Q2 2025 Cytokinetics Inc Earnings Call
Thank you for standing by. My name is fra and I will be your conference operator. Today, welcome to the site of kinetics Q2 2025 earnings conference call,
this call is being recorded and all participants are now listening, only mode. After the speakers remarks, we will open the call to questions. We will allow for 1 question per participant.
If you would like to ask a question during this time, seemed to press the star, followed, by the number 1 on your telephone keypad. If you would like to with your question, please press the star 1 again.
I would now like to turn the call over to Diane wiser. Pedro, kinetics senior vice president of corporate the players. Please go ahead.
Good afternoon and thanks for joining us on the call today. Robert Blum, president and chief executive officer will begin with an overview of the quarter and recent developments.
Andrew call us EVP and chief commercial officer will address commercial Readiness activities for a VP of R&D will provide updates related to the clinical development program. A medical Affairs activities for AIC, Campton Stewart cup for SVP and chief medical officer will provide updates on the clinical development program.
But on the count of marble and CK 586, which is now called Ula Campton.
Emily EVP and Chief Financial Officer will provide a financial overview of the past quarter. And finally, Robert will provide closing comments and review our expected key milestones for the remainder of 2025,
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 might differ materially from those projected. In these forward-looking statements additional information concerning factors that could cause our actual results to differ materially from those. And these, forward-looking statements is contained in our SEC filings, including our current report, regarding our second quarter of 2025 Financial results filed on Form 8K. That was furnished to the FCC. Today, we undertake no obligation to update any forward-looking statements after this call. And now, I will turn the call over to Robert.
Thank you, Diane, and thanks to all for joining us on the call today.
The first half of this year has been defined by solid progress as we continue to deliver on key Milestones that bring us closer to realizing our vision. A vision of being the leading muscle focused specialty. Bio for company. Intent on meaningfully, improving the lives of patients through Global access to our Innovative medicines.
during the second quarter, we announced that the FDA extended our Padua date for the NDA for AFI Campton, for the treatment of patients, with ocm to December 26th, 2025
Our late cycle review. Meeting has since been moved to September consistent with the 3-month Padua extension.
As we expect will occur soon and inform our next steps.
In the meantime, all activities expected alongside the FDA's ongoing review process continued on timeline. For example, GCP inspections of clinical trial sites, as well as those of Cytokinetics by the FDA, are now completed with no observations recorded.
In addition we're maintaining a productive dialogue with FDA and were answering questions to support their review of the MDA.
Also, during the quarter, we had a collaborative meeting with FDA on our submitted Rems program following their initial review.
Subsequent to the meeting. We promptly submitted an updated Rems package.
And during, or rather despite, the extension to the Padua date.
We remain confident in the US regulatory position of AFI Campton given the quality of our clinical data perceived alignment on a Rems program and ongoing collaborative dialogue with FDA.
We also maintain strong conviction that the data behind AI, Campton support, its potential FDA approval, its distinct benefit risk, and pharmaceutical profile and potentially differentiated label and risk, mitigation profile as the potential new treatment option.
For patients with ocm.
At the same time, regulatory reviews for AFI Campton continued during the second quarter in both Europe. And in China in April we received the day 120 list of questions from EMA regarding the MAA for AFI Campton in Europe and we're on track to submit responses soon in accordance with the timeline agreed with the EMA.
EMA, inspections of clinical sites and of St. Kinetics have also been completed with the overall conclusion, that the conduct of the phase 3 trial was compliant with regulations and guidelines and data are acceptable and reliable.
We remain on track for potential approval by EMA in the first half of 2026 and we're targeting Germany. For our first potential launch following approval,
We have also been working closely with Santa Fe, our partner in China, to support the NDA review of Afy, Campton with the NMPA. That's on an accelerated regulatory pathway for innovative therapies. We look forward to the prospect of bringing Happy Campton to patients in additional geographies, and we continue to expect potential approval in China in the second half of this year.
Moreover, in the past few months, our commercial launch Readiness activities. Have advanced with increased intensity and focus and we're taking advantage of the extra time to further strengthen our commercial launch and our operational strategies in the US as Andrew. Will elaborate key progress areas in the second quarter include recruiting a world-class Us sales force. Fine-tuning our patient Centric treatment experience and engaging key payers and also other important stakeholders
During the quarter, we also made important progress in our ongoing clinical trials program for afy. Canton notably, we announced positive Topline results from Maple HCM.
We look forward to expanding on these results and their implications for what standard of care treatment may look like in 08 cm following the presentation of the primary results at the upcoming European Society of Cardiology Congress, which will occur later this month.
We also continue to conducting Acacia, HCM the pivotal phase 3, clinical trial in mhcm, which is now fully enrolled and towards our expected Topline readout, in the first half of next year, nhm represents an area of significant unmet need and it's growing within the overall HCM population.
Action with no approved treatment options that address the underlying disease.
following the first potential approval in ohcm NHC represents a clear opportunity for AIC Campton and innovation
MC k586. Now called ulekan respectively.
Each trial addresses, a different form of advanced, heart failure. And these programs are Central to our mission of delivering new medicines to patients suffering from diseases of cardiac muscle dysfunction, and also addressing the high unmet needs in heart failure. As we progress our specialty Cardiology franchise forward.
In summary in the past quarter, we made important progress, across regulatory commercial Readiness, and also clinical development priorities. And we're building momentum as we approach important. Mi SPO Milestones expected to occur in the second half of 2025 with that. I'll turn the call over to Andrew, please.
Thanks, Robert with the pufa date extension. We adjusted our plans and our leveraging, the extra time to finalize us commercial wants Readiness activities as well as refine the implementation of our promotional campaign and patient Support Program.
Recently, a key Focus has been the hiring of our Us sales force, after our highly successful virtual recruiting event April, we received over 8,800 applications and proceeded to hire a very experienced cardiovascular sales, team with nearly all territories. Now filled
This exceptional level of interest in joining cytokinetics has provided a deep and experienced talent pool. Enabling us to be highly selective in assembling a best-in-class sales team. We we have now hired sales professionals who have existing relationships with cardiologists and possess deep therapeutic and Industry expertise positioning us to execute a highly impactful launch overall
Our new South colleagues have over 21 years of Industry experience, and an average of 14 years of cardiovascular experience. We expect to have the sales force on board and trained in Q4. So they're ready for an early q1 2026 us launch of aicamp.
Additionally, during the quarter. We also made progress and optimizing our distribution network of specialty. Pharmacies and Distributors, this infrastructure will be key in delivering, a high-quality patient Centric experience for both patients and providers alike.
