Q2 2022 Cytokinetics Inc Earnings Call

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Unknown Speaker: The conference will begin shortly.

Unknown Speaker: To raise your hand during Q&A, you can dial star 1 1.

Unknown Speaker: Good afternoon, and welcome, ladies and gentlemen, to Cryokinetics' second quarter 2022 conference call.

[music].

Yeah.

Good afternoon, and welcome ladies and gentlemen to crowd genetics second quarter 2022 conference calls.

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

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

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

Unknown Speaker: At the company's request, we will open the call for questions and answers after the presentation. We will allow for up to two questions per participant.

I'd now like to turn the call over to Diane Weiser Biokinetics Senior Vice President of corporate Communications and Investor Relations. Please go ahead.

Unknown Speaker: I would now like to turn the call over to Diane Weiser, Cryokinetics' Senior Vice President of Corporate Communications and Investor Relations.

Good afternoon, and thanks for joining us on the call today, Robert Brown, President and Chief Executive Officer will begin with a brief overview of the quarter and recent developments.

Malik EVP of R&D will provide updates related to one account in the cargo and empty.

Camden, Andrew countless EVP and Chief commercial officer will discuss commercialization planning activities behind the Camden, Mccargo, and our specialty cardiology franchise strategy related to IP Camden.

Stuart Kupfer, SVP and Chief Medical Officer will provide an update on the symptom Robert one VP and Chief Accounting Officer will provide a financial overview for the past quarter and Ching jaw, SVP and Chief Financial Officer will discuss our financial outlook and revised 2022 guidance.

Finally, Robert will provide closing comments and we will reveal that the upcoming milestone.

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.

Constitute forward looking statements our actual results may differ materially from those projected in these forward looking statements additional information concerning factors that could cause our actual results to differ materially from those in these forward looking statements is contained in our SEC filings, including our current report regarding our second quarter two.

22 financial results filed on form 8-K today, we undertake no obligation to update any forward looking statements. After this call and now I will turn the call over to Robert.

Unknown Speaker: Please go ahead.

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

We made significant progress in the second quarter across our pipeline.

We entered the second half of the year with a strong balance sheet.

Close of approximately $383 million.

Net proceeds through the offering of convertible senior notes, which we completed at the beginning of Q3.

Unknown Speaker: Good afternoon, and thanks for joining us on the call today.

As many of you know securing diversified non equity dilutive sources of capital to build our balance sheet has been a tenant of our business for many years.

SUNS rays did this transaction supports our continued progress and expansion of our pipeline all with the goal of improving the lives of people with cardiovascular and neuromuscular diseases of impaired muscle function.

Robert Blum: Robert Blum, President and Chief Executive Officer, will begin with a brief overview of the quarter and recent developments.

Importantly, during the quarter, we announced the scheduling of our cardiovascular and renal drugs Advisory Committee meeting from a captive mccarville to occur on December 13, 2022.

What was the extension of the Paducah date from the captive Mccarville to February 28 2023.

As a result, we've been able to adjust our launch readiness activities timelines and budgets and thus narrow our spending guidance. We also advanced our development program for LP Kimpton and ongoing trials and through preparations for additional trial is expected to begin later this year.

And also next year for relative sensitive.

We continued enrollment and conduct accourage ALS according to plan.

We also recently started the open label extension trial courage ALS O L.

E.

Behind the scenes to these late stage programs. Our work continues on track and against goals set forth in our vision 2025 to bring forward earlier stage programs to expand our pipeline.

Fatih Malik: Fatih Malik, EVP of R&D, will provide updates related to Omicampton-McCarble and Affy Campton.

Firstly to touch on <unk> captive Mcardle, our next important milestone is participating in the advisory Committee in December .

While we do not yet have the agenda, nor specific topics of interest to FDA.

But the FDA may want to discuss the scope of the potential indication given the galactic HFF was conducted in a broad population of more than 8000 patients with heart failure and reduced ejection fraction, but the results demonstrated that the treatment effect of <unk> seems to be.

Amplified and certain pre specified and other subgroups of patients with worsening heart failure, whether thats measured by low left ventricular ejection fraction.

<unk> Pro BNP recent hospitalization low blood pressure or other measures.

Yes.

Also want to discuss the dosing of <unk> and how it may be implemented in clinical practice and suffice it to say our teams are keenly focused to preparations for the advisory Committee meeting and will be well prepared to engage constructively with FDA and its advisers.

Andrew Kalos: Andrew Kalos, EVP and Chief Commercial Officer, will discuss commercialization planning activities for Omicampton-McCarble and our specialty cardiology franchise strategy related to Affy Campton.

At the same time, we're pushing ahead on several work streams related to the potential approval and launch of <unk> and due to the shift in the Paducah date, we've adjusted certain timelines and the associated spending to account for the potential approval taking place in 2023, rather than 2000.

Stuart Kupfer: Stuart Kupfer, SVP and Chief Medical Officer, will provide an update on Royal Deceptive.

22, which has prompted us to refine our 'twenty to 'twenty two guidance related to spending.

<unk> can elaborate on this extension of our cash runway in a moment.

As we continue our European partnering campaign, we have in parallel advanced a path towards approval and expect to submit a marketing authorization application for <unk> to the European medicines agency or EMA by the end of the year.

If we're successful at partnering on the character Mccarville in Europe , we would expect to receive additional capitals to support flexibility and progressing our cardiovascular pipeline globally.

As it relates to work to advance <unk> in the second quarter continued enrollment and conduct our Sequoia HCM is progressing and we're pleased to see the enthusiasm from the many dozens of sites planned to participate in this trial. We also continued planning for a second phase III clinical trial about the kimpton.

In obstructive HCM, which we anticipate will start in the fourth quarter of this year.

Saudi will be describing objectives of that trial in more detail to elaborate on its purpose and goals supportive of our overall strategy for <unk> Kimpton.

And finally in Q2, we presented the first longer term data from Redwood HCM LTE showing significant sustained reductions in <unk> gradients improvements in symptoms and cardiac biomarkers, all with a favorable safety and Tolerability profile.

These data build on the 10 week treatment results from Redwood HCM and we look forward to sharing additional longer term data throughout 2022 and 312 months later this year at medical meetings.

Shifting to <unk>, we continue to enroll patients and activate centers encourage LLS and we also recently started the courage AOS open label extension study, we look forward to the first interim analysis encourage AOS designed to test for potential futility, that's expected to occur.

In the fourth quarter of this year.

As Youll hear from our team today, we're moving full steam ahead as we entered the second half of the year with a reinforced balance sheet to support our advancing pipeline and as we undergo the transformation to be what we expect to be a fully integrated biopharmaceutical company.

With that ill now turn the call over to fatty please.

Robert Wong: Robert Wong, VP and Chief Accounting Officer, will provide a financial overview for the past quarter.

Ching Ja: And Ching Ja, SVP and Chief Financial Officer, will discuss our financial outlook and revised 2022 guidance.

Thanks, Robert as we continue our dialogue with the FDA and prepare for our upcoming Advisory Committee meeting for <unk>. We're pleased to see additional analyses emerging that reinforced the definition of those patients who may be SP served by treatment with <unk> that is higher risk.

Unknown Speaker: Finally, Robert Blum will provide closing comments and will review expected upcoming milestones. 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.

Unknown Speaker: Our actual results might differ materially from those projected in these forward-looking statements.

Unknown Speaker: Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings, including our current report regarding our second quarter 2022 financial results filed on Form 8K today.

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

Robert Blum: And now I will turn the call over to Robert.

Patients with worsening heart failure.

During the quarter, we presented results at the heart failure 2022 meeting.

Diane Weiser: Thank you, Diane, and thanks to everyone for joining us on the call today.

We're then published in the European Heart Journal of in a new analysis from Galactic HFF on the effect of treatment with <unk> in patients with heart failure, and reduced ejection fraction and low blood pressure.

Results showed that there was greater treatment effect for moment Camden Mccarville on the primary composite endpoint of cardiovascular death, or first heart failure event than in patients with outlook blood pressure and that <unk> did not further low lower blood pressure in those patients.

Those receiving OMA Camden mccarville.

A lower incidence of treatment emergent serious aes and adjudicated per strokes compared to placebo.

Safety of patients and <unk> is similar to patients on placebo in this low pressure blood group.

Robert Blum: We made significant progress in the second quarter across our pipeline, and we entered the second half of the year with a strong balance sheet inclusive of approximately $383 million in net proceeds through the offering of convertible senior notes, which we completed at the beginning of Q3.

Robert Blum: As many of you know, securing diversified, non-equity diluted sources of capital to build our balance sheet has been a tenet of our business for many years, and the funds raised through this transaction support our continued progress and expansion of our pipeline, all with the goal of improving the lives of people with cardiovascular and neuromuscular diseases of impaired muscle function.

Blow pressure group.

These findings are important because patients with low blood pressure can often be challenging to treat and blood pressure can often be eliminate factor for up titration and initiation of available standard of care therapies.

Robert Blum: Importantly, during the quarter, we announced the scheduling of a Cardiovascular and Renal Drugs Advisory Committee meeting for Omicamptomicarbal to occur on December 13, 2022, as well as the extension of the PDUFA date for Omicamptomicarbal to February 28, 2023. As a result, we've been able to adjust our launch readiness activities, timelines, and budgets, and thus narrow our spending guidance.

The importance of these findings is not lost on the heart failure community, many of whom commented to us on its value for their patients and discussions we had with them following the data presentation.

These results add to the growing body of evidence showing that the treatment effect of <unk> is amplified in patients who have worsening heart failure, whether thats defined by lower ejection fraction recent hospitalization or in this case lower blood pressure.

As Robert mentioned, we also advanced the development program for <unk> Camden.

Robert Blum: We also advanced our development program for apicamptin in ongoing trials and through preparations for additional trials expected to begin later this year and also next year.

During this quarter, we presented the first a longer term data from Redwood HCM OLED at heart failure, 2022, encompassing 38 patients who completed either 12 or 24 weeks of treatment.

The data showed that treatment with happy Campton was associated with substantial reductions in the average resting left ventricular outflow tract gradient and the valsalva gradient.

These reductions started to occur within two weeks of treatment.

Were sustained through 24 weeks of treatment.

And were achieved with only modest decreases in the average left ventricular ejection fraction.

The majority of patients had an improvement in one or more NY HLA class.

And there was also significant improvements in NT pro BNP and cardiac proponent to cardiac biomarkers.

Notably treatment was well tolerated with no permanent discontinuation of App you Camden.

As we look forward to sharing additional longer term data from Redwood OLED. Later this year. We are encouraged by these initial data cut. This initial data cut supportive of Appy campton being an excellent class therapy with a strong safety efficacy and Tolerability profile.

And.

Hoping a therapy addressing the underlying cause of HCM. We're also interested in impacting the disease process are hallmarks of disease progression and demonstrating potential reversal of the adverse thickening and stiffening of the myocardium that results from increased contractility.

At the American Society of Echocardiographer 30, <unk> annual scientific sessions, we presented data from an analysis of Redwood HCM looking at changes from baseline in echocardiographic measures of cardiac structure and function. After 10 weeks of treatment with Abbvie campton compared to placebo.

What we found was that we 10 measures of cardiac structure diastolic and mitral valve function improved and treatment treated with happy Camden and in fact, there was a significant reduction in left atrial volume index at trend towards reduction in left ventricular hypertrophy improvements in ventricular relaxation.

And filling a reduction in the proportion of patients with systolic and tier motion of the mitral valve leaflet.

And a trend towards reduction those with eccentric mitral regurgitation.

Together these data suggest that treatment with Abbvie Campton may help address each of the main defining characteristics of HCM left ventricular hypertrophy impaired cardiac relaxation induced mitral regurgitation and to ultimately improve cardiac structure and function.

Moving to Sequoia HCM, we're pleased to share that we're continuing to progress with steady startup enrollment and conduct and now with regulatory approvals in nearly all 14 countries participating in the trial.

Including more recently, China, where our partner <unk> Sheng will conduct the China cohort.

Initiation of sites in the U S continues and we're also activating many sites in Europe and China.

We are overcoming site startup challenges related to the pandemic that impacted staff availability and we anticipate this third quarter will Mark further progress in global site Activations and subsequent enrollment in this trial.

In fact, we expect the majority of planned sites in Sequoia HCM to be activated by the end of Q3 give.

Given the number of international trial sites and the enthusiasm of our investigator group. We continue to believe the trial will complete enrollment in the first half of 2023 with results from Sequoia HCM expected to be available in the second half of 2023.

