Q1 2020 Earnings Call

Good afternoon him welcome late into German.

Unknown Executive: Good afternoon, and welcome, ladies and gentlemen, to Cytokinetics' first quarter 2020 conference call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode.

<unk> Shadow kinetics first quarter 2020 conference call at this time I would like to formulate this costs being recorded and then I'll participate trying to listen only node at the company's requests we will open they call for questioning that she was after the presentation now 10 call ever to Diane license connect senior Vice President.

Unknown Executive: 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. Please go ahead.

And corporate corporate communications and Investor Relations. Please go ahead.

Good afternoon, and thanks for joining us on the call today, I've Islam, our president and Chief Executive Officer will kick off the call with an overview of the quarter and the impact of covert 19, I'm certain clinical trial.

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 an overview of the quarter and the impacts of COVID-19 on certain clinical trials. Then Fady Malik, our EVP of Research and Development, will provide updates on key developments for Omicamtiv-McCarville, our cardiac myosin activator, and AMG594, our cardiac troponin activator, both in our collaboration with Amgen. Next, Stuart Kupfer, our SVP and Chief Medical Officer, will update on recent progress with CK274, our wholly owned cardiac myosin inhibitor, now Then Robert Wong, our VP and Chief Accounting Officer, will provide a financial overview for the quarter, and Ching Ja, our SVP and Chief Financial Officer, will discuss corporate development strategies before Robert Blum provides concluding thoughts on the company's outlook, including an update on Rel-Deceptive, our fast skeletal muscle troponin activator, as well as expected key milestones for the remainder of the year.

Saudi Malik R.E.V.P. of research and development will provide updates on t. developments, but let me tempted horrible cardiac niacin activate R.M.G. five nine for cardiac proponent after they they're both under our collaboration with M. Jan <unk> hour as C.P. and Chief Medical Officer update.

On me some progress with T.K. two seven for our wholly owned cardiac mice and then head but are now in face too and C.K. 271 hour additional cardiac mice and inhibitor.

<unk> R.V.P. and she's counting officer will provide a financial overview for the quarter and teaching job at T.P. and Chief Financial Officer, we'll discuss corporate development strategies before Robert Blake provides concluding thoughts and the company's outlook.

Including an update on <unk> are fast skeletal muscle proponent activator as well as expected key milestones for the remainder of the year.

Please note the portions of the following discussion, including our sponsors to question contain statements that relate to future events and performance rather than historical facts and constitute forward looking statements. Examples of such statements include but are not limited to statements related to the potential impact as a covert 19 pandemic on or at least.

Robert I. Blum: Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Examples of such statements include, but are not limited to, statements related to the potential impact of the COVID-19 pandemic on our research and development activities and business operations, including our anticipated cash expenditures during the 2020 calendar year; statements relating to cytokinetics and its partners' research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing, and results of clinical trials. 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. And now, I will turn the call over to Robert.

Search and development activities in business operations, including aren't dissipated cash expenditure during the 2020 calendar year statements relating to settle kinetic and it's partners research and development and commercial readiness activities, including the initiation conduct design enrollment progress continuation completion time.

And results of clinical trials.

Actual results might different materially some notes projected in these forward looking statements additional information concerning factors that could cause a actual results different materially from those and these forward looking statements is contained in R.S.P.C. filing we undertake no obligation to update any forward looking statements. After this call now.

I will turn the call over to Robert.

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

Robert I. Blum: Thank you, Diane. And thanks again to everyone for joining us on the call today. I want to begin today's call by extending to you and your families our wishes for safety, health, and well-being during these unprecedented and uncertain times. Our top priority has been the health, safety, and well-being of our employees, clinical trial participants, and business and community partners. In accordance with California and Bay Area shelter-in-place orders, our employees have been and continue to work primarily from home.

I want to begin today's call by extending to you and your families or wishes for safety health and wellbeing. During these unprecedented an uncertain times.

Or top priority has been the health safety and well being of our employees clinical trial participants and business and community partners.

In accordance with California, and Bay area shelter and place orders our employees have been and continue to work primarily from home.

Robert I. Blum: As such, all business travel has been suspended, and we have been participating in medical and investor conferences virtually, as many of you have. During this time, we are doing all that we can to ensure that the critical work required to bring our potential medicines to patients continues. Toward that end, on today's call, we'll update you on progress during the quarter and specifically how the COVID-19 pandemic has and has not impacted our business and operations. While we have made the decision to temporarily suspend enrollment in certain of our clinical trials, we are still on track to report top-line results from Galactic HF in Q4. Fady will elaborate on that key strategic objective in a moment. We will hit the ground running in 2020 with a busy and productive first quarter.

Such all business travel has been suspended and we have been participating in medical it investor conferences virtually as many of you have.

During this time, we are doing all the weekend to ensure that the critical work required to bring or potential medicines to patients continues.

Toward that end on today's coal, we'll update you on progress during the quarter and specifically held the code that 19 pandemic pad and has not impacted our business and operations.

While we have made the decision to temporarily suspend enrollment in certain of our clinical trials. We are still one truck to report top wind results from Galactic H. up in Q. for.

Study will elaborate on that key strategic objective in a moment.

We hit the ground running and 2020 with a busy and productive first quarter.

As we previously stated our primary focus this year is our cardiovascular pipeline, which now includes for drug candidate advancing in all stages of development.

Robert I. Blum: As we've previously stated, our primary focus this year is our cardiovascular pipeline, which now includes four drug candidates advancing in all stages of development. The most notable achievements during the quarter centered around GALACTIC-HF, one of the largest phase 3 global cardiovascular outcome studies in heart failure, which is being conducted by Amgen under our longstanding collaboration. These recent achievements include, firstly, the publication of the design manuscript for the trial. Next, we are passing through the second and final planned interim analysis of GalacticHF, with no changes recommended by the DMC for its conduct, and finally, the virtual presentation of the baseline characteristics and demographics from GalacticHF at ACC 2020.

Most notable achievements during the quarter centered around Galactic h.

One of the largest phase three global cardiovascular outcome studies in heart failure, which is being conducted by am Jen under our longstanding collaboration.

These recent achievements included personally the publication of the design manuscript for the trial.

Next or passing through the second and final play and interim analysis of Galactic Kate show with no changes recommended by the D.M.C. towards conduct and finally, the virtual presentation of the baseline characteristics and demographics from Galactic H.L.A.C.C. 2020.

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Study will elaborate on these batteries in particular, but suffice it to say we are pleased to see that the trial enrolled the high risk patient population intended by the design and protocol.

Robert I. Blum: Fady will elaborate on these matters in particular, but suffice it to say we are pleased to see that the trial enrolled the high-risk patient population intended by the design and protocol. And as the design paper articulates, this clinical trial will include the largest number of cardiovascular events accumulated in a heart failure trial. In the first quarter of this year, we also began Redwood HCM, the Phase 2 clinical trial of CK274, our next-in-class cardiac myosin inhibitor for the potential treatment of obstructive hypertrophic cardiomyopathy. We recently announced the temporary suspension of enrollment in Redwood HCM, but we continue startup activities with an objective to activate new sites in both North America and Europe.

And that's the design paper articulation. This clinical trial will include the largest number of cardiovascular events accumulated in a heart failure trial.

In the first quarter of this year. We also began redwood H.T.M. the phase two clinical trial of C.K. two seven for our next in class cardiac myosin inhibitor for the potential treatment of structure hypertrophic cardiomyopathy, We recently announced the temporary suspension of enrollment in Redwood H.C.M., but we can.

When you start up activities with an objective to activate new sites in both North America and Europe.

Stuart will lab rate on how those startup activities are going in our approach to whether the coconut 19 storm.

Robert I. Blum: Stuart will elaborate on how those startup activities are going and our approach to weathering the COVID-19 storm. Additionally, in the last quarter, we presented important preclinical data for CK274, which detailed its mechanism of action and properties to modulate cardiac contractility in vitro and in vivo. These data characterized a distinct and selective binding site for CK274, which we believe could translate to potential opportunities in the clinical setting. We also presented preclinical data for AMG594, our cardiac proponent activator being developed in our collaboration with AMG. This represented the first scientific presentation of the mechanism of action for AMG-594, which included evidence suggesting a favorable pharmacodynamic window. Enrollment in the Phase 1 study of AMG 594 has been temporarily suspended, but we look forward to data from this study when available.

Additionally, in the last quarter, we presented important pre clinical data for C.K., two seven for which elaborated on its mechanism of action and properties to modulate cardiac contractual in in vitro and Invivo. These data characterize that stinks and selective binding site for C.K. two seven for.

Which we believe could translate to potential opportunities in the clinical setting.

Also presented pre clinical data for A.M.G. five nine.

Cardiac proponent architecture being developed under our collaboration with them.

This represented the first scientific presentation of the mechanism of action for A.M.G. five nine for which included evidence adjusting a favorable pharmacodynamic window.

Enrollment in the phase one study of A.M.G. 594 has been temporarily suspended but we look forward to data from this study when available.

Despite the new reality related to the Corona virus. Our team has never been more focused nor more motivated to advance our mission to bring novel mechanism medicines to patients suffering from diseases of muscle dysfunction.

Robert I. Blum: Despite the new reality related to the coronavirus, our team has never been more focused nor more motivated to advance our mission to bring novel mechanism medicines to patients suffering from diseases of muscle dysfunction. I continue to be so impressed with the passion and commitment of our employees, and I want to assure you that we're doing all we can to ensure that the critical work required to bring our potential medicines to patients continues. And with that, I'll turn the call over to Fady to elaborate on key developments in our collaboration with Amgen.

I continued to these so impressed with a passion and commitment of our employees.

Sure you that we're doing all weekend to ensure that critical work required to bring more potential medicines to patients continues.

