Q3 2020 Cytokinetics Inc Earnings Call

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

Unknown Executive: At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company's request, we will open the call for questions and answers after the presentation. I will now turn the call over to Diane Weiser, Cytokinetics' Senior Vice President of Corporate Communications and Investor Relations.

The company's request, we will open the call for questions and answers after the presentation.

I'll now turn the call over to Dianne Wiser Cytokinetics Senior Vice President of corporate Communications and Investor Relations. Please go ahead.

Good afternoon, and thanks for joining us on the call today, probably our president and Chief Executive Officer will kick off the call with a recap of our top line results from Galactic HF and an overview of our progress during the quarter, then Sadie Malik our SVP of research and development will provide perspective on the top line.

Diane Weiser: Good afternoon, and thanks for joining us on the call today. Robert Blum, our President and Chief Executive Officer, will kick off the call with a recap of our top-line results from Galactic HF and an overview of our progress during the quarter. Then, Fady Malik, our EVP of Research and Development, will provide perspective on the top-line results, what we can expect from presentations at AHA, and an update on Meteoric HF, the second phase 3 clinical trial of Omicamptive Mercarbol. Next, Stuart Kupfer, our SVP and Chief Medical Officer, will update on recent progress with CK274, our cardiac myosin inhibitor, which is being studied Then, Robert Wong, our VP and Chief Accounting Officer, will provide a financial overview for the quarter, and Qing Jia, our SVP and Chief Financial Officer, will discuss strategic planning and our financial outlook before Robert Blum provides concluding thoughts on the company's path forward and expected key milestones for the remainder of the year.

So what we can expect from presentations at ha and an update on meteoric H. ask the second phase three clinical trial of Omecamtiv Mecarbil next door Kupfer, our SVP and Chief Medical Officer will update on recent progress with CK two seven for our cardiac myosin inhibitor, which is a sub.

Got to read what HCM as well as T.K. 271, our additional cardiac myosin inhibitor then Robert won our VP and Chief Accounting Officer will provide a financial overview for the quarter and changed our SVP and Chief Financial Officer will discuss strategic planning and our financial outlook before Robert Blake.

Provides concluding thoughts on the company's path forward and expected key milestones for the remainder of the year.

Please note that portions of the following discussion, including our responses to questions contains statements that relate to future events and performance rather than historical facts and constitute forward looking statements. Our actual results may differ materially from those projected in these forward looking statements additional information concerning factors that could cause our actual results.

Diane Weiser: 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. We undertake no obligation to update any forward-looking statements after this call.

To differ materially from those in these forward looking statements is contained in our SEC filings. We undertake no obligation to update any forward looking statements. After this call and now I will turn the call over to Robert.

Robert I. Blum: And now I will turn the call over to Robert. Thank you, Diane, and thanks again to everyone for joining us on the call today. I'll begin with our most recent news. A few weeks ago, we were pleased to announce the top-line results of GALACTIC-HF, which demonstrated treatment with Omicamptive-McCarbol achieved the primary composite efficacy endpoint of the trial and demonstrated a statistically significant effect to reduce the risk of cardiovascular death or heart failure-related events compared to placebo in patients treated with standard of care and with a p-value less than Galactic HF is a large-scale, over 8,000 patient international trial, and the first Phase III trial to test this novel mechanism, and admittedly, we and Amgen swung for the fences with this Phase III outcomes trial and the overall development program for Omicamptive McCarville.

Thank you Diane and thanks again to everyone for joining us on the call today Okay.

Beginning with our most recent news a few weeks ago. We were pleased to announce top line results of Galactic HF, which demonstrated treatment with Omecamtiv mecarbil achieved the primary composite efficacy endpoint of the trial and demonstrated statistically significant effect to reduce the risk of cardiovascular.

Joe or heart failure related events compared to placebo in patients treated with standard of care and with a P value less than 0.05.

Good luck to take true is a large scale over 8000 patient international trial.

The first phase three trial to test this novel mechanism and it.

Admittedly, we and Amgen swung for the fences with this phase three outcomes trial and the overall development program for Omecamtiv Mecarbil.

We had hopes of hitting a home run for patients with heart failure by decreasing heart failure events, reducing cardiovascular mortality, improving quality of life and extending patient stamina and insurance.

Robert I. Blum: We had hopes of hitting a home run for patients with heart failure by decreasing heart failure events, reducing cardiovascular mortality, improving quality of life, and extending patient stamina and endurance. And while results from Galactic HF may have fallen short of our most ambitious expectations by missing on the first secondary end point of cardiovascular death alone, we believe the results, as already communicated, put us in a potential scoring position by hitting on the primary efficacy endpoint and by demonstrating balanced safety across treatment arms. Considering the novel mechanism of action of Omicamptin-McCarville and the scope and scale of Galactic HF, having enrolled patients in 35 countries, both inpatients and outpatients, and patients well maintained on the standard of care, we believe there's a lot more to the results of this trial, as will be illuminated by the presentation of the primary results at the upcoming AHA scientific sessions next week.

And well results from Galactic HF may have fallen short of our most ambitious expectations by missing on the first secondary endpoint of cardiovascular death alone.

We believe the results has already communicated put us in potential scoring position like getting on the primary efficacy endpoint and by demonstrating balance safety across treatment arms.

Considering the novel mechanism of action of Omecamtiv, Mecarbil, and the scope and scale of Galactic HF, having enrolled patients in 35 countries, both inpatient and outpatient and patients well maintained on standard of care. We believe there's a lot more to the results of this trial as well.

Be illuminated by the presentation of the primary results at the upcoming Ha scientific sessions next week.

Already Galactic HF has revealed to be a very important clinical trial for heart failure patients and the heart failure community. Because we now have evidence that increasing contractility can safely improve meaningfully relevant outcomes important to physicians patients and payers.

Robert I. Blum: Already, Galactic HF has revealed itself to be a very important clinical trial for heart failure patients and the heart failure community because we now have evidence that increasing contractility can safely improve meaningfully relevant outcomes important to physicians, patients, and payers. And, of course, this is an important outcome for cytokinetics and our employees and shareholders. A major event for us, in fact, having committed over 15 years to the clinical development of Omicamptin-McCarbol and, more recently, the commercial readiness for the potential launch of our first-in-class cardiac myosin activator. We are now immersed in ongoing analyses of data from Galactic HF and discussions about potential next steps with Amgen, as well as with members of the academic executive committee of the trial. Together, we're continuing to conduct pre-specified and supplemental analyses suggested by the top-line results in preparation for the late-breaking presentation to be given by Dr. John Tierlink at AHA, as well as other activities to follow.

And of course this is an important outcome for cytokinetics and our employees and shareholders a major event for us in fact, having committed over 15 years to the clinical development of Omecamtiv Mecarbil and more recently the commercial readiness for the potential launch of our first in class.

S. cardiac myosin activator.

We're now in burst in ongoing analyses of data from Galactic HF and discussions about potential next steps with Amgen as well as with members of the academic Executive Committee of the trial together, we're continuing to conduct pre specified and supplemental analyses.

Suggested by the top line results in preparation for the late breaking presentation to be given by Dr., John purely at ha as well as other activities to follow we look forward to our ability to discuss these results in more detail very soon.

Robert I. Blum: We look forward to our ability to discuss these results in more detail very soon. Following Dr. Tierling's presentation at AHA, Cytokinetics will convene a publicly available investor and media call with Dr. Tierling and others from the executive committee of the trial to review the results in the context of the high clinical unmet need for patients with heart failure, as well as the growing economic burden of the disease. Recognizing we can't say too much more prior to the presentation at AHA, Fady will review the top-line results in a moment and put them into the context of the trial design.

Following dr. tier leagues presentation at A.J., Cytokinetics will convene a publicly available investor and media call with Dr. tier link and others from the Executive Committee of the trial to review the results in the context of the high clinical unmet need for patients with heart.

So your as well as the growing economic burden of the disease.

Recognizing we can't say too much more prior to the presentation today, Jay Saudi will review the topline results in a moment and put them into the context of the trial design.

He will also provide an update on progress and meteoric age up the second phase three clinical trial of Omecamtiv Mecarbil.

Robert I. Blum: He'll also provide an update on progress in METEORIC-HF, the second phase three clinical trial of Omicamptin-McCarbol. Turning to our Cardiac Myosin Inhibitor Program, we continue to make progress, and look forward to advancing Redwood HCM to its Cohort 2 by year-end. Much like in heart failure, HCM patients are in great need of novel therapies to address the underlying contractile dysfunction of their disease.

Turning to our cardiac myosin inhibitor program, we continue to make progress.

And look forward to advancing Redwood HCM to its co or two by year end much like in heart failure HCM patients are in great need of novel therapies to address the underlying contract I'll just function of their disease, and we're working with urgency to progress our program.

Robert I. Blum: And we're working with urgency to progress our program on the heels of our licensing deal with Zhijing Pharmaceuticals and our royalty deals with RTW. Stuart will provide more details on progress with this program in a moment. And finally, during the third quarter, we continued readiness activities in preparation for the potential start of a Phase III clinical trial of rel-deceptive in patients with ALS. And to remind you, we've communicated that we would make a decision regarding the potential advancement of Rel-Deceptive to Phase 3 following a review of the results of Galactic HF, and that decision has not been made. It's still forthcoming,

On the heels of our licensing deal was using pharmaceuticals, and our royalty deals with our T. W.

Stuart will provide more details on progress for this program in a moment.

And finally during the third quarter, we continued readiness activities in preparation for the potential start of a phase three clinical trial of real deceptive in patients with less.

And to remind you we've communicated that we would make a decision regarding potential advancement of rail deceptive to phase three following a review of results of Galactic HF and that decision has not been made its still forthcoming.

We will have more clarity on our plans following the presentation of results of Galactic HF Ah ha as well as <unk>.

Robert I. Blum: We will have more clarity on our plans following the presentation of the results of Galactic HF at AHA, as well as upon the conclusion of ongoing internal planning and budgeting, and also discussions to be convened with our board later this quarter. And with that, I'll turn the call now over to Fady to elaborate on developments related to Omicamp and McCarville. Thanks, Robert.

Upon conclusion of ongoing internal planning and budgeting and also discussions to be convert convene with our board later this quarter.

