Q2 2021 Cytokinetics Inc Earnings Call

[music].

Good afternoon, and welcome ladies and gentlemen, <unk> second quarter 2021 conference call.

Operator: Cytokinetic's second quarter 2012 conference call. At this time, I'd like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company's request, we will open the call for questions and answers after the presentation, and we will allow for up to two questions per participant. I'll now turn the call over to Diane Weiser, cytokinetics, Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.

At this time I'd like to inform you that this call is being recorded and that all participants are in a listen only mode.

At the company's request, we will open the call for questions and answers. After the presentation, we will allow for up to 2 questions per participant.

Ill now turn the call over to Diane Weiser Cytogenetics Senior Vice President of corporate Communications and Investor Relations. Please go ahead.

Diane Weiser: Good afternoon, and thank you everyone for joining us on the call today. Robert Blum, our president and chief executive officer, will begin with an overview of the quarter and recent developments. Ben, Fatty Malik, our EVP of Research and Development, will provide an update on Omicampden Macarbal, including the secondary analyses from Galactic HF, our positive phase three clinical trial of Oma Campta Macarble, as well as recent interactions and next steps with the FDA.

Good afternoon, and thanks, everyone for joining us on the call today, Robert Blum, our President and Chief Executive Officer will begin with an overview of the quarter and recent developments then <unk> Malik our EVP of research and development will provide an update on on the Camden mccarville, including the secondary analyses from Galactic <unk>.

Our positive phase III clinical trial of <unk> as well as the recent interactions and next steps with the F. D. A next Andrew Carlos our EVP and Chief Commercial officer will provide an update on progress towards our go to market strategy for on <unk> and how those plans intersect with our franchise development strategies.

Diane Weiser: Next, Andrew Callos, our EVP and Chief Commercial Officer, will provide an update on progress towards our go-to-market strategy for Omicampton McCarble and how those plans intersect with our franchise development strategies and our future plans for the commercialization of Affi-Campton or CK274.

And our future plan for the commercialization of epic Camden or CK 274, then Stuart Kupfer, our SVP and Chief Medical Officer will provide an update on our development program per FTE Camden with focus to recently announced results from Redwood HCM, our positive phase II clinical trial next Robert 1.

Robert I. Blum: Then, Stuart Kupfer, our SVP and Chief Medical Officer, will provide an update on our development program for Affey-Campton with focus on the recently announced results from Redwood-H-CM, our positive phase two clinical trial. Next, Robert Wong, our VP and Chief Accounting Officer, will provide a financial overview for the past quarter, and Ching Da, our SVP and Chief Financial Officer, will discuss our financial outlook and corporate development strategies before Robert Blum will return to provide concluding thoughts and expected milestones for the remainder of 2021.

On our VP and Chief Accounting Officer will provide a financial overview for the past quarter and Ching jaw, our SVP and Chief Financial Officer will discuss our financial outlook and corporate development strategies before Robert Blum overturned to provide concluding thoughts and expected milestones for the remainder of 2021. Please note the poor.

Robert I. Blum: 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 in these forward-looking statements is contained in our SEC filings, including our current report regarding our second quarter 2021 financial results filed on Form Form 8. We undertake no obligation to update any forward-looking statements after the, and now I will turn the call over to Robert.

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 <unk>.

Differ materially from those in these forward looking statements is contained in our SEC filings, including our current report regarding our second quarter 2021 financial results filed on form 8-K, we undertake no obligation to update any forward looking statements. After this call and now I will turn the call over to Robert.

You Dianne and thanks to everyone for joining us on the call today.

Robert I. Blum: Thank you, Diane, thanks to everyone for joining us on the call today. We had a productive second quarter, which has continued with intensity more recently, as we've delivered against multiple milestones across our cardiovascular and also our neuromuscular development programs. In the past few quarters, we've made tremendous progress on the clinical development front, punctuated by positive phase three results from Galactic, positive phase two results from Redwood HCM, completion of enrollment in Meteoric HF, and initiation of Courage ALS, the phase three clinical trial of REL deceptive in patients with ALS.

We had a productive second quarter, which has continued with intensity more recently.

We've delivered against multiple milestones across our cardiovascular and also our neuromuscular development programs.

In the past few quarters, we've made tremendous progress on the clinical development front punctuated by positive phase III results from Galactic positive phase 2 results from Redwood HCM completion of enrollment in meteoric HFF and initiation of courage unless the phase III clinical.

Trial of relative <unk> in patients with ALS.

Looking forward, we're preparing for our first NDA submission and executing well against commercial readiness objectives. While also advancing 3 distinct late stage development programs all expected to be in phase III clinical trials by the fourth quarter.

This is an extraordinary achievement for any company much less 1 of our size, but it is a testament to our focus our innovation our resilience, our resourcefulness and our disciplined strategic corporate development.

Robert I. Blum: Looking forward, we're preparing for our first NDA submission and executing well against commercial readiness objectives while also advancing three distinct late-stage development programs, all expected to be in phase three clinical trials by the fourth quarter. This is an extraordinary achievement for any company, much less one of our size, but it's a testament to our focus, our innovation, our resilience, our resourcefulness, and our disciplined strategic corporate development. Importantly, progress across our pipeline also catalyzed our recent equity offering, which fortified our balance sheet and is expected at year end to have us with over $600 million.

Importantly progress across our pipeline also catalyzed our recent equity offering which fortified our balance sheet and which is expected at year end to have us with over $600 million.

This will ensure a strong financial position as we pass through key milestones in building, a sustainable and durable business anchored in our industry, leading muscle biology focused on.

The study will elaborate new analyses from Galactic HFF reinforce previous results, which reinforce that patients with higher risk factors underscoring more severe heart failure derived greater treatment benefit from <unk> when added to standard of care and the AGA.

Well for a defined clearly identifiable target patient population. These patients remain amongst the toughest to treat despite the availability of guideline directed medical therapy and based on continued feedback from the healthcare professional community, we believe only kempton.

Robert I. Blum: This will ensure a strong financial position as we pass through key milestones in building a sustainable and durable business anchored in our industry-leading muscle biology focus. As Fatti will elaborate, new analyses from Galactic HF reinforce previous results, which show that patients with higher risk factors, underscoring more severe heart failure, derived greater treatment benefit from Omicamp to Macarbal when added to standard of care, and they augur well for a defined, clearly identifiable, target patient population. These patients remain amongst the toughest to treat despite the availability of guideline-directed medical therapy.

<unk> may fill an unmet need in the treatment armamentarium.

As Youll hear more in recent months, we've conducted several additional interactions with FDA towards our goal of submitting an NDA for <unk> in the second half of the year.

And concurrently under Andrew's leadership, our commercialization strategy is also taking further shape.

We have active work streams progressing across every element of our go to market strategy, including product positioning market research value proposition development market access and manufacturing and other logistics scale up.

Robert I. Blum: And based on continued feedback from the healthcare professional community, we believe Omicampton McCarble may fill an unmet need in the treatment arsenal. As you'll hear more in the coming months, we've conducted several additional interactions with FDA towards our goal of submitting an NDA for Omicamp to Macarbel in this second half of the year. And concurrently, under Andrew's leadership, our commercialization strategy is also taking further shape. We have active work streams progressing across every element of our go-to-market strategy, including product positioning, market research, value proposition development, market access, and manufacturing and other logistics scale up.

Turning to another underserved cardiovascular patient population, we were pleased to share top line results of Redwood HCM, which met our high expectations for this dose ranging trial and our next in class objectives.

As pioneers in the science of modulating cardiac myosin, it's rewarding to see that the physiochemical properties that we prioritized and optimizing <unk> are translating into clinically meaningful results for patients.

With positive results from Redwood HCM now in hand, we have received constructive FDA feedback from our recent type C and end of phase II interactions supportive of progression into our phase III trial intended to get underway in the fourth quarter of 2021.

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With enthusiastic clinical trial sites across North America, and Europe, We anticipate high interest for enrollment and we will provide updates as the trial gets underway.

Robert I. Blum: Turning to another underserved cardiovascular patient population, we were pleased to share top-line results of Redwood HCM, which met our high expectations for this dose-ranging trial and our next-in-class objective. As pioneers in the science of modulating cardiac myosin, it's rewarding to see that the physiochemical properties that we prioritized in optimizing Afficampton are translating into clinically meaningful results for patients. With positive results from Redwood HCM now in hand, we have received constructive FDA feedback from our recent Type C and end of Phase 2 interactions supportive of progression into our phase 3 trial intended to get underway in the fourth quarter of 2021.

And finally with clarity on our submission strategy for <unk> as well as positive results from Redwood HCM supporting a phase III trial, and a reinforced balance sheet earlier. This week, we announced the start of courage ALS, our phase III clinical trial of rail deceptive.

In patients with ALS and as a reminder, under the terms of our amended collaboration agreement with Astellas subtle kinetics now controls development and commercialization of relative <unk> and Astellas will contribute $12 million toward the conduct of this trial.

We feel fortunate to be at a major turning point in our corporate development. The promise of modulating contractile proteins that drive muscle contractility is being realized with our positive clinical trial programs and we're grateful to our shareholders for continuing to believe in the potential of <unk>.

This platform so that we may deliver to patients first in class and next in class drug candidates that may improve their health span and also overall quality of life.

Robert I. Blum: With enthusiastic clinical trial sites across North America and Europe, we anticipate high interest for enrollment, and will provide updates as the trial gets underway. And finally, with clarity on a submission strategy for Omicamp of McCarble, as well as positive results from Redwood HCM supporting a phase three trial and a reinforced balance sheet, earlier this week we announced the start of Courage ALS, our Phase 3 clinical trial of Rel deceptive in patients with ALS.

And with that I'll turn the call over to <unk> to elaborate on recent developments related to <unk>.