In addition, during the second quarter, we continued enrolling patients with non obstructive HCM and cohort four of Redwood HCM.

We've now enrolled nearly half of our planned number of patients in this open label cohort and we are pleased with its progress.

We may be able to conduct an interim analysis of data from this cohort by the end of this year to inform planning for potential FDA interactions in the first half of 2023.

We look forward to providing a further update with our next earnings call and sharing data from this cohort in the first half of 2023, which is supportive would enable the start of a potential phase III pivotal trial in patients with non obstructive HCM to occur in 2023.

In the second quarter. We also continued planning activities for the second phase III clinical trial of <unk> in obstructive HCM.

The goal of this additional phase III trial is to better understand and position the use of <unk> Camden relative to current standard of care therapy.

We believe we are on track to begin this trial in the fourth quarter and now I would like to share a few details about the intended trial design.

This phase III multicenter randomized double blind trial.

To evaluate the safety and efficacy of <unk>, Camden as monotherapy compared to metoprolol as monotherapy and people with symptomatic obstructive HCM.

<unk> is a beta blocker, commonly prescribed to people with obstructive HCM and by studying it against <unk> and we expect to evaluate the potential for <unk> to be considered for first line therapy in people with symptoms and.

And functional limitations due to HCM.

Not ready to share all the details of this trial, but we recently met with FDA and have alignment on the clinical trial design.

We hope this level of detail provide some context into our goals for the trial and how it may contribute eventually to potentially differentiated expected labeling for athlete canton.

We look forward to sharing more details and to starting this clinical trial for our next in class drug candidates later this year.

Moving now to medical affairs at Cytogenetics, as we mature our capabilities in the recent quarter. We continued hiring and have now onboard a complete managed healthcare medical sciences team and have successfully initiated medical support for our global value access and distribution activities.

Activities.

We were also pleased to hold the inaugural meeting of the investigator sponsored study review committee during this quarter and to launch a field based customer relationship management or CRM system to support our medical scientists and their engagements with scientific leaders around the country.

Coming up we look forward to presentations at HSA and HRA with additional data from our specialty cardiovascular franchise details for which we will we plan to be sharing soon.

With that I'll turn the call over to Andrew to provide an update on our commercial readiness activities in support of our planned specialty cardiology franchise strategy.

Thanks, Paddy our commercial activities in the second quarter focused on hiring the field management and other ongoing launch related activities.

With the extension of the <unk> data into next year, we have evaluated and adjusted certain of our timelines, particularly for activities that are gated to the potential approval and subsequent launch of on the captive mccarville.

In particular, the hiring of the remaining first line Charles leaders and customer facing colleagues, including our approximate 200 person sales force has been shifted to occur after the <unk> date next year.

Our plan remains to have two thirds of our planned spending related to the launch of OMA Captain Mccarville gated to take place. After the <unk> date other work streams and support a potential commercial launch remain on track.

During the second quarter, we completed hiring of the majority of our headquarter based team and now have in place all key roles needed for launch, including the majority of our marketing team.

Pricing and market access teams analytical and commercial operations teams.

Senior sales leadership as well as over 50% of our intended first line shelf managers in terms of market access our teams have been actively engaging with key payers to share our clinical healthcare utilization as well as economic data consistent with FDA guidance for unapproved products as it relates to supply chain, we have built on Q1 <unk>.

Minimum with significant progress made in ERP implementation serialization and supply readiness as well as in recruiting activities filling key roles for our commercial supply chain.

The FDA is reviewing the NDA for OMA captive Mccarville, we're also engaging in discussions related to the potential use of a diagnostic test a plasma concentrations to guide the OS optimization with OMA Captain Mccarville.

To facilitate getting the FERC.

Right patients to the right dose ultimately optimizing the benefit the drug may have.

Moving to Ft campaign. We also continued our go to market strategies in the U S. With the goal of having an initial plan in place by the end of the year.

As we plan for a potential launch of efficacy we are closely tracking the HCM market dynamics and launch of <unk>.

Market intelligence has indicated there are hundreds of patients who are beginning treatment and there is enthusiasm for this new mechanism of action from cardiologist.

We are witnessing the beginning of a paradigm shift in the treatment of ATM with the availability of the first cardiac myosin inhibitor and we will continue to monitor the launch and uptake of <unk>.

That's helpful to understand the HCM market gain insight to learn from this commercial launch experience to form our commercial planning for <unk> cancer and with that I'll turn the call over to Stuart to provide an update on <unk>.

Robert Blum: For Reldeceptive, we continued enrollment and conduct of COURAGE-ALS according to plan, and we also recently started the Open Label Extension Trial, COURAGE-ALS-OLE.

Thanks, Andrew.

In the second quarter, we continued enrolling patients encourage ILS and have now enrolled approximately 250 patients to date.

Robert Blum: Behind the scenes to these late-stage programs, our work continues on track and against goals set forth in our Vision 2025 to bring forward earlier-stage programs to expand our pipeline.

We have nearly completed activation of the full complement of sites with over 75 centers activated around the world.

Robert Blum: Firstly, to touch on Omicamptomicarbal, our next important milestone is participating in the Advisory Committee in December.

Robert Blum: And while we do not yet have the agenda nor specific topics of interest to FDA, we expect that FDA may want to discuss the scope of the potential indication, given that Galactic HF was conducted in a broad population of more than 8,000 patients with heart failure and reduced ejection fraction. But the results demonstrated that the treatment effect of Omicamptomicarbal seems to be amplified in certain pre-specified and other subgroups of patients with worsening heart failure.

Susie anthem for this large international Phase III trial has remained high from investigators.

Robert Blum: And suffice it to say, our teams are keenly focused to preparations for the Advisory Committee meeting and will be well prepared to engage constructively with FDA and its advisors.

And we're pleased to see enrollment advancing well.

Robert Blum: At the same time, we're pushing ahead on several work streams related to the potential approval and launch of Omicamptomicarbal.

We're also paying close attention to the evolving landscape for potential treatments for ALS.

There is also a great deal of interest in potential new medicines.

And we believe we're all defensive is well positioned to align with interest of regulatory authorities and patient communities given us muscle directed mechanism action and.

Promised including clinical evidence related to relative percentage generated to date.

Robert Blum: And due to the shift in the PDUFA date, we've adjusted certain timelines in the associated spending to account for the potential approval taking place in 2023, rather than 2022, which has prompted us to refine our 2022 guidance related to spending.

Importantly, we remain on track for the data monitoring committee to conduct the first interim analysis encourage analysts.

Which will have a sense for futility.

In the fourth quarter of this year.

This futility analysis was triggered 12 weeks after approximately one third of the planned number of patients were randomized.

We look forward to the readout of that milestone for <unk>.

Hopefully then continue with trial conduct.

We also recently started courage Alice Li the open label extension of coverage analysts.

In the OLED patients will receive 300 milligrams of rather sensitive dose orally twice daily for 48 weeks.

After which they may transition to a managed access program.

The managed access program aligned with our strong commitment to the patient community and to ensuring access to our investigational medicines in a safe and ethical way.

As such patients who have participated in any society kinetics Atlas trial will be eligible to enroll in the managed access program, which we expect to launch in the fourth quarter of this year.

Morris recently and just this morning.

We jointly announced with the ALS Association, a new release of the pooled resource open access ALS clinical trial database more proactive now.

Now inclusive of donated clinical trial data from our completed clinical trials in ALS.

Including benefit ALS vitality, ALS and Fortitude ALS.

This database houses the largest ALS clinical trial dataset with nearly 11000 ALS patient records from 'twenty three completed clinical trials.

The data harmonized and Anonymize to create a unique really available resource for the scientific community.

We're proud to contribute our clinical trial data to the Pro Act database.

And it may contribute to new therapies and potential breakthroughs for people with analysts.

And with that I'll turn it over to Robert Wong.

Robert Blum: Ching's going to elaborate on this extension of our cash runway in a moment.

Thanks, Stuart we ended the second quarter with approximately $597 million in cash and investments our revenue in Q2 2022, primarily from the recognition of our deferred revenue for royalties on net sales of products containing <unk> canton as a result of the extinguishment of.

Royalty obligations.

Our second quarter 2022, R&D expenses increased to $57 1 million from $36 4 million in the second quarter of 2021, primarily due to increases in spending related to our skeletal muscle program, our cardiac myosin inhibitor program and our early research programs.

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

Our second quarter 2022, G&A expenses were $42 7 million up from $21 2 million in Q2, 2021, due to higher commercial readiness spending and higher personnel related costs, including stock based compensation and now Ching will review, our financial outlook and corporate development strategy.

Thanks, Robert we ended the second quarter in a strong financial position was approximately $600 million cash on the balance sheet. In addition in July we raised approximately 523 million in net proceeds from the offering of three 5%.

<unk> senior notes the notes have a 30% conversion premium and our <unk> in 2027.

In connection with this transaction, we repurchased approximately $117 million in aggregate principal amount of outstanding 2026 notes through privately negotiated transactions.

The remainder of the proceeds will be divided among the following priorities one to expand the clinical development program for <unk>, including <unk>.

Second phase III clinical trial in patients with obstructive HCM and a potential phase III clinical trial in patients with non obstructive HCM.

Two to expand commercial capabilities and conduct readiness activities in the U S for potential launches of <unk> and ft Kempton.

Three to advance our early stage clinical development pipeline, including progressing CK 1362 phase II studies and the potential development of additional cardiac myosin inhibitors for half path.

Four to expand our muscle biology focused research activities to energetics growth and metabolism of muscle.

And five for general corporate purposes, including working capital.

We're pleased with having executed a successful convertible debt offering and bolstering our balance sheet in support of the advancement and expansion of our pipeline.

Turning into our 2022 guidance due to the <unk> extension, we have revised our guidance to reduce our net cash utilization for the year.

Previously, we expected our operating expenses to be in the range of $380 million to $400 million.

Net cash utilization to be approximately $365 million to $385 million.

We have reduced our net cash utilization to approximately $360 million to $365 million.

Due to the shift in hiring of our sales force and spending on activities planned to occur only after the launch of <unk>, which now has a <unk> date in February of 2023.

We believe our balance sheet inclusive of the cash raised through the convertible debt offering represents between two and three years of forward cash and we expect to end 2022 with more than $800 million in cash.

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

Thank you Cheng.

So we're entering the second half of this year with strong financial footing multiple programs progressing across our pipeline and our commercial transformation underway where.

We're building teams and capabilities and we are engaging in new activities and work streams and at the same time working to expand our pipeline by advancing earlier stage drug candidates.

As Jim mentioned, we raised more than $500 million.

Through our convertible debt offering.

These funds will allow us to advance CK $103 six into early development in the second half of the year with a goal of mapping out our strategy for proof of concept phase II studies to be underway in 2023, and specialty cardiovascular indications that would be complementary.

Told me Camden Mccarville.

This program offers an entirely new vector for value.

We look forward to sharing more developments with you.

And Additionally, new capital allows us to bring forward new compounds arising from our research aligned with the goal outlined in our vision 2025.

Of our having 10 therapeutic area programs running by 2025, you should expect to hear more with regards to new <unk>.

In the coming months.

So as we scale our company, we're continuing our business development discussions.

Plan to add to our long term history of deal, making to further bolster our balance sheet and ultimately bring forward our therapies to more patients around the world.

During the second quarter, we advanced discussions focused on potential partnerships in Asia and also in Europe , including partnering <unk> in Europe , and partnering both <unk> and <unk> Kimpton in Japan.

We're being deliberate and these interactions as we intend to choose the right partner and the right deal structure in each geography, while also preserving rights responsibilities and economics for cytogenetics as we believe to be in the interest of our science and also our confidence in our abilities to execute on what should.

A matter to our shareholders.

Finally, we're now also expanding our footprint beyond South San Francisco, and we'll be opening a small east coast office outside of Philadelphia later, this summer and Thats going to be for employees, primarily in our commercial medical affairs and supply chain teams.

This new office represents an important milestone in our growth and maturation to a fully integrated biopharmaceutical company.

Hopefully allow us to continue to attract top talent on both coasts.

Now I'd like to recap our upcoming milestones for.

Robert Blum: As we continue our European partnering campaign, we have in parallel advanced a path toward approval and expect to submit a marketing authorization application for Omicamptomicarbal to the European Medicines Agency, or EMA, by the end of the year.

<unk>, we expect to participate in an advisory Committee meeting to review the NDA for them, we can't Mccarville.

