Q2 2020 Cytokinetics Inc Earnings Call

[music].

Good afternoon, and welcome ladies and gentlemen.

Operator: Good afternoon. This is the Cytokinetics second quarter 2020 conference call. At this time, I'd like, At the company's request, we will open the call for questions and answers after the I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate, Investor Relations. Please go ahead. Good afternoon, and thanks for joining us on the call today. Robert Blum, our President and Chief Executive Officer, will kick off the call with an overview of the quarter and our recent progress.

Second quarter 2020 conference call.

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

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

Now I'd like to turn the call over to Diane Wiser Cytokinetics Senior Vice President of corporate Communications and Investor Relations. Please go ahead.

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

Most of them.

As an N. and Chief Executive Officer will kick off the call with an overview of the corridor and our recent progress then study Malik our SVP of research and development will provide updates on key developments for Omecamtiv mecarbil cardiac myosin activator being developed under our collaboration with Amgen an expanded accelerated.

Diane Weiser: Then Fady Malik, our EVP of Research and Development, will provide updates on key developments for Omacamptin-McCarbol, our cardiac niacin activator being developed under our collaboration with Amgen, and the expanded and accelerated development plan for CK274, our next-in-class cardiac niacin inhibitor. Next, Stuart Kupfer, our SVP and Chief Medical Officer, will update on recent progress with Then Robert Wong, our VP and Chief Accounting Officer, will provide an overview of the quarter, and Ching Jaw, our SVP and Chief Financial Officer, will discuss our updated financial guidance in the context of recent corporate development activities before Robert Blum provides concluding thoughts on the company's outlook and expected key milestones for the remainder of the year.

Belt and plan for CK two seven for our next in class cardiac myosin inhibitor next do a kupfer, our SVP and Chief Medical Officer will update on recent progress with Teekay to seven four in Redwood HCM as well as Teekay to seven for our additional cardiac myosin inhibitor.

Then Robert lung, our VP and Chief Accounting Officer.

We'll provide an overview of the corridor and Ching job, our SVP and Chief Financial Officer will discuss our updated financial guidance in the context of recent corporate development activities before rubber black provides concluding thoughts on the company's outlook unexpected key milestones for the remainder of the year.

Diane Weiser: Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Our actual results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings. We undertake no obligation to update any forward-looking statements after this call.

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

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

Diane Weiser: And now I will turn the call over to Robert. Thank you, Diane, and thanks again to everyone for joining us on the call today. It was a productive second quarter, and the momentum continues into this third quarter.

Thank you die and things to drug to everyone for joining us on the cold today.

It was a productive second quarter than the momentum continues into this third quarter.

Video view of how the opportunity to participate in cold relating to our licensing collaboration and royalty monetization transactions, followed by our Investor and analyst day event last month.

Robert I. Blum: Many of you have had the opportunity to participate in calls relating to our licensing collaboration and royalty monetization transactions, followed by our Investor and Analyst Day event last month. We shared a lot of information on those calls just a few weeks ago, so we'll try not to be too repetitive today. There's no doubt that this is truly a transformative time in our company's maturation, and I couldn't be more proud of the high level of strategic execution demonstrated by our leadership team. The combination of licensing, royalty monetization, and equity capital market deals we transacted fortifies our expected cash balance sheet at year-end to over $500 million and ensures our strong financial position as we approach the top-line results of GALACTIC-HF, one of the largest Phase III global cardiovascular outcomes trials in heart failure, which is being conducted by Amgen under our longstanding collaboration.

We shared a lot of information on those calls just a few weeks ago, who will try not to be two repetitive today.

There's no doubt that this is truly a transformative time in our company's maturation that I couldn't be more pro or the high level of strategic execution demonstrated by our leadership team.

Combination of licensing royalty monetization and equity capital market deals, we transacted fortifies, our expected cash balance sheet at year end to over 500 million and ensures our strong financial position as we approach top line results of Galactic HF one of the largest phase three.

The global cardiovascular outcomes trials in heart failure, which is being conducted by Amgen under our long standing collaboration.

Robert I. Blum: These deals, considered alongside our previously announced renegotiation of our Estellis Agreement, enable us to continue readiness and implementation activities related to the potential commercialization of Omicamptomicarbol, as well as concurrently plan for the advancement of CK274 and Rel-Deceptive, all within the context of our Vision 2025. In addition to having the opportunity to co-commercialize Omicamptin-McCarbol in partnership with Amgen, these recent deals enable us to continue to control the development of CK274 and Reldaceptive through an expanded set of pivotal clinical trials while retaining full rights in North America, Europe, and Japan for our shareholders. It's particularly gratifying when our R&D strategies can synchronize with and enable our corporate development and business development strategies.

These deals considered alongside our previously announced renegotiation of ours still this agreement enables us to continue readiness and implementation activities related to the potential commercialization of Omecamtiv mecarbil as well as concurrently plan for the advancement of CK two so.

Seven poor enrolled the symptom all within the context of our vision 2025 in.

In addition to having the opportunity to co commercialize omecamtiv Mecarbil in partnership with Amgen. These recent deals enabled us to continue to control the development of CK 274, and real just some to do an extended set a pivotal clinical trials, while retaining food right.

In North America, Europe, and Japan for our shareholders.

It's particularly gratifying when our R&D strategies can synchronized with and enable the corporate development in business development strategy.

Robert I. Blum: Cytokinetics continues to leverage our innovative science through partnerships to maximize opportunities across the breadth and depth of our pipeline of investigational medicines focused on muscle biology. And with that, I'll turn the call over to Fady to elaborate on key developments for Omicamptomacarbal and CK274. Thanks, Robert.

Auto kinetics continues to leverage our innovative science through partnerships to maximize opportunities across the breadth and depth of our pipeline of investigational medicines focus to muscle biology.

With that I'll turn the call over to study to elaborate on key developments for Omecamtiv Mecarbil and CK 274.

Thanks Robert.

When Amgen made significant progress during the quarter, despite the Corona virus pandemic.

Fady Ibraham Malik: We in Amgen made significant progress during the quarter despite the coronavirus pandemic. As we previously explained, we are in a fortunate position with the conduct of GALACTIC-HF given how advanced we are in the trial's conduct. Emptin adapted the conduct of the trial to enable delivery of the investigational product to patients' homes and the conduct of study visits and to conduct study visits remotely for collection of study input.

As we previously explained we are in a fortunate position with the conduct of Galactic HF given how advanced we are in the trial conduct.

Amgen adapted the conduct of the trial do enabled delivery of investigational product that patients home and the conduct of study visit and the can add to conduct study visits remotely for collection in the study endpoints.

As a reminder, none of the trials main endpoints, including heart failure events, you need death, or a collection of the Kansas City of Cardium up the questionnaire, we 24.

Fady Ibraham Malik: As a reminder, none of the trial's main endpoints, including heart failure events, CV death, or collection of the Kansas City cardiomyopathy questionnaire at week 24, are dependent on patients physically visiting clinical trial sites. Now, as we approach the completion of the trial, Amgen, in collaboration with Cytokinetics, continues to work steadfastly on trial closeout activities. The trial remains blinded as final events continue to accrue, and we head towards final data collection and database lock. We expect to soon accrue the final events to close out Galactic HF in Q3, and we remain on track to report top-line results for Galactic HF in Q4. Regarding Meteoric HF, the second phase three trial of omicampin, macarbol, in patients with heart failure.

Our depended on patients physically visiting clinical trial site.

Now as we approach the completion of the trial Amgen collaboration Cytokinetics continues to work said vastly on trial close out activities.

Trial remains blinded that's final events continue to accrue and we had towards final data collection and database lock.

We expect the soon accrue the final events to close out Galactic HF in Q3, and we remain on track to report topline results of Galactic HF in Q4.

Regarding meteoric H. up the second phase three trial of Omecamtiv mecarbil in patients with heart failure.

Police the say that despite the suspension of enrollment earlier in the quarter due to the Corona virus pandemic.

We resumed screening and enrollment in June partnership in partnership with our clinical trial site.

How does the nine countries participating in meteoric catch up for our actively recruiting and we expect the remaining five to come online later in this third quarter.

We now have approximately 75% of our targeted 92 sites activated in the United States, Canada, France, Germany, Italy, Hungary, and the Netherlands.

Fady Ibraham Malik: I'm pleased to say that despite a suspension of enrollment earlier in the quarter due to the coronavirus pandemic, we resumed screening and enrollment in June in partnership with our clinical trial site. Out of the nine countries participating in Meteoric HF, four are actively recruiting, and we expect the remaining five to come online later in this third quarter. We now have approximately 75% of our targeted 92 sites activated in the United States, Canada, France, Germany, Italy, Hungary, and the Netherlands.

Recruiting has resumed and were very grateful to our clinical trial site personnel for their collaboration to ensure the health and safety trial participants who conduct of this trial.

As we've stated results from New York, each up or not on the critical path to submitting regulatory filings for the potential approval of Omecamtiv Mecarbil.

Instead, the findings for me to York HFR supported it would be included in the supplemental filing following the potential commercial was predicated on expected results from Galactic HF.

We now expect a complete enrollment of New York HF in early 2021.

Fady Ibraham Malik: Recruiting is resumed, and we're very grateful to our clinical trial site personnel for their collaboration to ensure the health and safety of trial participants through the conduct of this trial. However, as we have stated, results from METEORIC-HF are not on the critical path to submitting regulatory filings for the potential approval of omicantin-micarbyl. And instead, if the findings from METEORIC-HF are supportive, they would be included in a supplemental filing following the potential commercial launch predicated on expected results from GALACTIC-HF. We now expect a complete enrollment of Meteoric HF in early 2021. Given the growing health economic burden of heart failure worldwide, we remain enthusiastic about the promise of Omicamp and McCarville. The novel mechanism of action of our potential medicine works in an entirely different way from currently available therapies and has the potential to become foundational to standard of care.

Given the growing health economic burden of heart failure worldwide remain enthusiastic about the promise of Omecamtiv Mecarbil <unk>.

A novel mechanism of action of our potential medicine works and an entirely different way I'm currently available therapies and has the potential to become foundational to standard of care.

Of note during the quarter. The FDA granted fast track designation tell me, a captive mccarville, which may potentially lead to an expedited review.

We also collaborated with Amgen Sergei on preparations for a potential marketing application dossier for Omecamtiv Mecarbil and prepared for possible meeting regulatory authorities as maybe requested to discuss phase three trial results and potential marketing applications.

Turning now to our cardiac myosin inhibitor program, it's an exciting time as we expand and accelerate the development program.

As Robert mentioned regarding the licensing collaboration and royalty monetization deals with physician pharmaceuticals, and Archie W. investment.

They enable us to develop CK two seven for multiple indications in parallel as well as across a wider span of geography.

In terms the specifics regarding the development program associated with Teekay to seven for these deals provide support to conduct a planned phase three clinical trial of our next in class My son inhibitor in patients with obstructive ATM in North America, Europe down with our partner in China.

Fady Ibraham Malik: Of note, during the quarter, the FDA granted Fast-Track designation to Omicamptin-McCarbol, which may potentially lead to an expedited review. We also collaborated with Amgen and Servier on preparations for a potential marketing application dossier for Omicant and McCarville and prepared for possible meetings with regulatory authorities as may be requested to discuss phase 3 trial results and potential marketing applications. Turning now to our Cardiac Myosin Inhibitor Program, it's an exciting time as we expand and accelerate this development program. As Robert mentioned regarding the licensing collaboration and royalty monetization deals with Fijishen Pharmaceuticals and RTW Investments, they enable us to develop CK274 in multiple indications in parallel, as well as across a wider span of geography. In terms of specifics regarding the development program associated with PK274, these deals provide support to conduct a planned phase 3 clinical trial of our next-in-class myosin inhibitor in patients with obstructive HCM in North America, Europe, and with our partner in China, promptly after we have results from Redwood HCM and receive feedback from regulatory authorities.

Promptly after we have results from Redwood HCM and receive feedback from regulatory authorities.

Our current goal is to initiate a phase three registration program for CK 274, and obstructed HCM and late 2021, and we're working with our new partner she says to enable concurrent development in China.

In parallel we're playing for the conduct of clinical trials of CK, 274, and not obstructive HCS HCM and in a subgroup of heart failure patients with preserved ejection fraction, perhaps have also in the 2021 or 2022 timeframe.

To sum up the deal can July reinforce our commitment to rapidly broadly advance our cardiac myosin inhibitor program works with the intent to potentially deliver the next in class medicine that can meaningfully impact the underlying challenges of patients suffering from hypertrophic cardiomyopathy season have stuff related to.

The hyper contractility of cardiac muscle.

Now I'm going to turn it over to Stuart to provide an update on Redwood HCM as well as our plans for phase one study SDK to seven one our second cardiac myosin inhibitor.

Thank you Patty.

I'm pleased to report that following a brief suspension and enrollment due to the Corona virus pandemic.

During the second quarter, we resumed screening and patient enrollment in Redwood HCM and collaboration with our CRL and clinical trial site partners.

As you know Redwood AC and is the phase two clinical trial of CK 274 in obstructive HCM.

We activated in many sites in the second quarter and I expect to have approximately 25 of the 27 total sites activated and enrolling patients in the U.S. and Europe by the end of Q3.

Fady Ibraham Malik: Our current goal is to initiate a Phase III registration program for CK274 in obstructive HCM in late 2021, and we are working with our new partner, Jishin, to enable concurrent development in China. At the same time, we're planning for the conduct of clinical trials of CK274 in non-obstructive HCF, HCM, and in a subgroup of heart failure patients with preserved ejection fraction, or HFAP, also in the 2021 or 2022 timeframe.

Screening and enrollment have increased recently and I were glad with the ongoing preparatory work that went on behind the scenes during the three trial suspension is paying off.

Well I will try it was not enrolling sites were still being activated patients were identified and screen visits were scheduled through coordination between RCR rose and the sites.

We're now seeing new centers enrolling patients in some sites had multiple patients and their screening Q.

We plan to enroll 18 patients in the first cohort.

And we expect to have data to inform progression to cohort two by the end of this year.

Fady Ibraham Malik: To sum up, the deals in July reinforce our commitment to rapidly and broadly advance our cardiac myosin inhibitor program with the intent to potentially deliver the next-in-class medicine that can meaningfully impact the underlying challenges of patients suffering from hypertrophic cardiomyopathies and hepatitis related to the hypercontractility of cardiac muscles. Now I'm going to turn it over to Stuart to provide an update on Redwood HCM as well as our plan for a Phase 1 study of CK271, our second cardiac myosin inhibitor. Thank you, Fady.

During the quarter, we and others were pleased to see results of explore the phase three clinical trial read out positively.

Which provides encouraging validation for the mechanism of cardiac myosin inhibition in patients with obstructive HCM.

And affords optimism for an impactful new potential therapy for these patients.

As good students of clinical development, we have an opportunity to apply lessons from explore through our clinical development program.

And further advance the field as we progressed, CK 274, and obstructive and non obstructive HCM.

As well as in a subgroup of Hep have patience with hyper contractility, a cardiac muscle.

Yeah.

Given the potential advantages of CK 274, as an X in class therapy, we have an opportunity to improve upon the safety and efficacy profile observed and explore.

Stuart Kupfer: I'm pleased to report that following a brief suspension in enrollment due to the coronavirus pandemic, during the second quarter, we resumed screening and patient enrollment in Redwood HCM in collaboration with our CRO and clinical trial site partners. As you know, Redwood HCM is the phase 2 clinical trial of CK274 and obstructive HCM. We activated many sites in the second quarter and expect to have approximately 25 of the 27 total sites activated and enrolling patients in the US and Europe by the end of Q3. Screening and enrollment have increased recently, and we're glad that the ongoing preparatory work that went on behind the scenes during the brief trial suspension is paying off.

Moving to our additional cardiac myosin inhibitor CK 271.

Following a recent set back due to a resurgence of Corona virus cases in the vicinity of our phase one site.

We now plan to begin screening in the first cohort during this quarter.

As a reminder of the primary objective of this first in human Phase one study.

As to assess the safety and Tolerability and pharmacokinetics of single ascending oral doses of CK 271, and healthy adult subjects.

Finally, cytokinetics was pleased to support the patient focused drug development meeting, where HCM patience hosted by Big HCM today.

This important median shed light on the extraordinary burden of disease, and the challenges patience and door on a daily basis.

Stuart Kupfer: While the trial was not enrolling, sites were still being activated, patients were identified, and screening visits were scheduled through coordination between our CROs and the sites. We're now seeing new centers enrolling patients, and some sites have multiple patients in their screening queue. We plan to enroll 18 patients in the first cohort. And we expect to have data to inform progression to Cohort 2 by the end of this year. During the quarter, we and others were pleased to see the results of EXPLORER, a phase 3 clinical trial, read out positively, which provides encouraging validation for the mechanism of cardiac myosin inhibition in patients with obstructive HCM and affords optimism for an impactful new potential therapy for these patients. As good students of clinical development, we had an opportunity to apply lessons from Explorer to our clinical development program and further advanced the field as we progressed CK274 in obstructive and non-obstructive HCMs, as well as in a subgroup of HFTEF patients with hypercontractility of cardiac muscle.

There's no doubt the unmet need for new therapies to treat hypertrophic cardiomyopathy is great and.

And we applaud the ace DNA for bringing this issue to the forefront.

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

Thanks, Stuart I'll first provide an update on cash revenue and spending and then Ching will review our progress toward corporate development strategies.

More detailed on our actual results for the second quarter are included in the press release, which was released earlier this afternoon.

We ended the second quarter with approximately 213 million in cash and investments.

Our revenues in Q2 2020 came from our strategic alliances with Amgen and Astellas.

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

Our Stella we recognize revenue for their reimbursement of expenses related to our scientists engaged and collaborative research.