We also advanced the development of our bespoke Patient Support Program. Taken together, we have a goal to create an integrated, simple, and patient-centric treatment and assistance experience across all touch points, both for HCPs and their patients.
as we approach potential approval later this year, and commercialization, we remain focused, and driven by the compelling unmet need,
We believe that Approximately 80% of eligible, obstructive ATM patients will be treatment naive relative to a cardiac myosin inhibitor. So symptomatic ocm patients naive to cmis and primarily in specialty centers, for HCM represent an entry point for AIC campus.
Our launch strategies to expand the market. Ensure more cardiologists are comfortable with aicamp in and more patients can potentially benefit from this new therapy.
Importantly, according to our market research, nearly 80% of atp's, pled. And hm, specialized centers are familiar with Asic Campton on a native basis. Giving us a strong starting point for initial engagements, from which we expect to grow market adoption and to expand to community Cardiology
Recently, market research findings that incorporated a target product profile, based on Maple HCM, resulted in further support, likely expanding prescribed and Beyond ATM specialized centers.
Our promotional launch campaign for both ACP and patients which are currently in final market, research, testing and refinement are designed to evolve in step with our Market positioning and key areas of differentiation. We believe that given the differentiated profile of AIC Campton, these messages will resonate and contribute both to commercial launch as well as category preference.
Pear engagement also remains a priority. And in the second quarter, we continue to educate payers on the results, from Sequoia HCM along with the clinical and economic burden of ATM.
We also began building, uh, foundational, Health economics, and outcomes. Research models around budget impact costs effective, Effectiveness, and cost comparisons to support both us and xus. Payer requirements as we approach, potential regulatory approval, and key us and EU geographies.
2026. Overall, I am pleased with where we positioned relative to the potential upcoming approval of AIC Campton.
With that, I'll turn the call over to fatty to share updates on our ongoing clinical trials program and medical Affair activities for African.
Andrew.
During the second quarter, we were pleased to report positive Topline results from Maple HCM, which demonstrated a statistically significant Improvement in Peak oxygen uptake from Baseline to week 24.
Bradley Campton compared to the standard of care. Beta blocker. Metoprolol
Safety and tolerability profile of AI camps. And was also favorable in comparison to my topical law.
April 8th. CM the only trial comparing a cardiac myosin inhibitor head-to-head with a long-standing standard of care. Therapeutic approach of beta adenuric receptor, blockade.
As we recently announced the full results from Maple HCM will be presented in a hotline session on Saturday, August 30th at the European Society of Cardiology Congress in Madrid. Later, this month, a prespecified analysis from the trial on the effective AI camp and versus metropoli law. And cardiac structure and function will also be presented on Sunday, August 31st until then we can't elaborate on the top line results but we look forward to sharing much more detail in a few weeks.
Why are these data important Maple to HTM reads? Not only on the treatment effect and safety of AIC Campton compared to Mr. Law but also on the impact of mol itself on exercise performance gradients symptoms and biomarkers.
As you'll see when the results are presented at ESC, we believe these results May lead to their incorporation into treatment guidelines. It may lead to changes in standard of care treatment, algorithms and obstructive HCM.
We also plan to share other data analyst and analyses of interest that is see including a late breaking clinical trial presentation on the incidents and impact of atrial fibrillation in patients with ocm. We had integrated analysis of Redwood, HCM scoy, ACM and Forest HCM.
Atrial fibrillation has been an emerging topic of conversation around the safety of cardiac myosin inhibitors, but speculation exists as to whether adverse events of atrial fibrillation are disease-specific or treatment-dependent.
As we've previously shared and completed studies of acupuncture, we've observed no difference in the rates of atrial fibrillation between Placebo and athuk Campton. And in the open label extension trial, Forest HCM the incident remains similar to historical data.
We're looking forward to sharing these data that we believe, reinforce a consistent safety profile throughout the Campton and patients with ocm.
At ESC will also have an oral presentation on longer-term. Follow-up of patients, treated with AIC, camped and Forest HCM with up to 3 years of data. Combined together into an updated, integrated safety analysis of the clinical trials program for AIC Campton in ocm inclusive of maple HCM.
In totality we expect the data presented to DC will importantly expand on the safety and longer term effects of eyikan and patients with oacm.
Moving on to non-obstructive HCM, during the quarter, we continued the conduct of Acacia HCM.
Pivotal phase 3, clinical trial of AI Campton in non-obstructive HCM.
As we previously communicated, Acacia completed patient enrollment ahead of schedule earlier this year and, in fact, exceeded our original targets to randomize a total of 516 participants.
During the second quarter, we reviewed the emerging safety data from a K8 CM with the data monitoring committee, which recommended continuing the trial without any changes to the protocol or study conduct.
We expect to be able to share topline results of the primary cohort from a KCM excluding Japan in the first half of 2026.
Speaking of Japan, we recently dosed the first patient in the Japan cohort of the KCM and our partner. Buyer opened to enrollment chamille HCM a phase 3, clinical trial in Japanese patients with obstructive HCM a trial which is intended to support potential marketing authorization in Japan.
CM, which is evaluating at the camps and pediatric obstructive ATM.
The trial remains on track to complete enrollment of its adolescent cohort in the second half of this year.
Finally, in addition to progress in our clinical development programs, during the quarter, our Field Medical Affairs teams engaged with nearly 600 U.S. HCP interactions, including over 200 HCM KOLs.
As well as over 50. European kols.
The team also attended key payer conferences, including the Sambia AMCP and regional AMCP meetings, to actively engage with national and regional payers.
I'll turn it over to Stuart to provide updates on our other late-stage development programs.
Thanks fattie.
First, and we continue startup activities and enrollment accommodate HF. The confirmatory phase 3 clinical trial of Oman. And marble in patients with symptomatic, heart failure. With severely reduced, ejection fraction less than 30%.
During the quarter, our first sites in Europe came online and we continue to expanding site activations in the us both of which are driving progress in enrollment.
We expect to continue enrolling and accommodating CHEF through this year and to complete enrollment in 2026.
Second as we announced in today's press release, we received approval from the in program of the World Health Organization for Ula, Campton to be used as a non-proprietary name for ck5.
During the second quarter, we continue conduct of Amber heft the face to clinical trial of ulekan and patients with symptomatic. Heart failure with preserved, ejection fraction of at least 60%.
Enrollment in the first cohort is progressing and we're pleased by the progress we've made in activating nuclear clinical, trial sites, and an engaging investigators in this important trial.
Overall we're encouraged by the clinical trials, progress of both of these later stage pipeline programs, which represent the next strategic pillar as an advancing. Our specialty Cardiology franchise.