Robert Blum: If we're successful at partnering Omicamptomicarbal in Europe, we'd expect to receive additional capital to support flexibility in progressing our cardiovascular pipeline globally.

December 13 2022.

We also expect to launch on <unk> in the U S pending FDA approval in Q1 2023.

For assay Kimpton, we expect to continue enrolling patients with obstructive HCM in Sequoia HCM through 2022 with results expected in second half 2023, we also expect to continue enrolling patients with non obstructive HCM and cohort four.

Robert Blum: As it relates to work to advance AFI-CAMPTN in the second quarter, continued enrollment, and conduct of Sequoia HCM is progressing, and we're pleased to see the enthusiasm from the many dozens of sites planned to participate in this trial.

Redwood HCM with data expected in first half 2023, we also expect to begin a second phase III clinical trial of assay Kempton.

Robert Blum: We also continue planning for a second Phase III clinical trial of AFI-CAMPTN in obstructive, HCM, which we anticipate will start in the fourth quarter this year.

Robert Blum: Today, Fadi will be describing objectives of that trial in more detail to elaborate, on its purpose and goals supportive of our overall strategy for AFI-CAMPTN.

Structure of HCM in Q4 2022.

Robert Blum: And finally, in Q2, we presented the first longer-term data from Redwood HCM OLE, showing, significant sustained reductions in LVOT gradients, improvements in symptoms, and cardiac biomarkers, all with a favorable safety and tolerability profile.

And we expect to share additional longer term data from Redwood HCM L. E. The open label extension study of <unk> Camden.

Robert Blum: These data build on the 10-week treatment results from Redwood HCM, and we look forward, to sharing additional longer-term data throughout 2022 and through 12 months later this year at medical meetings.

Second half 2022.

For CK 136, we expect to reactivate the development program in.

Second half 2022.

For <unk>, we expect the data monitoring committee of courage AOS to conduct the first interim analysis from that trial in this next Q4 2022.

For ongoing research, we expect to advance new muscle directed compounds and to conduct IND, enabling studies for one to two potential drug candidates.

Robert Blum: Shifting to RELDIS symptoms, we continue to enroll patients and activate centers in COURAGE-ALS, and we also recently started the COURAGE-ALS Open Label Extension Study.

Operator with that we can now open the call up to questions. Please.

Robert Blum: We look forward to the first interim analysis in COURAGE-ALS designed to test for potential, futility. That's expected to occur in the fourth quarter of this year.

Robert Blum: And as you'll hear from our team today, we're moving full steam ahead as we enter the second, half of the year with a reinforced balance sheet to support our advancing pipeline, and as we undergo the transformation to be what we expect to be a fully integrated biopharmaceutical company.

Thank you Sir.

Robert Blum: With that, I'm going to now turn the call over to Thaddeus, please.

Thaddeus: Thanks, Robert.

As a reminder to ask a question you will need to press star one one on your phone.

Thaddeus: As we continue our dialogue with the FDA and prepare for our upcoming Advisory Committee, meeting for omicamps of McCarville, we're pleased to see additional analyses emerging that reinforce the definition of those patients who may best be served by treatment with omicamps of McCarville, that is, higher risk patients with worsening heart failure.

Thaddeus: During the quarter, we presented results at the Heart Failure 2022 meeting that were then, published in the European Heart Journal of a new analysis from GalacticHF on the effect of treatment with omicamps of McCarville in patients with heart failure and reduced ejection fraction and low blood pressure. The results showed that there was greater treatment effect from omicamps of McCarville, on the primary composite endpoint of cardiovascular death or first heart failure event than in patients without low blood pressure, and that omicamps of McCarville did not further lower blood pressure in those patients.

Thaddeus: Those receiving omicamps of McCarville had a lower incidence of treatment-emergent serious, AEs and adjudicated first strokes compared to placebo.

These standby as we compile the Q&A roster.

And our first question will come from Justin Kim of Oppenheimer. Your line is open.

Thaddeus: Safety of patients on omicamps of McCarville was similar to patients on placebo in this, low-pressure blood group or low-pressure group.

Thaddeus: These findings are important because patients with low blood pressure can often be challenging, to treat, and blood pressure can often be a limiting factor for uptitration and initiation of available standard-of-care therapies.

Thaddeus: The importance of these findings was not lost on the heart failure community, many of whom commented to us on its value for their patients and discussions we had with them following the date of presentation. These results add to the growing body of evidence showing that the treatment effect of omicamptomacarbal is amplified in patients who have worsening heart failure, whether that's defined by lower ejection fraction, recent hospitalization, or in this case, lower blood pressure.

Good afternoon, just high.

Thaddeus: As Robert mentioned, we also advanced a development program for apicamptin.

Thaddeus: During this quarter, we presented the first longer-term data from Redwood HCMOLE at Heart Failure 2022, encompassing 38 patients who completed either 12 or 24 weeks of treatment. The data showed that treatment with apicamptin was associated with substantial reductions in the average resting left ventricular outflow tract gradient and the valsalva gradient. These reductions started to occur within two weeks of treatment, were sustained through 24 weeks of treatment, and were achieved with only modest decreases in the average left ventricular ejection fraction.

Thaddeus: The majority of patients had an improvement in one or more NYHA class, and there was also significant improvements in antiprobian P and cardiac troponin, two cardiac biomarkers. Notably, treatment was well-tolerated with no permanent discontinuations of apicamptin.

Thaddeus: Moving to Sequoia HCM, we're pleased to share that we're continuing to progress with Steady Startup, Enrollment in Conduct, and now with regulatory approvals in nearly all 14 countries participating in the trial, including more recently China, where our partner Xisheng will conduct the China cohort.

Hey, Robert Good afternoon, and thanks for taking the questions and congrats on all the progress.

Thaddeus: As we look forward to sharing additional longer-term data from Redwood OLE later this year, we're encouraged by this initial data cut supportive of apicamptin being a next-in-class therapy with a strong safety, efficacy, and tolerability profile.

Thaddeus: In addition, during the second quarter, we continued enrolling patients with non-obstructive HCM in Cohort 4 of Redwood HCM. We've now enrolled nearly half of the planned number of patients in this open-label cohort, and we are pleased with its progress.

Thaddeus: In developing a therapy addressing the underlying cause of HCM, we're also interested in impacting the disease process or hallmarks of disease progression and demonstrating potential reversal of the adverse thickening and stiffening of the myocardium that results from increased contractility.

Thaddeus: At the American Society of Echocardiography's 33rd Annual Scientific Sessions, we presented data from an analysis of Redwood HCM looking at changes from baseline and echocardiographic measures of cardiac structure and function after 10 weeks of treatment with apicamptin compared to placebo. What we found was that at week 10, measures of cardiac structure, diastolic, and mitral valve function improved in treatments treated with apicamptin. In fact, there was significant reduction in left atrial volume index, a trend toward reduction in left ventricular hypertrophy, improvements in ventricular relaxation and filling, a reduction in the proportion of patients with systolic anterior motion of the mitral valve leaflet, and a trend towards reduction in those with eccentric mitral regurgitation. Together, these data suggest that treatment with apicamptin may help address each of the main defining characteristics of HCM, left ventricular hypertrophy, impaired cardiac relaxation, induced mitral regurgitation, and to ultimately improve cardiac structure and function.

Just maybe trying to connect the dots here between the things that you've been mentioning.

With the guidance of the IND, enabling studies for what to do drug candidates next year and I mentioned earlier this quarter around potential additional myostatin inhibitors could correct.

Specifically.

Just wondering if it's fair to assume that half path would be sort of a primary indication of interest here and whether it be sort of new compound relative to maybe at the Camden Targa.

Targeting it.

Very good question and I'll start and ask <unk> to elaborate.

Thaddeus: We may be able to conduct an interim analysis of data from this cohort by the end of this year to inform planning for potential FDA interactions in the first half of 2023.

Yes, you should assume pleased that half path is.

Key interest to us for the mechanism of action of cardiac myosin inhibition with regard to which compound or compounds may advance there that's still to be determined maybe you can elaborate on how we're thinking about that.

Yes, I mean, I think with regards to the.

The development in that area.

The question is defining the patient population.

As a as really modeled by our work in ACM.

Those patients in HCM have many features in common with the population have path.

And so I think.

In thinking about advancing our program and have passed you'd want to look to what we're learning in any Sam is we may be reporting beginning of next year.

And as may be indicative of the direction, we're going.

Okay, great great.

And maybe just one follow up before I hop in the queue.

Maybe not directly specific to the phase III design of the second half the captain study in HCM, but to the Companys knowledge has there been a study of any beta blocker prospectively demonstrating improvement in exercise capacity for patients with <unk> HCM.

I can answer that question.

Thaddeus: We look forward to providing a further update with our next earnings call and sharing data from this cohort in the first half of 2023, which, if supportive, would enable the start of a potential Phase III pivotal trial in patients with non-obstructive HCM to occur in 2023.

Yes, there was a nice publication.

<unk>.

End of last year that looked basically at a crossover study of patients on metoprolol, and then crossed over to placebo and vice versa, starting on placebo and crossing them over to metoprolol.

Thaddeus: In the second quarter, we also continued planning activities for the second Phase III clinical trial of affeyKampton in obstructive HCM. The goal of this additional Phase III trial is to better understand and position the use of affeyKampton relative to current standard of care therapy. We believe we're on track to begin this trial in the fourth quarter. And now I'd like to share a few details about the intended trial design. This Phase III multicenter, randomized, double-blind trial is planned to evaluate the safety and efficacy of affeyKampton as monotherapy compared to metoprolol as monotherapy in people with symptomatic obstructive HCM. Metoprolol is a beta blocker commonly prescribed to people with obstructive HCM.

Thaddeus: And by studying it against affeyKampton, we expect to evaluate the potential for affeyKampton to be considered as a monotherapy.

Looked at its impact on the gradient on symptoms on exercise performance using <unk>.

And that reference provides a nice baseline I think for what beta blockers do an HCM they tend to reduce.

The gradient.

You do see some symptomatic improvement.

You don't see any improvement in exercise capacity in part because they limit the increase in heart rate.

They are accompanied by side effects that some people find.

Bothersome so.

Paper published by <unk> at all.

And Jack is a good sort of benchmark for what beta blockers do an HCM at least over the short term there are short term studies.

Okay, great. Thanks, so much.

Thank you.

Thank you.

One moment please for the next question.

Our next question will come from a cash tillery of Jefferies. Your line is open.

Hello.

Alright.

Okay. Thanks for taking our questions. We have two questions. If I may so the first is about so looking at wireless label, if anything from malware was quite limited in patients.

Okay.

Compared to those who are now so well is it possible.

You may need to sell side up blockers before they start using Bala and also based on your understanding what's the percentage of HCM patients.

Paul Kirsch Cambria Award and the second question is really about like drug pricing.

Medicare is a major player in cardiovascular space, how do you think the scale will impact evaluation and will yield comes today, perhaps any like.

That's all my questions. Thank you very much.

Sure so.

I think you asked three questions. So let's take them one at a time the first related to our understanding of the Mavic Campton label is that right with regard to beta blockers could you repeat that please.

Yes, correct.

And could you repeat that and as to.

Specifically, what youre getting at.

Oh for sure I'm asking about the benefits from <unk> with quite limited in patients that all add up blogger compared to those who are not.

But if you would take that one please.

Okay.

Well I think.

People have looked at the subgroup analyses in and explore in the benefit appear.

Appears to be attenuated in patients in beta blockers.

There's some language in the FDA materials with regards to that.

I think other analyses.

Have shown that you do see improvements in those patients.

Despite the fact.

They are on beta blockers of course they.

To get into the trial, they still have to have high.

High gradients in you would call them incompletely treated or treated with their beta blockers.

So I think Thats really a question of.

Sort of looking at the data a little more deeply.

Your other your other point was what percentage of patients are on beta blockers, and then roughly 70% to 80% of patients.

Start with beta blockers in terms of.

And stay on them with the terms of their initial therapy for HCM and.

And in particular metoprolol tends to be the drug of choice.

So that's I think the answer to both your questions.

And your third question I believe relates to.

Legislation pertaining to Medicare and pricing negotiations and how that might read on <unk> is that correct.

Yes, Greg.

I think it's premature for us to be speculating on where that market bottom out but.

But I do think that.

There.

Appearances of carve outs that might relate to orphan indications and specialty indications that might not have.

The same kind of competitive dynamic for which there may not be the same sorts of pricing pressures and budget impact, but I suspect that that's going to be evolving and fluid for some time and I think it's premature for us to.