And without altering the call over to fatty to elaborate on c. developments under our collaboration with them Jen.

Thanks Robert.

Summarized under our collaboration with Amgen, we accomplished several significant goals during the first quarter, including publication of the design manuscript for Galactic H. up.

Jack Heart failure, passing through that second and final planned interim analysis conducted by the data monitoring Committee.

Most recently presenting the baseline characteristics and demographics of patients enrolled in this trial.

Fady Ibraham Malik: Thanks, Robert. As Robert summarized, in our collaboration with Amgen, we accomplished several significant goals during the first quarter, including publication of the design manuscript for Galactic HF and Jack Hart failure. Passing through the second and final planned interim analysis conducted by the Data Monitoring Committee and, most recently, presenting the baseline characteristics and demographics of patients enrolled in this trial. Since I covered the previous two milestones during our Q4 earnings call, I'll focus today on some key takeaways from the baseline characteristics of Galactic HF, as well as how Amgen is proceeding to facilitate continuity of the trial and reporting of top-line results in Q4 2020. As intended, patients enrolled in GALACTIC-HF represent a heart failure population at risk for cardiovascular events.

Since I covered the previous to milestones during our Q4 innings call I'll focus today on some key take away from the baseline characteristics of <unk>.

As well as how Amgen is proceeding.

Continuity of the trial and reporting up top line result in Q. for 2020.

As intended patients enrolled him galactic H.F. represent a heart failure population at risk for cardiovascular events.

Fight being well treated on standard of care therapy.

The baseline patient characteristics of this trial describe the balance representation from countries around the world.

And from both inpatient and outpatient treatment settings.

As you'll recall, all outpatients and Galactic H.F. were required to have a prior hospitalization within a year.

The actual median time from last talk heart failure hospitalization or your visit for heart failure in Galactic H. after three months.

And with the recruitment of a population are at risk for rehospitalization or cardiovascular death.

In addition is I'll remind you 25% of the patients randomized during their index park failure hospitalization.

Fady Ibraham Malik: Despite being well-treated on standard of care therapy. Baseline patient characteristics of this trial describe a balanced representation from countries around the world and from both inpatient and outpatient treatment settings. As you recall, while all outpatients in GALACTIC-HF were required to have a prior hospitalization within a year, the actual median time from last heart failure hospitalization or ER visit for heart failure in GALACTIC-HF is three months, consistent with the recruitment of a population at higher risk for re In addition, as I'll remind you, 25% of the patients were randomized during their index heart failure hospitalization. Accordingly, they represent a somewhat sicker and more symptomatic patient group, as reflected by their higher median antiproliferative P, as well as their lower blood pressures, estimated glomerular filtration rate, and baseline Kansas City cardiomyopathy questionnaire scores.

Accordingly, they represent somewhat thicker and more symptomatic patient group as reflected by their higher median N.T. probing p. as well as their lower blood pressures.

<unk> filtration rate and baseline, Kansas City Cardio my apathy questionnaire scores.

The data also show that adherence to standard of care background medical therapy, and Galactic H.F. is quite good with 94% of patience on beta blockers.

7% on Rina Magic tempting system blockers.

And the 77% on a mineralocorticoid antagonists.

Additionally, many you have been interested in the per cent of patient in Galactic Kate show being treated with interest.

Yearly 20% representing over 1500 patients are being treated with a standard of care that includes interest up. So we should have we should have a good assessment of how long the cancer Mecarbil may improve outcomes and patients receiving treatment with interest up.

To put the patient population of Galactic H.I. in contact.

Fady Ibraham Malik: The data also show that adherence to standard-of-care background medical therapy in galactic HF is quite good, with 94% of patients on beta blockers, 87% on renin-angiotensin system blockers, and 77% on aminorallocorticoid antagonists. Additionally, many of you have been interested in the percent of patients in GALACTIC-HF being treated with Entresto. Nearly 20%, representing over 1,500 patients, are being treated with a standard of care that includes entrustment. So we should have a good assessment of how mecanthemocarbal may improve outcomes in patients receiving treatment with Entresto.

Useful to compare the cardiovascular risk profile patience and Galactic H. up with the population of other recently recorded outcome trials in heart failure.

Overall in terms of predictors of the risk of future cardiovascular events.

Particular, N.P. pro being P.

Baseline characteristics of the patient population collect <unk> intermediate between the lower his patient populations of paradigm h. up and down the H.S.

And the page three trials of interest and far Sega respectively.

And the higher risk.

Population of Victoria.

Eight three clinical trials are very Sig, what that was recently presented at 80 feet 20.

<unk> design Galactic H.F., two enrolled patients at higher risk than those in paradigm h. up in particular.

Fady Ibraham Malik: To put the patient population of GALACTIC-HF in context, it's useful to compare the cardiovascular risk profile of patients in GALACTIC-HF with the populations of other recently reported outcome trials in heart failure. Overall, in terms of predictors of the risk of future cardiovascular events, in particular Nt-proBNP, the baseline characteristics of the patient population in GALACTIC-HF appear intermediate between the lower-risk patient populations of PARADIGM-HF and DAPA-HF and the Phase III trials of Entresto and Farsiga, respectively, and the higher-risk patient population of Victoria. The Phase III clinical trial of variciguat that was recently presented at ACC20. We and Amgen designed GalacticHF to involve patients at higher risk than those in ParadigmHF, in particular requiring 25% of patients to be randomized from the hospital setting.

Hiring 25 per cent of patient to be randomized from the hospital setting.

Broadly representative of the majority of heart patients remain at risk for cardiovascular events.

Patient population of Galactic H. geographically diverse and very well maintained on standard of care.

But we think the trial may provide clinically meaningful edited and how this new mechanism cardiac my son activation may play an important role in the potential treatment of chronic heart failure.

I've turning to cope with 19 and the continued conduct of Galactic at the time, we Enam Sanders still operating under the planned assumption blocking the database and proceeding to report top line results and cute for 2020.

Events continued a crew and are being closely monitored.

Reminds you that back in February when the D.M.T. conducted the second and final planned interim analysis.

Analysis was triggered by the cruel of two thirds of the target number 1500, and 90 TV deaths.

In order for that analysis to have been conducted Ben triggering event had do occur in the fourth quarter of 2019.

Additional events continued the crew up to the time of the interim analysis.

Analysis provided an opportunity to collect clean and analyze a large majority of clinical trial data and therefore should facilitate final trial database block later this year.

Fady Ibraham Malik: This list is still broadly representative of the majority of heart failure patients who remain at risk for cardiovascular events. The patient population of galactic HF is geographically diverse and very well maintained on standard of care, so we think the trial may provide clinically meaningful evidence of how this new mechanism of cardiac myosin activation may play an important role in the potential treatment of chronic heart failure.

During this corona virus crisis, many patients do not have the same access to their studies centres that they did before.

However engine has adapted to conduct of the trial to enable delivery of investigational product that patients home.

The conduct that study visit.

Remotely for collection of study endpoint.

Fady Ibraham Malik: Turning to COVID-19 and the continued conduct of GALACTIC at this time, we in Amgen are still operating under the planned assumption of locking the database and proceeding to report top-line results in Q4 of 2020, although events continue to accrue and are being closely monitored. I'll remind you that back in February when the DMC conducted the second and final planned interim analysis, that analysis was triggered by the accrual of two-thirds of the target number of 1,590 CV deaths. In order for that analysis to have been conducted then, the triggering event had to occur in the fourth quarter of 2019, with additional events continuing to accrue up to the time of the interim analysis. This analysis provided an opportunity to collect, clean, and analyze a large majority of the clinical trial data and therefore should facilitate the final trial database block later this year. During this coronavirus crisis, many patients do not have the same access to their study centers as they did before.

At this point, none of the main trial endpoint, including heart failure event.

Yeah or collection of the Kansas City Cardium apathy questionnaire, we 24 are dependent on patients physically visiting trials.

And then doing an enormous amount of logistical planning and work to prepare for trial closed down.

I'm grateful to our collaborators Nam Chen or clinical trial investigators and their personnel and the patients themselves for all they're doing to adapt and even especially challenging time.

In some I believe we are fortunate position with Galactic H.F. given how advanced we are in the trial conduct.

And as you may have seen clinical trials dot Gov with recently updated to reflect the study completion date above it seven which gives the soundtracks report top line results and Q. for.

Regarding the second phase three trial in that program meteoric can't show the.

Temporarily suspended disenrollment due to the Corona virus pandemic.

We continue to Prioritise startup activity in order to add more active sites once in Rome, and can resume in particular looking to add a substantial number in Europe.

Already there are a number of site toys to join meteoric h. up as conditions improve in Europe, and we continue to work towards the objective of adding over 50, new site throughout North America and Europe.

Fady Ibraham Malik: However, Amgen has adapted the conduct of the trial to enable delivery of the investigational product to patients' homes and the conduct of study visits remotely for collection of study endpoints. At this point, none of the main trial endpoints, including heart failure events, CV death, or collection of the Kansas City Cardiomyopathy Questionnaire at Week 24, are dependent on patients physically visiting trial sites. Sam Jensen is doing an enormous amount of logistical planning and work to prepare for trial closeout.

Once clinical research can resume at clinical site.

May well be position to advance screening and enrollment in the coming months.

Although we suspended new patients screening.

We are ensuring remote monitoring of the patients who had already begun receiving investigation of treatment, but not yet completed the trial prior ours suspending enrollment of new patients.

It's enrollment can be reactivated by the end of cute to 2020.

Leave enrollment maybe still completed by the end of the year.

As we've stated results from meteoric H.F. or not on the critical path submitting regulatory filings for the potential approval of on the camps mccardell.

