 2024 Alzheimer's Association International Conference, held at the end of July. We are very excited about the trial positive results which we have reviewed previously. The trial achieved the primary safety and secondary efficacy endpoints and the clinical trial Lomicell B treated patients showed an overall slowing prevention of disease worsening compared to placebo. We believe the results from ClearMind support the therapeutic potential of Lomicel B in the treatment of mild Alzheimer's disease and provided evidence-based support for further clinical development.
Speaker Change: Thank you for data from clear mindfully to a clinical trial evaluating <unk> in our designer disease were selected for a huge huge oral presentation.
Speaker Change: Thank you. Thank you for Diamond Association International Conference held at the end of July.
Speaker Change: We are very excited about the trial's positive results.
Speaker Change: We have reviewed previously the trial achieved the primary safety and secondary efficacy endpoints.
Speaker Change: And the clinical trial, let me still be achieved the patients showed an overall slowing prevention of disease worsening compared to placebo.
Speaker Change: We believe the results from clear mine support the therapeutic potential of <unk> in the treatment of my eyes.
Speaker Change: Diagnose disease and provided evidence based support for further clinical development.
Nataliya Agafonova: Based on the data generated in our Phase 1 and Phase 2 Alzheimer's clinical trials, in July, the FDA has granted Lomacell B both regenerative medicine advanced therapy, ARMAT designation, and fast track designation for the treatment of mild Alzheimer's.
Speaker Change: Based on the data generated in our phase one and phase two clinical.
Speaker Change: Clinical trials in July the FDA has granted Laramie Sobibor regenerative medicine advanced therapy are mark designation and fast track designation for the treatment of mild Alzheimer's disease.
Nataliya Agafonova: We plan to meet with the FDA in March to review the future clinical and regulatory strategy for the Alzheimer's program to continue advancing this potentially important therapeutic option for patients living with Alzheimer's disease.
Speaker Change: We plan to meet with the FDA in March to review, the future clinical and regulatory strategy for that program to continue I think in this potentially important therapeutic option for patients, but we didn't give underdiagnosed disease.
Lisa Locklear: I will hand the call over to Lisa Locklear, our Chief Financial Officer, to discuss our financial results for the year. Thank you, Nataliya. And good afternoon, everyone.
Speaker Change: I will hand, the call over to we still are clear, our chief financial officer to discuss our financial results for the year Lisa.
Lisa: Thank you Natalia and good afternoon, everyone.
Lisa Locklear: This afternoon, we issued a press release and filed our annual report on Form 10-K, both of which present our financial results in detail. So I will touch on some highlights. Revenues for 2024 were $2.4 million, up $1.7 million or 237% when compared to 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. Contract manufacturing revenue for 2024 was $1 million, consisting of $0.5 million from our manufacturing lease services and another $0.5 million from our manufacturing services contract.
Lisa: This afternoon, we issued a press release and filed our annual report on Form 10-K, both of which present our financial results in detail. So I will touch on some highlights.
Lisa: Revenues for 2024, or $2 $4 million up $1 $7 million or 237% when compared to 2023, mainly as a result of increased purchase demand for our frailty and cognitive impairment registry trial in the Bahamas, and new contract Manny.
Lisa: Factoring revenue contract manufacturing revenue for 2024 was $1 million.
Lisa: Consisting of zero point $5 million from our manufacturing lease surfaces, and another <unk> $5 million from our manufacturing services contract.
Lisa Locklear: This year, we have focused on prioritizing investments in our clinical programs and expense management, and we have successfully executed in both areas. Total operating expenses for the year declined 13% year-over-year, with G&A expenses decreasing to approximately $10.3 million from $12.2 million in 2023. This G&A expense decrease of approximately $1.9 million, or 16%, was primarily due to lower personnel expenses as a result of reduced severance in 2024 and lower legal and other administrative expenses. R&D expenses for 2024 also decreased approximately $1 million or 10% to approximately $8.1 million. The decrease was primarily due to a reduction of $2.3 million in expenses related to the completed ClearMind Alzheimer's Disease clinical trial, reduced costs for the aging-related frailty clinical trial following our decision earlier this year to discontinue trial activities in Japan, and a $0.9 million decrease in supply costs.
Lisa: This year, we are focused on prioritizing investments in our clinical programs and expense management and we have successfully executed in both areas.
Lisa: Total operating expenses for the year declined 13% year over year, the G&A expenses decreasing to approximately $10 3 million from $12 $2 million in 2023 <unk>.
Lisa: SG&A expense decrease of approximately $1 9 million or 16% was primarily due to lower personnel expenses as a result of reduced severance in 2024, and lower legal and other administrative expenses.
Lisa: R&D expenses for 2024 also decreased approximately $1 million or 10% to approximately $8 1 million.
Lisa: The decrease was primarily due to a reduction of $2 3 million in expenses related to the completed clear mind Alzheimers disease clinical trial reduced cost for the aging related royalty clinical trial. Following our decision earlier this year to discontinue trial activities in Japan and.
Lisa: <unk> 9 million decrease in supply costs. These reductions were partially offset by $1 7 million in higher compensation and benefit costs in R&D and another zero point $3 million increase in equity based compensation for that team.
Lisa Locklear: These reductions were partially offset by $1.7 million in higher compensation and benefit costs in R&D, and another $0.3 million increase in equity-based compensation for that team. Net loss decreased 25% to approximately $16 million for 2024 from a net loss of $21.4 million for 2023. Cash and cash equivalents as of December 31, 2024 were $19.2 million.
Lisa: Net loss decreased 25% to approximately $16 million for 2024 from a net loss of $21 4 million for 2023.
Lisa: Cash and cash equivalents as of December 31, 2024 were $19 $2 million.