Our second quarter 2020, R&D expenses decreased to 21.8 billion from 24.0 million in the second quarter of 2019, primarily due to lower spending related to our neuromuscular development activities with the completion of four to two tail left in 2019.

Offset by increased activities related to Redwood HCM in 2020.

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

Stuart Kupfer: Given the potential advantages of CK274 as a next-in-class therapy, we have an opportunity to improve upon the safety and efficacy profile observed in EXPLORER. Moving on to our additional cardiac myosin inhibitor, CK271. Following a recent setback due to a resurgence of coronavirus cases in the vicinity of our Phase 1 site, we now plan to begin screening in the first cohort during this quarter. As a reminder, the primary objective of this first in human phase one study is to assess the safety and tolerability and pharmacokinetics of single ascending oral doses of CK271 in healthy adult subjects.

Our second quarter 2020, DNA expenses were 14.2 million up from 9.8 million in Q2, 2018, due primarily to higher personnel related costs, including stock based compensation and higher outside services for pre commercial activity.

And now Chipotle chicken.

King will review progress in connection with corporate development strategy.

Thanks Robert.

As we have discussed we had been working with our management team and our floor over the past year to ensure that our financial position is solid.

Stuart Kupfer: Finally, Cytokinetics was pleased to support the patient-focused drug development meeting for HCM patients hosted by the HCMA. This important meeting shed light on the extraordinary burden of disease and the challenges patients endure on a daily basis. There is no doubt the unmet need for new therapies to treat hypertrophic cardiomyopathy is great.

As we transitioned the company into a fully integrated biopharmaceutical organization.

With our recent business Evolvement royalty monetization and equity offering transactions, we are well positioned financially to operationalize the fund.

To operationalize and fun near term to mid term projects and initiatives.

Robert C. Wong: And we applaud the HCNA for bringing this issue to the forefront. And with that, I'll turn it over to Robert Wong, who will provide an update on our financial performance. Thanks, Stuart. I'll first provide an update on cash, revenue, and spending. And then Ching will review our progress toward our corporate development strategy. More details on our actual results for the second quarter are included in the press release, which was released earlier this afternoon. We ended the second quarter with approximately $213 million in cash and investments.

To recap our cash position. We ended the second quarter was 213 million cash and will add 160 million of additional capital upon closing of being modernization of how the 10th and loyalty.

Plus 90 million in additional capital available at our option problem, the our tw transactions.

In addition.

We raised approximately 190 million through our recent equity offering net of expenses.

We expect to end 2020 with more than 500 million in cash plus committed cash subject to closing conditions.

Robert C. Wong: Our revenues in Q2 2020 will come from our strategic alliances with Amgen and Estella. For Amgen, we recognize revenue associated with their reimbursement of our development expenses related to Meteoric HF. For Astellas, we recognize revenue for their reimbursement of expenses related to our scientists engaged in collaborative research. Our second quarter 2020 R&D expenses decreased to $21.8 million from $24.0 million in the second quarter of 2019, primarily due to lower spending related to our neuromuscular development activities with the completion of Fortitude ALS in 2019, offset by increased activities related to Redwood HCM in 2020. More than 50% of our R&D expenses were attributable to our cardiovascular programs Our second quarter 2020 G&A expenses were $14.2 million, up from $9.8 million in Q2 2019, due primarily to higher personnel-related costs, including stock-based compensation and higher outside services for pre-commercial activities.

The company also updated financial guidance for 2020.

We still anticipate cash revenue will be in the range of 18 to 22 million and operating expenses will be in the range of 120 230 million. However.

We have narrowed our range for projected full year net cash utilization to be.

110 to 115 million.

Well, we will not give formal guidance for 2021 until our Q4 earnings call. We expect to end this year with more than 500 million on the balance sheet, which we anticipate will represent more than three years. So for cash even as we expand the development program course, he had to southern.

Sure.

Alongside plans to co promote on weekends of mccarville with Amgen.

If results of Galactic HF are positive in Q4, we can anticipate milestone payments over the next 12 to 18 month.

Plus upon its commercialization royalties on tier worldwide sales of old becomes a workable outside Japan semi exceed 20% was a low lower royalty rate in Japan.

The recent transactions, we completed further enable us to leverage our partnership with Amgen to build our commercial business.

In parallel we have the capital to expand our bio pharmaceutical research platform with a goal of doubling the size of our development pipeline over the next five years as we have outlined in our vision 2025.

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

Thank you King.

Was indeed, a productive quarter and we continue to build momentum into the second half of this year.

Ching W. Jaw: And now Ching will review progress in connection with the corporate development strategy. Thanks, Robert. As we have discussed, we have been working with our management team and our board over the past year to ensure that our financial position is solid as we transition the company into a fully integrated biopharmaceutical organization. Through our recent business development, loyalty monetization, and equity offering transaction. We are well positioned financially to operationalize the fund and fund near-term to mid-term projects and initiatives. To recap our cash position, we ended the second quarter with $213 million in cash and will add $160 million of additional capital upon the closing of the modernization of Maverick-Hampton Rich, plus $90 million in additional capital available at our option from the RTW transaction. In addition, we raised approximately $190 million through our recent equity offering, net of expenses.

To pick up on Cigs earlier comments regarding the potential commercialization of Omecamtiv, Mecarbil, Amgen and Cytokinetics expects to leverage the strength of both companies to educate the heart failure community about potential clinical effects and the economics of Omecamtiv Mecarbil and how it may be position to the continuum of care.

Through our co promotion with Amgen, we expect to conduct a coordinated field deployment strategy leveraging a reach and frequency approach in institutional accounts in North America.

Toward that end, we recently conducted analyses relating to the United States Heart failure institutional care market segment, including potential target account assessment and prioritization for our planned commercialization.

We also continue to conduct commercial readiness activities in collaboration with Amgen in preparation for the commercialization of Omecamtiv mecarbil, including market research related to product branding elements potential positioning physician preferences and potential customer accounts.

And finally, we continued our collaboration with providers and health care systems to generate health economics and outcomes research related to the health care costs associated with the treatment of heart failure patients.

Ching W. Jaw: We expect to end 2020 with more than $500 million in cash, plus committed cash, subject to closing conditions. The company also updated its financial guidance for 2020. We still anticipate cash revenue will be in the range of $18 to $22 million, and operating expenses will be in the range of $120 to $130 million. However, we have narrowed our range for projected full-year net cash utilization to be between 110 to 115 million.

Regarding heart failure education, as we discussed at our recent Investor and Analyst day, we initiated a disease state education program to educate the heart failure community on the unmet needs of heart failure patients and explain how contractility drives cardiac performance in half throughout.

And importantly, the commercial operations were building to support Omecamtiv Mecarbil funded largely by Amgen can be leveraged to commercialize CK 274, if successful in North America Europe.

And Furthermore, our recent transactions with RG W. Inducing pharmaceuticals accelerate our development programs and expand our geographic reach while preserving opportunities for further leverage to potential additional partnerships.

Ching W. Jaw: While we will not give formal guidance for 2021 until our Q4 earnings call, we expect to end this year with more than $500 million on the balance sheet, which we anticipate will represent more than three years of forward cash, even as we expand the development program for CK24, alongside plans to co-promote Omicantum Carbo with Amgen. If the results of GALACTIC-HF are positive in Q4, we can anticipate milestone payments over the next 12 to 18 months. Plus, upon its commercialization, royalties on pure worldwide sales of only cancer macabre outside Japan might exceed 20% with a lower royalty rate in Japan.

Finally in the second quarter on the neuromuscular front, we continue to prepare for the potential advancement of relative to some to through a phase three clinical trial in patients with they allow us and we engaged with clinical experts and patient advocates and health technology assessment organizations to secure feedback on endpoints and.

Other matters relating to the design of the trial.

We also received advice from your me through protocol assistance for the Phase three trial.

And also during the quarter, we announced the continuation of our longstanding partnership with the election Association in the fight against they have less again further evidence of our steadfast commitment to this courageous and inspiring patient population.

In summary, Cytokinetics is well positioned to continue to execute against our vision 2025, as we look forward to what we believe is a transformative time in the company's maturation.

Ching W. Jaw: The recent transactions we completed further enable us to leverage our partnership with Amgen to build our commercial business, and in parallel, we have the capital to expand our biopharmaceutical research platform with the goal of doubling the size of our development pipeline over the next five years, as we have outlined in our Vision 2025. And with that, I'll turn the call back over to Robert Wong.

Leading into the other this year and are expected results from Galactic HF in Q4.

Now, let me recap our expected milestones for Twentytwenty.

For Omecamtiv Mecarbil, we expect topline results from Galactic HF in the fourth quarter.

We expect enrollment impede your to catch up in patients with heart failure to be completed in early 2021.

Robert I. Blum: Thank you, Ching. It was indeed a productive quarter, and we continue to build momentum into the second half of this year. To pick up on Ching's earlier comments regarding the potential commercialization of Omecamptomicarbol, Amgen and Cytokinetics expect to leverage the strengths of both companies to educate the heart failure community about potential clinical effects and the economics of Omecamptomicarbol and how it may be positioned in the continuum of care. Additionally, in our co-promotion with Amgen, we expect to conduct a coordinated field deployment strategy, leveraging Toward that end, we recently conducted analyses relating to the United States heart failure institutional care market segment, including potential target account assessment and prioritization for our planned commercialization.

For AMC Fivenine for the Phase one study of AMG Fivenine for is now complete with data analyses ongoing.

Amgen and Cytokinetics or discussing next steps in the development program.

For CK 274, we expect to complete enrollment in the first cohort of Redwood HCM and you have data to inform progression of the trial to the second cohort by the end of Twentytwenty.

For CK 271, we expect to initiate a phase one study in Q3 Twentytwenty for rail deceptive, we expect to continue to prepare for potential phase three clinical trial and registration program in patients with they are less.

And for our ongoing research, we expect to continue research activities directed to the cardiac and skeletal sarcomere and or other muscle biology research programs and we expect to continue research in collaboration with the Stellus directed to the discovery of next generation go to sarcomere muscle activators through.

Twentytwenty.

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

Robert I. Blum: We also continue to conduct commercial readiness activities in collaboration with Amgen in preparation for the commercialization of Omicamptomacarbal, including market research related to product branding elements, potential positioning, position preferences, and potential customer accounts. And finally, we continued our collaboration with providers and health care systems to generate health economics and outcomes research related to the health care costs associated with the treatment of heart failure patients. Regarding heart failure education, as we discussed at our recent Investor and Analyst Day, we initiated a disease state education program to educate the heart failure community on the unmet needs of heart failure patients and explain how contractility drives cardiac performance in half-breath.

Ladies and gentlemen at this time that you'd like to ask a question. Please press star and then the number one on your telephone keypad.

Once again that is star and the number one.

And your first question comes from the line of Dane Leone with <unk>.

Raymond James.

Okay.

Questions.

So maybe starting with me, we've gotten a questions and from the investment community.

Posted deal on to some for just trying to think strategically from your point of view as you advance to seven one how you would manage a two assets with similar on the way in the clinic at the same time and how that might differentiate on indication if you've thought that far ahead.

And then the second one for me would just be anything you can give us for setting the table on the Redwood HTM readout for cohort one by the ended a year.

And how you think about the key data points that you'll be looking at a that you would want investors to focus on as well.

Robert I. Blum: And importantly, the commercial operations we're building to support Omicampt and McCarville, funded largely by Amgen, can be leveraged to commercialize BK274 if successful in North America and Europe. And furthermore, our recent transactions with RTW and Jixing Pharmaceuticals accelerate our development programs and expand our geographic reach while preserving opportunities for further leverage to potential additional partners. Finally, in the second quarter, on the neuromuscular front, we continue to prepare for the potential advancement of REL-Deceptive to a Phase III clinical trial in patients with ALS, and we engage with clinical experts and patient advocates and health technology assessment organizations to secure feedback on endpoints and other matters relating to the design of the trial. We also received advice from EMA through protocol assistance for the Phase 3 trial. And also during the quarter, we announced the continuation of our longstanding partnership with the ALS Association in the fight against ALS.

Thank you.

Sure I'll start and then turn it over to Saudi and maybe study.

We'll turn it over to Stewart, we've got.

Two questions there one with regard to 271.

So as has been our history, it's sort of kinetics, and you're just getting to know us a bit but we've always been advancing a lead compounds backups follow ons and diversified book chemical and pharmacokinetic space for mechanisms of action that we look.

To bring through clinical research. That's why are we call. It clinical research because obviously, there's opportunity to expand and diversify with regard to CK two seven poor we're committed to as you heard obstructive a non obstructive as well as as we're considering to pick up and as far as CK 271 is concerned.

It really depends on the profile things will learn about CK two so before but also PK to seven one that may enable us to consider a broader development program.

We're also advancing other compounds from the same program different mechanisms different properties.

Such that we might expect to see other compounds enter the clinic.

So let that be enough for me and maybe Saudi to elaborate and also we answer your second question relating to what data, we'll look at Redwood in order to inform the second cohort.

I think you covered the first question Robert to seven one I think there's the data come out of its phase one trial and and as we start to see more date on two seven or will begin a form.

Robert I. Blum: Again, further evidence of our steadfast commitment to this courageous and inspiring patient population. In summary, Cytokinetics is well positioned to continue to execute against our vision 2025 as we look forward to what we believe is a transformative time in the company's maturation. Leading into the end of this year and our expected results from Galactic HF in Q4, now, let me recap our expected milestones for 2020. For Omicampt and McCarble, we expect top-line results from GalacticHF in the fourth quarter, and we expect enrollment in meteoric HF in patients with heart failure to be completed in early 2021.

Strategy with those two compound.

With regard to.

Redwood HCM, maybe I'll turn it over to Stewart and it's been very closely.

See overseeing the progress of that study and and to discuss what our strategy will be towards the end of year terms of data and next steps.

And thank you that so as we mentioned we plan to have the results of cohort one by the end of the year.

You know the main objective of this study is really safety and Tolerability. So we'll be primarily focused.

On the safety endpoints, but strategically now we're very.

Robert I. Blum: For AMG-594, the phase one study of AMG-594 is now complete with data analyses ongoing. Amgen and Cytokinetics are discussing next steps in the development program. For CK274, we expect to complete enrollment in the first cohort of Redwood HCM and to have data to inform progression of the trial to the second cohort by the end of 2020. For CK271, we expect to initiate a Phase 1 study in Q3 2020. For Rel-disease, we expect to continue to prepare for a potential Phase 3 clinical trial and registration program in patients with ALS. And for our ongoing research, we expect to continue research activities directed to the cardiac and skeletal sarcomere and our other muscle biology research programs, and we expect to continue research in collaboration with Astellas directed to the discovery of next generation skeletal sarcomere muscle activators through 2020. Operator, with that, we can now open up the call, please, to questions. Ladies and gentlemen, at this time, if you would like to ask a question, please press star and then the number one on your telephone. Again, that is the star in the number.

Very much focused on.

This individualized dosing strategy that we've incorporated into the study design.

Because there will be quite a spectrum of disease severity in the population were in romaine. So we anticipate.

You know depending on.

Patients individual pathophysiology or severity that the dose as may vary.

Depending on the the individual patient, but in terms of Pharmacodynamic endpoints will be looking at improvement as a lesson trick our outflow tracked a great and that and this patient population contributes quite substantially to.

The heart failure symptoms and poor cardiac function.

As well as looking at the signs and symptoms.

Other pharmacodynamic endpoints like NT pro BNP. So the totality of of the data from this study then will give us a read out on the range of doses were studying and cohort one and then those data Roland form.

Progression to a higher dose range that we're planning and cohort two.

Great just one clarification on my first question, sorry, I think investors or or just trying to understand whether there's anything reclusive legally within the Archie W. Agreement from 271 being developed in the in the same indications Oh sorry.

I would just wanted to clarify that.

Sorry, your neck, there's nothing in order agreement that concludes our ability to develop CK 271 is we see fit but we have no intention right now, but right now CK 271 still needs to be characterized in phase one as to CK 274.

Dane Vincent Leone: And your first question comes from the line of Dane Leone with Raymond James, question: So maybe starting with me, we've gotten questions in from the investment community, posted deals on 274, just trying to think strategically from your point of view, as you advance 271, how you would manage two assets with a similar MOA in the clinic at the same time and how they might differentiate on indication if you've thought that far ahead. And then the second one for me would just be anything you can give us for setting the table for the Redwood HDM readout for Cohort 1 by the end of the year, and how you think about the key data points that you'll be looking at that you'd want investors to focus on as well. Thank you. I'll start and then turn it over to Fady, and maybe Fady will turn it over to Stuart.

In phase two so our goal is to be advancing multiple compounds forward as I've mentioned and we'll learn about these compounds physiochemical properties and otherwise in order to ensure that we can lead in this space across different types of indications different types of sub types of patients et cetera. So to your question no. There's.

Nothing that precludes us.

Excellent. Thank you so much.

Thank you.

Your next question comes from the line of Jeff <unk> with Morgan Stanley.

Hi, Joe Thanks.

Hey, thanks for taking the questions.

You indicated that AMC fivenine for phase one is complete one mobile front data from the and are you likely to move forward and only one indication or is it likely that you'll proceed in parallel with multiple indications like CKD seven for and then I will follow ups.

Yes, very good question.

So we're right now in the process.

Receiving in evaluating and analyzing those data and that's a process that.

It's really just at its beginnings.

As far as phase two indications are concerned we're thinking broadly here.

We've been undergoing an exercise that includes market research and working with key opinion leaders clinical assessments clinical trial design endpoint.

