Q2 2024 Acumen Pharmaceuticals Inc Earnings Call
Operator: Hello, and thank you for standing by. Welcome to Acumen Pharmaceuticals' Q2 2024 conference call and webcast. At this time, all participants are in a listen-only mode.
Operator: Hello, and thank you for standing by.
Hello, and thank you for standing by.
Operator: Welcome to Acumen Pharmaceuticals Q2, 2024 conference call and webcasts. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question in the session.
To acumen Pharmaceuticals, Q2, 2024 conference call and webcast.
Speaker Change: At this time all participants are in a listen only mode.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 11 on your telephone. You will then receive an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to turn the call over to Alex Braun, Head of Investor Relations. Please go ahead.
After the speaker's presentation, there will be a question and answer session.
Operator: To ask the question during this session, you will need to press Star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.
Speaker Change: To ask a question during the session you will need to press star one on your telephone.
Speaker Change: You would then your automated message advising your hand is raised.
Speaker Change: To withdraw your question. Please press star one again.
Alex Braun: I would now like to turn the call over to Alex Braun, Head of Investigative Relations. Please go ahead.
Speaker Change: I would now like to turn the call over to Alex Brown head of Investor Relations. Please.
Alex Braun: Thank you, operator. Good morning and welcome to the Acumen conference call to discuss our business update and financial results for the quarter-ended June 30th, 2024. With me today, are Dan O'Connell, our CEO, and Matt Zuga, our CHIFO and Chief Business Officer.
Alex Braun: Thank you, operator. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended June 30, 2024. With me today are Dan O'Connell, our CEO, and Matt Zuga, our CFO and Chief Business Officer. Dan and Matt have some prepared remarks, and then we'll open the call for questions. Joining us for the Q&A session is Dr. Jim Doherty, our President and Chief Development Officer, and Dr. Eric Siemers, our Chief Medical Officer.
Speaker Change: Please go ahead.
Thank you operator good morning.
Alex Brown: And welcome to the acumen conference call to discuss our business update and financial results for the quarter ended June 30th 'twenty 'twenty four with me today are Dan O'connell, our CEO and Matt Yoga, our CFO and Chief business Officer.
Alex Braun: Dan and Matt, some prepared remarks, and then we'll open the call for questions. Joining for the Q&A session, we also have Dr. Jim Doherty, our President and Chief Development Officer, and Dr. Eric Siemers, our Chief Medical Officer.
Alex Brown: Dan and I have some prepared remarks, and then we'll open the call for questions.
Joining for the Q&A session. We also have Dr. Jim Doherty, our president and Chief Development Officer, and Dr. Eric Siemers, our Chief Medical Officer.
Alex Braun: Before we begin, we encourage listeners to go to the investor's section of the Acumen website to find our press release issued this morning that we'll discuss today.
Alex Braun: Before we begin, we encourage listeners to go to the Investors section of the Atumen website to find our press release issued this morning that we'll discuss today. Please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statement.
Alex Brown: Before we begin we encourage listeners to go to the investors section of the Ottoman website to find our press release issued this morning that we'll discuss today.
Alex Braun: Please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Please see slide two of our corporate presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements.
Alex Braun: Please see slide 2 of our corporate presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in these forward-looking statements. We undertake no obligation to update or revise the information provided in this call or in the accompanying presentation as a result of new information or future results or developments. So with that, I'll turn the call over to Dan. Thanks, Alex. Good morning, everyone.
Alex Brown: Please note that during today's conference call. We may make forward looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans.
Alex Brown: These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward looking statements.
Alex Brown: Please see slide two of our corporate presentation. Our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward looking statements.
Alex Braun: We undertake no obligation to update or revise the information provided on this call or any accompanying presentation as a result of new information or future results or developments.
Alex Brown: We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments.
Alex Braun: So, with that, I'll turn the call over to Dan. Thanks, Alex.
Alex Brown: So with that I'll turn the call over to Dan.
Dan O'Connell: And thanks for joining us today. We've made significant progress in the first half of 2024 as we continue to execute our clinical plans for Sobernata, our next generation amyloid beta-oligomer targeted antibody for the treatment of early Alzheimer's disease. Altitude AD, our Phase 2 study designed to evaluate the clinical efficacy and safety of SobrenaTug in patients with MCI or mild dementia due to AD, is actively enrolling. Altitude AD is a randomized, double-blind, placebo-controlled, pre-armed study with approximately 180 participants per treatment arm for a total of 540 participants.
Dan O'Connell: Good morning, everyone. And thanks for joining us today. We've made significant progress in the first half of 2024 as we continue to execute our clinical plans for Suburnitone, our next generation, and Lloyd-Data-Ligan-Retargeted antibody for the treatment of early Alzheimer's disease. Out to 2DAD, our Phase 2 study designed to evaluate the clinical efficacy and safety of suburnitone in patients with MCI, old mild, dementia due to AD, is actively enrolling. Altitude AD is a randomized, double-blind, placebo-controlled, three-arm study with approximately 180 participants per treatment arm for a total of 540 participants. Altitude currently has more than 50 sites active across North America, the UK, and the EU, with the first subject dose it made, 2024.
Dan O'Connell: Thanks, Alex and good morning, everyone and thanks for joining US today, we've made significant progress in the first half of 2024 as we continue to execute on our clinical plans for our next generation <unk>.
David: David I was looking more targeted antibody for the treatment of early Alzheimer's disease.
Speaker Change: <unk>, our phase III study designed to evaluate the clinical efficacy and safety of <unk> in patients with Mci mild and that should lead to a D is actively enrolling.
Speaker Change: Altitude <unk> is a randomized double blind placebo controlled three arm study with approximately 180 participants per treatment arm for a total of 540 participants.
Dan O'Connell: Altitude currently has more than 50 sites active across North America, the UK, and the EU, with the first subject dosed in May 2024. At present, enrollment in Altitude is progressing faster than our original projections, which is highly encouraged. We attribute this to CibernaPEG's distinct profile based on its mechanism of action and positive feedback and interest from investigators, supported by our strong phase one data. Additionally, our team has built highly productive working relationships with quality trial sites in all three regions.
Speaker Change: <unk> currently has more than 50 sites active across North America, the UK and EU with the first subject dosed at May 2024.
Dan O'Connell: At present, enrollment in altitude is progressing faster than our original projections, which is highly encouraging. Restricted this to suburnitone's distinct profile based on its mechanism of action and positive feedback and interest from investigators supported by our strong Phase 1 data. Additionally, our team has built highly productive working relationships with quality trial sites in all three regions. Patience. These combined factors have translated into an encouraging enrollment rate and underpin the growing interest in novel treatment options for early AD and differentiated treatment potential of suburnitug. In July, we also announced we had dosed our first subject in a phase one study of subcutaneous suburnitug.
Speaker Change: At present enrollment in altitude is progressing faster than our original projections, which is highly encouraging.
Attributed to <unk> distinct profile based on its mechanism of action and positive feedback and interest from investigators supported by our strong phase one data. Additionally, our team has built a highly productive working relationships with quality trial sites in all three regions.
Dan O'Connell: These combined factors have translated into an encouraging enrollment rate and underpinned the growing interest in novel treatment options for early AD and differentiated treatment potential of Cerverna types. In July, we also announced we had dosed our first subject in a phase one study of subcutaneous subornitug. The study will compare the pharmacokinetics between intravenous and subcutaneous administrations of subornitug in healthy volunteers, and we will review this workstream as an important extension of CivernaCog's product profile, which aims to offer flexibility and convenience in dosing for patients and caregivers. We anticipate the top-line results from this study will be available in the first quarter of 2025. Once we have the P.K.
Speaker Change: These combined factors have translated into an encouraging enrollment rate and underpin the growing interest in novel treatment options for early.
Speaker Change: <unk> differentiated treatment potential of Savannah.
Speaker Change: In July we also announced we have dosed our first subject in a phase one study of subcutaneous <unk>. The study will compare the pharmacokinetics between intravenous and subcutaneous administrations of <unk> in healthy volunteers.
Dan O'Connell: The study will compare the pharmacokinetics between intravenous and subcutaneous administrations of suburnitug in healthy volunteers. Review this work stream as an important extension of Suburnitug's product profile, which aims to offer flexibility and convenience in dosing for patients and caregivers. We anticipate the top line results from this study will be available in the first quarter of 2025. Once we have the PK bioavailability results in hand, we will be best positioned to discuss next steps in clinical plans for subcutaneous suburnitug.
Speaker Change: We view. This work stream is an important extension of <unk> product profile, which aims to offer flexibility and convenience and dosing for patients and caregivers.
Speaker Change: We anticipate the top line results from this study will be available in the first quarter of 2025.
Dan O'Connell: Bioavill, though With the result in hand, we will be best positioned to discuss next steps in clinical plans for subcutaneous suburnetites. Turning now to continued learnings from our clinical experience with Suburnatide, the Acumen team recently presented further data analysis from the Intercept AD trial at the Alzheimer's Association International Conference, or AEC. Our team presented posters at this major Alzheimer's medical conference detailing patient interviews, biomarker data supportive of subvertifoges' mechanism of action, and acumen's ultra-sensitive method of measuring small amounts of subvertifoges in cerebral spinal fluid.
Speaker Change: Once we have the PK bioavailability results in hand, we will be best positioned to discuss next steps in clinical plans for subcutaneous <unk>.