Thanks, Robert as you mentioned results from additional analyses of Galactic HFF presented during the quarter at heart failure 2021, and International Congress of the European Society of Cardiology continue to build upon previous results underscoring that patients with markers of more severe heart failure.

Or a greater risk drive greater clinical benefit from treatment with them a captive mccarville when added to standard of care spin.

Specifically results of analyses on patients with higher baseline NT <unk> and patients with severe heart failure based on modified criteria from the heart failure Association of the European Society of Cardiology advanced heart failure position statement or presented.

Robert I. Blum: And as a reminder, under the terms of our amended collaboration agreement with Estellus, Cytokinetics now controls the development and commercialization of RELDES, and Estellus will contribute $12 million toward the conduct of this trial. We feel fortunate to be at a major turning point in our corporate development.

Despite the availability of an adherence to guideline directed medical therapy, many patients with severe heart failure remain at high risk for significant clinical events and based on these data on the Camden Mccarville may offer a new treatment option for more severe heart failure patients from maxed out on standard of care.

And still in and out of hospital.

Robert I. Blum: The promise of modulating contractile proteins that drive muscle contractility is being realized with our positive clinical trial programs, and we're grateful to our shareholders for continuing to believe in the potential of this platform so that we may deliver to patients first in class and next in class drug candidates that may improve their health span and also their overall quality of life. And with that, I'll turn the call over to Fadi to elaborate on recent developments related to Omicamp of Macarbo. Thanks, Robert.

As I've said before these results align well with the mechanism of action of OMA captive mccarville insofar as its ability to improve cardiac function and performance appears to impact the outcomes in patients who present with signs that their cardiac function is particularly limiting.

It's been affirming and encouraging to hear key opinion leaders share this perspective, especially given that the greatest need exists among those patients for which the benefits of OMA captive mccarville are most concentrated.

Specifically, we've heard that the results lend themselves to an opportunity to highlight a clear population of patients who may benefit from potential treatment with Mckesson mccarville.

Many physicians with whom we've engaged point out that options are limited in these patients and if approved on mechanics of Mccarville may provide a key addition to existing standard of care given its mode of action and lack of adverse impact on hemodynamics or kidney function.

Fady Ibraham Malik: As you mentioned, results from additional analyses of Galactic HF presented during the quarter at Heart Failure 2021, an international Congress of the European Society of Cardiology, continue to build upon previous results underscoring that patients with markers of more severe heart failure who are at greater risk derive greater clinical benefit from treatment with Omicamp to Macarble when added to standard of care. Specifically, results of analyses in patients with higher baseline NT ProbNP and patients with severe heart failure based on modified criteria from the Heart Failure Association of the European Society of Cardiology, or the Advanced Heart Failure Position Statement are presented.

Okay.

Meteoric HFF the second phase III clinical trial of him and Camden <unk> aims to expand on the nature of benefit by potentially demonstrating that a drug candidate that improves the solid function may enable patients to improve exercise capacity and stamina, allowing them to do more of the things they enjoy every day.

During the second quarter, we completed enrollment in meteoric HFF. Despite the headwinds of the pandemic and expect to complete its conduct by year end, which would enable reporting results in early 2022.

Now onto the regulatory front since.

Since the beginning of the year, we've participated in 3 productive meetings with FDA, including a top line meeting to review and gained feedback on initial results from Galactic HFF a type C meeting to elaborate on key aspects of results from Galactic HFF and the use of OMA captive mccarville informing our approach to it.

Fady Ibraham Malik: Despite the availability of and adherence to guideline-directed medical therapy, many patients with severe heart failure remain at high risk for significant clinical events. And based on these data, Omicampson McCarbo may offer a new treatment option for more severe heart failure patients who are maxed out on standard of care and still in and out of hospitals. As I said before, these results align well with the mechanism of action of Omicamp to Macarbal, insofar as its ability to improve cardiac function and performance appears to impact outcomes in patients who present with signs that their cardiac function is particularly limiting.

NDA submission.

In a pre NDA meeting to review results, rather review details of the submission, including such things as specifics of its content and the format of datasets.

Together these meetings have been engaging in constructive and have met our objectives to inform the content and format of our NDA submission.

We remain on track as we continue to work towards the submission of our NDA in the second half of this year based on the results of Galactic HFF in combination with the rest of the development program comprising over 30 clinical trials and informed by our long standing regulatory discussions.

Okay.

In parallel we're also discussing with FDA, our strategy to enable personalized dose optimization and patients being treated with <unk> to be available at the time of potential approval and utilizing the most robust technology and a centralized approach to collect and process samples as well as to make pace.

Fady Ibraham Malik: It's been affirming and encouraging to hear key opinion leaders share this perspective, especially given that the greatest need exists among those patients for which the benefits of Omicamp of Macarbal are most concentrated. Specifically, we heard that the results lend themselves to an opportunity to highlight a clear population of patients who may benefit from potential treatment with Omecancer-McCarwell. The many physicians with whom we've engaged point out that options are limited in these patients, and if approved, Omicampanacarbo may provide a key addition to existing standards of care, given its mode of action and lack of adverse impact on hemodynamics or kidney functions.

<unk> data available to physicians.

We look forward to elaborating on this strategy for optimized optimal personalized dosing in the future.

As we move closer to our goal of submitting our NDA to the FDA for the potential approval of on campus and mccarville, our growing team of medical Science liaisons are working to educate hospital based and community cardiologists on the challenge of impaired contractility in patients with heart failure with reduced ejection fractions.

And we remain committed to helping physicians increased our understanding of the sarcomere in cardiac muscle function.

Additionally, we've made progress on development of a framework for an investigator sponsored study program that we expect to further elucidate the.

The potential of <unk> within the treatment armamentarium.

And with that I'll turn the call over to Andrew to elaborate on progress against the go to market strategy from a captive mccarville.

Fady Ibraham Malik: Meteoric, the second phase three clinical trial of Omecamptumacarble, aims to expand on the nature of benefit by potentially demonstrating that a drug candidate that improves solid function may enable patients to improve exercise capacity and stamina, allowing them to do more of the things they enjoy every day. During the second quarter, we completed enrollment in Meteoric HF, despite the headwinds of the pandemic, and expect to complete its conduct by year end, which would enable reporting of results in early 2022. Now onto the regulatory front.

Thanks, Patty during the second quarter, our board of directors endorsed our proposal to go to market strategy from a captive mccarville and since then we have proceeded and its implementation as we prepare for potential commercial launch in 2022.

We plan to present, a deep dive into the strategy.

Intersect with our cardiac muscle franchise strategy and planning for the commercial launch of Epic campaign, and an Investor day later this year, but today I will share a few highlights on our progress.

From an organizational development perspective. In addition to the stellar team I joined we're expanding the commercial organization at all levels with key hires in marketing health economics outcomes research analytics supply chain logistics and market access and the day.

Fady Ibraham Malik: Since the beginning of the year, we've participated in three productive meetings with FDA, including a top line meeting to review and gain feedback on initial results from Galactic HF, a type C meeting to elaborate on key aspects of results from Galactic HF and the use of Omicampton McCarble informing our approach to an NDA submission, and a pre-MBA meeting to review results, rather than review details of the submission, including such things as Together, these meetings have been engaging and constructive and have met our objectives to inform the content and format of our NDA submission.

I anticipate having the full leadership team in place by the end of the summer.

As you heard from <unk> the results of the Galactic ETF and the secondary analyses provide clarity around on a subset of heart failure patients and with the benefit of OMA captive mccarville are most concentrated that is those with an ejection fraction less than 30 or who can no longer tolerate guideline direct.

Medical therapy, due to renal or blood pressure impairment, although was recently hospitalized.

Those patients likely to derive the most benefit from OMA captive mccarville represent 50% approximately 50% of all heart failure with reduced ejection fraction patients and.

In addition, our market research has confirmed confirmed that.

They are managed by fewer than 30% of total cardiologist and fewer than 15% of total hospitals in the U S. Net treat the majority of the use of your strength.

Fady Ibraham Malik: We remain on track as we continue to work towards the submission of our NDA in the second half of this year, based on the results of Galactic HF in combination with the rest of the development program, comprising over 30 clinical trials and informed by our longstanding regulatory discussions. In parallel, we're also discussing with FDA our strategy to enable personalized dose optimization in patients being treated with Omicamp to Macarbal, to be available at the time of potential approval and utilizing the most robust technology and a centralized approach to collect and process samples, as well as to make patient data available to physicians.

Okay.

Targeting this will define intractable subset of cardiologists on hospital also enables us to effectively launch with a modest sized specialty cardiology field force.

Notably there was also a significant overlap between heart failure and EQM directed accounts, specifically there are approximately 1100 high value hospitals and centers of excellence training both patient populations. So the cardiac muscle directed field force we are building today.

Its purpose driven to leverage infrastructure and relationships, we established and support a moment on the captive mccarville for App attempt in 2 to 3 years puts.

Put simply we expect that our reps will have another product in their bag without need to build an independent field force.

Furthermore, we recognize and appreciate the hard cost burden of heart failure as it represents the most common hospital admission diagnosis for Medicare hospitalizations, and Readmissions are considerably higher among patients with lower ejection fraction.

Fady Ibraham Malik: We look forward to elaborating on the strategy for optimal personalized dosing in the future. As we move closer to our goal of submitting our NDA to the FDA for the potential approval of Omicampson-McCarbo, our growing team of medical science liaisons is working to educate hospital-based and community cardiologists on the challenge of impaired contractility in patients with heart failure with reduced ejection fraction, and we remain committed to helping physicians increase their understanding of the sarcomere in cardiac muscle function. Additionally, we've made progress I expect to further elucidate the potential of Omicampson Macarbal within the treatment arsenal.

You May know these are the patients who become the frequent flyers on hospitals, given the increased risk of re hospitalization with every subsequent hospitalization event.