Lisa Locklear: 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 2025 based on our current operating budget and cash flow forecast. It is important to note, however, that as a result of our Type C meeting with the U.S. FDA in August 2024, with respect to the HLHS regulatory pathway, we have started to ramp up Biologics License Application, BLA, enabling activities as we currently anticipate a potential filing with the FDA in 2026 if the current ELPIS-II trial is successful. Our operating expenses and capital expenditure requirements are expected to accelerate in calendar 2025 as a result of these activities, including CMC chemistry manufacturing controls and manufacturing readiness spent as we prepare for the BLA.
Lisa: The company believes that existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025 based on our current operating budget and cash flow forecast.
Lisa: It's important to note however that as a result of our type C meeting with the U S. FDA in August 2024, with respect to the HL Hs regulatory pathway. We have started to ramp up biologics license application BLA, enabling activities as we currently anticipate a potential filing with the FDA in 2026.
Lisa: Current opus two trial is successful.
Lisa: Our operating expenses and capital expenditure requirements are expected to accelerate in calendar 2025, as a result of these activities, including CMC chemistry manufacturing and controls and manufacturing readiness spend as we prepare for the BLA.
Lisa Locklear: And there will be a need to increase our current proposed spend and further increase our capital investments as a result.
Lisa: And there will be a need to increase our current proposed spending further increase our capital investments as a result.
Lisa Locklear: We intend to seek additional financing and non-dilutive funding options to support these activities and the current cash projections will be impacted by these ramped up activities and any financing transactions entered into.
Lisa: We intend to seek additional financing and non dilutive funding options to support these activities and the current cash projections will be impacted by these ramped up activities and any financing transactions entered into.
Wael Hashad: I will now hand the call back to YL.
Lisa: I will now hand, the call back to <unk>.
Wael Hashad: Thank you, Lisa. Over the past decade, stem cell therapy has made tremendous progress transforming from promising fields into one delivering tangible clinical outcomes. We have seen the solidification of cell therapy's role in regenerative medicine and its potential to treat a wide range of conditions. signaling an exciting future for both scientific innovation and patient care. We believe LAMSL-B has the potential to be an important cellular therapy option for multiple chronic and life-threatening conditions. The data generated to date in HLHS Alzheimer's disease support that belief. The strength of our clinical data, our experienced and committed team, and unwavering focus on patients give me confidence in the future of Lomacell B and Longeveron.
Speaker Change: Thank you Lisa.
Over the past decade stem cell therapy has made tremendous progress.
Speaker Change: Forming from promising field into one delivering tangible clinical outcome.
Speaker Change: We have seen the solidification of cell therapies roll and regenerative medicine, and its potential to treat wide range of conditions signaling an exciting future for both scientific innovation and patient care.
Speaker Change: We believe <unk> b has the potential to be important cellular therapy option for multiple chronic and life threatening conditions.
Speaker Change: The data generated to date in natural a chess alzheimers disease support that belief.
Speaker Change: The strength of our clinical data, our experienced and committed team and unwavering focus on patients give me confidence in the future of <unk> and lots of room.
Unknown Executive: Operator. Now we would like to open the call for questions from covering. Thank you.
Speaker Change: Operator.
Speaker Change: Now we would like to open the call for questions from covering analysts.
Speaker Change: Thank you we will now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
Unknown Executive: We will now be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star two. One moment, please, while we poll for questions. Thank you.
Press Star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
Speaker Change: One moment, please while we poll for questions.
Bob alone: Thank you. Our first question is from Bob alone try upon with Roth Capital Partners. Please proceed with your question.
Boobalan Pachaiyappan: Our first question is from Boobalan Pachaiyappan with Roth Capital Partners. Please proceed with your question. Good afternoon, team. Can you hear me? Okay. Yes, Boobalan, hi. Hi, thank you so much. Thanks for taking our questions. So we have a couple of them.
Bob: Good afternoon, Tim can you hear me okay.
Bob alone: Yes, Bob Alan Hi.
Speaker Change: Hi, Thank you so much thanks for taking our questions. So we have a couple of them. So firstly with respect to Lp's two enrollment delay I was wondering maybe if you could provide some additional color on what's causing the enrollment delay because I mean im following up here sorry for quite some time. So initially we were planning I mean I wanted to see the engine.
Boobalan Pachaiyappan: So firstly, with respect to LP's to enrollment delay, I was wondering maybe if you could provide some additional color, you know, so what's causing the enrollment delay? Because, I mean, I'm following up your story for quite some time. So initially we were planning, I mean, I wanted to see the enrollment wrap up sometime in fourth quarter of last year. And then after that, you said it will be first quarter. So I'm curious, you know, what's causing the delay? I understand you have no control in terms of setting the surgery date, which I feel is a key factor.
Speaker Change: To wrap up sometime in fourth quarter of last year and then after that he said it will be first quarter. So I'm curious to know what is causing the delay I understand.
Speaker Change: You have no control in terms of setting the surgery date, which I feel is a key factor, but other than the surgery date are there any other factors that are.
Boobalan Pachaiyappan: But other than the surgery date, are there any other factors that are causing the enrollment delay?
Speaker Change: Causing the enrollment delays.
Wael Hashad: Yeah, Boobalan, I'll take that question and Nataliya can add color. Of course, as you know, HLHS is a rare disease and actually goes into the border of ultra-rare disease, and it is very hard sometimes to predict it with great details of accuracy. The team is pushing to finish enrollment as fast as possible, but sometimes delays of the surgery itself can things like that. The great news is we continue to make progress, as you can see, from one quarter to another or from one call to another, and right now we're spending above 90% enrolled. Actually, that means that we have 35 patients enrolled, so we are talking about, honestly, the last couple of patients left in the trial, and we now with absolute full confidence, we believe that we can finish that enrollment in the next couple of months.