Dan O'Connell: Turning now to continued learnings from our clinical experience with suburnitug, the Accurate team recently presented further data analysis from the Intercept AD trial at the Alzheimer's Association International Conference, or AAC. Our team presented posters at this major Alzheimer's medical conference detailing patient interviews, biomarker data supportive of suburnitug's mechanism of action, and Acumen's ultra sensitive method of measuring small amounts of suburnitug in cerebral spinal fluid. To take away from our patient interviews, underscore the importance of incorporating the patient voice into trial design and humanizing the unmet need in Alzheimer's disease. As expected, nearly all patients reported difficulty with memory and cognition, difficulty with getting lost, difficulty with communication, and changes in mood were also commonly reported.
Speaker Change: Turning now to continued learnings from our clinical experience with Subaru Acura.
Speaker Change: Accurate team recently presented further data analysis from the intercept trial at the Alzheimers Association International Conference or AIC are.
Speaker Change: Our team presented posters at this major Alzheimers medical conference detailing patient interviews biomarker data supportive of <unk> mechanism of action and documents ultra sensitive method of measuring small amounts of <unk>.
Speaker Change: In cerebral spinal fluid.
Dan O'Connell: The takeaways from our patient interviews underscore the importance of incorporating the patient voice into trial design and humanizing the unmet need in Alzheimer's disease. As expected, nearly all patients reported difficulty with memory and cognition, difficulty with getting lost, difficulty with communication, and changes in mood.
Speaker Change: Takeaways from our patient interviews underscore the importance of incorporating the patient voice into trial design of humanizing the unmet need.
Speaker Change: <unk> disease as.
Speaker Change: As expected nearly all patients reported difficulty with memory and cognition difficulty with getting loss difficulty with communication and changes in mood or also commonly reported.
Dan O'Connell: Almost 90% of patients would like a treatment to slow the progression of disease or keep it from getting worse, as well as maintaining the ability to recognize loved ones. We also received strong interest in the synaptic biomarker changes observed in our phase one study. Both pre and post-synaptic cerebral spinal fluid proteins, VAT2 and neurogranin, showed significant reduction towards normalization, which is consistent with suburnitug's ability to inhibit amyloid beta oligomer synaptic binding. These posters can be found on the investor section of our website if you haven't already had a chance to review them. As usual, there was a great deal of interesting information shared at AIC, including a number of topics relevant to our suburban program.
Dan O'Connell: Almost 90% of patients would like a treatment to slow the progression of the disease or keep it from getting worse, as well as maintain the ability to recognize loved ones. We also received strong interest in the synaptic biomarker changes observed in our Phase 1 study. Both pre and post synaptic cerebrospinal fluid proteins, VAMPF2 and Neurogranin, showed significant reduction towards normalization, which is consistent with Subarnathug's ability to inhibit amyloid beta-oligomer synaptic binding.
Speaker Change: Almost 90% of patients who'd like a treatment to slow the progression of disease or keep it from getting worse as well as maintain the ability to recognize loved ones.
Speaker Change: We also received strong interest in the synaptic biomarker changes observed in our phase one study, both pre and post synaptic cerebral spinal fluid proteins. They have two in neuro granting shared significant reduction towards normalization, which is consistent with <unk> ability to inhibit amyloid beta oligomers synaptics.
Dan O'Connell: These posters can be found in the investor section of our website if you haven't already had a chance to review them. As usual, there was a great deal of interesting information shared at AEIC, including a number of topics relevant to our Subartic Tug program. These topics included the continued development of fluid biomarkers like PTAU-217 as diagnostics for tracking the progression of Alzheimer's, further data on the important role that soluble amyloid beta species play in the pathophysiology of AD, and extended safety and efficacy data on chronic dosing with anti-amyloid monoclonal antibody therapy.
Nick: Hi, Nick.
Speaker Change: These posters can be found on the investors section of our website. If you haven't already had a chance to review them.
Speaker Change: As usual there was a great deal of interesting information shared at AIC, including a number of topics relevant to our savanna type program.
Dan O'Connell: These topics included the continued development of fluid biomarkers, like PETA217, as diagnostics for tracking the progression of Alzheimer's. Further data on the important role that soluble amyloids beta species play in the pathophysiology of AD, and extended safety and efficacy data on chronic dosing with anti-amyloid monoclonal antibody therapies. We believe the increased acceptance of the toxicity and persistence of soluble amyloid beta species, such as oligomers, will help move the field towards next generation antibodies, such as Suburnitug. The confluence of fluid biomarker breakthroughs will support expanded future access to novel treatments in AD.
Speaker Change: These topics included.
Speaker Change: Continued development of fluid Biomarkers like <unk> 2017, as diagnostics for tracking the progression of Alzheimers further data on the important role that soluble amyloid beta species play in the pathophysiology of <unk> and extended safety and efficacy data on chronic dosing with anti amyloid monoclonal antibody therapies.
Dan O'Connell: We believe the increased acceptance of the toxicity and persistence of soluble amyoid beta species such as oligomers will help move the field towards next-generation antibodies such as burnitug. And the confluence of fluid biomarker breakthroughs will support expanded future access to novel treatments in AD. Finally, we are planning to host a virtual R&D day on October 2. We intend for this event to provide a deep dive into the scientific rationale supporting Sobernatogin's mechanism of action for phase one clinical results and phase two clinical plans for Sobernatogin. We will communicate the registration details and agenda closer to the event.
Speaker Change: We believe the increased acceptance of the toxicity and persistence of soluble amyloid beta species, such as oligomers will help move the field towards next generation antibodies such as <unk>.
Speaker Change: And the confluence of fluid biomarker breakthroughs will support expanded future access to novel treatments in a day.
Dan O'Connell: Finally, we are planning to host a virtual R&D Day on October 2nd. We intend for this event to provide a deep dive into the scientific rationale of supporting suburnitug's mechanism of action. We are phase 1 clinical results and phase 2 clinical plans for Suburnitug. We will communicate the registration details and agenda closer to the event. We remain committed to delivering on our strategic priority to efficiently and topfully advance the global development suburnatog and encouraged by the direction the Alzheimer's field is headed with new data and an updated understanding of the disease that is in line with our science.
Speaker Change: Finally, we are planning to host a virtual R&D day on October 2nd we intend for this event to provide a deep dive into the scientific rationale supporting some prototypes mechanism of action.
Speaker Change: As one clinical results in phase III clinical plans for similar enough Doug.
Speaker Change: We will communicate the registration details and agenda closer to the event.
Dan O'Connell: We remain committed to delivering on our strategic priority to efficiently and thoughtfully advance the clinical development of Subarna Tug and are encouraged by the direction the Alzheimer's field is headed with new data and an updated understanding of the disease that is in line with our science. I look forward to updating you as we work towards phase two data that we believe will provide a significant value inflection for the program and demonstrate Sobernatog's true potential as a next-gen treatment with a highly compelling benefit-to-risk profile. And with that, I'll turn the call over to Matt for the financials.
Speaker Change: We remain committed to delivering on our strategic priority.
Speaker Change: Efficiently and thoughtfully advanced the clinical development Subaru and are encouraged by the direction will be also under scaled is headed with new data and an updated understanding of the disease that is in line with our science.
Matt Zuga: I look forward to updating you as we work towards face to data that we believe will provide a significant value inflection for the program and demonstrate Suburnatog's true potential as a highly compelling benefit to risk profile, and with that I'll turn the call over to Matt for the financials.
Look forward to updating you as we work towards phase II data that we believe will provide a significant value inflection for the program and demonstrate cybernetics true potential as a next gen treatment.
Speaker Change: With a highly compelling benefit to risk profile.
Speaker Change: And with that I'll turn the call over to Matt for the financials. Thank you.
Matt Zuga: Thank you. Thanks, Dan.
Speaker Change: Yeah.
Matt Zuga: Thank you. Thanks, Dan. As a reminder, our second quarter 2024 financial results are available in the press release we issued this morning and in our 10Q, which we will file later today. As of June 30, we had approximately $281 million in cash and marketable securities on our balance sheet and continue to expect the cash runway to last into the first half of 2027. R&D expenses were $19.5 million in the second quarter.
Matt Zuga: As a reminder, our second quarter 2024 financial results are available in the press release we issued this morning and in our 10-Q we will file later today. As of June 30th, we had approximately $281 million in cash and marketable securities on our balance sheet and continue to expect the cash runway to last into the first half of 2027. R&D expenses were $19.5 million in the second quarter. The increase over the prior year was primarily due to the increased spending to support the altitude AD trial. G&A expenses were $4.8 million in the quarter. With the increase over the prior year, primarily the result of increased headcount.
Thanks, Dan.
Matt Yoga: A reminder, our second quarter 2024 financial results are available in the press release, we issued this morning.
Matt Yoga: And in our 10-Q, we will file later today.
Matt Yoga: As of June 30, we had approximately $281 million in cash and marketable securities on our balance sheet and continue to expect the cash runway to last into the first half of 2027.
Matt Yoga: R&D expenses were $19 $5 million in the second quarter.
Matt Zuga: The increase over the prior year was primarily due to the increased spending to support the Altitude AD trial. GNA expenses were $4.8 million in the quarter. With the increase over the prior year, primarily due to an increased headcount, this led to a loss from operations of $24.4 million in the quarter.
Matt Yoga: The increase over the prior year was primarily due to the increased spending to support the altitude <unk> trial.
Matt Yoga: G&A expenses were $4 $8 million in the quarter with the increase over the prior year, primarily the result of increased head count.
Matt Zuga: This led to a loss from operations of $24.4 million in the quarter.
Matt Yoga: This led to a loss from operations of $24 $4 million in the quarter.
Matt Zuga: I'm very pleased with our clinical execution thus far in 2024. We are well-resourced for our phase two study and to develop a subcutaneous formulation of suburnatog and are committed to delivering on the opportunity ahead of us for the benefit of patients, caregivers, and shareholders.