Go down that path in terms of how it might affect <unk> kimpton when ultimately this might become legislation.

Zinc.

Over time, we'll be assessing for that and how it could impact or potential business interests, but right now he captains in phase III. So we will focus to clinical research.

And if you think you are large but this is very helpful.

Thank you.

Thank you.

One moment. Please for the next question again, we ask you to please limit yourself to two questions.

One moment please.

Our next question comes from Martin <unk> Kumar.

Thank you.

Thank you.

One moment. Please for the next question again, we ask you to please limit yourself to two questions.

One moment please.

Our next question comes from Matthew Kumar of Goldman Sachs. Your line is open.

Hello.

Hi, This is rob on for Madhu, Thanks for taking our question.

So where specifically are you looking to reduce spending in 2022, and how should we think about potential for label clarification out of the the only AD com.

So we will take those one at a time and I'll start with maybe asking Ching and then Andrew.

You speak about where we might be seeing some savings in terms of commercial spending in 2022.

And then maybe we'll.

We will talk.

How we might think about the outcome although I.

I suspect you will appreciate we can't be.

Two prognostic about that not even yet knowing what are the questions of the agenda.

Starting with the question.

Well, maybe I'll start and then I'll hand, it over to Andrew So.

We have plan to hire a sales force only after we receive approval for <unk>.

We tend to mccarville. So originally the <unk> was at the end of November . This year is now being pushed out to February of next year. So.

The field force cost for the month of December for example would be pushed out to next year as well as some of the marketing spend.

Spending in <unk>.

Media purchase agency cost some of that will be pushed out to 2023 as well.

And the only thing maybe I would add is that with a modest reduction in 'twenty two because of the Paducah date being in November .

Or more.

Being pushed out in 'twenty three early 'twenty three as we expect it to have a field force in place in January .

Pushed out several months, so very modest reduction in 'twenty two given the lag.

For original Paducah date of end of November .

Moreover, just as we enter the second half of the year.

And recognizing the environment in which we're operating we take a sharp pencil to revising our financial spending across the organization.

We for.

We identified other places, where we thought we could save some money this year and we think that's just prudent and good housekeeping.

With respect to your second question pertaining to expected labeling.

I don't think we can really do justice to that question in the absence of yet.

Having.

More fulsome discussions with FDA and as would follow.

An ad com.

So.

We conducted the Galactic study and.

As you know that study enrolled a heterogeneous population with <unk>, but for which we saw a more amplified efficacy and pre specified.

Subgroup of patients with lower ejection fraction as well as in other subgroups, some pre specified and others that were post hoc all of which contribute together to an understanding of the efficacy being.

Amplified in patients with worsening heart failure.

So there could be.

Our conversation around which we might discuss.

What would be the indication in patients with higher risk.

Those are things that could be addressed through graphs tables and figures in the.

Potentially approved package insert or otherwise in the indication statement and.

Those are ultimately things that are up to FDA and its advisers to determined to talk about so I'm not sure I'm answering your question well enough, but I'm sure that you can understand that maybe the best we can do right now.

Yes, I appreciate that thank you for taking our questions.

Thank you.

Thank you and again, one moment as we get our next question.

Our next question will come from ethylene Rahimi Piper Sandler Your line is open.

Hi, Robert and team. Thank you so much for taking my questions.

Thaddeus: To be considered for first-line therapy in people with symptoms and functional limitations due to HCM.

So thank you first of all for providing a little bit Mark glimpse of information on the second phase III study that youre contemplating in obstructive HCM and considering running at a four potential to be first line therapy.

Should we be thinking about effect size size of the study.

And what data.

I'm sorry, that's repetitive.

This.

With Abbvie captain to give us confidence to be.

Equally.

Competitive with first line therapies, if not superior.

Yes, so I'll briefly start in our strategy.

Thaddeus: We're not ready to share all the details of this trial, but we recently met with FDA and have alignment on the clinical trial design.

These comments and certainly for the fact that we believe assay Kimpton may represent a next in class approach. It's incumbent upon us to as we've indicated advance the field and we foresee that this is a big opportunity to demonstrate that cardiac myosin inhibition has.

Thaddeus: We hope this level of detail provides some context into our goals for the trial and how it may contribute eventually to potentially differentiated expected labeling for affeyKampton.

Potential beyond where the field exists today.

So hence the <unk>.

Interest in doing this study.

Our strategy to speak more about the rationale.

Thanks Robert.

Think.

It's probably premature for me to give you specifics with regards to the numbers and powering and so forth but.

We would expect a sizeable achievement difference.

As opposed to beta blockers remember studying app in campton currently.

On top of standard of cares and against against patients who are on standard of care.

And so the.

If you will we think we can achieve the same thing.

Agree of efficacy with Abbvie campton as monotherapy.

And if we can do that in patients who are.

Again, basically on monotherapy with beta blockers, and we would expect.

Or if not greater effects, then we plan to observe in Sequoia.

So I think thats part of the answer to your question.

And that would imply a study that was smaller than Sequoia.

Order to demonstrate those those effects.

I think the other Oh go ahead do you want to.

I was just going to ask Craig what's the rate limiting steps are just kicking off the study that is it just further discussions with the agency on finalizing the protocol.

This left today.

I apologize for interrupting you talk sorry.

No no problem I mean, starting in any study is a complicated exercise, especially one where you are.

Thaddeus: We look forward to sharing more details and to starting this clinical trial for our next-in-class drug candidate later this year.

Unknown Speaker: Moving now to medical affairs at Cytokinetics. As we mature our capabilities in the recent quarter, we continued hiring and have now on board our complete managed healthcare medical scientist team and have successfully initiated medical support for our global value access and distribution activities.

Unknown Speaker: We were also pleased to hold the inaugural meeting of the Investigator Sponsored Study Review Committee during this quarter and to launch a field-based Customer Relationship Management, or CRM, system to support our medical scientists in their engagements with scientific leaders around the country.

Unknown Speaker: Coming up, we look forward to presentations at HFSA and AHA with additional data from our specialty cardiovascular franchise, details for which we plan to be sharing soon.

Andrew: With that, I'll turn the call over to Andrew to provide an update on our commercial readiness activities in support of our planned specialty cardiology franchise strategy.

Maddy: Thanks, Maddy.

Unknown Speaker: Our commercial activities in the second quarter focus to hiring to field management and other ongoing launch-related activities.

Double blinding against an active comparator so.

Unknown Speaker: With the extension of the PDUFA date into next year, we have evaluated and adjusted certain of our timelines, particularly for activities that are gated to the potential approval and subsequent launch of Omicamp for McCarville.

Unknown Speaker: In particular, the hiring of the remaining first-line sales leaders and customer-facing colleagues, including our approximate 200-person sales force, has been shifted to occur after the PDUFA date next year.

Manufacturing drug.

Unknown Speaker: Our plan remains to have two-thirds of our planned spending related to the launch of Omicamp for McCarville gated to take place after the PDUFA date.

Unknown Speaker: Other work streams in support of potential commercial launch remain on track. During the second quarter, we completed hiring of the majority of our headquarter-based team and now have in place all key roles needed for launch, including the majority of our marketing team, pricing and market access teams, analytical and commercial operations teams, and senior sales leadership, as well as over 50% of our intended first-line sales managers.

And.

Unknown Speaker: In terms of market access, our teams have been actively engaging with key payers to share our clinical, healthcare utilization, as well as economic data consistent with FDA guidance for unapproved products.

A placebo for the active comparator in beginning.

Unknown Speaker: As it relates to supply chain, we have built on 2-1 momentum with significant progress made in ERP implementation, serialization, and supply readiness, as well as in recruiting activities filling key roles for our commercial supply chain.

Unknown Speaker: As FDA is reviewing the NDA for Omicamp for McCarville, we are also engaging in discussions related to the potential use of a diagnostic test of plasma concentrations to guide dose optimization with Omicamp for McCarville to facilitate getting the right patients to the right dose, ultimately optimizing the benefit the drug may have.

Preparations in terms of the.

Electronic systems of the trial and so forth. So there's a lot of work to get the study going so I would.

The study is in some sense started meeting them.

Initiating all appropriate preparations and doing a lot of work to get it up and off the ground.

Unknown Speaker: Moving to Afecamptin, we also continued our go-to-market strategies in the U.S. with the goal of having an initial plan in place by the end of the year.

And we expect to be interacting with site soon in order to get it to them.

Unknown Speaker: As we plan for a potential launch of Afecamptin, we are closely tracking the HCM market dynamics and launch of KimZyos. A market intelligence has indicated there are hundreds of patients who are beginning treatment, and there is enthusiasm for this new mechanism of action from cardiologists. We are witnessing the beginning of a paradigm shift in the treatment of HCM with the availability of the first cardiac myosin inhibitor and will continue to monitor the launch and uptake of KimZyos.

Andrew: This helps us to understand the HCM market, gain insights, and learn from this commercial launch experience to form our commercial planning for Afecamptin.

<unk>.

In time for the end of the year.

Andrew: Andrew.

Unknown Speaker: In the second quarter, we continued enrolling patients in COURAGE-ALS, and have, now enrolled approximately 250 patients to date. We have nearly completed activation of the full complement of sites, with over 75 centers activated around the world. Enthusiasm for this large international Phase III trial has remained high from investigators, and we're pleased to see enrollment advancing well.

Unknown Speaker: And with that, I'll turn

Unknown Speaker: We're also paying close attention to the evolving landscape for potential treatments for ALS. There's also a great deal of interest in potential new medicines, and we believe REL Decentive is well-positioned to align with interests of regulatory authorities and patient communities, given its muscle-directed mechanism of action and the promising clinical evidence related to REL Decentive generated to date.

I think the last thing I was just going to comment on this question is that.

Unknown Speaker: Importantly, we remain on track for the Data Monitoring Committee to conduct the first interim analysis of COURAGE-ALS, which will, assess for futility in the fourth quarter of this year. This futility analysis was triggered, 12 weeks after approximately one-third of the planned number of patients were randomized.

Unknown Speaker: We look forward to the readout of that milestone for COURAGE-ALS, and will hopefully then continue, with trial conduct.

Unknown Speaker: We also recently started COURAGE-ALS OLE, the open-label extension of COURAGE-ALS. In the OLE, patients will receive 300 milligrams of REL Decentive dosed orally twice daily for 48 weeks, after which they may transition to a managed access program.

Unknown Speaker: The managed access program aligns with our strong commitment to the patient community and to ensuring access to our investigational medicines in a safe and ethical way. As such, patients who have participated in any of Cytokinetic's ALS trials will be eligible to enroll in the managed access program, which we expect to launch in the fourth quarter of this year.

The field I think what's ultimately no.

Unknown Speaker: More recently, and just this morning, we jointly announced with the ALS Association a new release of the Pooled Resource Open Access ALS Clinical Trials Database, or PROACT, now inclusive of donated clinical trial data from our completed, clinical trials in ALS, including Benefit ALS, Vitality ALS, and Fortitude ALS. This database houses the largest ALS clinical trial data set with nearly 11,000 ALS patient, records from 23 completed clinical trials. The data are harmonized and anonymized to create a unique, freely available resource for the scientific community.

Robert Wong: it over to Robert Wong.

Unknown Speaker: We're proud to contribute our clinical trial data to the PROACT database and hope that it may contribute to new therapies and potential breakthroughs for people with ALS.

What.

How these therapy stack up against one another and the only way that you can do that is by <unk>.

Doing side by side trials.

And looking at things that speak not only to functional and symptom improvement, but also disease modification.

Over time, and I think all of those things are important for the field to understand how to use these therapies and sequence them.

Robert Wong: Thanks, Stuart.

Robert Wong: We ended the second quarter with approximately $597 million in cash and, investments.

Great. Thank you so much for taking my question.

Thank you.

Thank you.

Our next question.

Robert Wong: Our revenue in Q2 2022 came primarily from the recognition of our deferred revenue for royalties on the net sales of products containing Mavicantin as a result of the extinguishment of royalty obligations.

Okay.

Our next question today will come from <unk> side.

<unk> group your line is open.

Robert Wong: Our second quarter 2022 R&D expenses increased to $57.1 million from $36.4 million in the second quarter of 2021, primarily due to increases in spending related to our skeletal muscle programs, our cardiac myosin inhibitor programs, and our early research programs.

Hello Celine.

Hi, It's Mike Lyndon on first lien. Thanks, so much for taking our questions.