Despite the advances in heart failure care over the years as substantial unmet need persists, across the spectrum of the disease and 1 that we believe are potential. Medicines, may impact
With that, I'll pass it to some.
Thanks Stuart, we're pleased to report our second quarter of 2025 Financial results. Starting with the balance sheet. We finished the second quarter with the approximately 1.04 billion dollars in cash, cash equivalents and Investments compared to 1.09 billion dollars at the end of the first quarter of 2025,
In the second quarter, we exercise our option on the trench for loan provided by royalty Pharma and receive proceeds of 75 million. We have an option to draw 100 million dollars on the tranche 5 loan prior to November 25th of this year.
R&D expenses for the second quarter were $112.6 million compared to $79.6 million for the same period in 2024. The increase was primarily due to advancing our clinical trials, higher personnel-related costs, and medical affairs-related activities.
DNA expenses for the second quarter of 2025 were 65.7 million compared to 50.8 million. For the same period in 2024. The increase was primarily due to Investments toward commercial Readiness and higher Personnel related costs.
Net loss for the second quarter of 2025 was 134.4 Million for our dollar. 12 per share compared to a net loss of 143.3 million for a131 per share for the same period in 2024.
Turning to our financial guidance. We are maintaining our full year 2025 Financial Guidance with gaap operating expense expected to be between 670 million and 710 million.
Stock-based compensation, that is included in gaap. Operating expense, is expected to be between 100 110 million and 120 million.
Excluding stock-based compensation from gaap operating expense results. In a range of 550 million to 600 million.
We've continued to monitor the pace of our commercial Readiness Investments. As we move closer to the Padua date, Rafi, Canton, and we will update you accordingly.
With our current balance sheet and access to additional Capital. We are well positioned to fund the potential launch of aicamp in the US later this year and continue to advance our Pipeline with that. I'll hand it back to Robert. Thank you so much.
2025, I'm pleased with the progress we've made in the position. We are in ahead of a very important, second half of the year.
As we approach a significant inflection point 1 that has been more than 25 years in the making.
Our company stands at the cusp of transformative growth.
This moment reflects the culmination of Decades of scientific innovation, Strategic investment in R&D and a steadfast commitment to delivering potentially meaningful therapies to patients in need.
None of this would be possible without the dedication of our teams across the organization whose tireless work is propelling US towards these long anticipated. Milestones
With a strong Foundation, a Clear Vision, and the right people in place were poised to unlock substantial value for patients and shareholders. Ushering in the next chapter of maturation, as a fully integrated high impact leader in specialty biofarma.
Now, I'll recap our upcoming milestones.
For AIC Campton, we expect to advance NDA review activities with FDA to support the potential us approval of AIC Campton in the second half of this year.
We expect to advance go to market strategies and to continue launch preparations for AIC Campton in the United States. In the second half of this year, we expect to continue. Go to market planning in Germany and expand commercial Readiness activities, throughout Europe in 2025, in preparation for the potential approval, by the EMA, in the first half of 20126,
we expect a coordinate with Santa Fe to support the potential approval of applicants. In China, pending approval by the nmpa
and we expect to present primary results from Maple HCM later this month at ESC,
We expect to report topline results from the primary cohort of Acacia HCM in the first half of 2026, while we continue enrolling the Japan cohort of aesa HCM in 2025.
And we expect to complete enrollment of the Adolescent cohort in Cedar HCM. In the second half of this year.
For ohmic Camp of marble. We expect to continue patient enrollment in Comet, HF throughout 2025 to enable completion of enrollment in 2026.
For Ula Campton, we expect to complete enrollment of the first 2 Patient cohorts in Amber hefta in the second half of this year. And finally for preclinical development and our ongoing research, we expect to continue ongoing pre-clinical development and research activities directed to additional muscle biology focused programs.
Operator with that. We can now open up the call to questions, please.
Thank you. We will now begin the question and answer session if you have dialed in and would like to ask a question. Please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw, your questions, simply press star 1. Again, if you are called upon to ask your question and are listening by a loudspeaker on your device, please speak up your handset and ensure that your phone is not on mute when asking your question, just a reminder, we reminder, we will allow for 1 question per participant and with that our first question comes from the line of Jenna Wong with Barclays. Please go ahead.
Thank you for taking my, hey, uh, thank you for taking my questions. So I have so many okay, but I will limit my question to 1, uh, that's regarding the ESC update. Uh, if you did mention the maple data could be potentially guidelines change. Can you elaborate a little bit like what kind of uh, mechanic you to benefit? Uh, like you are looking for? What are the key data points that we should be focusing on? And
What kind of a magnitude benefit the payer or Physicians are willing to use?
first line or switch, those patient on beta, blocker to Fick, Campton,
So obviously it's difficult to answer your question until you have the data that we have, but I'll ask fatty to do his best.
I can. Yeah, you know, I think the...
Data. This is really the 1 of the few comparative efficacy trials is conducted in cardiology and
um when the data themselves will present a picture, not only of the difference between the 2 but what is you know, the absolute benefit of each of the 2 drugs themselves compared to to Baseline when these patients start the drug
Thought of as, you know, last line of treatment after you fail, everything else. Uh and I think, you know, when we see the data from Maple HCM, uh, that conversation will be Revisited and hopefully as guidelines as well will be updated to reflect. Um, you know, what we have already announced as a superiority of of a happy Campton versus molal and exercise tolerance.
But, you know, I think we'll just have to wait to be able to expand on that 1's the data out.
Thank you, Gina.
And your next question comes from the line of Akash diari with Jeffrey, please. Please go ahead.
Hey thanks so much so hey hey um how's it going? Um, so look it looks increasingly like either. You're going to get the cams out, its Odyssey data at ESC. What are the 2 or 3 things investors should be looking at in that data that would support. You know, the teams hypothesis that Acacia will be successful where can I ask? Wasn't and also would support a clear exposure response relationship in this population. Thank you.
yeah, so I'll take a stab at that and maybe ask that to add
Um, I think it's very important to distinguish between that which is related to clinical trial conduct and that which is related to potential mechanism of action as translates to that patient population.
uh, clearly uh, with Acacia, we um took what we believe to be an optimized dosing regimen that was verified in a phase 2 study and took that into a phase 3 trial where we um
Elected to proceed without altering, a lot of other things, we took a dose optimization regimen. We took a um, population, we focused to centers where we already had experience.
And obviously here at cytokinetics, we have an expert team of HCM experts that have been both academic and uh industry trained. In order to be able to ensure that patients met the criteria, the kinds of things that will be focused on is related to from a study conduct standpoint and operations. Uh how much might there have been a change between the phase 2 and the phase 3 study for mavic Campton and how much might that have read on the outcome in Phase 3 versus
Where we think we've been uh quite uh linear and focused 1 to the next.
