Q4 2024 Cognition Therapeutics Inc Earnings Call
Operator: Greetings and welcome to the Cognition Therapeutics fourth quarter and full year 2024 earnings call. At this time, all participants are in a listen-only mode.
Greetings and welcome to the cognition therapeutics fourth quarter and full year 2024 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.
Operator: A question-and-answer session will follow the formal presentation.
Operator: If anyone should require operator assistance during the conference, please press star zero on your telephone. As a reminder, this conference is being recorded.
Speaker Change: As a reminder, this conference is being recorded I would now like to turn the conference over to your host Mr. My lawyer with lifestyle advisors. Thank you you may begin.
Mike Moyer: I would now like to turn the conference over to your host, Mr. Mike Moyer with Lifesign Advisors. Thank you. You may begin. Thank you, operator.
Speaker Change: Thank you operator, and good morning, everyone welcome to cognition Therapeutics fourth quarter and year end 2024 results conference call.
Mike Moyer: And good morning, everyone. Welcome to Cognition Therapeutics fourth quarter and year end 2024 results conference call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Dr. Tony Caggiano, Chief Medical Officer. This morning, the company issued a press release detailing its 2024 fourth quarter and year-end results. We encourage everyone to read this morning's press release, as well as Cognition's annual report and Form 10-K, which is now filed with the SEC and available on our website. In addition, this conference call is being webcast through the company's website and will be archived for 30 days.
Speaker Change: With me today or at least we're starting <unk>, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Dr. Tony Casciano, Chief Medical Officer. This morning, the company issued a press release detailing its 2020 for fourth quarter and year end results. We encourage everyone to read this morning's press release as well as conditions in your report in Form 10-K, which has now filed with the SEC.
Speaker Change: She and available on our website. In addition, this conference call is being webcast through the company's website and will be archived for 30 days. Please note that certain information discussed on the call today is covered under the safe Harbor provisions of the private Securities Litigation Reform Act, we caution listeners that during this call management will be making forward looking statements actual results could differ.
Mike Moyer: Please note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, management will be making forward-looking changes. Actual results could differ materially from those stated or implied by these four looking statements due to the risks and uncertainties associated with the company. These forward-looking statements are qualified by the cautionary statements contained in Cognition's press releases and SEC filings, including its annual report on Form 10-K and previous filings.
Speaker Change: Too early from those stated or implied by these forward looking statements due to the risks and uncertainties associated with the company's business. These forward looking statements are qualified by the cautionary statements contained in cognition press releases and SEC filings, including its annual report on Form 10-K in previous filings. This conference call contains time sensitive information that is accurate only as of the data.
Mike Moyer: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. Cognition undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.
Speaker Change: This live broadcast August undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call with that I would like to now hand, the call over to Lisa for surety.
Lisa Ricciardi: With that, I would like to now hand the call over to Lisa Ricciardi. Mike, thank you, and good morning, everyone. Cognition Therapeutics Focus is the development of zirvimicin for patients with Alzheimer's disease and dementia with Lewy bodies, which I'll refer to as DLB. For clarity, zirvimicin is the USAN or the generic name for our lead candidate, CT1812. Last year, we reported data from two studies in both patient populations, and the results showed strong efficacy signals, making it clear that zirvimicin has the potential to bring great value to patients and their care partners, and we believe to investors as well.
Mike: Mike Thank you and good morning, everyone.
Lisa: Cognition Therapeutics focus is the development of their vimizim for patients with Alzheimer's disease, and dementia with lewy bodies, which I'll refer to as D. L. B.
Lisa: These are vimizim, if they use <unk> or the generic name for our lead candidate C. T 18 12.
Lisa: Last year, we reported data from two studies in both patient populations and the results showed strong efficacy signals, making it clear that you are in this thing has the potential to bring great value to patients and their care partners and we believe you investors as well.
Lisa Ricciardi: Many of you are wondering what are the next steps to advance the remissing inter-registrational trials. Our clinical operations and development teams are working to prepare final study documents from both trials. To be clear, these are very large dossiers. They need to be compiled, reviewed, and cross-checked, and when we're satisfied with these documents, we will submit them to the FDA, along with requests for two different end-of-phase II meetings, one for Alzheimer's and one for DLB. At the same time, we're having discussions with advisors to ensure that we are as prepared as possible when approaching the FDA.