Wanted to ask the captain and the recent <unk> launch if I may I'm curious to see or to hear how you're thinking about where.

Where the myosin inhibitor market is headed as you talk to docs and prescribers.

Maybe what's been learned so far where theres uptake or if there are any blockages.

Anything like that.

And then maybe to follow up on that just maybe whether you think.

Based on existing data of course that this might be a switch market versus new patients.

Yes, so we've been.

Both doing our own work in this space as well as learning from the work done.

By equity research analyst and investors all of whom seem to be.

Great focus from this launch.

And coming about this in ways that I think are now coalescing around the launch seems to be going well launch seems to be going according to expectations. There are seemingly one hundreds of patients that may already be started on maverick kimpton and theres a lot of free drug out there.

Some of it is 30 days supply some is more than 30 date and typically coming through specialty channels.

It seems that.

The feedback that we're hearing is positive I'll ask Andrew to comment.

Some of the things specifically in Saudi also if he wishes regarding what we're learning from our commercial and medical teams in particular.

But then as far as your question on.

Patient switches.

I Trust, you mean as it relates to beta blockers.

You're asking about what will be our strategy.

If it's a ladder our strategy.

It's premature for us to speak to that certainly this is a new product.

Launch with a new mechanism and its most important that education and awareness building around <unk> and how that can benefit patients who to this point haven't had.

Much to be.

Positive about Maverick Camden appears to be a very important new medicine.

So maybe ill ask Andrew <unk> to comment on anything else, they're hearing about the launch.

And maybe Robert only thing I will build on us.

Uptake is occurring mainly at HCM centers.

Cardiologists associated with those centers the launch is going as we expected it to go with BMS payer coverage is starting on the commercial side of patients are getting access to the drug through likely true.

Guessing here, but likely true free programs and hub services at medical exceptions are being processed.

Physicians are gaining experience and as we gain more experience, we'll continue to put more patients on the product.

So as we can tell it is a transformation.

<unk>.

From a mechanism point of view for patients with HCM.

Again, as Youre going as we expected.

Some of that if there's anything you wanted to add or Robert and I covered it.

I think that covers it.

I think that covers it well.

The the launch these are still early days.

But all seems to be going well.

And in that way I think it reflects the enthusiasm for the mechanism.

Thanks, guys I appreciate it.

Thank you.

Thank you.

And again, one moment for our next question.

Robert Wong: Our second quarter 2022 G&A expenses were $42.7 million, up from $21.2 million in Q2 2021, due to higher commercial readiness spending and higher personnel-related costs, including stock-based compensation.

Robert Wong: And now Ching will review our financial outlook and corporate development strategies.

Our next question will come from Joe <unk> of H C. Wainwright.

Your line is a little joke.

Ching: Thanks, Robert.

Ching: We ended the second quarter in a strong financial position with approximately $600 million cash on the balance sheet. In addition, in July, we raised approximately $523 million in net proceeds from the offering of 3.5% convertible senior notes. The notes have a 30% conversion premium and are due in 2027. In connection with this transaction, we repurchased approximately $117 million in aggregate principal amount of outstanding 2026 notes through privately negotiated transactions.

Hey, everybody. Good afternoon. Thanks for taking the question two questions for <unk> I guess, the first one is more of a housekeeping and the other one is.

Ching: The remainder of the proceeds will be divided among the following priorities. One, to expand the clinical development program for Aficamptin, including for the second Phase III clinical trial in patients with obstructive HCM and a potential Phase III clinical trial in patients with non-obstructive HCM.

Ching: Two, to expand commercial capabilities and conduct readiness activities in the U.S. for potential launches of Omicamptin-McCarbol and Aficamptin.

Ching: Three, to advance our early-stage clinical development pipeline, including progressing CK136 to Phase II studies and the potential development of additional cardiac myelosin inhibitors for HAP-PAF.

Ching: Four, to expand our muscle biology-focused research activities to energetics, growth, and metabolism of muscle.

Ching: And five, for general corporate purposes, including working capital.

Ching: We're pleased with having executed a successful convertible debt offering and bolstering our balance sheet in support of the advancement and expansion of our pipeline.

Ching: Turning into our 2022 guidance, due to the PDUFA extension, we have revised our guidance to reduce our net cash utilization for the year. Previously, we expected our operating expenses to be in the range of $380 to $400 million and net cash utilization to be approximately $365 to $385 million. We have reduced our net cash utilization to approximately $360 to $365 million due to the shift in hiring of our sales force and spending on activities planned to occur only after the launch of Omicamto Macarbo, which now has a PDUFA date in February of 2023.

Ching: We believe our balance sheet, inclusive of the cash raised through the convertible debt offering, represents between two and three years of forward cash, and we expect to end 2022 with more than $800 million in cash.

Bigger picture so for the housekeeping.

Ching: And with that, I'll turn the call back over to Robert Wong.

Robert Wong: As Ching mentioned, we raised more than $500 million through our convertible debt offering.

Robert Wong: These funds will allow us to advance CK136 into early development in this second half of the year with a goal of mapping out our strategy for proof of concept phase two studies to be underway in 2023 in specialty cardiovascular indications that would be complementary to Omicanto Macarbo.

I just want to make sure. So all of the PK data that the FDA requested is in place and you provided it to them and is there anything else outstanding that you need to provide.

Robert Wong: This program offers an entirely new vector for value, and we look forward to sharing more developments with you.

Robert Wong: And additionally, new capital allows us to bring forward new compounds arising from our research aligned with the goal outlined in our vision 2025 of our having 10 therapeutic area programs running by 2025.

Robert Wong: During the second quarter, we advanced discussions focused on potential partnerships in Asia and also in Europe, including partnering Omicanto Macarbo in Europe and partnering both Omicanto Macarbo and Aficampton in Japan.

Robert Wong: We're being deliberate in these interactions as we intend to choose the right partner and the right deal structure in each geography while also preserving rights, responsibilities, and economics for cytokinetics as we believe to be in the interest of our science and also our confidence in our abilities to execute on what should matter to our shareholders.

Robert Wong: Finally, we're now also expanding our footprint beyond South San Francisco, and we'll be opening a small East Coast office outside of Philadelphia later this summer. And that's going to be for employees primarily in our commercial, medical affairs, and supply chain teams. This new office represents an important milestone in our growth and maturation to a fully integrated, biopharmaceutical company and will hopefully allow us to continue to attract top talent on both coasts.

At this point, we've provided but everything that you <unk>.

They've asked for but that doesn't preclude them from asking for more down the line.

Robert Wong: Now I'd like to recap our upcoming milestones.

Robert Wong: For Omicamptomicarbal, we expect to participate in an advisory committee meeting to review, the NDA for Omicamptomicarbal on December 13, 2022.

Now of course.

And then the broader question that I have here is with regard to your market preparedness more specifically marketing research that you might be conducting.

I guess I would ask it this way with regard to market readiness for acceptance by the market.

Meaning as Youre talking to physicians and the broader community and cardiovascular health care for heart failure.

The how rapidly you think the drug could be implemented into the treatment paradigm with other drugs and is the market already accepting the complementarity of AUM and AUM of captive.

Robert Wong: We also expect to launch Omicamptomicarbal in the U.S. pending FDA approval in Q1, 2023.

Robert Wong: For Afecamptin, we expect to continue enrolling patients with obstructive HCM in Sequoia HCM, through 2022 with results expected in second half 2023.

So obviously, we can't be.

Promoting <unk> before it would be potentially approved.

But there are things that we couldnt be observing as would be enabling of that.

Hopefully upon approval.

And I'm really pleased with how we're using especially this extra time to be ready for what will be a commercial launch when that does occur.

Maybe I could just ask Saudi to speak to how we see the guidelines evolving and Andrew if there's anything further you want to add.

Yes, I mean I think the.

With with a <unk>.

Papers that have been coming out with <unk>.

The data that have been published with regards to <unk>.

And low blood pressure.

And other things.

When guidelines committees.

<unk> were to fit it in where does it fit in.

What we would hope to see would be that they would acknowledge that in patients that have sort of sale.

Sailed on foundational therapy, meaning that they can put on as much of the foundational therapy as they can tolerate and yet are still not doing well and still have high risk features such as hospitalization or recurrent hospitalization or.

Our high end <unk>.

Our other things.

They may consider Mccann mccarville as an option and you can see in the current guidelines.

Sort of what's next box after you've tried everything what do you do what's next what you might do and when we think of <unk> as one of those.

Next in line therapies.

And maybe just to build on from a market research point of view, we go through two medical Congresses, we talked to Kols, we conduct commercial advisory boards, we do something called demand study, which we will put a label, which we think is the target level based on where we think it will wind up and once approved in <unk>.

Physicians and SM about utilization and largely you can generate.

I think market share will be in demand will be.

But uniformly across when we ask physicians and cardiologists I'm talking about.

We always get this a similar answer of Theres, a handful of patients or a particular patient profile or type of patient in mind that they know they would use this product already.

We feel good about the launch we feel good about the profile for worsening heart failure.

And we feel good about where physicians are telling us in terms of utilization for appropriate patients.

The proof will be when we launch the product and we get the final label, but overall the demand seems to be appropriate for for a launch and for our utilization based on the field force were.

Planning on deploying.

Got it. Thank you for another way of looking at it sorry Robert.

Just a final comment another way to look at this as sort of what are the proxies for what might be.

Predictive of a successful commercial launch there's high awareness of <unk> Theres high awareness of the high unmet need and the apps.

Absence of satisfaction.

Need for.

Current guideline mandated treatments.

And at the same time guidelines are getting updated with with <unk>.

More frequency so we foresee those to be good signs of what could be hopefully a positive commercial launch when the time comes.

Understood. Thanks again.

Thank you.

Thanks, Jeff.

Thank you one moment for our next question.

Okay.

Our next question will come from.

Carter Gould of Barclays. Your line is open.

Hey, Carter.

Great Hey, guys, you've got Edwin on the line for Carter.

We wanted to ask a follow up to the question on the <unk> launch in this new world, where there's a therapeutic options specifically if you could frame for us any views on impact of diagnosis or an early take on the burden of the Rems program or monitoring from your discussions with Kols and stakeholders and then our second question. If you could just frame for us your expectations for potential.

Robert Wong: We also expect to continue enrolling patients with non-obstructive HCM in cohort four of, Redwood HCM with data expected in first half 2023.

Readout of course far from Redwood.

Sure.

Yes, so with regard to the first I don't think we're going to get into the business of.

Speaking too much about our competitors launch.

We foresee that may have a camden is.

Going well, but.

As to how.

That might be ultimately tailored to the kinds of things you're asking about I don't think its for us.

To be addressing those matters for you I think that's more important that the equity research.

Immunity you'd be doing its own independent analyses of those kinds of matters.

Sorry about that but I, just kind of feel like thats.

May be improper for us to be addressing things to that level of detail.

What was your second question.

Yes, no problem.

Sure.

Yes.

If you could frame for us.

Got it got it go forward. Thank you.

And just with regards to what might they might expect with.

US report for cohort four so.

Dave data with cohort four as we've said before we're looking at many of the things that we've looked at in cohorts, one two and three with the exception of left ventricular outflow tract gradient because these patients don't have them.

So safety and Tolerability.

We will be looking at NOI J class movement will be looking at Biomarkers like empty pro BNP.

Proponent will be looking at echocardiographic response.

Either declines in LTE, but also we want to look more closely at changes in cardiac structure and function in diastolic function. So.

All of those things.

<unk> seen us report for.

Robert Wong: We also expect to begin a second phase three clinical trial of Afecamptin in obstructive, HCM in Q4, 2022, and we expect to share additional longer-term data from Redwood HCM OLE, the open-label extension study of Afecamptin in second half 2022.

Matthew Campton in the obstructive.

HCM cohorts, we plan to also do the same sort of measurements and report those for non obstructive groups.

Thank you.

Thank you.

Yes.

Thank you one moment for our next question.

Our next question will come from Jason Butler of JMP Securities.

Hi, Thanks for taking the question Hey, Robert.

So you mentioned one of the potential discussion topics for the mechanical I come are you preparing for it.

Saying and thoughts on how to apply.

Clinical practice can you just give us your thoughts on how youre planning to direct and educate physicians.

To find the right dose to maintain the right dose for a patient and then you also mentioned essentially yes.

Banyan diagnostics.

How quickly into a launch do you think that something like that could be implemented and how would that change the overall.

Our strategy of getting patients onto the drug.

<unk>.

Yes, so maybe just to.

Starch.

And maybe also amend the statement you made.