Fady Ibraham Malik: I'm grateful to our collaborators at Amgen, our clinical trial investigators and their staff, and the patients themselves for all they're doing to adapt in these especially challenging times. In sum, I believe we are in a fortunate position with Galactic HF, given how advanced we are in the trial's conduct. And as you may have seen, clinicaltrials.gov was recently updated to reflect a study completion date of August 7th, which keeps us on track to report top-line results in Q4. Regarding the second phase three trial in this program, METEORIC-HF, we've temporarily suspended its enrollment due to the coronavirus pandemic. We continue to prioritize startup activities in order to add more active sites once enrollment can resume, in particular looking to add a substantial number in Europe. Already, there are a number of sites poised to join METEORIC-HF as conditions improve in Europe, and we continue to work towards the objective of adding over 50 new sites throughout North America and Europe.

And instead, if the findings the meteoric are supportive would be included in a supplemental filing following a potential commercial lunch predicated on our results from Galactic H. yeah.

Regarding H.M.G. 594, as Robert mentioned during the quarter pre clinical data. They keep five nor 594 presented at the Keystone Symposium on heart failure.

We are pleased to share in vitro finding demonstrating that aims you five then forced selectively increases the calcium sensitivity of cardiac muscle fibers and increases cardia contractility.

Supporting the approach of cardiac proponent activation potentially treat diseases characterized by reduce install it function.

Invivo results also suggests the pharmacodynamic window, the energy 594, maybe favorable.

As previously mentioned enrollment and sad Mad pays one study of aims you 594 has been temporarily suspended due to the Corona virus pandemic.

However, we look forward to the data from the study is the main form are from potential progressing to say two.

Fady Ibraham Malik: Once clinical research can resume at clinical sites, we may well be positioned to advance screening and enrollment in the coming months, although we have suspended new patient screening. We are ensuring remote monitoring of the patients who had already begun receiving investigational treatment but had not yet completed the trial prior to our suspending enrollment of new patients. If enrollment can be reactivated by the end of Q2 2020, we believe enrollment may still be completed by the end of the year. As we've stated, results from EDIORC-HF are not on the critical path to submitting regulatory filings for the potential approval of Omicamptive-McArdle but instead, if the findings of METEORIC are supportive, would be included in a supplemental filing following a potential commercial launch predicated on our results from Galactic HF.

To that point, we're working with am's into a line on the plan for a pay to program.

And that will turn it over to Stewart to provide an update on our cardiac mice and inhibitor program.

Thanks Saturday.

As you May know, our cardiac myosin and Hitler program includes C.K. 274, and she K. 271.

I'll begin with an update on site activation screening enrollment in Redwood H.T.M. face to clinical trial of C.K. 274.

Potential treatment obstruct at H.T.M.

And then provide an update on our preparedness for the phase one study of C.K. to set in one.

In response to the current a virus pandemic Cytokinetics has created an internal task force specifically for clinical trials and is activated business continuity plan for ongoing trials.

Fady Ibraham Malik: Regarding AMG-594, as Robert mentioned during the quarter, preclinical data for AMG-594 were presented at the Keystone Symposium on heart failure. We were pleased to share in vitro findings demonstrating that AMG-594 selectively increases the calcium sensitivity of cardiac muscle fibers and increases cardiac contractility. Supporting the approach of cardiac troponin activation to potentially treat diseases characterized by reduced systolic function. In vivo results also suggest that the pharmacodynamic window of AMG-594 may be favorable. As previously mentioned, enrollment in the SADMAD Phase 1 study of AMG 594 has been temporarily suspended due to the coronavirus pandemic. However, we look forward to the data from the study that may inform our potential progress in Phase 2. To that point, we are working with Amgen to agree on a plan for a Phase II program. Now, we'll turn it over to Stuart to provide an update on our Cardiac Myosin Inhibitor Program.

We were in communication with R.C.R. rose and other vendors regarding their business continuity plans.

And have been tracking the clinical trials like policies regarding ongoing research and access to the hospital.

As with meteoric H.S. to protect the safety and health of clinical trial participants and healthcare professionals.

We've temporarily suspended enrollment in Redwood H.T.M.

However, we've been working with sites to enable provision of investigational product to patients already enrolled in a trial.

And accommodate remote visits where possible.

In the meantime, we're continuing to work in turn only with R.C. arose vendors and sites to activate new sites with the goal of activating over 20 news sites throughout North America and Europe.

I'll remind you that for this trial, we won't be active any more sites and the number of patients required in each cohort.

So we remain optimistic that data from Cold War, one maybe available by year end if enrollment in this first cohort.

Can be completed by mid year.

As Robert mentioned preclinical results for C.K. 274 were presented at the recent by physical Society annual meeting.

Stuart Kupfer: Thanks, Fady. As you may know, our cardiac myosin inhibitor program includes CK274 and CK271. I'll begin with an update on site activation, screening, and enrollment in Redwood HCM, the Phase II clinical trial of CK274 for the potential treatment of obstructive HCM, and then provide an update on our preparedness for the Phase 1 study of CK271. In response to the coronavirus pandemic, Cytokinetics has created an internal task force specifically for clinical trials and has activated a business continuity plan for We're in communication with our CROs and other vendors regarding their business continuity plans, and have been tracking clinical trial site policies regarding ongoing research and access to the hospital. As with Meteoric HF, to protect the safety and health of clinical trial participants and health care professionals, we've temporarily suspended enrollment in Redwood HCM. However, we've been working with sites to enable the provision of the investigational product to patients already enrolled in the trial and accommodate remote visits where possible. In the meantime, we're continuing to work internally with our CROs, vendors, and sites to activate new sites with the goal of activating over 20 new sites throughout North America and Europe.

These data demonstrated that C.K. 274 reduces cardiac my us an activity in vitro.

And importantly does not inhibit the activity of smooth muscle niacin.

Which is supported by the activity for cardiac myosin.

The study results also indicated that C.K. 274 has an alastair binding site distinct from that of camping.

Which made differentiate the Pharmacodynamic features are these two promising drug candidates.

Moving to C.K. 271, or additional cardiac myosin inhibitor.

We're pleased to announce that R.I.M.D. wasn't boat submitted and accepted during the first quarter.

The gun to engage in studies started activities for a phase one study of C.K. 271, and healthy volunteers.

The primary objective this person human phase one study.

Assess the safety and Tolerability and pharmacokinetics, a single a., sending oral doses of C.K. 271, and healthy adult subjects.

We remain optimistic we can start this study during the second quarter, but does whether other trials started this study will depend on evolving conditions that are studies site.

And with that I'll turn it over to Robert long will provide an update on our financial.

Thanks to work.

Oh first provide an update on cash revenue in spending and then changeable review, our 2020 financial guidance and corporate development strategy.

More details on our actual results for the first quarter 2020 or included in the press release, which was released earlier this afternoon.

We ended the first quarter with approximately 237 billion in cash and investing.

Stuart Kupfer: I'll remind you that for this trial, we will be activating more sites with the number of patients required in each cohort. So we remain optimistic that data from Cohort 1 may be available by year-end if enrollment in this first cohort can be completed by mid-year. As Robert mentioned, preclinical results for CK274 were presented at the recent Biophysical Society annual meeting. These data demonstrated that CK274 reduces cardiac myosin activity in vitro and, importantly, does not inhibit the activity of smooth muscle myosin, which is supportive of the selectivity for cardiac myelitis. The study results also indicated that CK274 has an allosteric binding site distinct from, which may differentiate the pharmacodynamic features of these two promising drug candidates.

Our revenue in Q1 2020 came from our strategic alliances with <unk> and that Stella.

For Amgen, we recognize revenue associated with their with their reimbursement of our development expenses related to meteoric h. out.

<unk>, we recognize rather again for their reimbursement of expenses related to our scientists engage in collaborative research.

Our first quarter of 2020, R.D. expenses decreased to 21.7 million from 23.5 million in the first quarter of 2019.

Ordinarily do to lower spending related to our neural muscular development activities with the completion afford a T.V.A.L.S. in 2019 offset by increased activity.

Could both meteoric H.F. and Redwood H.T.M. in 2020.

More than half of our R. and D. expenses were trippy do attributable to our cardiovascular programs as expected given activity for meteoric H.F. and the cardiac myosin inhibitor program in the remainder of our expenses for attributable primarily to our early research activity.

Stuart Kupfer: Moving to CK271, our additional cardiac myosin inhibitor. We're pleased to announce that our IND was both submitted and accepted during the first quarter. And we've begun to engage in study startup activities for a phase one study of CK271 in healthy volunteers. 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.

Our first quarter 2020, G.N.A. expenses were 12.4 million.

From 9.4 million from Q1, 2019, due primarily to hire personnel related costs, including stop based compensation and hire outside service.

And now Ching, we'll review our guidance for 2020 and highlight our corporate development strategy.

Thanks Robert.

Stuart Kupfer: We remain optimistic we can start this study during the second quarter, but as with our other trials, the start of this study will depend on evolving conditions at our study site. And with that, I'll turn it over to Robert Wong, who will provide an update on our financial... Thanks, Stuart.

Company continues to put put your cash revenue for 2020 will be in the range of 18 to 22 million.

<unk> expenses will be in the rain, Joel 122, 130 million and net cash <unk> for the full year will be between 105 and 115 million.

Robert C. Wong: I'll first provide an update on cash, revenue, and spending. And then Ching will review our 2020 financial guidance and corporate development strategy. More details on our actual results for the first quarter of 2020 are included in the press release which was released earlier this afternoon. We ended the first quarter with approximately $237 million in cash and investments.

Given the Corona virus and potential impacts of the clinical studies and operations.

We have monitoring our spending and they update.

Financial guidance later in the year, if it looks like our spending my change.