Lisa: Many of you are wondering what are the next steps to advance their vimizim into Registrational trials.
Lisa: Our clinical development team, our clinical operations and development teams are working to prepare a final study documents from both trials to be clear. These are very large dossier, they need to be compiled reviewed and cross checked and when we're satisfied with these documents, we will submit them to the FDA along with requests for.
Lisa: Two different end of phase two meetings, one for Alzheimers and one for D. L. B at the same time, we're having discussions with advisers to ensure that we are as compare to possible when approaching the F. D. A.
Lisa Ricciardi: Now let's talk about capital allocation. We decided to conclude our dry AMD phase two dry AMD study before its completion. The reduced expense extends our runway and now 100% of our attention and resources are allocated to our Alzheimer's and DLB programs. Let me be clear, the decision to conclude the dry AMD study was not due to any safety concerns. Quite the contrary, our clinical research organization partner conducted an analysis of the mask data. This type of analysis is referred to as a futility study and it is used to determine if an experimental drug has signals of efficacy during a clinical trial.
Lisa: So let's talk about capital allocation, we decided to conclude our dry AMD phase two dry AMD study before its completion the reduced expense extends our runway and now 100% of our attention and resources are allocated to our Alzheimers and D. L D programs.
Lisa: To be clear the decision to conclude the dry AMD study was not due to any safety concerns quite the contrary.
Lisa: Clinical research organization partner conducted an analysis of the mask data. This type of analysis is referred to as a futility study and it is used to determine if an experimental drug has signals of efficacy during the clinical trial, we reported that we had indeed passey analysis, which support.
Lisa Ricciardi: We reported that we had indeed passed the analysis, which supports the potential of zirvimazine in patients with dry AMD. However, we felt then we still believe that the decision to conclude the dry AMD study was necessary for the success of our Alzheimer's and DLB programs. Dervimazine has shown clear activity in these two large patient populations, and there is such a clear need for new, effective, convenient drugs in both Alzheimer's and Lewy body dementia.
The potential is there have been the same in patients with dry AMD. However, we felt them we still believe that the decision to conclude the dry AMD study was necessary for the success of our Alzheimers and D. L B programs.
Lisa: If you've ever seen has shown clear activity in these two large patient populations and there is such a clear need for new effective convenient drugs in both alzheimers in lewy body dementia. Therefore, we intend to discuss with the FDA plans to pursue each indication in separate studies now we are.
Lisa Ricciardi: Therefore, we intend to discuss with the FDA plans to pursue each indication in separate studies. Now, we are not naive about the significant capital needed to fund these studies. We have an active business development program ongoing. We've built strong relationships with biotech and pharma players in this space since we began as a company. We have conducted a number of fruitful meetings since the beginning of the year, updating interested parties on the data from Shine and Shimmer. The ideal scenario would be to find a partner to work with on the development and registration program, and in the process, obtain non-dilutive funding for one or both indications.
Lisa: Not naive about the significant capital needed to fund. These studies, we have an active business development program ongoing we've built strong relationships with biotech and pharma players in this space. Since we began as a company. We have conducted a number of fruitful meetings since the beginning of the year updating interested.
Lisa: Party on the data from Schein and Shimmer, the ideal scenario would be to find a partner to work with on the development and registration program and in the process of cane non dilutive funding for one or both indications. There's nothing I can confirm today and I have no guarantee that we're going to sign the deal.
Lisa Ricciardi: There's nothing I can confirm today, and I have no guarantee that we're going to sign a deal, but I am confident we will find a path forward with funding. We are evaluating all our options to finance our clinical development efforts.
Lisa: I am confident we will find a path forward with funding we are evaluating all our options to finance our clinical development efforts.
Lisa Ricciardi: In addition, beyond securing capital, we're making strides to ensure we're Phase III ready. Our CMC team has developed a novel chemical process for the manufacture of zirvimicin. Provisional patent applications covering this chemical process have been filed. We expect that this manufacturing process will produce materials sufficient for future clinical studies, and if zirvimicin is approved, we expect it will support commercial manufacturing needs. On that same front, we're working with a domestic CMO, or contract manufacturing organization, that will be capable of producing commercial quantities of zirvimicin.