Given the evidence from Galactic F demonstrating the risk reduction, resulting from on the campus from a comparable with greatest among patients with lower ejection fraction levels, we are evaluating the cost effectiveness potential for patients.

Being potentially treated with OMA captive mccarville.

Finally, it will be critical to our work with payers to ensure patients have access to on the captive mccarville.

Garrett Heart Tiger reimbursement mix is approximately 55% Medicare part D and approximately 30% commercial payers, we have initiated payor discussions with several of these key stakeholders and again, we're getting a better understanding what drives their decision and the heart failure arena, particularly as they contemplate.

Fady Ibraham Malik: And with that, I'll turn the call over to Andrew to elaborate on progress against the go-to-market strategy from McCarver. Thanks. During the second quarter, our board of directors endorsed our proposed go-to-market strategy for Omecamps of Macarbel, and since then, we have proceeded with its implementation as we prepare for a potential commercial launch in 2022. We plan to present a deep dive into the strategy and how it intersects with our cardiac muscle franchise strategy and planning for the commercial launch of Epicampton at an investor day later this year.

A host of new branded therapies to treat this patient population.

For this and we're also developing a distinct value proposition based on the results from Galactic HFF and we believe a well defined patient population with.

With severe heart failure will be a welcome strategy among the payer community.

And with that I will turn it over to Stuart to provide an update on Aflac Camden and next steps on the cardiac myosin inhibitor development program.

Thanks, Andrew.

As we announced in today's press release during the quarter. We received final approval from the World Health organization and the United States adapted named Council adopted named Council or at the Camden to be used as the international non proprietary name or CK 274.

Fady Ibraham Malik: But today, I will share a few highlights of our product. From an organizational development perspective, in addition to the stellar team I joined, we are expanding the commercial organization at all levels, making key hires in marketing, health economics and outcomes research, analytics, supply chain logistics, and market access. In addition, I anticipate having the full leadership team in place by the end of the summer.

About 3 weeks ago, we announced positive top line results from cohorts, 1 and 2 of Redwood HCM the phase II clinical trial on Athene Camden.

Since we held a dedicated conference call to report the results on.

I'm not going to go into detail, but rather a recap key data and focus on next steps toward opening a phase III clinical trial by the end of this year.

Top line results from Redwood HCM demonstrated that treatment with epic Hampton for 10 weeks resulted in highly statistically significant reductions from baseline compared to placebo and the average resting and post valsalva left ventricular outflow tract pressure gradients in both cohorts 1 and 2.

Andrew Callos: As you heard from Fatti, the results of the galactic HF and the secondary analyses provide clarity around a subset of heart failure in which the benefit of omicampeter macarmal is most constant. That is, those with an ejection less than 30, or who can no longer tolerate guideline-directed medical therapy due to renal or blood pressure impairment or those recently hospitalized. Those patients likely to derive the most benefit from Omicampter of Carvel represent approximately 50% of all heart failure with reduced ejection fraction patients.

In cohort, 1 which evaluated a lower dose range of 5 to 10 milligrams, 79% of patients treated with Apple campton achieved the target goals of treatment defined as resting gradient less than 30 millimeters of Mercury.

Post valsalva gradient less than 50 millimeters of Mercury at week 10.

Compared to 8% per placebo.

In cohort, 2 which studied a higher dose range of 10% to 30 milligrams, 93% of patients treated with Abbvie Camden achieved the target goal.

Patients treated with Abbvie Camden experienced decreases in both the resting and post valsalva gradient by week, 2 and a maximum treatment effect was achieved by week 6 after completion of dose titration, which was sustained through the final visit at week 10.

Andrew Callos: In addition, our market research has confirmed that they are managed by fewer than 30% of total cardiologists and fewer than 15% of total hospitals in the U.S. that treat the majority of these severe patients. Targeting this well-defined and tractable subset of cardiologists and hospitals also enables us to effectively launch with a model size, especially cardiology. Notably, there is also a significant overlap between HART value and ATM-directed accounts.

Trading with Abbvie Campton was generally well tolerated the incidence of adverse events were similar between treatment arms.

Serious adverse events were attributed to epic Hampton and no treatment interruptions occurred on drug treatment.

Importantly, we were pleased to see that only 1 patient experienced a transient decrease in left ventricular ejection fraction less than 50%, which required a dose adjustment, but did not result in dose interruption.

Andrew Callos: Specifically, there are approximately 1,100 high-value hospitals and centers of excellence treating both patient populations. So the cardiac muscle-directed fuel force we are building today is purpose driven to leverage the infrastructure and relationships we establish in support of Omicampum McArville for Afakampton in two to three years. Put simply, we expect that our reps will have another product in their bag without needing to build an independent field. Furthermore, we recognize and appreciate the high cost burden of heart failure as it represents the most common hospital admission diagnosis for Medicaid hospitalizations, and readmissions are considerably higher among patients with lower ejection pressure.

Overall feedback from the investigators of the trial has been quite positive and enthusiastic given the magnitude of the treatment effect a proportion of patients who achieved response criteria and the overall safety and Tolerability profile observed.

In the quarter, we initiated the open label extension trial of Redwood HCM.

Which continues to enroll patients from cohort 1 and is now enrolling patients from cohort 2.

The primary objective of this trial is the evaluation of long term safety of Abbvie Camden.

And the secondary objectives focus on the evaluation of gradient reduction and pharmacokinetics with long term administration of App at Camden.

We are also conducting a cardiac MRI sub study to assess changes in cardiac morphology function in fibrosis <unk>.

Patients in the open label extension will begin at the lowest dose of 5 milligrams and we will be individually titrated to achieve target gradients as informed by cohorts 1 and 2.

As a reminder, we still have cohort 3 in Redwood HCM ongoing which includes patients treated with Abbvie Campton, who are also on disopyramide as background therapy.

This cohort will further inform the inclusion of this small but important patient population in phase III.

Andrew Callos: And as you may know, these are the patients who become their frequent flyers in hospitals, given their increased risk of re-hospitalization with every subsequent hospitalization event. Given the evidence from Galactus HF, demonstrating the risk reduction resulting from Omicampta McArval was greatest among patients with lower rejection fraction levels, we are evaluating the cost effectiveness potential for patients being potentially treated with Omicampta of Macarval. Finally, it will be critical to our work with payers to ensure patients have access to one McCarp of McCarville. The current heart value reimbursement mix is approximately 55% Medicare Part D and approximately 30% commercial payers.

We are moving rapidly to begin our phase III clinical trial of Athey Hampton in patients with obstructive HCM in the fourth quarter.

Continuing preparations that began last December when we obtain results of cohort 1 interim analysis from Redwood HCM.

During the second quarter, we had a type C meeting with the FDA to review our plan for the phase III trial in <unk>.

That meeting we reviewed the design endpoints and patient populations.

And found the feedback we received enabling of our plans to advance to phase III.

Building on this informative type C meeting, we recently received FDA feedback from our end of Phase II meeting.

After review of the final dose is selected for phase III, namely 510, 15, and 20 milligrams.

And our proposal to continue individualized echocardiogram guided dosing the.

The agency agreed with our dose titration strategy.

We also received helpful feedback on other aspects of the overall development program, including non clinical safety clinical pharmacology and the preferred format for datasets among other components in.

Andrew Callos: We have initiated payer discussions with several of these key stakeholders, and they're getting a better understanding of what drives their decisions in the heart failure arena, particularly as they contemplate a host of new branded therapy options for this patient population. Toward this end, we're also developing a distinct value proposition based on the results from Calactic HS, and we believe the well-defined patient population with severe heart failure will be a welcome strategy among the payer community.

In addition, we initiated interactions with Eni during the quarter and received feedback that informs our proposed phase III clinical trial design.

We anticipate additional engagements this quarter from <unk> to further inform our strategy for this program in Europe.

Moreover, under our collaboration with <unk> pharmaceuticals during the second quarter, you're saying continued enrolling patients in a phase 1 study of epic Camden in China and prepare for participation in the phase III clinical trial of Athey Camden in obstructive HCM.

Andrew Callos: And with that, I will turn it over to Stewart to provide an update on Asikantan and next steps in the cardiac myosin inhibitor development. Thanks, Andrew. As we announced in today's press release, during the quarter, we received final approval from the World Health Organization,

As we finalize preparations for a phase III trial, and as part of our clinical development program per assay Camden.

We are now considering the best path forward for a trial in patients with non obstructive HCM.

And expect to clarify our approach later this year.

And as we have previously stated in addition to exploring the opportunity to address hyper contractility, and obstructive and non obstructive HCM.

Stuart Kupfer: and the United States adopted name counsel for Appy Campton to be used as the international non-propriation symbol.

We believe there is also a subset of heart failure patients with preserved ejection fraction, whose underlying cause of their disease is driven by a left ventricular hyper contractility and hypertrophy.

Stuart Kupfer: International Non-Proprietary Name or CK274. About three weeks ago, we announced positive top line results from cohorts 1 and 2 of Redwood HM, the Phase 2 clinical trial of Aphicamp, Since we held a dedicated conference call to report the results, I'm not going to go into detail, but rather recap the key data and focus on next steps toward opening a phase three clinical trial by the end of this year. Topline results from Redwood HCM demonstrated that treatment with Epi Campton for 10 weeks resulted in highly statistically significant reductions from baseline compared to placebo in the average resting and postalva left ventricular outflow tract pressure gradients in both cohorts 1 and 2, cohort one, which evaluated a lower dose range of 5 to 10 milligrams, 79% of patients treated with Apicampton achieved the target goals of treatment, defined as resting gradient less than 30 millimeters of mercury, and post-valvalve gradient less than 50 millimeters of mercury at week 10, compared to 8% for placebo.

These patients may also benefit from treatment with an optimized next in class cardiac myosin inhibitor.

And we remain interested in pursuing this population as a development program matures.

And with that I'll turn it over to Robert Wong, who will provide an update on our financials.