With that I'll turn the call now over to Fady to elaborate on developments related to Omecamtiv mecarbil.

Thanks Robert.

Fady Ibraham Malik: I'd like to express my thanks to the research and development teams, as well as all of our colleagues at Cytokinetics, for their commitment to the program over these years, and commend our colleagues at Amgen for their conduct of galactic HF and collaboration. And, as we announced a few weeks ago, the results of GALACTIC-HF show that treatment with ilmecansin-micarbol achieved the primary efficacy endpoint and demonstrated a statistically significant effect to reduce risk for the composite outcome of the time to a heart failure event or cardiovascular death, whichever occurred first, compared to placebo in patients treated with standard of care. A heart failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for worsening heart failure leading to treatment intensifications beyond changed oral diuretic therapy. The hazard ratio for this benefit was 0.92, with a p-value of 0.025. No reduction in the secondary endpoint of CV death was observed.

I'd like to express my thanks to the research and development teams as well as all of our colleagues at Cytokinetics for their commitment to the program over these years and commend our colleagues at Amgen for their conduct of Galactic HF in collaboration.

And as we announced a few weeks ago. The result of Galactic HF showed that treatment with Omecamtiv mecarbil cheap the primary efficacy endpoint and demonstrated a statistically significant effect to reduce risk or the composite outcome or the time to a heart failure event or cardiovascular death.

Ever occurred first compared to placebo in patients treated with standard of care.

Heart failure event was defined as an urgent clinic visit emergency department visits or hospitalization for worsening heart failure, leading to treatment intensification beyond changed oral direct therapy.

The hazard ratio for this benefit was 0.92 with a P value of 0.0 to five.

No reduction in the secondary endpoint of CV death was observed adverse events, including major eamich cardiac adverse events were balanced between treatment arms.

Fady Ibraham Malik: Adverse events, including major ischemic cardiac adverse events, were balanced between treatment arms. Additional pre-specified and supplemental subgroup analyses are ongoing and may suggest one or more populations in which the effect of the drug may be larger than in the overall population. Given the size of galactic HF, some of these subgroups are quite sizeable, and in and of themselves are larger than many contemporary heart failure trials. I'll remind you that we enrolled a broad and heterogeneous patient population, including patients within and outside of the hospital and patients with lower blood pressures and reduced kidney function than is customary in many trials that preceded galactic HF. We look forward to the upcoming presentation that John Skierlink will give virtually on November 13th and expect to expand ourselves in this initial presentation in the weeks and months to come.

Additional pre specified and supplemental subgroup analyses are ongoing and may suggest one or more populations in which the effect of the drug may be larger than in the overall population.

Given the size of Galactic HF. Some of these subgroups are quite sizable and then have them have themselves are larger than many contemporary heart failure trial.

I'll remind you that we enrolled a broad and heterogeneous patient population, including patients within and outside of the hospital and patients with lower blood pressures and reduce kidney function and its customary in many trials that preceded galactic HF.

We look forward to the upcoming presentation that John Stirling forgive virtually on November 13, and expect to expand ourselves on are in the initial presentation in the weeks and months Uh Huh.

Well the opportunity for Omecamtiv Mecarbil in light of these top line results may be different and perhaps not as broad as we had anticipated.

Fady Ibraham Malik: Well, the opportunity for Omicam for McCarble, in light of these top-line results, may be different, and perhaps not as broad as we'd anticipated. However, we believe this novel mechanism drug candidate that improves cardiac contractility may play an important and complementary role with other therapies to increase cardiac function and performance, as well as to reduce heart failure hospitalizations and events. These remain a high unmet clinical and economic need despite the availability of standard of care therapies.

We believe its novel mechanism drug candidate that improves cardiac contractility may play an important and complimentary role along other therapies to increased cardiac function and performance as well as to reduce heart failure hospitalizations and events.

These remain a high unmet clinical and economic need despite the availability of standard of care therapies.

We also look forward to learning about the effect of increasing cardiac contractility patients with heart failure through the addition of Omecamtiv Mecarbil to standard of care as is being studied in a meteoric hfs.

Fady Ibraham Malik: We also look forward to learning about the effects of increasing cardiac contractility in patients with heart failure through the addition of omicamptive macbals to standard of care as is being studied in meteoric HF. The second phase 3 trial of Omacampton-McCarville that continued during the third quarter will provide insight into another key aspect aimed at improving the lives of patients who are failing with reduced ejection fraction, that is, exercise capacity.

Second phase three trial of Omecamtiv Mecarbil that continued during the third quarter.

Meteoric will provide insight into another key aspect aimed at improving the lives of patients heart failure with reduced ejection fraction that is exercise capacity.

Exercise capacity is recognized by the FDA as appropriate to demonstrate benefit and in conjunction with the efficacy and safety data we have seen thus far from Galactic HF meteoric HF may elaborate further on the potential benefit of Omecamtiv mecarbil.

Fady Ibraham Malik: Exercise capacity is recognized by the FDA as appropriate to demonstrate benefits, and in conjunction with the efficacy and safety data we have seen thus far from galactic HF, meteoric HF may elaborate further on the potential benefit of Omecamptin-McCarbol. During the quarter, meteoric HF continued enrollment in North America, and we saw enrollment accelerate in the EU during the summer and fall months. All countries involved in the trial of screened patients and nearly all of the randomized patients. We recently surpassed the 50% mark for the target number of randomized patients and are grateful to our participating sites for the momentum we regained after reopening the trial to enrollment following the pause earlier this year due to the COVID-19 pandemic. As you all know, conditions remain unpredictable, but we are optimistic that METEORIC-HF will continue to perform well over the coming months, given the measures to be in our sights of influence. I'm pleased to share that during the quarter, the Data Safety and Monitoring Committee, or DMC, for Meteoric HF, met to review data generated thus far and recommended the trial continue as planned with no changes to the protocol. We expect the complete enrollment of Meteoric HF to take place in the first half of 2021.

During the quarter meteoric HF continued enrollment in North America, and we saw enrollment accelerate in the EU during the summer and fall months.

All countries involved in the trial of screen patients nearly all randomized patients.

Recently surpassed the 50% Mark for the target number of randomized patient and are grateful to our participating sites for the momentum we regained after reopening the trial to enrollment following the pause earlier this year due to the COVID-19 pandemic.

As you all know conditions remain unpredictable, but we're optimistic that meteoric HF will continue to enroll well over the coming months given amendment fee sites have implemented.

I'm pleased to share that during the quarter, the data safety and monitoring committee or DMC for meteoric HF met to review data generated thus far and recommended the trial continue as planned with no changes to the protocol.

Expect to complete enrollment of meteoric Asia in the first half of 2021.

We remain enthusiastic about the potential for Omecamtiv mecarbil to provide new mechanism therapy to the physicians aren't armamentarium.

To address the progression of heart failure.

And importantly, reduce the cycle of hospitalizations and re hospitalizations that plague patients lives a significant cost to hospitals and payers.

Fady Ibraham Malik: We remain enthusiastic about the potential for omicancin-McCARBAL to provide new mechanism therapy to the physician's armamentarium, to address the progression of heart failure, and, importantly, reduce the cycle of hospitalizations and re-hospitalizations that plague patients' lives at significant cost to hospitals and payers. We will be considering next steps together with Amgen in the coming weeks and months and continue to believe that increasing cardiac contractility with Omicampt and McCarble may represent a novel strategy to complement standard of care therapy in managing patients still at risk despite standard of care therapy. And now, we'll turn it over to Stuart to provide an update on our cardiac myosin inhibitor program. Thanks, everybody.

We will be considering next steps together with Amgen in the coming weeks and months and continue to believe that increasing cardiac contractility with omecamtiv mecarbil. They represent a novel strategy to complement standard of care therapy, and managing patients still at risk Despite standard therapies.

And now I'll turn it over to Stuart to provide an update on our cardiac myosin inhibitor program.

Thanks.

Let's start with an update.

Okay.

Thanks Troy.

Let's see.

Hey.

Correct.

I'm pleased to report that.

Please.

One.

Great.

I'm sorry to interrupt you I think that we'll have Sadie pickup there seems to be some major static on your line.

Hey.

All right I'll I'll.

I'll start.

So let me start with an update on Redwood HCM.

Stuart Kupfer: Let me start with an update on the... This is a basic clinical trial of CK274 in patients with intrusive hypertrophic cardiomyopathy. I'm pleased to report that in October, we completed the development of COVID-19 in the Rhode Island Health System. I'm sorry to interrupt, Stuart. I think that we'll have Fady pick up. There seems to be some major static on your line.

A phase two clinical trial of CK, two seven for patients with obstructive hypertrophic cardiomyopathy.

I'm pleased to report that in October we completed enrollment of cohort, one and Redwood HCM.

I remind you of the trial design in a blinded manner patients are randomized in a two to one fashion to placebo or escalating doses of CK 274.

Fady Ibraham Malik: Fady? All right, I'll start. So let me start with an update on Redwood HCM. A Phase II Clinical Trial of CK274 in Patients with Obstructive Hypertrophic Cardiomyopathy, I'm pleased to report that in October we completed enrollment of Cohort 1 in Redwood HCM. To remind you of the trial design, in a blinded manner, patients are randomized in a two-to-one fashion to placebo or escalating doses of CK274. Daily doses of 5, 10, or 15 mg are employed in cohort 1, with dose titration individually determined on the basis of achieving specific echocardiographic targets.

Daily doses of 510 or 15 milligrams are employed in cohort one with dose titration individually determined on the basis of achieving specific echocardiographic target.

Overall, the treatment duration is 10 weeks and will support assessments of safety and Tolerability pharmacokinetics and Pharmacodynamic responses we.

We expect the last patient to complete dosing in this fourth quarter and to inform progression to co or two by the end of the year with full results available by mid Twentytwenty one.

We are well positioned to initiate cohort two with the majority of sites activated in North America, and key countries in Europe, including Spain, The Netherlands and Italy.