Robert I. Blum: We've got two questions there, one with regard to 271. So, as has been our history at Cytokinetics, and you're just getting to know us a bit, but we've always been advancing lead compounds, backups, follow-ons, and diversifying both chemical and pharmacokinetic space for mechanisms of action that we look to bring through clinical research. That's why we call it clinical research because obviously there's opportunity to expand and diversify. With regard to CK274, we're committed to, as you've heard, obstructive and non-obstructive as well as we're considering PEPP-PEPP, and as far as CK271 is concerned, it really depends on the profile.

Evaluation, all sorts of things that might inform abroad development program that could be encompassing of.

Many different indications recognizing that.

As a cardiac muscle activator there are many different directions, we could go booked at address large market opportunities as well as what might otherwise be referred to is more specialized care segments. So we're thinking about that with Amgen and in a way that.

We'll probably have more to say about all this later in the year.

But in the meantime, it's still at the.

Paper and pencil exercise level.

And so and when you said later this year is that when we might see aspects of the phase one data or [noise].

Yeah, I suspect that as we will make certain decisions will be in a position to share data that could be supportive of those decisions.

Okay, Great and then at the fall into the previous question.

I recognize you still need to characterize CK two centers one in humans, but maybe you can talk about the differences in the profile from the preclinical data between CK 271, and seeking to some for thank you.

Robert I. Blum: Things we'll learn about CK274 but also CK271 that may enable us to consider a broader development program. We're also advancing other compounds from this same program, different mechanisms, and different properties so we might expect to see other compounds enter the clinic. So I'll let that be enough for me and maybe ask Fady to elaborate and also answer your second question relating to what data we'll look at at Redwood in order to inform the second cohort. I think you covered the first question, Robert, 271.

Now do you want to pickup.

I can take that's yeah, I mean, Preclinically K 274, and then 271 have similar mechanisms of action, primarily up there or are our differences the little bit in terms of the steepness of the exposure response relationship.

Between two molecules and also there pharmacokinetics.

Our bit different pre clinically as well, which is the reason that we.

Basket and to get a little diversity of.

PK and PK PD and.

In the clinic.

And and use that to inform advancement of.

All of our this mechanism of action when patients as well as provides the opportunity this presentation or other things that we might think about.

Robert I. Blum: I think that data comes out of its phase one trial, and as we start to see more data on 274, we'll begin to form a strategy with those two compounds. With regard to Redwood HTM, maybe I'll turn it over to Stuart, who's been very closely overseeing the progress of that study, and discuss what our strategy will be towards the end of the year in terms of data and next steps. Thank you, Fady.

Thank you.

Your next question comes from the line as Jason Butler with JMP Securities.

Hi, Jason.

Hi, James My feeling is open.

He was in either.

Proprietor looks like we might have lost Jason maybe you can go back into queue and we can go to the next one.

Your next question comes from the line of Charles Duncan with Kantar.

Hi, Charles.

Hi, I'm, Robert and his team.

Kobe be darned.

You guys had made a lot of progress congratulations.

Stuart Kupfer: So, as we mentioned, we plan to have the results of Cohort 1 by the end of the year. You know, the main objective of this study is really safety and tolerability. So, we'll be primarily focused on those safety endpoints, but strategically, you know, we're very, very much focused on this individualized dosing strategy that we've incorporated into the study design, um because there will be quite a spectrum of disease severity in the population we're enrolling so we anticipate You know, depending on the patient's individual pathophysiology, or severity that the doses may vary, depending on the individual patient.

Had a quick question on Omecamtiv timing and then on strategy first Bob regarding your only camtek timing sandy dated create schab laying out.

What to expect right I'm I'm kind of wondering in terms of.

Assuming success and kill laughing when would you anticipate being able to file and then da is is all the CMC done would you anticipate being able to conduct and a meeting a pre NDA meeting with the come with the agency before say mid first quarter of.

Next year.

Now ill turn it over to you and elaborate afterwards.

Sure.

Hi, Hi, Charles you know I think I can say that that and Ben Cytokinetics doesn't create fairing very aggressively for.

Stuart Kupfer: But in terms of pharmacodynamic endpoints, we'll be looking at improvement of the left ventricular outflow tract gradient that in this patient population contributes quite substantially to, Heart Failure Symptoms and Poor Cardiac Function, As well as looking at signs and symptoms, other pharmacodynamic endpoints like NT, Pro-B, and P. So the totality of the data from this study then will give us a readout on the range of doses we're studying in cohort one, and then those data will inform progression to a higher dose range that we're planning in cohort two. Great. Just one clarification on my first question. Sorry.

In the past couple of years, that's for are essentially a filing so.

Everything is then it accelerated to shorten the time as much as possible between trial results.

And the filing of an N. da.

I think you know you would see a [noise].

The results are supportive and mix and that the path forward.

Clear.

Yeah, I think you would see us moving forward should end the h. filing quite early [noise] out are quite rapidly.

There isn't really anything I would say that is that you know other than the result to that needs to be our hands in order to.

Progressed in India pilot.

Yeah, just maybe to elaborate a little bit.

These work streams to Fatties point have been going on for quite awhile and [noise].

Well both companies working diligently on preparing study reports and.

Dane Vincent Leone: I think investors are just trying to understand whether there is anything legally preclusive within the RTW agreement that prevents 271 being developed in the same indications. Sorry, I would just want to clarify that. Sorry, there's nothing in our agreement that precludes our ability to develop CK271 as we see fit, but we have no intention right now.

Ensuring that they all good quality controls its not just for the what would be the U.S. filing, but also outside the U.S. and I think this is a credit to the collaboration that we've been engaging very proactively in these work streams, recognizing we do want to move swiftly to enable potential approvals.

The drug.

How's the fast track designation as you know and that could be enabling a very fast to review time as well. So all these things are aligned with expectations that we need to be in a position to be ready to co commercialize but as soon as possible in twentytwenty one.

Okay, and that's very helpful. And then quick question on strategy in Asia I know you updated the partnership reached a couple couple of years ago to include Japan, but I can't recall, what is the plan for other Asian countries such as China.

Robert I. Blum: Right now, CK271 still needs to be characterized in phase one, as does CK274 in phase two. So our goal is to be advancing multiple compounds forward, as I mentioned, and we'll learn about these compounds, their physiochemical properties and otherwise, in order to ensure that we can lead in this space across different types of indications, different types of subtypes of patients, etc. So to your question, no, there's nothing that precludes us. Excellent. Thank you so much.

Can you provide color.

Sure. So the collaboration we have with Amgen is a worldwide collaboration includes trying to.

It previously excluded Japan, but as you mentioned in 2013. It was expanded to include Japan. So now it is truly worldwide.

And not just between Amgen and Cytokinetics, but with our consent Amgen also provided a sub license to serve you in Europe and other Commonwealth independent states to be enabling of what will be the muscle pardon. The pun of 38 in order to be a commercial partner in areas, where they have space.

Jeff Hung: Thank you. This is a question from the line of Jeff Hung with Morgan: Hey Jeff, thanks for... Hey Jeff, thanks for doing the questions. You indicated that AMG-594 Phase 1 is complete. When might we see the data from the study, and are you likely to move forward with only one indication, or is it likely that you'll proceed in parallel with multiple indications like CK-274 and then after follow-up? Yeah, very good question.

As if it fits for cheese.

Our role in co commercialization is a global goal, it's a worldwide rule.

Spends all countries.

That's under the commercialization oversight of a joint commercialization committee or co promotion rule is a north American rule, and where we will have sales and marketing people focused will be in North America or royalty is earned on worldwide sales hope that helps.

Robert I. Blum: Um, so we're right now in the process of receiving, evaluating, and analyzing that data, and that's a process that is really just at its beginning. As far as Phase 2 indications are concerned, we're thinking broadly here. We've been undergoing an exercise that includes market research and working with key opinion leaders, clinical assessments, clinical trial design, end point evaluation, all sorts of things that might inform a broad development program that could encompass many different indications, recognizing that as a cardiac muscle activator, there are many different directions we could go. Both of those address large market opportunities as well as what might otherwise be referred to as more specialized care segments. So we're thinking about that with Amgen and in a way that we'll probably have more to say about all this later in the year. But in the meantime, it's still at the paper and pencil exercise level.

Okay. It does unlike the time last question for chain chain, you were laying out a cash position at the end of this year and I'm not sure a few misspoke or I Miss heard more likely the ladder that at the end of 21. You main also a end the year with 500 million and I missed.

Assuming that includes some assumption about milestones and perhaps even royalties is that was that the case or did I Miss here, though Charles but what I heard what I said it was we were and Twentytwenty was.

More than 500 million.

I didn't say anything about 2021.

Oh, Okay. That's that's clear, but you you you did mention milestones and potentially royalties and next 12 to 18 months correct. Yes, yes that that is correct and that's associated with only canton mccarville, if collector or to be positive.

Got it thanks for the clarification.

Thank you Charles.

Your next question comes from the line of Joseph paying enough with H.C. Wainwright.

Hello, Joe.

Hello, guys isn't the way last calling for Jochen goal.

Thanks for taking my question I have the copper that I was wondering if it kinda give as a little bit more color on that as I used to be Aluko, you are not kicking in and they feel at the farming and they're.

Well my presentation activities and would like I guess I'm trying to understand it.

Jeff Hung: And so when you said later this year, is that when we might see aspects of the phase one data or not? Yeah, I suspect that as we make certain decisions, we'll be in a position to share data that could be supportive of those decisions. Okay, great. And then as a follow-on to the previous question, I recognize you still need to characterize CK271 in humans, but maybe you can talk about the differences in the profile from the preclinical data between CK271 and CK274. Thank you. Fady, do you want to take this?

We there wont be oxaydo population, a week Sacramento station seawater.

Looking at Paris, then of course going I can't see Ah well, that's going to get to the counties in Paris.

Sure. So there'll be a time when we can be more specific can elaborate on this but in a general sense. What I can say is the following.

That we're looking at where cytokinetics accompany with more limited access to capital and resources can put forward a commercial organization that can be highly effective to drive the business and in institutional care segments, where there is high volume heart failure and some of these are accounts that may.

Fady Ibraham Malik: I can take that. Yeah, I mean, preclinically, CK274 and 271 have similar mechanisms of action. Primarily, there are differences a little bit in terms of the steepness of the exposure response relationship between two molecules, and also their pharmacokinetics are a bit different preclinically as well, which is the reason that we advanced it and to get a little diversity of PK and PKPD in the clinic and use that to inform advancement of, you know, of our mechanism of action in patients as well as provide, you know, the opportunity to split indications or other things that we might think about.

The unique to sort of kinetic some of them might be a ones that are shared with amgen, but we're looking at this from a.

Strategic standpoint, where do we think we can be most impactful for the opportunity in terms of education awareness and pull through and whereby they also provide.

Advantages and pay dividends down the road for us in connection with or interest with regard to CK 274.

Were similarly, it's a concentrated customer care segment, where there is high overlap with heart failure high volume centers and where these centers of excellence will be treating a majority of the HCM patients. So we're looking at that Nexus. If you will between heart failure and HCM in order to drive our strategy about.

Fady Ibraham Malik: Thank you. Your next question comes from the line of Jason Butler with JNP Securities. Jason, your line is open. Are you there?

Jason Nicholas Butler: Operator, looks like we might have lost Jason. Maybe he can go back in the queue, and we can go to the next one. Okay, your next question comes from the line of, "[inaudible] Hi, Robert, and team COVID be darned. You guys have made a lot of progress. Congratulations."

Using that there's still work to be done between us and Amgen to align and agree on next steps with regard to our co promotion and that's something that we're discussing with Amgen.

With the goal of having more granularity and clarity on all of this by the under this year.

Got it thank you.

And it was that they are picking up on Jay.

Operator: I had a quick question on omicamptive timing and then on strategy. First of all, regarding omicamptive timing, Fady did a great job laying out kind of what to expect. But I'm, I'm kind of wondering in terms of, you know, assuming success in Galactic, when would you anticipate being able to file an NDA? Is all the CMC done? Would you anticipate being able to conduct a pre-NDA meeting with the company and the agency before, say, mid-first quarter of next year? Fady, I'll turn that over to you, and I'll elaborate afterwards. Sure. Hi Charles.

I still think I try to adopt off at that on Jeff Olson that post trial toxicity.

Well I don't think come to access will be provided to patients who participated in Galactica chat Italian is not active yet, but I was wondering if there isn't that's probably a lot that kind of kind of along that path oil I'll try and like I was wondering what what you're trying to achieve one theme.

Lung data service.

This is a strategy that allow study to speak to elaborate on obviously this is something that is dependent on results from galactic as those will be known in the fourth quarter.

Yep.

Yeah. There there are certain countries in the world, where post trial box that mandatory for patients that are.

Charles Cliff Duncan: You know, I think I can say that Amgen and Cytokinetics have been preparing very aggressively for, in the past couple of years, for a potential NDA filing. So everything has been accelerated to shorten the time as much as possible between trial results and the filing of an NDA. All clear.

Our enrolled in clinical trials in those jurisdictions and so are we have a post trial access.

Program that is being put in place too.

All those patients into it after they've completed galactic and.

Fady Ibraham Malik: You know, I think you would see us moving forward to an NDA filing quite early or quite rapidly. There isn't really anything I would say that is, you know, other than the results that need to be in our hands in order to progress an NDA filing. And just maybe to elaborate a little bit, these workstreams, to Fady's point, have been going on for quite a while, and both companies have been working diligently on preparing study reports and ensuring that they all get quality controlled. It's not just for what would be the U.S. filing but also outside the U.S. And I think this is a credit to the collaboration that we've been engaging very proactively in these workstreams, recognizing we do want to move swiftly to enable potential approvals.

If the results are supportive of continued.

Continued dosing.

It's not necessarily intended to be a worldwide study you know across every single country, but will be determined in those countries, where it's a requirement.

Got it thank you very much.

Your next question comes from the line I've had pentathlon hyper Sandler.

Okay, great. Thank you very much sorry about the noise in the background things too for the update and cardio and going to ask about rather sensitive. They just to see if we can have any update there. What's the latest says we're thinking that's a stellar Craig.

Oh.

Pardon me I was on view so it's a very good question and as we've been consistent across different communications. It is the case that we continue to prepare for potential phase three trial and as we mentioned a lot of activities during the second quarter in recognition of that Im very pleased with the feed.

Fady Ibraham Malik: The drug has a fast-track designation, as you know, and that could be enabling a faster review time as well. So all these things are aligned with expectations that we need to be in a position to be ready to co-commercialize as soon as possible in 2021. Okay, and that's very helpful. And then a quick question on strategy in Asia. I know you updated the partnership a couple years ago to include Japan, but I can't recall what the plan is for other Asian countries, such as China. Can you provide color?

Back we're getting from both FDA and EMA made which is very aligned with the trial designed and endpoints that we have in mind, we circled with H.T.K.'s in Europe in order to get a sense of how they value. These endpoints in accordance with a potential trial. All these things are pointing to the.

Not that where we do a trial it would be received well by the less community and it's one that from a practicality standpoint design timeline and budget, we have our arms around but recognizing that.

We havent committed to do the trial yet.

We've indicated that's going to be awaiting being the galactic results in order to really understand what's our runway, what's our cost of capital what's our ability to finish what we start and that continues to be a trial that we would like to do if we can and recognizing all things considered but one that we have not yet committed to.

Robert I. Blum: Sure. So the collaboration we have with Amgen is a worldwide collaboration and includes China. It previously excluded Japan, but as you mentioned, in 2013, it was expanded to include Japan.

[music].

Great I can appreciate that thank you very much.

Thank you.

Your next question comes online.

Hi.

Yeah.

Mostly.

Robert I. Blum: So now it is truly worldwide. And not just between Amgen and Cytokinetics, but with our consent, Amgen also provided a sublicense to Servier in Europe and other Commonwealth independent states to be the enabler of what will be the muscle, pardon the pun, of Servier in order to be a commercial partner in areas where they have specific expertise. Our role in co-commercialization is a global role. It's a worldwide role. Thank you very much. Okay, it does. I like the pun.

Hey, guys. This is Dennis staying on first aleem. Thanks for taking the questions and congrats on a on the progress I'm I've two questions. If I may on the first question is on a lactic so [laughter] around half the galactic patients had a history of ischemia and I guess, the hard presumably should have less.

Functional tissue and like even after a recall I feel like it should have less functional tissue. So I guess whats data have you seen that gives you the confidence you'll be able to show the same clinical benefit in this group.

And my second question is on H.T. and specifically you know how are you thinking about the opportunity in Europe.

Charles Cliff Duncan: Last question for Ching. Ching, you were laying out a cash position at the end of this year. And I'm not sure if you misspoke or I misheard, more likely the latter, that at the end of 21, you may also end the year with 500 million. And I'm assuming that includes some assumptions about milestones and perhaps even royalties. Is that, was that the case? Or did I mishear that?

How does the U.M. anything about the phase three endpoints and it's something like peak field to.

Like the right end point and Ah Thanks for taking the questions.

Sure, let's say Colescott ready to answer both of those please.

Sure the.

With regard to the first question.

The data support and affecting both the scheme economic scheming party mop athenes come from the lack I mean from cosmic work.

Ching W. Jaw: No, Charles, but what I heard, what I said, it was, we will end 2020 with more than 500 million. I didn't say anything about 2021. Okay, that's clear. But you did mention milestones and potentially royalties in the next 12 to 18 months, correct? Yes, that is correct. And that's associated with Omicantin-McCarville if the results are positive. Got it.

Moving to the effect of home a cancer mccarville in those patient subgroups.

And you know what you essentially it's our very similar effects on the.

Measurements of improvements in cardiac function the.

Changes in volumes changes in mentioned Cobian team.

Yeah, you know, while there are fewer muscle cells to essentially in a patients that have the scheme at cardium up at the just you have to recall there they're generally still lots of viable myocardium myocardium that is a lot I perjure keys and gets bigger.

