Q3 2024 Cytokinetics Inc Earnings Call
Okay.
Speaker Change: Good afternoon, and welcome to Cyberkinetics third quarter, 'twenty 'twenty four conference call.
At this time I would like to inform you that this call is being recorded and that all participants are in a listen only mode.
Speaker Change: At the company's request, we will open the call to questions. After the presentation.
Speaker Change: We will allow for only one question per participant.
Speaker Change: I will now turn the call over to Diane Weiser Cytogenetics Senior Vice President of Corporate Affairs. Please go ahead.
Diane Weiser: Good afternoon, and thanks for joining us on the call today, Robert band, President and Chief Executive Officer will begin with an overview of the quarter and recent developments.
Diane Weiser: Malik E V. P of R&D will provide an update related to the critical development program, perhaps he Camden.
Diane Weiser: And to Kal, our EVP and Chief commercial officer will address commercial readiness activities for happy camping, Stuart Kupfer, SVP and Chief Medical Officer, who will provide updates regarding on the Camden Mcardle, CK 586, and our earlier stage development pipeline.
Speaker Change: Only EVP and Chief Financial Officer will provide a financial overview of the third quarter and finally, Robert will review, our corporate development strategies and review expected upcoming milestones.
Speaker Change: Please note that portions of the following discussion, including our responses to questions contain statements that relate to future events and performance rather than historical facts and constitute forward looking statements. Our actual results may differ materially from those projected in these forward looking statements.
Speaker Change: Information concerning factors that could cause our actual results to differ materially from those in these forward looking statements is contained in our SEC filings, including our current report regarding our third quarter 2024 financial result filed on form 8-K that was furnished to the SEC. Each day, we undertake no obligation to update any forward looking.
Speaker Change: Statements. After this call and now I will turn the call over to Robert Thank you Diane and thanks to all for joining us today.
Robert: As we communicated just a few weeks ago at our Investor and Analyst day, we made significant progress across our pipeline in the third quarter. Most importantly, we completed the rolling submission and submitted our new drug application to the FDA for epic Hampton.
Robert: This is an exciting milestone for subtle kinetics as well as the physician and patient communities and it brings us one step closer to hopefully, bringing up your camden to patients suffering from obstructive HCM.
Robert: It reflects a tremendous amount of work from our colleagues for which we are especially grateful.
Robert: We have requested priority review of the submission our base case at standard review. The next step will be the expected announcement of filing acceptance and assign paducah date.
Robert: During Q3, we also supported core cell, formerly changing in filing the NDA in China for RP Camden for obstructive HCM, which we're pleased to announce today was recently accepted for filing.
Robert: Meanwhile, our commercial preparations for the potential approval and launch of Alfie campaign in the United States are dialing up according to plan.
Robert: As Andrew will elaborate we're executing prelaunch activities, including recently launching in HCM disease awareness campaign for health care professionals.
Robert: In addition, we selected third party external partners to support education distribution and patient support altogether, forming a bespoke patient experience and we refined sales territory configurations, as well as sales training and recruiting programs in the United States.
Robert: While we also concurrently hired our initial geographic and functional team leaders in Europe.
Robert: During the quarter, we continued to present and publish additional data from Sequoia HCM further strengthening the evidence supporting its potential next in class safety and efficacy profile.
Speaker Change: Scotty will elaborate the additional analysis show that treatment with Abbvie campaign is associated with improvements in exercise capacity gradients symptoms biomarkers cardiac structure and function as well as favorable cardiac remodeling together these analyses expand and meaningful way.
Speaker Change: Based on the overall profile of Alfie campaign.
Robert: And our enabling of the positioning that we foresee for a next in class cardiac myosin inhibitor.
Robert: We believe can expand the category and activate broader adoption.
Robert: Beyond the <unk> Kimpton, we prepared to start two new clinical trials from within our emerging specialty cardiology franchise comedy check the confirmatory phase III clinical trial of Omi captive mccarville and amber half path the phase II clinical trial of CK 586.
Robert: As Stuart Stuart will share each of Omi captive <unk> and CK 586 offers an opportunity to expand our specialty cardiology franchise by targeting underserved populations at opposite ends of the spectrum of heart failure, those with severely reduced ejection fraction.
Robert: And those with Super normal ejection fraction.
Robert: Finally, while our specialty cardiology franchise remains our top priority our research dedicated to novel muscle directed therapies has continued within our labs in South San Francisco and our longstanding innovation in muscle biology continues with another promising drug candidates.
Robert: Called CK, Oh wait nine readying to begin our first in human study.
Robert: CK 089 is our fast skeletal muscle troponin activator, which we believe may have potential therapeutic application to a specific type of muscular dystrophy youll be hearing more about how we have applied lessons learned with prior fast skeletal troponin activators to our next leg.
Robert: Plans for CK 089.
Robert: It will soon begin clinical development in this fourth quarter.
Robert: Where do we stand today at Shadow kinetics is a reflection of thoughtful planning strategic positioning and prudent capital deployment.
Robert: All in service of realizing the full potential of our muscle biology platform.
Robert: We are not a company expecting to simply build for the success of a single drug candidates instead were focused on building momentum across our pipeline and planning for our future by prosecuting a portfolio of multiple muscle directed drug candidates designed to address.
Robert: Diseases of high unmet need.
Robert: By doing so we hope to impact the lives of both patients as well as return meaningful value to shareholders.
Speaker Change: Enduring ways with that I'll turn the call over to fatty please.
Speaker Change: Thanks Robert.
Speaker Change: In the third quarter, we presented additional data from Sequoia HCM and forest HCM at.
Speaker Change: At three medical Congresses.
Speaker Change: European Society of Cardiology Congress, the hypertrophic Cardiomyopathy Society scientific sessions, and the heart failure Society of America annual scientific meeting.
Speaker Change: These pre specified analyses build on the primary results presented and published earlier this year to dig deeper into the profile of that be captain.
Speaker Change: The depth and volume of these analyses is truly extraordinary with eight presentations five being late breakers, thus five simultaneous publication in leading cardiac journals.
Speaker Change: Each of these analyses exceeded our best case expectations, Rafi, Camden and gives us confidence in the opportunity for <unk> to address the significant unmet need in obstructive HCM.
Speaker Change: Key amongst the additional data from Sukhoi HCM, our findings show that Abbvie campton, maybe associated with favorable cardiac remodeling and improvement in several measures of cardiac structure and function.
Speaker Change: Together these data show that Abbvie campton appears to change the architecture of the heart and its potential to be disease, modifying something thats key to changing the trajectory of HCM.
Speaker Change: Other analyses from Sukhoi HCM presented during the quarter showed that treatment with abbvie camped and improve patient symptoms quality of life and cardiac biomarkers.
Speaker Change: Furthermore, a responder analysis showed abbvie kimpton was associated with broad clinical efficacy as the majority of patients who received <unk> kimpton and Sukhoi HCM achieved one or more clinically relevant outcome.
Speaker Change: One of the four pre specified outcomes was a complete hemodynamic response defined as having a resting <unk> gradient of less than 30, and El Salvador Lv Ot gradient of less than 50, which was achieved by two thirds of patients since the core HCM.
Speaker Change: These data are complemented by findings from an integrated safety analysis, the pooled data from Redwood HCM, So coy HCM enforced HCM and reinforce the safety profile of RP Campton.
Speaker Change: Finally, an analysis of open label data from Forest HCM showed that the majority of patients who attempted withdrawal of standard of care medications at the discretion of an investigator we're successful with some patients achieving monotherapy.