Speaker Change: Yeah, Bob Allen I'll I'll take that question and Natalia can add color of course as you know.
Speaker Change: And so the tests is a rare disease and actually it goes into the broader ultra rare disease and it is very hard sometimes to predict it.
Speaker Change: He was a great details of accuracy. The team is pushing to finish enrollment as fast as we as possible, but sometimes delays of the surgery itself can happen and things like that.
Speaker Change: The Great News is we continue to make progress as you can see from one quarter to another or from one quarter to another and right now were spending above 90% in gold.
That means that we have 35 patients and also we are talking about honestly. The last a couple of patients left in that trial and we know with absolute full confidence we believe that we can finish that enrollment in the next couple of months.
Speaker Change: Great and then.
Boobalan Pachaiyappan: Great.
Boobalan Pachaiyappan: And then moving on, so I have a question. Sorry, go ahead.
Speaker Change: Question.
Speaker Change: Sorry go ahead.
Nataliya Agafonova: I was going to say, if Natalia wants to add any comments, feel free as well, if you have anything to add. Thank you, Boobalan. It's a great question. And as Rayel said, we are definitely making a very, very good progress. And the nature of disease sometimes have surprises. And as you mentioned, the gland surgery, sometimes the patient goes to the surgery, seems promising, and during the surgery, unfortunately, some patients are not eligible based on intraoperative decision. So, again, it's a very complicated indication, and we are so far have been very successful. So, because of that, sometimes we have promising patients, but they are not eligible at the end of the surgery.
Speaker Change: I was going to say, it's not how you want to add any comments feel free as well yeah Robyn blossom.
Speaker Change: Thank you everybody and it's a great question in Israel Fab.
Speaker Change: We are definitely making a very very good progress and the nature of the disease, sometimes have surprised us and as you mentioned the Glen Gery.
Speaker Change: Sometimes the patient goes to the surgery seems promethium MBR in the soldiery. Unfortunately, some patients are not eligible BB from intra operative decision. So again, it's a very complicated indication and Dr. So far have been very successful so because of that.
Speaker Change: Sometimes we have about <unk>.
Speaker Change: Permission patients, but they are not eligible at anthem.
Speaker Change: Definitely decision, but we keep track of every single patient who are potentially eligible.
Nataliya Agafonova: So, it's definitely a decision. But we keep track of every single patient who are potentially eligible. We approach them, and we are making great progress on that. So, hopefully, within one, two months, we will be able to complete enrollment.
Speaker Change: Roche them and they're making great progress on that so hopefully, we then want to moms to be there'll be able to complete enrollment.
Boobalan Pachaiyappan: That's very helpful. Thanks for that.
Speaker Change: That's very helpful. Thanks for that and then.
Boobalan Pachaiyappan: And then staying on LPS2 lane. So I was wondering, I mean, I understand the primary endpoint is RVEF, and you're tracking that for 12 months. So I was wondering if the FDA would be open to the possibility of considering a composite endpoint, you know, because I'm not very sure whether a clinically meaningful difference could be recognized in that 12 months timeframe. So assuming, I mean, in addition to RVEF, is it possible, you know, you can get some data about the other factors, such as prolonged hospitalization and Macy's, such as reoperation and percutaneous interventions and all other events that could potentially, you know, all these HLHS patients would normally go through, whether that would be embedded in your composite endpoint?
Speaker Change: Staying on Lp's two lane.
Speaker Change: So I was wondering I mean I understand the primary endpoint is RV eef on Youre tracking there for 12 months.
Speaker Change: So I was wondering if the FDA would be open to the possibility of considering a composite endpoint because I'm not very sure weather.
Speaker Change: A clinically meaningful difference could be recognized in the 12 months timeframe. So assuming I mean in addition to <unk> is it possible you can.
Speaker Change: Get some data about the other other factors such as prolonged hospitalization and Macy's such as re operation and for cutaneous interventions and all other evens that could potentially all of these situations patients who would normally go through with it that would be embedded in your composite endpoint that was my question.
Boobalan Pachaiyappan: That was my question. Thank you. Thank you so much.
Speaker Change: Why else would you like Nikola yes.
Speaker Change: Yes, you can respond then that's okay. Okay. Thank you. Thank you so much so it's a great question and the Euro region, our mind soar.
Nataliya Agafonova: So it's a great question and you're reading our minds. So we definitely thinking in a line that just to have right ventricular ejection fraction, it would be not sufficient. So we did have conversation with FDA and currently, as we mentioned, if the accepted LPS2 clinical trial as pivotal, and also they were willing to see more thoughts around primary endpoint. And we currently working with our data, we are working to prepare response to FDA, to compile convincing evidence that composite endpoint would be the way to go. So we are thinking exactly what you mentioned, we are thinking about composite endpoint, we are thinking about different type of endpoint and hospitalization, maybe something else.
Speaker Change: The data Natalie.
Speaker Change: Thank you I'm in line.
Speaker Change: Just to have rights in Chicago ejection fraction it would be no expectation.
Speaker Change: So we did have conversations with FDA and currently as we mentioned.
Speaker Change: <unk> accepted LP school clinical trial SB vital and also they were resilient to see more thoughts around primary endpoint can be currently work Mds.
Speaker Change: Our data they are working to prepare a response to a me too.
Speaker Change: To compile.
Speaker Change: <unk> evidenced that composite endpoint would be the way to go. So we are thinking exactly what you mentioned, we are thinking about composite endpoint are you thinking about different type of endpoint.
Speaker Change: And hospitalization, maybe something else so definitely in our plan is to.