Friday, anything you want to add?
I think I just might add that, you know, when you look see, the Odyssey data and we see the Odyssey data, we haven't seen them yet. Uh, you know, the question will be whether the the trials didn't meet its primary end point because of specific features of mavic Campton, or, or file conduct versus, uh, you know, mechanism of action and, um, you know, I think ultimately uh, that is what will provide some confidence in terms of Acacia. Um, potential success. Um, but I think as Robert mentioned, you know, we believe strongly in the case of success, just based on the strength of the phase 2 data, we generated. And the fact that, you know, case is being conducted in a manner that was very consistent with the way we conducted Phase 2.
Thank you, Akash.
And your next question comes from the line of test Romero with JP Morgan. Please go ahead.
Hi, good afternoon, Robert and team. Thanks so much for taking our question.
So what does an ideal label look like for AI? Camped in an obstructive HCM here and Robert can you just double click on?
Any specifics, you can give us on the updated rims that it sounds like you submitted versus the original 1 and how these updates tracked to your expectations for a differentiated rims. Thank you.
Yes, so there's a lot in that question that I cannot unpack given that we are in ongoing conversations with FDA.
but I think what I can say is that an ideal label for Phi Campton is 1 that tracks with its
Uh, engineered properties and the way it's been studied.
Of of our expected profile.
You know, we designed into AFI Campton features that fatty has spoken of often.
And we've studied afy Campton in ways that we believe elaborate on how those features read on benefit risk.
And the data from our Phase 2 and phase 3 studies. And also, as further substantiated in the open label, extension are supportive of what we've argued would be a potential differentiated program.
In the clinical setting for patients, but also for Physicians.
I might ask Andrew our chief commercial officer to speak to how his market research has been pointing to the unmet need and where we believe uh a differentiated label could support our expectations and aspirations
Sure, Robert. So I I think you addressed well, that differentiated label really would reflect the results of the clinical trial and the properties of of eyikan. And in terms of market research, I think what we've seen in our research is if the rims and the label do reflect the properties and the study, that we would be expecting good uptake at the centers of excellence, where most of the prescribing is occurring. Now,
There's already um as I mentioned in my remarks earlier there's a lot of um you know 80% plus of physicians in those centers or aware of that. And so very, very high awareness. Even before we come to Market,
You know, that expansion into Community Cardiology and general Cardiology supported by that differentiation further supported by Maple. Um, that's what we're finding in our market research leading to, uh, a preference here. Even adjusted for overstatement, in, in our market research. So, uh, ultimately we have to wait to see what that label and REM looked like from the FDA, uh, but we're pretty bullish. Given those comments?
Thank you Andrew. Thank you, Tess.
And your next question comes from the line of Salem. Please go ahead.
Hey guys. Uh, good afternoon. Thanks for the question. Um, I guess 1 for us on the ocm late, cycle meeting. So, um, Robert, what exactly are you planning to to learn or discuss in that September late cycle meeting and just can you remind us how much of the Rams negotiation here? Actually happens post the late cycle meeting actually during the the label negotiations themselves. Thank you.
You know Seline very good questions. I'm not sure. I can answer them to your full satisfaction simply because
Um, so much has already been discussed between cytokinetics and FDA. I would hope that come the late cycle meeting were learning that everything we are, uh, assuming continues to be tracking towards potential approval, and that there's nothing new that gets introduced, but as far as the activities that have occurred, we believe we've addressed them, uh, without a lot of, um, difference or distance between what FDA might be interested in and what we could provide, uh, with support of evidence,
case in point the Rems,
Um, FDA and Saito, kinetics convened. A meeting to discuss the Rems promptly after we submitted 1.
and,
Um, the conversation was a very fruitful 1.
We were able to turn around very quickly, uh, revisions that we believed were responsive to fda's interest. And as such, I would hope that at a late cycle meeting, we get validation that we're all good to go. Um, but um,
You know, this is uh, somewhat unchartered territory with regard to a Rems conversation and it may um, be that uh, we learn something new, I hope not. But we're very much in a position where we think we're aligned together with FDA on what it's interested in. And to that point um it was anticipated, very nicely by cytokinetics our colleagues here. Such that when we heard from FDA that they did, in fact want a Rems, we were ready to submit 1 uh, right afterwards.
Uh, I guess in that regard to answer your question at the late cycle meeting, I'd like to learn that we're proceeding to final label conversations and that uh, we're um expecting no other new news.
Okay, got it. Thank you very much.
Thank you.
And your next question comes from the line of Corey Kasimov with Evercore. Isi, please go ahead.
Hello Corey.
Hey Robert, good afternoon. Um, so I wanted to ask go back to Acacia and wondering if you could walk us through how drug interruptions and discontinuation protocols differ versus Odyssey. I guess, I'm particularly curious about how a case should differ from the 4-week dose. Interruption that is necessary. If lvf drops below 50% uh as was the case in Odyssey and maybe you can point out any other significant design differences you would maybe call out between the 2 studies. Thank you.
Yeah, so the design differences are significant. It would appear much like there are design differences in other studies. And again, how um, Acacia is conducted in accordance with that design, May ultimately prove to matter. So, I'll ask fatty to comment now that we have
Uh Odyssey as published in terms of the design. And we know what we're doing with Acacia, I think it's good to highlight some of those distinctions.
Yeah, hi Corey. I think, you know, with regards to um, what happens when lvef, Falls below 50? Um, you know, in in an unobstructed you don't have a left ventricular outflow, tract, gradient, uh, to buffer. You, you know, for that you really I I, I think of what we do in ocm is we're tolerating, a minimum, effective dose, whereas in nhm, you know, we're tolerating the maximum tolerated dose uh which is quite a different concept. Um, and so with es less than 50, you know, it's nice that in with acacia.
You know, primarily as long as the es above 40, uh, patients can just down. Titrate drug. There is no treatment Interruption uh, for an EF below, 40. They do interrupt drug for about a week and they would um, resume drug after that at a lower dose.
The um, so that's a, a substantial difference. I think from Odyssey, where patients have to interrupt drug for 4 weeks and and restart and um you know, leads to a lot of um disruption if you will in in the uh in treatment.
you know another um, aspect of this is that we um
Tested all the doses if you will and in Phase 2, 5 10, 15 and 20 and primarily, uh, the 15 and 20 milligram doses were the ones that were most commonly used.