Charles Cliff Duncan: Thanks for the clarification. Thank you, Charles. Hello guys, this is Emanuela calling for Joe Pantginis. Thanks for taking the questions. I have a couple.

And so late can still augment their function.

Joseph Pantginis: I was wondering if you could give us a little bit more color on the result of the analysis you are performing and the commercialization activities. With like, I guess I'm trying to understand within the failure population, which segment of patients you are targeting first and who is going to get the most benefit, who is going to get to the county first. Sure.

In response to try by phone Kempton Mccarville, and we've seen that also on earlier child's bus cosmic.

So I think there's rationale expect benefit in both types of subgroups.

HM can you repeat your second question. Please.

Yes, sure I guess, the HCM opportunity in Europe like how how are you thinking about it you know in terms of phase three how does the U.M. anything about phase three endpoints, there's something like Pico too.

Like a proper endpoint.

Robert I. Blum: So there'll be a time when we can be more specific and elaborate on this. But in a general sense, what I can say is that we're looking at where cytokinetics, a company with more limited access to capital and resources, can put forward a commercial organization that can be highly effective to drive the business, especially in institutional care segments where there is high volume heart failure. And some of these are accounts that might be unique to cytokinetics.

It's a good question and I think you know from a just a little bit early for us to comment on what you may think about endpoints and case degree.

We're planning we have engaged them initially and we plan to can engage and more.

Equally in the coming month, we plan for phase three that would be conducted both in Europe and the U.S. you know there there's clearly a.

Guidance it comes out of your but functional improvements in patients with heart failure or we'd ATM are.

Robert I. Blum: Some of them might be ones that are shared with Amgen, but we're looking at this from a strategic standpoint. Where do we think we can be most impactful for the opportunity in terms of education, awareness, and pull-through?

Certainly oh.

Well endpoint and it's maybe a question of how you define function or symptoms and right now I think we're still in the.

Oh, hey to of learning, what they what what their vision or what their opinions on that art.

Robert I. Blum: And where might that also provide advantages and pay dividends down the road for us in connection with our interests with regard to CK274, where, similarly, it's a concentrated customer care segment where there's high overlap with heart failure, high volume centers, and where these centers of excellence will be treating a majority of the HCM patients? So we're looking at that nexus, if you will, between heart failure and HCM in order to drive our strategy, albeit recognizing that there's still work to be done between us and Amgen to align and agree on next steps with regard to our co-promotion, and that's something that we're discussing with Amgen, with the goal of having more granularity and clarity on all of this by the end of this year I got it.

Got it thank you.

Thank you.

Ladies and gentlemen, just as a reminder, if you'd like to ask a question. Please press star and then the number one on your telephone keypad.

Your next question comes from the line as Chad Messer Whitney.

Hi, good.

Hi, Thanks for taking my question and you know congratulations on all the on all the recent progress I mean, given me time and effort. It took to get there I would already had been ecstatic just to be on a call one quarter away from home a captive data, but to have you guys. So well position with the rest of the pipeline.

Going into that is truly fantastic.

Notice for very long time, Chad so its gratifying I know, but to be able to share. This with you and looking forward to the results later in the year to be sure.

<unk> likewise.

Maybe a bigger picture question on your vision 2025.

Fady Ibraham Malik: Thank you. And speaking of Amgen, I saw on clinicalcareer.gov that Amgen has opened a post-trial access study where the county's access will be provided to patients who participated in Galactica Health. The trial is not active yet, but I was wondering if this is a follow-up, like a kind of longer-term follow-up trial? Like, I was wondering what you're trying to achieve with this. Yes, that's it.

To that is to you know not trying to stop at the programs, we've been talking about today, but keep going you're having a 10 drugs.

In development by Dan, which you know given how prolific your drug discovery engine as Dennis.

It's a it's aggressive but certainly feasible and I know in your corporate debt, you're kinda talk about.

Kinda talk about branching out away from your focus on contract facility to a you know muscle energy and metabolism and learned a couple of weeks ago that you've been working on inhibitors of skeletal protein parasites, Oh, you know all different things stuff. He can you maybe.

Fady Ibraham Malik: This is a strategy that I'll ask Fady to speak to and elaborate on. Obviously, this is something that is dependent on results from Galactic, as those will be known in the fourth quarter. Yeah. Yeah, there are certain countries in the world where post-trial access is mandatory for patients that are enrolled in clinical trials in those jurisdictions. And so we have post-trial access. This is a program that is being put in place to roll those patients into it after they've completed Galactic and if the results are supportive of continued dosing. It's not necessarily intended to be a worldwide study across every single country, but we'll be targeting those countries where it's a requirement. I got it.

More broadly to some of these areas and what kinds of what kinds of conditions you can address by going after it.

New biology.

Very good question and I'll start, but better for you to hear from Saudi on this.

We've we've taken at approach and you've known us for a long time in this way.

Where we never want it to be a company that was going to pivot on one product when indication.

And it's taken us a very long time, obviously to get to where we are now but at the same time, we're enabled both financially and operationally and with a pipeline to be able to build we hope very sustainable in durable business that grows with the science and continues to innovate and bring forward new medicines.

Joseph Pantginis: Thank you very much. Okay, thank you very much. Sorry about the noise in the background.

Operator: Thanks, too, for the update on cardio. I'm going to ask about broad assumption and just see if we can have any update there or what the latest is with thinking. Thanks.

With that said, it's important to be self aware and understand where we think we can have a competitive advantage and be leaders and that's where we pioneered and continue to lead in the area of contractility of muscle, which by itself has afforded us a very broad pipeline, which could go well beyond even the indications we have been speaking about.

Robert I. Blum: So it's a very good question, and as we've been consistent across different communications, it is the case that we continue to prepare for a potential phase three trial. And as we mentioned, a lot of activities during the second quarter in recognition of that. I'm very pleased with the feedback we're getting from both FDA and EMA, which is very aligned with the trial design and endpoints that we have in mind. We met with HTAs in Europe in order to get a sense of how they value these endpoints in accordance with a potential trial. All these things are pointing to the fact that were we to do a trial, it would be received well by the ALS community. And it's one that from a practicality standpoint, design timeline, and budget, we have our arms around.

For the compounds that are in clinical trials real defensive by itself could be a pipeline in of itself, which at this point, we've really been focus too as you know LS and possibly estimate.

But we also want to make sure that we're constantly listening to the marketplace as well as patients and that's where we think we've established a leadership position as it relates to the bio mechanics of muscle that extends but also to how muscle is a pivot point in energetics growth and metabolism.

In other indications, but still should remain within our cardiovascular neuromuscular vertical.

So we're going to continue to invest in pipeline cardiovascular and neuromuscular and as we find out as you saw.

Robert I. Blum: But recognizing that we haven't committed to doing the trial yet, as we've indicated, that's going to be awaiting seeing the galactic results in order to really understand what our runway is, what our cost of capital is, what our ability to finish what we start. And that continues to be a trial that we would like to do, if we can, and, all things considered, but one that we have not yet committed to. Great; I can appreciate that.

Another company recently based on things, we discovered those are going to be more tangential and more going to be monetized in other ways in order to be enabling of our leadership in these verticals.

Now with that said, we have to be thinking biologically as well as from the marketplace and that's where Saudi and his colleagues have put together a very good roadmap as we move beyond the contractility of muscle to include mitochondrial Biogen, maybe he can speak to some of those thoughts and ideas as we are thinking about.

Salim Qader Syed: Thank you very much. Thank you. Hello, Salim.

Salim Qader Syed: Hey guys, this is Dennis Bing on behalf of Salim. Thanks for taking the questions and congrats on all the progress. I have two questions, if I may. The first question is about Galactic.

Where we go from five products in development, because many is 10 development programs by 2025.

Hi, Thanks, Robert you know chat and very good question and.

Robert said Weve.

Fady Ibraham Malik: So, around half the galactic patients had a history of ischemia, and I guess the heart presumably should have less functional tissue, and like even after REVAT, I feel like it should have less functional tissue. So, what data have you seen that gives you the confidence that you'll be able to show the same clinical benefit in this group? And then my second question is on HCM specifically, you know, how are you thinking about the opportunity in Europe? You know, what does the EMA think about the phase 3 endpoints? And is something like peak VO2, you know, like the right endpoint?

And leveraging the biology of sarcomere for.

Nearly 20 years now and that develop the pipeline activators of cardiac muscle inhibitors of cardiac muscle.

Activators of skeletal muscle and.

The you know that that pipeline is maturing in the clinic and there are certainly other opportunities within the Sarcomas, there and we'll continue to.

To take advantage of our leading expertise and that.

Muscle structure, but.

Yeah, we have a lot of programs in that area now and and as we're thinking of how can we.

Move to another important.

Feature of muscle, which is how this muscle generate energy and your muscles chock full.

Fady Ibraham Malik: And thanks for taking the question. Sure, I think I'll ask Adi to answer both of those, please. Sure. With regard to the first question, the data that support an effect in both ischemic and non-ischemic cardiomyopathies come from COSMIC, where you look at the effect of omicantin and macabol in those patient subgroups, which you essentially thought were very similar effects on the measures of improvements in cardiac function. It, you know, while there are fewer, [inaudible] And we've seen that also So I think there's a rationale to expect benefit from both types of subgroups.

Mitochondria, it's critical for heart health and skeletal muscle health, obviously mitochondria are not muscle specific but.

There are certainly muscle specific applications of mitochondrial biology, and and we're going to Oh, we have already been doing this for a while we'll begin to you'll see begin to see some programs emerged from that space in the coming coming years.

In trying to just one other point dimension is that.

We'll continue with what has been the hallmark of our productivity to look for those kinds of measures that we can observe preclinically and through the clinic pharmaco dynamic leak that can read on functions and because we believe that's important to inform what ultimately will better the patients.

Fady Ibraham Malik: Can you repeat your second question, please? Yes, sure. Um, the HCM opportunity in Europe, like how, how are you thinking about it, you know, in terms of phase three? How did the EMA think about phase three endpoints, with something like peak VO two, like a proper, It's a good question.

As we think about function and performance quality of life and health spend this is where for muscle activators, our muscle inhibitors. These drug candidates read on not only morbidity and mortality, but things that ultimately will define held spend especially as play to an aging demographic.

Fady Ibraham Malik: And I think, you know, it's just a little bit early for us to comment on what EMA may think about endpoints in phase three. We're planning, we have engaged them initially, and we plan to engage them more deeply in the coming months. We plan for phase three to be conducted both in Europe and the US. You know, there's clearly guidance that comes out of Europe that functional improvements in patients with heart failure or with ATM are certainly, but this is a question of how you define function or symptoms. Right now, I think we're still in the phase of learning what their vision or what their opinions on that are. I got it.

That's where we see our business constantly.

Evolving.

Yeah, I know that that that's great and it's a really good to see you guys I'm thinking so strategically and being in such a good position to sort of [noise].

Plan ahead for for a for many years of progress backed by the way it's hauntingly familiar this idea of.

Sitting in pre clinical compounds into a new company that you incubate in exchange for equity and royalties I have just sneaking suspicion officers.

Salim Qader Syed: Thank you. Thank you. Press Star and then the number one.

Operator: [inaudible] Hi, thanks for taking my question and, You know, congratulations on all the recent progress. I mean, given the time and effort it took to get here, I would already have been ecstatic just to be on a call one quarter away from Omicamptive data, but to have you guys so well-positioned with the rest of the pipeline going into that is truly fantastic. I've known us for a very long time, Chad, so it's gratifying, I know, to be able to share this with you. Looking forward to the results later in the year, to be sure. Likewise, um, you know.

This is something that could work out for you.

Well. Thank you for noticing but you know it does play into our corporate development strategy that there are things that we should be doing and things. We can always be doing ourselves, but that's not to say that there aren't opportunities to monetize them down the road.

Yeah go ahead.

Okay, let's let's see if it works again.

Thank you said that step.

Our next question comes on line of Jason Butler with JMP Securities.

Hi, Jason welcome back.

But maybe not.

[laughter], Jason can you hear us.

Chad Messer: Maybe a bigger picture question on your Vision 2025, you know, part of that is to... And not kind of stop at the programs we've been talking about today, but to keep going and having Penn Drug. [inaudible] I'm going to talk about branching out away from your focus on contractility to, you know, muscle energy and metabolism. You learned a couple weeks ago that you've been working on inhibitors of skeletal protein parasit Unknown Speaker Can you maybe speak broadly to some of these areas and what kinds of conditions you can address by going after New Biology? Very good question.

Jason Your line is open.

Operator sounds like we may have lots to begin.

Okay.

And there are no further questions at this time.

Okay, well thank you.

Thanks, very much to everybody on the call today. Thank you for your continued interest in what we're doing and obviously this past quarter was I think some of the best evidence yet of our ability to execute.

In alignment between R&D strategies, and our corporate development strategies from the standpoint, a financial engineering and also operationalize to enable what we think we will be an expansion an acceleration of our development programs still maintaining good fiscal discipline. Good cash runway and also ensuring that we can.

A build our pipeline.

Robert I. Blum: And I'll start, but it's better for you to hear from Fady on this. You know, we've taken an approach, and you've known us for a long time in this way, where we never wanted to be a company that was going to pivot on one product, one indication. And it's taken us a very long time, obviously, to get to where we are now.

We're coming into the second half of the year with expected results from collector catch up in the fourth quarter. Obviously, we're very optimistic and hopeful as that will be further transformative for our business. We look forward to keeping you updated on that progress and with that operator, we can conclude the call. Thank you very much.

Ladies and gentlemen, this concludes today's conference call. We thank you for your participation you may now disconnect.

Robert I. Blum: But at the same time, we're enabled both financially and operationally and with a pipeline to be able to build, we hope, a very sustainable and durable business that grows with the science and continues to innovate and bring forward new medicine. With that said, it's important to be self-aware and to understand where we think we can have a competitive advantage and be leaders. And that's where we pioneered and continue to lead in the area of contractility of muscle, which by itself has afforded us a very broad pipeline, which could go well beyond even the indications we've been speaking about for the compounds that are in clinical trials. Rel-deceptive, by itself, could be a pipeline in and of itself.

[music].

Uh huh.

Robert I. Blum: And to this point, we've really been focused on, as you know, ALS and possibly SMA. But we also want to make sure that we're constantly listening to the marketplace as well as patients. And that's where we think we've established a leadership position as it relates to the biomechanics of muscle that extends also to how muscle is a pivot point in energetics, growth, and metabolism, and other indications but should still remain within our cardiovascular and neuromuscular vertical.

[music].

Robert I. Blum: So we're going to continue to invest in pipeline, cardiovascular, and neuromuscular. And as we spin out, as you saw with another company recently based on things we discovered, those are going to be more tangential and more going to be monetized in other ways in order to be enablers of our leadership in these verticals. Now, with that said, we have to be thinking biologically as well as from the marketplace, and that's where Fady and his colleagues have put together a very good roadmap as we move beyond the contractility of muscle to include mitochondrial biology, and maybe he can speak to some of those thoughts and ideas as we are thinking about where we go from five products in development to as many as 10 development programs by 2025. Thanks, Robert. You know, Chad, it's a very good question.

Fady Ibraham Malik: And, you know, as Robert said, we've been leveraging the biology of the sarcomere for, [inaudible] The pipeline for that pipeline is maturing in the clinic. There are certainly other opportunities within the sarcomere, and we'll continue to take advantage of our leading expertise in that muscle structure. But, you know, we have a lot of programs in that area now, and as we're thinking of how can we move to another important question about muscle, which is how does muscle generate energy.

Fady Ibraham Malik: Muscle is chock-full of mitochondria. It's critical for heart health and skeletal muscle health. Obviously, mitochondria are not muscle-specific, but there are certainly muscle-specific applications of mitochondrial biology, and we've already been doing this for a while.

Fady Ibraham Malik: And Chad, just one other point to mention is that we'll continue with what has been the hallmark of our productivity to look for those kinds of measures that we can observe preclinically and through the clinic pharmacodynamically that can read on function. And because we believe that's important to inform what ultimately will matter to patients. As we think about function and performance, quality of life, and health span, this is where our muscle activators, our muscle inhibitors, these drug candidates read on not only morbidity and mortality but things that ultimately will define health span, especially as applied to an aging demographic.

Robert I. Blum: And that's where we see our business constantly evolving. I know that that's great, and it's really good to see you guys thinking so strategically and being in such a good position to sort of plan ahead for many years of progress. But by the way, it's hauntingly familiar, this idea of spinning preclinical compounds into a new company that you incubate in exchange for equity and royalties. I have this sneaking suspicion that it is.

Chad Messer: This is something that could work out for you. Well, thank you for noticing. But, you know, it does play into our corporate development strategy that there are things that we should be doing and things we can't always be doing ourselves. But that doesn't mean that there aren't opportunities to monetize them down the road.

Robert I. Blum: Um, yeah. Let's see if it works again. Thank you, Chad. Thank you, Chad. Your next question comes from the line of Jason Butler with JMP Security. Hi Jason, welcome back, or maybe not. Jason, can you hear us?

Jason Nicholas Butler: The case on your line is open. Operator sounds like we might have lost him again. And there are no further questions at this. Okay, well, thank you. Thanks very much to everybody on the call today. Thank you for your continued interest in what we're doing. And obviously, this past quarter was, I think, some of the best evidence yet of our ability to execute in alignment between R&D strategies and our corporate development strategies, from the standpoint of financial engineering, and also operationalize to enable what we think will be an expansion and acceleration of our development programs. We are still maintaining good fiscal discipline, a good cash runway, and also ensuring that we can build our pipeline.

Operator: We're coming into the second half of the year with expected results from Galactic HF in the fourth quarter. Obviously, we're very optimistic and hopeful, as that will be further transformative for our business. We look forward to keeping you updated on that progress. And with that, Operator, we can conclude the call. Thank you very much.