Matt Zuga: I'm very pleased with our clinical execution thus far in 2024. We are well resourced to support our Phase II study and to develop a subcutaneous formulation of subornitogin, and are committed to delivering on the opportunity ahead of us for the benefit of patients, caregivers, and shareholders. And with that, we can open the call for Q&A. Operator? Thank you. Ladies and gentlemen, to ask the question... To withdraw your question, please press star 1-1 on your telephone and then wait to hear your name announced. Then, please press star 1 again.
Matt Yoga: I am very pleased with our clinical execution, thus far in 2024, we are well resort.
Matt Yoga: Our phase II study and to develop a subcutaneous formulation of suburban Doug.
Matt Yoga: And are committed to delivering on the opportunity ahead of us for the benefit of patients caregivers and shareholders.
Operator: And with that, we can open the call for Q&A, operator. Thank you. Ladies and gentlemen, to ask the question, please first start 1-1 on your telephone and then wait to hear your name announced. To withdraw your question, please first start 1-1 again. Please stand by while we compile the Q&A roster.
Speaker Change: And with that we can open the call for Q&A operator.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen to ask the question.
Speaker Change: Please press star one on your telephone and then wait to hear your name announced.
Speaker Change: So withdraw your question. Please press star one again.
Operator: Please stand by while we compile the Q&A roster. Our first question comes from the line of Tom Shrader with BTIG. Your line is open. Good morning.
Speaker Change: Please standby, while we compile the Q&A roster.
Tom Schrader: Our first question comes from the line of Tom Schrader with BTIG. The line is open.
Thomas Shrader: Thanks for taking the question and the updates. I have a question on the phase two trial and what patients you're getting. What is enrollment like in the US with two approved products? Is it Tricky, or are patients highly compelled by the Potential for Less ARIA? Hi, Tom.
Speaker Change: Our first question comes from the line of Tom Shrader with <unk>. Your line is open.
Tom Schrader: Good morning. Thanks for taking the question and the updates. I have a question on the phase two trial and what patients you're getting. What is enrollment like in the US with two approved products? Is it tricky, or are patients highly compelled by the potential for less ARIA? And I would expect enrollment in Europe.
Tom Shrader: Hey, good morning, Thanks for taking the question and the updates I have a question on the phase III trial, and what patients you're getting.
Speaker Change: What does the enrollment like in the U S. With two approved products is it trick.
Speaker Change: Tricky or Ah patients highly compelled by the.
Speaker Change: Potential for less ARIA and I would expect enrollment in Europe people are very enthusiastic but are you going to limit or are you going to require some number of U S patients. Thank you.
Tom Schrader: People are very enthusiastic, but are you going to limit, or are you going to require some number of US patients?
Tom Schrader: Thank you.
Dan O'Connell: Hi Tom. Thanks. Great question. And as I mentioned earlier in the work with the prepare remarks, we are encouraged at the enrollment rate, and to date it has exceeded our expectations from original forecasts. I think this is a consequence of the a met need in this population, as well as the phase one data that really underpin the differentiation of suburniture. Lastly, the study design itself; the feedback from sites and investigators has been very favorable in that the study incorporates two active doses versus placebo and then an open-label extension. So, in terms of choice and participation, we're seeing a lot of demand to participate in the Altitude AD study, and we do anticipate a split between North America and Europe. Can't haven't pre-set those next, but they will have patients covering each of the territories or regions that I mentioned earlier.
Dan O'Connell: Yeah, thanks. Great question. And as I mentioned earlier in the prepared remarks, we are encouraged that the enrollment rate, and to date, it has exceeded our expectations from our original forecast. I think this is a consequence of the unmet need in this population, as well as the Phase 1 data that really underpin the differentiation of Sobernatyte. Lastly, the study design itself, and the feedback from sites and investigators has been very favorable in that the study incorporates two active doses versus placebo and then an open-label extension.
Speaker Change: Hi, Tom Yes, Thanks, Great question and as I mentioned earlier in the.
Speaker Change: Prepared remarks, we are encouraged that the enrollment rate.
Speaker Change: And to.
Speaker Change: To date it has exceeded our expectations from our original forecast I think this is a consequence of the unmet need in this population.
Speaker Change: As well as the phase one data that really underpin the differentiation of cybernetic lastly, the study design itself the feedback from sites and investigators have been very favorable.
Speaker Change: The study incorporates two active doses versus placebo and then an open label extension so in terms of.
Dan O'Connell: So, in terms of choice and participation, we're seeing a lot of demand to participate in the Altitude AD study, and we do anticipate a split between North America and Europe. I haven't preset those numbers, but I think we'll have patients covering each of the territories or regions that I mentioned earlier. Okay, all right, thank you. Maybe I can just add a little bit to that. Yeah, the rate at which we're seeing patients really exceeds our projections and expectations, which is great. You might, you know, ask yourself why that might be.
Speaker Change: Choice and participation, we're seeing a lot of demand to participate in the altitude <unk> study.
Speaker Change: We do anticipate a split between North America and Europe.
Speaker Change: I haven't set those those mix, but pick will have patients are covering each of the territories are regions that I mentioned earlier.
Dan O'Connell: Thank you.
Matt Zuga: Maybe I'll just add a little bit to that. The rate at which we're seeing patients really exceeds our projections and expectations, which is great.
Speaker Change: Okay all right. Thank you.
Speaker Change: I'd, just add a little bit to that.
Speaker Change: Yes.
Speaker Change: The rate at which we're seeing patients really exceeds our projections and expectations, which is great.
Matt Zuga: You might ask yourself why that might be. And as Dan mentioned, it's probably moly factorial, but I think partly it's the strength of our phase one data that was done in patients. We've seen a lot of biomarker changes that are really encouraging for the drug. And secondly, what we've heard from the sites is that they do like the protocol design. It's a phase two study, but really it's like a small phase three study with an open label extension in the sites like that. We started the study in the US, and that's where currently we have most of our patients, but now we're adding sites.
Matt Zuga: And as Dan mentioned, it's probably multifactorial, but I think partly it's the strength of our phase one data that was done in patients. We've seen a lot of biomarker changes that are really encouraging for the drug. And secondly, what we've heard from the sites is that they do like the protocol design. It's a phase two study, but really, it's like a small phase three study with an open-label extension, and the sites like that. We started the study in the US, and that's where we currently have most of our patients, but now we're adding sites. We've already added sites in Canada, the UK, and then Europe.
Speaker Change: You might ask yourself why that might be and as Dan mentioned is probably multi factorial, but I think partly its the strength of our phase one data that was done in patients. We've seen a lot of biomarker changes that are really encouraging for the drug and secondly, what we've heard from the sites.
Speaker Change: Is that they.
They do like the protocol design.
Speaker Change: Phase two study, but really.
Speaker Change: Like a small phase III study with an open label extension and the sites like that we started the study in the U S and that's where currently we have most of our patients but now we are adding sites we've already added sites.
Matt Zuga: We've already added sites in Canada, the UK, and then Europe. So we'll be enrolling more patients in those other geographies.
Speaker Change: Canada, the UK and Europe, So we will be enrolling more patients in those other.
Speaker Change: Geographies.
Matt Zuga: Okay, great. Thank you.
Matt Zuga: So we'll be enrolling more patients in those other geographies. Okay, great. Thank you. Thank you. Please name back for our next question. Our next question comes from the line of Jason Zemansky with Bank of America. Your line is open. Hi, good morning. This is Cameron Bozdog on behalf of Jason.
Okay, great. Thank you.
Cameron Bozdog: Please stand by for our next question. Our next question comes from a lot of Jason's MSDAT with Bike of America.
Speaker Change: Thank you.
Speaker Change: Please standby for our next question.
Speaker Change: Our next question comes from the line of Jason <unk> with Bank of America. Your line is open.
Cameron Bozdog: The line is open. Hi, good morning. This is Cameron Bozdog on for Jason. Congrats on the quarter, and thanks for taking our question. So in thinking about the anti a beta commercial landscape, you know, what do you think have been the major challenges or gaining factors? Is it educating physicians, you know, engaging with patients, or has it been an issue of infrastructure, payer access, reimbursement? And then appreciating it's early, but do you see opportunities for subordinate to potentially differentiate itself? Where is it more that you know the broader market needs to finish undergoing maturation itself?
Jason Zemansky: Congratulations on the quarter and thanks for taking our questions. So, in thinking about the anti-ABETA commercial landscape, what do you think have been the major challenges or gating factors? Is it educating physicians, you know, engaging with patients, or has it been an issue of infrastructure, payer access, or reimbursement?
Speaker Change: Okay.
Kevin <unk>: Hi, Good morning. This is Kevin <unk> on for Jason Congrats on the quarter and thanks for taking our question.
Speaker Change: And thinking about the anti a beta commercial landscape.
Speaker Change: You think have been the major challenges are gating factors is it educating physicians engaging with patients or has it been an issue that infrastructure payer access reimbursement and then appreciating it's early but do you see opportunities for Asbury in tag to potentially differentiate itself or is it more of that.
Dan O'Connell: And then appreciating it's early, but do you see opportunities for a subornitag to potentially differentiate itself, or is it more that, you know, the broader market needs to finish undergoing maturation itself? Thank you. Thanks, Cameron. And I think you've listed out the multifactorial sort of issues that are basically inhibiting or at least metering out the ramp and the growth and expansion of these treatments, these first couple of approved products.
Speaker Change: The market needs to finish undergoing maturation itself. Thank you.
Cameron Bozdog: Thank you.