Fady Ibraham Malik: Overall, the treatment duration is 10 weeks and will support assessments of safety and tolerability, pharmacokinetics and pharmacodynamic responses. We expect the last patient to complete dosing in this fourth quarter and to inform progression to COVR2 by the end of the year with full results available by mid-2021. We are well positioned to initiate cohort 2, with the majority of sites activated in North America and key countries in Europe, including Spain, the Netherlands, and Italy. Investigators and study teams remain enthusiastic to participate in this trial to characterize the benefit-risk profile of our next-in-class cardiac myosin inhibitor, and we look forward to further engaging with, In terms of what you can expect from our communications when we progress to Cohort 2, since the trial will still be ongoing and treatment assignments not fully unblinded, we anticipate providing the doses selected for Cohort 2 based on experience in Cohort 1 and perhaps directionality on aggregate data.

Investigators and study teams remain enthusiastic to participate in this trial to characterize the benefit risk profile of our Nexsan class cardiac myosin inhibitor and we look forward to further engaging with them.

In terms of what you can expect from our communications when we progressed to co or two since the trial will still be ongoing and treatment assignments not fully in blinded, we anticipate providing the doses selected for cohort two based on experience in cohort one and.

And perhaps directionality on aggregate data ultimately the goal of Redwood HCM it to determine the optimal dosing regimen of CK two seven for for a phase III clinical trial on the basis of Pharmacodynamic effects, such as reducing left ventricular outflow obstruction as well as the safety and Tolerability.

The profile of CK 274.

Our goal remains to initiate a phase three registration program for CK 274 in patients with obstructive hypertrophic cardiomyopathy in late Twentytwenty one.

I'm pleased to report that during the quarter the data monitoring committee for Redwood HCM convene a meeting and after review of the data thus far data monitoring Committee recommended the trial continue as planned with no changes to the protocol.

Also during the quarter, we made progress with our new partners that growing pharmaceutical.

Fady Ibraham Malik: Ultimately, the goal of Redwood HCM is to determine the optimal dosing regimen of CK274 for a Phase 3 clinical trial on the basis of pharmacodynamic effects, such as reducing left ventricular outflow obstruction, as well as the safety and tolerability profile of CK274. Our goal remains to initiate a Phase III registration program for CK274 in patients with obstructive hypertrophic cardiomyopathy in late 20 I'm pleased to report that during the quarter, the Data Monitoring Committee for Redwood HCM convened a meeting, and after review of the data thus far, the Data Monitoring Committee recommended the trial continue as planned with no changes to the protocol. Also, during the quarter, we made progress with our new partners at Zhixing Pharmaceuticals.

We are proceeding to ready for the start of clinical development of CK 274 in China that would enable China to be part of the pivotal phase three clinical trial.

We believe that enrolling patients.

In.

We believe that enrolling patients from China, and a potential international registration trial may confer key advantages for potential global registration program with CK 274.

In parallel during the quarter Cytokinetics continued planning for the conduct of clinical trials of CK, two some for and potentially other indications.

Such as non obstructive hypertrophic cardiomyopathy, and then the subgroup of heart failure patients with preserved ejection fraction or hep.

We look forward to sharing more regarding our potential plans for CK 274 in these areas and Twentytwenty one.

During the quarter. We also initiated a phase one study of CK 271 art.

Additional cardiac myosin inhibitor.

As a reminder, the primary objective of this first in human Phase. One study is to assess the safety and Tolerability pharmacokinetics of single ascending oral doses of CK 271 in healthy adult subjects.

Fady Ibraham Malik: We are proceeding to ready for the start of clinical development of CK274 in China that would enable China to be part of the pivotal Phase III clinical trial. We believe that enrolling patients from China in... may confer key advantages for a potential global registration program with CK274. In parallel, during the quarter, Cytokinetics continued planning for the conduct of clinical trials of CK274 and potentially other indications, such as non-obstructive hypertrophic cardiomyopathy and in the subgroup of heart failure patients with preserved ejection fraction or HFPAF. We look forward to sharing more regarding our potential plans for CK274 in these areas in 2021. During the quarter, we also initiated the Phase 1 study of CK271, our additional cardiac myosin inhibitor. As a reminder, the primary objective of this first in human phase 1 study is to assess the safety and tolerability and pharmacokinetics of single ascending oral doses of CK271 in healthy adult subjects.

On track to complete the study during this fourth quarter.

Finally during the quarter were proud to provide a 1 million dollar grant and enter a four year partnership with the HCM registry, a global registry of patients with hypertrophic cardiomyopathy focused on improving predictive measures of risk for complications and identifying biomarkers.

Associated with adverse clinical outcome.

The registry has been funded to date by the National Heart lung and Blood Institute part of the National Institutes of health and is being conducted by the University of Virginia, and the University of Oxford.

As an industry sponsor Cytokinetics will join the HCM, our steering committee and an observational capacity.

Our long term commitment to this important initiative is aligned with our dedication to outcomes research along with our own device drug development in the interest of patient centric engagement and improve health spin.

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

Robert.

Thanks, Betty I'll first provide an update on cash revenue and spending and then Ching will review, our strategic planning and financials looking forward more.

More details on our actual results for the third quarter are included in the press release, which we released earlier this afternoon.

We ended the third quarter with approximately $451 million in cash and investments.

Fady Ibraham Malik: We're on track to complete the study during this fourth quarter. Finally, during the quarter, we're proud to provide a $1 million grant and enter a four-year partnership with the HCM Registry, a global registry of patients with hypertrophic cardiomyopathy focused on improving predictive measures of risk for complications and identifying biomarkers associated with adverse clinical outcomes.

This balance does not include $85 million, which as expected upon the closing of our sale of a royalty on myocardial now the khamsin.

Our tw investments.

Our revenue in Q3 2020 came primarily from license revenue for the our TWC transaction and from our strategic alliances with Amgen and the Stella.

Our third quarter 2020, R&D expenses increased to 24.2 million from $20.2 million in the third quarter of 2019, primarily due to higher spending related activities associated with Redwood ATM as well as readiness activities for a potential phase three.

Fady Ibraham Malik: The registry has been funded to date by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, and is being conducted by the University of Virginia and the University of Oxford. As an industry sponsor, Cytokinetics will join the HCMR Steering Committee in an observational capacity. Our long-term commitment to this important initiative is aligned with our dedication to outcomes research, along with our own drug development, in the interest of patient-centric engagement and improved health span. And with that, I'll turn it over to Robert Wong, who will provide an update on our financials. Robert.

Trial overall disruptive.

More than 50% of our R&D expenses were attributable to our cardiovascular programs as expected given activity for meteoric HL and the cardiac myosin inhibitor program and the remainder of our expenses were attributable primarily to our early research activity.

Our third quarter 2020, DNA expenses were $12.3 million up from 9.8 million in Q3, 2019, due primarily to higher personnel related costs, including stock based compensation.

And now Jim will review, our strategic planning and cash runway through year end.

Thanks Robert.

As we have shared previously we conduct a strategic planning process every summer.

Robert C. Wong: Thanks Fady. I'll first provide an update on cash, revenue, and spending, and then Ching will review our strategic planning and financials looking ahead. More details on our actual results for the third quarter are included in the press release which we released earlier this afternoon. We ended the third quarter with approximately $451 million in cash and investments.

In preparation for a presentation to and discussion with our board in early September.

For 2020, the focus of ours strategic plan was on scenario planning for potential outcomes of collective.

There was also a galactic catch up aligned with one of the scenarios, we discussed with our board.

And I'm pleased to share that we have an operational plan in place to move the program and the company forward.

Robert C. Wong: This balance does not include $85 million, which is expected upon the closing of our sale of a royalty on Myocardia's Mavacampton to RTW Investments. Our revenue in Q3 2020 will come primarily from licensed revenue for the RTW transaction and from our strategic alliances with Amgen and Estella. Our third quarter 2020 R&D expenses increased to $24.2 million from $20.2 million in the third quarter of 2019, primarily due to higher spending related to activities associated with Redwood HCM, as well as readiness activities for a potential phase three trial of REL December. More than 50% of our R&D expenses were attributable to our cardiovascular programs, as expected given activity for meteoric HF and the cardiac myosin inhibitor program, and the remainder of our expenses were Our third quarter 2020 G&A expenses were $12.3 million, up from $9.8 million in Q3 2019, due primarily to higher personnel-related costs, including stock-based compensation.

As we together with our partner engine continued to analyze data we will evolve operational plan to ensure that we allocate the appropriate resources to support the potential plans for me tend to mccarville at the right time.

As we approach year end, we remain in a strong financial position as a result of several transactions we executed this summer.

It's a serious of licensing royalty monetization and equity financing deals now ensure we have ample cash runway to prepare for potential commercialization of Omecamtiv mecarbil to advance the development plans with CK, two sudden floor and to potentially conduct at phase three clinical trial.

I'll have relatives sensor in patients with a outlets.

Which is the decision that has yet to be made and we'll follow ongoing discussions later this quarter.

As a reminder, we executed a series of transactions with affiliates of our Tw investments LP and GP seeing pharmaceuticals limited, we laid that to CK two some floor.

By Cytokinetics will receive a combination of committed capital funding and sales proceeds of up to $250 million and is eligible to receive up to 200 million the milestone payments plus royalties on future sales of CK two some floor in certain Asian countries.

Ching W. Jaw: And now, Ching will review our strategic planning and cash runway through year-end. Thanks, Robert. As we have shared previously, we conduct a strategic planning process every summer in preparation for a presentation to and discussion with our board in early September. For 2020, the focus of our strategic plan was on scenario planning for potential outcomes of galactic etch-ups. The results of the Galactic Edge App align with one of the scenarios we discussed with our board, and I'm pleased to share that we have an operational plan in place to move the program and the company forward. As we, together with our partner Amgen, continue to analyze data, we will evolve that operational plan to ensure that we allocate the appropriate resources to support the potential plans for McKenzie-McCarville at the right time. As we approach year-end, we remain in a strong financial position as a result of several transactions we have executed this summer.

We also raised 189 million in net proceeds from an underwritten public offering in July.

To recap our cash position. We ended the third quarter was 461 million in cash and now anticipate ending 2020 with more than $500 million in cash plus committed cash subject to closing conditions of royalty monetization portion of VR TWC transaction.

We believe that our cash balance then would represent at least three years, so floor cash based on our 2020 spending.

In addition, we have an additional 90 million available to draw upon at our option for the further development of CK two seven for part of the our TWC transaction.