Lisa: In addition, beyond securing capital, we're making strides to ensure we're phase III ready our CMC team has developed a novel chemical process for the manufacturer of Zimmer who's seen provisional patent applications covering this chemical process have been filed we expect that this manufacturing process will produce materials sufficient for.
Lisa: Future clinical studies and if you're in the scene is approved we expect to most important commercial manufacturing needs on that same front, we're working with the domestics CMO or contract manufacturing organization that will be capable of producing commercial quantities or has there been missing with that John Doyle will review our.
John Doyle: With that, John Doyle will review our financial results and provide color around our cash position and capital requirements. John? Thank you, Lisa.
Lisa: Actual results and provide color around our cash position and capital requirements. Chuck Thank you Lisa.
John Doyle: We made the strategic decision in January 2025 to voluntarily conclude our Phase II magnified study in dry AMD. This pipeline prioritization will result in cost savings that we expect will extend our cash runway into the fourth quarter of 2025. This allows us to focus our resources entirely on our Alzheimer's and DLB programs. During 2024, we use one of the tools we have at our disposal, our at-the-market or ATM facility with B. Reilly Securities. For the year ended December 31st, 2024, we sold almost 20 million shares of our common stock for gross proceeds of approximately $12.8 million.
Lisa: Made the strategic decision in January 2025 to voluntarily conclude our phase III Magnify study in dry AMD. This pipeline prioritization will result in cost savings that we expect will extend our cash runway into the fourth quarter of 2025. This allows us to focus our resources entirely on Alzheimer's and D. L D programs during <unk>.
Lisa: 24, where he was one of the tools, we have at our disposal, our aftermarket or ATM facility with B Riley Securities for the year ended December 31, 2024, we sold almost 20 million shares of our common stock for gross proceeds of approximately $12 $8 million.
John Doyle: Now, let's proceed to the financials for the fiscal year 2024. Cash and cash equivalents as of December 31st, 2024, were approximately $25 million, and total obligated grant funds remaining from the NIA were $50 million. As indicated earlier, we estimate that we have sufficient cash to fund operations and capital expenditures into the fourth quarter of 2025. Research and development expenses were $41.7 million for the year. and the December 31st, 2024, compared to $37.2 million for 2023. This increase is primarily related to higher costs associated with activities underway to complete two phase two trials. General and administrative expenses were $12.3 million for the year ended December 31, 2024, compared to $13.5 million for 2023.
Lisa: Now let's proceed to the financials for the fiscal year 2024, cash and cash equivalents as of December 31, 2020 for approximately $25 million and total obligated grant funds remaining from the Nia were $50 million as indicated earlier, we estimate that we have sufficient cash to fund operations and capital expenditures into the fourth quarter.
Lisa: 25.
Lisa: Research and development expenses were $41 7 million for the year.
Lisa: And at December 31, 2024, compared to $37 2 million for 2023. This increase was primarily related to higher costs associated with activities underway to complete two phase III trials.
Lisa: General and administrative expenses were $12 3 million for the year ended December 31, 2024, compared to $13 5 million for 2023. The decrease was primarily related to lower equity based compensation professional fees. The company reported a net loss of $34 million or <unk> 86 per.
John Doyle: The decrease was primarily related to lower equity-based compensation and professional fees. The company reported a net loss of $34 million, or $0.86 per basic and diluted share, for the year ended December 31, 2024, compared to a net loss of $25.8 million, or $0.86 per basic and diluted share, for 2023.
Lisa: Cents per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $25 8 million or <unk> 86 cents per basic and diluted share for 2023, Lisa. Thank you John.
Lisa Ricciardi: Lisa? Thank you, John.
Lisa Ricciardi: I want to take this opportunity to address the question of NASDAQ compliance. As many of you saw last week, we were granted a six-month grace period to come back into compliance with NASDAQ's minimum bid requirement. This means our stock has to close above $1 for 10 days consecutively before September 8, 2025. We are confident we will regain compliance during the allotted time.