Dan O'Connell: Thanks, Cameron. And I think you've listed out the multifactorial sort of issues that are that are basically inhibiting or at least. Meandering out the rap and the growth and extension of these treatments, these first couple of proof products. We think that it's interesting now with Lily coming into the marketplace, the infrastructure will continue to be built out that awareness around the possibility of seeking treatment. We'll continue to draw more awareness and patients into this new treatment paradigm. There are also, I think, one of the points we made from the AC meeting is that the anticipation of fluid biomarkers, you know, blood-based diagnostics is likely to impact the growth and expansion of this field.
Speaker Change: Thanks, Kamran I think you've listed out the multifactorial sort of issues that are that are basically inhibiting or at least.
Speaker Change: Metering out the ramp in the growth and expansion of these treatments. These first couple of approved products.
Dan O'Connell: We think that now that Lilly is coming into the marketplace, the infrastructure will continue to be built out, and awareness around the possibility of seeking treatment will continue to draw more awareness and patients into this new treatment paradigm. There are also, I think, one of the points we made from the AIC meeting is that the anticipation of fluid biomarkers, you know, blood-based diagnostics is likely to impact the growth and expansion of this field. So it is multifactorial. I think there's been good progress made, and they'll continue to be the infrastructure rolled out in terms of Sobernatug and differentiation. We absolutely have high conviction that its mechanism is differentiated.
Speaker Change: We think that.
Speaker Change: Interesting that with.
Speaker Change: Coming into the marketplace the infrastructure.
We will continue to be built out that awareness around the possibility of seeking treatment will continue to drive more awareness in patients into this new treatment paradigm. There are also I think one of the one of the points. We made from the AIC meeting is that the anticipation of fluid Biomarkers blood based diagnostics is likely.
Speaker Change: To impact the growth and expansion of this.
Dan O'Connell: So it is multifactorial. I think there's been good progress made, and they'll continue to be the infrastructure world out in terms of subordinate differentiation. We absolutely have high conviction that its mechanism is differentiated, and yet, as a consequence of that, has the promise of differentiating either or both on efficacy and safety. And that's really our single focus is to offer early 80 patients an improved treatment option in terms of benefit-to-risk profile.
Speaker Change: This field. So it is multifactorial I think there's been good progress made and continue to be the infrastructure rolled out in terms of <unk> differentiation, we absolutely have high conviction that its mechanism this differentiated and yet.
Dan O'Connell: And yet, as a consequence of that, there is the promise of differentiating either or both on efficacy and safety. And that's really our single focus is to offer early A.D. patients an improved treatment option in terms of benefit to risk profile. So that's I think that addresses most of your questions. I don't know, Jim or Eric, if you have any follow-up. Thank you. Please stand by for our next question. Our next question comes from the line of Paul Mathias with Stiefel.
Speaker Change: As a consequence of that has the promise of differentiating either or both on efficacy and safety and Thats really our single focus is to offer early 80 patients.
An improved treatment option in terms of benefit to risk profile. So that's I think that addresses most of your questions I don't know.
Unknown Executive: So that's, I think, that addresses most of your questions. I don't know. Jim or Eric, if you have any following.
Speaker Change: Joe or Eric if you have any follow on comments.
Speaker Change: Okay.
Unknown Executive: Thank you.
Joe: Thank you thanks.
Operator: Please, nearby for our next question.
Speaker Change: Please note that for our next question.
Mark: Our next question comes from the line of Paul Matias with Steve.
Speaker Change: Our next question comes from the line of Paul <unk> with Stifel. Your line is open.
Mark: Your line is open.
Mark: Hey, this is Mark on for Paul. Thanks for taking our questions. So, we were curious. What does the path forward look like for the sub queue formulation for Sabirna Tuggan then? You know, would that be assessing parallel to the intravenous formulation? If the phase one were successful, and then separately on that, you know, what dose could you pursue? And would that, you know, enable robust plaque target engagement? Or that being more of like, you know, like a murder dose?
Paul Mathias: Your line is open. Hey, this is Marc Antropoulos. Thanks for taking our questions. So, we were curious, what the path forward looks like for the sub-Q formulation for Sabirna Tug? And then, you know, would that be assessed in parallel to the intravenous formulation if the Phase I were successful? And then, separately on that, what dose could you pursue? And would that, you know, enable robust plaque target engagement?
Hey, this is mark on for Paul Thanks for taking our question. So we were curious what does the path forward look like for the sub Q formulation for severe and a tug and then would that be assessing in parallel to the intravenous formulation.
Speaker Change: As one more successful and then separately on that.
Speaker Change: What dose could you pursue in with that.
Speaker Change: Enable robust plaque target engagement or would that be more of like oligomer dose and then if you could provide any additional details for the altitude <unk> interim analysis that would be great as well. Thank you.
Mark: And then, if you could provide any additional details for the altitude aid in term analysis, that would be great as well. Thank you.
James Doherty: Sure, I want to direct that one to Jim as our lead development efforts. Sure, happy to take it down that. Mark, the answer to your question, I think, is we're the first step really for the subcutaneous development program is to understand the viability of a sub queue version. So that's the goal of the first study here in healthy volunteers is to really align the PK from the sub queue administration with the halosine formulation with what we're learning from the IV studies from intercepts and ongoing work with altitude AD. You know, I think beyond that, we have a number of options on how to proceed.
James Doherty: Or would that be more of like an oligomer dose? And then, if you could provide any additional details for the altitude AD interim analysis, that would be great as well. Thank you. Sure, I want to direct that one to Jim as our lead on development efforts. Sure, happy to take it, Dan.
Speaker Change: Sure.
Jim: Direct that wanted to Jim.
Jim: As our lead.
Jim: Development efforts.
James Doherty: Mark, to answer your question, I think the first step, really, for the subcutaneous development program is to understand the bioavailability of the sub-Q version. So that's the goal of the first study here in Healthy Volunteers is to really align the PK from the sub-Q administration with the halozyme formulation with what we're learning from the IB studies from Intercept and ongoing work with Altitude AD. You know, I think beyond that, we have a number of options on how to proceed.
Jim: Sure.
Jim: Dan.
Mark: Mark the answer to your question I think.
Jim: Sure.
Speaker Change: The first half really for the subcutaneous development program is to understand that.
The bioavailability of the sub Q version. So that's the goal of the first study here in healthy volunteers has been really.
Speaker Change: Align the PK from the sub Q administration with the Amazon formulation with what we're learning from the IV studies from intercepts and ongoing work without the G&A.
James Doherty: I think from the point of view of dosing, the targeting of the dose is intended to hit the same range that we're targeting with the IB formulation, and the purpose of that, of course, is based on our target engagement data from Phase 1. We've got high confidence that we are targeting a range that's having an effect dose-dependently on a soluble oligomer in the brain, and also, as we've demonstrated from Intercept, some evidence for plaque reduction as well.
Speaker Change: Yeah.
Speaker Change: I think beyond that we have a number of options on how to proceed I think from the point of view of dosing the targeting of the dosing is intended to hit the same range that we're targeting with the IV formulation and the purpose of that of course is based on our target engagement data from phase one we've got high.
James Doherty: I think from the point of view of dosing, the targeting of the dosing is intended to hit the same range that we're targeting with the IV formulation. And the purpose of that, of course, is based on our targeting engagement data from phase one. We've got high confidence that we are targeting a range that's having an effect. It's definitely on a side low living room in the brain, and also, as we've demonstrated from intercept, some evidence for plaque reduction as well. And I think, you know, we see these as both effects of sub burn inside. We're focused around the hypothesis that reduction of side low laborers is going to be beneficial to snap the function and to overall cognitive function in AD.
Speaker Change: Confidence that we are targeting a range thats, having an effect dose dependent on.
Speaker Change: Soluble oligomer in the brain and also as we've demonstrated from intercept some evidence for plaque reduction as well and I think we see these as both effects.
James Doherty: And I think, you know, we see these as both effects of subordinates. We're focused around the hypothesis that reduction of soluble oligomers is going to be beneficial to synaptic function and to overall cognitive function in AD.
Speaker Change: So Vernon side were.
Focused around the hypothesis that reduction of <unk> is going to be beneficial to snap the function of the overall cognitive function and I think no reason to think that would be different for the subcutaneous formulation.
James Doherty: And I think no reason to think that would be different for the subcutaneous formulation.
Pete Stavropoulos: And I think there is no reason to think that would be different for the subcutaneous formulation. So, that's sort of where we stand at this point. Our efforts are to complete the ongoing Phase 1 subcutaneous study by the end of the year, and then, based on data-driven analysis, move forward with next steps. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Pete Stavropoulos with Canna Fitzgerald. Your line is open. Hi, this is Samantha on the line for Pete.
James Doherty: So that's sort of where we stand at this point. Our efforts are to complete the ongoing Phase One sub queue study by the end of the year. And then we'll, based on a day-driven analysis, move forward with next steps. Thank you.
Speaker Change: Sort of where we stand at this point.
Speaker Change: Our efforts are to complete the ongoing phase one so few study by the end of the year and then we will.
Based on our data driven analysis move forward with next steps.
Speaker Change: Thank you.
Operator: Please name by for our next question.
Speaker Change: Thank you please.
Speaker Change: Please standby for our next question.
Samantha: An expression comes from a line of Pete Stavre-Polis with Cannabis Journal.
Speaker Change: Our next question comes from the line of Pete Staver, Polish with Cantor Fitzgerald. Your line is open.
Samantha: Your line is open.