Operator: Ladies and gentlemen, this concludes today's conference call. We thank you for your participation. [inaudible] , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Thank you for watching! Copyright © 2020 Mooji Media Ltd. All Rights Reserved.

Operator: No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. (inaudible). ....................

Diane Weiser: At the end of the company's request, we will open the call for questions and answers after the presentation. I would now like to turn the call over to Diane Weiser. Cytokinetics Senior Vice President of Corporate, Please go ahead. Good afternoon, and thanks for joining us on the call today. Robert Blum, our President and Chief Executive Officer, will kick off the call with an overview of the quarter and our recent progress.

[music].

Diane Weiser: Then Fady Malik, our EVP of Research and Development, will provide updates on key developments for Omacamptin-McCarbol, our cardiac myosin activator being developed under our collaboration with Amgen, and the expanded and accelerated development plan for CK274, our next-in-class cardiac myosin inhibitor. Next, Stuart Kupfer, our SVP and Chief Medical Officer, will update on recent progress with CK Then Robert Wong, our VP and Chief Accounting Officer, will provide an overview of the quarter, and Ching Jaw, our SVP and Chief Financial Officer, will discuss our updated financial guidance in the context of recent corporate development activities before Robert Blum provides concluding thoughts on the company's outlook and expected key milestones for the remainder of the year.

Diane Weiser: Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Our actual results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings. We undertake no obligation to update any forward-looking statements after this call.

Robert I. Blum: And now I will turn the call over to Robert. Thank you, Diane, and thanks again to everyone for joining us on the call today. It was a productive second quarter, and the momentum continues into this third quarter.

Robert I. Blum: Many of you have had the opportunity to participate in calls relating to our licensing collaboration and royalty monetization transactions, followed by our Investor and Analyst Day event last month. We shared a lot of information on those calls just a few weeks ago, so we'll try not to be too repetitive today. There's no doubt that this is truly a transformative time in our company's maturation, and I couldn't be more proud of the high level of strategic execution demonstrated by our leadership team. The combination of licensing, royalty monetization, and equity capital market deals we transacted fortifies our expected cash balance sheet at year end to over $500 million and ensures our strong financial position as we approach the top-line results of Galactic HF, one of the largest phase three global cardiovascular outcomes trials in heart failure, which is being conducted by Amgen under our longstanding collaboration.

[music].

Robert I. Blum: These deals, considered alongside our previously announced renegotiation of our Estellis Agreement, enable us to continue readiness and implementation activities related to the potential commercialization of Omicamptomicarbol, as well as concurrently plan for the advancement of CK274 and Rel-Deceptive, all within the context of our Vision 2025. In addition to having the opportunity to co-commercialize Omicamptin-McCarbol in partnership with Amgen, these recent deals enable us to continue to control the development of CK274 and Reldaceptive through an expanded set of pivotal clinical trials while retaining full rights in North America, Europe, and Japan for our shareholders. It's particularly gratifying when our R&D strategies can synchronize with and enable our corporate development and business development strategies.

Robert I. Blum: Cytokinetics continues to leverage our innovative science through partnerships to maximize opportunities across the breadth and depth of our pipeline of investigational medicines focused on muscle biology. And with that, I'll turn the call over to Fady to elaborate on key developments for Omicamptomacarbal and CK274. Thanks, Robert.

Fady Ibraham Malik: We in Amgen made significant progress during the quarter despite the coronavirus pandemic. As we previously explained, we are in a fortunate position with the conduct of GALACTIC-HF given how advanced we are in the trial conduct. Emptin adapted the conduct of the trial to enable delivery of the investigational product to patients' homes and the conduct of study visits and to conduct study visits remotely for collection of study input.

Fady Ibraham Malik: As a reminder, none of the trial's main endpoints, including heart failure events, CV death, or collection of the Kansas City cardiomyopathy questionnaire at week 24, are dependent on patients physically visiting clinical trial sites. Now, as we approach the completion of the trial, Amgen, in collaboration with Cytokinetics, continues to work steadfastly on trial closeout activities. The trial remains blinded as final events continue to accrue, and we head towards final data collection and database lock. We expect to soon accrue the final events to close out Galactic HF in Q3, and we remain on track to report top-line results for Galactic HF in Q4. Regarding Meteoric HF, the second phase three trial of omicampin, macarbol, in patients with heart failure.

Good afternoon, and welcome ladies and gentlemen.

Second quarter 2020 conference call at this time I'd like to inform you that this call is being recorded in the all participants Arnie listen only mode.

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

I'd now like to turn the call over to Dialyzer, Cytokinetics Senior Vice President of corporate Communications and Investor Relations. Please go ahead.

Good afternoon, and thanks for joining us on the call today, probably.

As it as an chief Executive Officer will kick off the call with an overview of the core Guy.

I'm proud that then study Malik our SVP of research and development well provide updates on key developments for Omecamtiv mecarbil cardiac myosin activator being developed under our collaboration with Amgen an expanded accelerated development plan for CK two seven for our next in class cardiac myosin inhibitor.

Fady Ibraham Malik: I'm pleased to say that despite a suspension of enrollment earlier in the quarter due to the coronavirus pandemic, we resumed screening and enrollment in June in partnership with our clinical trial site. Out of the nine countries participating in METEORIC-HF, four are actively recruiting, and we expect the remaining five to come online later in this third quarter. We now have approximately 75% of our targeted 92 sites activated in the United States, Canada, France, Germany, Italy, Hungary, and the Netherlands.

Next door, Kupfer, SVP and Chief Medical Officer, well update on recent progress with CK 274 in Redwood HCM.

As well as teekay to settle for our additional cardiac myosin inhibitor.

Then Robert Wong, our VP and Chief Accounting Officer.

Fady Ibraham Malik: Recruiting is resumed, and we're very grateful to our clinical trial site personnel for their collaboration to ensure the health and safety of trial participants through the conduct of this trial. However, as we have stated, results from METEORIC-HF are not on the critical path to submitting regulatory filings for the potential approval of omicantin-micarbyl. And instead, if the findings from METEORIC-HF are supportive, they would be included in a supplemental filing following the potential commercial launch predicated on expected results from GALACTIC-HF. We now expect METEORIC-HF to complete enrollment in early 2021.

I'll provide an overview of the corridor and chicken job, our SVP and Chief Financial Officer will discuss our updated financial guidance at the context of recent corporate development activities before Robert Blonde provides concluding thoughts on the companys outlook and expect that key milestones for the remainder of the year.

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

Actual results to differ materially from those and these forward looking statements contained in our FCC filings, we undertake no obligation to update any forward looking statements. After this call and now ill turn the call over to Robert.

Fady Ibraham Malik: Given the growing health and economic burden of heart failure worldwide, we remain enthusiastic about the promise of Omicam for McCarville. The novel mechanism of action of our potential medicine works in an entirely different way from currently available therapies and has the potential to become foundational to standard of care. Of note, during the quarter, the FDA granted fast-track designation to Omicamp to McCarble, which may potentially lead to an expedited review. We also collaborated with Amgen and Tervier on preparations for a potential marketing application dossier for Omicamptomacarbal and prepared for possible meetings with regulatory authorities as may be requested to discuss phase 3 trial results and potential marketing applications. Turning now to our Cardiac Myosin Inhibitor Program. It's an exciting time as we expand and accelerate this development program.

Thank you die and thinks it doesn't get everyone for joining us on the call today.

It was a productive second quarter and the momentum continues into this third quarter.

Many of you have had the opportunity to participate in called relating to our license and collaboration and royalty monetization transactions, followed by our Investor and Analyst day event last month.

We shared a lot of information on those calls just a few weeks ago, we'll try not to be two repetitive today.

There's no doubt that this is truly a transformative time in our company's maturation and I couldn't be more proud of the high level of strategic execution demonstrated by our leadership team.

Combination of licensing royalty monetization, an equity capital market deals, we transacted fortifies, our expected cash balance sheet at year round to over 500 million and ensures our strong financial position as we approach top line results of Galactic HF what are the largest phase three.

Fady Ibraham Malik: As Robert mentioned regarding the licensing collaboration and royalty monetization deals with Pijishin Pharmaceuticals and RTW Investments, they enable us to develop CK274 in multiple indications in parallel, as well as across a wider span of geography. In terms of specifics regarding the development program associated with PK274, these deals provide support to conduct a plan-based three-clinical trial of our next-in-class myosin inhibitor in patients with obstructive HCM in North America, Europe, and with our partner in China, promptly after we have results from Redwood HCM and receive feedback from regulatory authorities. Our current goal is to initiate a Phase III registration program for CK274 in obstructive HCM in late 2021, and we are working with our new partner, Jishen, to enable concurrent development in China. In parallel, we're planning for the conduct of clinical trials of CK274 in non-obstructive HCF, HCM, and in a subgroup of heart failure patients with preserved ejection fraction, or HFAP, also in the 2021 or 2022 timeframe.

Weak global cardiovascular outcomes trials in heart failure, which is being conducted by Elton John under our long standing collaboration.

These deals.

Deterred alongside our previously announced renegotiation of ours still this agreement.

Enables us to continue readiness and implementation activities related to the potential commercialization of Omecamtiv mecarbil as well as concurrently plan for the advancement of CK two seven for Unreal disruptive all within the context of our vision once each once you fall.

In addition to having the opportunity to co commercialize omecamtiv Mecarbil in partnership with Amgen. These recent deals enable us to continue to control the development of CK 274, and real just jumped to do an expanded itself a pivotal clinical trials, while retaining food.

Right and North America, Europe, and Japan for our shareholders.

It's particularly gratifying when our R&D strategies 10, synchronized with and enable the corporate development in business development strategy.

No I don't kinetic continues to leverage our innovative science through partnerships to maximize opportunities across the breadth and depth of our pipeline of investigational medicines focus to muscle biology.

With that I'll turn the call over the body elaborate on key developments for Omecamtiv Mecarbil and CK 274.

Fady Ibraham Malik: To sum up, the deals in July reinforce our commitment to rapidly and broadly advance our cardiac myosin inhibitor program with the intent to potentially deliver the next-in-class medicine that can meaningfully impact the underlying challenges of patients suffering from hypertrophic cardiomyopathies and hepatitis related to the hypercontractility of cardiac muscles. Now I'm going to turn it over to Stuart to provide an update on Redwood HPM, as well as our plan for a Phase 1 study of CK271, our second cardiac myosin inhibitor. Thank you, Fady.

Thanks Robert.

We now John made significant progress during the quarter, despite the Corona virus pandemic.

As we previously explained we are fortunate position what the conduct of Galactic HF given how advanced we are in the trial conduct.

Amgen adopted the conduct of the trial do enabled delivery of investigational product that patients home.

And the conduct of study visit and the can add to conduct study visits remotely or collection in the study endpoints.

As a reminder, none of the trials main endpoints, including artillery, then you need death or collection of the Kansas City of Cardium up the peak questionnaire week 20 or.

Our depended on patients physically visiting clinical trial site.

Stuart Kupfer: I'm pleased to report that following a brief suspension in enrollment due to the coronavirus pandemic, during the second quarter, we resumed screening and patient enrollment in Redwood HCM in collaboration with our CRO and clinical trial site partner. As you know, Redwood HCM is the phase 2 clinical trial of CK274 and obstructive HCM. We activated many sites in the second quarter and expect to have approximately 25 of the 27 total sites activated and enrolling patients in the US and Europe by the end of Q3. Screening and enrollment have increased recently, and we're glad that the ongoing preparatory work that went on behind the scenes during the brief trial suspension is paying off.

Now as we approach the completion of the trial Amgen collaboration Cytokinetics.

He needs to work said vastly I'm trying to close out activities.

Trial remains blinded that's final events continue to accrue and we had towards final data collection and database lock.

We expect that soon accrue the final events the closed out Galactic HF in Q3, and we remain on track to report topline results of Galactic HF in Q4.

Regarding meteoric H. out the second phase three trial of Omecamtiv mecarbil in patients with heart failure.

We used to say that despite the suspension of enrollment earlier in the quarter due to the clone of virus pandemic.

We resumed screening and enrollment in June partnership in partnership with our clinical trial site.

How does the nine countries participating in New York catch up.

Or actively recruiting and we expect the remaining five it come online later in this third quarter.

We now have approximately 75% of our targeted 92 sites activated in the United States, Canada, France, Germany, Italy, Hungary, and the Netherlands.

Stuart Kupfer: While the trial was not enrolling, sites were still being activated, patients were identified, and screening visits were scheduled through coordination between our CROs and the sites. We're now seeing new centers enrolling patients, and some sites have multiple patients in their screening queue. We plan to enroll 18 patients in the first cohort. And we expect to have data to inform progression to Cohort 2 by the end of this year. During the quarter, we and others are pleased to see the results of EXPLORER, a phase 3 clinical trial, read out positively, which provides encouraging validation for the mechanism of cardiac myosin inhibition in patients with obstructive HCM and affords optimism for an impactful new potential therapy for these patients. As good students of clinical development, we had an opportunity to apply lessons from EXPLORER to our clinical development program and further advanced the field as we progressed CK274, an obstructive and non-obstructive HCM, as well as in a subgroup of HFTEF patients with hypercontractility of cardiac muscle.

Recruiting has resumed and were very grateful our clinical trial sites personnel for their collaboration to ensure the health and safety trial participants.

Conduct of this trial.

As we've stated results from New York, each up or not on the critical path to submitting regulatory filings for the potential approval of Omecamtiv Mecarbil.

Instead, the findings for me to York HFR supported it would be included in the supplemental filing following the potential commercial was predicated on expected results from Galactic HF.

We now expect a complete enrollment of New York H. out in early 2021.

Given the growing health economic burden of heart failure worldwide remain enthusiastic about the promise of Omecamtiv mecarbil.

Novel mechanism of action or potential medicine, working an entirely different way currently available therapy has the potential to become foundational to standard of care.

Of note during the quarter the FDA granted fast track designation Selma captive Mecarbil, which may potentially lead to an expedited review.

We also collaborated with Amgen survey on preparations for a potential marketing application dossier for Omecamtiv Mecarbil unprepared for possible meeting regulatory authority as maybe requested to discuss phase three trial results and potential marketing applications.

Turning now to our cardiac myosin inhibitor program, it's an exciting time, we expand and accelerate the development program.

As Robert mentioned regarding the license and collaboration and royalty monetization deals what he said.

Stuart Kupfer: Given the potential advantages of CK274 as a next-in-class therapy, we have an opportunity to improve upon the safety and efficacy profile observed in EXPLORER. Moving on to our additional cardiac myosin inhibitor, CK271. Following a recent setback due to a resurgence of coronavirus cases in the vicinity of our Phase 1 site, we now plan to begin screening in the first cohort during this quarter. As a reminder, the primary objective of this first in human phase one study is to assess the safety and tolerability and pharmacokinetics of single ascending oral doses of CK271 in healthy adult subjects.

In the surgical and Archie W. investment they enable us to develop CK, two seven or multiple indications in parallel as well as across a wider span of geography.

In terms the specifics regarding the development program associated with Teekay Q seven for these deals provide support to conduct a planned phase three clinical trial of our next in class My from inhibitor in patients with instructive ATM in North America Europe.

With our partner in China.

Promptly after we have results from Redwood HCM and receive feedback from regulatory authorities.

Our current goal is to initiate a phase three registration program for CK 274, and instructive HCM and late 2021, and we're working with our new partner GE said to enable concurrent development in China.

Stuart Kupfer: Finally, Cytokinetics was pleased to support the patient-focused drug development meeting for HCM patients hosted by the HCMA. This important meeting shed light on the extraordinary burden of disease and the challenges patients endure on a daily basis. There is no doubt the unmet need for new therapies to treat hypertrophic cardiomyopathy is great.

In parallel we're playing for the conduct of clinical trials have seen KPN seven or not obstructive eight yeah HCM.

And in a subgroup of heart failure patients with preserved ejection fraction, perhaps have also in the 2021 or 2022 timeframe.

To sum up the deals in July reinforce our commitment to rapidly broadly advance our cardiac myosin inhibitor program with the intent to potentially deliver the next in class medicine like meaningfully impact the underlying challenges of patients suffering from I picked up the cardium opposite season have stuff related to.

Robert C. Wong: And we applaud the HCNA for bringing this issue to the forefront. And with that, I'll turn it over to Robert Wong, who will provide an update on our financial... Thanks, Stuart.

Hi for contractility of cardiac muscle.

Robert C. Wong: I'll first provide an update on cash, revenue, and spending, and then Ching will review our progress toward our corporate development strategy. More details on our actual results for the second quarter are included in the press release, which was released earlier this afternoon. We ended the second quarter with approximately $213 million in cash and investments.

Now going to turn it over to Stuart to provide an update on Redwood HCM as well as our plans for phase one study of CK 271, our second cardiac myosin inhibitor.

Thank you Patty.

I'm pleased to report that following a brief suspension and enrollment due to the Corona virus pandemic.

During the second quarter, we resumed screening and patient enrollment in Redwood HCM and collaboration with our CRL and clinical trial site partners.

Robert C. Wong: Our revenues in Q2 2020 will come from our strategic alliances with Amgen and Estella. For Amgen, we recognize revenue associated with their reimbursement of our development expenses related to Meteoric HF. For Astellas, we recognize revenue for their reimbursement of expenses related to our scientists engaged in collaborative research. Our second quarter 2020 R&D expenses decreased to $21.8 million from $24.0 million in the second quarter of 2019, primarily due to lower spending related to our neuromuscular development activities with the completion of Fortitude ALS in 2019, offset by increased activities related to Redwood HCM in 2020. More than 50% of our R&D expenses were attributable to our cardiovascular programs Our second quarter 2020 G&A expenses were $14.2 million, up from $9.8 million in Q2 2019, due primarily to higher personnel-related costs, including stock-based compensation and higher outside services for pre-commercial activities.