Nataliya Agafonova: So definitely, and our plan is to get an alignment with FDA this year, that we are analyzing the data based on this Yeah, so thank you, Natalia.
Speaker Change: Get into alignment with Abbvie. This year that we are analyzing the data based on this combined with pinpoint.
Speaker Change: Yeah.
Wael Hashad: Boobalan, I will add just one thing. It's not just our thoughts. We have actually had that discussion with the FDA, as you said. So, the agreement is, yes, they will accept the composite endpoints. And we want to make sure that these composite endpoints happen in a frequency that allows us to detect the difference and success of the trial. And the FDA was open to several suggestions from our side, including hospitalization, survival, and other endpoints. And we are in the process of preparing an SAP and sharing it back. And they said that they will be happy to discuss that further once they receive the SAP from us.
Speaker Change: Thank you Bob and I will add just one thing is it's not just our thoughts we have actually had that discussion with the FDA as you said.
Speaker Change: So that the agreement is yes, they will accept our composite endpoints and we want to make sure that these composite endpoints that happened in the frequency that allow us to detect the difference Ah and success of the trial and the FDA was open to several suggestions from our side.
Speaker Change: And including hospitalization survival.
And other endpoints and we are in the process of preparing and S&P and share and get back and they said they will be happy to discuss that further once they received S&P from us.
Boobalan Pachaiyappan: Great.
Speaker Change: Great switching gears and talking about the Alzheimers program. So you mentioned that youll be speaking to the agency sometime this quarter. So I'm curious what are some of the key items that you wanted cash obligations from the agency.
Boobalan Pachaiyappan: Switching gears and talking about the Alzheimer's program. So you mentioned that you'll be speaking with the agency sometime this quarter. So I'm curious, you know, what are some of the key items that you wanted clarifications from the agency? Because you have this RMED designation and this is, you know, it's a very long program. Alzheimer's is not for the faint of heart, just to tell you that. So do you plan to sort of propose a plan such that you will have to do a Phase 2B prior to Phase 3? Or is there a way you could sort of bypass 2B and directly go to Phase 3?
Speaker Change: Because you have this our med designation and this is.
Speaker Change: It's a very long program Alzheimers is another it's not it's not for the faint of heart just to tell you that so do you plan to propose a plan such that you will have to do a phase II b prior to phase three or is there a way you could sort of bypass to be on directly go to phase III is there is there is.
Boobalan Pachaiyappan: Is there a possibility to do that for that?
Is there a possibility to do that for that.
Nataliya Agafonova: So that's a great question. I will tell you that's the reason why we're meeting. We are proposing, and we'll get into the details after the meeting, but we are proposing a very accelerated path. to commercialization and regulatory approval, of course, but at the same time, providing the agency an opportunity to ensure that the safety and efficacy of the product is fully demonstrated as well. And that path for approval, if the FDA agrees with our proposal, will definitely present a great differential opportunity over existing paths, and that will be one of the values that we can.
Speaker Change: So that's a great question I will tell you that the reason why we're meeting we are proposing and we'll get into the details after the meeting, but we are proposing.
Speaker Change: A very.
Speaker Change: The accelerated path.
Speaker Change: To the commercialization and regulatory approval of course.
Speaker Change: But at the same time.
Speaker Change: Providing the agency on opportunity to ensure that the safety and efficacy of the product is fully demonstrated as well.
Speaker Change: And that path for approval if the FDA agreed with our proposal will definitely presents a great differential opportunity over existing path and that would be one of the values that we can and by the way. This is part of the arm that because the arm that give you an opportunity for an accelerated path for approval.
Nataliya Agafonova: And by the way, this is part of the RMAT, because the RMAT gives you an opportunity for an accelerated path for approval. So that's what we're asking for. And that's what we're hoping the FDA will agree with our plans for that as well. But, you know, we have to wait and see what happens at the meeting.
Speaker Change: So that's what we're asking for and that's what we're hoping the FDA will agree with our plan for that as well but.
Speaker Change: We have to wait and see what happened at the meeting.
Boobalan Pachaiyappan: Great, maybe one last question.
Speaker Change: Great maybe one last question I'm sorry. This is the last question from me. So after September 32026. So the agency may not about any pediatric disease priority review voucher business has been around for quite some time. So I'm curious what are the prospects for a in your case for Columbus will be in terms of receiving a PR.
Boobalan Pachaiyappan: I'm sorry, this is the last question from me. So after September 30th, 2026, so the agency may not award any pediatric disease priority review voucher, and this has been around for quite some time. So, I'm curious, you know, what are the prospects for, in your case, for the Lomis-LB in terms of receiving a PRV, should this agent be approved, say, either late 26 or first half of 27 for HLH? That's a great question, Boobalan. First, as you know, the PRV is going for renewal next month. On the ballot, there is a Give Kids a Chance Act 5 to extend the whole PRV.
Speaker Change: Sure. This agent to be approved see either late 'twenty six for first half of 2007 for intelligence.
Speaker Change: That's a great question.
Speaker Change: <unk> first as you know that <unk> is going for renewal next month there is a.
Speaker Change: On the ballot that is give us give kids a chance act five.
Speaker Change: <unk> to extend the hope Harvey.
Wael Hashad: We believe if we are, and that's going to be part of the pre-BLA because, you know, we have been acting in a very fast and judicious way, we believe that we will have an extension on this but we have to get agreement with the agency at the pre-BLA meeting for this.
Speaker Change: We believe if we are and that's going to be part of the pre BLA because.
Speaker Change: We are have been acting in a very fast and judicious way. We believe that we will have an extension on this one but we have to get agreement with the agency at the pre BLA meeting for this as well.
Boobalan Pachaiyappan: All right.