Thanks, Stuart I will first provide an update on cash revenue and spending and then Ching will review our financial outlook revised financial guidance for 2021, and corporate development strategies looking forward more.

Details on our actual results for the second quarter 2021 are included in the press release, which we released earlier this afternoon.

We ended the second quarter with approximately $424 million in cash and investments.

Our revenues in Q2, 2021 came primarily from our strategic alliances with Amgen and Astellas.

Our second quarter 2021, R&D expenses increased to $36.4 million from $21.8 million in the first quarter of 2020, primarily due to the transition costs related to the termination of our collaboration with Amgen the purchase from Amgen of approximately $7.3.

Of materials, including manufactured quantities of active pharmaceutical ingredient for on the captive mccarville and increases in spending on our clinical development activities for our cardiac myosin inhibitor programs.

More than 70% of our R&D expenses are attributable to our cardiovascular program as expected given activity for transition from Amgen meteoric HFF and the cardiac myosin inhibitor programs and the remainder of our expenses were attributable to our early research and skeletal activity.

Stuart Kupfer: In cohort 2, which studied a higher dose range of 10 to 30 milligrams, 93% of patients treated with Affie Campton achieved the target goal. Patients treated with Apicampton experienced decreases in both resting and post-salve gradients by week two, and a maximum treatment effect was achieved by week six after completion of dose titration, which was sustained through the final visit at week 10. Treatment with Affie Campton was generally well The incidence of adverse events was similar between

Our second quarter 2021, G&A expenses were $21.2 million up from $14.2 million in Q2, 2020, due to higher personnel related costs, including stock based compensation and higher commercial readiness spending and now Ching will review, our financial outlook and corporate development strategy.

<unk>.

Thanks Robert.

As Robert indicated we ended the second quarter was approximately $124 million in cash. In addition, we recently raised approximately $297 million through.

Stuart Kupfer: In treatment arms. No serious adverse events were attributed to Appetampton, and no treatment interruptions occurred during drug treatment. Importantly, we were pleased to see that only one patient experienced a transient decrease in left ventricular ejection fraction less than 50%, which required a dose adjustment, but did not result in a dose interruption.

Through an equity offering net of expenses.

Therefore, our pro forma attached today is approximately $721 million, which represents more than 3 years of cash runway based on our revised net cash utilization guidance of $195 million to $215 million in 2021.

This new guidance includes non recurring new building construction cost of approximately $35 million and assumes receipt of $45 million under our funding agreement with RW investments.

Stuart Kupfer: Overall, feedback from the investigators of the trial has been quite positive.

Stuart Kupfer: They were quite positive and enthusiastic, given the magnitude of the treatment.

Net proceeds from the equity offering will support the conduct.

Phase III clinical trial of <unk> kimpton in patients with HCM.

Stuart Kupfer: Given the magnitude of the treatment effect, the number of patients who achieved response criteria, and the overall safety and tolerability profile observed. In the quarter, we initiated the Open Label for Redwood H&Rour, which continues to enroll patients from cohort one and is now enrolling patients from cohort two. The primary objective of this trial is the evaluation of long-term safety of APPACPT, and the secondary objectives focus on the evaluation of gradient reduction and pharmacokinetics with long-term administration of APICAM. We are also conducting a cardiac MRI substudy to assess changes in cardiac morphology, function, and fibrosis. Patients in the open-label extension will begin at the lowest dose of 5 milligrams and will be individually titrated to achieve target gradients as determined by cohorts 1 and 2.

Expansion of the clinical development program quasi kimpton to include other indications.

Planned commercial launch activities or on weekends on carbo.

Conduct of courage AOS are now ongoing phase III clinical trial of relative center in patients with ALS.

And core research and general corporate purposes, including working capital.

During the second quarter, we also made progress against our twofold corporate development strategy. So of course seek potential royalty monetization and or structured financing deals in order to further support commercial launch of only cancer with carbo and continued development of ASIC Kimpton.

And second to seek a development and commercialization partner for Omni channel Mccarville and ethnic kimpton in complementary geographies to that where we intend to go to market ourselves.

Our partnership priorities are focused to Japan with the goal of securing a deal which bundles on kept on mccarville and asking him to support co funding of our lifecycle management studies as well as regulatory and commercial activities respectively.

Stuart Kupfer: As a reminder, we still have cohort three in Redwood HCM ongoing, which includes patients treated with Apicampton who are also on Dysipuramide as background therapy. This cohort will further inform the inclusion of the small but important patient population in phase three. We are moving rapidly to begin our phase three clinical trial of Apicampton in patients with obstructive HCM in the fourth quarter, continuing preparations that began last December when we obtained results of the cohort one interim analysis from Redwood HCM.

Our focus will also.

China in order to secure a potential licensing agreement on the cancer Mccarville.

And selectively to Europe and other markets.

To enter into potential agreements was co development and co commercialization partners on the Kansas Mccarville.

As such we expect to preserve North America, and potentially European rights for development and commercialization.

I am pleased to report that we had encouraging and productive interactions to advance these strategies and we look forward to continuing those discussions as May result in a deal or deals in the second half of the year.

<unk> has always gained access to capital through a diverse array of deal structures and we continue to believe that our path to commercialization is sustainable cash flows and profitability will be served by our continued monetization of our leadership in muscle pharmacology.

Stuart Kupfer: During the second quarter, we had a type C meeting with the FDA to review our plan for the phase three trial. In that meeting, we reviewed the design endpoints and patient populations, and found the feedback we received enabled our plans to advance to phase three. Building on this informative type C meeting, we recently received SDA feedback from our end of Phase 2 meeting. After review of the final dose selected for phase three, namely 5, 10, and 20 milligrams, and our proposal to continue individualized, a chocardiogram-guided dose, the agency agreed with our dose titration strategy.

Through dealmaking.

And with that I'll turn the call back over to Robert pump.

Thank you Ching says.

So as we look towards the remainder of 2021 on our upcoming milestones I'm reminded of the vision, we established more than 2 decades ago.

It was a time when most pharmaceutical and biotechnology companies, we're stepping away from research in cardiology, and Cytogenetics was boldly pursuing a novel scientific rationale discovery platform in biology.

Now that vision is coming into more refined focus as we continue to double down on our cardiovascular pipeline.

With 2 muscle biology, directed drug candidates advancing and with several others close behind.

Stuart Kupfer: We also received helpful feedback on other aspects of the overall development program, including non-clinical safety, clinical pharmacology, and the preferred format for datasets, among other, In addition, we initiated interactions with EMA during the quarter and received feedback that informed our proposed phase three clinical trial to, We anticipate additional engagements this quarter from HTAs to further inform our strategy for this program in Europe. Moreover, under our collaboration with Ging pharmaceuticals, during the second quarter, Xi continued enrolling patients in a phase one study of AppyCampton in China, and prepared for participation in the Phase 3 clinical trial of Apicam and obstructive ACM, as we finalize preparations for a phase three trial, and as part of our clinical development program for Appycanton, We are now considering the best path forward for a trial in patients with non-obstructed HCM, and expect to clarify our approach later this year.

And as we make progress in our neuromuscular vertical based on regulatory clinical commercial and financial clarity.

In addition to the clinical regulatory and commercial progress we made related to <unk> during the quarter we.

We successfully reached several agreements to facilitate the transition of the programs for <unk> and CK 136 from Amgen to subtle kinetics include.

Including an agreement for the sale and our purchase of approximately 2 tons of active pharmaceutical ingredient of OMA kept of a carnival.

As you can imagine transition activities. Following a 15 year collaboration takes significant time and attention and I want to thank my many colleagues who have been engaged diligently on this activity.

Stuart Kupfer: And as we have previously stated, in addition to exploring the opportunity to address hypercontractility and obstructive and non-obstructive HCM, we believe there is also a subset of heart failure patients with preserved ejection fraction whose underlying cause of their disease is driven by left ventricular hypercontractility and hypertralia.

Robert C. Wong: These patients may also benefit from treatment with an optimized nexent class cardiac miasin inhibitor, and we remain interested in pursuing this population as a development program mure. And with that, I'll turn it over to Robert Wong, who will provide an update on our financials. Thanks, Stuart. I'll first provide an update on cash, revenue, and spending, and then Ching will review our financial outlook, revise financial guidance for 2021, and discuss corporate development strategies looking forward. More details on our actual results for the second quarter of 2021 are included in the press release, which we released earlier this afternoon. We ended the second quarter with approximately 424 million in cash and investments.

Do you have to insure ethical and equitable access we fully recognize the urgency to bring new medicines to people living with Alice and were diligently working with purpose passion and compassion.

In summary, we expect that the next 12 to 18 months may be even more transformational for Cytokinetics with 2 positive late stage trials for our lead cardiovascular programs. We look forward to advancing our goal towards NDA submission of Omi captive mccarville for the Patel.

Robert C. Wong: Our revenues in Q2 came primarily from our strategic alliances with Amgen and, In our second quarter, R&D expenses increased to $36 million from $21.8 million in the first quarter of 2020, primarily due to the transition costs related to the termination of our collaboration with AMR. The purchase from Amgen of approximately 7.3 million units of materials, including manufactured quantities of active pharmaceutical ingredients for Omicampton Macarbo and increases in spending on our clinical development activities for our cardiac myosin inhibitor program.

Shall treatment of heart failure with reduced ejection fraction and also starting a phase III clinical trial of athey campton in patients with obstructive HCM.

Together these potential medicines may change the treatment landscape for these severe cardiovascular diseases by harnessing the power of myosin modulation.

And in that way offering patients new hope.

Now let me recap are expected milestones for 2021.

For only camped of mccarville, we expect to submit an NDA to the F D a and the second half of 2021.