Speaker Change: I wanted to take this opportunity to address the question of NASDAQ compliance as many of you saw last week, we were granted a six month Grace period could come back into compliance with nasdaq's minimum bid requirement. This means our stock has to close above a dollar for 10 days consecutively before September eight 2025.
We are confident we will regain compliance during the allotted time, we have multiple milestones coming up that we believe will drive value in the stock effect of home to phase two and the phase two meetings with the FDA for all time, whose disease in lewy body dementia, gaining clarity on our clinical programs going forward.
Lisa Ricciardi: We have multiple milestones coming up that we believe will drive value in the stock. Expect to hold two phase two – end of phase two meetings with the FDA for Alzheimer's disease and Lewy body dementia, gaining clarity on our clinical programs going forward. And we anticipate having announcements about partnering or other sources of funding.
And we anticipate having announcements about partnering or other sources of funding now I'll turn the call back to the operator, who can open the call to questions. We'll begin with the sell side and then take questions from recent conferences.
Operator: Now, I'll turn the call back to the operator who can open the call to questions. We'll begin with the cell side and then take questions from recent conferences. If you'd like to ask a question, please press star 1 on your telephone. Your confirmation tone will indicate your line is in the question. You may press star 2 if you'd like to remove your question from the line.
Speaker Change: Thank you 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. Kim You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
Mayank Mamtani: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start Our first question comes from the line of Mayank Mamtani. with B. Reilly. Please proceed with your question. Yes, good morning team. Thanks for taking our questions and appreciate the detailed update.
Speaker Change: Our first question comes from the line of Miami, Montana with B Riley Securities. Please proceed with your question.
Miami Montana: Yes, good morning team, thanks for taking our questions and appreciate the detailed update as.
Mayank Mamtani: As you prep for the end of Phase 2 FDA meeting, do you have any latest thoughts on the tau cutoff threshold that you might be thinking about based on the SHINE study learnings? And also if you could comment on, you know, implications of that biomarker to the ongoing Phase 2 early AD study and if there's any update on enrollment for that early AD study would be helpful too. Yeah, sure.
Speaker Change: As you perhaps for the end of phase two FDA meeting.
Miami Montana: Any latest thoughts on the DAU cut off threshold.
Miami Montana: That you might be thinking about based on the Shine study learnings and also if you could comment on.
Miami Montana: You know obligations of that biomarker to be ongoing phase two early study and if there's any update.
Miami Montana: Data on enrollment for that study would be helpful. Too and then I have a follow up.
Tony Casciano: Yeah, sure Hi, Mike, It's Tony Casciano.
Tony Caggiano: Hi, Mayank.
Tony Caggiano: It's Tony Caggiano. Yeah, so we certainly are planning to do an enrichment of participants in the next study for those who have the lower tau. We haven't announced exactly what that level is going to be, but it'll be very, very similar to what we used in the SHINE study. Now, we're looking at the data, and we're looking at databases and our collaborators' databases around what we would expect in the population, and then making cuts to see where the effects are most robust and where that best number would be. But we haven't landed on a specific number, but you can expect it to be very similar.
Tony Casciano: Yeah. So we certainly are planning.
Tony Casciano: To do a.
Tony Casciano: Enrichment of participants in the next study for those who would go lower Tau.
Tony Casciano: We haven't announced exactly what that level is going to be but it'll be very very similar to what we used in the shine.
Tony Casciano: <unk> studied now we're looking at the data and we're looking at databases and our collaborators databases around what we would expect in the population and then making cuts to see where the the effects there must robust and where that best number would be but we haven't landed on a specific number but you can expect it to be very similar.
Tony Caggiano: So, and then relating to the early AD study, we haven't made any announcements as to how we're progressing in that study. It is still continuing to recruit. Now, there you had asked about whether there is a particular cut around tau in that study. So, in that study, there is not. So, understand this is a different population of people with Alzheimer's disease. These are folks at the early end of the spectrum. So, inherently, what's going to be enriched with those who have a slightly lower tau anyway, but that's not part of that study. Thank you.
Tony Casciano:
Tony Casciano: And then as relating to the early eighties study, we haven't made any announcements as to.
Tony Casciano: How we're progressing in that study it is still continuing to recruit.