Speaker Change: I think there is a potential for abbvie Camden be tolerated and effective as monotherapy in patients with <unk> HCM.
Speaker Change: As I processes is being explored further in the Maple HCM trial, which I'll address in a moment.
Speaker Change: Five of the recent publications were recently assembled collectively in the November issue of the journal of American College of Cardiology.
Speaker Change: Nearly an entire issue devoted to Abbvie campton.
Speaker Change: As we continue to curate the data from Sukhoi HCM. Each subsequent analysis elaborates on the primary results from its core HCM to reinforce the effective abbvie campton clinical outcomes symptom burden cardiac biomarkers in cardiac structure and function.
Speaker Change: Together this large and growing body of evidence paints a clear picture of the relevance of <unk> captain to clinical practice as a next in class cardiac myosin inhibitor and potentially the cardiac myosin inhibitor of choice for both physicians and patients.
Speaker Change: All of these clinical work streams also continue to be supported by our medical Affairs organization.
Speaker Change: During the quarter, our field medical teams met with health care professionals, including many HCM Kols Hospital, and IGN leadership, and formulary decision makers to discuss and educate about the results from Sequoia HCM.
Speaker Change: Now moving to the ongoing clinical trials program for App Camden, We're pleased to report that during the third quarter, we completed enrollment in Maple HCM.
Speaker Change: Through the rest of this year, we will continue conducting this important trial and we expect to share results from Maple HCM in the first half of 2025 ahead of when we hope to launch <unk> campton commercially.
Speaker Change: If positive Maple HCM represents the first potential label expansion opportunity for Abbvie Captain with results that may provide the rationale to position it as first line therapy in practice guidelines.
Speaker Change: During the quarter. We also continued enrollment in Acacia HCM, the pivotal phase III clinical trial of App at Camden in patients with symptomatic non obstructive HCM.
Speaker Change: We now have activated over 90 sites in 13 countries, ensuring that the results from Acacia HCM will be representative of a broad and diverse study population.
Speaker Change: <unk> is brisk and we expect to continue to activate new sites and enroll patients at existing and new sites through this year and into next year towards our goal of completing enrollment in 2025.
Speaker Change: Additionally, we continued conduct of Cedar HCM.
Speaker Change: Value, adding the pediatric population of patients with symptomatic HCM as well as an additional phase one study of Abbvie campton in healthy Japanese and Caucasian participants that may support development of Abbvie camped in Japan.
Speaker Change: Altogether I'm proud of the substantial progress we made across our clinical development program for <unk> in campton in the third quarter.
Andrew: Now I'll turn it over to Andrew.
Speaker Change: Yes.
Andrew: Thanks, Patty and the third quarter, we continued our commercial readiness activities for the potential approval and launch of <unk> campaign in the U S.
Speaker Change: We were pleased to launch ATM beyond the heart.
Speaker Change: Branded disease awareness campaign for health care professionals.
Speaker Change: Campaign was born out of market research and real world feedback from cardiologists nurses and patients and highlight the story of five individuals living with ATM to illuminate the multi dimensional struggle.
Speaker Change: Daily by people living with HCN.
Speaker Change: We are planning to showcase this campaign.
Speaker Change: At the upcoming <unk> scientific.
Speaker Change: Scientific session in Chicago next week, and we plan to launch a similar patient focused on a Brent unbranded awareness campaign in first quarter 2025.
Speaker Change: The launch of ATM beyond the heart also Mark the first deployment of our Omnichannel digital communication strategies.
Speaker Change: Which has successfully validated.
Speaker Change: <unk> and planning and set the stage for a broader digital engagement to come ahead and through the time of potential approval and launch in 2025.
Speaker Change: During the third quarter, we selected third party external partners for our bespoke patient experience, which we believe is a key element of differentiation for a potential commercial launch. We also made significant progress towards solidifying our promotional launch campaign.
Speaker Change: Additionally, we advanced our <unk> preparations, including finalizing aircraft can recall list and establishing the geographic boundaries for our planned sales territory.
Speaker Change: We are also designed to robust recruiting plan training curriculum for the proxy it would be approximately 125 to 150 reps, we expect to bring on board.
Speaker Change: While we do not plan to hire Caldolor can talk closer to launch next year, we already have hundreds of qualified candidates in our pipeline and our pipeline prior to going out into the marketplace to recruit.
Speaker Change: From the payer side, we continued preapproval information exchange with key payers and made progress in developing our payer value dossier for both U S and ex U S. Payers are AQR team was also active in presenting and publishing research highlighting the unmet need in ATM the associated cost burden given current treatment and the potential value of <unk>.
Speaker Change: If you can't and Atms.
Speaker Change: Moving on to commercial readiness activities in Europe. Our plan is to prioritize major market can gate hiring and capital deployment alongside regulatory and reimbursement milestones at a country level.
Speaker Change: During the third quarter, we designed our distribution model.
Speaker Change: Refinery regulatory and labeling strategy.
Speaker Change: Tablets country launch sequencing again engage with European key opinion leaders and progressed development of HCA dossier, while continuing.
Speaker Change: Engaging with key HCA for early scientific advice.
Speaker Change: We also establish our initial go to market plan for Germany, which is expected to be the first country, where we launched <unk> in Europe.
Speaker Change: We now have we now have a head of Europe in place and are recruiting for key country leadership in the UK and France as well as functional leadership roles for European operations again alongside gated investment.
Speaker Change: As we get closer to the potential approval of warranty Rafi Captain our commercial readiness activities are continuing to ramp up importantly, what we're building today for Etsy, Camden will enable synergies with future potential commercial launches across our specialty cardiology franchise.
Stuart: Third resources systems commercial infrastructure and sales organization will facilitate enhanced efficiencies and effectiveness with each specialty cardiology launch with that I will turn the call over to Stuart.
Stuart: Thanks, Andrew.
Stuart: I'll start with CK 586, our next cardiac myosin inhibitor for the potential treatment of a subset of patients with heart failure with preserved ejection fraction on hepatitis.
Stuart: And hyper contractility.
Stuart: During the quarter, we presented the full data from the Phase one study of CK 286 at the American College of clinical Pharmacology, which showed that CK 586 was safe and well tolerated.
Stuart: No serious adverse events were observed and no study stopping criteria were met.
Stuart: The half life of CK, Tommy <unk> to be between 14 to 17 hours.
Stuart: C J body, which demonstrated dose proportional exposure and.
Stuart: In a PK PD relationship for Latam, <unk> ejection fraction and appeared shallow and predictable.
Stuart: At the highest single dose of 600 milligram, the mean decrease in ejection fraction less than 5%.
Stuart: These data demonstrate pharmacologic properties may enable once daily fixed dose administration.
Stuart: Because the data from its phase one study was supported advancing to phase two we began startup activities for Amber Park.
Stuart: Which is the phase III clinical trial of CK six in patients with symptomatic.
Stuart: With the Jackson fraction of the 60% designed to evaluate the safety Tolerability and.
Stuart: And pharmacodynamic profile of CK targets <unk> compared to placebo.
Stuart: The journey that we're on track to start Ameren have passed before the end of the year.
Stuart: Next let's move down looking at the Carnival, our cardiac myosin activator for the potential treatment of a subset of patients with heart failure.
Stuart: Bierley reduced ejection fraction.
Stuart: During the quarter, we conducted study startup activities for comment Hs, the confirmatory phase III clinical trial assessing the efficacy and safety of all my comments on the Carnival in 1800 patients with symptomatic heart failure with severely reduced ejection fraction less than 30%.