Robert C. Wong: More than 70% of our R&D expenses are attributable to our cardiovascular program, as expected, given activity for transitioning from Amgen, Meteoric HF, and the cardiac-myosin inhibitor programs, and the remainder of our expenses were attributable to our early research and skeletal activity. Our second quarter 2021 G&A expenses were 21.2 million, up from 14.2 million in Q2 2020 due to higher personnel-related costs, including stock And now, Ching will review our financial outlook and corporate development strategy. Thanks, Robert. As Robert indicated, we ended the second quarter with approximately $424 million in cash.

Day dial up there thanks.

Okay, so to unpack that let's start with only captive in you.

Ching W. Jaw: In addition, we recently raised approximately 297 million through an equity offering that will be expensive. Therefore, our pro forma cash today is approximately 721 million, which represents more than three years of cash runway based on our revised net cash utilization guidance of 195 to 21. This new guidance includes non-recurring new building construction costs of approximately 35 million and assumes receipt of 45 million under our funding agreement with RTW Investments. Net proceeds from the equity offering will support the conduct of a phase three clinical trial of Epicampum in patients with obstructive HCM.

You asked a question about our plans some of this I'm not gonna be able to speak to on this call of course, but I'll tell ya.

That for the fact that Galactic H F was a positive clinical trials, we expect that it's indication as we will proposed to F. D. A would be inclusive of those patients.

That participated in the study but to your specific question as would be potentially inclusive in the label of those data.

As highlights those patients that benefit the most and we think there's ample precedent in already approved drugs in heart failure for the inclusion of data, especially as was in our case prespecified for those subpopulations that seemed to be due.

Doing better than others.

Hope that May answer that first question. Your second question I believe related to C. K 274, and our plans for regulatory outside the U S is that right.

Yeah exactly yes.

So that's something that is.

Ching W. Jaw: Expansion of the Clinical Development Program for Ethic Kempton to include other indications, planned commercial launch activities for Omicampal, The conduct of Courage ALS, a phase three clinical trial of route incentive in patients with ALS, and for research and general corporate purposes, including working capital. During the second quarter, we also made progress against our two-fold corporate development strategy to first seek potential royalty modernization and or structured financing deals in order to further support the commercial launch of Omicam Carbo and continued development of African, and second, to seek a development and commercialization partner for Omicampan and Aphicampan in complementary geographies to that where we intend to go to market ourselves.

Beginning and I'd say ongoing I don't think we can yet be as.

Clear minded and definitive about that in light of those being still ongoing conversations Saudi anything you want to add to that.

I think only in that.

Our plan is to conduct.

Phase 3 outside of North America, So <unk>.

Including Europe, and China of course.

And regulatory interactions to enable that are underway.

As it relates to your question about China, our expectation is through our collaboration with ziyang that they will be ready to go so as to be enabling their enrollment of patients in China as part of the same global registration program and pivotal.

Study.

Great. That's helpful. Thanks for taking my questions.

Thank you Jason.

Our next question comes from the line of day Man.

Raymond James.

Hello day.

From each year high.

Good afternoon.

How's it going on.

I'll I'll keep it brief I just wanted to ask in terms of the FTA discussions on on the captive it sounds like you're probably moving forward, but the submission with ahead of the meteoric data is that going to be integrated into the submission package at some point or do you feel like it is not necessarily relevant for the law.

Ching W. Jaw: Our partnership priorities are focused on Japan with the goal of securing a deal which bundles Omicampton McCarbo and Epi Kempton to support co-funding of life cycle management studies, as well as regulatory and commercial activities, respectively. Our focus will also be on China in order to secure a potential licensing agreement for Omicampanacarbo and selectively to Europe and other markets to enter into potential agreements with co-development and co-commercialization partners for only can't of Macauville. As such, we expect to preserve North American and, potentially, European rights for development and commercialization.

Cable that you're trying to get approved with the F. D. A at this point.

Good question. So we believe that our submission will stand on Galactic alone.

And that as meteoric may provide further information and we won't have that data until 2022, we could then consider whether and this may be occurring post approval hopefully of only captive whether then the label might be then.

Handed to incorporate that which incorporates results pertaining to only captive in meteoric H F, but our strategy pivots on Galactic H F.

Okay. Thank you.

Thank you.

Ching W. Jaw: I'm pleased to report that we've had encouraging and productive interactions to advance these strategies; we look forward to continuing those discussions, which may result in a deal or deals in the second half of the year. Cytokinetics has always gained access to capital through a diverse array of deal structures, and we continue to believe that our path to commercialization and sustainable cash flows and profitability will be served by our continued monetization of our leadership in Musco Pharmacology through dealmaking. And with that, I'll turn the call back over to Robert Palm. Thank you, Chang.

Your next question comes from the line of Carter and called West Park claims.

Hello, Carter, Hey, good afternoon, Robert I agreed to see on the progress I guess 2 questions from US first off on you know you've talked on the past around there being a distinction between your phase 3 and explore now that you've had these meetings with fda's does that still hold true and will that expand beyond the potential inclusion of that population.

And cohort 3 of Redwood and then maybe just as we think about finally getting getting a look at the the Redwood data presentation at on an upcoming medical meeting can you, maybe just give a little bit more color on what other incremental analyses, we might see in those upcoming medical presentation. Thank you.

Robert I. Blum: As we look toward the remainder of 2021 and our upcoming milestones, I'm reminded of the vision we established more than two decades ago. It was a time when most pharmaceutical and biotechnology companies were stepping away from research in cardiology, and cytokinetics was boldly pursuing a novel scientific rationale discovery platform and biology. Now that vision is coming into more refined focus as we continue to double down on our cardiovascular pipeline, with two muscle biology-directed drug candidates advancing and with several others close behind, and as we make progress in our neuromuscular vertical, based on regulatory, clinical, regulatory, commercial, and financial clarity.

Sure I'll turn it over to fatty who they also then turn it over to Stewart, but I'll say that for having now a couple of interactions with FDA pertaining to C. K 274, I think it's affirming of our plans for the phase 3 trial and ER fatty and Stewart can pick it up from there.

Yeah, I mean, our.

Trial design for phase 3 well certainly borrow from what was conducted with Mavacamten and explore but.

Will be different in other ways and will elaborate on that later in the year.

We certainly have I think agreement on how we plan to go forward.

And phase III with with FDA.

And maybe store can comment on on what we May plan to present at a subsequent medical meeting regarding redwood well.

Well, we'll certainly plan to expand on the results.

Robert I. Blum: In addition to the clinical and commercial progress we made related to Omicamp to McArbel during the quarter, we successfully reached several agreements to facilitate the transition of the programs for Omicampton McCarbel and CK-136 from Amgen to cytokinetics, including an agreement for the sale and our purchase of approximately two tons of the active pharmaceutical ingredient of Omicamp to McArbel. As you can imagine, transition activities following a 15-year collaboration require significant time and attention.

On the size and the recent press release.

We'll have details on our baseline characteristics.

Biomarkers pharmacokinetic data.

And YHA class just as an example.

So there's more interesting data to come thanks for the question.

Our next question comes from the line absolutely insane with Mcneil Hal.

Hello Shirley.

Good afternoon, Robert team I did a couple of questions on so you can teach them on for.

So you know Bristol had on their call. A question on you can choose from 4 versus Mavacamten. Just curious you know, they're saying that they don't see differentiation.

Between the 2 molecules I'm curious how you guys are seen does everything that we've seen with the published explorer data and everything that you've seen with teaching too soon for how confident are you that teach you soon or is actually a differentiated molecule and and is there anything in the phase 3 day to send that you produce that you think could alter that.

Robert I. Blum: And I want to thank my many colleagues who have been engaged diligently in this activity as we've assumed more responsibilities and built out our teams over the past six to nine months. On the neuromuscular front, we're also pleased to have Courage ALS underway, and we believe its design leverages key learnings from Fortitude ALS, our Phase 2 clinical trial of Rel deceptive in patients with ALS, as well as the dynamics of ALS therapy development and the urgent needs of the patient community.

Thinking and then the second question just as in the mind from inhibition in general.

Just curious how you would perceive and add calm if mavacamten work till you got 1 would it be a net net negative positive are you expecting 1 or are you thinking about this generally thank you.

Sure. So very good questions I'll start and asked my colleagues if they want to add.

Robert I. Blum: With crater efficacy seen in patients whose disease seems to be progressing more rapidly, we believe the design of Courage ALS is itself enriched towards that patient population accordingly. Additionally, based on feedback from patients, caregivers, advocates, payers, as well as health care professionals.

We do believe we very much believe that these are differentiated molecules and in fact, if we didn't believe that we wouldn't be taking.

Coffee campton into phase 3 and we've verified that so it's not just our own thinking it's verified also by our conversations with key opinion leaders and investigators in this space.

But I understand a perspective that would suggest that the data from Redwood are comparable would I would underscore is that we believe that some of these things. We specifically designed into C. K 274, or Alfie campton like a more rapid time.

Robert I. Blum: The design of Courage ALS incorporates important elements that are intended to remove key barriers to clinical trial participation, including our incorporation of remote clinic and home nursing visits, as well as mobile app-based endpoint measurement. Importantly, we're working towards a goal to provide continued access to RELD for patients who complete Courage ALS, as well as for patients who have previously participated in our ALS trials. The program is being developed with the objective to ensure ethical and equitable access.

To onset of activity and enabling better easier dose titration as well as more rapid reverse ability. These are things that enable in the conduct of future clinical trials, the inclusion and exclusion of patients. These are things that are enabling them.

A clinical trial design that should in fact further advance the category in the field. If we didn't think that these properties of a next in class molecule.

Didn't do that we wouldn't be in a position to invest here as we expect could be advancing the field. So we can't elaborate today on what will be those features and how they play out in a phase 3 trial, but you'll know that soon enough when we announced the start of the study.