Samantha: Hi, this is Samantha on the line for Pete. Thanks for taking our question. So the Altitude 80 study is enrolling patients with early AD, considering the outcomes from other A beta antibodies and the subpopulations that showed greater clinical benefits, such as with low tau versus high tau. How are you thinking about the patient population you would like to ideally enroll? Are you looking to have patients with a higher proportion with specific baseline characteristics like sensual levels, class, or tau. And perhaps increase the likelihood of being efficacy signals. Thanks so much.
Speaker Change: Hi, This is Samantha on the line for Pete Thanks for taking our question so the altitude.
Operator: Hello, and thank you for standing by. Welcome to Acumen Pharmaceuticals Q2, 2024 conference call and webcasts. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question in the session. To ask the question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.
Eric Siemers: Thanks for taking our question. So the Altitude AD study is enrolling patients with early AD. Considering the outcomes from other A-beta antibodies in the subpopulations that showed greater clinical benefits, such as those with low tau versus high tau, how are you thinking about the patient population you would like to ideally enroll? Are you looking to have patients with a higher proportion with specific baseline characteristics like sensoloid levels, PLAS, or TAU to perhaps increase the likelihood of seeing efficacy signals? Thanks so much. Thanks for that, Eric. Would you like to take that one?
Eddie is enrolling patients with early considering.
Speaker Change: Considering the outcome from other a beta antibodies in the subpopulation that showed greater clinical benefits such as those with low taubert, Hi, Tao how are you thinking about the patient population you would like to ideally enroll are you looking to have patients with higher proportion with specific baseline characteristics like centralized level class.
Speaker Change: Or.
Speaker Change: Perhaps increase the likelihood of being efficacy signals. Thanks, so much.
Alex Braun: I would now like to turn the call over to Alex Braun, head of investigative relations. Please go ahead. Thank you, operator.
Samantha: Thanks about that.
Eric Siemers: Eric, do you want to take that one? Yeah, sure. So, yeah, great question. We're targeting actually the same patient population that we used for the phase one study, which is patients with MCI and mild dementia, which is frequently being called early symptomatic Alzheimer's disease now. You know, as you point out, people who have less towel based on other antibodies may have a better response on those results carefully. What we've done in our trial is that people can enter the trial based on either a PET scan, a MOA PET scan, or CSF. For the PET scans in particular, we're using a visual read, which is what's used in practice right now.
Yes.
Speaker Change: Thanks, Eric do you want to take that one.
Eric Siemers: Yeah, sure. So, yeah, great question. We're targeting the same patient population that we used for the phase one study, which is patients with MCI and mild dementia, which is frequently being called early symptomatic Alzheimer's disease now. You know, as you point out, people who have less tau based on other antibodies may have a better response to these results carefully. What we've done in our cryo is that, um, people can enter the trial based on either a PET scan, an amyloid PET scan, or CSS. For the PET scans in particular, we're using a visual read, which is what's used in practice right now. But by doing that, you tend to get people with a little bit lower cell weight.
Eric: Yes, sure so yes, great question.
Alex Braun: Good morning and welcome to the Acumen conference call to discuss our business update and financial results for the quarter-ended June 30th, 2024. With me today, our Dan O'Connell, our CEO, and Matt Zuga, our CHIFO and Chief Business Officer. Dan and Matt, some prepared remarks, and then we'll open the call for questions.
Eric: We are targeting actually the same patient population that we used for the phase one study which is patients with.
Eric: Mci and mild dementia.
Speaker Change: Frequently being called early symptomatic Alzheimer's disease now.
Speaker Change: As you pointed out.
Alex Braun: Joining for the Q&A session, we also have Dr. Jim Doherty, our President and Chief Development Officer, and Dr. Eric Siemers, our Chief Medical Officer. Before we begin, we encourage listeners to go to the investor's section of the Acumen website to find our press release issued this morning that we'll discuss today. Please note that during today's conference call, we may make forward-looking statements within the meeting of the federal securities laws, including statements concerning our financial outlook and expected business plans.
Speaker Change: People, who have less tau based on other antibodies may have a better response.
Speaker Change: Those results carefully.
Speaker Change: What we've done in our trial is that.
Speaker Change: People can enter the trial based on either a pet scan amyloid pet scan or CSF for.
Speaker Change: The pet scans in particular, we're using a visual read which is what used in practice right now.
Eric Siemers: But by doing that, you tend to get people with a little bit lower cell, with lots of people who are relatively a little bit earlier in the disease. And so, we feel pretty confident that we've targeted the right population here. So, there are obviously people who have AMOLED, and they have Alzheimer's disease, but they're relatively early in the course of both based on symptoms and based on PET scans or CSF.
Alex Braun: These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Please see slide two of our corporate presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call or any accompanying presentation as a result of new information or future results or developments.
Speaker Change: But by doing that you tend to get people with a little bit lower snow.
Eric Siemers: It's people who are relatively a little bit earlier in the disease. And so we feel pretty confident that we've targeted the right population here. So there are obviously people who have amyloid, and they have Alzheimer's disease, but they're relatively early in the course of it, both based on symptoms and based on PET scans or CSR.
Speaker Change: People, who are relatively a little bit earlier in the disease.
So we feel pretty confident that we've targeted the right population here. So they are obviously people who are.
Speaker Change: Have amyloid and they have all climbers disease, but they are relatively early in the course of it both based on symptoms and based on pet scans or CSS.
James Doherty: I maybe just add to that a little bit, Samantha.
James Doherty: And maybe just to add to that a little bit, Samantha; this is Jim. I think part of the reason we're investing so much in both imaging and fluid-based biomarkers in the altitude study is that the space is still evolving and understanding exactly what the diversity is amongst patient populations. And so I think, as Eric's pointing out, we're very intentionally targeting the early Alzheimer's space. But I think as our understanding as a field grows in this area, Acumen is going to be very well positioned to understand the importance of individual biomarkers and how that's going to relate to the emerging understanding around different patient populations. So we think we're in pretty good shape at this point.
Speaker Change: And maybe just add to that a little bit better. This is Jim I think part of the reason we're investing so much in both imaging and fluid based biomarkers in the <unk> study.
James Doherty: This is Jim. I think part of the reason we're investing so much in both imaging and fluid-based biomarkers in the altitude study is that the space is still evolving and understanding exactly what the diversity is amongst patient populations. And so, I think, as Eric's pointing out, we're very intentionally targeting the early Alzheimer's space, but I think as our understanding as a field grows in this area, acting is going to be very well positioned to understand the importance of individual biomarkers and how that's going to relate to the emerging understanding around different patient populations. So, we think we're in pretty good shape at this point.
Alex Braun: So with that, I'll turn the call over to Dan. Thanks, Alex.
Dan O'Connell: Good morning, everyone. And thanks for joining us today. We've made significant progress in the first half of 2024 as we continue to execute our clinical plans for suburnitone, our next generation, and Lloyd-Data-Ligan-Retargeted antibody for the treatment of early Alzheimer's disease. Out to 2DAD, our Phase 2 study designed to evaluate the clinical efficacy and safety of suburnitone in patients with MCI, old mild, dementia due to AD, is actively enrolling. Altitude AD is a randomized, double-blind, placebo-controlled, three-arm study with approximately 180 participants per treatment arm for a total of 540 participants.
Eric: Is that the space is still evolving and understanding exactly what the diversity is amongst patient populations and so I think as Eric pointing out we're very intentionally targeting the early Alzheimer's space, but I think as our understanding is that field grows in this area.
Speaker Change: <unk> is going to be very well positioned to understand the importance of individual biomarkers and how thats going to.
Speaker Change: Relates to the emerging understanding around different patient population. So we think we're in pretty good shape at this point.
Samantha: Thanks so much.
Speaker Change: Thanks, so much.
Operator: Thank you. Please stand by for our next question.
Speaker Change: Thank you.
Speaker Change: Please standby for our next question.
Trong: Our next question comes from the line of Trong with UBS. Your line is open.
James Doherty: Thanks so much. Thank you. Please stand by for our next question. Our next question comes from the line of Trung with UBS. Your line is open. Hi guys, Trung Huynh from UBS.
Dan O'Connell: Altitude currently has more than 50 sites active across North America, the UK, and the EU, with the first subject dose it made, 2024. At present, enrollment in altitude is progressing faster than our original projections, which is highly encouraging. Retricted this to suburnitone's distinct profile based on its mechanism of action and positive feedback and interest from investigators supported by our strong Phase 1 data. Additionally, our team has built highly productive working relationships with quality trial sites in all three regions.
Speaker Change: Our next question comes from the line of Trung with UBS. Your line is open.
Trong: Hi guys. Trong went from UBS. Thanks for taking my questions. Just on the sub-Q administration, I've got a couple on there. So, do you have any details on this? Is it an auto-injector? Can it be done at home or in the hospital? And what's the injection volume that you're using? Just trying to get an idea of the convenience for this product. And then can you just give any color on what could be presented in one queue with this data? In particular, could we see any safety data? Thanks very much.
Trung: Hi, guys turn win from UBS, Thanks for taking my questions.
Trung Huynh: Thanks for taking my questions. Just on the sub-Q administration, I've got a couple on there. So, do you have any details on this? Is it an auto-injection? Can it be done at home or in the hospital?
Trung: Just on the sub Q administration I got a couple on that so do you have any details on this is it and also injection can it be done at home or in the hospital and what's the injection volume that youll using just trying to get an idea of the convenience of this product.
James Doherty: And what's the injection volume that you're using? I'm just trying to get an idea of the convenience of this product. And then, can you just give us any color on what could be presented in OneCube with this data? In particular, could we see any safety data? Thanks very much. Thanks for the question. I'll just quickly say, we will have safety data, and we will have bioavailability data. At this point, we're not guiding or disclosing volumes and so forth.