As you know right, where they see and it's a phase two clinical trial of CK 274 in obstructive HCM.

[noise], we activated many sites and the second quarter and I expect to have approximately 25 of the 27 total sites activated and enrolling patients in the U.S. and Europe by the end of Q3.

Screening and enrollment have increased recently and I were glad with the ongoing preparatory work that went on behind the scenes during the three trial suspension is paying off.

Well I will try it was not enrolling sites were still being activated patients were identified and screen visits were scheduled through coordination between RCR rose and the sites.

We're now seeing new centers enrolling patients in some sites had multiple patients and their screening Q.

We plan to enroll 18 patients in the first cohort.

And we expect to have data to inform progression to cohort two by the end of this year.

During the quarter, we and others were pleased to see results of explore.

Phase three clinical trial read out positively.

Which provides encouraging validation for the mechanism of cardiac myosin inhibition in patients with obstructed HCM.

And affords optimism for an impactful new potential therapy for these patients.

As good students of clinical development, we have an opportunity to apply lessons from explore so our clinical development program.

And further advanced the field as we progressed, CK 274, and obstructive and non obstructive HCM.

As well as in a subgroup of have patience with hyper contractility, a cardiac muscle.

Ching W. Jaw: And now, Ching will review progress in connection with corporate development strategies. Thanks, Robert. As we have discussed, we have been working with our management team and our board over the past year to ensure that our financial position is solid as we transition the company into a fully integrated biopharmaceutical organization. Through our recent business development, loyalty monetization, and equity offering transaction. We are well positioned financially to operationalize the fund. The Royal Operation Alliance funds near-term to mid-term projects and initiatives. To recap our cash position, we ended the second quarter with $213 million in cash and will add $160 million of additional capital upon the closing of the modernization of Maverick-Hampton Wealthy, plus $90 million in additional capital available at our option from the RTW transaction. We raised approximately $190 million through our recent equity offering, net of expenses.

Given the potential advantages of CK 274, as an X in class therapy, we have an opportunity to improve upon the safety and efficacy profile observed and explore.

Moving to our additional cardiac myosin inhibitor CK 271.

Following a recent set back due to a resurgence of Corona virus cases in the vicinity of our phase one site.

We now plan to begin screening in the first cohort during this quarter.

As a reminder of the primary objective of this first in human Phase one study.

It's to assess the safety and Tolerability and pharmacokinetics of single ascending oral doses of CK 271, and healthy adult subjects.

Finally, cytokinetics was pleased to support the patient focused drug development meeting or H.C.N. patience hosted by the eight sandy.

This important meeting said like on the extraordinary burden of disease, and the challenges patience and door on a daily basis.

There's no doubt the unmet need for new therapies to treat hypertrophic cardiomyopathy is great and.

And we applaud the ace DNA for bringing this issue to the forefront.

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

Thanks Stuart.

First provide an update on cash revenue and spending and then Ching will review our progress toward corporate development strategies.

Ching W. Jaw: We expect to end 2020 with more than $500 million in cash, plus committed cash, subject to closing conditions. The company also updated its financial guidance for 2020. We still anticipate cash revenue will be in the range of $18 to $22 million, and operating expenses will be in the range of $120 to $130 million. However, we have narrowed our range for projected full-year net cash utilization to be between 110 to 115 million.

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

We ended the second quarter with approximately 213 million in cash and investments.

Our revenues in Q2 2020 came from our strategic alliances with Amgen and Astellas.

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

Stella we recognize revenue for their reimbursement of expenses related to our scientists engaged and collaborative research.

Our second quarter 2020, R&D expenses decreased to 21.8 billion from 24.0 million in the second quarter have 2019, primarily due to lower spending related to our neuromuscular development activities with the completion of four to two hail left in 2019.

Ching W. Jaw: While we will not give formal guidance for 2021 until our Q4 earnings call, we expect to end this year with more than $500 million on the balance sheet, which we anticipate will represent more than three years of forward cash, even as we expand the development program for CK274, alongside plans to co-promote Omicantum Carbo with Amgen. If the results of Galactic HF are positive in Q4, we can anticipate milestone payments over the next 12 to 18 months. Plus, upon its commercialization, royalties on tier worldwide sales of Omicantin or Carbo outside Japan might exceed 20% with a lower royalty rate in Japan.

Offset by increased activities related to redwoods keeps me up in 2020.

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

Our second quarter 2020, DNA expenses were 14.2 million up from 9.8 million in Q2, 2019, due primarily to higher personnel related costs, including stock based compensation and higher outside services for pre commercial activity.

Ching W. Jaw: The recent transactions we completed further enable us to leverage our partnership with Engen to build our commercial business, and in parallel, we have the capital to expand our biopharmaceutical research platform with the goal of doubling the size of our development pipeline over the next five years, as we have outlined in our Vision 2025. And with that, I'll turn the call back over to Robert Blum. Thank you, Ching.

And now shingle <unk> Chicken will review progress in connection with corporate development strategy.

Thanks Robert.

As we have discussed we have been working with our management team and outboard over the past year to ensure that our financial position as solid as we transition the company into a fully integrated biopharmaceutical organization.

With our recent business Evolvement, well, if you monetization and equity offering transactions, we are well positioned financially to operationalize the bond.

Robert I. Blum: It was indeed a productive quarter, and we continue to build momentum into the second half of this year. To pick up on Ching's earlier comments regarding the potential commercialization of Omecamptomicarbol, Amgen and Cytokinetics expect to leverage the strengths of both companies to educate the heart failure community about potential clinical effects and the economics of Omecamptomicarbol and how it may be positioned in the continuum of care. Through our co-promotion with Amgen, we expect to conduct a coordinated field deployment strategy, leveraging a reach and frequency approach in institutional accounts in North America. To that end, we recently conducted analyses relating to the United States heart failure institutional care market segment, including potential target account assessment and prioritization for our planned commercialization. We also continue to conduct commercial readiness activities in collaboration with Amgen in preparation for the commercialization of Omicamptomacarbal, including market research related to product branding elements, potential positioning, position preferences, and potential customer accounts. And finally, we continued our collaboration with providers and health care systems to generate health economics and outcomes research related to the health care costs associated with the treatment of heart failure patients.

Rockaway show lies and fun near term to mid term projects and initiatives.

Well recap our cash position. We ended the second quarter was 213 million cash and will add 160 million of additional capital upon closing of the modernization.

With Tencent Lucky.

Last night email in additional capital available at our option problem, the our tw transactions.

In addition.

We raised approximately 190 million throughout recent equity offering net of expenses.

We expect to end 2020 with more than 500 million in cash plus committed cash subject to closing conditions.

The company also updated financial guidance for 2020.

We still anticipate cash revenue will be in the range of 18 to 22 million and operating expenses will be in the range of 120 230 million. However.

We have never old our range for projected full year net cash utilization to be.

110 to 115 million.

Well, we will not give formal guidance slide 2021 until our Q4 earnings call. We expect to end this year with more than 500 million on the balance sheet, which we anticipate will represent more than three years. So for cash even as we expand the development program course, he heads with others.

Sure.

Alongside plans to co promote on weekends and mccarville with Amgen.

If results of Galactic HF are positive in Q4, we can anticipate milestone payments over the next 12 to 18 month.

Robert I. Blum: Regarding heart failure education, as we discussed at our recent Investor and Analyst Day, we initiated a disease state education program to educate the heart failure community on the unmet needs of heart failure patients and explain how contractility drives cardiac performance in half-reps. And importantly, the commercial operations we're building to support Omicampt and McCarville, funded largely by Amgen, can be leveraged to commercialize BK274 if successful in North America Furthermore, our recent transactions with RTW and Zhixing Pharmaceuticals accelerate our development programs and expand our geographic reach while preserving opportunities for further leverage to potential additional partners. Finally, in the second quarter, on the neuromuscular front, we continue to prepare for the potential advancement of REL-deceptive to a phase three clinical trial in patients with ALS.

Plus upon its commercialization well a piece on the tier worldwide sales of will only be kept them, but cobble outside Japan, thereby exceed 20% was a low lower royalty rate in Japan.

The recent transactions, we complete its fair to enable us to leverage our partnership with Amgen to build our commercial business.

In parallel we have the capital to expand our bio pharmaceutical research platform with a goal of doubling the size of our development pipeline over the next five years as we have outlined in our vision 2025.

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

Thank you King.

Wasn't you need a productive quarter and we continue to build momentum into the second half of this year.

To pick up on Cigs earlier comments regarding the potential commercialization of Omecamtiv, Mecarbil, Amgen and Cytokinetics expects to leverage the strength of both companies to educate the heart failure community about potential clinical effects and the economics of Omecamtiv Mecarbil, that's how it may be position to the continuum of care.

Through our co promotion with Amgen, we expect to conduct a coordinated field deployment strategy, leveraging a reach and frequency approach and institutional accounts in North America.

Toward that end, we recently conducted analyses relating to the United States Heart failure institutional care market segment.

Robert I. Blum: And we engage with clinical experts and patient advocates and health technology assessment organizations to secure feedback on endpoints and other matters relating to the design of the trial. We also received advice from EMA through protocol assistance for the Phase 3 trial. And also during the quarter, we announced the continuation of our longstanding partnership with the ALS Association in the fight against ALS.

Including potential target accounts assessment and privatization for our planned commercialization.

We also continue to conduct commercial readiness activities in collaboration with Amgen.

Operation for the commercialization of Omecamtiv, mecarbil, including market research related to product ramping elements potential positioning physician preferences and potential customer accounts.

And finally, we continued our collaboration with providers and health care systems to generate health economics and outcomes research related to the health care costs associated with the treatment of heart failure patients.

Robert I. Blum: Again, further evidence of our steadfast commitment to this courageous and inspiring patient population. In summary, cytokinetics is well positioned to continue to execute against our vision 2025 as we look forward to what we believe is a transformative time in the company's maturation. Leading into the end of this year and our expected results from Galactic HF in Q4. Now, let me recap our expected milestones for 2020. We're only camped in McCar

Regarding heart failure education, as we discussed at our recent Investor and Analyst day, we initiated a disease state education program educate the heart failure community on the unmet needs of heart failure patients can explain how contractility drives cardiac performance in half throughout.

And importantly, the commercial operations were building to support Omecamtiv Mecarbil.

Good largely by Amgen can be leveraged to commercialize teekay to 74, if successful in North America Europe.

Robert I. Blum: We expect top-line results from Galactic HF in the fourth quarter, and we expect enrollment in meteoric HF in patients with heart failure to be completed in early 2021. For AMG594, the phase one study of AMG594 is now complete, with data analyses ongoing.

And Furthermore, our recent transactions with Archie W and finishing pharmaceuticals accelerate our development programs and expand our geographic reach while preserving opportunities for further leverage to potential additional partnerships.

Finally in the second quarter on the neuromuscular front, we continue to prepare for the potential advancement of relative subject to a phase three clinical trial in patients with they allow us and we engage with clinical experts and patient advocates and health technology assessment organizations to secure feedback when endpoints and.

Robert I. Blum: Amgen and Cytokinetics are discussing next steps in the development program. For CK274, we expect to complete enrollment in the first cohort of Redwood HCM and to have data to inform progression of the trial to the second cohort by the end of 2020. For CK271, we expect to initiate a Phase I study in Q3 2020. For rel-deceptive, we expect to continue to prepare for a potential Phase III clinical trial and registration program in patients with ALS. And for our ongoing research, we expect to continue research activities directed to the cardiac and skeletal sarcomere and our other muscle biology research programs, and we expect to continue research in collaboration with Astellas directed to the discovery of next generation skeletal sarcomere muscle activators through 2020.

Other matters relating to the design of the trial.

We also received advice for you make the protocol assistance for the phase three trial.

And also during the quarter, we announced the continuation of our longstanding partnership with the election Association and the fight against they have less again further evidence of our steadfast commitment to this courageous and inspiring patient population.

In summary, Cytokinetics is well positioned to continue to execute against our vision twentytwenty, but as we look forward to what we believe the transformative time in the company's maturation.

Leading into the USDA this year and are expected results from Galactic HF in Q4.

Now, let me recap our expected milestones for Twentytwenty.

For Omecamtiv Mecarbil, we expect topline results from Galactic HF in the fourth quarter.

We expect enrollment in New York HF in patients with heart failure to be completed in early 2021.

For AMC Fivenine for the Phase one study of AMG Fivenine for is now complete with data analyses ongoing.

Operator: Operator, with that, we can now open up the call, please, to questions. Ladies and gentlemen, at this time, if you would like to ask a question, please press star and then the number one on your telephone. Again, that is star and the number.

Amgen and Cytokinetics or discussing next steps in the development program.

For CK 274, we expect to complete enrollment in the first cohort of Redwood HCM and you have data to inform progression of the trial to the second cohort by the end of Twentytwenty.

Dane Vincent Leone: And your first question comes from the line with Dane Leone and Raymond James. Hi Dane, question. So maybe starting with me, we've gotten questions in from the investment community, posted deals on 274, just trying to think strategically from your point of view, as you advance 271, how you would manage two assets with a similar MOA in the clinic at the same time and how they might differentiate on indication if you've thought that far ahead. And then the second one for me would just be anything you can give us for setting the table for the Redwood HDM readout for cohort one by the end of the year, and how you think about the key data points that you'll be looking at that you'd want investors to focus on as well. Thank you. I'll start and then turn it over to Fady, and maybe Fady will turn it over to Stuart.

For CK 271, we expect to initiate a phase one study in Q3 Twentytwenty for relative to some did we expect to continue to prepare for a potential phase three clinical trial and registration program in patients with they are less.

For our ongoing research, we expect to continue research activities directed to the cardiac and skeletal sarcomere and our other muscle biology research programs and we expect to continue research in collaboration with the Stellus directed to the discovery of next generation.

Total sarcomere muscle activators through Twentytwenty.

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

Ladies and gentlemen at this time, if you'd like to ask a question. Please press star and then the number one on your telephone keypad.

Once again that is star in the number one.

And your first question comes from the line of it Dane Leone with.

Raymond James.

Hi, good.

Questions.

So maybe starting with me, we've gotten a questions and from the investment community.

Hosted deal on to some for just trying to think strategically premier point of view as you invest to seven one.

Robert I. Blum: We've got two questions there, one with regard to 271. So, as has been our history at Cytokinetics, and you're just getting to know us a bit, but we've always been advancing lead compounds, backups, follow-ons, and diversifying both chemical and pharmacokinetic space for mechanisms of action that we look to bring through clinical research. That's why we call it clinical research because obviously there's opportunity to expand and diversify. With regard to CK274, we're committed to, as you've heard, obstructive and non-obstructive, as well as we're considering PEPP-PEPP, and as far as CK271 is concerned, it really depends on the profile.

How you would manage to assets with similar I'm away in the clinic at the same time and how they might differentiate on indication if you've thought that far ahead.

And then the second one for me would just be anything you can give us for setting the table on the Redwood HTM readout for cohort one by the ended a year.

And how you think about the key data points that you'll be looking at a that you would want investors to focus on as well.

Thank you.

Sure I'll start and then turn it over to Saudi and maybe study.

We'll turn it over just Stewart we've got.

Two questions there one with regard to 271.

So as has been our history of sort of kinetics, and you're just getting to know us a bit but we've always been advancing a lead compounds backups follow ons and diversified book chemical and pharmacokinetic space for mechanisms of action that we look to bring through clinical research that's why.

Fady Ibraham Malik: Things we'll learn about CK274 but also CK271 that may enable us to consider a broader development program. We're also advancing other compounds from this same program, different mechanisms, different properties, such that we might expect to see other compounds enter the clinic. So I'll let that be enough for me and maybe ask Fady to elaborate and also answer your second question relating to what data we'll look at at Redwood in order to inform the second cohort. I think you covered the first question, Robert, 271. I think that's the data coming out of its phase one trial.

We call it clinical research, because obviously, there's opportunity to expand and diversify with regard to CK two seven poor we're committed to as you've heard obstructive and nondestructive as well as as we're considering.

And as far as CK 271 is concerned it really depends on the profile things will learn about CK 274, but also PK to seven one that may enable us to consider a broader development program.

We're also advancing other compounds from the same.

Program different mechanisms different properties.

But we might expect to see other compounds enter the clinic.

Fady Ibraham Malik: And as we start to see more data on 274, we'll begin to form a strategy with those two compounds. With regard to Redwood ATM, maybe I'll turn it over to Stuart, who's been very closely overseeing the progress of that study, and discuss what our strategy will be towards the end of the year in terms of data. And thanks, Beth. Thank you, Fady.

Well, let that be enough for me and maybe Saudi to elaborate and also answer your second question relating to what data, we'll look at at Redwood in order to inform the second cohort.

I think you covered the first question Robert to seven one I think the data come out of a its phase one trial and as we start to see more date onto seven or will begin a form.

Strategy with those two compounds.

With regard to.

Stuart Kupfer: So, as we mentioned, we plan to have the results of Cohort 1 by the end of the year. You know, the main objective of this study is really safety and tolerability. So we'll be primarily focused on those safety endpoints. But strategically, you know, we're very, very much focused on this individualized dosing strategy that we've incorporated into the study design. Um, because there will be quite a spectrum of disease severity in the population we're enrolling. So we anticipate, depending on the patient's individual pathophysiology or severity, that the doses may vary depending on the individual patient.

Redwood ATM, maybe I'll turn it over to Stewart and that's been very closely.

See overseeing the progress of that study and add to discuss what our strategy will be towards the end of the year.

Terms of data and next steps.

And thank you have had so as we mentioned we plan to have the results of cohort one by the end of the year.

Yeah. The main objective of this study is really safety and Tolerability. So we'll be primarily focused.