Robert I. Blum: We fully recognize the urgency to bring new medicines to people living with ALS, and we're diligently working with purpose, passion, and compassion. In summary, we expect that the next 12 to 18 months may be even more transformational for cytokinetic. With two positive late-stage trials for our lead cardiovascular programs, we look forward to advancing our goal towards NDA submission for Omicampton-McCarble for the potential treatment of heart failure with reduced ejection fraction and also starting a phase three clinical trial of Afficampton in patients with obstructive HCM.

Talk about the clinical trial design and hopefully those will come into more clarity.

So I think that's my answer to your first question. Your second question can you remind me.

Yeah, just on their Mavacamten I'm calm.

You perceive it as a negative or positive from haven't where to get 1.

Yeah, why don't I turn to <unk>, maybe to speak to the.

Yeah I.

I, frankly don't Wanna really speculate on whether or not they may or may not get an AD com, that's really up to F. D a to determine and based on on the submission.

Robert I. Blum: Together, these potential medicines may change the treatment landscape for these severe cardiovascular diseases by harnessing the power of myosin modulation and, in that way, offering patients new hope. Now, let me recap our expected milestones for 2021. For Omicamp of McCarble, we expect to submit an NDA to the FDA in the second half of 2021, and we expect to complete the conduct of meteoric HF by year end, with results expected in early 2022.

Submission that was made so.

It will just have to wait and see if they decide to have 1.

There hasn't been any suggestion yet that there will be an AD com. So we're certainly not assuming that there should be but.

But if there is we'll certainly be prepared to be.

Astute observers and how that might inform our planning as well.

Great. Thanks, so much on the color on congrats on the progress.

Thank you sleep.

Your next question comes from the line of sadness or when you need them and company.

Hello, Chad.

Hello, Great good afternoon, and thanks for for taking my questions.

First of all it's you know congratulations on your.

First appearance, but with all of these programs, it's great to see you guys have.

Robert I. Blum: We expect to begin a phase three clinical trial of Afficampton in patients with obstructive HCM in the fourth quarter of 2021. For Reldescent, we expect to continue enrollment of Courage ALS throughout 2021. And for our ongoing research, we expect to advance programs and conduct I&D with one to two potential drug candidates through the remainder of 2021. An operator With that, we can now open up the call to questions, please.

At least 3 exciting programs that are kind of in and play if you will win and could bring.

Great benefit to patients. They all have not had the easiest C easiest time.

Just.

Operator: Ladies and gentlemen, if you'd like to ask a question, please press star and then the number one on your telephone keypad. And once again, please be aware that we will be taking two questions per participant. And your first question comes from the line of Jason Butler with JMP Securities.

Jason Nicholas Butler: Hey, hi, Robert, thanks for taking the questions. First one, just based on the regulatory feedback that you know there is on Omicampiv, can you talk about what you plan to propose to include in the label in terms of the analyses around patients with lower baseline ejection fraction? And then the second question for 274, can you talk about conducted or planned ex-U.S. regulatory interactions and specifically how you think including patients from China can affect enrollment and the regulatory dialogue there?

Support for Phase III.

But as we committed to shareholders, we wanted to make certain that before we advanced relative SMT to phase 3.

We had a number of things that we had to accomplish first we wanted to discuss those results with FDA, but also with payers both in the U S and in Europe. We wanted to discuss a design of a clinical trial that would be enabling of some looks into the data as it would.

Jason Nicholas Butler: Okay, so to unpack that, let's start with Omicampive and you asked a question about our plans. Some of this I'm not going to be able to speak to on this call, of course, but I'll tell you that because Galactic HF was a positive clinical trial, we expect that its indication, as we will propose to FDA, would be inclusive of those patients that participated in the study. But to your specific question, it would potentially be potentially inclusive in the labeling of those data, highlighting those patients that benefit the most. And we think there's ample precedent in already approved drugs in heart failure for the inclusion of data, especially as was, in our case, pre-specified, for those subpopulations that seem to be doing better than others.

Enabling of a interim stop for futility, if it looked like that was appropriate and a second interim down the road as could also be expanding of the study if it looked like that may be warranted. We wanted to understand the cost of the study and we wanted to renegotiate.

Our collaboration agreement with Astellas in order to have them.

Enable our lead in this area and also their co funding of that trial both of those things we negotiated successfully.

We wanted to best understand what patients would be looking for in their participation in our clinical trial because as you may know the landscape for trials in AOS has become more crowded which is a good thing but at the same time, we wanted to make certain we could be enrolling our study.

Robert I. Blum: I hope that may answer that first question. Your second question is related to CK274 and our plans for regulatory outside the U. Is that right? Exactly, yeah. So that's something that is beginning, and I'd say ongoing. I don't think we can yet be as clear-minded and definitive about that in light of those being ongoing conversations. Faddy, anything you want to add to that?

<unk> and know that we would have the support of the patient community. It. So happens that in these last couple of years. During this time when we were assessing these matters. The ALS community as led by certain advocacy groups has become much more assertive and engaged it's a good.

Robert I. Blum: I think only in that, you know, our plan is to conduct phase three outside of North America, so, you know, including Europe and China, of course, and, you know, regulatory interactions to enable that are underway. Yeah, as it relates to your question about China, our expectation is, through our collaboration with Ji Jing, that they will be ready to go so as to enable their enrollment of patients in China. China as part of the same global registration program and pivotal study.

And at the same time, they've been assessing and evaluating which clinical trials would be best to direct patients to participate in I'm really pleased to be able to share today that I am a unless 1 of those advocacy groups that does rate clinical trials gave.

Our trial courage AOS its highest rating and there are only a couple of trials that have that 5 star rating. They look at this design in terms of what's in the best interest of patients and they scored it amongst their highest ever clinical trials. So all of these things we wanted to.

Unknown Attendee: Great, that's helpful. Thanks for taking the questions. Thank you, Jason.

Dane Vincent Leone: Your next question comes from the line of Dane Leon with Raymond James. Hello, Dana.

Operator: Your line is open. Hi. Good afternoon. How's it?

Line up before we started this trial in order to make certain that we could finish what we started and do so to give the drug and patients the best chance for success here and I think we did that well and hence we've started courage AOS now with that said I'll turn it.

Unknown Attendee: I'll keep it brief. I just wanted to ask, in terms of the FDA discussions on Omicampiv, it sounds like you're probably moving forward with a submission with the head of the meteorological data. Is that going to be integrated into the submission package at some point or not?

Over to fatty to answer the second part of your question.

Thanks, Chad.

With respect to the design of courage and how it may.

Unknown Attendee: Or do you feel like it is not necessarily relevant for the label that you're trying to get approved by the FDA at this point? Good question.

You have a higher probability of success I think you have to look back to our conduct of Fortitude, which you mentioned to begin with.

<unk> was a pretty sizable study in ALS enrolled over 450 patients.

Robert I. Blum: Good question. So we believe that our submission will stand on Galactic alone, and that as Meteoric may provide further information, and we won't have that data until 2022, we could then consider whether, and this may be occurring post-approval, hopefully, of Omicampive, whether then the label might be expanded to incorporate that which incorporates results pertaining to Omicampive in Meteoric, H, but our strategy pivots on Galactic HF

We.

Had I think compelling signals of slowing of decline in both the primary endpoint of this phase.

Phase III study, the ALS FRS as well as in slow vital capacity.

And those signals were strengthened when you looked at patients that came into the study that we're progressing more quickly than than than others and so in designing courage.

As others are doing now at AOS is focusing on.

Enrolling patients, whose disease may be bear crossing more rapidly.

And and other things that we've done in the design to optimize we think its chances for success.

Unknown Attendee: Your next question comes from the line of Carter Gold with Barclays.

So we're fairly encouraged.

Based on.

Carter Lewis Gould: Hello, Carter. Hey, good afternoon, Robert.

Both the precedent in fortitude ALS as well as.

As well as the way we've implemented it encourage.

Unknown Attendee: Great to see all the progress. I guess we have two questions from us. First off, you know, you've talked in the past around there being a distinction between your phase three and Explorer. Now that you've had these meetings with FDAs, does that still hold true, and will that expand beyond the potential inclusion of that population in cohort three of Redwood? And then maybe just as we think about, you know, finally getting a look at the Redwood data presentation at an upcoming medical meeting, can you maybe just give a little bit more color on what other incremental analyses we might see in those upcoming medical meetings?

From a portfolio standpoint, it was incumbent upon also to know that when we're advancing relative <unk> in ALS.

It's occurring alongside of the advancement of our pipeline for new cardiovascular medicines. So when we captive mccarville moving forward as well as Effie Kimpton moving forward. We believe is enabling of our advancement of real dissented in key ways and as is in the interests of diversified.

Product development risk as well as hopefully maximizing potential shareholder value.

Yeah.

Alright, great. Thank you I appreciate it.

The answers on.

They've been in.

Once again on.

Robert I. Blum: Sure, I'll turn it over to Fattie, who may also then turn it over to Stewart, but I'll say that having now had a couple of interactions with FDA pertaining to CK274, I think it's supportive of our plans for the Phase 3 trial, and Fattie and Stewart can pick it up from there. Yeah, I mean, our trial design for phase three will certainly borrow from what was conducted with Mavik Kempton and Explorer, but we'll be different in other ways, and we'll elaborate on that later in the year. We certainly have, I think, agreement on how we plan to go forward in phase three with FDA. And maybe Stewart can comment on what we may plan to present.

Getting to net lease with all.

All 3 major programs as well as the other things you're working on.

Thank you Chuck Chad.

Yeah.

Okay.

Operator.

Your next question comes from the line of Jeff Hung with Morgan Stanley.

Hello, Jeff.

Hey, Robert Thanks for taking the questions.

To clarify Jason's question earlier on I'm looking at the book Carnival are you going from a broad label or would you expect that the label will focus on the more severe patients specifically, calling out patients with the lower ejection fraction.

Yeah.

So again I'm not going to be so elaborative to our strategy, but I think it's.