As is our practice, we will provide 2021 guidance in concert with our Q4 earnings in early 2021 with the goal of deploying capital prudently against executing our vision 2025, and ending the year with more than three years of floor cash.

Ching W. Jaw: The series of licensing, royalty monetization, and equity financing deals now ensure that we have ample cash runway to prepare for potential commercialization of Omicantin-McCarville, to advance the development plan for CK274, and to potentially conduct a phase three clinical trial of radiocenters in patients with ALS, which is the decision that has yet to be made and will follow ongoing discussions later this quarter. As a reminder, we executed a series of transactions with affiliates of RTW Investments, LP, and Gcine Pharmaceuticals Ltd. related to CK274, whereby Cytokinetics will receive a combination of committed capital funding and sales proceeds of up to $250 million and is eligible to receive up to $200 million in milestone payments plus royalties on future sales of CK274. In certain Asian countries,

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

Thank you Ching.

Oh, and this call where I began it that is.

We are gratified to have recently shared results from Galactic HF. The first large scale phase three clinical trial, demonstrating that omecamtiv mecarbil reduced risk for the composite outcome of cardiovascular death for heart failure related events compared to placebo in patients treated with standard of.

Sure and with the P value less than 0.05.

This is indeed, an important event for the heart failure community and for Cytokinetics, We believe that our cardiac myosin activator has shown to increase cardiac performance and function and to reduce related clinical events in a landmark clinical trial with adverse events balance between treatment arms.

We believe that thereby has the potential to offer physicians and their patients. A welcome addition to manage the clinical and economic burden of heart failure, and we look forward to the sharing of additional results today.

Ching W. Jaw: We also raised $189 million in net proceeds from an underwritten public offering in July. To recap our cash position, we ended the third quarter with $451 million in cash and now anticipate ending 2020 with more than $500 million in cash plus committed cash subject to closing conditions on the royalty monetization portion of the RTW transaction. We believe that our cash balance then will represent at least three years of forward cash based on our 2020 spending. In addition, we have an additional $90 million available to draw upon, at our option, for the further development of CK274 per ZRTW transaction. As is our practice, we will provide 2021 guidance in concert with our Q4 earnings in early 2021 with the goal of deploying capital prudently against executing our Vision 2025 and ending the year with more than three years of lower cash. And with that, I'll turn the call back over to Robert Blum. Thank you, Ching.

No we're discussing potential next steps with Amgen in.

In addition, we may hold meetings with clinical experts as could inform our further conduct of market research and health economics and outcomes research and other commercial analyses that may better inform a potential path forward, we look forward to sharing more as we know more.

You heard from Saudi about progress with our cardiac myosin inhibitor, so I won't repeat that but I will say on the neuro muscular front as you heard today, we continued in the third quarter certain readiness activities in preparation for our potentially starting a phase three clinical trial of rail deceptive and pay.

Patients where they have less.

We've maintained that this decision is dependent on what scenario, we find ourselves in regarding galactic HF and what our cost of capital is at that point in time.

Now that we have more visibility we're discussing the path forward as a leadership team internally and with our board and with the goal of making that decision whether to proceed by year end.

Robert I. Blum: I'll end this call where I began it, that is... We're gratified to have recently shared results from GALACTIC-HF, the first large-scale Phase III clinical trial demonstrating that Omicamptive McCARBAL reduced risk for the composite outcome of cardiovascular death or heart failure-related events compared to placebo in patients treated with standard of care and with a p-value less than 0.05. This is indeed an important event for the We believe that our cardiac myosin activator has shown to increase cardiac performance and function and to reduce related clinical events in a landmark clinical trial with adverse events balanced between treatment arms.

Finally during the quarter, we once again demonstrated cytokinetics commitment to the communities we serve by renewing our partnership with Curis or me to increase education awareness public policy and fund raising.

For spinal muscular atrophy as well as announcing the third annual Cytokinetics Communications Fellowship Grant program intended to support increased capacity in communications awareness building and community engagement in heart failure, HCM Payless and also.

So may.

To summarize we are approaching the final months of Twentytwenty with continued focus and optimism toward our diversified pipeline, our research portfolio and our commercial prospects.

Robert I. Blum: We believe it thereby has the potential to offer physicians and their patients a welcome addition to manage the clinical and economic burden of heart failure, and we look forward to the sharing of additional results at AHA. Now we're discussing potential next steps with Amgen. In addition, we may hold meetings with clinical experts that could inform our further conduct of market research and health economics and outcomes research and other commercial analyses that may better inform a potential path forward. We look forward to sharing more as we learn more. You heard from Fady about progress with our cardiac myosin inhibitor, so I won't repeat that, but I will say on the neuromuscular front, as you heard today, we continued in the third quarter certain readiness activities in preparation for our potentially starting a phase 3 clinical trial of rel-deceptive in patients with ALS. We've maintained that this decision is dependent on what scenario we find ourselves in regarding galactic HF and what our cost of capital is at that point in time.

Now, let me recap our expected milestones for the remainder of Twentytwenty for Omecamtiv Mecarbil, we expect results from Galactic HF to be presented in a late breaking clinical trial session at Ha scientific sessions in this fourth quarter next week and we.

Back to enrollment of patients with heart failure immediate work HF to be completed in the first half of 2021.

For AMG Fivenine for we expect to continue discussing next steps in the development program with Amgen for CK 274, we expect to have data from cohort one of Redwood HCM to inform progression of this phase two clinical trial to assess.

Cohort by the end of 2020 for CK 271, we expect to complete the phase one study in the fourth quarter of this year for rail deceptive, we expect to continue to prepare for a potential phase III clinical trial and registration program in place.

Robert I. Blum: Now that we have more visibility, we're discussing the path forward as a leadership team, internally and with our board, and with the goal of making that decision whether to proceed by year end. Finally, during the quarter, we once again demonstrated Cytokinetics' commitment to the communities we serve by renewing our partnership with Cure SMA to increase education, awareness, public policy, and fundraising for Spinal Muscular Atrophy, as well as announcing the third annual Cytokinetics Communications Fellowship Grant Program, intended to support increased capacity in communications, awareness building, and community engagement in heart failure, HCM, ALS, and also SMA. To summarize... We're approaching the final months of 2020 with continued focus and optimism toward our diversified pipeline, our research portfolio, and our commercial prospects.

Actions with a less and for our ongoing research. We expect to continue research activities directed to the cardiac and skeletal sarcomere and our other muscle biology research programs and we expect to continue research in collaboration with the Stellus directed to the discovery of next.

Generation skeletal sarcomere muscle activators through the end of this year 2020.

And operator with that we can now open up the call please to questions.

To ask a question you will need to press star one on your telephone.

Withdraw your question press, the pound or hash key please standby will be compiled acuity roster.

Your first question comes from some insight from Mizuho.

Robert I. Blum: Now let me recap our expected milestones for the remainder of 2020. For Omicampt of McCarble, we expect results from GalacticHF to be presented at a late-breaking clinical trial session at AHA Scientific Sessions in this fourth quarter next week, and we expect enrollment of patients with heart failure in MeteoricHF to be completed in the first half of 2021. We expect to continue discussing the next steps in the development program with AMG.

Okay.

Hello, Robert and Hello.

And then team.

Three for me if I can turn.

And on the Kimpton one on so you can see some foreign thanks for all the color.

Robert you mentioned that you're in potential scoring position.

For Omecamtiv. So I'm just curious if you've actually met with the FDA shared the data with them.

And if there are any gating factors to submitting a regulatory application for approval. There and then just a couple for fatty fatty I know you can't speak to the data that we'll be getting in shape, but.

Unknown Executive: For CK274, we expect to have data from Cohort 1 of Redwood HCM to inform progression of this Phase 2 clinical trial to a second cohort by the end of 2020. For CK271, we expect to complete the Phase 1 study in the fourth quarter of this year. For REL December, we expect to continue to prepare for a potential Phase III clinical trial and registration program in patients with ALS. And for our ongoing research, we expect to continue research activities directed to the cardiac and skeletal sarcomeres and our other muscle biology research programs, and we expect to continue research in collaboration with Astellas directed to the discovery of next-generation skeletal sarcomere muscle activators through the end of this year An operator With that, we can now open up the call, please, to questions. If you want to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key.

Perhaps in theory is there is there anything here that we can.

You mentioned the mechanism as it relates to the in patient population why this drug may actually work better in patient population versus the.

The outpatient which would be the opposite of what we've seen in a paradigm and Apple trial and then one on CK 274 can.

Can you just clarify if we'll be getting all of your t. gradient data on.

On the cohort one.

So good questions I'll start with the first wouldn't know.

We havent had interactions with regulatory authorities, we at Amgen have a lot of work to do.

Around analyzing the data in order to understand a path forward it would be premature to have any such discussions.

Studied you want to pick off the next two.

Yeah I'll take the next one you know it with regard to your question about inpatient and outpatient we haven't really pointed to any directionality in those two subgroups.

Those those data will be presented at the ha I can't really fan.

Expand on them.

[music].

In regards to CK, two seven or.

We won't necessarily.

Present, quantitative data with regards to the L. VIP gradient, but.

Unknown Executive: Please stand by while we compile the Q&A roster. Your first question comes from Salim Syed from Mizzou Home. Hello Salim. Hello Robert, and hello Fady and team. Three from me if I can, two on Omicamtiv, one on CK274, and thanks for all the color.

But we may we may discuss some directionality there remember the first cohort is just.

Starting at the lower doses meant to tell us with lowest starting dose would be.

And so obviously, we're not expecting that reach maximal pharmacodynamic effects and the first group.

So I think quantitative data more appropriate to wait till we have completed the study.

Robert I. Blum: Robert, you mentioned that you're in a potential scoring position for Omicamtiv, so I'm just curious if you've actually met with the FDA or shared the data with them, and if there are any gating factors to submitting a regulatory application for approval there. So, good questions. I'll start with the first one.

Great. Thanks, so much.

Thank you Shirley link.

Your next question comes from Dane Leone from Raymond James.

Okay.

Hi.

Thanks for taking the questions.

Congrats on the updates.

Robert I. Blum: And no, we haven't had interactions with regulatory authorities. We at Amgen have a lot of work to do around analyzing the data in order to understand the path forward. It would be premature to have any such discussion. Fady, do you want to pick off the next two?