Speaker Change: Alright, Thank you Tim Congrats on the progress.
Boobalan Pachaiyappan: Thank you, team.
Unknown Executive: Congrats on the progress.
Unknown Executive: Thank you.
Speaker Change: Thank you thank you for that.
Unknown Executive: Thank you, Booba.
Raghuram Selvaraju: Our next question is from Raghuram Selvaraju with HC Wainwright. Thanks so much for taking my questions and congratulations on all the recent progress. I was just wondering if you could confirm specifically how many patients remain to be enrolled in LPIS-2 at this juncture? So, that trial is, as you know, it's 38 patients. We have enrolled 35. So, we're waiting on three more patients. But if there is one or two more patients are in the hopper and things like that, we may take them and we're not declining them. But the goal is to enroll three, but we could end up enrolling a couple of more if they happen to be in the hopper and consented.
Speaker Change: Our next question is from Ram Silverado with H C Wainwright.
Ram Silverado: Thanks, very much for taking my questions and congratulations on all the recent progress.
Ram Silverado: I was just wondering if you could confirm specifically how many patients remain to be enrolled in opus two at this juncture.
Ram Silverado: So.
Ram Silverado: Trial is.
Ram Silverado: As you know it's the 38 patients we have enrolled 35, so we're waiting on three more patients, but if there is one or two or more patients are in the hopper and things like that we may take them.
Ram Silverado: And we're not declining them, but but the goal is to in grocery, but we could end up enrolling a couple of more if they happen to be in the hopper and consented.
Raghuram Selvaraju: Okay, so just to clarify, it's possible that you could over enroll the study by one or two patients if during the process of screening to finish enrollment, you wind up having a couple extra. Is that correct? Correct. You know, sometimes you have to be, you know, I don't want to take a chance, Ram, on losing a patient, as Natalia has mentioned in her answer to Boobalan, is sometimes you get surprises at the time of randomization and so on. So, we keep the hopper or the feeding pool full because I'm interested in finishing the trial and get done with it once and for all.
Ram Silverado: Okay. So just to clarify it's possible that you could over enrolled the study by one or two patients if during the process of screening to finish enrollment you wind up having a couple of extra is that correct.
Ram Silverado: Correct you know sometimes you have to be you know I don't want to take a chance a ROM on losing that patient is nathalia I have mentioned in here answer to barbell on is sometimes you get surprises at the time of randomization and so on so we keep we keep that the.
Speaker Change: The hopper or the feed and pools.
Speaker Change: For because I'm interested in finishing the trial and get done with it once and for all in that process. We may end up finishing one or two more patients and that would be a good thing not a bad thing to have.
Raghuram Selvaraju: In that process, we may end up finishing one or two more patients and that would be a good thing, not a bad thing. But we're not delaying it beyond study eight being enrolled. I mean, not intentionally. But if we happen to involve a few more patients, we'll involve them. You can confirm, right, that at this juncture, you don't see any issue with reaching full enrollment in the trial based on the current complement of sites that you have up and running. In other words, you would not need to open any new sites in order to complete enrollment.
Speaker Change: But we're not delay beyond 38 being enrolled I mean, nothing congratulant definitely but if we happen to do a few more patients.
Speaker Change: In Brooklyn.
Speaker Change: But you can confirm rights that are at this juncture you don't see any issue with reaching full enrollment in the trial based on the current complement of sites that you have up and running in other words, you would not need to open any new sites in order to complete enrollment is that correct.
Raghuram Selvaraju: Is that correct? Absolutely correct.
Speaker Change: Absolutely correct.
Raghuram Selvaraju: Okay, can you just remind us, let us assume that you complete the study in the second quarter, or you complete enrollment in the second quarter. When approximately would you expect to report top-line results? So let's say I'm just hypothetical here, so we can get. If I finish enrollment in May, we need 12 months for a study to lock the database on last patient out. And then within three, four weeks after that, we'll have the data announced and everything moving on. So within three weeks after the database lock, which would happen 12 months from the last patient in.
Speaker Change: Okay can you just remind us let us assume that you complete the study in the second quarter or you thought you complete enrollment in the second quarter.
Speaker Change: When approximately would you expect to report top line results.
Speaker Change: So, let's say I'm just hypothetical here. So we can we can get.
Speaker Change: If I finish enrollment in may.
Speaker Change: Well.
Speaker Change: You need 12 months for a leader for a study to lock the database and last patient out and then within three or four weeks after that we'll have data.
Speaker Change: That data announced in and everything moving on so within three weeks after the data base lock, which what happened 12 months from the last patient in.
Raghuram Selvaraju: So just to confirm, that's basically sort of like the summer of 2026 timeframe, is that correct? Correct.
Speaker Change: So just to confirm that basically sort of like the summer of 2026 timeframe is that correct.
Speaker Change: Correct.
Speaker Change: Okay.
Raghuram Selvaraju: Switching with respect to the potential future commercial scenario for Lomacel B in the HLHF context, maybe you can give us some sort of frame of reference regarding how the drug might be commercialized in that indication and what kind of commercial infrastructure would need to be put in place, because I would expect, given the nature of the epidemiology and how these patients are triaged, you would not really need significant sales and marketing infrastructure, and this is potentially an area in which Longeveron could handle commercialization independently. Is that correct? You're absolutely correct, Ram.
Speaker Change: Switching with respect to the potential future commercial scenario for long it's L. B.
Speaker Change: In the HLA chess context, maybe you can give us some sort of frame of reference regarding how the drug might be.
Speaker Change: <unk>, that's indication and what kind of commercial infrastructure would need to be put in place because I would expect given the nature of the epidemiology and how these patients are triaged, you would not really need significant sales and marketing infrastructure and this is potentially an area.