During the quarter, we continue to pursue opportunities for project financing reality, modernisation and partnerships to expand Devolvement OVARA cardiac soccer <unk> and to further east than our cast runway.

Robert C. Wong: Our revenue in Q1 2020 came from our strategic alliances with Amgen and Estella. For Amgen, we recognize revenue associated with their reimbursement of our development expenses related to Meteoric HF. For Astellas, we recognize revenue for their reimbursement of expenses related to our scientists engaged in collaborative research.

Advancement of rubber <unk>, Yeah, and face one study of C.K. to settle on one provide momentum to these discussions.

In addition, we are eligible for approximately 100 million you milestone payments.

Robert C. Wong: Our first quarter 2020 R&D expenses decreased to $21.7 million from $23.5 million in the first quarter of 2019, primarily due to lower spending related to our neuromuscular development activities with the completion of Fortitude ALS in 2019, offset by increased activities related to both Meteoric HF and Redwood HCM in 2020. More than half 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 attributable primarily to our early research activities. Our first quarter 2020 G&A expenses were $12.4 million, up from $9.4 million in Q1 2019, due primarily to higher personnel-related costs, including spot-based compensation, and higher outside service. Now Ching will review our guidance for 2020 and highlight our corporate development strategy. Thanks, Robert.

There are a collaboration was m. Jen over the next 12 to 18 month or.

Assuming positive results from collected a cat.

We are fortunate to be in a strong financial position, especially given the uncertainties in today's equity capital markets and we continue to make strides to ensure that we prudently deployed capital against our prioritized clinical programs to maximize shareholder returns.

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

Thank you change.

These are truly extraordinary tons, but soto kinetic says persevere through business challenges in the past.

And as we have done before our employees are rising to the occasion, focusing forward and keeping their health and our mission top of mine.

I'm extremely proud of the camaraderie and collaboration we've demonstrated internally and with our business partners.

Despite these newer challenges are commitment toward pioneering science and you patients has not changed in our dedication has not falter.

We remain optimistic for what may prove to be a transformational year for the company and we are pleased that are most valuable program for me camped at <unk> remains on truck for top line registration trial results in two for later this year.

Ching W. Jaw: The company continues to project cash revenue for 2020 will be in the range of $18-22 million, operating expenses will be in the range of $120 to $130 million, and net cash utilization for the full year will be between $105 and $115 million. Given the coronavirus and potential impact on clinical studies and operations, we are monitoring our spending and may update Financial Guidance later in the year if it looks like our spending might change. During the quarter, we continued to pursue opportunities for project financing, royalty monetization, and partnerships to expand the development of our cardiac sarcomere inhibitor program and to further extend our cash runway. Advancements in Redwood HCM and the Phase 1 study of CK271 provide momentum for these discussions. In addition, we are eligible for approximately $100 million in milestone payments under our collaboration with Amgen over the next 12 to 18 months, assuming positive results from Galactic HF. We are fortunate to be in a strong financial position, especially given the uncertainties in today's equity capital markets. And we continue to make strides to ensure that we prudently deploy capital against our prioritized clinical program to maximize shareholder return. And with that, I'll turn the call back over to Robert Blum.

Additionally, I want to provide an update on roads assumptions in our collaboration with this goes.

Recently, we issued an eight k. related to our entry into agreements, which taken together amend and restate our research development and commercialization collaboration agreement with a still.

And follow up to our previously disclosed agreement in principle. These amendments provide subtle kinetic with the exclusive control and responsibility for the development and commercialization of <unk>.

She k. six so one.

And other skeletal regulatory activate or compounds.

Stole us agreed to pay certain costs up to $12 million, which may be incurred in connection with sort of kinetics potential. They use three clinical trial of relative to the L.S.

Which we estimate could cost between approximately $30 million to $40 million advertise over several years.

Oh still US has also agreed to non cash contributions to photo kinetics, including the transfer of its inventories of active pharmaceutical ingredient of relevant some too and C.K. six so one and the continued conduct of ongoing stability studies, it's called.

In return Soto kinetics would pay is still that's a load of did single digit royalty on sales of relevant symptoms in certain countries if commercialized.

Moreover.

Extended the joint research program, it's subtle kinetics through the remainder of this year with a minimum of 15 research F.T. ease being supported by is still this.

Robert I. Blum: Thank you, Ching. These are truly extraordinary times. But Cytokinetics has persevered through business challenges in the past, and as we have done before, our employees are rising to the occasion, focusing forward, and keeping their health and our mission top of mind. I'm extremely proud of the camaraderie and collaboration we've demonstrated internally and with our business partners. Despite these newer challenges, our commitment to our pioneering science and to patience has not changed, and our dedication has not faltered. We remain optimistic about what may prove to be a transformational year for the company, and we're pleased that our most valuable program, Omicamptomacarbal, remains on track for top-line registration trial results in Q4 later this year. Additionally, I want to provide an update on rel-deceptive in our collaboration with Estella.

How's exclusive rights to co develop encode commercialize skillful sarcomere activators.

Then south skill to regulatory activate or compounds in all indications subject to a certain soto kinetics development and co commercialization right.

Kinetics make coke promote and conduct certain commercial activities in the U.S., Canada and or Europe.

We're pleased to finalize these new agreements and look forward to our continuing partnership with a still this focus to scale to muscle activation.

Furthermore, regarding role deceptive during Q1, we convened to type C. meeting would that be gay in which F.D.A. provided useful feedback to our propose phase three clinical trial design, and it's endpoints and statistical clan.

Feedback, which will inform further development of rolled or something.

Robert I. Blum: Recently, we issued an 8K related to our entry into agreements which, taken together, amend and restate our Research, Development, and Commercialization Collaboration Agreement with Estella. In follow-up to our previously disclosed agreement in principle, these amendments provide Cytokinetics with exclusive control and responsibility for the development and commercialization of rel, CK601, and other fast skeletal regulatory activator compounds. Astellas agreed to pay certain costs, up to $12 million, which may be incurred in connection with cytokinetics' potential phase three clinical trial of raldosemtiv and ALS, which we estimate could cost between approximately $30 to $40 million amortized over several years. Astellas has also agreed to make non-cash contributions to Cytokinetics, including the transfer of its inventories of the active pharmaceutical ingredient in Reldaceptive and CK601 and the continued conduct of ongoing stability studies at its cost.

In the meantime, we're continuing to convene additional interactions in meetings with U.M.A. as well as H.T.K.'s.

Inform the finalization of the potential protocol.

As mentioned previously we do not expect to make any final decisions regarding.

Central Phase three trial of relative to some too in patients with illness until we have this ability to the results from galactic H.M. and are associated costs of palatable.

Kept it later in the year.

And so many things up we continue 2020 in a strong operational and financial position and we look forward to continuing to update you on our dancing pipeline of novel mechanism drug candidates and our further preparations for potential commercialization activities.

No. Let me recap are expected milestones for 2020.

<unk>, we expect top line results from Galactic eight show in the fourth quarter.

And we believe enrollment may be completed in meteoric h. up in patients with heart failure in 2020, if we can reactivate enrollment by the end up to 220 20.

For A.M.G. 594 am Gen and sort of kinetics of agreed to suspend enrollment in the phase one study of A.M.G. 594.

Robert I. Blum: In return, Cytokinetics would pay Estellas a low-to-mid single-digit royalty on sales of Rel-Deceptive in certain countries if commercialized. Moreover, Astellas extended the joint research program at Cytokinetics through the remainder of this year with a minimum of 15 research FTEs being supported by Astellas and has exclusive rights to co-develop and co-commercialize skeletal sarcomer Cytokinetics may co-promote and conduct certain commercial activities in the U.S., Canada, and or Europe.

For C.K. two seven for.

We expect data from the first cohort of patients enrolled in Redwood H.C. to be available in the second half of 2020, if enrollment in the first cohort can be completed by mid year.

For C.K. 271, we expect to initiate a phase one study before the end of Q2 22 20.

<unk>.

Spectra continued to engage with regulatory and reimbursement authorities in 2020 to prepare for a potential phase three clinical trial and registration program in patients with L.S.

Robert I. Blum: We're pleased to have finalized these new agreements and look forward to our continuing partnership with Astellas focused on skeletal muscle activation. Furthermore, regarding rel-decem- During Q1, we convened a Type C meeting with FDA, in which FDA provided useful feedback to our proposed Phase III clinical trial design and its endpoints and statistical plan, feedback which will inform the further development of REL-DSEM. In the meantime, we're continuing to convene additional interactions and meetings with EMA as well as HTAs to further inform the finalization of the potential protocol. As mentioned previously, we do not expect to make any final decisions regarding a potential phase 3 trial of rel-deceptive in patients with ALS until we have visibility to the results from GALACTIC-HF and our associated cost of capital, more to be expected later in the year. In summing things up, we continue to be in a strong operational and financial position, and we look forward to continuing to update you on our advancing pipeline of novel mechanism drug candidates and our further preparations for potential commercialization activities. Now, let me recap our expected milestones for 2020.

For ongoing research, we expect to continue research activities directed to the cardiac and <unk> and our other muscle biology research programs.

And we expect to continue research in collaboration with the spell this directed to the discovery of next generation <unk> activators through 2020.

Operator with that we can now open up a call police to questions.

Of course at this time, if one does have a question you could pass star and then I remember one on your telephone keypad again that star and the number one to go to our first question from the line of Charles Duncan from Cantor Fitzgerald.

Hi, Hello so.

Oh for Charles how are you.

Very good. Thank you how are you.

Good.

For all that.

This quarter and.

Two I report type on data later this year.

Question I have is.

Approval.

Farsi, though.

Hello.

Instruction fraction.

Just wanted to get your perspective on.

And.

And.

Regarding.