Stuart: Accommodate Jeff design with pragmatic features to improve efficiency of study conduct and reduce the patient burden. We expect to begin this trial during this fourth quarter.
Stuart: Heart failure with reduced ejection fraction or <unk> represents about half of the population of heart failure.
Stuart: Drilling down further estimates point to a large and growing population of patients with high risk heart failure and severely reduced ejection fraction below 30%.
Stuart: These are patients who have recurrent heart failure events and May have limited use guideline directed medical therapy due to poor tolerability.
Stuart: And have very elevated NT pro BNP consistent with severe heart failure.
Stuart: Despite the use of <unk> inhibitors with the large residual risk of cardiovascular events in the subset of patients with <unk>.
Stuart: In Galactic <unk>, the subset of patients with severely reduced ejection fraction and experienced a substantially greater treatment benefit without looking at the carnival.
Speaker Change: Alright, gentlemen, cancer Mccarl is targeting patients with heart failure and severely reduced ejection fraction.
Stuart: <unk> six is designed to address patients with Super a normal ejection fraction at the opposite end of the spectrum of heart failure.
Stuart: These patients also have high unmet need and despite advances in care with <unk> inhibitors have a poor prognosis following heart failure hospitalization.
Stuart: While the pathophysiology that lead to heart failure population is different.
Stuart: You'll need for both patient subgroups remains high despite guideline directed medical therapy.
Stuart: With markedly increased risks of cardiovascular mortality and hospitalization for acute decompensate of heart failure.
Stuart: Both Almucantar Mcfarland TK finance six represent opportunities to expand our specialty probably housing franchise into these populations at either end of the heart failure spectrum.
Stuart: Now looking beyond our specialty cardiology franchise as Robert mentioned, we're pleased to be renewing our neuromuscular pipeline with a novel drug candidate arising from our research called CK all eight nine.
Stuart: <unk> is a fast skeletal muscle troponin activator of Bastogne design.
Stuart: Designed to amplify skeletal muscle response to nerve input extending times, its teig and increasing muscle force and power.
Stuart: With potential therapeutic applications in a specific type of muscular dystrophy.
Stuart: Having completed IND, enabling studies.
Stuart: We expect to start in the first in human Phase one study of CK like nine in healthy subjects.
Stuart: We look forward to sharing more details of our plans to reinvigorate our neurovascular development activities is informed by prior learnings very soon.
Stuart: What this means is the by the end of this year, we will have one or more drug candidates in each phase of clinical development from phase one to phase III, which conveys the richness of our pipeline and muscle directed therapies and with that I'll pass it over to John.
John: Thanks, Stuart we're pleased to report our third quarter of 2024 financial results starting with the balance sheet. We finished the third quarter of 2024 with approximately $1 $3 billion in cash cash equivalents and investments compared to $1 4 billion at.
John: At the end of the second quarter of 2020 for cash.
John: Cash cash equivalents and investments declined by approximately $81 million during the third quarter of 2024.
John: Moving on to the income statement total revenues in the third quarter of 2024 were <unk> 5 million compared to <unk> 4 million for the same period in 2023.
John: R&D expenses in the third quarter of 2024 were $84 6 million compared to $82 5 million for the same period in 2023.
John: The increase was primarily driven by higher personnel related expenses to progress our pipeline, partially offset by the completion of clinical trials in 2023.
John: G&A expenses in the third quarter of 2024 were $56 $7 million.
John: Third to $40 1 million for the same period in 2023.
John: The increase was primarily driven by investments toward commercial readiness and personnel related expenses.
John: Net loss for the second quarter of 2024 was $165 million or $1 36 per share basic and diluted compared to a net loss of $129 $4 million or $1 35 per share basic and diluted for the same period in 2023.
John: Turning to the financial guidance for 2024, we are reiterating all aspects of our prior guidance, which can be found in our press release as.
John: As we head towards the end of 2024, our balance sheet remains an asset and positions us well to prepare for the potential launch of <unk> Camden advance our earlier and later stage pipeline and invest in our proven muscle biology platform.
John: We stand to realize synergies from the commercial and R&D investments as a potential future medicines in development activities can all leverage the infrastructure and capabilities that we are creating today and in the years to follow.
John: We believe these capital allocation priorities can enable us to become a leader in specialty cardiology with multiple medicines delivering benefit for patients and sustainable growth for investors with that I'll hand, it back over to Robert.
Robert Band: The third quarter. Indeed was marked by important achievements continuing a year marked by substantial progress.
Robert Band: By this time next year, we expect that our company will look quite different and we are building.
John: Our infrastructure and capabilities to ensure our successes in the years to come.
John: To that end during the quarter, we further strengthened our executive leadership team with the addition of Brett Pletcher, who joined as EVP Chief Legal officer in August.
John: Brett is a seasoned attorney and industry executive with deep experience developing operational reach and capacity and providing practical legal advice, having spent 17 years at Gilead 13 of those as general counsel.
John: We're fortunate to have Brett joined our team as we look ahead to the next important chapter for Sato kinetics and increased scope and scale as we mature corporate development.
John: Sato kinetics, as well funded and well positioned for future successes as we advance towards the potential approval and launch of <unk> in the United States with global launches hopefully to follow we're approaching an important inflection point for our company.
John: As we look ahead to that point and beyond we're laying the groundwork for our vision 2030, and sustained growth and enduring future successes as a premier specialty cardiology company.
John: As you've heard this business remains anchored in <unk> Camden for the potential treatment of HCM, followed by <unk> for the potential treatment of heart failure with severely reduced ejection fraction and then CK 586 for the potential treatment of heart failure with preserved ejection fraction.
John: Franchise design is intentional with common features across these patient populations and the prescribers that treat them.
John: Including a limited distribution model few or in effective available therapies and high unmet patient need each of these underscore our potential for higher return on investment and provide us the ability to realize R&D and commercial synergies.
John: To achieve these objectives, we are committed to investing wisely and maintaining a strong financial foundation to enable both forward motion as well as velocity looking back at the quarter I'm proud of the tremendous progress we've made towards achieving our vision.
John: Now I'll recap our upcoming milestones for <unk>, we expect to continue advancing our go to market strategies and prepare to launch <unk> Camden in the United States in 2025 of course subject to FDA approval, we expect to submit an MAA to the EMA in Q4 2012.
John: Four and coordinate with core sale to support the planned launch of <unk> in China in 2025 pending approval.
John: We expect to complete conduct of Maple HCM and share results in the first half of 2025, we expect to continue enrollment in Acacia HCM through 2024 with objective to complete enrollment in 2025, and we expect to continue enrollment in Cedar HCM.
John: The phase <unk> as well as the phase one study of <unk> in Japanese and Caucasian participants.
John: And for <unk>, we expect to start comment HFF, the confirmatory phase III clinical trial in this Q4 2024 for CK 586, we expect to start amber half path. The phase III clinical trial also in this Q4 2024.
John: And for earlier clinical development preclinical development and ongoing research, we expect to initiate clinical development of CK, Oh wait nine by starting a phase one study in healthy volunteers in this fourth quarter and we expect to continue ongoing preclinical development and research activities direct.
John: Two additional muscle biology focused programs through this year.
Speaker Change: Operator with that we can now please open the call up to questions.
Speaker Change: Thank you.
Speaker Change: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
John: The interest of time, we do ask that you. Please kindly limit yourself to one question at this time please.
Speaker Change: Standby, while we compile the Q&A roster.