I wanted to I guess first just kind of clarify.

The the Valon was cutting out a little bit around redwood to start.

So just to make sure we're on the same page here.

The first cohort is fully enrolled and when will the last patient have 10 weeks of follow up.

Fady Ibraham Malik: Yeah, I'll take the next one. You know, with regard to your question about inpatient and outpatients, we haven't really pointed to any directionality in those two subgroups. Those data will be presented at the AHA. I can't really expand. If, in regard to CK274, we won't necessarily present quantitative data with regard to the LVOT gradient, but we may discuss just some directionality there.

And is that what you would wait for before discussing or starting enrollment into cohort two and then what's your projection in terms of enrollment on cohort two I know your rehashing some of us that it was difficult to hear some of that.

Yeah as I said, we completed enrollment in.

Fady Ibraham Malik: Remember, the first cohort is just starting at lower doses meant to tell us what the lowest starting dose would be. And so, obviously, we're not expecting to reach maximal pharmacodynamic effects in the first group. So I think quantitative data, more appropriate, we'll wait until we've completed the study. Great. Thanks so much.

[noise] cohort one.

Just at the very beginning of the quarter.

So we'd expect all patients to be through 10 week before the end of the year.

The.

Second cohort, we expect should enroll much faster we have all this we have many more sites activated idle.

Have the opportunity to pre screen patients and and get them.

Hopefully a range for their visits and things.

Unknown Executive: Thank you, Salim. Your next question comes from Dane Leone from Raymond James. Hi. Thanks for taking the questions. Congratulations on the updates. I want to, I guess, first, just kind of clarify, as the line was cutting out a little bit around Redwood to start.

<unk> open 19 remains a wildcard, but so far I think.

Sites are well prepared and hopefully I will see them continue to stay open.

Through the winter months.

The.

The data that inform the transition from cohort one cohort two.

Unknown Executive: So just to make sure we're all on the same page here. The first cohort is fully enrolled, and when will the last patient have 10 weeks of follow-up? And is that what you would wait for before discussing or starting enrollment into Cohort 2? And then what's your projection in terms of enrollment in Cohort 2? I know you're rehashing some of this, but it was difficult to share some of that.

Won't necessarily include every single patient in cohort one but.

That concludes.

Financial fraction of them.

Enough. So that we can set doses for the next group.

And Dave deep out the second cohort.

We'll just say that.

During the time that the enrollment was interrupted Saudi and his team were able to add.

Fady Ibraham Malik: Yeah, as I said, we completed enrollment in cohort one just at the very beginning of the quarter. So we'd expect all the patients to be through 10 weeks before the end of the year. The second cohort, we expect, should enroll much faster. We have, you know, all this, we have many more sites activated; they'll have the opportunity to pre-screen patients and, you know, hopefully, arrange for their visits and things. You know, COVID-19 remains a wildcard, but so far, I think sites are well prepared, and hopefully, we'll see them continue to stay open through the winter months.

Out a whole bunch of centers onto the trial such that we now can expect more sectors to be enrolling patients.

We need to patients in each cohort so that second cohort should roll substantially faster than the first one we would expect.

Okay. Thanks for that clarification, just one more on that topic.

The data so you will not be blinded to the data that's informing that just started the second cohort.

You're just not going to discuss it in granularity or sorry, I was trying to understand that comment in terms of what of how the Unblinding works between cohort one and then moving into cohort two.

Robert I. Blum: The data that inform the transition from cohort 1 to cohort 2 won't necessarily include every single patient in cohort 1, but it will include a substantial fraction of them, enough so that we can set doses for the next group. And Dane, about the second cohort and... We'll just say that, during the time that the enrollment was interrupted, Fady and his team were able to add a whole bunch of centers to the trial such that we now can expect more centers to be enrolling patients, then we need patients in each cohort so that the second cohort should enroll substantially faster than the first one we would expect. Okay, thanks for that clarification.

Yeah.

The teams will not be unblinded to patient level data will have summaries.

Our aggregate data.

So that we can look at.

The effective drug on ejection fraction the effect of the drug on left ventricular outflow gradient.

As well as you know adverse events as they may have occurred over the course of the trial that'll help us.

Set.

You know what doses, we want to plan on for cohort two.

The data monitoring committee will have unblinded data, but obviously they will review those in confidence.

Unknown Executive: Just one more on that topic. The data, so you will not be blinded to the data that's informing the start of the second cohort. You're just not going to kind of discuss it in granularity, or sorry, I was trying to understand that comment in terms of how the unblinding works between cohort one and then moving into cohort two. Yeah, the teams will not be unblinded to patient-level data, you know; we'll have summaries that are aggregate data so that we can look at the effect of the drug on ejection fraction, the effect of the drug on left ventricular outflow gradient, as well as, you know, adverse events as they may have occurred over the course of the trial.

And they will validate choice of doses that the blinded analysis.

So Jeff.

Hopefully that okay.

Yes, sorry, just really dumb question why does cohort one need to stay blinded once it completes 10 weeks of dosing.

So the the reason its stays on blinded is because the.

Trial, obviously is not complete the placebo group in cohort one is going to be combined with the placebo group and co are too.

To form a a.

Integrated placebo group. So remember we were Randomizing. This trial in a two to one fashion so.

Unknown Executive: That'll help us set, you know, what doses we want to plan on for cohort two. The Data Monitoring Committee will have unblinded data, but obviously they will review those in confidence, and they will validate the choice of doses that the blinded analysis chose. Hopefully, that helps. Yeah, sorry, just a really dumb question. Why does cohort one need to stay blinded once it completes 10 weeks of dosing?

12 patients on them on CK 2746 on placebo and core one and then another 12 on the active and another six on placebo and co are to combining those two groups. Then gives US 12 placebo patients 12 active patients on the lower doses 12 active patients on the higher.

Services.

We just think it's better.

Trial conduct to leave that blinded to.

Individual patient this drug assignments until we've completed an unblinded the entire study.

Fady Ibraham Malik: So the reason it stays blinded is because the trial, obviously, is not complete. The placebo group in cohort one is going to be combined with the placebo group in cohort two, um... to form an integrated placebo group. So, remember we were randomizing this trial in a two to one fashion, so twelve patients on CK274, 6 on placebo and cohort 1, and then another 12 on active and another 6 on placebo and cohort 2, combining those two groups then gives us 12 placebo patients, 12 active patients on the lower doses, and 12 active patients on the And we just think it's better trial conduct to leave it blinded to individual patient drug assignments until we've completed and unblinded the entire study. Okay, so essentially, the I.

Okay, so essentially the.

The the data for cohort one that you had discussed before your ads are around year end.

Would be an integrated data set of all patients placebo and or active drug or were you referring to kind of high level data for actually the cohort that would be.

On active drug I guess, that's one pool use of that.

Yeah, I think Dan I thought I know, we haven't even seen the data. So I don't want to get into details of exactly what we intend to construct in a press release.

Might the statements that we made just point to directionality did we see the elvia t. gradient start to decline did we have patients that had to discontinue drug to with regard CEF below 50 things like that.

Fady Ibraham Malik: The data for cohort one that you would discuss before your end or around your end would be an integrated data set of all patients taking placebos and or active drugs, or were you referring to kind of high-level data for actually the cohort that would be, um, Unactive Drug? I guess that's what I'm a little confused about. Yeah, I think Dane, I don't, I don't, we haven't even seen the data. So I don't want to get into details of exactly what we intend to construct in a press release. The statements that we made just point to directionality. Did we see the LVOT gradient start to decline? Did we have patients that had to discontinue the drug with regard to EF below 50, things like that? I don't think we're going to get into specific numbers because we won't have unblinded the data. We will not have the appropriate comparator, which is the combined placebo group. You can't calculate it.

I don't think we're going to get into specific numbers, because we won't have unblinded. The data we will not have the appropriate compared or which is the complying combined placebo group you can't calculated.

Leabo corrected change from baseline if you don't have the placebo group for instance.

Right, but you had the data you're talking about would actually be for the active drug not the placebo group.

I'm just trying to understand whether it had to do next together and what you are saying.

We will we will be reporting.

The data presumably.

That we think are the active group that's correct.

Okay understood. Thank you so much.

Thanks, David.

Your next question comes from Charles Duncan from Cantor Fitzgerald.

Hi, Charles.

Hi, This is Peter Stavropoulos on for Charles how are you.

Good thing.

Congratulations on the on the Galactic study and all the progress made in the quarter.

Fady Ibraham Malik: You know, placebo-corrected change from baseline if you don't have the placebo group, for instance. Right, but the data you're talking about would actually be for the active drug, not the placebo group. I'm just trying to understand whether it's mixed together in what you're saying. We will be reporting the data, presumably, that we think are the active group. That's correct. Okay, understood. Thank you so much.

Thank you.

A couple of questions.

Can you discuss the patient population of meteoric and how it compares to classic and.

Welcome to study how to differentiate only relative to other drugs in the space.

Good question, So maybe work is enrolling.

Patients, who are outpatients and who are not as.

Believed.

I believe to be at risk given they had not been admitted into the hospital with a diagnosis of acute heart failure within one year as the inclusion criteria for Galactic required. So these are more stable outpatients.

Unknown Executive: Thanks, Dave. Your next question comes from Charles Duncan from Cantor Fitzgerald. Thank you. Thank you. Thank you. Hi, this is Pete Steparopoulos on behalf of Charles. How are you?

I have to be able to perform an exercise protocol, obviously as well.

Unknown Executive: Good, Pete. Well, congratulations on the galactic study and all the progress made in the quarter. Thank you. I have a couple questions.

So there are perhaps not as high risk or lower risk than some of those in the galactic trial, but still these are patients with heart failure and low injection fraction stall dysfunction.

Fady Ibraham Malik: I I I I I I I I I I I, We've discussed the patient population of meteoric and how it compares to galactic and how could the study help to differentiate OMI relative to other drugs in the space? Good questions. So, METEORQ is enrolling. Patients who are outpatient, and who are not as believed to be at risk given they had not been admitted into the hospital with a diagnosis of acute heart failure within one year as the inclusion criteria for GALACTIC required. So these are more stable outpatients. They have to be able to perform an exercise protocol, obviously, as well.