Um, you know, we know that in Odyssey the um EMS introduced doses of 1 milligram and 2 and a half milligrams, uh, patients could down titrate to those Doses. And you know, ultimately we don't know what the dose density if you will. Um, is in the range that that is known to be is potentially effective. Um, and and and, and and you know, we are testing doses. Where at least we believe we saw meaningful clinical benefits in the phase 2. Um, and as we're trying now to replicate in Phase 3,
So I think you know, with regard to dosing, those are and Es is less than 50. Those are the major differences.
Um,
you know, there are some differences in the entry criteria with regards to thresholds upper limit for Peak BO2 or or NT probnp. Um we you know, we have a group here that is um highly uh knowledgeable about HCM and and and really look at every patient. Echo that came came into the
Study and so, you know, trying to maximize if you will the appropriateness of the patient population. Um, so I think there is a number of differences there. And, you know, ultimately, when we see the Odyssey data, we can uh, ask ourselves how which of them might be impactful in terms of of cases, um, success down the road.
That's very helpful. Appreciate it.
Thanks Corey.
And your next question comes from the line of Yasin rahimi with Piper Sandler, please go ahead.
Question, I guess mine is uh what are your expectations in regards to potential? REM differences between the US and EU and implications of that?
So, uh, understanding that in the EU, there is not the same sort of mechanism for a Rems, it would otherwise be addressed in other means.
um,
I don't think there's going to be altogether. So many differences taking collectively in light of the fact that we conducted an international study.
and the conversations we're having with FDA and EMA are tracking very, similarly,
so,
while there's not a formal Rems um in Europe, we should expect and we are anticipating uh labels that are encompassing from a
Risk mitigation drug drug interaction pharmacology, and otherwise dosing an indication that there's going to be so much more in common than necessarily would be different.
Thank you.
Thank you.
And your next question comes from the line of David libutti with City. Please go ahead.
Hello David. Hi there. Thanks for taking our questions. This is Ike on for David. Lewoods wanted to ask about the larger market opportunity and non-obstructive HCM, which we all know is there presumably, you will need to reach more Community. Doctors is our understanding, um, upon that launched. So thinking about that, how much larger do you think your sales force is going to be? If and when that time comes, thank you.
Yeah. Perhaps I'll ask fatty and and maybe Stewart if he wants to add uh with regard to how nhm is treated and where and then maybe ask Andrew also to add his perspective to that especially as it might ultimately read on the size of our commercial group.
Ya know, you know, nhm is, uh, um, really like the tip of the iceberg, you know? I think we're seeing we see nhm cases, and Clinics. Uh, that are more severe, um, more obvious on echocardiograms and things. Um, but the it's a disease that is difficult to diagnose.
uh, and maybe steuart, I'll ask you to comment on, you know, what are the challenges with recognizing it and why, you know, it might be far more prevalent throughout the community than we recognize
Well, I think as you, uh, commented previously, of course, the non-destructive patients, uh, don't have gradients. And so that's 1 sort of key Criterion. That makes it more difficult to diagnose. Um, and there are, you know, a number of features that, um, make this sort of the HCM patients, sort of appear like,
Patients with heart preserved, ejection fraction.
Um and and so it does take some discrimination.
Um, to identify these patients with that sort of, assuming they're patients with heart failure with preserved ejection fraction.
I think another important factor is, um,
You know, unlike obstructive HCM, where there are some more specific guidance, guidelines, referring to.
Um, available treatments, and we can debate about the evidence base to support those treatments. But there, there there's sort of even more less guidance.
Around treatments and non-obstructive HCM. So, um, it's clear the me, the medical need is even higher and I think that um, maybe Andrew can address that
Sure. So, when you look at
Nhm versus 08cm.
The initial physician Target list won't be any different. So we're not expecting, uh,
To increase our fuel Force at the launch of nhm notifications, positive, and it gets approved, uh, by regulatory authorities.
The way we Target and look at the cardiologist who are engaged in HCM. Um, both diagnosis and treatment is through claims data and ICD 10 codes.
And the Physicians were calling on for ocm treat both nhm and ocm and there's a really large overlap with those. Um, sub Specialties who are Advanced heart failure, uh, cardiologists as well, who treat HCM. So,
The the around 10,000 who are 80% of the HCM diagnosis and treatment is where we're focused.
Will certainly expand Field Force as needed, but at launch, we're not expecting it.
Thank you. And your next question comes from the line of Paul Choi with Goldman Sachs. Please go ahead.
Hi. This is Kalia calling in for Paul. Thank you so much for taking our question, um, since there's been a lot of questions about, um, regulatory interaction, so I guess we'll ask about, um, Afghans and and Commercial suppose, um, given the long, some other launches in cardiology recently, there's been this focus on patient access so we're just curious. Um, whether you had any strategies in place to differentiate against perhaps Zio on patient access, whether that be um you know, uh commercial age patients or medical patients. Um, that would be helpful for us. Thank you so much.
Yeah, this is an area where I think Saito connectex has been laser focused already for quite some time and Andrew and his expert. Uh, Team have been very diligently attending to this from a market development standpoint and what we'll read on AFI Campton. So I'll ask him to come in.
Sure. So, as Robert had mentioned, we've had our account manager, fuel Personnel, talking to payers for quite some time. We've hit um, or have interacted with every major payer
When we look at commercial, we expect to have kind of parity of access in commercial. When we look at Medicare, we expect to have parity in access and Medicare.
so, the really the strategy really is to
Um, have have the same access and really have differentiation and support be the differentiators.
And when you look at patient support, we are designing our patient Support Program. Um, around this patient population and the journey they go through and the support that's needed, including rents.
When you look at the kinds of programs will support, we certainly will have uh for eligible patients. You know, commercial patients will have co-pay assistance or patient assistance programs for those who are uninsured or underinsured. So I think you'll find that the patient support programs the access, the affordability um or really targeted to be at par. Um if not slightly differentiated positively from where Mavs is
The differentiation again is really going to be focused on the clinical data, the rims and the patient experience.
Got it. Thank you very much.
And your next question comes from the line and of Jason Butler with citizens DMP piece ahead.
Hi, thanks for taking the question.
Uh, just I guess an extension of that when, when you think about, um, the expansion into Europe and the commercial work that you're doing there, what can you maybe speak to some of the similarities and differences of of, what needs to be done to get ready for for the European launch?
yeah, so understand our focus is on the US launch but we're taking measured and deliberate steps in Europe to prepare for what would hopefully be a launch in the first half of the year with Focus to Germany and then from there
So Andrew, uh, in leading those activities with colleagues already Velma styled in Europe are looking at this country by country and where reimbursement is going to be ungating of some significant investment but I'll ask him to describe more in detail how we're thinking about this.