Speaker Change: And our first question will come from a cost to worry from Jefferies. Your line is open.
Speaker Change: Hi, Thank you for taking our question. This is BB Andre cause I'm looking at the Sequoia data. It seems like the largest magnitude of reductions Kristine and hyper contact how patients with <unk> greater than 75, if you had a mechanism that could show gradient relief benefits without affecting Lvs first.
Speaker Change: What would be considered.
Speaker Change: Clinically useful for patients with severe hyper contractility and second would you still expect to see a benefit on PDL two thank you.
Speaker Change: Thank you I'll ask <unk> to respond to that please.
Speaker Change: Yes, I think the underlying point that you made is that this is a disease of hyper contractility and in some cases in most cases it leads to obstruction as well.
Speaker Change: Having an ejection fraction of 80% is just not normal it's not normal even in people that have.
Speaker Change: That don't have hypertrophic cardiomyopathy.
Speaker Change: And so.
Speaker Change: We think one of the targets.
Speaker Change: Trading this diseases to both reduce the contractility to more normal levels.
Speaker Change: So that the tissue remodeling the my favorite.
Speaker Change: Pivotal disarray, the cardiac wall stress as Ken I'll begin to decline.
Speaker Change: As well as to reduce the gradient.
Speaker Change: So I don't know if just treating of obstruction by itself.
Speaker Change: Is sufficient.
Speaker Change: You can do that with septal reduction therapy for instance, and that does result in substantial improvement in patient symptoms, but.
Speaker Change: Often they go on to develop.
Speaker Change: Non obstructive HCM and issues over time.
Speaker Change: As their disease progresses so.
Speaker Change: I don't believe that just treating.
Speaker Change: But not not not decreasing the hyper contractility as potentially a therapeutic benefit.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Our next question will come from Tess Romero from Jpmorgan. Your line is open.
Speaker Change: Hello tests.
Tess Romero: Good afternoon, Robert and chemo.
Tess Romero: I hope you're all well thanks for taking our question.
Speaker Change: On the phase III Naval HCM trial in patients with symptomatic OA HCN, how confident are you in a positive trial here and specifically could you walk us through the magnitude of change for Etsy Camden over net metoprolol, you need to hit a P value that is significant.
Speaker Change: And Relatedly, what can you tell us on how the patients that enrolled jived with your expectations.
Speaker Change: Good questions, obviously as we approach the readout of Maple HCM expected next year, we believe that this study will play an important role in.
Speaker Change: Consideration and adoption of P. Camden, hopefully also in line with evolving guidelines.
Speaker Change: And the study Maple HCM was specifically designed if anything perhaps as would be accelerating what would otherwise be potentially a phase four study.
Speaker Change: Enable.
Speaker Change: Label expansion I'll ask Patty to.
Speaker Change: How we design the study and how we feel about the patients that were enrolled.
Speaker Change: Yes, Hi test I think.
Speaker Change: This has been a study that has been very highly welcomed by the investigator community is answering an important question for them.
Speaker Change: In terms of enrolling patients.
Speaker Change: We've done very well.
Speaker Change: I think in enrolling patients to meet the target to have meaningful.
Speaker Change: Symptoms have meaningful reduction in their extra.
Speaker Change: Exercise capacity and.
Speaker Change: And whom initiating treatment with Abbvie canton metoprolol.
Speaker Change: Well, we will be able to assess which what is the magnitude of benefit for each of those therapies and how they compare.
Speaker Change: So.
Speaker Change: We think.
Speaker Change: For several reasons that Abbvie campton has already shown.
Speaker Change: Benefit on top of beta blockers and so these are.
Speaker Change: Patient said.
Speaker Change: So who were symptomatic and Kevin beta blockers have inadequate treatment.
Speaker Change: Adequate response to treatment and subsequently responded Daffy campton.
Speaker Change: Sequoia, we had patients on that campaign.
Speaker Change: Not on beta blockers, we had beta blocker patients not on any other therapy.
Speaker Change: And.
Speaker Change: I think that gave us a window into what we expect to see area in which I think is that the results will be consistent.
Speaker Change: With the hypothesis of this trial.
Speaker Change: I'm not going to speculate really on what is meaningful or how big of a change we're looking for.
Speaker Change: We have.
Speaker Change: Powered the trial somewhat conservatively with looking at a.
Speaker Change: Delta <unk> of about two.
Speaker Change: Decent power to show anything down to probably one five in terms of change in peak <unk>.
Speaker Change: Which covers.
Speaker Change: The region, where.
Speaker Change: <unk> was positive as well so.
Speaker Change: I think we're adequately powered and we look forward to the results.
Speaker Change: Great. Thanks, so much for taking our questions.
Speaker Change: Thank you. Thank you.
Speaker Change: Thank you.
Speaker Change: And our next question will come from film Sayed from Mizuho. Your line is open.
Speaker Change: Hello.
film Sayed: Hey, Robert Thanks for the color and the question.
Speaker Change: I guess, one for me on Maple as well as assuming you guys actually.
film Sayed: Get the result, you won here could you just maybe give us your thoughts on.
film Sayed: On getting getting those results published.
film Sayed: And then to treatment guidelines.
Speaker Change: And.
Speaker Change: Does the committee.
Speaker Change: And when that could potentially happen could it happen prior to the supplementary approval. Thank you.
Speaker Change: Yes.
Speaker Change: Yes, so obviously, we can't commit for what others will be doing but the guidelines are updated.
Speaker Change: In a continuous way and regularly not just once a year and as.
Speaker Change: You've seen already.
Speaker Change: And this year, we've been aggressive about ensuring that data go quickly from.
Speaker Change: Presentation to publication I think we've had a quite uncommon.
Speaker Change: Number of presentations and publications this year underscoring how closely we're working with the academic community to make sure. These data get.
Speaker Change: Properly peer reviewed and published.
Speaker Change: Published for consideration so that won't change next year.
Speaker Change: Okay could you could you think you can get it done prior to the actual approval because I think too.
Speaker Change: The threshold this publication correct.
Speaker Change: For consideration of guidelines Youre, saying, yes, yes, correct yeah.
Speaker Change: I would think that that makes a big difference and it's certainly our goal to get it published.
Speaker Change: As soon as possible next year, but I don't think we should be ahead of even having the data committing to whether that would be ahead of potential approval, but.
Speaker Change: Knowing that this is our objective.
Speaker Change: I think you should assume we'll continue to be very aggressive.
Speaker Change: Okay got it thank you so much.
Speaker Change: Thank you.
Speaker Change: Our next question will come from marijuana Ruiz from Leerink partners. Your line is open.
Speaker Change: Good afternoon.
Speaker Change: Hi, Good afternoon. This is with gasich onto marijuana. Thanks for taking my questions. Maybe first on Maple maybe asked a different way I guess looking ahead to the results.
Speaker Change: For <unk> relative to <unk> for all next year I guess.
Speaker Change: What does the peak <unk> improvement with Aussie look like in this study relative to what you saw in Sequoia previously.
Speaker Change: Like what's what's the outlook on that.
Speaker Change: The timeline as possible guideline adoption.
Speaker Change: For using <unk> in earlier lines of therapy, if the April data are positive.
Speaker Change: I feel like we might have just answered that but maybe I'll turn to fatty and see if theres anything more he might want to add.
Speaker Change: Yes.
Speaker Change: I will reiterate in Sequoia we had.
Speaker Change: One seven for milk.
Speaker Change: 1000 per kilo per minute improvement.