In Galactic.

We did employ method.

Methodology for assessing PK exposures in order to dose titrate patients to a target dose level.

And that.

That was described.

And as published in terms of how we will ultimately get.

Patients to target doses.

As defined by PK parameters.

What I wanted to mentioned however, as you use the terminology companion diagnostic in <unk>.

It's not necessarily a companion diagnostic as would be the literal sense of that word.

And in that way.

We're looking at various ways of approaching this that would be.

Labeling of different strategies to get patients.

To target dose that would.

Enable them to be using different kinds of assets that could be useful.

It could be useful.

In clinical practice as we go beyond what was used in a clinical trial. So that's still somewhat dynamic in terms of how we might best approach that post launch that's a matter of that.

We will be.

Communicating over time, as we might assess the different alternatives in the different options.

Afraid I won't be able to do much better than that right now I don't know, Saudi or Andrew if you want to.

Take a stab at that but our goal is to be in a position.

To be equipping physicians to be able to get to the best target dose with a PK assay, but for which the way in which we might do that is still not yet something we intend to be communicating now.

Okay, Great I appreciate it thanks for taking the question.

Okay.

Thank you.

And one moment for our next question.

Our next question will come from Charles Duncan of Cantor. Your line is open.

Robert Robert team.

Congrats on the progress in the quarter and thanks for taking my question.

Yes.

A question on Omi and then a question on <unk> as well in that program. So on obese Multipart question is as Youre preparing for the AD com.

Four months.

Can you <unk>.

A little bit of color on.

Really the work plan.

Yes.

Mark add comps and.

If so how many or at least one and.

Let me just kind of be the one.

The key focus.

About.

A high burden patients.

Connection fraction or is it going to be hospitalization or blood pressure.

Okay.

Alright.

Yes.

Yeah, So all of that strategy to speak to how we're preparing but yes, we will have a mark out Tom will do a number of these different types of preparations in order to be best suited in best prepared.

Where.

The team and there is a core team is working.

Very feverishly now already and these preparations and meeting frequently each week cloudy anything you want to elaborate.

Well I guess I'll say, obviously, we're quite focused on our preparations we don't have.

Specific agenda or topics yet but.

There's certainly a number of things we need to do and prepare background materials.

And clear slide presentations and prepare with mock panels in terms of.

Getting the team practice to answer questions I think.

We have a <unk>.

<unk> team, that's very experienced and has worked on this drug for a long time and.

It's gone through the process now.

Submitting an NDA in.

And working through the approval process. So.

We will be ready when the time comes.

Okay.

The case looking forward to that and then my question on royalty, perhaps for Stewart insurance income and.

Actually some progress you've made.

At least for some of that.

So in terms of.

Paradigm, but relative to your encourage program I guess I am wondering if you can.

Give us some sense.

What it means for interim analysis for futility.

I get that generally, but I'm wondering if there is a certain kind of can see youre expecting out of that there was one third of patients at 12 weeks.

And also if you could tell us whether or not with <unk>.

The old <unk> had any any patients actually enrolling darrin. Thank you alluded to there, but I didn't catch up for sure.

Thank you Charles.

The interim analysis.

Is fairly straightforward.

It's a relatively low bar.

I'd say to continue the trial.

We really want to determine yes.

There is a trend of favorable trends in <unk>.

Terms of the main outcome.

Rather sensitive compared to placebo.

And we fully expect that based on our phase two data.

But it's just sort of a matter of being efficient and.

Responsible in terms of study conduct and.

And then what's best for the development program and what's best for patients.

And your next regarding.

The OLED we are just.

Getting storage with.

With the OLED so.

Just at the cusp.

<unk> started to rollover.

So the open label extension that we're pretty excited and proud that we have that.

As to offer to those patients.

Okay very good thanks for taking them.

Thank you.

Yeah.

Thank you.

And one moment our next question.

Our next question will come from Rohit.

Boston of Needham <unk> Company. Your line is open hi.

Hi, This is rohit up research good afternoon. Thanks for taking my question.

Can you talk about how the older captive delays with the FDA.

Our effective possible partnership discussions and then second question is there any.

You can share regarding feedback you're receiving from providers regarding the data on the AOS database.

Sure with regard to partnering.

Don't think the.

Producer date extension has had an effect.

Our conversations are continuing and I think that.

Potential partners see this as maybe more par for the course these days, especially for.

New mechanisms. So it has not changed the way we're approaching our strategy for partnering.

Your second question could you repeat it please.

Sure. Yeah is there anything you can share regarding the feedback you're receiving from providers regarding the data on the AOS database.

Oh, you are referring to this morning's press release.

The feedback.

I think generally one of appreciation.

This has been the conversation we've been having with.

The people who.

Administer and manage to the proactive debase for quite some time.

And we've made now a major contribution to the.

Database for.

The data from these three completed studies so the incorporation of our data into Pro Act as something that was contemplated and considered and planned for for quite a long time 30 fewer stores anything you want to add to that.

Sure.

This is <unk>.

Yeah.

I think its just another example of some kind of exiting as global citizens and.

We have these robust datasets.

From.

Previous clinical trials and.

We're obviously very committed.

Two finding therapies to help these patients.

So I think that we're seeing very very positive feedback and.

It just further strengthened.

Our commitment to this community in these patients.

Yes, I might add that.

Or the fact that cytogenetics has a reputation in the ALS community for having conducted large very rigorous robust clinical research I think there's a view that these are high integrity data that should make a big difference in a big impact for their inclusion in this database.

Thank you.

Thank you.

Yes.

Thank you.

Robert Wong: For CK136, we expect to reactivate the development program in second half 2022.

I see no further questions into queue I would now like to turn the conference back to management for closing remarks.

Robert Wong: For reldacentive, we expect the data monitoring committee of COURAGE-ALS to conduct the first, interim analysis from that trial in this next Q4, 2022.

Thank you operator, and thanks to everybody for joining us on this conference call today.

Robert Wong: And for ongoing research, we expect to advance new muscle-directed compounds and to conduct, IND-enabling studies for one to two potential drug candidates.

Clearly we've made a lot of very good progress in the second quarter and again more recently in this third quarter. We have set the table, we believe for a very.

<unk> successful second half of this year and moving into next year, what could be transformational for cytogenetics for its science for patients and ultimately also for shareholders. We very much appreciate your persistence support and enthusiasm for what we're doing what we're doing.

Unknown Speaker: Operator, with that, we can now open the call up to questions, please.

And look forward to.

Operator with that we can now conclude the call. Please.

Yes, Sir.

This concludes today's conference call. Thank you all for participating you may now disconnect and have a pleasant day.

Unknown Speaker: Thank you, sir.

Unknown Speaker: As a reminder, to ask a question, you'll need to press star-1-1 on your phone.

The conference will begin shortly to raise Johan during Q&A you can dial one one.

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Unknown Speaker: Please stand by as we compile the Q&A roster.

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Unknown Speaker: And our first question will come from Justin Kim of Oppenheimer.

Justin Kim: Your line is open.

Unknown Speaker: Good afternoon, Justin.

Justin Kim: Hi.

Robert Blum: Hi, Robert.

Okay.

Justin Kim: Good afternoon, and thanks for taking the questions, and congrats on all the progress.

Justin Kim: Just maybe trying to connect the dots here between the things that you've been mentioning.

Robert Blum: With the guidance of the IND-enabling studies for one to two drug candidates next year and, the mention earlier this quarter around potential additional myotin inhibitors to address HF-TEF specifically, just wondering if it's fair to assume that HF-TEF would be sort of a primary indication of interest here, and whether it'd be sort of new compounds relative to maybe afacantin targeting it.

Fadi: Very good question, and I'll start and ask Fadi to elaborate.

Robert Blum: Yes, you should assume, please, that HF-TEF is of key interest to us for the mechanism, of activation.

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Unknown Speaker: Douglas Collins, Ph.

Unknown Speaker: D., Dean of the School of Public Health and Human Services, Duke, College of Medicine, Nassau P.M. San Diego, USA, Douglas Collins, Ph.

Unknown Speaker: D., Dean of the School of Public Health and Human Services, Duke, College of Medicine, Nassau P.M. San Diego, USA, College of Medicine, Duke Douglas Collins, Ph.

Unknown Speaker: D., Dean of the School of Public Health and Human Services, Duke, There was a nice publication at the end of last year that looked basically at a crossover study of patients on metoprolol and then crossed over to placebo and vice versa, either starting on placebo and crossing them over to metoprolol.

Unknown Speaker: They looked at its impact on the gradient on symptoms, on exercise performance using peak VO2, and that reference provides a nice baseline, I think, for what beta blockers do in HCM.

Unknown Speaker: They tend to reduce the gradient.

Unknown Speaker: You do see some symptomatic improvement.

Unknown Speaker: You don't see any improvement in exercise capacity, in part because they limit the increase in heart rate, and they are accompanied by side effects that some people find bothersome.

Unknown Speaker: So that paper published by Dybo et al.

Unknown Speaker: and Jack is a good sort of benchmark for what beta blockers do in HCM, at least over the, short term. They were short-term studies.

Justin Kim: Great.

Unknown Speaker: Thanks so much.

Okay.

Unknown Speaker: Thank you.

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Unknown Speaker: Thank you.

Unknown Speaker: One moment, please, for the next question.

Unknown Speaker: Our next question will come from Aakash Tewari of Jefferies.

Unknown Speaker: Your line is open.

Yes.

Yes.

Aakash Tewari: Hello, Aakash.

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Unknown Speaker: Hi, this is Iri for Aakash.

Aakash Tewari: Thanks for taking our questions.

Unknown Speaker: We have two questions we made.

Unknown Speaker: So the first is about, so looking at Malwa's label, the benefit from Malwa was quite limited, in patients on beta blocker therapy compared to those who are not.

Unknown Speaker: So will it be possible that physicians may need to stop beta blockers before they start using Malwa?

Unknown Speaker: And also, based on your understanding, what's the percentage of OHCM patients are on beta blockers in real world?

Unknown Speaker: And my second question is really about, like, drug pricing.

Unknown Speaker: So given Medicare is a major player in cardiovascular space, how do you think this bill will impact your evaluation?

Unknown Speaker: And will you consider partnering out any assets?

Unknown Speaker: That's all my questions.

Unknown Speaker: Thank you very much.

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Unknown Speaker: I think you asked three questions, so let's take them one at a time.

Unknown Speaker: The first related to our understanding of the Mavacampton label, is that right, with, regard to beta blockers?

Unknown Speaker: Could you repeat that, please?

Okay.

Unknown Speaker: Yes, correct.

Yes.

Unknown Speaker: And could you repeat the question as to specifically what you're getting at?

Okay.

Unknown Speaker: Oh, for sure.

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Unknown Speaker: I'm asking about the benefit from Mavac with quite limited in patients that are on beta, blockers compared to those who are not.

Unknown Speaker: Copyright © 2020 Mooji Media Ltd. All Rights Reserved.

Unknown Speaker: Patty, if you would take that one, please.

Unknown Speaker: No part of this recording may be reproduced, without Mooji Media Ltd.'s express consent.

Unknown Speaker: Well, I think, you know, people have looked at the subgroup analyses in Explorer, and, the benefit, you know, appears to be attenuated in patients in beta blockers.

Unknown Speaker: There's some language in the FDA materials with regards to that.

Unknown Speaker: You know, I think other analyses have shown that you do see improvements in those patients, despite the fact, you know, they are on beta blockers.

Okay.

Unknown Speaker: Of course, to get in the trial, they still had to have high gradients, and, you know, you'd call them incompletely treated with their beta blockers.

Unknown Speaker: So I think that's really a question of sort of looking at the data a little more deeply.

Unknown Speaker: You know, your other point was what percentage of patients are on beta blockers, and then, roughly, you know, 70 to 80 percent of patients start with beta blockers in terms of and stay on them with terms of their initial therapy for OHCM, and in particular, metoprolol tends to be the drug of choice.

Unknown Speaker: So that's, I think, the answer to both your questions.

Okay.

Unknown Speaker: And your third question, I believe, relates to legislation pertaining to Medicare and, pricing negotiations and how that might read on AFICAMPTON, is that correct?

Unknown Speaker: Yes, correct.

Okay.

Unknown Speaker: I think it's premature for us to be speculating on where that's all going to bottom out, but, I do think that there are appearances of carve-outs that might relate to orphan indications and specialty indications that might not have the same kind of competitive dynamic for which there may not be the same sorts of pricing pressures and budget impact, but I suspect that that's going to be evolving and fluid for some time.