Tony Casciano: Now there you had asked about whether there is a particular cut around tau in that study. So in that study there is not so.
Tony Casciano: This is a different population of people with Alzheimer's disease is the folks at the early end of the spectrum. So inherently what's going to be enriched with those who have a slightly lower tau.
Tony Casciano: Anyway, but that's not part of that study.
Mayank Mamtani: And then on Shimmer data that was presented at a recent conference, are you able to share any investigative physician feedback that you came away with and also obviously interested in what sort of next steps in terms of publication strategy that you may have there in DLD because obviously not a lot going on there.
Speaker Change: Thank you and then.
Tony Casciano: Schindler.
Tony Casciano: Data that was presented at the <unk>.
Speaker Change: At a recent conference are you able to share any.
Speaker Change: Investigators are physician feedback that you came away with and also obviously.
Speaker Change: Interested in what sort of next steps in terms of publication side.
Speaker Change: And do you think you may have there and the LD, because obviously not a lot going on there and if you would.
Mayank Mamtani: And if you're able to just maybe update us on, you know, how corporate development activity could look like, you know, if it's the same partner interested in both indications, or do you think one indication could be more sort of manageable by a company your size versus maybe another indication being pursued by a larger company? We would love to hear your thoughts on that. And thanks again for taking the time.
Speaker Change: We will do just maybe update us on.
Speaker Change: You know, how our corporate development activity could look like if at.
Speaker Change: Uh huh.
Speaker Change: <unk> adjusted in both indications do you think what indication could be more.
Speaker Change: Sort of manageable by a company your size versus maybe another indication being pursue biologic I.
Speaker Change: We would love to hear your thoughts on that and thanks again for taking my question.
Lisa Ricciardi: Mayank, good morning. Thank you.
Speaker Change: Good morning. Thank you we don't have any updates on partnering we have lots of interest in different forms you alluded to several one indication both indications. So when the deal is concluded we will make that announcement and you know where we're talking to them all the interested parties with regard to feedback.
Lisa Ricciardi: We don't have any updates on partnering. We have lots of interest in different forms. You alluded to several, one indication, both indications. So when a deal is concluded, we will make that announcement. And you know, we're talking to all the interested parties. With regard to feedback, what I can tell you is we have excellent feedback from KOLs, from people we were with in the international conference in Amsterdam, from surveys we've done of neurologists and from payers. So as we are approaching the coming days, we'll make more of that information public in various ways. But I can tell you it is consistently strong feedback where KOLs are and others, payers in particular, identifying the fact there are great needs, this is a convenient drug, they appreciate the safety profile, patients don't have many options out there.
Speaker Change: What I can tell you is we have excellent feedback from Kols.
Speaker Change: Kols from people, we were within the International conference in Amsterdam from surveys, we've done of neurologist and from payers. So as we are approaching the coming days, we will make more of that information public in various ways, but I can tell you. It is consistently strong feedback where kols.
Speaker Change: Our and others payers in particular identifying the fact, they're great needs. This is a convenient drawn they appreciate the safety profile patients don't have many options out there. It's all the kind of feedback we would have hoped to receive and it's very very consistent with regard to the publication I'll turn that back to Tony sure. So.
Lisa Ricciardi: It's all the kind of feedback we would have hoped to receive. And it's very, very consistent.
Tony Caggiano: With regard to the publication, I'll turn that back to Tony. You know, obviously, it's a long cycle, right? So the preparation will take a little bit. And then there's a submission review, revision and publication, but it's underway. And hopefully we'll be out in the next many, many months.
Speaker Change: The publication is already underway.
Speaker Change:
Speaker Change: You know obviously, it's a long cycle right. So the preparation.
Speaker Change: Take a little bit and then there's a submission review revision in publication, but its underway and hopefully we'll be out in the next many many months.
Mayank Mamtani: And this is, thanks again. Thank you.
Speaker Change: Understood. Thanks again.
Danielle: Thank you. Our next question comes from the line of Danielle got talent with Chardan capital. Please proceed with your question.
Daniil Gataulin: Our next question comes from the line of Daniil Gataulin with Chardon Capital. Hey, good morning, guys. Thank you for taking my question. I have one for DLB. Specifically, similar to the Alzheimer's program, are you looking at any biomarkers or any biomarkers to try to increase the probability of success of that program in the pivotal studies?