Speaker Change: In patients not on beta blockers that effect was.
Speaker Change: Modestly bigger.
Speaker Change: So we're kind of in that range.
Speaker Change: Peak <unk> improvement.
Speaker Change: Prior publications.
Speaker Change: Metoprolol use in HCM.
Speaker Change: Said that metoprolol doesn't increase peak too.
Speaker Change: And so you can guess it for in the same ballpark, we might see something in that range.
Speaker Change: Smaller study than Sequoia was it we're treating patients to whom.
Speaker Change: Our slightly less symptomatic because we wanted to sort of expand the aperture to naive patients newer patients. So.
Speaker Change: The exact effect sizes, a little tricky to handicap, but I don't think the exact effect size is really what's important and what's important is that.
Speaker Change: That there is a meaningfully different and better effect.
Speaker Change: He can't prove exercise function and symptoms.
Speaker Change: Ben.
Speaker Change: <unk> does in these patients.
Speaker Change: That should guide its use and.
Speaker Change: In therapy.
Speaker Change: I'd say the guidelines.
Speaker Change: We will present this will get published I think fairly rapidly.
Speaker Change: The guideline committees they don't publish their meeting schedules they don't publish.
Speaker Change: There are timing of updated guidelines, but they are aware that this is a fast moving field.
Speaker Change: But they do need to be timely and sort of considering the evidence and revising there.
Speaker Change: Their guidelines so.
Speaker Change: I'll leave it at that.
Speaker Change: Got it and then maybe if I may.
Speaker Change: Could you could you comment on how youre thinking about the European launch dynamics for us.
Speaker Change: The program just any learnings that you can apply based on what Youre seeing.
Speaker Change: Popular launch.
Speaker Change: Thank you.
Speaker Change: So we're really just taking one question per analyst right now, but I suspect Youll get to your question answered as we go through what looks to be a very long list of folks who want to ask questions will come back to that.
Speaker Change: Thank you operator, if we could move to the next one please.
Speaker Change: Our next question comes from Jason Symanski from Bofa. Your line is open.
Speaker Change: Hey, Jason.
Speaker Change: Hey, Good afternoon. This is Cameron Doug on for Jason Congrats on the quarter and thanks for taking our question. So.
Speaker Change: In terms of leveraging assay profile tour to potential pricing premium I guess, what factors are likely to be critical here is it going to be efficacy safety administrative profile or I guess in other words do you think less frequent of EES reductions below 50% and declared with explore is enough to warrant a pricing premium.
Speaker Change: Would you need to see the safety benefit reflected in the monitoring protocols are the label to establish a basis for a premium here. Thank.
Speaker Change: Thank you.
Speaker Change: So first off your question is kind of pre supposing that there'll be a pricing premium and we haven't spoken to that.
Speaker Change: But instead, we have referred to pricing within a relative same ZIP code, but maybe I'll ask Andrew to comment if you will on what we believe is ultimately going to translate to wider adoption for our next Gen class therapeutic in this category.
Speaker Change: Sure. So I think Robert answer the pricing and I'm, assuming you're asking about U S pricing, where we have the ability to set the price.
Speaker Change: But in the U S will be in the proximity of the established price where the market is.
Speaker Change: In terms of uptake of payers based on price, we're certainly going to be working and have already been with commercial payers are working on medical exception through Medicare payers I think we addressed.
Speaker Change: Challenges, which is an industry challenge is not unique to us.
Speaker Change: That's how we'll get access that we believe will be within priority of competition. So we're really then.
Speaker Change: Taking that out of the equation and focusing on.
Speaker Change: Catering promoting an uptake as well as supporting patients.
Speaker Change: So the market research, we've done underscores the importance.
Speaker Change: Risk mitigation and ultimately how that can translate to.
Speaker Change: Hopefully more physicians prescribing a cardiac myosin inhibitor for more patients.
Speaker Change: And we do hope that.
Speaker Change: If approved <unk> could be.
Speaker Change: <unk> by our risk mitigation profile that fits with next in class objectives.
Speaker Change: Thank you.
Speaker Change: Our next question will come from Schon Mccutcheon from Raymond James Your line is open.
Shawn Mccutcheon: Hey, Shawn Hey, guys, Hey, guys. Thanks for taking the question.
Speaker Change: Taking it 586.
Speaker Change: Can you speak to the lessons that you took from the Embarq results how are the target patients and amber meaningfully similar or different in your estimation from embark pharmacologic properties do you view as the most valuable provided.
Speaker Change: Muniz improves out any of the sub segment of that presentation.
Speaker Change: Yes.
Speaker Change: Sure. So that's a good question for Stuart maybe to pick up on an fad if he wants to add anything.
Stuart: Sure. Thanks for the question so.
Stuart: First of all we're very encouraged.
Stuart: With the potential benefit in this population with CK six.
Stuart: In large part from the data we observed in non obstructive HCM with naphtha.
Speaker Change: So and similar results were observed Atlantic Hampton and non destructive.
Speaker Change: And in terms of the Pharmacodynamic improvements symptomatic improvement.
Speaker Change: But the Embarq data do inform and encourage.
Speaker Change: The potential benefit of CK six.
Speaker Change: In this population of patients.
Speaker Change: Patients with hyper contractility.
Speaker Change: Now.
Speaker Change: We are enriching and population of course of injection fraction.
Speaker Change: At least 60%.
Speaker Change: We can have a lot to learn.
Speaker Change: The terms.
Speaker Change: <unk> potential.
Speaker Change: Dosing range that may be affected.
Speaker Change: And safe and tolerable and so on.
Speaker Change: On.
Speaker Change: This first in patient study.
Speaker Change: <unk> will help us characterize on departments.
Speaker Change: <unk> benefits will be measuring cardiac biomarkers, such as NT pro BNP cardiac troponin.
Speaker Change: As well as of course of evaluating ejection fraction.
Speaker Change: We observed.
Speaker Change: I think.
Speaker Change: Very favorably in our phase one studies is very shallow.
Speaker Change: Exposure response profile with respect to.
Speaker Change: The only small incremental increases in ejection fraction.
Speaker Change: With increasing doses of CK six.
Speaker Change: So.
Speaker Change: I'm not going to go into a lot of speculation about comparing radio designs or data from embark data we've accumulated so far.
Speaker Change: Our very encouraging with CK 586, as long as that the Camden in non obstructive HCM.
Speaker Change: Quite optimistic and look forward to this.
Speaker Change: <unk> trial.
Speaker Change: The embark study was not a large study and therefore theres still a lot to be learned from testing.
Speaker Change: Cardiac myosin inhibitor and a larger longer study so our goal will be to do a proper development program for.
Speaker Change: CK 586 to inform CK five asics.
Speaker Change: Operator next question please.
Speaker Change: I just wanted to ask I'm sorry, Robert.
Speaker Change: KBR controlled trial.
Speaker Change: And so it's going to get much more rigorous assessment the cardiac myosin inhibitor.
Speaker Change: And this population will cut back on hyper contractility of some personal remarks.
Speaker Change: Yes.
Speaker Change: Thank you Stuart.
Speaker Change: Thank you. Our next question will come from Paul Choi from Goldman Sachs. Your line is open.
Speaker Change: Good afternoon Paul.
Paul Choi: Good afternoon, Robert and team. Thank you for taking our question.
Speaker Change: I just wanted to return to the subject of Maple and with regard to.
Speaker Change: Any sort of clinical efficacy bar that.