And what was the second question.

How can it help to differentiate on me I'll relative to other drugs in the space Oh, Yeah. So that's a very good question.

You know as we approach this phase three clinical trials program, we being Cytokinetics together with Amgen, we thought about ways that we could differentiate from standard of care as well as a potential new medicines that were on the horizon.

It would be.

Hey.

Real distinguishing feature if we had a drug that was increasing cardiac performance in function and also extending time to exercise fatigue or increasing endurance and stamina. Currently there aren't heart failure drugs that can do that and that would be a.

Fady Ibraham Malik: So they're perhaps not as high risk or lower risk than some of those in the galactic trial, but still, these are patients with heart failure and low ejection fraction systolic dysfunction. And what was the second question? How can it help to differentiate OMI relative to other drugs? Oh yeah, so that's a very good question. You know, as we approached this phase three clinical trials program, we, Cytokinetics, together with Amgen, thought about ways that we could differentiate from standard of care, as well as potential new medicines that were on the horizon. And it would be a real distinguishing feature if we had a drug that was increasing cardiac performance and function and also extending time to exercise fatigue or increasing endurance and stamina. Currently, there aren't any heart failure drugs that can do that, and that would be a meaningful distinguishing feature for a new medicine in heart failure.

Meaningful distinguishing feature for a new medicine in heart failure. So.

That's why we set about to do both the large outcomes trial and ER. This trial meteoric and we look forward to the results from meteoric next year.

Okay.

And one.

One more.

For the Galactic results.

How should we think about the risk reduction observed relative to other recent studies in heart failure and I do believe that the not only could be competitive in the space.

It's a tough question to answer in the absence of you're seeing the full results as you will see next week at Jay, but I would caution you to think about these medicines as all directly substituted for one to another because they're not different mechanisms.

For trial designs, it's really not an apples and apples comparison.

I get the fact that wall Street would like to line them up but I don't think thats. So feasible given the unmet need that still exists with standard of care and that's where I think once we have presented the data next week, we can speak to your question a bit more constructively.

Robert I. Blum: So that's why we set about to do both a large outcomes trial and this trial, Meteoric, and we look forward to the results from Meteoric next year. And one more, for the galactic results, how should we think about the risk reduction observed relative to other recent studies in heart failure? And do you believe that OMI could be competitive in space?

All right. Thank you and just by some chance.

Do you believe coal that may have impacted those numbers on the secondary endpoint on the Q1.

Robert I. Blum: It's a tough question to answer in the absence of your seeing the full results, as you will see next week at AHA. But I would caution you not to think about these medicines as all directly substitutable one to another because they have different mechanisms and different trial designs. It's really not an apples to apples comparison.

I don't think we have any reason to believe that right now but of course, we're still doing additional analyses, but I don't see that that's contributed to anything that we know of today.

Okay. Thank you and congratulations again.

Thank you.

Your next question comes from Jeff Hong from Morgan Stanley.

Hello, John.

Robert I. Blum: I get the fact that Wall Street would like to line them up, but I don't think that's so feasible given the unmet need that still exists with standard of care. And that's where I think once we have presented the data next week, we can speak to your question a bit more constructively. All right, thank you. And just by some chance.

Yes.

Just two quick.

Okay.

For.

Okay.

So.

And now we're having a hard time hearing you.

There's a lot of static on your line.

Yes.

Robert I. Blum: We believe COVID may have impacted those numbers on the secondary endpoint, on the key one. I don't think we have any reason to believe that right now, but, of course, we're still doing additional analyses, but I don't see that that's contributed to anything that we know of today. Okay, thank you, and congratulations again. Thank you. Your next question comes from Jeff Hung from Morgan. Hello, Jeff. Hi, guys.

Thank you very much.

Okay.

Where do we think about the ability to bio based.

Good luck.

Wait for another trial is that what you said.

Yes.

Yeah.

Yes, I think it's way too premature to talk about.

These strategies or anything of that sort.

It's completely analyses, let us discuss these matters.

Unknown Executive: Just two quick ones for us. What are your thoughts on being able to file for specific subgroups without doing additional studies? Hannah, we're having a hard time hearing you. There's a lot of static on your line.

You'll see these results in some more detail next week and frankly, there will be more analyses that will follow and other activities.

Unknown Executive: Can you speak up a little better? I think I made up the question, what do we think about the ability to file based on galactic evidence versus having to wait for another trial? Is that what you said? Correct, yeah. Yeah, I think it's way too premature to talk about filing strategies or anything of that sort. Let us complete the analyses, let us discuss these matters, you'll see these results in some more detail next week, and frankly, there'll be more analyses that will still follow, and other activities, and I think any conversation about regulatory strategies should wait on a lot more work that needs to be done. Okay, and then, have you been able to share any data with the investigators, and have you heard any early feedback from them? You know, the investigators... What were you asking about? I'm sorry.

I think any conversation about regulatory strategy should wait on.

Got more work that needs to be done.

Okay and.

You bet.

Okay.

Yeah.

Uh huh.

You bet.

You know the investigators are you asking about.

Hi, Good question, Diane and the Investor the question, what Theyve been shared data with investigators and got back from them.

The answer is no we have not done that broadly yet.

That will be expiries actions after the sale.

David matters.

Okay. Thank you very much.

Your next question comes from Jason Butler from JMP Securities.

Robert I. Blum: I did have a question, Diana. The question was, have you shared the data with the investigators and gotten any feedback from them? And the answer is, no; we have not done that broadly yet. There will be a series of interactions after the APA shares the data with the investigators. Okay, thank you very much. Your next question comes from Jason Butler from GMP Security. Hello, thanks. Hey, Robert, thanks for taking the questions. There are two quick ones.

Okay, all right. Thanks, Hey.

Hey, Robert Thanks for taking the questions to two quick ones first of all can you just remind us of your cost obligations for Omecamtiv from now through to approval and then secondly for AMG Fivenine for just just give us remind us of what.

You had hoped to learn from the the phase one study PK PD parameters and how that's reading on what the potential you know pharmacological attribute to the program product would be and the indications. Therefore that you know that could potentially lead on.

Unknown Executive: First of all, can you just remind us of your cost obligations for OMIC AMTIV from now until approval? And then secondly, for AMG 594, just give us reminders of what you had hoped to learn from the Phase 1 study, PK, and PD parameters, and how that's reading on, you know, what the potential pharmacological attributes of the program and product would be, and the indications, therefore, that you could potentially read on. I'll ask Ching to speak to the first question on costs we may be incurring with regard to Omicamptive, and then, maybe, I'll ask Fady to speak to the second one. Yeah, so Jason, I think you're referring to the conduct of the meteoric trial. According to the agreement, MGM is paying all of the Out-of-Pocket Costs, and MGEN and Cytokinetics each will fund 50% of the FTE related costs. That's according to the agreement.

I'll ask ching to speak to the first question on cost we may be incurring with regard to the captive and then maybe I'll ask Patty to speak to the second.

Yeah, So Jason Hi, I think you're referring to the.

Conducted the meteoric trial.

According to the agreement Amgen is paying all that the.

Out of pocket costs and.

Amgen and Cytokinetics, each will fund 50% of the FTC related costs, that's part of the agreement.

Okay.

And Jason I'm, sorry could you repeat your second question.

Uh huh.

Fivenine for just what you'd hope to learn from the phase one program, how you're thinking about the pharmacology.

Of overcome pound and how that could read on potential indications.

Yeah, I think you know with the phase one program, we want to look at the Pharmacodynamic responses when the increases dosing and compare that to what we've seen with Omecamtiv mecarbil. So are there any pharmacodynamic differences. We believe there are given the preclinical.

Ching W. Jaw: And Jason, I'm sorry, could you repeat your second question? Yeah, Fady, on 594, just what you'd hope to learn from the Phase 1 program, how you're thinking about the pharmacology of the compound, and how that could read on potential indications. Yeah, I think, you know, with the phase one program, we want to look at the pharmacodynamic response as one increases the dose and compare that to what we've seen with Omacam and McCarble. So, you know, are there any pharmacodynamic differences?

Characterization that we've made.

But it takes a fairly detailed and meticulous phase one trial to two.

Put that all together so what we hope to do is understand how they may be differentiated and and then whether that leads is a basis for continuing to advance fivenine for into into indications that are different than where we might apply on the captain mccarville.

Okay, great. Thanks for taking the questions.

Sure good talking to.

Fady Ibraham Malik: We believe there are given the preclinical characterization that we've made. But it takes a fairly detailed and meticulous phase one trial to put that all together. So what we hope to do is understand how they may be differentiated and then whether that is a basis for continuing to advance 594 into indications that are different than what we might apply on the Campton-McCarble. Okay, great. Thanks for taking the question. Sir, good talking to you. Your next question comes from Emanuela Branchetti with HC Wayne. Hello.

Your next question comes from Meanwhile, a franchisee with H.C. Wainwright.

Hello.

Hi, guys. Thank you for taking my question.

Okay. This question has already been asked but I try to ask it in a different way I know you cannot disclose obviously the data.

I'd love to be information about the data we are going to.

Yes, but maybe you can provide a minute I'll call.

Well try to.

Unknown Executive: Hi guys, and thank you for taking my question. Okay, this question has already been asked, but I tried to ask it in a different way. I know you cannot disclose, obviously, the data. A lot of information about the data we are going to see at the AHA, but maybe you can provide a little bit of color or try to with regards to how you envision the path forward, the tour on the campus, meaning we are going to see data possibly showing differences in different subpopulations of patients. I was wondering if any of these scenarios would require additional studies to be conducted with the MacCumbees. Is there a possibility of that?

With regards to how do you envision deposits for the quarter to quarter MACOM, Kansas, meaning.

We're going to see data.

Possibly showing differentiating defense appropriation of stations.

I was wondering if any of these scenarios would require additional studies to be conducted little bit Tom gave them.

Ladies at the possibility of data and also how we should look at the relevance of meteoric.