On the safety endpoints, but.

Strategically yeah, we're very.

Very much focused on.

This individualized dosing strategy that we've incorporated into the study design.

Because there will be quite a spectrum of disease severity in the population where on romaine. So we anticipate.

Stuart Kupfer: But in terms of pharmacodynamic endpoints, we'll be looking at improvement of the left ventricular outflow tract gradient that in this patient population contributes quite substantially to Heart Failure Symptoms and Poor Cardiac Function, As well as looking at signs and symptoms, other pharmacodynamic endpoints like NT, Pro-B, and P. So the totality of the data from this study then will give us a readout on the range of doses we're studying in cohort 1, and then those data will inform progression to a higher dose range that we're planning in cohort 2. Great. Just one clarification on my first question. Sorry.

Yeah, depending on.

Patients individual pathophysiology or severity that a dose as may vary.

Depending on the that the individual patient, but in terms of Pharmacodynamic endpoints will be looking at improvement of they left ventricular outflow tracked a great in that and this patient population contributes quite substantially to.

The heart failure symptoms and poor cardiac function.

As well as looking at the signs and symptoms.

Other pharmacodynamic endpoints like NT pro BNP. So in totality of other data from this study that will give us a read out on the range of doses were studying and cohort one and then those data well and perform.

Dane Vincent Leone: I think investors are just trying to understand whether there was anything legally preclusive within the RTW agreement that prevented 271 being developed in the same indication. Sorry, I just wanted to clarify that. Sorry, there's nothing in our agreement that precludes our ability to develop CK271 as we see fit, but we have no intention right now.

Progression to a higher dose range that we're planning and cohort two.

Great just one clarification on my first question, sorry, I think investors or or just trying to understand whether there's anything occlusive legally within the Archie W. Agreement from 271 being developed in the in the same indications Oh sorry.

Robert I. Blum: Right now, CK271 still needs to be characterized in phase one, as does CK274 in phase two. So our goal is to be advancing multiple compounds forward, as I mentioned, and we'll learn about these compounds, their physiochemical properties and otherwise, in order to ensure that we can lead in this space across different types of indications, different types of subtypes of patients, etc. So to your question, no, there's nothing that precludes us. Excellent. Thank you so much. Thank you. Operators from the line of Jeff Hung with Morgan.

I would just wanted to clarify that.

Okay, sorry, there's nothing in our agreement that concludes our ability to develop CK 271 is we see fit well we have no intention right now.

Right No CK 271 still needs to be characterized two phase ones as to CK to sell them for a in phase two so our goal is to be advancing multiple compounds forward as I've mentioned and we'll learn about these compounds physiochemical properties and otherwise in order to ensure that we can lead in this space.

Well, it's different types of indications different types of sub types of patients et cetera.

So to your question no there's nothing that precludes us.

Excellent. Thank you so much.

Thank you.

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

Jeff Hung: Hey Jeff, thanks for... Hey, thanks for doing the questions. You indicated that AMG 594 Phase 1 is complete. When might we see the data from the study and are you likely to move forward with only one indication, or is it likely that you'll proceed in parallel with multiple indications like CK274 and then after follow-up? Yeah, very good question.

Hi, Jeff Thanks.

Hey, Thanks for taking the question you indicated that AMG Fivenine for phase one is complete one might not one data from the and are you likely to move forward and only one indication or is it likely that you'll proceed in parallel with multiple indications like CKD. Some core and then a follow up.

Yes, very good question.

Robert I. Blum: Um, so we're right now in the process of receiving, evaluating, and analyzing that data, and that's a process that is really just at its beginning. As far as Phase 2 indications are concerned, we're thinking broadly here. We've been undergoing an exercise that includes market research and working with key opinion leaders, clinical assessments, clinical trial design, endpoint evaluation, all sorts of things that might inform a broad development program that could encompass many different indications, recognizing that as a cardiac muscle activator, there are many different directions we could go, both that address large market opportunities as well as what might otherwise be So we're thinking about that with Amgen, and in a way that we'll probably have more to say about all this later in the year. But in the meantime, it's still at the paper and pencil exercise level.

So we're right now in the process.

The thieving in evaluating and analyzing those data.

That's a process that.

It is really just out its beginnings.

As far as phase two indications are concerned we're thinking broadly here.

We've been well undergoing an exercise that includes market research and working with key opinion leaders clinical assessments clinical trial design endpoint.

Evaluation, all sorts of things that might inform abroad development program that could be encompassing of.

Many different indications recognizing that has a cardiac muscle activator. There are many different directions. We could go booked at address large market opportunities as well as what might otherwise be referred to as more specialized care segments.

Thinking about that well with Amgen and in a way but.

We'll probably have more to say about all this later in the year, but in the meantime, it's still at the.

Paper and pencil exercise level.

Jeff Hung: And so when you said later this year that when we might see aspects of the phase one data, or yeah, I suspect that as we make certain decisions, we'll be in a position to share data that could be supportive of those decisions. Okay, great. And then as a follow-on to the previous question, I recognize you still need to characterize CK271 in humans, but maybe you can talk about the differences in the profile from the preclinical data between CK271 and CK274.

And so and when you said later this year is that when we might see aspects of the phase one data or [noise].

Yeah, I suspect that as we will make certain decisions will be in a position to share data.

Would be supportive of those decisions.

Okay, Great and then at the fall under the previous question.

I recognize you still need to characterize he gets you said is one of the humans, but maybe you can talk about that differences in the profile from the preclinical data between CK 271, and CK two seven for thank you.

Fady Ibraham Malik: Thank you. Fady, do you want to take this? I can take that. Yeah, I mean, preclinically, CK274 and 271 have similar mechanisms of action. Primarily, there are differences a little bit in terms of the steepness of the exposure response relationship between the two molecules, and also their pharmacokinetics are a bit different preclinically as well, which is the reason that we advanced this and to get a little diversity of PK and PKPD in the clinic and use that to inform the advancement of this mechanism of action in patients as well as provide the opportunity to split indications or other things that we

Now do you want it picked up.

Hi can take that's yeah, I mean, preclinically K two sub par and then 271 have similar mechanisms of action, primarily up there or are our differences a little bit in terms of the steepness of the exposure response relationship.

Between two molecules and also there pharmacokinetics.

Our bit different pre clinically as well, which is the reason that we.

Basket and to get a little diversity of.

PK and PK PD and.

In the clinic.

And and use that to inform advancement of you know a bar this mechanism of action when patients as well as provide.

The opportunity this presentation or other things that we might think about.

Jason Nicholas Butler: Thank you. Our next question comes from the line of Jason Butler with JNP Securities. Jason, your line is open. Are you there?

Thank you.

Our next question comes from the line as Jason Butler with JMP Securities.

Hi, Jason.

And Jason Your line is open.

Using either.

Operator: Operator, looks like we might have lost Jason. Maybe he can go back in the queue, and we can go to the next one. Okay, your next question comes from the line of Charles Duncan with Kantor. Hi Charles. Hi Robert and team COVID be darned. You guys have made a lot of progress. Congratulations. I had a quick question on Omicamptive timing and then on strategy. First of all, regarding Omicamptive timing, Fady did a great job laying out kind of what to expect. But I'm, I'm kind of wondering in terms of, you know, assuming success in Galactic, when would you anticipate being able to file an NDA? Is, is all the CMC done? Would you anticipate being able to conduct a meeting, a pre-NDA meeting with the agency before, say, mid-first quarter of next year? Fady, I'll turn that over to you, and I'll elaborate afterwards. Sure. Hi Charles.

Operator looks like we might have lost Jason maybe you can go back into queue and we can go to the next one.

Your next question comes from the line of Charles Duncan with Cantor.

Hi, Charles.

Hi, I'm, Robert and his team Kobin be darned.

You guys had made a lot of progress congratulations [laughter] had a quick question on Omecamtiv timing and then on strategy first Bob regarding your own they can't get the timing Saturday to create jobs laying out kind of what to expect right I'm I'm kind of wondering in terms of you know assuming success.

And collapse it when would you anticipate being able to file and then D.A. is is all the CMC done would you anticipate being able to conduct and a meeting a pre NDA meeting with the come with the agency before say mid first quarter of next year.

Now ill turn that over to you and elaborate afterwards.

Sure.

Hi, Charles you know I think I can say that that and Ben Cytokinetics, ABS and create fairing very aggressively or.

Charles Cliff Duncan: You know, I think I can say that Amgen and Cytokinetics have been preparing very aggressively for, in the past couple of years, for a potential NDA filing, so everything has been accelerated to shorten the time as much as possible between trial results and the filing of an NDA. All clear. You know, I think you would see us moving forward to an NDA filing quite early or quite rapidly. There isn't really anything I would say that is, you know, other than the results that need to be in our hands in order to progress with the NDA filing. And just maybe to elaborate a little bit, these work streams, to Fady's point, have been going on for quite a while, and both companies have been working diligently on preparing study reports and ensuring that they all get quality controlled.

In the past couple of years, thus far in central <unk> filing so.

Everything is then accelerated to shorten the time as much as possible between trials result.

And the filing of an end da.

I think you know you always see a.

The results are supportive and and that the path forward.

Clear.

Yeah, I think you would see us moving forward should end the filing quite early.

Rapidly.

There isn't really anything I would say that is that you know other than the result said that needs to be our hands in order to.

Progressed in San Diego pilot.

Yeah, just baby to elaborate a little bit.

These work streams to Friday's point have been going on for quite awhile and.

Both companies working diligently on preparing study reports and.

Ensuring that they all good quality controls its not just for the what would be the U.S. filing, but also outside the U.S. and I think this is a credit to the collaboration that we've been engaging very proactively in these work streams, recognizing we do want to move swiftly to enable potential approvals.

Charles Cliff Duncan: It's not just for what would be the U.S. filing but also outside the U.S. And I think this is a credit to the collaboration that we've been engaging very proactively in these work streams, recognizing we do want to move swiftly to enable potential approvals. The drug has a fast track designation, as you know, and that could be enabling a faster review time as well.

The drug.

How's the fast track designation as you know and that could be enabling a very fast to review time as well. So all these things are aligned with expectations that we need to be in a position to be ready to co commercialize.

Robert I. Blum: So all these things are aligned with expectations that we need to be in a position to be ready to co-commercialize as soon as possible in 2021. Okay, and that's very helpful. And then quick question on strategy in Asia. I know you updated the partnership a couple years ago to include Japan, but I can't recall what the plan is for other Asian countries such as China. Can you provide more color?

As soon as possible in 20 to 21.

Okay, and that's very helpful. And then quick question on strategy in Asia I know you updated the partnership reached a couple couple of years ago to include Japan, but I can't recall, what is the plan for other Asian countries such as China.

Can you provide color.

Robert I. Blum: Sure. So the collaboration we have with Amgen is a worldwide collaboration and includes China. It previously excluded Japan, but as you mentioned, in 2013, it was expanded to include Japan.

Sure. So the calibration we have with Amgen is a worldwide collaboration includes trying to.

It previously excluded Japan, but as you mentioned in 2013. It was expanded to include Japan. So now it is truly worldwide.

And not just between Amgen and Cytokinetics, but with our consent Amgen also provided a sub license to serve gig in Europe and other Commonwealth independent states to be enabling of what will be the muscle pardon the pun Serbia in order to be a commercial partner in areas, where they have spin.

Robert I. Blum: So now it is truly worldwide. And not just between Amgen and Cytokinetics, but with our consent, Amgen also provided a sublicense to Servier in Europe and other Commonwealth independent states to be the enabler of what will be the muscle, pardon the pun, of Servier in order to be a commercial partner in areas where they have specific expertise. Our role in co-commercialization is a global role. It's a worldwide role. Thank you very much. Okay, it does. I like the pun. Last question for Ching. Ching, you were laying out a cash position at the end of this year.

If it cuts for cheese.

Our role in co commercialization.

As a global goal, it's a worldwide rule.

Spends all countries and that's under the commercialization oversight of a joint commercialization committee or co promotion rule is a north American role and where we will have sales and marketing people focused will be in North America. Our royalty is earned on worldwide sales.

Sales hope that helps.

Okay. It does I like the time last question for chain chain Youre laying out a cash position at the end of this year and I'm not sure a few misspoke or I Miss heard more likely the ladder that at the end of 21, you May also a end the year with 500 million and I'm.

Charles Cliff Duncan: And I'm not sure if you misspoke or I misheard, more likely the latter, that at the end of 21, you may also end the year with 500 million. And I'm assuming that includes some assumption about milestones and perhaps even royalties. Is that, was that the case? Or did I mishear that?

Assuming that includes some assumption about milestones and perhaps even royalties is that was that the case or did I Miss here, though Charles but.

Ching W. Jaw: No, Charles, but what I heard, what I said, was that we were more than 500 million in 2020. I didn't say anything about 2021. Okay, that's clear. But you did mention milestones and potentially royalties in the next 12 to 18 months, correct? Yes, that is correct, and that's associated with Omicantin-McCarville if Galactic were to be positive. Got it. Thanks for the clarification. Thank you, Charles. Hello, Joe. Hello guys, this is Emanuela calling for Joe Pantginis. Thanks for taking the question. I have a couple.

What I heard what I said it was we will and Twentytwenty was more than 500 million.

I didn't say anything about 20.1.

Oh, Okay. That's that's clear, but you you you did mention milestones and potentially royalties and next 12 to 18 months correct. Yes, yes that is correct and that's associated with only candidate mccarville, if galactic that were to be positive.

Got it thanks for the clarification.

Thank you Charles.

Your next question comes from the line of Joseph.

H.C. Wainwright.

Hello, Joe.

Hello, guys is now underway last coding for Jochen goal.

Thanks for taking my question.

Oh I have the copper that I was wondering what kinda give as a little bit more color on that as I said de Luca you are not to economic they feel outperforming and there.

Joseph Pantginis: I was wondering if you could give us a little bit more color on the results of the analysis you are performing, the marketing analysis you are performing, and the Commercialization Activities. I guess I'm trying to understand within the heart failure population, which segment of patients you are targeting first, and who is going to get to the market first? Sure. There'll be a time when we can be more specific and elaborate on this. But in a general sense, what I can say is that we're looking at where cytokinetics, a company with more limited access to capital and resources, can put forward a commercial organization that can be highly effective to drive the business, and in institutional care segments where there is high volume heart failure. And some of these are accounts that might be unique to cytokinetics. Some of them might be ones that are shared with Amgen.

Well my presentation it appears there.

Oh, yeah, when like I guess I'm trying to understand it.

We there wont be on failure population, we Sacramento station thing it why that tied to get will occur sentiment coin, it's going to get to Ah well, that's going to get those accounting Paris.

Sure so they'll be a time when we can be more specific can elaborate on this but in a general sense. What I can say is the following.

We're looking at where Cytokinetics a company with more limited access to capital in resources can put forward a commercial organization that can be highly effective.

To drive the business and in institutional care segments, where there is high volume heart failure and some of these are accounts that might be unique to cytokinetics. Some of them might be a ones that are shared with amgen. What we're looking at this from a.

Robert I. Blum: But we're looking at this from a strategic standpoint. Where do we think we can be most impactful for the opportunity in terms of education, awareness, and pull-through? And where might they also provide advantages and pay dividends down the road for us in connection with our interests with regard to CK274, where, similarly, it's a concentrated customer care segment where there's high overlap with heart failure, high volume centers, and where these centers of excellence will be treating a majority of the HCM patients. So we're looking at that nexus, if you will, between heart failure and HCM in order to drive And that's something that we're discussing with Amgen, with the goal of having more granularity and clarity on all of this by the end of this year.

Strategic standpoint, where do we think we can be most impactful for the opportunity in terms of education awareness and pull through and whereby they also provide.

Advantages and pay dividends down the road for us in connection with or interest with regard to CK 274 were similarly, it's a concentrated customer care segment, where there's high overlap with heart failure high volume centers and where these centers of excellence will be treating a majority of the HCM.

So we're looking at that Nexus, if you will between heart failure and HCM in order to drive our strategy, albeit recognizing that there's still work to be done between us and amgen to align and agree on next steps with regard to our co promotion and that's something that we're discussing with Amgen.

With the goal of having more granularity and clarity on all of this by the under this year.

Got it thank you.

Joseph Pantginis: Thank you. And regarding, speaking of Amgen, I saw on clinicalcare.gov that Amgen has opened a post-trial access study where over-counted access will be provided to patients who participated in Galactic HF. The trial is not active yet, but I was wondering if this is a follow-up, like a kind of longer-term follow-up trial? Like, I was wondering what you're trying to achieve with this.

And it was that they are picking up on Jay.

I saw total panic I try to adopt gossip that on Jeff Olson that Paul try at Hospice study.

Well I don't think Comcast access will be provided to patients who participated in galactica chat entirely self upkeep, yet, but I was wondering.

That's probably a lot that kind of kind of along that path oil law.

Like I was wondering what what you're trying to achieve good day.

Lung data service.

Fady Ibraham Malik: This is a strategy that I'll ask Fady to speak to and elaborate on. Obviously, this is something that is dependent on results from Galactic, as those will be known in the fourth quarter. Yeah. Yeah, there are certain countries in the world where post-trial access is mandatory for patients that are enrolled in clinical trials in those jurisdictions. And so we have post-trial access. This is a program that is being put in place to roll those patients into it after they've completed Galactic and if the results are supportive of continued dosing. It's not necessarily intended to be a worldwide study across every single country, but we'll be targeting those countries where it's a requirement. I got it.

Just as a strategy that Oh last Friday to speak to an elaborate on obviously this is something that is dependent on results from galactic as those will be no in the fourth quarter.

Yep.

Yeah. There there are foreign countries in the World, where post trial box the mandatory for patients that.

Our enrolled in clinical trials in those jurisdictions and so.

We have a post trial access.