I would show clearly differentiated mechanism of action, how do you believe it will be perceived in the market.

Very good question all answer and then also outside to elaborate.

Robert I. Blum: For Omicampt of McCarble, we expect top-line results from GalacticHF in the fourth quarter, and we believe enrollment may be completed in meteoric HF in patients with heart failure in 2020 if we can reactivate enrollment by the end of Q2. For AMG 594, Amgen and Cytokinetics have agreed to suspend enrollment in the Phase 1 study of AMG 594. For CK274, we expect data from the first cohort of patients enrolled in Redwood HCM to be available in the second half of 2020 if enrollment in the first cohort can be completed by mid-year. For CK271, we expect to initiate a Phase I study before the end of Q2 2020, and Pharrell DeSim. We expect to continue to engage with regulatory and reimbursement authorities in 2020 to prepare for a potential Phase III clinical trial and registration program in patients with ALS. And for 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 Astellas directed to the discovery of next generation skeletal sarcomere muscle activators through 2020. Operator, with that, we can now open up the call, please, to questions.

With regard to.

Do drugs approved for the treatment of heart failure and reduced deduction fraction just yesterday.

You know it's been available for the treatment of patience with diabetes for a number of years and it has demonstrated now more recently activity impressive activity for the treatment of heart familiar with reduced rejection of correction.

We think that it's going to contribute to increase education and awareness of still the very highly unmet need in the treatment of heart failure and the importance of new mechanisms to bring down behind morbidity and mortality.

Also we believe it will contribute to ILLUMENATE, what may be the benefit of enhancing cardiac muscle function with only <unk>.

Pertains to potentially complementary therapies without altering it over to Saudi collaborate.

Yeah, I think you know that paycheck preference I mean Kappa glosses and Sega represents an advance in heart failure, but even in that trial, where patients are well treated and other standard of care and it represented a lower risk population potentially.

You still had event rate.

For C.D. debt.

And mortality that is seven to eight per cent per year.

You know for perspective that that's three times higher than the event that you see and large outfitter sclerosis trials and so forth.

And we expect in if you look in a trial like Victoria, which was recorded recently.

Unknown Executive: Of course, at this time, if anyone does have a question, you can press star and then the number one on your telephone keypad. Again, that's star and then number one. Now, we will go to our first question from the line of Charles Duncan from Cantor Fitzgerald. Hi, this is... Hello, Charles.

In the sicker population there the event rates for their primary outcome were.

We're in the 30 per cent range so as.

As we begin to develop and and we see new approvals for medicine and heart failure. The clinical need is still overwhelming in this area represents a enormous financial burden.

Unknown Executive: ..

Unknown Executive: ASAP Pete, on behalf of Charles, how are you?

To our society and and and is one of the most common conditions in in people that are in middle aged or above.

Unknown Executive: Very good. Thank you. How are you?

Unknown Executive: Good. Congratulations on all that's successfully completed in this quarter, and glad to hear that you reaffirmed Galactica is on track to report pipeline data later this year. The question I have is given the recent approval of Farsigo for hard failure with reduced injection fraction, I just want to get your perspective on the market opportunity and the unmet need. And, in addition, regarding OMACEMPTIV, which clearly has a differentiated mechanism of action, how do you believe it will be perceived in the market?

So we think only camp that will be.

If if galactic Kate chef readout has it in a positive way has the potential to become part of this foundation for heart failure and you know one of the.

Challenges I think and evolving heart failure care will be to determine the sequencing of how these medicines will be used but.

We like the fact that <unk> like like that the glove person has a very.

Good profile in terms of it doesn't affect.

Robert I. Blum: Very good question. I'll answer and then also ask Fady to elaborate. With regard to that new drug approved for the treatment of heart failure and reduced ejection fraction just yesterday, as you know, it's been available for the treatment of patients with diabetes for a number of years, and it has recently demonstrated activity, impressive activity for the treatment of heart failure with reduced ejection fraction. We think that it's going to contribute to increased education and awareness of the still very high unmet need in the treatment of heart failure and the importance of new mechanisms to bring down the high morbidity and mortality. Also, we believe it'll contribute to illuminate what may be the benefit of enhancing cardiac muscle function with Omicamptomacarbal as regards potentially complementary therapy. With that said, I'll turn it over to Fady to elaborate.

Blood pressure or doesn't adversely affect kidney function. Other things. It's scene is relatively easy to use which is I think why people are interested in <unk>.

Alright, thank you.

Very informative.

Congratulations.

Thank you. Thank you.

I have another question on the line crushing comes from.

Names tie it from his Uh huh.

Hello to leave it.

<unk>.

This is.

I'm for selling thanks for taking the question and congrats on T.I. process on the progress so far.

I'd a couple of questions first off on Galactic H.F. on how how're you guys thinking about what the clinically meaningful improvement on the primary endpoint I saw it <unk>.

It's a very good question. Thank you again, I'll start and turn it over to fatty and Stuart if he also wants to elaborate well say about galactic H.M. is now that we have recent trials relating to and trust too and very sick water and that we have an opportune.

Fady Ibraham Malik: Yeah, I think, you know, DAPA-HF, I mean, DAPA-glofacin for CIGA represents an advance in heart failure. But even in that trial where patients were well treated and received other standard of care, and it represented a lower risk population, potentially, you still had an event rate for CV death and mortality of seven to 8% per year. So, as we begin to develop and we see new approvals for medicines for heart failure, the clinical need is still overwhelming in this area. It represents an enormous financial burden on our society and is one of the most common conditions in people that are in middle age or above. So, we think OMECAMPTIV will become, if GALACTIC-HF reads out in a positive way, has the potential to become part of this foundation for heart failure.

I need to compare and contrast reductions in C.V. death.

As well as other endpoints, but it really is an apples and oranges comparison in some respects given that these trials enrolled at different times and different populations with different risk criteria.

With that said I think it's reasonable to assume that an event right reduction in the neighborhood of 10% to 20% is meaningfully important in clinically significant.

The more that is weighted to the higher end of that range with respect to see the death the more it gets even significantly.

High visibility amongst the clinical community, we're not gonna handicap that to any specifics other than that other than to say that lactic h. was designed very much to accrue a large number of events and a large number of C.V. deaths with a high medium.

Fady Ibraham Malik: And, you know, one of the challenges, I think, in evolving heart failure care will be to determine the sequencing of how these medicines will be used. We like the fact that Omicamptive, like dapaglifosin, has a very good profile in terms of it doesn't affect blood pressure, it doesn't adversely affect kidney function, other things, and it's relatively easy to use, which is, I think, why people are interested

Duration of treatment and with patients that are at risk given that they have recently been hospitalized for acute heart failure, but still would be M.T. is in a range that suggests that they are still salvageable. If you will.

That in mind, it's reasonable to expect up to Galactic H. up criteria represent a large cross section of patients with heart failure and reduced ejection fraction and importantly, those that contribute meaningfully to not only hike clinical burden, but <unk> economic burden.

Unknown Executive: All right. Thank you. Very informative. Congratulations again on the quarter. Thank you.

Unknown Executive: Thank you. Thank you.

Unknown Executive: We do have another question on the line. This question comes from Salim Syed from Mizzou. Hello Salim. Hey guys, this is his associate Dennis speaking on behalf of Salim. Thanks for taking the question and congrats on the interview.

Without I'll turn it over to Saudi and see how he wants to also add to that.

I think you know the the threshold for what people consider clinically meaningful in terms of mortality.

Unknown Executive: Thank you for joining us on the program so far. I have a couple of questions. First off, on Galactic HF, how are you guys thinking about what the clinically meaningful improvement would be on the primary endpoint, as well as the CV?

Not that the symbol are in no matter what the indication is <unk>, you know, 10% or more is often viewed as positive effect on mortality into trial like.

Unknown Executive: as well as Stevie Duck.

Galactic where where the.

Robert I. Blum: It's a very good question; thank you. Again, I'll start and turn it over to Fady and Stuart if they also want to elaborate. What I'll say about galactic HF is now that we have recent trials relating to Entresto and Verisiquat and DAPA, we have an opportunity to compare and contrast reductions in CV death as well as other endpoints, but it really is an apples and oranges comparison in some respects given that these trials enrolled at different times and different populations with different risk criteria. With that said, I think it's reasonable to assume that an event rate reduction in the neighborhood of 10 to 20% is meaningfully important and clinically significant, and the more that is weighted to the higher end of that range with respect to CV death, the more it gets, even significantly high visibility amongst the clinical community.

Number of event is so large a difference like that would still be relatively typically significant and so.

You have at least good certain t. in terms of the the veracity of that finding.

And and <unk> the combination of that too I think again, there and 15% to 20% or better.

You look at the other heart failure therapies that sometimes not a question of what clinically meaningful but how you benchmark against the other therapies that have come before you.

And if you have anything to add there.

Thanks.

Thing I will add is.

Point that collects h. I've seen her older very high risk population.

So while it's important the focus on the relative risk reduction.

The absoluteness reduction is also important and so it's really the total disease burden.

Reducing that absolutely rest reduction is also important to consider.

Going God.

Robert I. Blum: We're not gonna handicap that to any specifics other than that, other than to say that galactic HF was designed very much to accrue a large number of events and a large number of CV deaths with a high average duration of treatment. And with patients that are at risk, given that they have recently been hospitalized for acute heart failure but still with BNPs in a range that suggests that they are still salvageable, if you will. And with that in mind, it's reasonable to expect that the GALACTIC-HF criteria represent a large cross-section of patients with heart failure and reduced ejection fraction, and importantly, those that contribute meaningfully to not only a high clinical burden but a high economic burden. With that, I'll turn it over to Fady and see how he wants to also add to that.

And we can have another question on on on this is from the line of Joe pension is from each seat Wayne right.