Robert I. Blum: And also how we should look at the relevance of meteorics, you know, in relation to the data that we are going to see at the end. So I appreciate you're trying to ask a question in a different way, but I'm not sure I'm gonna be able to give you much of a different answer. It's better that we have this conversation after the results are presented, and we can be more forthcoming about what the data say. But keep in mind that GALACTIC, as an 8,000 patient clinical trial, we've already published on the baseline characteristics, teaches us a lot about heart failure and where there still remains high unmet need and where Omicampt and McCarble may have differential effects in different large pre-specified subgroups. So there's a lot still to be learned, and there is still a lot of work to do in order to understand what the next steps could be. And we wanna do right by our commitments to Amgen to have those conversations together and understand together what the next step should be. So I apologize; I don't think I can do better than that.

Uh huh.

In addition to.

Yeah.

Uh huh.

Sure I appreciate you're trying to ask a question a different way, but I'm not sure I'm going to be able to give you much of a different answer.

It's better that we have this conversation after the results are presented and we can be more forthcoming about what the data say, but keep in mind that galactic as an 8000 patient clinical trial and Weve already published on the baseline characteristics teach.

Gives us a lot about heart failure, and where others still remains high unmet need and where omecamtiv mecarbil they have differential effects and different large a.

Pre specified subgroups. So there's a lot still to be learned still lot of work to do in order to understand what could be.

Next steps and.

We want to do right by our commitments to Amgen to have those conversations together and understand together what should be the next step. So I apologize I don't think I can do better than that well I hope you understand and let's have these reductions have gotten down the road.

Diane Weiser: Well, I hope you understand and we can have these discussions again down the road. Yeah, sure. I understand. And just to clarify, you mentioned that you're going to have a call after the AHA presentation. I'm not sure I understood correctly if this call is going to be the same day as the AHA presentation, or it's going to be in the future. Diane, do you want to take that? Hi, sure, it's going to be the same day. We'll actually announce the details tomorrow, but it'll follow Dr. Cherling's presentation. We have to cooperate with any embargoes, so it'll be soon after he presents the data at AHA. So on the 13th,

Yes, sure I understand and just to clarify you mentioned that you had been a hard that's caused us to change our presentation I am not sure I understood correctly, let's call. It is going to be the same day of good shape presentation or its in the future.

Hi, Andrew will take that.

Hi, I'm sure it's going to be the same day.

Okay, well actually announced the detail.

Tomorrow, but ill follow that to tailings presentation.

We have to cooperate.

Cooperate with any embargo. So it will be soon after he presents to date at old Chang.

So on the 13th.

Awesome. Thank you very much.

Unknown Executive: Awesome. Thank you very much. Thank you. Your next question comes from Ted Tentop with Piper. Hello, Tess. Hi, guys. How are you?

Thank you.

Your next question comes from Ted Tenthoff with Piper Sandler.

Hello to.

Hi, guys. How are you. Thanks, so much for the update.

Unknown Executive: Thanks so much for the update. It's been an exciting year, to say the least. I'm looking forward to more data next week. Most of the questions are focused on the cardiovascular side, so I'll ask one on the muscle side.

An exciting year to say the least I'm looking forward to more data next week.

Most of the questions are focused on the cardiovascular side saw ask one form of muscle side, but can you give us a little bit more of a sense in terms of what goes into the decision whether to progress on relative or something and the reason I asked this is it.

Robert I. Blum: But can you give us a little bit more of a sense in terms of what goes into the decision, whether to progress on RAL deceptive? And the reason I ask this is that it seems to me like the primary, Thank you so much. Good questions, Ted, and you're right. To be clear, as we've communicated several times, our first priority is to prepare for the potential commercialization of Omicampt and McCarble. Our second priority is to conduct development programs with CK274 in order to make sure we expand upon the opportunity there in HCM as well as other indications. And then we need to make sure that we can finish what we start if we were to go forward with rel-de-sem. So we spent the better part of a year analyzing the data from the Phase 2 study, having conversations with FDA and EMA, interacting with HTAs in Europe and payers, doing a whole bunch of market research and other things.

Seems to me like the primary gaming factor should be whether or not the due to support and this is a drop and if it is then it seems to be worth pursuing so I want to make sure I understand sort of how you guys are framing or prioritizing that decision. Thank you so much.

Good questions, Ted and you're right.

To be clear as Weve communicated several times, our first priority is to get ready for the potential commercialization of Omecamtiv mecarbil.

Our second priority is to conduct development programs plural with CK 274 in order to make sure we expand upon.

The opportunity there HCM as well as other indications.

And then we need to make sure that we can finish what we start if we were to go forward with rail deceptive. So.

So we spent the better part of a year analyzing.

The data from the phase two study, having conversations with F.D.A.M.A. interacting with H T A's in Europe, and payers doing a whole bunch of market research and other things we.

We had to renegotiate our deal with the specialists in order to be able to understand what would be their commitment and funding and.

Robert I. Blum: We had to renegotiate our deal with Astellas in order to be able to understand what would be their commitment and funding. And we had to discuss with academics what would be a potential Phase III trial that could serve as registration and talk to FDA and EMA about that. So that takes time. And all of that is important alongside of, you know, what does the phase two data teach us about a path forward in phase three? All of that comes together in terms of our ability to conduct an affordable trial and also make certain that it's not subtracting from the other things that we're doing and that's conversations we still need to finish internally and with our board but we'll get there and we'll do that this quarter and, You know, we want to understand much more our cost of capital, and that's, in part, going to be informed by how we might proceed with regard to Omicampt of McCarble, given what we know from Galactic.

And we had to discuss with academics, what would be a potential phase three trial that could serve.

As registration and talk to the FDA and EMA may about that so that takes time and all of that is important alongside of.

What does the phase two data teach us a path forward in phase three.

All of that comes together in terms of our ability to conduct an affordable trial and also make certain that.

It's not subtracting from the other things that we're doing and that's conversations we still need to finish internally and with our board, but we'll get there and we'll do that this quarter.

And you know we want to understand much more our cost of capital and that's in part going to be informed by.

How are we might proceed with regard to Omecamtiv mecarbil, given what we know from Galactic.

So all those things factor together I hope you understand the trial itself. If we were to do it is a trial that would be perhaps in the range of $35 million to $40 million as would be conducted over a couple of years. So amortized over a couple of years and.

Robert I. Blum: All those things factor together. I hope you understand. The trial itself, if we were to do it, would be perhaps in the range of $35 to $40 million, which would be conducted over a couple of years, so it would be amortized over a couple of years. We already have commented that Astellas would be funding about a third of that, so the trial would not be all that expensive relative to our current operating burn, but we still need to make sure it doesn't. Subtract from the other things we need to be prioritizing as well. So that's hopefully an answer to your question. Does that help?

We already have commented that let's tell us would be.

Funding about a third of that so.

The trial would not be all that expensive relative to our current operating burn, but we still need to make sure it doesn't.

Truck from the other things, we need to be prioritizing as well so thats hopefully if that answer to your question does that help.

Very much so Robert Thank you very much.

Robert I. Blum: Very much so, Robert. Thank you very much. Thank you. As a reminder, to ask a question, press star 1. Your next question comes from Greg Sivanavich from Goldman Sachs. Please go ahead. Hello, Greg. Greg, are you there?

Thank you.

As a reminder to ask a question press star one.

Your next question comes from Graig Suvannavejh from Goldman Sachs. Please go ahead.

Hello, Greg.

Greg are you there.

Yep, Okay, sorry about that.

Unknown Executive: Yep, hey, sorry about that. I'm here. Sorry about that. Hi, Greg. Hi, how are you?

Sorry about that hi, correct Uh huh.

Hi, how are you. Thanks, so much for taking my questions and congrats on the progress that you've been making I'm just several questions if I could.

Unknown Executive: Thanks so much for taking my questions and congrats on the progress that you've been making. Just several questions, if I could, fully realizing that we still need to see the AHA data, which is coming relatively shortly. I'm curious about a couple things.

Fully realizing that we still need to see the A.H.A. data, which is coming relatively shortly so curious if couple of things. One is have you had the opportunity to discuss with Amgen.

Robert I. Blum: One, have you had the opportunity to discuss with Amgen, you know, the data? Or is that something that is going to happen post the presentation of the data at AHA? With the follow-up being, in terms of being able to communicate to the market what's next, either from a regulatory perspective or from a commercial perspective, when should we expect to hear such an update? Is that something that perhaps is a first half of 21 event? Is it a by the end of the year event?

The data or is that something that is going to happen post.

The presentation of the data at H.A.

With the follow up being.

In terms of being able to communicate to the market. What's next either from a regulatory perspective or from a commercial perspective.

When should we expect to hear such an update is that something that perhaps in the first half of 21 event as it up by the end of the year event. So let me stop there with without question.

Robert I. Blum: So let me stop there with that. Yeah, so we have had many, many, many, many meetings, with Amgen, but they've been focused to the data and There are being many pre-specified analyses and going through those, those analyses inform other supplemental analyses that are also being generated and prioritized, So, the conversations we're having with Amgen are very focused to understanding the results from galactic... And everything else that you're asking about would have to come later, and only can be, really initiated once we have our arms around the data and a sense of how they may be viewed by the heart failure community starting with AHA next week, but then obviously there would have to be a bunch of market research and other HEOR and other analyses that I mentioned in my prepared remarks.

Yeah. So we have had many many many many meetings.

With Amgen, but there have been focused to the data.

And there are being many pre specified analyses and going through those those analyses inform other supplemental analyses that are also being.

Being generated and prioritized.

So the conversations we're having with Amgen are very focused to understanding the results from galactic and everything else that you are asking about would have to come later and only can be.

Really.

Initiated once we have our arms around the data and a sense of how they may be viewed by the heart failure community starting with Ha next week, but that obviously there would have to be a bunch of market research and other H O R. Another analyses that I.

I mentioned in my prepared remarks, so it's hard to say right now, whether that's weeks or months or whether that's this year next year and I would just ask that you permit us to continue those activities with our partners at Amgen and we'll give you clarity once we have clarity.