Speaker Change: Our longevity could handle commercialization independently is that correct.
Speaker Change: Youre absolutely correct Rob.
Raghuram Selvaraju: I can tell you right now the number of treating physicians is about 50 in the United States is the surgeons who do doing this surgery. As you know, we are our treatment is adjunct to the to the surgery. So the surgeons are our target. And actually more than 70% of these surgeries happen in the centers that we have conducted our clinical trials. So number one, we have a great opportunity that we know all the treating physician in the future because they have participated in the trial. And then the second thing is the 50, the number 50 of physician treating does not require a significant infrastructure from a sales organization.
Speaker Change: I can tell you right now the number of treating physicians.
Speaker Change: Is about 50 in the United States is that surgeons will do doing this surgery. As you know we are our treatment as adjunct to the surgery. So the surgeons are our target.
Speaker Change: And actually more than 70% of these surgeries happened in the centers that we have conducted our clinical trial. So number one we have a great opportunity that we know all the premium position in the future because they have participated in the trial.
Speaker Change: And then the second thing is the 50 the number 50, a physician treating does not require a significant infrastructure from a sales organization I mean, that's absolutely right.
Raghuram Selvaraju: I mean, it's actually, at most, you don't need more than two or three sales individuals with a manager. The whole commercial organization can be less than 15 people, including payer, patient services, all of these types of things. So very minimal infrastructure on the commercial organization side, which is one of the beauty of operating in an orphan disease. It's you don't have to make a massive investment. So you're absolutely correct.
Speaker Change: As most of you don't need more than two or three yourselves individuals was the manager the whole commercial organization can be less than 15 people, including payer patient services. All of these type of things so very minimal infrastructure on the commercial.
Speaker Change: Organization side, which is one of the beauty of operating in an orphan disease.
You don't have to make a massive investment.
Speaker Change: Youre, absolutely correct any of our assumptions.
Raghuram Selvaraju: Okay, with respect to Alzheimer's disease. I was wondering if you had had any recent interactions with non-U.S. regulatory authorities and if there appears to be any differentiated picture with respect to how regulators outside of the U.S. are thinking about potential, you know, approvability criteria for a drug like Lomacell-B, and if you are exploring the possibility of conducting any clinical exploration of Lomacell-B and Alzheimer's disease outside the U.S. at this time, and if so, what the format and scope of that might take. Yes. Thank you so much for this great question.
Speaker Change: Okay with respect to Alzheimers disease.
Speaker Change: I was wondering if you had had any recent interactions with non U S regulatory authorities and if there appears to be any differentiated picture with respect to how regulators outside of the U S are thinking about potential approval ability criteria for a drug like Columbus L. B.
Speaker Change: And if you are exploring the possibility of conducting any clinical exploration of <unk> in Alzheimer's disease outside the U S. At this time and if so what the format and scope of that might take.
Speaker Change: Yes. Thank you so much for this great question. So I'll answer the first part and explain what is our intention outside the U S. So we have not had any interaction with any of the agencies outside the United States is specifically regarding the development path for Alzheimers disease. So that's the answer to your first.
Raghuram Selvaraju: So, I'll answer the first part and explain what is our intention outside the U.S. So, we have not had any interaction with any of the agencies outside the United States specifically regarding the development path for Alzheimer's disease. So, that's the answer to your first question. We are in the process of hiring a full-time regulatory person now that we are heading into the BLA submission next year for this one. And we have at least candidates. And actually, one of the most important tasks that this individual will do as soon as they full-time join the company is to have a discussion with both the EMEA, the UK MHRA, as well as Health Canada, Australia, and Japan.
Speaker Change: Question.
Speaker Change: We are in the process of hiring a full time rig.
Speaker Change: Is it 40% and now that we are heading into the BLA submission next year for <unk>.
So this one and we have the lead candidates and actually one of the most important task that this individual will do as soon as they joined the company is to have a discussion with both the EMEA.
Speaker Change: Okay.
Speaker Change: As well as health, Canada, Australia, and Japan those are the priority.
Raghuram Selvaraju: Those are the priority international markets that we're going to go after. And that is in our plan is to engage and start the discussion regarding the filing of the biological license application in this respective health authorities. But for long as they'll be in HLHS, that is our top priority.
Speaker Change: International markets that we're going to go after and that is in our plan is to engage in the discussion regarding the filing of the biological license application in this respective health authorities, but for lummus there'll be an excellent chance that is our top priority.
Raghuram Selvaraju: And then once we do that, we'll get into the Alzheimer's disease. Our Alzheimer's disease focus moving on is going to be around partnership. We definitely don't want to dilute our efforts, but we want to focus 100% on partnership globally, U.S. and outside the U.S.
Speaker Change: And then once once we do that we'll get into the Alzheimer disease, our alzheimer disease focus moving on is going to be around partnership.
Speaker Change: We we definitely don't want add valued our effort there, but we want to focus 100% on partnership.
Speaker Change: Globally U S and outside the U S.
Raghuram Selvaraju: Okay, great.
Speaker Change: Okay, Great and one more from me with respect to the manufacturing revenue that you historically booked in 2024 can you give us some sense of what the perspectives are to potentially either.
Raghuram Selvaraju: And one more from me.
Raghuram Selvaraju: With respect to the manufacturing revenue that you historically booked in 2024, can you give us some sense of what the perspectives are to potentially either emulate that level of business or grow it in 2025? As an example, I believe that you previously had a client called Secretome, a privately held company, which successfully raised capital. Not sure whether that is going to be a source of repeat business for you, but just wanted to get a sense of what you expect the level of manufacturing revenue to be in 2025, and if you think it could be the same or higher than what you saw in 2024.