Hello, Joe Hi, everyone. Good afternoon Hope you on all your families are doing well I think my my question. I think also has to do with the good opportunity to remind us about the C.K. 274 program, you're going to have a significant boost invisibility with the upcoming results from.

The explorer study from out of a campton. So two things first can you remind US you do have potential financial benefit from the map Canton program, you do get a royalty I believe.

Some of the details and then number two I don't believe it's really a black and white outcome. The explorer study how it might impact your study where your program going for it for 274. So if explore were to fail there might be some obviously temporary read through one C.K.

Fady Ibraham Malik: I think, you know, the threshold for what people consider clinically meaningful in terms of mortality. With a number of events, a difference like that would still be relatively statistically significant. So, you have at least good certainty in terms of the veracity of that finding. And from the combination of the two, I think, again, there's a 15 to 20% or better when you look at the other heart failure therapies. It's sometimes not a question of what's clinically meaningful but how you benchmark against the other therapies that have come before you. Stuart, I don't know if you have anything to add to that.

274, but I'd like you've made me to discuss why you know that negative read through might not necessarily be necessitated because of the different therapeutic profile. Thanks.

Thank you Joe So I'll talk about in a couple of ways and then turn it over to Saudi Firstly, because we hope explores positive we believe it can be positive and we think this would be very important for patients, especially invalidating this mechanism through to this potential indication.

With that said we are developing U.K. two seven for.

Stuart Kupfer: Thanks, Fady. The only thing I will add is to your point that galactic HF enrolls a very high-risk population. So while it's important to focus on the relative risk reduction, the absolute risk reduction is also important, and so it's really the total disease burden reducing that absolute risk reduction is also important to consider.

Much as we have already we intend to be good students of the data arising from explore in ways that would enable us to advance the field.

For the benefit of both we hope by the camps in M.C.K. two seven for ultimately serving patients.

You're right in that we do receive upon commercialization royalty <unk> to be clear.

Unknown Executive: I've been very helpful.

Unknown Executive: And we do have another question on the line. This is from the line of Joe Pantginis from H.C. Wainwright.

Low single digit royalty, but it's still appropriate in light of our participation in the launch of that company and our contribution to the synthesis of my other campton with that said, we do believe C.K. two seven for like any good next generation drugs him that it was designed to.

Unknown Executive: Hello Joe,

Unknown Executive: Hi everyone. Good afternoon. I hope you and all your families are doing well.

Robert I. Blum: I think my question also has to do with the good opportunity to remind us about the CK-274 program. You're going to have a significant boost in visibility with the upcoming results from the EXPLORE study for Mavicampton. So, two things. If EXPLORE were to fail, there might be some, obviously, temporary read-through on CK-274, but I'd like you maybe to discuss why that negative read-through might not necessarily be necessitated because of the different therapeutic profile. Thanks.

Differentiating features that may it afford it certain next generation properties and to advance the clinical research and potentially the commercialization without I'll turn it over to 32 elaborate more specifically.

Yeah, Hi, Joe I think.

The data will there potentially can going to be complex. We were optimistic about how the mechanism of action will be helpful to these patients and improve their function and I think.

Robert I. Blum: Thank you, Joe. So I'll tackle that in a couple of ways and then turn it over to Fady.

And looking at the data ill inform us in terms of any changes we might consider in our development program.

Robert I. Blum: Firstly, as we hope Explorer is positive, we believe it can be positive. And we think this would be very important for patients, especially in validating this mechanism through to this potential indication. With that said, we are developing EK274, and much as we have already, we intend to be good students of the data arising from EXPLORE in ways that would enable us to advance the field.

Whether they're they're revisions to the primary endpoint, we might want to consider.

And as well to understand what the.

Farm.

Kinetic and Pharmacodynamic properties of two seven poor how they might.

Out in the context of what magic camped in a doing in these patients so.

You know if they very valuable experience very valuable.

Fady Ibraham Malik: For the benefit of both, we hope, Mavicampton and CK274 ultimately serving patients. You're right in that we do receive, upon commercialization, a royalty on Mavicampan. To be clear... Low Single-Digit Royalty. But it's still appropriate in light of our participation in the launch of that company and our contribution to the synthesis of Mavicamtin. With that said, we do believe CK274, like any good next-generation drug candidate, was designed to have differentiating features that may afford it certain next-generation properties and to advance clinical research and potentially its commercialization. With that said, I'll turn it over to Fatih to elaborate more specifically.

Experiments as being can.

And.

You guys still there.

Yeah.

Oh studies audio Okay, Oh, yeah, either way that was very helpful. I really really appreciate it.

Sure. Thank you Joe.

And you guys here.

We can hear email study.

Excuse me, we do not have more question to onto <unk> from the line of <unk> they're from.

Yeah.

Hey, Thanks for taking the question.

Redwood <unk> can you give us a sense of how are you.

Sounds like you're broke up a little bit there, but I think you said how far did we get with redwoods.

Okay.

But.

Oh.

Test muted.

Okay, so with regard to Redwood.

Fady Ibraham Malik: Yeah, hi, Joe. I think, you know, the data will be potentially going to be complex. We are optimistic about how the mechanism of action will be helpful to these patients and improve their function. And I think you know, in looking at the data, it'll inform us in terms of any changes we might consider in our development program, whether they're revisions to the primary endpoint we might want to consider, and as well as to understand what the Pharmacodynamic Properties 274, and how they might play out in the context of what Mavikampton is doing in these patients. So, you know, it's a very valuable experience, very valuable and important.

We did a start the trial into one we were in the midst of enrolling patients. So we do have patients enrolled in bed with H.C., but admittedly, whereas the beginnings of that first cohort that first cohort is designed to enroll looks a little with 18 patients.

And we expect by the end up to two we may have activated.

More than that and number of sucks.

So in light of that we do believe that we can start goal as stipulated in order milestones for 2020. So we should be in a position. If we can complete enrollment by mid year that we would have data from that first cohort.

Unknown Executive: Are you guys still there? I think we lost Fady.

Unknown Executive: [inaudible]

Unknown Executive: Okay. Either way, that was very helpful. I really appreciate it.

Stuck in half of the year.

Unknown Executive: Sure. Thank you, Jeff.

<unk>.

Excuse me a speaker tag since our questionnaire.

Unknown Executive: Can you guys hear me?

Fady Ibraham Malik: We can hear you now, Fady.

Needed them set I'll just go to the next question.

Unknown Executive: This is Nate's question comes from the line of Jason Butler from JMP Security. Hi, thanks for taking the question. Warren Redwood, can you give us a sense of how far you've got?

Next questions from a line of Chad message from eat Ham and company.

Oh, great. Thanks, I'll Oh well proceed in in in the hope we're all connected all right.

Unknown Executive: Sounds like you broke up a little bit there, but Jason, I think you said how far we got with each other.

<unk> interesting question about the matter campton dated the upcoming I I actually wanted a circle back on and get your guys opinion on on something else that happened with Mad at camp them and that was a maverick data in non obstructive H.T.M. well the last time, we talked about it.

Robert I. Blum: I'm not hearing you, but I'll answer that question.

Unknown Executive: Okay, so with regard to Redwood, we did start the trial in Q1. We were in the midst of enrolling patients, and we do have patients enrolled in Redwood HCM. But admittedly, we're at the beginning of that first cohort, which is designed to enroll a total of 18 patients. And we expect by the end of Q2, we may have activated more than that number of sites. So, in light of that, we do believe that we can meet our goal as stipulated in our milestones for 2020, that we should be in a position, if we can complete enrollment by mid-year, that we would have data from that first cohort in the second half of the year. Transcription by CastingWords

Looking forward to seeing how how that data came out.

In terms of coloring your own thoughts about it not obstructive program offered to seven for that that that date is out of came out.

Initially last year, but.

Presented in in in March at the virtual A.C.C., just wondering your thoughts on that and how it colors, how you feel about your chances.

Unknown Executive: Excuse me, uh... It seems like our questioner again has muted himself. I'll just go to the next question. The next question is from a line from Chad Messer from Needham and Company. Great, thanks. I'll proceed and hope we're all connected all right.

And running a non or obstructive H.T.M. studies.

<unk>.

We're having a problem with Bob audio.

How do you give it to say Santana <unk> not coming to his run his mark life one second.

Unknown Executive: Joe asked an interesting question about the Mavicampton data that's upcoming. I actually wanted to circle back and get your guys' opinion on something else that happened with Mavicampton, and that was the Maverick data in non-obstructive HCM. The last time we talked about it, I know we were looking forward to seeing how that data came out in terms of coloring your own thoughts about a non-obstructive program for 274. That data is out. It came out initially last year, but it was presented in March at the virtual ACC. Just wondering your thoughts on that and how it colors how you feel about your chance of running a non-obstructive HCM study.

Okay.

This is the operator I'll be speaker signs are still marked as open on my and but it seems Robert find may have come out on his hand.

I'm not sure if we can get him back Oh right now.

When I mean, just checking into this.

Do apologize for the right to delay.

Looks like Robert China Doll back again.

I can grab his find myself.

[noise].

I do not see his wind down and back in at this time, but I'm still keep an eye out on it.

This is this is still working here me.

We can hear you yeah.

Unknown Executive: We're having a problem with Robert's audio. Yes, I was about to say the same thing. It seems Robert's audio is not coming through. His line is marked live. One second. This is the operator. All of these speaker signs are still marked as open on my end, but it seems Robert's line may have cut out on his end.

Right, Yeah, so so and.

In response to chance question about matter. If we were of course aware of the Maverick Dana.

And.

It was a good proof of concept study to support.

Utilization of a cardiac <unk> inhibitor.