Danielle: Hey, good morning, guys. Thank you for taking my question.
Speaker Change: I have one for D O b specifically.
Speaker Change: Specifically this is similar to the Alzheimers program are you looking at any biomarkers or any group disclaims any biomarkers.
Speaker Change: To try to increase the probability of success of that program in the in the pivotal studies.
Tony Caggiano: Yeah, hi, this is Tony again. Good question. Right now, we don't have any definitive enrichment strategy. You know, the good news is we saw really good, robust response across all the people that we recruited, regardless of how we looked at it, whether it's age, you know, gender, amyloid status, alpha-synuclein status, whether they were on dopamine-related drugs, whether they were on acetylcholinesterase-related drugs. So the good news is, you know, we believe across the spectrum of people with DLB, we expect to see a good response.
Tony Casciano: Yeah, Hi, this is Tony again.
Tony Casciano: Question right now we don't have any definitive.
Speaker Change: An enrichment strategy. The good news is we saw really good robust response across all of the people that we recruited regardless of how we looked at it whether it's age gender amyloid status Alpha snoek and status, whether they were on dopamine related drugs, whether they were on mosquito call nest.
Tony Casciano: <unk> related drugs.
So the good news is you know we believe across the spectrum of people with D. L. B.
Tony Casciano: We expect to see a good response.
Tony Caggiano: Got it, thank you. And then with respect to dosing, so when you reported the news about GA and I think you had a green light from DSMB. What's that for a 200 milligram dose? And thinking about the dose for pivotal studies for AD and DLB, what are your current thinking? Are you leaning towards 100 or 200? We haven't selected an exact dose yet. Most likely, we will be operating, you know, below 300 milligrams. And the reason for that is, when you look at the data, you'll see we had a really nice, robust response that's nearly identical for the 100 and 300 milligram dose group, which means we can get the full effect of the drug, and then obviously, the less drug you're using, the fewer troublesome side effects you'll have.
Tony Casciano: Got it got it. Thank you and then with respect to dosing.
Speaker Change: So when when you reported the news about you and I think you had a green light from guests can be.
Tony Casciano: Hum.
Speaker Change: No it wasn't.
Speaker Change: For 200 milligram dose and thinking about the dose for pivotal studies for a day and there'll be a what what are your current thinking on the lending towards the 100 or 200.
Speaker Change: We haven't selected a alien exact dose yet most likely we will be operating a bill.
Speaker Change: Below 300 milligrams and the reason for that is when you look at the data you'll see we had a really nice robust response with nearly identical for the 103 hundred milligram dose group, which means we can get the full effect of the drug and then obviously the last drug you're using that few are troublesome side effects, you'll have so we'll be exploring dose.
Tony Caggiano: So, we'll be exploring, you know, doses below 300. But we haven't come to agreement exactly what that dose will be. Obviously, that'll be part of our end of phase two meeting, where, you know, you justify the dose, and you propose, you know, how it'll be designed, statistical analysis, and so forth.
Speaker Change: <unk> is below 300, but we haven't come to agreement.
Speaker Change: Exactly what that dose would be obviously that'll be part of our end of phase two meeting.
Speaker Change: Justified the dose and you propose you know call it design physical analysis and so forth. So you know.
Daniil Gataulin: So, you know, we'll have an announcement once that meeting is done, as to agreement on the exact plan. Got it.
Speaker Change: We will have an announcement once that meeting is done.
Speaker Change: The agreement on the exact plan.
Daniil Gataulin: All right. Thank you guys. I appreciate you taking Thank you.
Speaker Change: Got it alright. Thank you guys I appreciate you taking the questions.
Operator: Ladies and gentlemen, as a reminder, if you'd like to join the question Star 1 under Our next question comes from the line. Raghuram Selvaraju with.
Speaker Change: Thank you, ladies and gentlemen, as a reminder, if you'd like to join the question queue. Please press star one on your telephone keypad are.
Speaker Change: Our next question comes from the line of Ross Silver Rashi with H C. Wainwright. Please proceed with your question.