Speaker Change: That level of business or grow it in 2025.
Speaker Change: As an example, I believe that you previously had a client called secret home privately held company, which successfully raised capital.
Speaker Change: Not sure whether that is going to be a source of repeat business for you, but just wanted to get a sense of I guess, what do you expect the level of manufacturing revenue to be in 2025, and if you think it could be the same or higher than what you saw in 2024. Thank you.
Raghuram Selvaraju: Thank you. Yes.
Wael Hashad: So, Ron, that's a great question. We continue to have a very good relationship with Secretome. Actually, we may have some small amount of work in 2025 for them. But I don't know. I mean, we're happy if they have any additional needs that come throughout the year. We'll definitely, I think we establish a good relationship and expertise between the two companies. So, we continue to develop it depending on what their needs are. So, they are better to speak up about their needs than me speaking it up. Regarding other opportunities, we remain open to other opportunities.
Speaker Change: Yes.
Speaker Change: So so Ron that's a that's a great question. We continue to have a very good relationship with Secretary AUM actually we may have some some small amount of work in 2025 for them, but I.
Speaker Change: I don't know I mean, we're happy if they have any additional needs that come throughout the year will definitely I think we establish a good relationship and expertise between the two companies. So we continue to develop it depending on what their needs are so they are better to speak up about their needs than me speaking it regarding other opportunity we remain.
Speaker Change: Open to other opportunities I cannot guarantee the same thing because honestly. The other thing that is going on in parallel here is our CMC readiness process and that is going to require an extensive work on our side as you know shifting from a clinical development to a fully commercial CMC requirements as a major risk.
Wael Hashad: I cannot guarantee the same thing because, honestly, the other thing that is going on parallel here is our CMC readiness process. And that is going to require an extensive work on our side. As you know, shifting from a clinical development to a fully commercial CMC requirement is a major step upward.
Wael Hashad: We have recently hired Devin Blass, which we are extremely excited about having him on board. He has been a tremendous addition to our team, making great progress in establishing what I would say is the CMC master plan that ensure that our pre-approval and inspection for the facility as well as the whole product characterization will meet all the regulatory requirements at the time of the BLA filing. So, we are full of steam ahead on the CMC. That will keep us busy, but definitely will stay opportunistic on the CDMO business. And if there is an opportunity, we'll definitely use it.
Speaker Change: Upwards.
We have recently hired Devin glass, which we are extremely excited about having him on board. He has been a tremendous addition to our team making great progress in establishing what I would say is the CMC masterplan that ensure that our.
Speaker Change: Preapproval inspection for the facility as well as these.
Speaker Change: The whole product characterization will meet all the regulatory requirements at the time of the BLA filing. So we are full steam ahead on the CMC that will keep us busy but definitely well that will stay opportunistic on the CMC sorry on the <unk> business and if there is an opportunity.
Speaker Change: We'll definitely use it.
Wael Hashad: and Deliver Revenue for them.
<unk> delivered revenues for the company.
Michael Okunowicz: Thank you very much. Congrats once again on all the progress. Thank you.
Speaker Change: Thank you very much congrats once again on all the progress.
Speaker Change: Thank you.
Michael Okunowicz: Our next question is from Michael Okunowicz with Maxim Group. Please proceed with your question. Hey guys, thank you so much for taking my questions today, congrats on a lot of really good progress here. Thank you, Michael. Thank you.
Speaker Change: Our next question is from Michael <unk> with Maxim Group. Please proceed with your question.
Michael: Hey, guys. Thank you so much for taking my question today, Congrats on a lot of really good progress here.
Speaker Change: Thank you Michael Thank you.
Michael Okunowicz: I guess to start off, I wanted to follow up on one of the previous questions, specifically in regards to you mentioned potential outcomes for that upcoming meeting are really focused on designing the pathway forward, and potentially getting something more accelerated and streamlined to approval. So Do you consider the results of that upcoming meeting to be somewhat of a gating item for these potential partnering discussions, and then especially if you have an accelerated pathway, do you think that could really open up these discussions? Yes, so you're reading my strategy, my friend. So as you know, Michael, there is over 140 clinical development programs currently in the marketplace in various phases of development from phase one to phase three.
Speaker Change: I guess to start off I wanted to follow up on one of the previous questions.
Speaker Change: Specifically in regards to you mentioned.
Speaker Change: Outcomes from that upcoming meeting.
Speaker Change: Really focus on to buy this.
Speaker Change: Designing the pathway forward and potentially getting something more accelerated and streamline to approval.
Speaker Change: <unk>.
Speaker Change: Do you consider the results of that upcoming meeting to be somewhat of a gating item for these potential partnering discussions and then, especially if you have an accelerated pathway.
Speaker Change: Really open up these discussions.
Speaker Change: Yes.
Speaker Change: So youre reading my mind by strategy and my friends. So as you know.
Speaker Change: Michael There is over 140 clinical development program.
Speaker Change: Currently in the marketplace in various phases of development from phase one to phase III.
Wael Hashad: Many of them are developed by small companies. And many of these programs are hoping to get a partnership from one of the major players because the development costs as you move toward the finish line, phase three, it becomes expensive both on the clinical development and the CMC front and the hundreds of millions of dollars. So, everybody is looking for the same partnership.
Speaker Change: Many of them are developed by small companies.
Speaker Change: And many of these programs are all hoping to get a partnership from one of the major players because.
Speaker Change: The development costs when as you move towards the finish line that phase III. It becomes extensive both on the clinical development on the CMC front and the hundreds of millions of dollars.
Speaker Change: So everybody is looking for the same partnership.