Fair to say that our intention our objective is to go for a broader label, but as would also be inclusive of those data and results that are highlighting where the effects are more maximal.

And as such provide physicians more information as to guide.

Therapy.

Okay. Thanks, and then can you talk about the feedback that FDA provided at the type C and pre NDA meeting on your plans to submit the NDA on book.

Fady Ibraham Malik: Well, we'll certainly plan to expand on the results we published in the recent press release.

Tech data has there been any pushback about the focus on the more severe patients and have they suggested that any additional clinical work might need to be done or do they seem completely on board that the available data sufficient.

Stuart Kupfer: We'll have details on our baseline characteristics.

So good questions.

Stuart Kupfer: biomarkers, pharmacophonetic data, and NYHA class, just as an example. So there's more interesting data to come.

We believe in the multiple interactions we've had with FDA.

This year.

We have.

Heard what we need to hear in order to lend support for what I, just said, which is to say we believe that this.

Stuart Kupfer: more interesting data to come. Thanks for the question.

Salim Qader Syed: Your next question comes from the line of Saline Saeed with Missouho.

Filing should be built around galactic H F and the results and data that I am highlighting in particular and including of those.

Unknown Attendee: Good afternoon, Robert. I asked you a couple of questions on CK74. So Bristol had on their call a question on, you know, CK2-74 versus Maticamp. I'm just curious; they're saying that they don't see differentiation between the two molecules. And I'm curious how you guys are seeing it. Everything that we've seen with the published explorer data and everything that you've seen with CK2-7-4, how confident are you that CK2-7-4 is actually a differentiated molecule?

<unk> that may stand to benefit the most.

Thank you.

Thank you.

Your next question comes from the line.

Robert on jetty with H C Wainwright.

Hello on menu Ella.

Good afternoon, guys and thank you for taking my question.

You touched upon these may be earlier, but can you share some of the feedbacks from the Kols regarding Dennis on some things exactly that opt in relation to this differentiation from other continents that expectation at R&D day.

Unknown Attendee: And is there anything else?

Unknown Attendee: in the phase three data set that you produced that you think could alter that

Unknown Attendee: Thinking. And then the second question isn't about myosin inhibition in general. I'm just curious how you would perceive an adcom if Mavitam were to get one.

Unknown Attendee: Would it be a negative, negative,

Robert I. Blum: This generally. Sure, so very good questions. I'll start and ask my colleagues if they want to add anything. We do believe, we very much believe, that these are differentiated molecules, and in fact, if we didn't believe that, we wouldn't be taking Affi-Campton into phase three. And we've verified that, so it's not just our own thinking; it's verified also by our conversations with key opinion leaders and investigators in this space. But I understand a perspective that would suggest that the data from Redwood are comparable.

And switching gears to the FMT, it's nice to see that there are beginning to feel some study as planned and I know, it's early but I was hoping you could give more color on the expected timelines for the enrollment I saw you incorporated in the design a remote visits and so I just wanted just wondering based on your experience with.

Robert I. Blum: What I would underscore is that some of these things we specifically designed into CK274 or Affie Campton, like a more rapid time to onset of activity and enabling better, easier dose titration, as well as more rapid reversibility. These are things that will enable in the conduct of future clinical trials the inclusion and exclusion of patients. These are things that are enabling of a clinical trial design that should, in fact, further advance the category and the field.

On mental via less patients do you expect COVID-19 to have an impact on the trial.

And so when should we expect the interim analysis to core.

Robert I. Blum: If we didn't think that these properties of a next-in-class molecule didn't do that, we wouldn't be in a position to invest here as we expect to advance the field. So we can't elaborate today on what those features will be and how they will play out in a phase three trial. You'll know that soon enough when we announce the start of this study. We'll talk about the clinical trial design, and hopefully, that will come into more clarity. So I think that's my answer to your first question. Your second question: can you remind me? Yeah, just on the Mavocamp thing.

Yeah.

Well I'll start I'll turn it over to Stuart a little bit, but I think it's still very early to speculate on on.

Timing for the trial.

We're just literally starting to screen patients.

We're still on the process of getting sites up and going.

I think once we start to see the pace of enrollment we can maybe provide.

Some better estimated timing.

Stewart do you want to add anything to that.

All right.

That is that we have.

All learned a lot about conducting clinical trials.

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I think on other programs, we've managed reasonably well with.

Unknown Attendee: Yeah, why don't I turn to Thadi maybe to speak to that? Yeah, you know, I frankly don't want to really speculate on whether or not they may or may not get an adcom. That's really up to FDA to determine and, you know, based on the, um, submission that was made. We will just have to wait and see if they decide to have one. You know, there hasn't been any suggestion yet that there will be one.

With respect to meteoric and Redwood HCM.

But there have been lessons learned and we've designed encourage us.

So as much as possible preempt.

Issues related to disruptions from the pandemic.

And large part of.

That includes.

On a large portion of home visits.

Or for patients who enroll encourage ALS so.

Fady Ibraham Malik: Great. Thanks so much for the color and congrats on the progress. Thank you, Salim.

We have very proactively specifically designed the trial to on burden patients.

Salim Qader Syed: Your next question comes from the line of Chad Messer with Needaman. Hello, Chad.

So they won't have to.

Most of the from most of the study visits actually to happen because net themselves in person.

Chad Messer: Hello, great. Good afternoon, and thanks for taking my questions. You know, first of all, congratulations on your perseverance with all these programs. It's great to see you guys have at least exciting programs that are kind of in play, if you will, and could bring a great benefit to patients. They all have not had the easiest time.

On a clinic.

So.

All of this has been anticipated and incorporated these features into the study design and we hope that will bode well for managing any further bumps on the road related to pandemic.

Got it thank you very much.

You're welcome.

And your last question will come from the line of Craig Craig Savant.

Oldman Sachs.

Hello, Greg.

Hey, Robert and team how are you I. Thank you very much for the update and congrats on the progress.

Unknown Attendee: Um, Just a couple of questions on Rel deceptive, guys are moving forward with the phase three trial very excited about it. What's been the response from the ALS community? We've all been waiting around for a while to hear about this, but I think maybe the patients are the most anxious. And then maybe can you comment on what lessons you learn from fortitude that you think will make the we're calling it the Courage, is that right Sure, I'll take the first part of that question. I'll ask Faddy to take the second part.

I was curious about earlier comments you made on the call about your early experience with commercial payers I believe that was in relation to chip.

2 oh mcham from a car bolt on I was wondering if you could share.

Any of the insights.

From that early experience certainly there is still some time ago, but wondering what the initial feedback has been.

And then secondly.

I wanted to get a sense of and I might've missed this before from my apologies.

Think about the clinical trial design for Abbvie Hampton.

How similar or how difference might be from the Maverick Camden phase III.

Robert I. Blum: So in terms of the response from the ALS community, admittedly, the community was confused by what had been the delay between the announcement of the results of fortitude ALS and our start of courage ALS. Because, if you recall, when those results were first announced, they were characterized as amongst the most promising phase two results ever seen in ALS, and that being an international placebo-controlled large study, it showed quite encouraging data lending support for phase three.

You can expect that many of us will be trying to see how apples to apples it may be and it doesn't have to be but I'm. Just curious if you could.

Give us some high level thoughts around how you're thinking about that phase III trial. Thanks.

Sure. So I'll ask Andrew to tackle the first question, which is relating to.

Early feedback and perspectives related to players and then maybe I'll ask Stuart to comment on the.

Second part of your question relating to the trial.

4 Rafi Kimpton Andrew.

Sure Robert.

The payer meetings, we've had about a half a dozen payer meetings across large pbms med D and commercial.

Robert I. Blum: But as we committed to shareholders, we wanted to make certain that before we advanced Rel deceptive to phase three, we had a number of things that we had to accomplish first. We wanted to discuss those results with FDA, but also with payers, both in the U.S. and in Europe.

Most of the meetings have been introductory in nature and trajectory of our company our science, our people and we certainly have more.

Substantial interaction scheduled as the year progresses.

Totally.

Anticipate filing for <unk>.

In December for net.

The inclusion in the 2023 reimbursement and access team so.

Robert I. Blum: We wanted to discuss a design for a clinical trial that would be enabling of some looks into the data, as would be enabling of an interim stop for futility if it looked like that was appropriate, and a second interim down the road, as could also be expanding the study if it looked like that was appropriate, you know, looked like that may be warranted. We wanted to understand the cost of the study, and we wanted to renegotiate our collaboration agreement with Estellus in order to have them enable our lead in this area and also their co-funding of that trial. Both of those things were negotiated successfully.

Overall, the interactions have been positive literally.

Yes, I'd say that in large part these meetings are focused to socializing the science introducing the company.

We want to make sure were on their radar screen as you can well imagine they do budgeting and other activities in anticipation of new product launches and those things are already underway.

Now the second part of your question related to the Phase III design of Kimpton, and how it might compare to Maverick campton and whether this is going to be an apples and oranges or an apples on apples and I'll tell you.

We believe that.

For the.

The.

The fact that Redwood HCM delivered on its next in class.

Robert I. Blum: We wanted to best understand what patients would be looking for in their participation in a clinical trial because, as you may know, the landscape for trials in ALS has become more crowded, which is a good thing, but at the same time, we wanted to make certain we could be enrolling our study expeditiously and know that we would have the support of the patient community. It so happens that in these last couple of years, during this time when we would have the support of the patient community, and we would have the support of the patient community while we were assessing these matters, the ALS community, as led by certain advocacy groups, has become much more assertive and engaged. It's a good thing.

Profile.

That we need to design a study that is advancing the field and therefore, it should be apples and apples, but there are different kinds of apples and with that I'll just see if stewart wants to add anything more.

Only that.

We certainly have learned a lot from the Redwood HCM trial.

As well as the explorer trial, and we will take those learnings into our study design for phase III were not really prepared to offer any details.

Or discuss those in today's the day.