Robert I. Blum: So it's hard to say right now whether that's weeks or months or whether that's this year or next year. I would just ask that you permit us to continue those activities with our partners at Amgen, and we'll give you clarity once we have more information. Very much appreciated. Thank you very much for that. My next question is, just given at least what we've seen thus far and in terms of Galactic and the results on the primary endpoint and the secondary endpoints, how should, Hey, how do you think we should be thinking about a drug with such a profile and giving both you and Amgen full credit for, for, you know, swinging for the fences with the trial, but given the profile that we're seeing thus far, and again, And then second of all, have you done market research with payers, in particular, how they view the value from a payer perspective of a drug like Omacamptive, you know, irrespective of whether there's a novel mechanism of action, or maybe that has to be contemplated? You know, how do you think payers will think about that?

Very much appreciate it thank you very much for that matter.

My next question is just given at least what we've seen thus far in and in terms of Galactic.

Andy the.

The results on the primary endpoint and the secondary endpoints, how how should.

Hey, how do you think we should be thinking about.

Drop with such a profile and giving both you and Amgen full credit for for.

Swinging for the fences with the trial, but given the profile that were seeing thus far and again not knowing what the solar profile will look like with ha, but without a mortality benefit.

My question is how how are you thinking about that commercial opportunity versus if you did have a mortality benefit and then second of all have you done market research around.

Payors in particular.

How they view.

The value.

From a payer perspective.

What a drug.

Like Omecamtiv is irrespective of whether Theres a novel mechanism of action or maybe that has to be contemplated how do you think payers think about that I think we've heard some feedback.

Robert I. Blum: I think we've heard some feedback from KOLs that, you know, they sometimes have difficulties getting reimbursement for drugs that are beyond kind of the triple kind of, you know, regimen gold standard. Thanks. Yes, so it's a good question.

From Kent Wells that.

You know.

They sometimes are getting difficulties.

Getting.

Reimbursement for drugs that are beyond kind of the.

The triple kind of you know regimen gold standard thanks.

Yes, so it's a good question obviously the heart failure landscape is evolving quite rapidly and we have new medicines that.

Robert I. Blum: You know, obviously, the heart failure landscape is evolving quite rapidly, and we have new medicines that are being made available. But these work by different mechanisms, and they have been studied in trials that are different one to another. And even with these drugs.

Or being made available, but these work by different mechanisms and they were studied and trials that are different one to another and even with these drugs.

One sees that the unmet need here is quite high you are talking about morbidity and mortality that is higher than most cancers and for which there is a not only major clinical unmet need, but a very very significant economic.

Robert I. Blum: One sees that the unmet need here is quite high. You're talking about morbidity and mortality rates that are higher than most cancers and for which there is not only a major clinical unmet need but a very, very significant economic one, incredibly costly to Medicare and other payers. Based on what we've already top-lined, you can see that we have a drug that is safe. We have a potential drug here that is increasing cardiac function and performance, and that addressed and reduced clinically meaningful outcomes. Now, granted, it did not achieve an effect on CV death alone.

Incredibly costly to Medicare and other payers so.

Based on what we've already top line you can see that.

We have a drug that is safe.

We have a potential drug here that is increasing cardiac function and performance and that addressed and reduced.

Clinically meaningful outcomes now granted it did not achieve an effect on CV death.

Alone.

Robert I. Blum: But I think it's going to be important to understand which patients did benefit more, which ones perhaps less. And in an 8,000 patient trial, you've got ample opportunity to do that with pre-specified subgroups.

But I think it's going to be important to understand which patients did benefit more which ones, perhaps less and an 8000 patient trial, you've got ample opportunity to do that with pre specified subgroups and that's ultimately where I think physicians and payers might consider.

Robert I. Blum: And that's ultimately where I think physicians and payers might consider new mechanism drugs. You know, you look at Victoria HF, and Merck and Bayer are quite bullish on the prospects for verisiqua, which demonstrated in Victoria HF a clinically meaningful reduction in outcomes, not unlike what we've already top-lined, but for outpatients with worsening outcomes. And, you know, that drug is going to be reviewed with priority review by FDA and has a BDUFA date coming up in Q1. So things like that will inform, ultimately, how the Armentarium for Heart Failure may continue to evolve, and I suspect that given the high unmet need and the high economic burden, there will be places for these various medicines, as adjacent to one another, complementary to one another. And you're right. Not all of these will be used as foundational care for all patients.

Sure.

New mechanism drugs.

You know you look at.

Victoria, HF and Merck and buyer are quite bullish on the prospects for Vera sick, what which demonstrated in Victoria HF.

A clinically meaningful reductions.

And outcomes not unlike what we've already top line, but for outpatients with worsening outcomes.

And you know that drug is going to be reviewed with priority review by the FDA and has the twoq to date coming up in Q1.

So things like that will inform ultimately how the armamentarium for heart failure may continue to evolve and I suspect that given the high unmet need and the high economic burden that there will be places for these various medicines as adjacent to one another complementary to one another.

And you're right not all of these will be used as a foundational care and all patients, but there are meaningfully important subgroups and cohorts that are not well served and that's where I would suggest once we can assure.

Robert I. Blum: But there are meaningfully important subgroups and cohorts that are not well-served, and that's where I would suggest, once we can share our results and do the work we need to do, that having that conversation down the road could perhaps be fruitful. If I could just squeeze in one last question. It's about Redwood.

Sure our results and do the work we need to do that having that conversation down the road.

Could perhaps be fruitful.

Okay. If I could just squeeze in one last question is about Redwood.

You might have touched on this before so apologies if I missed this but in terms of what what would be.

Fady Ibraham Malik: And you might have touched upon this before. So apologies if I missed this. But in terms of what, what would be the bar for success?

The bar for success, what do you think it would look good in terms of the Redwood data. Thanks.

Fady Ibraham Malik: What do you think would look good in terms of the Redwood data? Thanks. Fady, do you want to take that? What would look good with regard to the Redwood data? I can't. Stuart's on the line, I think now. Maybe if you want to try and take that, Stuart, you solved your audio problem? You're on mute, though. Maybe I'll try that.

How did you want to take that what would look good with regard to the Redwood City.

I cannot Stuart on the line I think how maybe you want to try and take that Stuart you sold your audio from.

Yeah.

When you are on mute [laughter].

Okay, maybe I'll try that.

So the.

I think what we would expect out of out of hopefully the first group of patients is to begin to see reductions in their left ventricular outflow gradient and to see that that the drug is well tolerated.

Fady Ibraham Malik: I think what we would expect from, hopefully, the first group of patients is to begin to see reductions in their left ventricular outflow gradient and to see that the drug is well tolerated. That's really all you can expect from what's the first dose group of a study that's designed to have a lower dose group and a higher dose group. And obviously, you know, what will inform progress to phase three and doses that we select for final doses for phase three will be the second cohort as well. Okay, thank you, and congrats again. Thanks, Greg. Your next question comes from Chad Messer from Needham, Inc. Hello everyone, this is Gilans on behalf of Chad. Hey, I'm sorry if I might repeat some questions here. It's a little late. First off, I don't know if you guys talked about a potential subgroup analysis; are there any chances we'll see any regional assessments of galactic HS patients? Because we recently saw some weird-looking data from other studies where you showed very different outcomes in the US versus ex-US. Yeah, those are among the pre-specified subgroups.

That's really all you can expect from from what the first dosing group of.

Study, that's designed to have a lower dose group and a higher dose group.

And obviously.

If the what will inform progress.

Page, three and doses that we select and or for final.

Final doses for phase three will be the second cohort.

As well.

[laughter].

Okay. Thank you and congrats again.

Thanks, Greg.

Your next question comes from Chad Messer from Needham and company.

Hi, John This hi, everyone. This is gill on for Chad.

Okay.

I'm, sorry, if I I might repeat some question sounds a little late.

The first first off I don't know if you guys talk.

Talked about potential subgroup analyses are there any chances, we'll see any regional assessments of the galactic HF patients because we recently saw some weird looking data from other studies, where that you showed a very different outcomes and U.S. versus.

Excellent.

Yeah, those are among the pre specified subgroups.

Unknown Executive: So those data will be presented. Excellent. And kind of a follow-on from that. Do you feel that, considering we're a galactic top line, does this put more emphasis on data that's gonna come out of meteoric? And how will the data coming out of meteoric influence potential further development and kind of give us an idea of how a mechanism functions?

So that that those data will be presented.

Excellent and I'm kind of a follow on on that.

Do you feel that concern.

Considering where the galactic a topline business put more emphasis on data that is going to come out of me deal, where and how will the data coming out of New York influence potential further development and kind of give us an idea of how the captive functions.

You know me meteoric won't finish enrolling until the mill until sometime in the first half of next year.

Robert I. Blum: You know, METEORIC won't finish enrolling until sometime in the first half of next year, and the trial won't actually complete until the end of next year, so I don't think METEORIC is relevant to our deciding to move forward with the data in GALACTIC, and I expect long before we have data from METEORIC, we'll have devised and decided what to do with regard to the GALACTIC That does make sense.

And the trial won't actually complete till the end of next year. So I don't think meteoric is relevant to our exciting.

To move forward with the data and Galactic.

And I expect long before we have data from New York that will have devised inside what to do with regards to the galactic data.

Yeah. Thank you for clarifying that that but it does make sense.

Unknown Executive: All right, everyone. Thank you for taking our questions and congrats on all the proper answers. Great, thanks very much. And there are no further questions at this time. I will turn the call back over to the presenters. Okay. Thank you to all the participants in our teleconference today. Thank you for your continued support and interest in cytokinetics. Obviously, the third quarter was an incredibly busy one for us, both in terms of the advancement of our pipeline and in terms of doing deals, and also an especially gratifying one in light of the recent announcement of the results of Galactic.

All right everyone. Thank you for taking my questions and congrats on all the progress.

Great. Thanks, very much guys.

Yes.

There are no further questions at this time I will turn the call back over to the presenters.

Okay. Thank you to all the participants on our teleconference. Today. Thank you for your continued support and interest in Cytokinetics. Obviously, the third quarter was an incredibly busy one for US both in terms of advancement of our pipeline in terms of doing deals and also.

Especially gratifying one in light of the recent announcement of the results of Galactic, we do look forward to sharing more with regard to those results.

Unknown Executive: We do look forward to sharing more with regard to those results at AHA and afterwards, and we thank you for your continued interest in all that we're doing. Operator, with that, we can now conclude the call. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Ah ha and afterwards and we thank you for your continued.

Interest and all that we're doing operator with that we can now conclude the call. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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