Speaker Change: And then can you just give us any color on what could be presented at <unk> with this data in particular could we see any safety data thanks very much.
Dan O'Connell: Patience. These combined factors have translated into an encouraging enrollment rate and underpin the growing interest in novel treatment options for early AD and differentiated treatment potential of suburnitug. In July, we also announced we had dosed our first subject in a phase one study of subcutaneous suburnitug. The study will compare the pharmacokinetics between intravenous and subcutaneous administrations of suburnitug in healthy volunteers. Review this work stream as an important extension of suburnitug's product profile, which aims to offer flexibility and convenience in dosing for patients and caregivers.
James Doherty: Thanks for the question. I'll just quickly; we will have safety data, and we'll have bioavailability data at this point. We're not guiding or disclosing volumes and so forth. I do think that we're trying to establish the bioequivalence of sub-Q versus IB dosing in that therapeutic range that we're using in altitude AD. I think we will have looked for a variety of different delivery formats. We have a fairly clear view as to what we want to deliver on in terms of dosing frequency and volumes, but at this point I'm not prepared to comment. We're fortunate to be partnered up with Halazine on this program, and it brought to bear a good bit of information and content and been good partners to help us assess how to advance a subcutaneous formulation of sub-Q.
Speaker Change: Thanks for the question I'll just quickly we will have safety data and we will have bioavailability data at this point, we're not guiding or disclosing sort of volumes and so forth I do think that.
James Doherty: I do think that we're trying to establish the bioequivalence of sub-Q versus IV dosing in that therapeutic range that we're using in Altitude AD, and I think we will have looked for a variety of different delivery formats. We have a fairly clear view as to what we want to deliver in terms of dosing frequency and volumes, but at this point, I'm not prepared to comment. We're fortunate to be partnered with Halazime on this program, and they've brought to bear a good bit of information and content and been good partners to help us assess how to advance a subcutaneous formulation of subornitin.
Speaker Change: We're trying to establish the bio equivalents of sub Q versus IV dosing in that therapeutic range that we're using in altitude ADT and I think we will have looked for a variety of different.
Speaker Change: Delivery formats, we have fairly.
Speaker Change: Clear view as to what we wanted to deliver on in terms of dosing frequency and volumes, but at this point and are prepared to comment we're fortunate to be partnered up with <unk> on this program and it brought some brought to bear a good bit of information and content have been good partners to help us assess how to advance a subcutaneous formulation of <unk>.
Dan O'Connell: We anticipate the top line results from this study will be available in the first quarter of 2025. Once we have the PK bioavailability results in hand, we will be best positioned to discuss next steps in clinical plans for subcutaneous suburnitug.
Dan O'Connell: Turning now to continued learnings from our clinical experience with suburnitug, the accurate team recently presented further data analysis from the Intercept AD trial at the Alzheimer's Association International Conference or AAC. Our team presented posters at this major Alzheimer's medical conference detailing patient interviews, biomarker data supportive of suburnitug's mechanism of action, and acumen's ultra sensitive method of measuring small amounts of suburnitug in cerebral spinal fluid.
James Doherty: And maybe just to expand on that a little bit, just to remind you that this study is in healthy volunteers. It's not in patients. And so R.A. really shouldn't be an issue in terms of safety. So the safety is more just injection site reactions and that sort of thing, but we anticipate that that should be quite good.
James Doherty: Yeah, and maybe just to expand on that a little bit, just to remind you that this study is in healthy volunteers. It's not in patients. And so, ARIA really shouldn't be an issue in terms of safety.
Speaker Change: Thanks.
Speaker Change: And maybe just.
Speaker Change: And on that a little bit just to remind you that this study is in healthy volunteers if not in patients and so are you really shouldnt be an issue in terms of safety. So the safety is more just the injection site reactions and that sort of thing, but we anticipate that that should be quite good.
Trong: And just following up, you mentioned a partnership with Halesheim there.
James Doherty: So, the safety is more just injection site reactions and that sort of thing, but we anticipate that that should be quite good. [inaudible] And just following up, you mentioned a partnership with Halozyme there. Should we expect the financials there to pay for this?
Speaker Change: And just following up you mentioned a partnership with <unk> that should we expect what the financials. There should we expect to pay away here.
Dan O'Connell: To take away from our patient interviews, underscore the importance of incorporating the patient voice into trial design and humanizing the unmet need in Alzheimer's disease. As expected, nearly all patients reported difficulty with memory and cognition, difficulty with getting lost, difficulty with communication, and changes in mood were also commonly reported. Almost 90% of patients would like a treatment to slow the progression of disease or keep it from getting worse, as well as maintaining the ability to recognize loved ones.
James Doherty: Should we expect what the financials there should we expect to pay away here? I know it's a bit down the line. Yeah. So it's down the line. I mean, those are the terms and are not disclosed publicly. I think it is; it's been a matter of public record, though. It's a non-exclusive arrangement of Halesheim.
James Doherty: I know it's a bit down the line. Yeah, so it's down the line. I mean, those terms are not disclosed publicly.
Speaker Change: Okay.
Speaker Change: I know, it's a bit down the line.
Speaker Change: Yeah, So it's down a lot I mean the terms.
Speaker Change: Our non disclosed publicly.
James Doherty: I think it's been a matter of public record, though, that it's a non-exclusive arrangement with Halazon. Thanks very much. Thank you. As a reminder, ladies and gentlemen, that's star 11 to ask the question.
Speaker Change: I think it is a matter of public record.
Speaker Change: I'm not an exclusive arrangement with housing.
Speaker Change: Okay.
Trong: Thanks very much.
Speaker Change: Okay.
Speaker Change: Thanks very much.
Operator: Thank you.
Operator: As a reminder, ladies and gentlemen, that start one one to ask the question.
Speaker Change: Yes.
Speaker Change: Thank you as a reminder, ladies and gentlemen that start one one to ask the question.
Ananda Ghosh: Please stand by for our next question. An expression comes from the land of a man of Gosh with AC one right.
Operator: Please stand by for our next question. Our next question comes from the line of Ananda Ghosh with AC Wainwright. Your line is open. Yeah, hi, congrats on the quarter.
Dan O'Connell: We also received strong interest in the synaptic biomarker changes observed in our phase one study, both pre and post-synaptic cerebral spinal fluid proteins, VAT2 and neurogranin, showed significant reduction towards normalization, which is consistent with suburnitug's ability to inhibit amyloid beta oligomer synaptic binding.
Speaker Change: Please standby for our next question.
Speaker Change: Our next question comes from the line of Ananda Goss with HC Wainwright. Your line is open.
Ananda Ghosh: Your line is open. Yeah, hi. Congrats on the quarter.
Ananda Ghosh: I have two questions. The first is, can Pete out 217 predict a low and high child patient population? No, are there data from the, from the, from the, you know, prior clinical trials? And the second question is, with the Lycanema data at the AIC showing a long-term benefit due to specificity for neutralizing proto-fibreels, what's the read through for AC-19?
Ananda Goss: Yeah, Hi, congrats on the quarter I have two questions. The first one is Kevin Pete.
Ananda Ghosh: I have two questions. The first first one is can Peter 217 predict a low and high. Are the data from the prior clinical trials, and the second question is with the Lycanema data at the AIC showing a long-term benefit due to specificity for neutralizing proto-fibles. What's the read-through for if you want to address that question? Yeah. So, as far as the PTAL 217, great question. Intuitively, you would sort of think that, well, this is a form of PTAL, so it should correlate with TAL PET. And it turns out it's such a sensitive early marker. It actually tends to correlate with amyloid PET, which is not as sensitive.
Speaker Change: <unk> to $1 seven predict.
Kevin Pete: <unk> Hi E.
Speaker Change: The patient population.
Dan O'Connell: These posters can be found on the investor section of our website if you haven't already had a chance to review them.
No I'll give detail from the from the from the.
Speaker Change: Prior clinical trials and the second question is with the <unk> data.
Dan O'Connell: As usual, there was a great deal of interesting information shared at AIC, including a number of topics relevant to our suburnitug program. These topics included the continued development of fluid biomarkers, like PETA217, as diagnostics for tracking the progression of Alzheimer's. Further data on the important role that soluble amyloids beta species play in the pathophysiology of AD, and extended safety and efficacy data on chronic dosing with anti-amyloid monoclonal antibody therapies. We believe the increased acceptance of the toxicity and persistence of soluble amyloid beta species, such as oligomers, will help move the field towards next generation antibodies, such as suburnitug. The confluence of fluid biomarker breakthroughs will support expanded future access to novel treatments in AD.
Speaker Change: Showing a long term benefit due to its specificity for neutralizing prototype.
Speaker Change: Whats the read through for.
Speaker Change: If you want <unk>.
Eric Siemers: Thanks Ananda. Eric, do you want to address that? Yeah, so as far as the Pete towel 217, great question. Intuitively, you would sort of think that, well, this is a form of the Pete towel, so it should correlate with the towel pet.
Eric: Thanks, Eric.
Eric: Eric do you want to address that question.
Eric Siemers: And it turns out, it's such a sensitive early marker; it actually tends to correlate with amyloid PET, which is not as sensitive. So what we've actually done in our trial is to use Pete towel 217 as a screening measure for people who go on then to PET or CSF. And what we've found is by doing that, we reduce the number of negative PET scans and negative CSF by about 50%. So it seems to be working quite well as a screening procedure. And we actually think that that's something that could play out in critical practice, because uh, because it's not like a blood PET towel, 217.
Speaker Change: Yes, so as far as the <unk> 17, great question.