<unk>.

Unknown Speaker: And I think it's premature for us to go down that path in terms of how it might affect, AFICAMPTON when, ultimately, this might become legislation.

Unknown Speaker: I think over time, we'll be assessing for that and how it could impact our potential, business interests, but right now, AFICAMPTON's in phase three, so we'll focus to clinical research.

Unknown Speaker: And thank you very much, this is very helpful.

Unknown Speaker: Thank you.

Unknown Speaker: One moment, please, for the next question.

Unknown Speaker: Again, we ask you to please limit yourself to two questions.

Okay.

Unknown Speaker: Next question comes from Maru Kumar of Goldman Sachs, your line is open.

Unknown Speaker: Hello, Baru.

Unknown Speaker: Hey, this is Rob.

Unknown Speaker: Thanks for taking our question.

Unknown Speaker: So where specifically are you looking to reduce spending in 2022?

Unknown Speaker: And how should we think about potential for label clarification out of the only ad comp?

Unknown Speaker: So we'll take those one at a time.

Unknown Speaker: Let's start with maybe asking Ching and then Andrew to speak about where we might be seeing some savings in terms of commercial spending in 2022.

Unknown Speaker: And then maybe Fadi and I will tackle how we might think about the ad comp, although I suspect you'll appreciate we can't be too prognostic about that, not even yet knowing what are the questions or the agenda.

Unknown Speaker: Maybe I'll start and then I'll hand it over to Andrew.

Unknown Speaker: So we had planned to hire our sales force only after we received approval for Omicam to McCarville.

Unknown Speaker: So originally the PDUFA day was at the end of November this year. It's now being pushed out to February of next year. So the field force cost for the month of December, for example, would be pushed out to next year, as will some of the marketing spending in media purchase agency costs.

Unknown Speaker: Some of that will be pushed out to 2023 as well.

Unknown Speaker: The only thing maybe I would add is that it's a modest reduction in 22 because of the PDUFA date being in November.

Unknown Speaker: They're more being pushed out in 23, early 23, as we expected to have the field force in place in January.

Unknown Speaker: And now that gets pushed out several months.

Unknown Speaker: So very modest reduction in 22, given the late PDUFA, original PDUFA date of end of November.

Unknown Speaker: And moreover, just as we enter the second half of the year and recognizing the environment in which we're operating, we take a sharp pencil to revising our financial spending across the organization. And we identified other places where we thought we could save some money this year.

Unknown Speaker: And we think that's just prudent and good housekeeping.

Unknown Speaker: With respect to your second question pertaining to expected labeling, I don't think we can really do justice to that question in the absence of yet us having more fulsome discussions with FDA and as would follow an adcom.

Unknown Speaker: So we conducted the GALACTIC study. And as you know, that study enrolled a heterogeneous population with FREF, but for which we saw more amplified efficacy in pre-specified subgroup of patients with lower ejection fraction as well as in other subgroups, some pre-specified and others that were post hoc, all of which contribute together to an understanding of the efficacy being amplified in patients with worsening heart failure.

Unknown Speaker: So there could be a conversation around which we might discuss what would be the indication in patients with higher risk. Those are things that could be addressed through graphs, tables, and figures in the potentially approved package insert or otherwise in the indication statement.

Unknown Speaker: And those are ultimately things that are up to FDA and its advisors to determine to talk about.

Unknown Speaker: So I'm not sure I'm answering your question well enough, but I'm sure that you can understand that's maybe the best we can do right now.

Unknown Speaker: Yeah, I appreciate that.

Unknown Speaker: Thank you for taking our questions.

Unknown Speaker: Thank you.

Unknown Speaker: Thank you.

Unknown Speaker: And again, one moment as we get our next question.

Unknown Speaker: Our next question shall come from Yasmeen Rahimi of Piper Sandler.

Unknown Speaker: Your line is open.

Unknown Speaker: Hi, Roberts and team.

Unknown Speaker: Thank you so much for taking my questions.

Unknown Speaker: So thank you, first of all, for providing a little bit more glimpse of information on the second phase three study that you're contemplating an obstructive HCM and considering, you know, running it for potential to be first line therapy.

Unknown Speaker: How should we be thinking about effect size of this study?

Unknown Speaker: And what data, you know, and I'm sorry if it's repetitive, exists, you know, with Abbey Campton to give us confidence to be, you know, equally competitive with first line therapies, if not superior?

Unknown Speaker: Yeah, so I'll briefly start and ask Fadi to add to these comments.

Unknown Speaker: And certainly for the fact that we believe Abbey Campton may represent a next in class approach, it's incumbent upon us to, as we've indicated, advance the field.

Unknown Speaker: And we foresee that this is a big opportunity to demonstrate that cardiac myosin inhibition has a potential beyond where the field exists today.

Unknown Speaker: So hence the interest in doing this study.

Unknown Speaker: And I'll ask Fadi to speak more about the rationale.

Unknown Speaker: Thanks, Robert.

Unknown Speaker: You know, I think it's probably premature for me to give you specifics with regards to numbers and powering and so forth.

Unknown Speaker: But, you know, we would expect a sizable treatment difference as opposed to beta blockers.

Unknown Speaker: And if we can do that in patients who are, you know, again, basically on monotherapy with beta blockers, we'd expect similar, if not greater effects than we plan to observe in sequoia.

Unknown Speaker: So I think that's part of the answer to your question.

Unknown Speaker: And that would imply, you know, a study that was smaller than sequoia in order to demonstrate those effects.

Unknown Speaker: I was just going to ask what the rate-limiting steps are of just kicking off the study then.

Unknown Speaker: Is it just further discussions with the agency on finalizing the protocols or what is left, to do?

Unknown Speaker: And I apologize for interrupting your thoughts, Fady.

Unknown Speaker: No, no problem.

Unknown Speaker: I mean, you know, starting at any study is a complicated exercise, especially one where, you're, you know, double-blinding against an active comparator.

Unknown Speaker: So, you know, manufacturing drug and a placebo for the active comparator and beginning preparations, in terms of the electronic systems of the trial and so forth. So there's a lot of work to get the study going.

Unknown Speaker: So I would, you know, the study is in some sense started, meaning that we're, you know, initiating all the preparations and doing a lot of work to get it up and off the ground. And we expect to be interacting with sites soon in order to get it to them in time for, the end of the year.

Unknown Speaker: You know, I think the last thing I was just going to comment on this question is that, the field, I think, wants to ultimately know what, how these therapies stack up against one another.

Unknown Speaker: And the only way that you can do that is by doing side-by-side trials and looking at things, that speak not only to functional and symptom improvement, but also disease modification over time.

Unknown Speaker: And I think all of those things are important for the field to understand how to use these, therapies and sequence them.

Unknown Speaker: Great.

Unknown Speaker: Thank you so much for taking my questions.

Unknown Speaker: Thank you, Yasmin.

Unknown Speaker: Thank you.

Unknown Speaker: One moment, please, for our next question.

Unknown Speaker: Our next question shall come from Salim Saeed of Mizuho Group.

Unknown Speaker: Your line is open.

Unknown Speaker: Hello, Salim.

Unknown Speaker: Hi.

Unknown Speaker: It's Mike Linden on for Salim.

Unknown Speaker: Thanks so much for taking our questions.

Unknown Speaker: One on Afocaptin and the recent Kim's IOS launch, if I may, I'm curious to see or to, hear how you're thinking about where the myosin inhibitor market is headed as you talk to docs and prescribers.

Unknown Speaker: Maybe what's been learned so far, where there's uptake, or if there are any blockages, anything, like that.

Unknown Speaker: And then maybe to follow up on that, just maybe whether you think, based on existing, data, of course, that this might be a switch market versus new patients.

Unknown Speaker: Yeah.

Unknown Speaker: So we've been both doing our own work in this space as well as learning from the work done, by equity research analysts and investors, all of whom seem to be focused on this launch and coming about this in ways that I think are now coalescing around the launch seems to be going well.

Unknown Speaker: The launch seems to be going according to expectations.

Unknown Speaker: There are seemingly hundreds of patients that may already be started on Mavicamtin and there's, a lot of free drug out there. Some of it is 30 day supply, some is more than 30 day and typically coming through specialty, channels.

Unknown Speaker: It seems that the feedback that we are hearing is positive.

Unknown Speaker: I'll ask Andrew to comment on some of the things specifically and Fady also if he wishes regarding what we're learning from our commercial and medical teams in particular.

Unknown Speaker: Certainly, this is a new product launch with a new mechanism and it's most important that education and awareness be building around CAMS-IOS and how that can benefit patients who to this point haven't had much to be positive about.

Unknown Speaker: And Mavikampton appears to be a very important new medicine.

Unknown Speaker: So maybe I'll ask Andrew and Fady to comment on anything else they're hearing about the launch.

Unknown Speaker: Physicians are gaining experience and as they gain more experience, they'll continue to put more patients on the product.

Unknown Speaker: So, as what we can tell, it is a transformation from a mechanism point of view for patients with HCM.

Unknown Speaker: And, you know, again, it's going as we expected.

Unknown Speaker: I don't know, Fady, if there's anything you wanted to add or if Robert and I covered it.

Unknown Speaker: I think that covers it.

Unknown Speaker: Yeah, I think that covers as well.

Unknown Speaker: The launch, these are still early days, but all seems to be going well.

Unknown Speaker: And in that way, I think it reflects enthusiasm for the mechanism.

Unknown Speaker: Thanks guys.

Unknown Speaker: Appreciate it.

Unknown Speaker: Thank you.

Unknown Speaker: And again, 1 moment for our next question.

Unknown Speaker: Our next question will come from Joe of HC.

Unknown Speaker: Your line is a little job.

Unknown Speaker: Hey, everybody.

Unknown Speaker: Good afternoon.

Unknown Speaker: Thanks for taking the question.

Unknown Speaker: 2 questions.

Unknown Speaker: And I'm a captain McCarville.

Unknown Speaker: I guess the 1st, 1 is more of a housekeeping and the other 1 is a bigger picture.

Unknown Speaker: So, for the housekeeping, just want to make sure.

Unknown Speaker: So all of the PK data that the FDA requested is in place and you provided it to them.

Unknown Speaker: And is there anything else outstanding that you need to provide?

Unknown Speaker: At this point, we've provided everything that they've asked for, but that doesn't preclude them from asking for more down the line.

Unknown Speaker: Now, of course, and then the broader question that I have here is, you know, with regard, to your market preparedness, more specifically marketing research that you might be conducting, you know, I guess I'd ask it this way with regard to market readiness for acceptance by the market, meaning, you know, as you're talking to physicians and the broader community in cardiovascular health care for heart failure, you know, the – how rapidly you think the drug could be implemented into the treatment paradigm with other drugs, and is the market already accepting the complementarity of Omicamptive?

Unknown Speaker: So, obviously, we can't be promoting Omicamptive-McCARBAL before it would be potentially approved, but there are things that we can be observing as would be enabling of that, hopefully, upon approval.

Unknown Speaker: And I'm really pleased with how we're using, especially this extra time, to be readied, for what will be a commercial launch when that does occur.

Unknown Speaker: Maybe I could ask Fadi to speak to how we see the guidelines evolving, and, Andrew, if there's anything further you want to add.

Unknown Speaker: Yeah, I mean, I think the, you know, with a – the papers that have been coming out, with Omicamptive-McCARBAL and the data that have been published with regards to EF and low blood pressure and other things, you know, when guidelines committees consider, you know, where did it fit in, where does it fit in, what we would hope to see would be that they would acknowledge that in patients that have sort of failed on foundational therapy, meaning that they've been put on as much of the foundational therapy as they can tolerate and yet are still not doing well and still have high-risk features such as hospitalization or recurrent hospitalization or high antiprobian P or other things, you know, that they may consider Omicamptive-McCARBAL as an option.

Unknown Speaker: And, you know, you can see in the current guidelines sort of the what's next box.

Unknown Speaker: I mean, after you've tried everything, you know, what do you do, what's next that you, might do, and we think of Omicamptive-McCARBAL as one of those, you know, next in line therapies.

Unknown Speaker: And maybe just to build on from a market research point of view, I mean, we go to medical, congresses, we talk to KOLs, we conduct commercial advisory boards, we do something called the NAN study, which we will put a label, which we think is the target label based on where, we think it'll wind up in what's approved in front of physicians and ask them about utilization.

Unknown Speaker: And largely, you can generate what you think market share will be and demand will be.