Speaker Change: Has it been potentially discuss with payers as they think about potential guideline changes there and how do they provide any feedback to you.
Speaker Change: Or.
Speaker Change: Any sort of physician community commentary I'm, just sort of what would be considered clinically meaningful here versus meta profile as to drive guideline changes here. Thank you very much.
Speaker Change: Yes, so I'll ask Andrew to comment, but I think it would be premature for us to be talking about maple with payers before we have data from maple in before we have.
Speaker Change: Even an approval potentially based on Sequoia, but we are gathering insights into how payers think about these things in a general sense. So maybe Andrew if you could comment please.
Andrew: Certainly, yes, so as Robert mentioned, our focus right now with payers is based on Sequoia strategically we're discussing options in terms of how you then start to work maple into payer conversations as well as value arguments both in the U S as well as Europe.
Speaker Change: The value from April from a physician point of view really does two things.
Speaker Change: Expand physician population there is a subset of physicians, who are more apathetic to treating with new agents and are okay with beta blockers as it because they don't really have experience with <unk>. So when you show a head to head relative to.
Speaker Change: They are using today, that's certainly releases additional position so it expands the market.
Speaker Change: And then when you look at preferring share when you have a secondary study that has.
Speaker Change: Within the range of similar results as what we're expecting then that kind of as a validation for that primary study, which then further enhances our share. So it should work with for guidelines that should work with market expense and it should help with share preference and so it certainly is going to help with value arguments in the U S and in Europe.
Speaker Change: We're not talking to payers at the moment.
Speaker Change: In April.
Speaker Change: Okay, great. Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Jason Butler from citizens JMP. Your line is open.
Speaker Change: Hey, Jason.
Jason Butler: Hi, Robert Thanks for taking the question just.
Jason Butler: Just a quick one on OE nine you guys have a long history with this class can you just at a high level.
Jason Butler: Just tell us how it differs from the prior candidates.
Speaker Change: Yes, so nine comes from.
Speaker Change: From a very different chemical scaffold and for which.
Speaker Change: I'll ask <unk> to comment in a moment, but please understand that we have applied learnings to our interest as it relates to <unk> nine and in particular, you will hear more about how we're developing it going forward underscoring that.
Speaker Change: Not going to be pursuing the development of our eight nine in AOS, but rather than a muscular dystrophy and in fact, a rare form of disease, where we think it may play a potential role.
Speaker Change: Fatty do you want to comment on how it may differ from prior fast skeletal compounds.
Speaker Change: Yes.
Speaker Change: <unk> nine.
Speaker Change: The third molecule.
Speaker Change: And we view of each iteration have come to molecule that is more potent has better pharmaceutical properties.
Speaker Change: A challenging target and we think OE nine kind of maximizes the efficacy that we can pull out of this mechanism of action at least in preclinical models.
Speaker Change: And.
Speaker Change: It was better suited.
Speaker Change: And in terms of its physical properties.
Speaker Change: For doing dosing and dose ranging and so forth. So.
Speaker Change: Still early days.
Speaker Change: We have some very interesting.
Speaker Change: Staying in promising preclinical data.
Speaker Change: And we'll be looking to see if we can translate that going forward into the clinic.
Speaker Change: The world has evolved quite a bit.
Speaker Change: Skeletal muscle since we were advancing two prior compounds.
Speaker Change: And we're borrowing from those learnings to in terms of how we think about.
Speaker Change: Skeletal muscle force power endurance, fatigue, and muscle function and we do believe that.
Speaker Change: <unk> nine.
Speaker Change: It has an opportunity to establish a position where some others have been built.
Speaker Change: Building value for shareholders.
Speaker Change: And again, you'll hear more about our plans as we roll forward into phase, one and hopefully beyond.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question comes from Charles Duncan from Cantor Fitzgerald. Your line is open.
Speaker Change: Hello Charles.
Speaker Change: Heightening does it have.
Speaker Change: On for Charles Thank you for taking our question.
Speaker Change: Just have one floor only campus and the carnival.
Speaker Change: Near initiation for a comment.
Speaker Change: What is your view on its competitive position within the heart failure market, specifically on other treatments for heart failure and.
Speaker Change: Jackson question continue to develop.
Speaker Change: Thank you and excellent question I think it warrants.
Speaker Change: Being answered by both.
Speaker Change: Fatty and Stewart as well as Andrew May have a perspective on that and I'll ask our team to comments starting with 30. Please.
Speaker Change: Well sure I think.
Speaker Change: In the population that we plan to study <unk> in people with severely reduced ejection fraction.
Speaker Change: Really severe heart failure.
Speaker Change: There are.
Speaker Change: Few new options many of the drugs that are developed lower blood pressure.
Speaker Change: Can be challenging to use in these patients because they impact kidney function.
Speaker Change: And they don't.
Speaker Change: <unk> addressed the core element of why these patients are so symptomatic at this point in their disease process, which is their cardiac function has deteriorated.
Speaker Change: Substantially and is now severely reduced so.
Speaker Change: <unk>.
Speaker Change: Sort of a unique place in terms of being used in this area and it's conceptually easy to understand why it would benefit these patients in need explain a patient's why you would use it.
Speaker Change: And.
Speaker Change: And so I think the enthusiasm that we have been met with as we announced the initiation of this trial rather than announced.
Speaker Change: Intent to conduct comment.
Speaker Change: In the heart failure community has been quite large.
Speaker Change: Get E Mails weekly frankly from investigators that are interested in participating.
Speaker Change: Paul that we're continuing to develop a <unk> because it really fills an unmet need for them in terms of what do they do next win.
Speaker Change: Sort of foundational treatments for heart failure or not working.
Speaker Change: Stuart anything to add from a clinical perspective before we ask Andrew to comment commercially.
Speaker Change: Let's add that sorry.
Stuart: Is that is that these patients are running out of options and <unk>.
Speaker Change: If you look at the profile of our risk in this population there is end market inflection point.
Speaker Change: The threshold of 30% ejection fraction.
Speaker Change: Good mortality.
Speaker Change: And to be compensated heart failure. It goes up dramatically ejection fraction less than 30% as Andy was mentioning these patients are running out of options.
Speaker Change: <unk>.
Speaker Change: Don't have options.
Speaker Change: Drawing back online direct mackle therapy.
Speaker Change: And.
Speaker Change: Turning towards the end stage heart failure.
Speaker Change: Again, what we observed in Galactic HFF with this with the.
Speaker Change: Population.
Speaker Change: Not only at the highest risk.
Speaker Change: <unk>.
Speaker Change: Heart failure.
Speaker Change: Nancy and mortality was it this is a population of which came from our cardinal benefit the most.
Speaker Change: And so there's sort of an alignment of the stars here.
Speaker Change: This is the population of the cotulla assets.
Speaker Change: We're looking at some apparel.
Speaker Change: Thank you Stuart Andrew.
Speaker Change: Sure from a market positioning point of view so.
Speaker Change: A couple of considerations one when we look at kind of future competitive environment as well as what's on the market today and the guideline directed medical therapy kind of quad therapy, our expectation will be completely generic at that point.
Speaker Change: Also look at what is in the pipeline.
Speaker Change: We're pretty confident in terms of very clear positioning for our mechanical mccarville, especially when you consider the clinical arguments that were just <unk>.
Speaker Change: Described.
Speaker Change: This patient population also has challenges with hypertension renal dysfunction or hyperkalemia.
Speaker Change: We're expecting OMA camera will continue to showed a neutral effect on those side effects that are associated with guideline directed therapy with a strong health economic argument.