Speaker Change: Intuitively you would sort of think that well this is a form of <unk>.
<unk>, so it should correlate with Tau pet.
Speaker Change: Turns out it's such a sensitive early marker it actually tends to correlate with with amyloid pet which.
Eric Siemers: So what we've actually done in our trial is to use PTAL 217 as a screening measure for people who go on then to PET or CSF. And what we've found is that by doing that, we reduce the number of negative PET scans and negative CSF by about 50%. So it seems to be working quite well as a screening procedure, and we actually think that that's something that could play out in clinical practice. But yet, you know, blood PTAL 217, and you know, a lot of people who otherwise would go on to have a negative PET scan.
Speaker Change: Not as sensitive so what we've actually done in our trial.
Speaker Change: Is to use <unk> 217 is a screening measure for people who go on then to Pat or CSF and what we've found is by doing that.
Dan O'Connell: Finally, we are planning to host a virtual R&D day on October 2nd. We intend for this event to provide a deep dive into the scientific rationale of supporting suburnitug's mechanism of action. We are phase 1 clinical results and phase 2 clinical plans for suburnitug.
Speaker Change: We reduced the number of negative pet scans and negative.
CSF by about 50% so it seems to be working quite well as a screening procedure and we actually think that that's something that could play out in clinical practice.
Dan O'Connell: We will communicate the registration details and agenda closer to the event. We remain committed to delivering on our strategic priority to efficiently and topfully advance the global development suburnatog and encouraged by the direction the Alzheimer's field is headed with new data and an updated understanding of the disease that is in line with our science.
Eric Siemers: And you know, a lot of people who otherwise would go on to have a negative PET scan. So I think it's a really good biomarker. And I'm sorry, I didn't quite catch your second question. You know that with Licanumab, a long-term study, they are showing that, you know, that patients have this continued benefit based on their ability to target protofibrils. So what's the read through, you know, with the subonata?
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Blood ph out to 17.
Speaker Change:
Speaker Change: Good lineup of who otherwise would go on to have a negative pet scan. So I think it's a really good biomarker and I'm, sorry, I didn't quite catch your second question.
Eric Siemers: So I think it's a really good biomarker, and I'm sorry, I didn't quite catch your second question. You know, with the Lycanemab long term study, I see showing that, you know, that patient that is continued benefit based on the, you know, the ability to target protofibrils. So what's the read through, you know, with the subanitag. Well, yeah, so we've followed that very carefully, and there's really interesting data, and I think. What the field is learning, and we're learning along with the field, is that if you just look at amyloid based on PET scans, it's a very slow increase once you've reduced the amyloid that's there.
Dan O'Connell: I look forward to updating you as we work towards face to data that we believe will provide a significant value inflection for the program and demonstrate suburnatog's true potential as a highly compelling benefit to risk profile and with that I'll turn the call over to Matt for the financials. Thank you. Thanks Dan.
Speaker Change: With a kind of a long term study.
Speaker Change: Showing that.
Speaker Change: The patients have discontinued benefit based on the data.
Speaker Change: The ability to target five brands, so what's the read through.
Doug: It's the souvenir Doug.
Eric Siemers: Well, yeah, so we've followed that very closely. And there's some really interesting data. And I think what the field is learning, and we're learning along with the field, is that if you just look at amyloid based on PET scans, it's a very slow increase once you've reduced the amyloid that's there. But what you also see is that apparently PET scans are not that sensitive because some of the other pathology, increases in GFAP, increases in various forms of PTAL, those things come back a lot sooner than your PET scan gets worse.
Matt Zuga: As a reminder our second quarter 2024 financial results are available in the press release we issued this morning and in our 10Q we will file later today. As of June 30th we had approximately $281 million in cash and marketable securities on our balance sheet and continue to expect the cash runway to last into the first half of 2027. R&D expenses were $19.5 million in the second quarter. The increase over the prior year was primarily due to the increased spending to support the altitude AD trial. G&A expenses were $4.8 million in the quarter. With the increase over the prior year, primarily the result of increased headcount. This led to a loss from operations of $24.4 million in the quarter.
Doug: Well, yes, so far.
Doug: Followed that.
Speaker Change: Very carefully and there's really interesting data and I think.
Speaker Change: The field is learning and we're learning along with the field is that if you just look at amyloid based on pet scans.
Speaker Change: Very slow increase once you've reduced the amyloid thats there.
Eric Siemers: But what you also see is that apparently PET scans are not that sensitive because some of the other pathology increases in GFAP increases in various forms of PETal, those things come back a lot sooner than your pal and gets worse. And so in our view, that's a good indication that partly because they're maybe because LeCanemab targets these protophybrals, that when you stop treatment with the pathology comes back relatively quickly, and you don't pick that up just based on an amyloid PET scan. And we think that's completely consistent with our hypothesis of targeting these soluble alicomers.
Speaker Change: But what you also see is that apparently pet scans are not that sensitive because some of the other pathology increases in GFS.
Speaker Change: Increases in.
Speaker Change: In various forms of P. Tau those things come back a lot sooner than you are.
Eric Siemers: And so, in our view, that's a good indication that, partly because, or maybe because, Lacanemab targets these proto-fibrils, so when you stop treatment with it, the pathology comes back relatively quickly, and you don't pick that up just based on an AMOLED cut. And we think that's completely consistent with our hypothesis of targeting these soluble oligomers. Got it. Thanks, Eric. Very helpful. Thank you. Ladies and gentlemen, I'm showing no further questions in the queue.
Speaker Change: Gets worse and so in our view that's a good indication that.
Matt Zuga: I'm very pleased with our clinical execution thus far in 2024. We are well-resourced for our phase two study and to develop a subcutaneous formulation of suburnatog and are committed to delivering on the opportunity ahead of us for the benefit of patients, caregivers and shareholders.
Speaker Change: <unk>.
Speaker Change: Currently because or it may be because I can't imagine targets. These proto fibrils that when you stop treatment with the pathology comes back.
Speaker Change: Relatively quickly and you don't pick that up just based on an amyloid pet scan and.
Matt Zuga: And with that we can open the call for Q&A operator. Thank you.
Speaker Change: And we think that's completely consistent with our hypothesis of targeting these soluble oligomers.
Operator: Ladies and gentlemen to ask the question, please first start 1-1 on your telephone and then wait to hear your name announced.
Speaker Change: Okay.
Got it thanks.
Eric Siemers: Thank you.
Speaker Change: Thank you.
Operator: Ladies and gentlemen, I'm showing no further questions in the queue.
Speaker Change: Ladies and gentlemen, I'm showing no further questions in the queue I would now like to turn the call back to Alex for closing remarks.
Operator: To withdraw your question, please first start 1-1 again. Please stand by while we compile the Q&A roster.
Eric Siemers: I would now like to turn the call back to Alex for closing remarks. Great. Thank you everyone for joining the call today and for your interest in the company. Please don't hesitate to reach out to us if you have any follow-up questions and have a great day. Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you for watching!
Alex Braun: I would now like to turn the call back to Alex for close and remarks. Great. Thanks everyone for joining the call today and for your interest in the company. Please don't hesitate to reach out to us if you have any follow-up questions, and have a great day.
Speaker Change: Great.
Alex Brown: Thanks, everyone for joining the call today and for your interest in the company.
Tom Schrader: Our first question comes from the line of Tom Schrader with BTIG. The line is open.
Speaker Change: Please don't hesitate to reach out to us if you have any follow up questions and have a great day.
Operator: Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.
Dan O'Connell: Good morning. Thanks for taking the question and the updates. I have a question on the phase two trial and what patients you're getting. What is enrollment like in the US with two approved products? Is it tricky or are patients highly compelled by the potential for less ARIA? And I would expect enrollment in Europe. People are very enthusiastic, but are you going to limit or are you going to require some number of US patients? Thank you.
Speaker Change: Ladies and gentlemen that concludes today's conference call. Thank you for your participation you may now disconnect.
Speaker Change: Okay.
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Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Matt Zuga: Hi Tom. Thanks. Great question. And as I mentioned earlier in the work with the prepare remarks, we are encouraged at the enrollment rate and to date it has exceeded our expectations from original forecasts. I think this is a consequence of the a met need in this population, as well as the phase one data that really underpin the differentiation of suburniture. Lastly, the study design itself, the feedback from sites and investigators has been very favorable in that the study incorporates two active doses versus placebo and then an open label extension.
Speaker Change: Okay.
Matt Zuga: So in terms of choice and participation, we're seeing a lot of demand to participate in the altitude AD study and we do anticipate a split between North America and Europe can't haven't pre-set those next but they will have patients covering each of the territories or regions that I mentioned earlier. Thank you.
Matt Zuga: Maybe I'll just add a little bit to that. The rate at which we're seeing patients really exceeds our projections and expectations, which is great. You might ask yourself why that might be. And as Dan mentioned, it's probably moly factorial, but I think partly it's the strength of our phase one data that was done in patients. We've seen a lot of biomarker changes that are really encouraging for the drug. And secondly, what we've heard from the sites is that they do like that the protocol design.
Matt Zuga: It's a phase two study, but really it's like a small phase three study with an open label extension in the sites like that. We started the study in the US, and that's where currently we have most of our patients, but now we're adding sites. We've already added sites in Canada, the UK, and then Europe. So we'll be enrolling more patients in those other geographies. Okay, great. Thank you.
Cameron Bozdog: Please stand by for our next question. Our next question comes from a lot of Jason's MSDAT with Bike of America. The line is open.