So I think the, the the key thing is obvious is it's a country by country launched in Europe, you get, um, EMA for most of Europe, you know, excludes Switzerland in the UK for now, but you get EMA, uh, approval. Um, so you get uniform approval across, um, you know, the majority of the or the European countries and then you have to get reimbursement on a country by country basis. You have free pricing in Germany for 6 months while you're negotiating price. So, that is a key difference, in terms of launched, by launch, and the government is the main payer, you have to go through Health, technology, assessments and, um, assign pricing and reimbursement, and then you launch. So, you know, beyond the regulatory, um, gate, then you have a reimbursement gate. I think the other key difference is, once that reimbursement occurs, they're usually occurring in Focus centers of excellence. Uh hospitals specific Cardiology so it's more narrow.
Fundamentally, in terms of the differentiation in the market from the clinical trial and how we communicate that, you know, once we get that access is, um, that's going to be very similar. But again, on a country-by-country basis, most of our spend...
Does not occur on a country-by-country basis until reimbursement occurs. So, we have gated and we're building Europe slowly, or the US will launch all at once. Hopefully, and end of this year, early next year, Europe will launch really over about 2 to 2 and a half years based on that reimbursement timing.
You know, hopefully we're being good students of how companies have gone to Europe. Some who have done it more successfully, most who have not frankly. And that's where song working with Andrew working with others of our executives are taking a very disciplined deliberate approach to how we think about Europe and doing. So as is informed by de-risking milestones.
Thank you. And your next question comes from the line of James gongylus with Steele. Please go ahead.
Hey thanks so much for taking my question and, and congrats on all the progress. Maybe just a quick 1 on half puff. Just curious, we'll get those data like early next year and and wondering if you can kind of frame out what a win looks like, and kind of in that context, wondering how important you think success in Phase 3 within non-obstructive is um to kind of confirm any initial signals there, just kind of giving both our our driven by diastolic dysfunction. Thanks so much.
Yeah, good questions especially the linkage between what we're doing in nhms. Could read on half path. I'll ask fatty and Stewart, both to comment, please.
Yeah, I mean, I think the discussions we've had around Acacia, um, earlier are a good read on what we think will, um, um, we hope to see in in Amber, um, and they'll ask Stewart maybe to draw the parallels between the 2 conditions. And, um, and what, how we think each, uh, 1 will be reinforcing of the other.
Yeah, thank you for the question. Um, in, you know, as, as vetty mentioned the the non-destructive
Uh, HCM patients, um, do inform potential benefits.
And these patients with heft pests and hyper contractility.
And um, you know, the endpoints that we're evaluating are Phase 2. Amber has a trial that will read on the potential benefit, you know, we're
We evaluating for symptomatic Improvement. Looking at uh endpoints like kccq uh nyha class looking for improved. So improvements in symptoms cardiac biomarkers again he probably and P.
And troponin.
and, uh, you know, of course, um,
Evaluating Echo cardiographic parameters. Um looking for potential benefits in terms of diastolic function. Um, these will all contribute to the profile of potential benefits that will inform whether we progress to phase 3 and um, and you know, identifying, um, dose or doses, uh, that will result in a favorable benefit risk profile. So, um,
again we're we're encouraged by what we observe with non-obstructive HCM and the benefit uh with with the benefits of that to camp in and the phase 2 Redwood trial and the ongoing
Cohort that's been evaluated in forest.
Our open label extension. Um, so those are some of the key, um, findings that we'll be looking for, as well, you know, as, as well as safety and tolerability.
Thanks.
Thank you, and your next question.
Your next question comes from the line. If any team with RBC Capital markets, please go ahead.
Hey thanks. Uh, thanks for taking my question. Um, I just want to ask, um, as you, you know, approach commercialization, how you thinking about the message that you're going to lead with, in HCM? I guess what I'm getting at is, you know, what do you think really drives physician and patient enthusiasm to use the drug and is it, is it gradient? Which is readily checkable? Is it? Systemic benefits? Is it cardiac function? You have a lot of data across a lot of these endpoints and obviously potential convenience advantages. I guess. What's the messaging that you're going to lead with to try to drive you? Thanks.
Rather instead you should expect us to want to see the label and ultimately will be promoting to label in ways that we think will be to the advantage of adoption of AI Campton.
but as we've discussed in the way that we've designed AI Campton and the way, um, we've studied it, we do believe there's high levels of differentiation
And it would be reasonable for this being a next uh cardiac myosin inhibitor for us to want to be focused on. How might we be able to grow the category and grow preferential, share of the category for the benefit of more patients, more Physicians comfortable with cardiac myosin inhibitors.
so maybe with that, as a bit of a backdrop, I'll ask Andrew if there's anything further he might want to add
yeah, I mean to your point we're not going to get into what the
Our our messaging is. But generally once the products approved, by the FDA, the Physicians really want to understand and lead with the efficacy component, um, the the balance of safety relative to that efficacy. And then in this instance, then uh, the rims. So we'll communicate clearly the differentiation. We believe we have differentiation in each of those areas, um, as well as a very, very different cated positioning, but you'll have to wait until we get our
Our lawn can approval and our label, um, until that kind of gets unveiled.
Thanks for the question.
All right, thank you. And your next question comes from the line of Creeper condo with true security. Please go ahead.
Hi. This is Alex on for crypto.
Given that we might see approval in China at the First Market. Can you remind us of dynamics of the China market and, uh, what type of cadence of Revenue we can expect, um, in the upcoming quarters? Thanks
Yeah, so this is somewhat of an uncommon situation, isn't it? That we might could expect an approval in China even before an approval in the United States?
It's not without precedent but they are few and far between
With that said, we are working with Santa Fe, our partner, and maybe I'll ask Andrew, who's one of the leaders of that collaboration, to speak to your question.
You asked about Market sizing and and revenue. So,
is that right?
Yes, and the rate, uh, that we can expect adoption in the market.
so, um, you know, like the US China would be at the camp and would be second to Market um like um,
Kind of like Europe. You need to get ennard listing, you know, National reimbursed drug listing in China um that you that has on an annual basis and you have to file uh by the end of June of a given year to have reimbursement, the following January. So likely the first period of time, reimbursement would be through cash paying Market uh versus say, ma having ennard. So I I would imagine that. Um,
The uptake would be flow at start, but it's a large Market. As you can imagine.
There's 3 over 350,000 patients who are very concentrated into about 1,300 hospitals. Obviously, we have a very sophisticated multinational partner who knows that market extremely well. So I won't comment on the phasing, but I would only say that once reimbursement occurs, I would expect an acceleration, you know, following that National Drug reimbursement. Hopefully, that answers your question.
Yeah, thanks and congrats on the progress.