Wael Hashad: I really believe we have, our strategy is very simple. We have good clinical data and clinical outcomes that we have demonstrated so far, which we have shared. We also are meeting with the FDA and hopefully if the FDA agrees with our approach and accelerated, that also provides an economic opportunity for any partner to see a faster and more economical way to bring a product. And hopefully those two things, the clinical data combined with the accelerated path, give us some competitive advantage over the other programs being developed in improving our chance of landing this partner.
Speaker Change: The reason to believe we have our strategy is very simple we have good clinical data and clinical outcomes that we have demonstrated so far which we have shared.
Also our meeting with the FDA and hopefully at the FDA agree with our approach and accelerated.
Speaker Change: It also provides an economic opportunity for any partner to see a faster and more economical way to bring that product and hopefully those two things the clinical data combined with accelerated paths give us some competitive advantage over the other programs is being developed.
Speaker Change: And in improving our chance of lending this partnership.
Wael Hashad: Now, given that the increase in support from the FDA for cell therapy programs, in particular around granting these more streamlined paths to approval, do you think that could potentially de-risk this outcome from these upcoming meetings? I believe, yes, definitely, I'm cautiously optimistic with your position, but I don't like to make a statement I'm not in ownership of it. I would like to go through the meeting and hear the confirmation from the FDA with that principle. That's certainly fair.
Speaker Change: No just given that we did.
Increase in support from the FDA for cell therapy programs in particular around granting these more streamlined path to approval do you think that could potentially derisk. This outcome for these upcoming meetings.
Speaker Change: I I am.
Speaker Change: Yeah.
Speaker Change: I I believe yes, I definitely.
Speaker Change: Im cautiously optimistic with your position, but I don't like to make a statement I'm not in ownership of it I would like to go through the meeting in here the confirmation from the FDA, but with that.
Speaker Change: With our principal so.
Speaker Change: Certainly fair.
Michael Okunowicz: And then just one last one for me, and I'll hop back into the queue.
Speaker Change: And then just one last one for me and I'll hop back into the queue.
Wael Hashad: I'd like to see if you just touch a little bit on your current manufacturing capabilities, and then what else is needed on that front to become BLA ready, just given, you know, the relatively small size of this market, I wouldn't imagine you would need to scale all that much. Yeah, that's a great thing, Michael.
Speaker Change: See if you could just touch a little bit on your current manufacturing capabilities and then what else is needed on that front to become BLA ready just given the relatively small size of this market I wouldn't imagine you would need to scale all that much.
Speaker Change: Yes.
Speaker Change: That's a great thing.
Wael Hashad: We definitely, as I said, I'm very, very happy and I think the next call we can bring Devin to join our earning call and also we'll be in a position where we can answer a lot of more specific questions around CMC and have him answer those. But speaking on his behalf, I will tell you that moving from a clinical development to a fully commercial, it is a very major step up from a ramp up and that includes many steps, both at the facility level as well as the product level as well, including the stability studies and all of the final formulation and all of those type of things need to be done.
Michael we definitely.
Speaker Change: As I said I'm very very happy and I think that Mexico, we can bring a devon to join our earnings call and also will be in a position where we can answer a lot of more specific question around CMC and have them answer those but speaking on his behalf I would tell you that moving from a clinical.
Speaker Change: Development to a fully commercial it is a very major step up from a ramp up.
Speaker Change: And that include many steps both at the facility level as well as at the product level as well.
<unk> the stability studies and all of the final formulation and all of those type of things need to be done and we have a plan we have alignment from the FDA, but definitely that's a major work that has to take place.
Wael Hashad: And we have a plan. We have alignments from the FDA, but definitely that's a major work that has to take place. Also, in addition, as you know, CMC, a big portion of that is our quality system. They need to all be 100% into the commercialization level. Our supply chain needs to be upgraded to the same level and many other areas within the CMC that all need to do this. It is a major focus for us this year. We believe we have a good plan to ramp up these activities. It is going to be the largest portion of our investment this year is in the CMC.
Speaker Change: In addition, as you know in CMC Big portion of that is our quality system they need to all be.
Speaker Change: 100% into the commercialization level, our supply chain needs to be upgraded to the same level and many other areas within the CMC that all need to do this it is a major focus for us this year.
Speaker Change: We believe we have a good plan.
Speaker Change: To ramp up these activities it is going to be the largest portion of our investment. This year is in the CMC as I said, we have an agreement and alignment from the agency, but there's going to be a lot of a lot of work this year and I'm happy in the future to bring Devin.
Wael Hashad: As I said, we have an agreement and alignment from the agency, but it's going to be a lot of work this year and I'm happy in the future to bring Devin to answer any more specific questions related to CMC.
Speaker Change: Any more specific questions related to CMC.
Michael Okunowicz: All right. Thank you so much for taking my questions while lots of, you know, work ahead, but lots of exciting progress as well.
Speaker Change: Alright. Thank you so much for taking my questions while lots of them.
Speaker Change: Work ahead, but lots of exciting progress as well.
Michael Okunowicz: Thank you, Michael. Thank you.
Michael: Thank you Michael.
Speaker Change: Thank you there are no further questions at this time.
Unknown Executive: There are no further questions at this time.
Wael Hashad: I would like to hand the floor back over to Wael Hashad for any closing comments. Thank you, Paul. And thank you all for attending today's call. We greatly appreciate your interest and support and look forward to updating you on our progress soon. Thank you.
Hudson: I would like to hand, the floor back over to <unk> Hudson for any closing comments.
Hudson: Thank you Paul and thank you all for attending today's call with greatly appreciate your interest and support and look forward to updating you on our progress soon. Thank you operator, you may end the call now.
Unknown Executive: Operator, you may end the call. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
Speaker Change: This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
Hudson: Thank you.