Unknown Executive: I'm not sure if we can get him back right now. One moment, just still looking into this. Do apologize for the delay. Looks like Robert's trying to dial back in, he's out of his mind myself.

Unobstructed H.T.M. population and it does support our strategy for.

Considering use a cardiac <unk> did that are in in that population. So it's part of an overall strategy that were planning and you know with the matter. We're we're still considering.

Unknown Executive: I did not see his line dialing back in at this time, but I'm still keeping an eye out for it. This is Stuart. Can you hear me?

The precise strategy and tiny when we proceed to.

Stuart Kupfer: www.kenhub.com, In response to Jeff's question about Maverick, we are, of course, aware of the Maverick data, and certainly it was a good proof of concept study to support. Utilization of a cardiac sarcomere inhibitor in a non-obstructive ACM population. It does support our strategy for considering use of a cardiac sarcomere inhibitor in that population. So it's part of an overall strategy that we're planning. And, you know, it's a matter of we're still considering the precise strategy and timing of when we proceed to study that population.

Study that population, but.

We thought the results were encouraging and it's a good proof of concept.

Okay, great. Thanks, I I did have just one more I'll I'll I'll put out well put it out there.

And it's it's more of the strategic question you know may relate to some of your vision 2025 goals of course as you're we're all aware you. Your <unk> your deal with Amgen had an option that you've exercise to co promote and that gives you the right to field day Hospital based field alright sales.

Unknown Executive: But we thought the results were encouraging, and it's a good proof of concept. Okay, great. Thanks. I did have just one more.

Force.

Pretty specific sales force, but just wondering how having that kind of gets into your long term strategic goals.

Unknown Executive: I'll put it out there. And It's more of a strategic question. You know, it may relate to some of your Vision 2025 goals. Of course, as you were all aware, your deal with Amgen had an option that you've exercised to co-promote, and that gives you the right to field a hospital-based sales force. It's a pretty specific Salesforce, but I was just wondering how having that kind of gets into your long-term strategic goals. So I can take that while Robert and Fady are trying to get back in.

So I can finish that Robert in Tatiana trying to get back then.

I am can you hear me.

Oh fatty yeah, do you want to take that cause I I was going to jump in bucko flat.

I'll give it a shot but usually robert better than answering those questions. So.

You know I think our our strategy, they're really looking at it institutional sales force that is.

<unk> able to interact with the major providers you know major thought leaders major medical centers.

Unknown Executive: Diane, can you hear me?

Unknown Executive: Oh, Fady, yeah, do you want to take that? Because I was going to jump in, but I'll go for it.

Kind of leading institutions in heart failure that.

Fady Ibraham Malik: I'll give it a shot, but usually Robert's better at answering those questions. You know, I think our strategy there really is looking at an institutional sales force that is able to interact with the major providers, you know, major thought leaders, major medical centers, kind of leading institutions in heart failure. That sales force is, as we've said in the past, enabled by Amgen. It's paid for by Amgen. It gives us a head start in developing a field-based sales force, which, obviously, at the time, if 274 is successful, would give us a head start in terms of its commercialization. So we're very pleased with the way the deal was done. It's part of our strategy in terms of negotiating the original deal and subsequent deals to enable Cytokinetics growth as a company into that functionality. So it fits well with our strategy of developing a cardiovascular presence, really, from research through to commercialization.

You know that that sales forces as we said in the past enabled by M. channel. They they it's paid for by M. Chen gives us a head start in developing a field based sales force, which obviously at at the time at five to seven for successful would give us a head start in terms of.

Commercialization.

So we're we're very pleased to the way the deal was.

Had been.

You know as part of our strategy in terms of negotiating your original deal another subsequent deals.

10, able cytokinetics growth as a company into into that functionality.

So it fits well with our strategy of of developing your cardiovascular.

It's really from research due to commercialization.

Robert I. Blum: Hi, this is Robert. I can now, hopefully, be heard. I think Fady is absolutely correct. And what I'll say is, you know, this is part of a long-standing corporate development strategy at the company where we leverage our partnerships in order to enable us access to capabilities and financials to move to the next level in our maturation as a business. And as we think about potentially co-commercializing Omicamp with McCarble, it's part of a franchise strategy directed to institutional care specialty cardiology segments, where our sales force, alongside that That should enable us to get to positive marketing contribution far sooner than is typical following the first commercial launch for a company. And that's also going to enable us to be in those centers where we would expect CK274 and others of our cardiovascular products to also be commercialized. So this is a hand-in-hand R&D strategy together with business development and corporate development strategy.

Hi, This is Robert I can know hopefully be heard so I think Friday is absolutely correct. It will say is well. This is part of a long standing corporate development strategy at the company, where we leverage or partnerships in order to enable us.

Access to capabilities and financials too moved to the next level can or maturation as a business.

As we think about potentially co commercialize <unk>.

It's part of a franchise strategy directed to institutional care, especially cardiology segments.

We're.

Marshals forced along side of that of them John would be co promoting only camped of in North America.

And Oh, what a basis by which <unk> reimbursing certain of our costs that should be enabling of us to get to positive marketing contribution far sooner than is typical following the first commercial lunch for a company and that's also going to be enabling a bus to be in those centers, where we expect she k. two seven for.

And others have or cardiovascular products to also be commercialize. So this is hand in hand, r. and D. strategy together with business development in corporate development strategy.

Unknown Executive: Great. Well, thank you, Robert and team. I hope you all continue to stay healthy and safe and are not plagued by any more technical difficulties. Thank you, Jeff. Now we do have our speakers back online, so I'll move to our next question. The next question is from the line of Ted Tintoff from Piper Sandler. Hello, Ted. Hey everybody, how are you doing? All good.

Yeah.

<unk> well well, thank you Robert and a team I hope you all continue to stay a healthy and safe and or not plagued by any more technical difficulties.

Thank you Chuck.

And it does seem right now we do have our speaker online. So I moved my next question for the next question is from the line of Ted 10 tough from five per cent.

Good.

Hi, everybody How're, you Doin' Oh good.

Oh, good so you could hear that thanks, so much <unk> <unk> lots of good update.

Unknown Executive: Good, I'm pleased to hear that. Thanks so much for taking my question.

There were like Jimmy Carter for collected are particularly appreciate if the card picture provocative. There. My question I said, there was <unk> and do let's call. This partnership.

Unknown Executive: Lots of good updates there. I'm really getting excited about galactic data. I particularly appreciated the context you provided there.

I get a sense from your guard what do you mean to see user through her kischell data cuts or from conversations from <unk>.

Robert I. Blum: www.kenhub.com or from conversations in terms of what you're hoping to achieve with the FDA to really decide whether that would be a worthwhile investment. And with the return of 601 to you guys, is that a more potent compound that might even be a better candidate to take forward? Thanks so much.

What's the S.P.A. to really decided whether that would be a worthwhile investments.

The return of six or work to guard is that <unk> quite differently hmm be a better candidate to take for it I think so much.

Fady Ibraham Malik: Very good questions. I'll start and turn it over to Fady again. So with regard to your first question, I think with regard to other data cuts, we have already, both with pre-specified and some admittedly post hoc analyses, seen data that we consider to be compelling for the potential of rel-deceptive in the treatment of ALS. But with that said, we still need to ensure that we can conduct a proper clinical trial and one that would be both statistically and clinically relevant upon completion, but also generate results that could And we're in the midst of those discussions. We're doing this in an admittedly painstakingly thoughtful way. It's taking time, but we think that it's time well spent in order to ensure that we have dotted all the I's and crossed all the relevant T's.

Questions, Oh started and turn it over to study again, so with regard to your first question I think with regard to other data cooks, we have already both with pre specified some admittedly post talking overseas.

Seen data that we considered to be compelling.

For the potential of real deceptive into treatment of the L.S., but with that said, we still need to ensure that we can conduct a proper clinical trial and one that would be both.

Typically and clinically relevant upon completion, but also generating results that could be meeting fleet valuable to payers and reimbursement authorities and we're in the midst of those discussions were doing this in a admittedly painstakingly thoughtful way, it's taking time, but we think that's time will.

Spend in order to ensure that we have died at all the all these and crossed all the relevant keys.

We're encouraged by the feedback we've already received from F.D.A. and E.M.A. and as we're engaging reimbursement authorities in pairs, but we're not done yet and we are purposefully insuring that those timeline line up with our ability to start a clinical trial in the fourth quarter.

Fady Ibraham Malik: We're encouraged by the feedback we've already received from FDA and EMA and as we're engaging reimbursement authorities and payers, but we're not done yet. And we are purposefully ensuring that those timelines line up with our ability to start a clinical trial in the fourth quarter if the Galactic HF results enable us, and our cost of capital is such that we think this is the right thing to do based on our science and by our shareholders. So all that said is meant to indicate that we are very optimistic and we are already very encouraged by the interactions that we've been having. Fady, anything you want to elaborate on that?

If the galactic H.F. results or enabling of us and our cost of capitalist such that we think this is the right thing to do by or science in by our shareholders.

So all that said is meant to indicate that we are very optimistic and we are are very encouraged already by the interactions.

We've been topic.

How do you anything you want to elaborate on that.

No I think he says well I mean, I think we are preparing.

Robert I. Blum: No, I think you said it well. I think we are preparing by seeking all the regulatory and HPA feedback you mentioned and also considering how we may finalize a protocol. So we do want to be ready to consider starting that trial after we understand how Galactic reads out.

Seeking all the regulatory in H.K. feedback you mentioned and and also considering how we may finalize a protocol. So we do want to be ready to consider starting that trial. After after we understand how galactic readout.