Dan O'Connell: Hi, good morning. This is Cameron Bozdog on for Jason. Congrats on the quarter and thanks for taking our question. So in thinking about the anti a beta commercial landscape, you know, what do you think have been the major challenges or gaining factors? Is it educating physicians, you know, engaging with patients or has it been an issue of infrastructure, pair access reimbursement. And then appreciating it's early, but do you see opportunities for subordinate to potentially differentiate itself? Where is it more that you know the broader market needs to finish undergoing maturation itself? Thank you.
Dan O'Connell: Thanks, Cameron. And I think you've listed out the multi factorial sort of issues that are that are basically inhibiting or at least. Meadering out the rap and the growth and extension of these treatments, these first couple of proof products. We think that it's interesting now with with Lily coming into the marketplace, the infrastructure will continue to be built out that awareness around the possibility of seeking treatment. We'll continue to draw more awareness and patients into this new treatment paradigm.
Dan O'Connell: There are also, I think, one of the points we made from the AC meeting is that the anticipation of fluid biomarkers, you know, blood based diagnostics is likely to impact the growth and expansion of this field. So it is multi factorial. I think there's been good progress made and they'll continue to be the infrastructure world out in terms of subordinate differentiation. We absolutely have high conviction that its mechanism is differentiated and yet as a consequence of that has the promise of differentiating either or both on efficacy and safety. And that's really our single focus is to offer early 80 patients an improved treatment option in terms of benefit to risk profile.
Unknown Executive: So that's I think that addresses most of your questions. I don't know. Jim or Eric, if you have any following. Thank you.
Mark: Please, nearby for our next question. Our next question comes from the line of Paul Matias with Steve. Your line is open. Hey, this is Mark on for Paul. Thanks for taking our questions. So, we were curious.
Jim Doherty: What does the path forward look like for the sub queue formulation for Sabirna Tuggan then? You know, would that be assessing parallel to the intravenous formulation? If the phase one were successful, and then separately on that, you know, what dose could you pursue? And would that, you know, enable robust plaque target engagement? Or that being more of like, you know, like a murder dose?
Jim Doherty: And then, if you could provide any additional details for the altitude aid in term analysis, that would be great as well. Thank you.
Jim Doherty: Sure, I want to direct that one to Jim as our lead development efforts. Sure, happy to take it down that. Mark, the answer to your question, I think, is we're the first step really for the subcutaneous development program is to understand the viability of a sub queue version. So that's the goal of the first study here in healthy volunteers is to really align the PK from the sub queue administration with the halosine formulation with what we're learning from the IV studies from intercepts and ongoing work with altitude AD.
Jim Doherty: You know, I think beyond that, we have a number of options on how to proceed. I think from the point of view of dosing, the targeting of the dosing is intended to hit the same range that we're targeting with the IV formulation. And the purpose of that, of course, is based on our targeting engagement data from phase one, we've got high confidence that we are targeting a range that's having an effect.
Jim Doherty: It's definitely on a side low living room in the brain, and also as we've demonstrated from intercept some evidence for plaque reduction as well. And I think, you know, we see these as both effects of sub burn inside were focused around the hypothesis that reduction of side low laborers is going to be beneficial to snap the function and to overall cognitive function in AD. And I think no reason to think that would be different for the subcutaneous formulation.
Jim Doherty: So that's sort of where we stand at this point. Our efforts are to complete the ongoing phase one sub queue study by the end of the year. And then we'll based on a day driven analysis, move forward with next steps.
Jim Doherty: Thank you.
Samantha: Please name by for our next question. An expression comes from a line of Pete Stavre-Polis with cannabis journal. Your line is open. Hi, this is Samantha on the line for Pete. Thanks for taking our question. So the altitude 80 study is enrolling patients with early AD, considering the outcomes from other A beta antibodies and the subpopulations that showed greater clinical benefits, such as with low tau versus high tau. How are you thinking about the patient population you would like to ideally enroll? Are you looking to have patients with a higher proportion with specific baseline characteristics like sensual levels, class or tau. And perhaps increase the likelihood of being efficacy signals. Thanks so much. Thanks about that.
Eric Siemers: Eric, do you want to take that one? Yeah, sure. So, yeah, great question. We're targeting actually the same patient population that we used for the phase one study, which is patients with MCI and mild dementia, which is frequently being called early symptomatic Alzheimer's disease now. You know, as you point out, people who have less towel based on other antibodies, may have a better response on those results carefully. What we've done in our trial is that people can enter the trial based on either a PET scan, a MOA PET scan, or CSF.
Eric Siemers: For the PET scans in particular, we're using a visual read, which is what's used in practice right now. But by doing that, you tend to get people with a little bit lower cell with lots of people who are relatively a little bit earlier in the disease. And so, we feel pretty confident that we've targeted the right population here. So, there are obviously people who have AMOLED and they have Alzheimer's disease, but they're relatively early in the course of both based on symptoms and based on PET scans or CSF.
Jim Doherty: I maybe just add to that a little bit, Samantha. This is Jim. I think part of the reason we're investing so much in both imaging and fluid-based biomarkers in the altitude study is that the space is still evolving and understanding exactly what the diversity is amongst patient populations. And so, I think, as Eric's pointing out, we're very intentionally targeting the early Alzheimer's space, but I think as our understanding as a field grows in this area, acting is going to be very well positioned to understand the importance of individual biomarkers and how that's going to relate to the emerging understanding around different patient populations. So, we think we're in pretty good shape at this point. Thanks so much.
Samantha: Thank you.
Trong: Please stand by for our next question. Our next question comes from the line of Trong with UBS. Your line is open. Hi guys. Trong went from UBS. Thanks for taking my questions. Just on the sub-Q administration, I've got a couple on there. So, do you have any details on this? Is it an auto-injecture? Can it be done at home or in the hospital? And what's the injection volume that you're using? Just trying to get an idea of the convenience for this product. And then can you just give any color on what could be presented in one queue with this data? In particular, could we see any safety data? Thanks very much.
Jim Doherty: Thanks for the question. I'll just quickly, we will have safety data and we'll have bioavailability data at this point. We're not guiding or disclosing volumes and so forth. I do think that we're trying to establish the bioequivalence of sub-Q versus IB dosing in that therapeutic range that we're using in altitude AD. I think we will have looked for a variety of different delivery formats. We have a fairly clear view as to what we want to deliver on in terms of dosing frequency and volumes but at this point I'm not prepared to comment.
Jim Doherty: We're fortunate to be partnered up with Halazine on this program and it brought to bear a good bit of information and content and been good partners to help us assess how to advance a subcutaneous formulation of sub-Q. And maybe just to expand on that a little bit, just to remind you that this study is in healthy volunteers. It's not in patients. And so R.A, really shouldn't be an issue in terms of safety. So the safety is more just injection site reactions and that sort of thing, but we anticipate that that should be quite good.
Jim Doherty: And just following up, you mentioned a partnership with Halesheim there. Should we expect what the financials there should we expect to pay away here? I know it's a bit down the line. Yeah. So it's down the line. I mean, those are the terms and are not disclosed publicly. I think it is, it's been a matter of public record though. It's a non-exclusive arrangement of Halesheim. Thanks very much. Thank you.
Operator: As a reminder, ladies and gentlemen, that start one one to ask the question. Please stand by for our next question.
Ananda Ghosh: An expression comes from the land of a man of gosh with AC one right. Your line is open. Yeah, hi. Congrats on the quarter. I have two questions. The first first one is can Peter 217 predict a low and high. Are the data from the prior clinical trials and the second question is with the Lycanema data at the AIC showing a long-term benefit due to specificity for neutralizing proto-fibles. What's the read through for if you want to address that question?
Ananda Ghosh: Yeah. So as far as the PTAL 217, great question. Intuitively, you would sort of think that well, this is a form of PTAL, so it should correlate with TAL PET. And it turns out it's such a sensitive early marker. It actually tends to correlate with amyloid PET, which is not as sensitive. So what we've actually done in our trial is to use PTAL 217 as a screening measure for people who go on then to PET or CSF.
Ananda Ghosh: And what we've found is by doing that, we reduce the number of negative PET scans and negative CSF by about 50%. So it seems to be working quite well as a screening procedure, and we actually think that that's something that could play out in clinical practice. But yet, you know, blood PTAL 217, and you know, a lot of people who otherwise would go on to have a negative PET scan. So I think it's a really good biomarker, and I'm sorry, I didn't quite catch your second question.
Ananda Ghosh: You know, with the Lycanemab long term study, I see showing that, you know, that patient that is continued benefit based on the, you know, the ability to target protofibrils. So what's the read through, you know, with the subanitag. Well, yeah, so we've followed that very carefully and there's really interesting data and I think. What the field is learning, and we're learning along with the field, is that if you just look at amyloid based on pet scans, it's a very slow increase once you've reduced the amyloid that's there.
Ananda Ghosh: But what you also see is that apparently pet scans are not that sensitive because some of the other pathology increases in GFAP increases in various forms of petal, those things come back a lot sooner than your pal and gets worse. And so in our view, that's a good indication that partly because they're maybe because LeCanemab targets these protophybrals, that when you stop treatment with the pathology comes back relatively quickly, and you don't pick that up just based on an amyloid pet scan. And we think that's completely consistent with our hypothesis of targeting these soluble alicomers.
Eric Siemers: Thank you.
Operator: Ladies and gentlemen, I'm showing no further questions in the queue.
Alex Braun: I would now like to turn the call back to Alex for close and remarks. Great. Thanks everyone for joining the call today and for your interest in the company. Please don't hesitate to reach out to us if you have any follow up questions and have a great day.
Operator: Ladies and gentlemen, that concludes today's conference call. Thank you for your participation.
Operator: You may now disconnect.