Thank you.
And your next question comes from the line of Joe Pinis with HC Wayne Wright. Please go ahead.
Hey everybody. Good afternoon. Thanks for taking the question. Um, first I guess maybe for Andrew, it's as you're preparing with all your broad commercial, uh, preparations. Um, what do you feel are some of the components that you're required to do, but won't necessarily need, uh, but needed to go through the motions depending on how a potential Rems may or may not play out and secondly, um, potential, uh, for Stuart, um, you know, as you're looking at Comet with the company's broad, very broad experience with long term. How would you characterize? The, um, site excitement with regard to enrollment versus all the other row, campus studies. Thanks.
So the the first question was a complicated when I'm trying to make sure? I understand it. Joe your your question is the kinds of things we prepared for that. We might not need to do. Is that what I heard, correct? You know, based on how Rams may or may not play out?
Yeah. So, you know, we're
We're pretty clear-minded on how this is evolving. And then frankly it's
Quite um aligned to the 3 meetings. We have with FDA even before we submitted the NBA although you'll remember, we did not submit originally with a Rems.
we had already anticipated, what we thought mattered to FDA and we incorporated that into label
And then FDA indicated it would. In fact, like to see a Rems. So we were already prepared to um, execute on that in the form of a rims.
So, I don't know that. Um, there's much, uh, in the way of distance between what we expected and where we're at such that we had to prepare something that may not be relevant.
Um, I think we've got a pretty a good idea as to where this is going.
With respect to your next question. Uh, maybe I'll ask Stuart to comment on the level of investigator interest in comment.
Yeah, thank you. Uh bottom line is, there's a lot of interest in Comet and uh we're very pleased to see that and for several reasons, you know, 1 is recognition of the very high need uh in these patients with heart failure and severely reduced ejection fractions. They really
They really don't have medical options before, you know, uh, on the road to end-stage heart failure. So, they recognize that I'm a cancer marvel is a potential medical option to stave off that outcome.
Um, second, they're very well aware of the results of Galactic, uh, which of course, was a positive trial, and in the subgroup of patients, we're targeting now, in Comet, you know the treatment benefit was, uh, of large magnitude, uh, risk reduction for, you know, the heart failure outcome. So there's appreciation that, um,
You know, because of the large sample size of the subgroup of patients,
Um and the results we observed in Galactic, you know, there's a high probability of success.
And third, I think they're very pleased to see. We're running a very, um, streamlined trial, um, without much burden on investigators and their staff. And so, um, operationally, it's going to be an easier trial to conduct.
So overall, a lot of enthusiasm for comment.
Great. Appreciate the clarification in color, guys.
Thank you, Joe.
And your next question comes from the line of Jason zemansky with Bank of America. Please go ahead.
Hi, good afternoon. This is Jackie on for Jason. Um, thanks for taking your question and congrats on the progress. Um, so now that you've seen uh, more of the maple data, can you comment on your expectations for first line use? How receptive do you think prescribers and pairs are like B2B and how long do you think they'll take before? Uh, there can be appreciable uptake, um, in this part of the market,
Sure. So I'll start and I think fatty and Andrew can both respond from their respective, um, viewpoints.
what I will say is that
um,
we conducted a study head-to-head of AIC, Campton versus metoprolol.
And I do believe it'll raise some eyebrows as to what is currently guideline directed first line therapy.
But maybe that shouldn't be too surprising in retrospect because
Uh, those guidelines were written absent.
A randomized control study of metoprolol in this population. So this is building of a body of evidence that didn't exist before.
And for having done that, we do believe that aicamp and you'll understand maybe why we believe this after you see the results.
Should be part of the conversation about um what medicines to reach for in what order uh, for the treatment of these patients.
Now, granted my Toprol law.
Is a generic drug and there's ample experience with beta blockers.
But I do believe in cytokinetics.
um,
To inform guidelines and the guidelines uh will hopefully take into consideration the way in which the study was robustly conducted and the Fidelity of the results.
With that, I'll ask.
um, fatty to speak to that and maybe uh Andrew if he wants to, also comment on how that might ultimately get reflected and, over what time frame and guidelines, and how that may have formed uh adoption
yeah, I mean I think you know it's going to take a while before um, beta blockers are displaced as first line treatment, give them the cost differential, but I think
Say say like Maple HCM will facilitate uh earlier movements uh and hopefully Elevate AIC Campton in the guidelines. So it's not seen as the last
Um, you know, the last line of therapy before surgery potentially, but, uh, instead is, you know, seen on par with the other therapies that physicians can consider. Uh, and so, you know, if the patients are, uh, only modestly improved, you know, they know that they have an alternative that they can move to more quickly.
And with longer time, we hope to be able to develop evidence that there are things Beyond just symptom and function relief that happy camps and addresses that other therapies. Don't given Happy Camp and targets, you know? The underlying pathophysiology
Disease.
So with that uh we someday may be able to show that, you know, we reduce the progression of disease and then it becomes I think a much more important question as to which therapy to start. So this is the beginning, I think of a uh sort of a longer
Um, longer run in terms of of changing the standard of care in this.
In this disease.
Yeah, I would think that and our expectation is launched in the first several years after launch that first line therapy is likely not going to occur. Um, mainly because of payers and um you know, Robert mentioned beta blockers obviously are generic but we we do expect to occur is you know, more patients being on a um at the camp and then would have been otherwise without Maple. We expect the acceleration of an add-on of AIC Campton to a beta blocker and maybe weaning off a beta blocker after the start over time. So I think those are the kinds of things, you'll see for the first several years. Um, if guidelines are updated and um at the campus, as part of first line therapy,
Then, with broader youth, we could see uh, first line therapy but again, I think that's um, you know, several years out.
Thanks for the question. I think.
Your next question comes from the line. My young montani with B Riley Securities. Please go ahead.
Uh, thanks for taking our questions. This is William on for my young
Um, I just wanted to Circle back to Acacia. Uh, today, you've mainly focus on sort of the Odyssey and the phase 2 to say, 3 transitional on how that supports, uh, potential positive results, uh, when that reads out next year, but I was also curious how new data, um, from the maple study. Also, you know, from past Sequoia how those May uh that new data May support Acacia and what specifically uh you know, specific endpoints.
You may, you know, specifically can highlight that may support those claims. And then also just in terms of rams, um, how should we think about the Rams in uh, lcms wanted to read through to non-obstructive HCM? Would we should we think that those would be relatively the same or potentially uh differentiating. Uh, just based on profiles. Thank you.
Yeah, so you're asking us to speculate on some things that are pretty far down the road, and
obviously, we can't be, uh,
Considering claims.