Robert I. Blum: And Ted, the other part of your question related to CK601, so like all of our programs, CK6-01 is a backup and follow-on to the predecessor compounds, and we think that CK6-01 has some properties that may render it suitable for advancement, potentially even in other indications. You could imagine, for instance, rel-deceptive going forward in ALS and rare neuromuscular diseases. You could imagine CK6-01 going forward either in those same indications or potentially, as we contemplate expanding our skeletal muscle franchise to non-neuromuscular indications, and there are some indications that could even overlap between our cardiac and skeletal muscle programs. So, in keeping with our strategy to be a pioneer and leader in muscle biology, this is part of that strategy, and CK601 represents another vector, if you will, for value creation. Great. That makes a lot of sense.

And the other part of your question related to C.C.K. six so one so like all of our programs O.C.K. six so one is a backup and follow one to the predecessor compounds and we think that C.K. six. So one has some properties that may render it suitable for advanced.

[noise] potentially even in other indications you could imagine for instance, real deceptive going forward in the L.S. and Reverend or muscular diseases, you could imagine she k. six so one going forward either hidden those same indications are potentially even nod or a muscular indications for instance, as we can.

Template expanding or scotto muscle franchise to non neuromuscular indications and there are some indications that also could even overlap between or cardiac and skeletal muscle programs.

So in keeping with our strategy to be a pioneer in leader in muscle biology. This is part of that strategy and C.K. six so one represents another vector or if you will <unk> value creation.

Okay that makes a lot of <unk>. It's it's a real quick 114. Your primary came it was a little bit higher I think even in the <unk> noted this car for 10 minutes of risk. So nice share price performance it probably Puerto though is there anything in there that's going into kind of precommercial.

Unknown Executive: I have a quick one for Ching, if I may. Ching, it was a little bit higher, I think, even in the press release you noted stock-based...

Ah Upper <unk> I kind of look at sort of where you are for the first quarter and if we analyze huh annualized set it's actually a little bit of.

Unknown Executive: https://www.youtube.com.au I'm just trying to get a sense for maybe what the kinetics of expenses might look like for the rest of the year. Thanks.

You're the high end of your AAPEX kind of in terms of trying to get a sense horror movie what the kinetic cells expenses might look like for the rest of the effect.

Unknown Executive: Thanks, Ted. Good question.

Thanks to good question. So the the first quarter burden rate Oh $30 million. Yeah. You correct me. If you were to an annual lies that it would be higher than the Titans, we've given but <unk> is driven by we the fact that we end at 2019 was a Siamese tires.

Unknown Executive: So the first quarter burn rate of $30 million, you're correct. But if you were to annualize that, it would be higher than the guidance we've given. But part of it is driven by the fact that we ended 2019 with a slightly higher than normal accounts payable balance. So the fact that the first quarter cash burn is higher than expected is great, thank you so much. Stay well, everybody. Thank you.

Normal accounts payable balance so the the fact that of course holder attached Barnes is higher than.

Normal is and was anticipated incorporated into our guidance.

Great. Thank you so much say well everybody. Thank you.

And she said.

Unknown Executive: Thank you, Ted.

Unknown Executive: Excuse me, we do have one last question on the line. This is from the line of Jeff Hung from Oregon Stanley. Hello, Jeff. Hey, Ben, thanks for taking the questions. For Galactic, to the extent that you have visibility into it, can you talk about how the rate of events has been since the second interim analysis? And once the targeted number of events has occurred, can you remind us of the timing that you think you'll need for aspects like data cleanup and analysis?

Excuse me, we do have one last question on it and this is from the line of chat hung from Morgan Stanley Hello, Jeff.

Yeah, Hey, thanks for taking the questions shorter glass stick to the stuff that you have visibility into it can you talk about how the rate of events have been since the second interim analysis and once the targeted number events have occurred can you remind us that timing that you think you'll need for aspects like data clean up in analysis.

Sure good questions fatty Jordan tickets.

Unknown Executive: Sure, good questions. Fady, do you want to take this?

Yeah, I can take that I I think.

Fady Ibraham Malik: Yeah, I can take that. I think, at the macro level, as you know, people are not coming to the hospital with the same frequency that they used to for many conditions, including cardiovascular conditions. That said, I think our trial is driven by cardiovascular death at the end of the trial.

I can't really comment specifically on how event rate changed I mean in generally the macro level you know people are not.

Coming to the hospital with the same frequency that they have for for many conditions in including Ah cardiovascular conditions. Now that's sad I think are trial is driven by cardiovascular death as the the end of the trial in and <unk>.

Fady Ibraham Malik: That event rate, I think, has not been substantially affected over the last little bit. It's a little early to tell, you know; some of these things lag. We're only a few months into this. But that said, as you saw on clinicaltrials.gov, Amgen recently updated the timing for the last patient, last visit to August 7th.

<unk> that that event rate I think is not been.

<unk> affected over the last last little bit solar early to tell you know some of these things lag we're only a few months into the.

But that said the the some clinical trials dot Gov Amgen recently updated the timing for for last patient but is it.

To to August 7th and and.

And while that's you know an estimation at this point I think it gives you a sense of where we think that'd that will occur.

Fady Ibraham Malik: And while that's, you know, an estimation at this point, I think it gives you a sense of where we think that event will occur. You know, following the last one, there is a lot of data cleanup and event adjudication that has to occur. You need to gather documents from 35 countries, potentially, where the events may have occurred. There are several logistical aspects to that, and planning that's being put in place now to help facilitate the rapid acquisition of those events and the adjudication of those events. And I think, you know, we would be on time to read that out in the fourth quarter, but I'm not going to be able to get more specific than that. Sorry to say, Jeff.

You know following Ah.

The the last.

Event necessary to trigger the end of the trial. There is it's a big trial, there's a lot of data clean up and you know event adjudication that has to occur you need to gathered documents from 35 countries potentially where the events may have occurred there are several logistical <unk>.

Back to that that are and planning that's being put in place now to help facilitate.

The rapid acquisition of those events and the G. occasion data.

And and I think you know we would be on time to read that out in the fourth quarter, but I'm not going be able to get more specific than that sorry to say Joe.

Unknown Executive: All right, no problem. Thanks. And then, I guess, any updates on the commercial preparations for OMACAMPTIV ahead of the Galactic Readout?

Alright, no problem. Thanks, and then I guess any updates on the commercial preparations for I'm a captive ahead of the <unk>.

Robert I. Blum: Yes, so we are very, very busy together in collaboration with Amgen on those matters, and some of the increased spending that Ching and Robert were highlighting relates to increased G&A spending pertaining to commercial readiness. We at Amgen are mapping out and having launch readiness activity meetings associated with a potential commercial launch in the second half of 2021, and that means we are in that launch period. With that said, we have to be refining our positioning. We have to be locking down on a lot of our strategies, even as it relates to contracting and payers, even as it pertains to potential co-promotion, and in light of that, we are intending to negotiate with Amgen an agreement this year that affords us the rights and responsibilities in connection with that co-promotion and clarity for both companies as to what would be our role All of that needs to occur this year in order to ensure that we're poised maximally for readiness for a commercialization program next year. Both companies have dialed up resources, hiring and otherwise, in order to be able to make that happen, and I'm pretty pleased that we're getting high visibility and high commitment at both companies.

Yeah. So we were very very busy together in collaboration with M. gentlemen, those matters and some of the increase spending that <unk> and Robert we're highlighting relates to increase G.N.A. spending pertaining to commercial readiness.

<unk> nothing else and having lunch readiness activity meetings associated with a potential commercial lunch in the second half of 2021. So that means we are in that carry lunch period without said, we have to be refining our positioning we have to be locking down on a lot of our strategy.

Even as it relates to contracting and payers, even as it pertains to.

The potential copromotion fit in light of that we are intending to negotiate with M. John Oh, an agreement this year that affords us the rights and responsibilities in connection with that Copromotion and clarity for both companies as to what would be our role what would be their role and how would those be.

Mind, and where those folks would be working together all of that needs to occur. This year in order to ensure were poised maximally for readiness for commercialization program next year, both companies have dialed up resources hiring and otherwise in order to be able to make that happen and I'm pretty pleased that.

We're getting high visibility in height commitment at both companies.

Unknown Executive: Great, thanks. Thank you.

Great. Thanks, Thank you.

Unknown Executive: Thank you.

And again that with her last question.

Unknown Executive: And again, that was our last question.

Robert I. Blum: Excellent. Well, with apologies for falling off the call and not being able to hear some of those questions, I'm glad that our team members were able to address them. And for any folks on the call who didn't get their questions answered, please follow up with us. These are truly extraordinary times, we recognize that, and hopefully, you can see that cytokinetics is focused forward and delivering on the key strategic objectives for 2020. And that we're financially and operationally moving forward in a solid position and way. And at the same time, we're recognizing that we're moving to a new normal. And with that new normal, we want to be as agile and adaptable as we can be in order to deliver on the promise of our science. With that in mind, we look forward to keeping you updated on our progress through the remainder of the year. We thank all of the participants in the teleconference today for your continued support and interest in cytokinetics. Operator, we can now conclude.

Excellent well with apologies for a falling off the call and.

Being able to hear some of those questions I'm glad that or team members were able to address them.

And for any folks on the call who didn't get their questions answered. Please follow up with US. These are truly extraordinary times, we recognize that and hopefully you can see that cytokinetics is focused forward and delivering on the key strategic objectives for 2020 and that were financially and operationally moving forward.

In a solid position and way.

And at the same time, we're recognizing we're moving to a new normal and with that new normal we want to be as a child and adopting as we can be in order to deliver on the promise of our science.

With that we look forward to keeping you updated on her progress through the remainder of the year. We think all the participants on the teleconference. Today for your continued support and interest in photo <unk>. Operator, we can know conclude the call. Thank you.

Unknown Executive: Thank you for attending today's presentation.

Thank you very attending.

<unk>.