Dan Antaran: Good morning, this is Dan Antaran. Thanks for taking our questions. We were wondering, what does the competitive landscape in DLB look like and recognizing your plans to meet with the FDA regarding zubenazine, what are your thoughts around the potential provability of it in DLB based on neuropsychiatric parameters? And I'd like to ask a follow up if I could. You are, tell me. Yeah. The neuropsychiatric symptoms that you mentioned are a key or a core symptom of the disease. So we're very confident that physicians and FDA will be interested in this. Unlike Alzheimer's disease where there's guidance on a cognitive outcome with a functional outcome, that doesn't exist for DLB.
Speaker Change: Good morning. This is Dan on for Ron Thanks for taking our questions. We were wondering what does the competitive landscape in D O be looked like and recognizing your plans to meet with the FDA regarding the benefit and what are your thoughts around the potential approved the ability of the D. O b based on neuropsychiatric parameters and I'd like to ask a follow up if I could.
Tony Casciano: Sure Tony.
Speaker Change: Yeah.
Speaker Change: The the neuropsychiatric symptoms that you mentioned that you know are a key or a core symptom of the disease.
Speaker Change: So you know, we're very confident that the physicians and FDA will be interested in this.
Speaker Change: Unlike all Simons disease, where there's guidance out in a cognitive outcome with a functional outcome that doesn't exist for a.
Tony Caggiano: So a strong emphasis of our FDA meeting will be around which of the outcome measures we will propose, how they'll be ordered, whether they'll be standalone or co-primary or composite outcomes. So that's exactly what that meeting will be about. And again, once we have that meeting and have agreement and understand what that study will look like, there'll be an announcement.
Speaker Change: D L. B, so a strong emphasis of our FDA meeting, we'll be around which of the outcome measures.
Speaker Change: We will propose how they'll be ordered.
Speaker Change: Whether it'll be standalone or co primary composite outcomes. So that's exactly what that that meeting will be about and again once we have that meeting and have agreement and understand what that study will look like there'll be an announcement.
Dan Antaran: Awesome.
Dan Antaran: And then what are the outlooks in Europe versus the United States for accelerated approval of anti-Alzheimer's drugs?
Speaker Change: Awesome and then what are the outlooks in Europe versus the United States for accelerated approval of anti Alzheimer's drugs and what are your thoughts for more near or medium term grant funding given the reported NIH cutbacks. Thank you.
Tony Caggiano: And what are your thoughts for more near or medium-term grant funding given the reported NIH cutbacks? Thank you. So, right now, you know, we are primarily pursuing a very traditional path, right, of, you know, phase three studies that are, you know, adequately sized, well-controlled. You know, either two studies, you know, a supportive study and a single pivotal or two parallel studies. You know, the accelerated pathway in Alzheimer's disease, as you know, has been interesting, right, following Biogen and then now with successes from ACI and Lilly. And given our ability to clearly measure, you know, what are meaningful clinical outcomes, you know, our path is to follow the traditional outcomes and seek a traditional approval.
Speaker Change: So right now you know we are primarily pursuing a very traditional path right of <unk>.
Speaker Change: Phase III studies that are adequately sized well controlled.
Speaker Change: You know either two studies a supportive study in a single pivotal or two parallel studies.
Speaker Change: Yeah, the accelerated pathway in Alzheimers diseases do you know it has been interesting alright, following Biogen and then now with successes from ACI and.
Speaker Change: Lilly and.
Speaker Change: And given our ability to clearly measure you know what a meaningful clinical outcomes.
Speaker Change: The path is to follow the traditional outcomes and seek a traditional approval now in Europe.
Tony Caggiano: Now, in Europe, you know, we haven't seen that it's any easier to get an approval. So, again, we plan to follow a very traditional pathway.
Speaker Change: We haven't seen that it's it's any easier or to get an approval or so again, we plan to follow a very traditional pathway and then with regard to the NIH funding. John mentioned, we have a 50 million dollar balance of funding and that supports our start trial in early stage patients all of our other trials.