Paul.

On the study design.

Details will be forthcoming later this year.

Yes, you won't have to wait very long, we're gonna be providing those details soon enough now that we've had these recent interactions with FDA and we can lock in on the protocol. We expect to begin this study soon and we'll elaborate on those design elements soon.

Robert I. Blum: And at the same time, they've been assessing and evaluating which clinical trials would be best to direct patients to participate in. I'm really pleased to be able to share today that ALS, one of those advocacy groups that does rate clinical trials, gave our trial, Courage ALS, its highest rating. And there are only a couple of trials that have that five-star rating. They look at this design in terms of what's in the best interest of patients, and they score it amongst their highest ever clinical trials. So all of these things we wanted to do.

And there are no further questions at this time I'd like to turn the call back over to management for any closing remarks.

Thank you operator, and thank you to all the participants on our teleconference. Today.

We've had a very productive second quarter and it sets the table for what we hope will be our ability to continue to execute very well against other key milestones and metrics.

We thank you for your continued support and your interest in Cytogenetics, and we look forward to keeping you updated on our progress.

Operator.

Include the call.

Robert I. Blum: to line up before we started this trial in order to make certain that we could finish what we started and do so to give the drug and patients the best chance for success here. And I think we did that well, and hence we've started Courage ALS now. With that said, I'll turn it over to Fadi to answer the second part of your question. Chad, you know, with respect to the design of courage and how it may have a higher probability of success. I think you have to look back to our conduct of fortitude, which you mentioned to begin with. Fortitude was a pretty sizable study in ALS. It enrolled over 450 patients.

Ladies and gentlemen, we thank you for your participation. This does conclude today's conference call.

You may now.

[music].

Yes.

[music].

Fady Ibraham Malik: We had, I think, compelling signals of slowing decline in both the primary end point of this phase three study, the ALSFRS, as well as in slow vital capacity, and those signals were strengthened when you looked at patients that came into the study that were progressing more quickly than others. And so in designing courage, as others are doing now at ALS, is focusing on enrolling patients whose disease may be progressing more rapidly and other things that we've done in the design to optimize, we think, its chances for success.

Fady Ibraham Malik: So we're fairly encouraged based on both the precedent, Fortitude ALS, as well as the way we've implemented it. You know, from a portfolio standpoint, it was incumbent upon us also to know that when we're advancing RELDissemptive in ALS, it's occurring alongside of the advancement of our pipeline for new cardiovascular medicine. So Omicampton, Macarble moving forward, as well as Affie Campton moving forward, we believe is enabling our advancement of REL in key ways, and as is in the interests of diversified product development risk, as well as hopefully maximizing potential shareholder value. All right, thank you. I appreciate those answers, and you know once again on getting with all three major programs as well as the other things you're working on. Thank you, Chad.

[music].

Jeff Hung: Your next question comes from Jeff Hong with Morgan Stanley.

Robert I. Blum: Hey, Robert, thanks for taking the questions. Just to clarify Jason's question earlier on OmaCanthacarbel, are you going for a broad label, or would you expect that the label will focus on the more severe patients, specifically calling out, you know, the patients with a lower rejection fracture? Yeah, again, I'm not going to be so elaborative about our strategy, but I think it's fair to say that our intention, our objective, is to go for a broader label, but one that would also be inclusive of those data and results that are highlighting where the effects are more maximal, and as such, provide physicians with more information as to guide therapy. Okay, thanks. And then, can you talk about the feedback that FDA has provided at the Type C and pre-NDA meeting on your plans to submit the NDA on the Galactic data?

Unknown Attendee: Has there been any pushback about the focus on the more severe patients?

Unknown Attendee: suggested that any additional clinical work might need to be done, or do they seem completely on board with the available data? So, good questions. We believe in the multiple interactions we've had with FDA this year that we have heard what we need to hear in order to lend support for what I just said, which is to say we believe that this filing should be built around Galactic HF and the results of the data that I am highlighting in particular and including. Of those patients that may stand to benefit the most,

Robert I. Blum: Your next question comes from the line of Emmanuel Brandtetti with H. C. Wainwright.

Emmanuel Brandtetti: Hello, good afternoon, guys, and thank you for taking my question. Perhaps you touched upon this maybe earlier, but can you share some of the feedback you received from the KOLs regarding the results obtained with Redwood, perhaps in relation to the differentiation from Mavacampton and their expectations around the design and the target population for the upcoming phase three?

Unknown Attendee: Sure, so specifically your question relates to feedback we've received on Affie Campton and how it may set the stage for phase three.

Fady Ibraham Malik: Yeah, I think, you know, in presenting these results to our steering committee, we haven't, obviously, since we haven't presented them more broadly, focused on those that were involved in the trial. You know, they were really quite pleased with the profile of what we saw, the number of responders, the magnitude of effect, evidence of reversibility, and the overall safety profile that we observed in the number of responders, the magnitude of effect, evidence of reversibility, and the overall safety profile that we observed in the overall safety profile that we observed in the phase two trial.

Fady Ibraham Malik: You know, I think all of those things lend themselves to the design that we will implement in phase three, which, as I said, we'll elaborate on at a later time. But, you know, overall, the feedback was quite enthusiastic.

Unknown Attendee: Got it, got it. And switching gears to the relative, it's nice to see the drug beginning the Peevostol Study as planned. And I know it's early, but I was hoping you could give more color around the expected timelines for enrollment. I saw you incorporated remote visits into the design. And so I was just wondering, based on your experience with the enrollment of ALS patients, do you expect COVID-19 to have an impact on the trial? And so when should we expect it? back for the interim analysis to occur.

Fady Ibraham Malik: Well, I'll start it off, turn it over to Stewart a little bit, but I think, you know, it's still very early to speculate on the timing of the trial. We're just literally starting to screen patients. We're still in the process of getting sites up and going. You know, I think once we start to see the pace of enrollment, we can maybe provide some better estimated timing. Stuart, do you want to add anything? Well, what I'll add is that we've all learned a lot about conducting ourselves.

Stuart Kupfer: clinical trials in a pandemic. I think in other programs we managed reasonably well, with respect to Meteoric and Redwood HCM. But there have been lessons learned, and we've designed Courage ALS to, as much as possible, preempt issues related to disruptions from the pandemic.

[music].

Stuart Kupfer: That includes a large portion of home visits for patients who enroll in the trial. We have very proactively, specifically designed the trial to unburden patients, so they won't have to do most of the study visits.

Unknown Attendee: visits actually have to present themselves in person and the clinic. All of this has been anticipated. We've incorporated these features into the study design, and we hope that will bode well for managing any further bumps in the road related to the pandemic.

Unknown Attendee: Thank you.

Craig Savonavea: And your last question will come from the line of Craig Savonavea with Goldman Sachs.

Unknown Attendee: Hey, Robert, and team, how are you? Thank you very much for the update and congratulations on the progress. I was curious about earlier comments you made on the call about your early experience with commercial payers. I believe that was in relation to Oma Camp of McCarbel.

Unknown Attendee: I was wondering if you could share any of the insights from that early experience. There's still some time to go, but I was wondering what the initial feedback has been. And then secondly, I wanted to get a sense of, and I might have missed this before, some of my apologies, as you think about the clinical trial design for Affie-Campton, how similar or how different might that be from the Mavicampton Phase 3? As you can expect, many of us will be trying to see how apples-to-apples it may be, and it doesn't have to be, but I Thanks.

Robert I. Blum: Sure, so I'll ask Andrew to tackle the first question, which is relating to early feedback and perspectives relating to payers. Maybe I'll ask Stuart to comment on the second part of your question relating to the trial, for Ruffy Kempton. Andrew?

Andrew Callos: Sure, so the payer meetings, we've had about a half-dozen pair meetings across large BBMs, MedD, and commercial. Most of the meetings have been introductory in nature to our company, our science, our people, and, you know, we certainly have more substantial interactions scheduled as the year progresses, and we certainly anticipate filing for, in December, for inclusion in the 2023 reimbursement and access scheme. So overall, the interactions have been positive but early.

Andrew Callos: Yeah, I'd say that in large part these meetings are focused to socializing the science, introducing the company. We want to make sure we're on their radar screen, as you can well imagine, they do budgeting and other activities in anticipation of new product launches, and those things are already underway. Now, the second part of your question related to the phase three design of Afi-Campton and how it might compare to Mavik Campton, and whether this is going to be in apples and oranges or in apples and apples, and I'll tell you, We believe that for the fact that Redwood HCM delivered on its next in class profile that we need to design a study that is advancing the field and therefore it should be apples and apples but there are different kinds of apples, And with that, if Stewart wants to add anything more.

[music].

Andrew Callos: Only that we certainly have learned a lot from the Redwood HCM trial, as well as the Explorer trial, and we'll take those learnings into our study design for phase three. But we're not really prepared to offer any details.

Stuart Kupfer: or discuss those in today's show. You know, you know, the study design details will be forthcoming later this year. You won't have to wait very long,

Stuart Kupfer: Yeah, you won't have to wait very long. We're going to be providing those details soon enough. Now that we've had these recent interactions with FDA and we can lock in on the protocol, we expect to begin this study soon, and we'll elaborate on those design elements soon.

Unknown Attendee: And there are no further questions at this time. I'd like to turn the call back over to management for any closing remarks. Thank you, operator.

Robert I. Blum: Thank you, operator, and thank you to all the participants in our teleconference today. We've had a very productive second quarter, and it sets the table for what we hope will be our ability to continue to execute very well against other key milestones and metrics. We thank you for your continued support and your interest in cytokinetics, and we look forward to keeping you updated on our progress.

Operator: Ladies and gentlemen, we thank you for your participation. This does conclude today's conference call. You may now just...

Unknown Attendee: I'm and you know. The and and and and You and You and You Thank You, Bres. Thank you. Thank you. Thank you. Thank you.