But you know, the MAPLE study was conducted in a population of OHCM.
Where, uh, echoes are very informative to how one approaches dose titration, acacius.
uh, conducted absent that in a very different population. So,
um, I'll ask fatty and Stewart to comment, but I can already uh suggest that
We don't think that there's going to be a lot of translation from 1 to the other.
Buddy.
That might inform aaca uh and you know we've already published data from Sequoia that that look at how epic camped and improved diastolic function, you know, relaxation of the heart which is probably the primary mode by which, um, patients with nhdm Will.
Receive um, treatment benefit since they don't have a, a gradient to reduce and, you know, similarly, you'll see data presented on diastolic function in Maple, um, at the ESC that's part of the, uh, late breaker that I described earlier. And so, I think both of these data sets will inform
The fact that there is a meaningful pharmacological effect that, you know, we believe impacts the functioning of the heart in NHM. So I think both of those studies are supportive, and those analyses are supportive of a potential success.
Um, and that's the other questions. I agree. It's kind of a little too early to speculate on on those um, you know, labeling or rims, things like that.
I don't know if there's anything you'd like to add Stuart.
Well, the only thing I'll add uh is the safety tolerability profile, we've observed and obstructed HCM.
Um, in Sequoia and um, that would be the fact that you have. The captain is a drug with a shallow exposure response profile.
You know, relatively short half-life.
And um, you know, very quite um stable uh, PK profile. Uh I I think all that contributes to what we observe in the instructor today. And in terms of its
Tolerability and um you know expectation that will carry through to non-obstructive HCM.
you know, you didn't ask this but I'll add um,
In our Phase 2, Redwood cohort 4. We saw very large magnitude effect changes.
Um, that give us confidence.
Uh that if that translates in Phase 3, we should anticipate a good outcome for Acacia HCM but also and please don't lose sight of the fact that those patients roll over into Forest.
And Forest is an open-label study.
And later this year, you'll have a chance to see what we're already seeing in patients, who rolled into forest with NHC. And that gives us confidence in what we can expect from Acacia next year.
So, we remain quite optimistic about Acacia.
Appreciate that. You
All right, thank you. And your next question comes from the line of search, been with nitam and Company. Please go ahead.
Hi, good afternoon. This is John. I'm for search today. Thanks for uh squeezing. My question uh just want to touch back on uh with me campus in the comment trial seems like he has been getting some some positive feedback from invest investigators in cosas. Um just wanted to gauge uh kind of how enrollments tracking uh relative to your internal expectations uh as you're on your way to to completing enrollment next year. Thanks.
Stuart, you want to take that?
Sure. Yeah, that as we sort of indicated in our, um, you know, when the call today and a press release, you know, the accommodation trial enrollment is on track. Uh, we can we, we plan to, you know, this is an 1800 patient trial, uh, less than a fourth of the size of Galactic. So, uh, that's certainly makes it easy.
Easier in terms of the operational scope um however they have this is a more severe patient population so um we are targeting a smaller subgroup of patients with heft. Having said that, you know, the plan is still uh um to complete enrollment by the end of next year.
Um, we have sight activations, most of them, uh, complete in the US. And uh, we're on track for Sight activations in Europe as well. So,
Um, things are going according to plan.
You know, it's important to note with this study is it's not competing.
Um with a bunch of other studies for the same population. This is a population that we don't believe is well served by existing standard of care or other investigational treatments and instead,
We're building off of body of evidence where we've already seen in galactic.
Trial, so that's contributing We Believe to momentum for the study.
All right, thank you. And your next question comes from the line of marijuana Reese with living Partners. Please go ahead.
Uh, yep. Thank you. Uh, this is ma on for ruana. Uh, just wonderful obviously. Um, so from a cardiac myosin biology perspective as you advance AI Camp, dance and more of the HCM phenotypes and develop uh you looking at them for heft
With this distinct mechanism.
Can you just discuss the key differentiating factors and how these myosin Inhibitors differ in how they interact with cell from your function?
Sure, nobody better than Fady Malik to answer that question.
Well, so it's it's really interesting. You know, when we look at uh, the myosin motor protein, um, after 20 plus years, we've now identified 3 distinct, uh, binding sites for small molecule modulators of the protein at the camp and binds in 1 Place uh, omican mcarbo and mavic camps in bind in another place.
and uh, lastly the um,
Um, um, CK5 A6. Are you, uh, confident in, uh, finding a third place? Uh, and each of them has.
Distinct effects of um, on how they impact motor function in the sarcomere. You know you can that you can describe I won't really go into, you know, the the details and specifics here. Um but those differences uh I think as we may be seeing in in the clinic uh lead to differences in their profiles.
And you know, I think it's still a little early to know exactly how they differ and and which 1 maybe preferred. Um, but you know, there are I think differences that are emerging, you know, ULU Camp to ULU camp and we see um potentially a, a more shallow uh decrease and and ejection fraction and more shallow pkpd curve than even AI Campton. Um,
And uh um you know we think the reversibility of both compounds is is not just a feature of the compound itself but also potentially you know the mechanism of where they bind. So I'd say stay tuned and I hope to uh,
I'm they write a paper that describes all the various different biology and how it links to clinical.
Thank you so much.
Good question.
And your next question comes from the line of Ash BMA with ubsd. Go ahead.
Oh hi. Yeah. Thanks, uh, for taking my question. Um, I wanted to ask, like, uh, it's like a meeting pushed out from June to September.
Uh, is that the result of your prior 3 monthly for extension? Or is this a separate development which can now have a cascading effect on with the new for date? Uh, what kind of understand is like, does this September late cycle meeting, give FBA, you know, for for now finish up the wrap up, activities on the review. Um, before the deadline
Thanks.
Yes. So as, as we said in the scripted comments, uh, we believe that the shift in the late cycle, meeting is consistent with the Padua date extension, and we don't have any reason to think that there's anything else here. And, uh, we believe that based on interactions, we've been having in the meantime with FDA that, uh, we should consider still, um, this as a hopeful approval consistent with Padua date. No reason to believe otherwise,
Thanks.
Thank you.
And I'm showing no further questions at this time. I would like to turn it back to the president and CEO Robert Blum for closing remarks.
Thank you operator. And thanks to all the participants on our call today. We appreciate your continued support, we appreciate your continued interest in socinet, Lots going on and we think this mid year uh check-in is indicative of why we continue to be quite ambitious and hopeful and planning for success with uh what we hope will be our first medicine to be a potentially approved later this year and all that goes with it. With that operator, we can conclude the call. Thanks very much.
There is a ladies and gentlemen, this concludes today's conference call. Thank you all for joining you may now disconnect