Unknown Speaker: But uniformly, across when we ask physicians, there's some cardiologists I'm talking about, we always get a similar answer of there's a handful of patients or a particular patient profile or type of patient in mind that they know they would use this product on.

Unknown Speaker: So we feel good about the launch, we feel good about the profile for worsening heart, Robert Lewis, Unknown Attendee, Ashwani Verma, Srikripa Devarakonda, John Faurescu, a successful commercial launch.

Unknown Speaker: There's high awareness of omecanous and macarbal.

Unknown Speaker: There's high awareness of the high unmet need and the absence of satisfaction of need for current guideline mandated treatments.

Unknown Speaker: And at the same time, guidelines are getting updated with more frequency, so we foresee those to be good signs of what could be hopefully a positive commercial launch when the time comes.

Unknown Speaker: Understood.

Unknown Speaker: Thanks again.

Unknown Speaker: Thank you.

Unknown Speaker: Thank you.

Unknown Speaker: One moment for our next question.

Unknown Speaker: Our next question will come from Carter Gould of Barclays.

Unknown Speaker: Your line is open.

Unknown Speaker: Hey, Carter.

Unknown Speaker: Great.

Unknown Speaker: Hey, guys.

Unknown Speaker: You've got Edwin on the line for Carter.

Unknown Speaker: We wanted to ask a, follow-up to the question on the ChemZio's launch.

Unknown Speaker: In this new world where there's a therapeutic option, specifically, if you could frame for us any views on impacts of diagnosis or an early take on the burden of the REMS program or monitoring from your discussions with KOLs and stakeholders.

Unknown Speaker: And then our second question, if you could just frame for us your expectations for potential readout of Cohort 4 from Redwood.

Unknown Speaker: Thank you.

Unknown Speaker: Yeah.

Unknown Speaker: So, with regard to the first, I don't think we're going to get into the business of, speaking too much about a competitor's launch.

Unknown Speaker: We foresee that Mavacampton is going well, but as to how that might be ultimately tailored to the kinds of things you're asking about, I don't think it's for us to be addressing those matters for you.

Unknown Speaker: I think that's more, important that the equity research community be doing its own independent analyses of those kinds of matters.

Unknown Speaker: Sorry about that, but I just kind of feel like that's maybe improper for us to be addressing things to that level of detail.

Unknown Speaker: What was your second question?

Unknown Speaker: Yeah, no problem.

Unknown Speaker: Yeah, we just want to ask if you could frame for us.

Unknown Speaker: Got it.

Unknown Speaker: Got it.

Unknown Speaker: Go for it, Patty.

Unknown Speaker: Thank you.

Unknown Speaker: And just with regards to what they might expect with us to report for Cohort 4.

Unknown Speaker: So, you know, data with Cohort 4, as we've said before, we're looking at many of the things that we've looked at in Cohorts 1, 2, and 3, with the exception of left ventricular outflow tract gradients, because these patients don't have them.

Unknown Speaker: So safety and tolerability, we'll be looking at NYHA class movement.

Unknown Speaker: We'll be looking at biomarkers like NT ProBNP and troponin.

Unknown Speaker: We'll be looking at echocardiographic response, either declines in LVEF, but also we want to look more closely at changes in cardiac structure and function and diastolic function.

Unknown Speaker: So, you know, all of those things that you've seen us report for aficamptin in the obstructive HCM cohorts, you know, we plan to also do the same sort of measurements and report those for non-obstructive groups.

Unknown Speaker: Thank you.

Unknown Speaker: Thank you.

Unknown Speaker: Thank you.

Unknown Speaker: One moment for our next question.

Unknown Speaker: Our next question will come from Jason Butler of JMP Securities.

Unknown Speaker: Hi, Jason.

Unknown Speaker: Thanks for taking the question.

Unknown Speaker: Hey, Robert.

Unknown Speaker: So you mentioned one of the potential discussion topics for the OMICAM development outcome you're preparing for is dosing and thoughts on how to apply, you know, to clinical practice.

Unknown Speaker: Can you just give us your thoughts on how you're planning to direct and educate physicians to find the right dose and maintain the right dose for a patient?

Unknown Speaker: And then you also mentioned essentially a companion diagnostic.

Unknown Speaker: How quickly until launch do you think that something like that could be implemented?

Unknown Speaker: And how would that change, you know, the overall strategy of getting patients onto the drug?

Unknown Speaker: Thanks.

Unknown Speaker: Yeah, so maybe just to start and maybe also amend a statement you made.

Unknown Speaker: In Galactic, as you know, we did employ a methodology for assessing PK exposures in order to dose titrate patients to a target dose level. And that was described and is published in terms of how we were ultimately getting patients to target doses as defined by PK parameters.

Unknown Speaker: What I want to mention, however, is you used the terminology companion diagnostic, and it's not necessarily a companion diagnostic as would be the literal sense of that word.

Unknown Speaker: And in that way, we're looking at various ways of approaching this that would be enabling of different strategies to get patients to target dose that would enable them to be using different kinds of assays as could be useful. As could be useful in clinical practice as we go beyond what was used in a clinical trial.

Unknown Speaker: So that's still somewhat dynamic in terms of how we might best approach that post launch.

Unknown Speaker: That's a matter that we'll be communicating over time as we might assess the different alternatives and the different options.

Unknown Speaker: I'm afraid I won't be able to do much better than that right now.

Unknown Speaker: I don't know, fatty or Andrew, if you want to take a stab at that, but our goal is to be in a position to be equipping physicians.

Unknown Speaker: To be able to get to the best target dose with a PK assay, but for which the way in which we might do that is still not yet something we intend to be communicating now.

Unknown Speaker: Okay, great.

Unknown Speaker: Appreciate it.

Unknown Speaker: Thanks for taking the question.

Unknown Speaker: Thank you.

Unknown Speaker: And one moment for our next question.

Unknown Speaker: Our next question will come from Charles Duncan of Cantor.

Unknown Speaker: Your line is open.

Unknown Speaker: Hey, good afternoon, Robert and team.

Unknown Speaker: Yeah, congrats on the progress in the quarter and thanks for taking my question.

Unknown Speaker: I had a one multi-part question on OMI and then a question on Lysimptive as well in that program.

Unknown Speaker: So on OMI, the multi-part question is, as you're preparing for the outcome, there's about four months.

Unknown Speaker: Can you provide us a little bit of color on really the work plan?

Unknown Speaker: Do you plan to have mock ad comps and if so, how many or at least one?

Unknown Speaker: And what is going to be the one, the key focus when you think about the ad comps?

Unknown Speaker: Okay, great.

Unknown Speaker: Thank you.

Unknown Speaker: Unknown Speaker.

Unknown Speaker: I'll ask Fady to speak to how we're preparing, but yes, we will have, a mock adcom, we'll do a number of these different types of preparations in order to be best suited and best prepared, where the team, and there's a core team, is working very feverishly now already in these preparations and meeting frequently each week.

Unknown Speaker: Fady, anything you want to elaborate?

Unknown Speaker: Fady Malik Well, I guess I'll say, obviously, we're quite focused on our preparations.

Unknown Speaker: We don't have, you know, a, specific agenda or topics yet, but there's certainly a number of things we need to do to prepare background materials and clear slide presentations and prepare with mock panels in terms of getting the team practice to answer questions.

Unknown Speaker: I think we have a great team that's very experienced and has worked on this drug for a long time and, you know, has gone through the process now of submitting an NDA and working through the approval process.

Unknown Speaker: So, we'll be ready when the time comes.

Unknown Speaker: Okay.

Unknown Speaker: Don't doubt that that's the case.

Unknown Speaker: Looking forward to that.

Unknown Speaker: And then my question on RELDI, perhaps for Stuart, interesting content and, hopefully some progress here made, at least for some of the participants in terms of the paradigm.

Unknown Speaker: But relative to your COURAGE program, I guess I'm wondering if you could give us some sense of what it means for interim analysis for futility.

Unknown Speaker: You know, I get that generally, but I'm wondering if there's a certain kind of efficacy you're expecting out of those one-third of patients at 12 weeks.

Unknown Speaker: Then also, if you could tell us whether or not within the OLE, if you've had any patients actually enroll in that.

Unknown Speaker: I think you alluded to that, but I didn't catch it for sure.

Unknown Speaker: Thank you, Charles.

Unknown Speaker: Well, the interim analysis is fairly straightforward.

Unknown Speaker: It's a relatively low bar, I would say, to continue the trial.

Unknown Speaker: We really, want to determine if there is a trend, a favorable trend, you know, in terms of the main outcome for RELDI, you know, compared to placebo.

Unknown Speaker: And we fully expect that based on our Phase 2 data.

Unknown Speaker: But it's just sort of a matter of being efficient and, you know, responsible in terms of study conduct and doing what's best for the development program and what's best for patients.

Unknown Speaker: And then your next question.

Unknown Speaker: Regarding OLE.

Unknown Speaker: The OLE, we are just getting started with the OLE.

Unknown Speaker: So we're just at the cusp of patients starting to roll over into the open-label extension.

Unknown Speaker: So we're pretty excited and proud that we have this offer to those patients.

Unknown Speaker: Thank you for taking the time to speak with us today.

Unknown Speaker: Thank you.

Unknown Speaker: And one moment for our next question.

Unknown Speaker: Our next question will come from Rohit Basan of Needham & Company.

Unknown Speaker: Your line is open.

Unknown Speaker: Hi, this is Rohit for Serge.

Unknown Speaker: Good afternoon.

Unknown Speaker: Thanks for taking my question.

Unknown Speaker: Can you talk about how the over-camps and delays with the FDA have affected possible, partnership discussions?

Unknown Speaker: And then a second question, is there anything you can share regarding feedback you're receiving, from providers regarding the data on the ALS database?

Unknown Speaker: Thanks.

Unknown Speaker: Sure.

Unknown Speaker: With regard to partnering, I don't think the PDUFA date extension has had an effect.

Unknown Speaker: Our conversations are continuing, and I think that potential partners see this as maybe, more par for the course these days, especially for new mechanisms.

Unknown Speaker: So it has not changed the way we're approaching our strategy for partnering.

Unknown Speaker: Your second question, could you repeat it, please?

Unknown Speaker: Sure.

Unknown Speaker: Yeah.

Unknown Speaker: Is there anything you can share regarding the feedback you're receiving from providers, regarding the data on the ALS database?

Unknown Speaker: Oh, you're referring to this morning's press release.

Unknown Speaker: The feedback is, I think, generally one of appreciation.

Unknown Speaker: This has been the conversation we've been having with the people who administer and, manage to the PROACT database for quite some time, and we've made now a major contribution to the database for the data from these three completed studies. So the incorporation of our data into PROACT is something that was contemplated and considered, and planned for for quite a long time.

Unknown Speaker: Larry, you or Stuart, anything you want to add to that?

Unknown Speaker: Stuart?

Unknown Speaker: Yeah, this is, you know, I think it's just another example of connecting global citizens, and, you know, we have these robust data sets from previous clinical trials, and we're obviously very committed to finding therapies to help these patients.

Unknown Speaker: So I think that, you know, we're receiving very positive feedback, and it just further, strengthens and demonstrates our commitment to this community and these patients.

Unknown Speaker: Yeah, I might add that for the fact that cytokinetics has a reputation in the ALS community for, having conducted large, very rigorous, robust clinical research.

Unknown Speaker: I think there's a view that these are high-integrity data that should make a big difference and, a big impact for their inclusion in this database.

Unknown Speaker: Thank you.

Unknown Speaker: I see no further questions in the queue.

Unknown Speaker: I would now like to turn the conference back to management for closing remarks.

Unknown Speaker: Thank you, Operator, and thanks to everybody for joining us on this conference call today.

Unknown Speaker: Clearly, we've made a lot of very good progress in the second quarter, and again, more recently in this third quarter, we've set the table, we believe, for a very successful second half of this year and moving into next year, what could be transformational for cytokinetics, for its science, for patients, and ultimately also for shareholders.

Unknown Speaker: We very much appreciate your persistent support and enthusiasm for what we're doing, and look forward to, Operator, with that, we can now conclude the call, please.

Unknown Speaker: Yes, sir.

Unknown Speaker: This concludes today's conference call.

Unknown Speaker: Thank you all for participating.

Unknown Speaker: You may now disconnect and have a pleasant day.

Unknown Speaker: The conference will begin shortly.

Unknown Speaker: To raise your hand during Q&A, you can dial star 11.

Unknown Speaker: Thank you.

Unknown Speaker: Dr.