Tony Caggiano: And then with regard to the NIH funding, John mentioned we have a $50 million balance of funding, and that supports our START trial in early-stage patients. All of our other trials were funded by the NIH or the NIA within the NIH, and those trials have completed, and we're very confident that this final balance will be available to us. Like everyone else, we're watching what's going on. We're learning on a real-time basis, but we believe we'll have access to those funds to finish the trial. As for your other question about new grants, it's our understanding that by the time you're into phase three programs, you have the ability to reach other sources of funding the capital markets, partnerships, etc.
Speaker Change: Were funded by the NIH on D N I E within the NIH and those trials have completed and we're very confident that this final balance will be available to us like everyone else. We're watching what's going on we're learning on a real time basis, but we believe we will have access to those funds to finish the trial.
Speaker Change: As for your other question about new grants.
Speaker Change: It's our understanding that by the time you're into phase III Pro brands you have the ability to reach other sources of funding the capital market's partnerships etcetera, and that's the funding vehicles, we've seen so far really geared towards earlier stage programs. So I would say, we don't anticipate more grant funding from the.
Dan Antaran: And that the funding vehicles we've seen so far really geared toward earlier stage programs. So I would say we don't anticipate more grant funding from the NIA. It's possible. We'll certainly try. But I think it's a lower probability now than when we were an earlier stage company. Awesome, thank you. Thank you.
Speaker Change: And I E. It's possible, we'll certainly try but I think it's a lower probability now than when we were at earlier stage company.
Speaker Change: Awesome. Thank you.
Speaker Change: Thank you that concludes our questions over the phone I'll turn the floor back to Mr. <unk> for any final comments.
Operator: That concludes our questions over the phone.
Lisa Ricciardi: I'll turn the floor back to Ms. Ricciardi for any final comments. Great. I'm just looking at some prior questions we were asked. John addressed the question about the ATM, how we have an ATM in place. We've addressed planning for Phase 3 trials in AD and DLB. Someone had previously asked us, why are you not starting your Phase 3 trials yet? And I think we've covered it on this call. You prepare an enormous dossier. You sit with the agency. You review your protocol. From there, by identifying your funding, you're good to go. You have a plan and a source of funding to complete it.
Speaker Change: Great I'm just looking at some prior questions. We were asked John address the question about the ATM, how we have an ATM in place we've addressed our planning for phase III trials and a D. M D L b.
Speaker Change: Someone had previously asked US why are you not starting your phase III trials, yet and I think we've covered it on this call you prepare an enormous dossier you sit with the agency review your protocol from there.
Speaker Change: Identifying your funding you're good to go you have a plan and a source of funding to complete it and last with regard to partnerships. As we said earlier, we're very actively involved in that process and when we have something that we can announce we will.
Lisa Ricciardi: And last, with regard to partnerships, as we said earlier, we're very actively involved in that process, and when we have something that we can announce, we will. What I would like to conclude with is saying we have FDA meetings coming this year. While there are challenges ahead in terms of financing our studies, we're committed to meeting these challenges. We're positioned to achieve and deliver on multiple clinical milestones, and we're focused on creating long-term value for our shareholders as we create important new medications.
Speaker Change: Hmm.
Speaker Change: What I would like to conclude with is saying we have FDA meetings coming this year. While there are challenges ahead in terms of financing. Our studies were committed to meeting. These challenges we're positioned to achieve and deliver on multiple clinical milestones and we're focused on creating long term value for our shareholders as we create important new.
Lisa Ricciardi: As always, we want to thank study participants and their caregivers, our investors, as well as supporters at the NIA, Michael J. Fox, the ADVF, our CRO partners, and our team. Without all of these groups, we would not be where we are today, developing new medicines for neurodegenerative diseases.
Speaker Change: Medications, we as always we want to thank study participants and their caregivers our investors as well as supporters of the NIH, Michael J Fox the a D V F. R C. Our airport partners and our team without all of these groups, we'd not be where we are today developing new medicines for neurons.
Operator: Thank you, Operator.
Speaker Change: Generative diseases. Thank you operator that concludes our call.
Operator: That concludes our call. Thank you.
Operator: Ladies and gentlemen, this concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.
Speaker Change: Thank you ladies and gentlemen. This concludes today's conference call. You may disconnect. Your lines at this time. Thank you for your participation.
Speaker Change: Yeah.