Speaker Change: As well and then with little treatment options, we're expecting kind of premium pricing as well as the fact that this old lay on top of our existing specialty cardiovascular franchise, our field force our headquarter based employees, so very little add from a cost basis as well, so I'm really clear economic argument really core.
Speaker Change: Business pays for a clearer.
Speaker Change: Clinical argument as well as looking at the future competitive set from a positioning point of view and that's why we're moving forward with AUM of captives from a commercial point of view.
Speaker Change: That makes a loss I'm really pleased that.
Speaker Change: Sure I just wanted to comment I'm really pleased that.
Speaker Change: We're hearing from more investors and equity research analysts about our strategy for <unk> and that people are doing their work on this.
Speaker Change: I will suggest that I think it's an opportunity to realize the kind of synergies we have been talking about around our specialty cardiology model and it would be a mistake.
Speaker Change: To believe that we're targeting a population for which there are good alternatives because there are really not and we do believe we have a positioning as well as a profile for <unk> if positive and this confirmatory study that can translate into a meaningful opportunity. So looking forward to updating you more and more.
Speaker Change: More on that operator next question. Please.
Speaker Change: Thank you. Our next question will come from <unk> from <unk> Securities. Your line is open.
Speaker Change: Good afternoon.
Speaker Change: Good afternoon, Robert and team. Thank you so much for taking my question.
Speaker Change: A question on Nathan as well I think Bobby you talked about getting imaging data and maple that might suggest a difference in cardiac remodeling.
Speaker Change: I was wondering if six months you think six months is enough to demonstrate the difference I think you had mentioned that.
Speaker Change: Ox showing the difference.
Speaker Change: And do you think long term data from forest wood adds to that or would you need to see.
Speaker Change: Longer data from Maple.
Speaker Change: Well.
Speaker Change: Let me put it differently a little bit differently already with Sequoia for instance, we've presented data at six months.
Speaker Change: You start to see changes in terms of reduction of LD mass and left atrial size.
Speaker Change: It reflects positive changes in cardiac structure.
Speaker Change: So six months is enough those changes may increase over time, which means you need longer follow up but I think what we'll see my hope, we'll see with Maple is with beta blockers, you don't see any of those changes over six months so the process.
Speaker Change: Doesn't even start doesn't doesn't get underway, there's not really any mechanistic reason to believe that youll see it.
Speaker Change: And those patients in and so if you haven't started in six months. There is no reason to believe that.
Speaker Change: Somehow much longer treatment with that particular modality is going to lead to the same sort of changes that will.
Speaker Change: Demonstrate over time with Apple Hampton.
Speaker Change: Got it so I think the point I was trying to get too would this help from a reimbursement perspective that this is not just the exercise capacity, but also the cardiac remodeling that you see at six months.
Speaker Change: Okay.
Speaker Change: Andrew do you want to take that I mean, I know from.
Speaker Change: Physician perspective.
Andrew May: Just kind of frankly had a call on this this morning with our steering committee.
Andrew May: They are all interested in how to demonstrate that early use earlier use of this mechanism of action may.
Andrew May: Change the course of peoples disease progression and so there is really strong interest in the physician community of that question.
Speaker Change: It's difficult to show.
Speaker Change: And likely payers may feel differently, it's hard to know, but but I think it's an important question that ultimately answer.
Speaker Change: Thanks for the question I think ultimately the more.
Speaker Change: Data and that we can add two arguments for payers Maple certainly starts to add to that argument.
Speaker Change: Clearly adds to that argument.
Speaker Change: Having outcomes data so right now we're focused on linking <unk> to outcomes secondaries like New York Heart class and <unk>, They all resonate very well with payers.
Speaker Change: This added to that certainly should help to that argument.
Speaker Change: So we haven't broken that subject with payers yet but.
Speaker Change: But again I think additional evidence is always helpful.
Speaker Change: Got it thank you so much.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Next question comes from my Uncle, Bob Tony from B Riley Securities. Your line is open.
Bob Tony: Good afternoon.
Bob Tony: Good afternoon team congrats on a strong quarter and thanks for taking our question. So.
Bob Tony: <unk> phase II trial.
Bob Tony: At 12 week treatment period.
Bob Tony: The expectation for.
Bob Tony: Until then given what you've seen in the NMC and basins in February.
Bob Tony: Are you able to quantify beyond obviously that will be NB inflammation, you again or should we just.
Bob Tony: Wait for the Mic duty for Outerwear study data in early next year to understand what good looks like in a placebo controlled manner and also thinking how this stacks up relative to that.
Bob Tony: The blip fund drugs being increasingly used in that sense.
Speaker Change: Thanks for taking my question.
Speaker Change: Let me start I'll ask Stuart to comment, but I think just I'll make the point that in.
Speaker Change: Our NH Sam study in Redwood and UNH same cohort that was 10 weeks of treatment and that seemed adequate to see.
Bob Tony: Meaningful biomarkers signals in some symptom improvement.
Bob Tony: So.
Bob Tony: <unk>.
Bob Tony: That.
Bob Tony: Here.
Bob Tony: We have no just similar chance of seeing that in these patients.
Bob Tony: This is more of a dose finding trial by the time, we got to the non obstructive HCM cohort in Redwood, we already had a pretty good sense of doses.
Bob Tony: But.
Bob Tony: But I think again.
Bob Tony: <unk> of this trial should allow for us to get a sense of how this drug impacts patients symptoms and other measures.
Bob Tony: Cardiac function and structure.
Speaker Change: As to the use of <unk> do you want to comment on.
Speaker Change: How we're thinking about that in this population.
Speaker Change: I'm, sorry, I didn't quite get the question Cincinnati So.
Speaker Change: I guess, Mike was asking and how <unk> ones are now being used in half path.
Speaker Change: How are we incorporating the change in therapy, and our consideration of our plans going forward.
Speaker Change: Well the way we think about this is that there are different mechanisms of action.
Speaker Change: Sure.
Speaker Change: There has been some evidence some.
Speaker Change: Benefit for.
Speaker Change: For <unk> one receptor agonist.
Speaker Change: Pass it is not complete.
Speaker Change: Completely clear at this point, how much is related to <unk>.
Speaker Change: Weight reduction or some other potential mechanism.
Speaker Change: I think the point is that.
Speaker Change: Its population.
Speaker Change: It's one that high risk.
Speaker Change: Adverse cardiovascular outcomes and what we've seen.
Speaker Change: And certainly in patients with <unk> is that.
Speaker Change: Edition.
Speaker Change: New mechanism of action.
Speaker Change: And address different pathways results in incremental risk reduction for <unk> heart failure outcomes and so we anticipate the same.
Speaker Change: With the mechanism of action <unk> cardiac myosin inhibition.
Speaker Change: Again analogous to what we've seen so far in patients with non obstructive HCM. So theres no reason why these mechanisms.
Speaker Change: Mechanisms shouldnt be complementary.
Speaker Change: Yeah.
Speaker Change: So we don't see them as competitors.
Speaker Change: Amazon.
Speaker Change: So I think theres a lot to be appreciated about the spectrum or continuum of heart failure.
Speaker Change: From severely reduced to super normal.
Speaker Change: Yes and.
Speaker Change: I do believe the way we're positioning is.
Speaker Change: Different one shouldn't think that all drugs are going to be equally across that spectrum, including GOP ones.
Speaker Change: Yes, I remember GOP ones are applied in obese people not everybody with FF as obese.
Speaker Change: They are clearly segments of the well.