Program that is being put in place too.

All those patients into it after they've completed galactic and.

The results are supportive of continued.

Continued.

Good thing.

It's not necessarily intended to be a worldwide study you know across every single country, but will be determined in those countries, where it's a requirement.

Got it thank you very much.

Joseph Pantginis: Thank you very much. Okay, thank you very much. Sorry about the noise in the background.

Our next question comes from the line of.

Absolutely hyper Sandler.

Great. Thank you very much sorry about the noise in the background.

Operator: Thanks, too, for the update on cardio. I'm going to ask about the world assumption and just see if we can have any update there or what the latest is with thinking, which is stellar. Thanks.

Sure the update and cardio and going to ask about rather some said they just to see if we can have any update share. What's the latest says we're thinking the trust color. Thanks.

Pardon me ozone view, so it's a very good question and as we've been consistent across different communications. It is the case that we continue to prepare for potential phase three trial and as we mentioned a lot of activities during the second quarter in recognition of that Im very pleased with the fee.

Robert I. Blum: So it's a very good question, and as we have been consistent across different communications, it is the case that we continue to prepare for a potential phase three trial. And as we mentioned, a lot of activities during the second quarter in recognition of that. I'm very pleased with the feedback we're getting from both FDA and EMA, which is very aligned with the trial design and endpoints that we have in mind. We met with HTAs in Europe in order to get a sense of how they value these endpoints in accordance with a potential trial. All these things are pointing to the fact that were we to do a trial, it would be received well by the ALS community. And it's one that from a practicality standpoint, design timeline, and budget, we have our arms around.

But we're getting from both FDA and EMA made which is very aligned with the trial designed and endpoints that we have in mind, we circled with H.T. AIDS in Europe in order to get a sense of how they value. These endpoints in accordance with a potential trial. All these things are pointing to the.

Got that were we to do a trial it would be received well by the lift community and it's one that from a practicality standpoint design timeline and budget, we have our arms around but recognizing that we.

Robert I. Blum: But recognizing that we haven't committed to doing the trial yet, as we've indicated, that's going to be awaiting seeing the galactic results in order to really understand what our runway is, what our cost of capital is, what our ability to finish what we start. And that continues to be a trial that we would like to do, if we can, and, all things considered, but one that we have not yet committed to. Great, I can appreciate that. Thank you very much. Thank you. Hello, Salim. Hey guys, this is Dennis Sting on for Salim.

We haven't committed to do the trial yet.

We've indicated that's going to be awaiting being the galactic results in order to really understand what's our runway, what's our cost of capital what's our ability to finish what we start and that continues to be a trial that we would like to do if we can and recognizing all things considered but one that we have not yet committed to.

[music].

Great I can appreciate that thank you very much.

Thank you.

Your next question comes from the line.

Yeah.

Absolutely.

Hey, guys. This is Dennis staying on first Celine.

Salim Qader Syed: Thanks for taking the questions and congrats on all the progress. I have two questions, if I may. The first question is about Galactic. So, around half the Galactic patients had a history of ischemia, and I guess the heart presumably should have less functional tissue, and like even after rebath, I feel like it should have less functional tissue.

Thanks for taking my questions and congrats on a on the progress I'm I've two questions. If I may 1st question is on Galactic So [noise].

Around half the Galactic patients had a history of ischemia and I guess, the heart, presumably should have less functional tissue.

And like even after a rebound I feel like it should have less functional tissue. So I guess what data have you seen that gives you the confidence you'll be able to show the same clinical benefit in this group.

Salim Qader Syed: So I guess what data you've seen that gives you the confidence that you'll be able to show the same clinical benefit in this group? And then my second question is on HCM specifically, you know, how are you thinking about the opportunity in Europe? And what does the EMA think about the phase three endpoints? And is something like peak VO2, you know, like the right endpoint?

My second question is on HCM, specifically, you know how are you thinking about the opportunity in Europe.

How does the U.M. anything about the phase three endpoints and it's something like peak FBO too.

Like the right on point and thanks for taking the questions.

Fady Ibraham Malik: And thanks for taking the question. Sure, I think I'll ask Adi to answer both of those please. Sure, the, you know, with regards to the first question, you know, the data that support an effect in both ischemic and non-ischemic cardiomyopathies come from GALACT, I mean, from COSMIC, where you, where you look at the effect of omicantin-micarbol in those patient subgroups, and, you know, which you essentially saw were very similar effects on the measures of improvements in cardiac function, the changes in volumes, changes in entry co-BNP, You know, while there are fewer [inaudible] So I think there's the rationale to expect benefit in both types of subgroups.

Sure, let's say colescott he to answer both of those please.

Sure the.

With regard to the first question.

The data support and affecting both the scheme economic scheme as part of them off that needs a comes from polack from cosmic where.

The the effect of home a captive mccarville in those patient subgroups.

And when she essentially it's our very similar effects on the measurements of improvements in cardiac function the.

Changes in volumes changes I mentioned Cobian Pete.

Yeah, you know, while there are fewer muscle cells essentially in patients that have a scheme at cardium opposite paid a just you have to recall there, they're generally still lots of viable myocardium.

My Cardium that is a lot I purchased Tees and gets bigger.

And so in late can still augment their function.

Fady Ibraham Malik: Can you repeat your second question, please? Yes, sure. Um, I guess the HCM opportunity in Europe, like how, how are you thinking about it, you know, in terms of phase three? How did the EMA think about phase three endpoints with something like PQVO2, like a proper, It's a good question and I think, you know, from, it's still a bit early for us to comment on what the EMA may think about endpoints in phase 3. You know, we're planning, we have engaged them initially, and we plan to engage them more deeply in the coming months. We plan for a Phase 3 that would be conducted both in Europe and the U.S. You know, there's clearly guidance that comes out of Europe that functional improvements in patients with heart failure or with ATM are certainly, [inaudible] Got it. Thank you. Thank you. Press the star and then the number one on your telephone keypad.

And in response to buy back home camps, Mccarville, and we've seen that also in earlier trials.

Cosmic.

So I think there's the rationale expect benefit in both types of subgroups.

Can you repeat your second question. Please.

Yes, sure I guess, the HCM opportunity in Europe like how how are you thinking about it you know in terms of phase three how did the U.M. anything about phase three endpoints, there's something like peak if you go to like a proper.

That's a good question and I think you know.

Just a little bit early for us to comment on what you may think about endpoints and phase three.

No. We're planning we have engaged them initially and we plan to can engage them more.

Deeply in the coming months second we plan for phase three that would be conducted both in Europe and the U.S. there there's clearly a.

Guidance it comes out of your but functional improvements in patients with heart failure or we'd ATM, our certainly oh.

Well endpoints and that's maybe a question of how you define function or symptoms and right now I think we're still in the.

Oh.

Data of learning, what they what what their vision or what their opinions on that are.

Got it thank you.

Thank you.

Ladies and gentlemen, just as a reminder, if you'd like to ask a question. Please press Star then the number one on your telephone keypad.

Operator: Hi Chad, thanks for taking my question and, you know, congratulations on all the recent progress. I mean, given the time and effort it took to get here, I would already have been ecstatic just to be on a call one quarter away from Omicamp of data, but to have you guys so well-positioned with the rest of the pipeline going into that is truly fantastic. I've known you for a very long time, Chad, so it's gratifying, I know, to be able to share this with you. I am looking forward to the results later in the year to be sure.

Our next question comes from the line as Chad Messer Needham.

I should.

Hi, Thanks for taking my question and you.

Congratulations on all the on all the recent progress I mean, given me time and effort. It took to get here I would already had been ecstatic just to be on a call one quarter away from home a captive data, but to have you guys. So well position with the rest of the pipeline going into that is truly fantastic.

No no school very long time, Chad so its gratifying I know.

To be able to share this with you and looking forward to the results later in the year to be sure.

Chad Messer: Likewise, um, you know. Maybe a bigger picture question on your Vision 2025, part of that is to... Not kind of stop at the programs we've been talking about today, but keep going and have 10 drugs. I'm going to talk about branching out away from your focus on contractility to, you know, muscle energy and metabolism. You learned a couple weeks ago that you've been working on inhibitors of skeletal protein parasites. Unknown Speaker Can you maybe speak broadly about some of these areas and what kinds of conditions you can address by going after New Biology? A very good question.

Likewise.

You know maybe a bigger picture question on your vision 2025.

Part of that is to you know not trying to stop at the programs, we've been talking about today, but keep going you're having a 10 drugs.

In development by Dan, which you know given how proliferate your drug discovery engine has been is.

Yes.

Aggressive, but certainly feasible and I know in your corporate debt, you're kinda talk a barrel.

<unk> kinda talk about branching out away from your focus on contract to liddy to muscle energy and metabolism and learned a couple of weeks ago that you've been working on inhibitors of skeletal protein parasites Oh.

All different things stuff can you maybe.

Broadly to some of these areas and what kinds of what kinds of conditions you can address by going after that.

New biology.

Very good question.

Robert I. Blum: And I'll start, but it'd be better for you to hear from Fady on this. You know, we've taken an approach, and you've known us for a long time in this way, where we never wanted to be a company that was going to pivot on one product, one indication. And it's taken us a very long time, obviously, to get to where we are now. But at the same time, we are enabled both financially and operationally and with a pipeline to be able to build, we hope, a very sustainable and durable business that grows with the science and continues to innovate and bring forward new medicine. With that said, it's important to be self-aware and to understand where we think we can have a competitive advantage and be leaders. And that's where we've pioneered and continue to lead in the area of contractility of muscle, which by itself has afforded us a very broad pipeline, which could go well beyond even the indications we've been speaking about for the compounds that are in clinical trials. Rel-deceptive, by itself, could be a pipeline in and of itself.

Start, but better for you to hear from Saudi on this.

You know, we've we've taken that approach and you've known us for a long time in this way, where we never want it to be a company that was going to pivot on one product one indication.

It's taken us a very long time, obviously to get to where we are now but at the same time, we're enabled both financially and operationally and with a pipeline to be able to build we hope very sustainable and durable business that grows with the science and continues to innovate and bring forward new medicines.

With that said, it's important to be self aware and to understand where we think we can have a competitive advantage can be leaders and that's where we pioneered and continued to lead in the area of contractility of muscle, which by itself has afforded us a very broad pipeline, which could go well beyond even the indications we have been speaking about.

For the compounds that are in clinical trials real deceptive by itself could be a pipeline in of itself, which at this point, we've really been focus too as you know LS and possibly as summit.

Robert I. Blum: And to this point, we've really been focused on, as you know, ALS and possibly SMA. But we also want to make sure that we're constantly listening to the marketplace as well as patients. And that's where we think we've established a leadership position as it relates to the biomechanics of muscle that extends also to how muscle is a pivot point in energy, growth, and metabolism and other indications but should still remain within our cardiovascular neuromuscular vertical.

But we also want to make sure that we're constantly listening to the marketplace as well as patients and that's where we think we've established a leadership position as it relates to the bio mechanics of muscle that extends but also to how muscle.

Is a pivot point in energetics growth of metabolism, and other indications, but still should remain within our cardiovascular neuromuscular vertical.

Robert I. Blum: So we're going to continue to invest in pipeline, cardiovascular, and neuromuscular. And as we spun out, as you saw, another company recently based on things we discovered, those are going to be more tangential and more going to be monetized in other ways in order to be enablers of our leadership in these verticals. Now, with that said, we have to be thinking biologically as well as from the marketplace, and that's where Fady and his colleagues have put together a very good roadmap as we move beyond the contractility of muscle to include mitochondrial biology, and maybe he can speak to some of those thoughts and ideas as we are thinking about where we go from five products in development to as many as 10 development programs by 2025. Thanks, Robert. You know, Chad, it's a very good question.

So we're going to continue to invest in pipeline cardiovascular and neuromuscular and as we find out as you saw.

Another company recently based on the things we discovered those are going to be more tangential and more going to be monetized in other ways in order to be enabling of our leadership in these verticals.

Now with that said, we have to be thinking biologically as well as from the marketplace and that's where Saudi and his colleagues have put together a very good roadmap as we move beyond the contractility of muscle to include mitochondrial bow, Jim maybe he can speak to some of those thoughts and ideas as we are thinking about.

Where we go from five products in development as many as 10 development programs by Twentytwenty foot.

Hi, Thanks, Robert you know Chad, it's very good question and.

Fady Ibraham Malik: And, you know, as Robert said, we've been leveraging the biology of sarcomere for 20 years now and have developed a pipeline that activates cardiac muscle inhibitors of cardiac muscle activators in skeletal muscle and The, you know, that pipeline is maturing in the clinic. There are certainly other opportunities within the sarcomere, and we'll continue to take advantage of our leading expertise in that muscle structure, but, you know, we have a lot of programs in that area now. And as we're thinking of how we can move to another important issue, we'll begin to see some programs emerge from that space in the coming years. And Chad, just one other point to mention is that we'll continue with what has been the hallmark of our productivity to look for those kinds of measures that we can observe preclinically and through the clinic pharmacodynamically that can read on function, and because we believe that's important to inform what ultimately will matter to patients. As we think about function and performance, quality of life, and health span, this is where our muscle activators, our muscle inhibitors, these drug candidates read on not only morbidity and mortality but things that ultimately will define health span, especially as applied to an aging demographic.

Robert said Weve.

And leveraging the biology and sarcomere for.

Nearly 20 years now and that develop the pipeline activators of cardiac muscle inhibitors of cardiac muscle.

Activators of skeletal muscle and.

The you know that that pipeline is maturing in the clinic and there are certainly other opportunities within the Sarcomas, there and we'll continue to.

To take advantage of our leading expertise and that.

Muscle structure, but.

Yeah, we have a lot of programs in that area now and and as we're thinking out how can we.

Move to another important.

Feature of muscle, which is how this muscle generate energy and muscle chock full oh mitochondria, it's critical for heart health and skeletal muscle health.

So they might a copy or not muscle specific but.

There are certainly muscle specific applications of mitochondrial biology.

And and work on too.

We've already been doing this for a while it will become too.

You'll see begin to see some.

Grams emerged from that space and the coming coming years.

Chad just one other point the mentioned is that.

We'll continue with what has been the hallmark of our productivity to look for those kinds of measures that we can observe preclinically and through the clinic pharmacodynamically that can read on function and because we believe that's important to inform what ultimately will better the patients.

As we think about function and performance quality of life and health spend this is where or muscle activators. Our muscle inhibitors. These drug candidates read on not only morbidity and mortality, but things that ultimately will define health spend, especially as play to an aging demographic.

Robert I. Blum: And that's where we see our business constantly evolving. That's great, and it's really good to see you guys thinking so strategically and being in such a good position to sort of, plan ahead for many years of progress. By the way, it's hauntingly familiar, this idea of spinning preclinical compounds into a new company that you incubate in exchange for equity and royalties.

Thats, where we see our business constantly.

Evolving.

Yeah, I know that that's great and it's a really good to see you guys I'm thinking so strategically and being such a good position to a sort of.

Plan ahead for for a for many years of progress.

By the way, it's one thing we familiar this idea of.

Thinning pre clinical compounds into a new company that you incubate in exchange for equity and royalties I have just sneaking suspicion mixers.

Chad Messer: I have this sneaking suspicion that this is something that could work out for you. Well, thank you for noticing. But, you know, it does play into our corporate development strategy that there are things that we should be doing and things we can't always be doing ourselves. But that doesn't mean that there aren't opportunities to monetize them down the road.

This is something that could work out for you.

Well. Thank you for notice thing, but it does play into our corporate development strategy that there are things that we should be doing and things. We can always be doing ourselves, but that's not to say that there aren't opportunities to monetize them down the road.

Robert I. Blum: Um, yeah. Let's see if it works again. Thank you, sir. Our next question comes from the line of Jason Butler with JNP Security. Hi Jason, welcome back. Or maybe not.

Yeah.

Okay, what's a let's see if it works again.

Thank you said that step.

Our next question comes on line of Jason Butler with JMP Securities.

Hi, Jason welcome back.

But maybe not.

Jason Nicholas Butler: Jason, can you hear us? The case on your line is open. Operator sounds like we might have lost him again. And there are no further questions at this time. Okay, well, thank you.

[laughter].

They can can you hear us.

Jason Your line is open.

Operator sounds like we may have lots to begin.

And there are no further questions at this time.

Okay, well thank you.

Operator: Thanks very much to everybody on the call today. Thank you for your continued interest in what we're doing. And obviously, this past quarter was, I think, some of the best evidence yet of our ability to execute in alignment between R&D strategies and our corporate development strategies, from the standpoint of financial engineering, and also operationalize to enable what we think will be an expansion and acceleration of our development programs while still maintaining good fiscal discipline, a good cash runway, and also ensuring that we can build our pipeline. We're coming into the second half of the year with expected results from Galactic HF in the fourth quarter. Obviously, we're very optimistic and hopeful, as that will be further transformative for our business. We look forward to keeping you updated on this progress. And with that, operator, we can conclude the call. Thank you very much. Ladies and gentlemen, this concludes today's conference call. We thank you for your participation.

Thanks, very much to everybody on the call today. Thank you for your continued interest in what we're doing and obviously.

This past quarter was I think some of the best evidence yet of our ability to.

Execute.

In alignment between R&D strategies, and our corporate development strategies from the standpoint, a financial engineering and also operation wise to enable what we think will be an expansion an acceleration of our development programs still maintaining good fiscal discipline. Good cash runway and also ensuring that we can.

A build our pipeline.

We're coming into the second half of the year with expected results from Galactic HF in the fourth quarter, obviously, we're very optimistic and hopeful as that will be further transformative for our business. We look forward to keeping you updated on the progress and with that operator, we can conclude the call. Thank you very much.

Ladies and gentlemen, this concludes today's conference call. We thank you for your participation you may now disconnect.