Speaker Change: <unk> population that are.
Speaker Change: Im not going to be helped by <unk> ones, just because they're not going to need.
Speaker Change: Or it would be adverse to give them a lot of weight loss.
Speaker Change: Patients with high ejection fraction likewise.
Speaker Change: We will try to avoid people with metabolic syndrome.
Speaker Change: And obesity as a means of carving out.
Speaker Change: Dana type that we think is responsive to this mechanism of action.
Speaker Change: Thank you operator next question please.
Speaker Change: Thank you. Our next question will come from Yasmin Rahimi from Piper Sandler Your line is open.
Yasmin Rahimi: Good afternoon afternoon, Hi, Robert.
Speaker Change: It's a wonderful this is the first corn and two years that we did not bring up the word in the Q&A round. So.
Speaker Change: And warm.
Speaker Change: Nor am I going to ask a question on that okay.
Speaker Change: To access.
Speaker Change: Pretty good about not talking about that anymore, but would love to continue the dialogue on April I think ultimately what maybe we need your help one is to understand.
Speaker Change: What is the size of the.
Speaker Change: Obstructive Marquette.
Speaker Change: Got it.
Speaker Change: Phil Beta blocker.
Speaker Change: Or even get worse on beta blocker.
Speaker Change: And what kind of cost analysis could you potentially put together to kind of make the argument.
Speaker Change: Down the line.
Speaker Change: Out of Camden being positioned as first line, but maybe to the extent you could educate.
Speaker Change: On the size of the market.
Speaker Change: Naples showed superiority would greatly appreciate it.
Speaker Change: And I'll jump back into the queue.
Speaker Change: Thank you Andrew you've done some good work around market segmentation do you want to tackle that.
Andrew May: So good question so from a beta blocker point of view at least in our this is not from claims data or.
Speaker Change: Large data source from from market research, we do know that about 25% of patients experience.
Speaker Change: Your indication debatable AWK or at least what.
Speaker Change: Over 100, or so physicians told us and maybe about <unk>.
Speaker Change: 80%, 90%.
Speaker Change: Unwanted side effects. So certainly it is not a agent that patients love to take from what we've heard when we look at.
Speaker Change: Those that sale beta blockers and kind of the value argument I think our overall, it's hard to create a value argument around a low cost generic I think the value argument has to get elevated to a higher level.
Speaker Change: Things like KCG Q.
Speaker Change: We acquired class, what's actually does change outcomes as does <unk> change outcomes heart outcomes outcomes like hospitalization and deaths et cetera. Thank you have a lower New York heart class or a better PPO too and certainly have better outcomes, avoiding septal reduction therapy or surgery the associated co morbidities.
Speaker Change: Associated with ATM. So these are the kinds of value arguments that we really look at making I don't think that a failure of a beta blocker will really help from that regard I think it does help with I alluded to earlier.
Speaker Change: Creates additional evidence that creates evidence against.
Speaker Change: What is standard of care is for many physicians and gets them to rethink potentially therapy. So it opens up the market.
Speaker Change: Not a larger population, obviously, it's still owe HCM, but it is a larger market opportunity and therefore larger market penetration.
Speaker Change: Thank you Andrew.
Speaker Change: You got to think a lot of the questions. We're getting today relate to maple and I assume that means that a lot of the analysts are.
Speaker Change: Finding their models to understand what <unk> could mean in terms.
Speaker Change: Opening the market to get broader adoption and I appreciate that well I'll underscore and as Andrew is pointing out it's the body of evidence that I think creates a tipping point around which.
Speaker Change: Cardiologists activated perhaps outside of centers of excellence.
Speaker Change: Totally feel more comfortable prescribing <unk> and if approved we think thats going to make a big difference so it contributes to <unk>.
Speaker Change: Velocity of commercial launch.
Speaker Change: <unk> contributes to what will be the expansion of the category beyond where it's currently perhaps entrenched in centers of excellence.
Speaker Change: We've talked about the concentration of prescribers and we do believe that maple can make a meaningful difference in terms of.
Speaker Change: Adding to the evidence to support the use of cardiac myosin inhibitors, and that's where I think it will.
Speaker Change: Enable better diffusion of this innovation broader into the marketplace.
Speaker Change: Operator next question please.
Speaker Change: Thank you our.
Speaker Change: Our next question comes from Rohit <unk> from Oppenheimer. Your line is open.
Speaker Change: Good afternoon.
Speaker Change: Good afternoon. This is Ron answer leaning vishal. Thank you for the update and taking my question.
Speaker Change: On <unk>, just as you think about implications from <unk>.
Speaker Change: The ongoing launch of the cardiac cardiac myosin inhibitor.
Speaker Change: Steps on the commercial process, what are you expecting come in therapy, maybe catalyze in terms of growing market awareness and helping uptake and eventual payer coverage.
Speaker Change: Kempton is potentially available thank you.
Speaker Change: Yes, so we've done a lot of work around what our next in class opportunity can mean for category expansion broader penetration activating cardiologist, who might not be currently yet prescribing a cardiac myosin inhibitor.
Speaker Change: We think it has a lot to do with.
Speaker Change: Things that we've been talking about in terms of next Gen class profile.
Speaker Change: It's not just about safety and efficacy, it's about ease of use and convenience. It's about the patient experience and maybe Andrew you can talk a bit more about these things.
Speaker Change: Sure.
Andrew May: Really when you are the second agent and I think we can.
Speaker Change: <unk> disease. It is a new therapy that it hasnt had a targeted therapy.
Speaker Change: So we're doing our own disease awareness campaign, we rolled out a disease where campaign in HCP that long ago.
Speaker Change: And.
Speaker Change: With Ah patients in early Q1, I think many of us in the U S. It's in direct to consumer television advertising for the category.
Speaker Change: Broader disease awareness in Alberta patient organizations. So all these things create awareness by payers. They see these things out in the.
Speaker Change: <unk> by physicians that gets patients in the physician office is talking about maybe additional treatment options.
Speaker Change: The increased awareness certainly should it have an increased market opportunity.
Speaker Change: For us where we're not fighting awareness of disease, we're educating more and ft, Camden and the unique properties as well as the areas of differentiation.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Thank you for the question.
Speaker Change: Thank you and I am showing no further questions from our phone lines I'd now like to turn the conference back over to President and CEO, Robert Blum for any closing remarks.
Robert Blum: Thank you I want to thank all the participants on our call today for your continued support and interest in cytogenetics.
Speaker Change: A lot to cover today, we've had a very busy year Q3 was.
Speaker Change: A good quarter in terms of progress against our goals. If you haven't already I would encourage you to listen in on the Investor event, that's archived on our website.
Speaker Change: Went into some great detail around our strategies not just as it relates to Effie Camden and O HCM, but also <unk> and how that creates a through line to our specialty cardiology franchise.
Speaker Change: Anchored with both <unk> and CK five age six and what you heard today speaks to not just progress around those programs, but also in research in earlier development and how Thats all enveloped in a company that's being prudent with regard to capital investment deployment and efficiencies that could create.
Speaker Change: Commercial synergies as I mentioned, our goal is not simply to launch <unk> next year, but to do so in a way that's differentiated and could be enabling of us to set the table for the franchise.
Speaker Change: <unk> been talking about.
Speaker Change: I want to again, thank everybody for your interest in what we're doing your attention on this call. We look forward to keeping you up to date through the remainder of the year and with that operator, we can conclude the call. Please.
Speaker Change: Thank you. This concludes today's conference call. Thank you for your participation you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.