Cytokinetics, Incorporated (CYTK) Q2 2020 Earnings Report, Transcript and Summary

Good afternoon, and welcome ladies and gentlemen, to the Cytokinetics' Second Quarter 2020 Conference Call. At this time, I'd like to inform you that this call is being recorded, and that all participants are in a listen-only mode. At the company's request we will open the call for questions-and-answers after the presentation. I would now like to turn the call over to Diane Weiser, Cytokinetics' Senior Vice President of Corporate Communications and 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, then Fady Malik, our EVP of Research and Development, will provide updates on key developments for omecamtiv mecarbil, our cardiac myosin activator, being developed under our collaboration with Amgen and the expanded and accelerated development plan for CK-274, our next in class cardiac myosin inhibitor. Next, Stuart Kupfer our SVP and Chief Medical Officer will update on recent progress with CK-274 and REDWOOD-HCM, as well as CK-274 our additional cardiac myosin inhibitor. 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. 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 may differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings. We undertake no obligation to update any forward-looking statements after this call. 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. 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 will try not to be too repetitive today. There is 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 topline results of GALACTIC-HF, one of the largest Phase 3 global cardiovascular outcomes trials in heart failure, which is being conducted by Amgen under our long-standing collaboration. These deals considered alongside our previously announced renegotiation of our Astellas agreement enables us to continue readiness and implementation activities related to the potential commercialization of omecamtiv mecarbil as well as currently plan for the advancement of CK-274 and reldesemtiv, all within the context of our Vision 2025. 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 reldesemtiv through an expanded set of pivotal clinical trials while retaining full rights in North America, Europe, and Japan for our shareholders. It is particularly gratifying when our R&D strategies can synchronize with and enable the corporate development and business development strategy. Cytokinetics continue 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 omecamtiv mecarbil and CK-274.

Thanks Robert. We and 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. Amgen adapted the conduct of the trial to enable delivery of investigational product to patients home and to conduct study visits remotely for collection of the study endpoint. As a reminder, none of the trials made endpoint including heart failure events, any death or collection of the Kansas City of cardiomyopathy questionnaire week 24 or depended 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 close out 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 topline results of GALACTIC-HF in Q4. Regarding METEORIC-HF, the second Phase 3 trial of omecamtiv mecarbil in patients with heart failure, I'm pleased to say that despite the suspension of enrollment earlier in the quarter due to the coronavirus pandemic, we've resumed screening and enrollment in June and 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 is resumed and we are very grateful to our clinical trial site personnel for their collaboration to ensure the health and safety of our participants through the conduct of this trial. As we have stated, results from METEORIC-HF are not on the critical path to submitting regulatory filings for its potential approval of omecamtiv mecarbil and instead if the findings for METEORIC-HF are supportive it would be included in a supplemental filing following the potential commercial launch predicated on expected results in GALACTIC-HF. We now expect to 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 omecamtiv mecarbil. Novel mechanism of action of a potential medicine works in an entirely different way than 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 omecamtiv mecarbil, which may potentially lead to an expedited review. We also collaborated with Amgen and Servier on preparations for potential marketing application dossier for omecamtiv mecarbil and prepared for possible meeting with regulatory authorities as may be requested to discuss state pretrial results and potential marketing applications. Turning now to our cardiac myosin inhibitor program, it is an exciting time to expand and accelerate this development program. As Robert mentioned, regarding the licensing collaboration and royalty monetization deals with Ji Xing Pharmaceuticals and RTW Investments, they enable us to develop CK-274 in multiple indications in parallel, as well as across a wider span of geographies. In terms of specifics regarding the development program associated with CK-274, the 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 authority, our current goal is to initiate a Phase 3 registration program for CK-274 in obstructive HCM in late 2021 and we are working with our new partner, Ji Xing to enable current development in China. In parallel we're planning for the conduct of clinical trials of CK-274 in nondestructive HCM and in a subgroup of heart failure patients with preserved ejection fraction or HFPEF also in the 2021 or 2022 timeframe. 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 medicines that can meaningfully impact the underlying challenge of the patients suffering from hypertrophic cardiomyopathies and HFPEF related to the hypercontractility of cardiac muscle. Now, I'm going to turn it over to Stuart to provide an update on REDWOOD-HCM as well as our plan for Phase 1 study of CK-271 our second cardiac myosin inhibitor.

Thank you, Fady. 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 CK-274 in 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 U.S. 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 pretrial suspension is paying off. While the trial was not enrolling, sites were still being activated, patients were identified and screen visits were scheduled through coordination between our CROs and the sites. We are 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 two by the end of this year. During the quarter, we and others are pleased to see results of EXPLORER, our Phase 3 clinical trial readout 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 EXPLORER to our clinical development program and further advance the field as we progressed CK-274 in obstructive and nonobstructive HCM as well as in a subgroup of HFPEF patients with hypercontractility of cardiac muscle. Given the potential advantages of CK-274 as a next in class therapy, we have an opportunity to improve upon the safety and efficacy profile observed in EXPLORER. Moving to our additional cardiac myosin inhibitor CK-271, following a recent setback to the 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 1 study is to assess the safety and tolerability and pharmacokinetics of single ascending oral doses of CK-271 in healthy adult subjects. Finally, Cytokinetics was pleased to support the patient's 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. And we applaud the HCMA 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 financials.

Thanks Stuart. I will first provide an update on cash, revenue and spending, and then Ching will review our progress toward 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. Our revenues in Q2, 2020, came from our strategic alliances with Amgen and Astellas. For Amgen, we recognized revenue associated with their reimbursement of our development expenses related to METEORIC-HF. For Astellas, we recognized revenue for the 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 as expected, given activity for METEORIC-HF and the cardiac myosin inhibitor program, and the remainder of our expenses were attributable primarily to our early research activities. Our 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 or pre-commercial activity. And now, Ching will review progress in connection with corporate development strategy.

Thanks Robert. As we have discussed, we have been working with our management team and our poor - over the past year to ensure that our financial position is solid as we transition the company into a fully integrated biopharmaceutical organization. With our recent business development royalty monetization and equity offering transactions, we are well-positioned financially to operationalize and fund near-term to midterm projects and initiatives. To recap our cash position, we ended the second quarter with $213 million cash and will add $160 million of additional capital upon closing of the monetization of Mavacamten royalty plus $90 million in additional capital available at our option from the RTW transactions. In addition, we raised approximately $190 million through our recent equity offering net of expenses. We expect to end 2020 with as 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 million to $22 million and operating expenses will be in the range of $120 million to $130 million. However, we have narrowed our range for projected full-year net cash utilization to be $110 million to $115 million. 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 CK-274 alongside plans to co-promote omecamtiv mecarbil with Amgen. If 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 worldwide sales of omecamtiv mecarbil outside Japan that might exceed 20% with a lower royalty rate in Japan. 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 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 omecamtiv mecarbil, 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 omecamtiv mecarbil 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 our reach and frequency approach in institutional accounts in North America. Towards 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, position preferences and potential customer accounts. And finally, we continued our collaboration with providers and healthcare systems to generate health economics and outcomes research related to the healthcare 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 explained how contractility drives cardiac performance in HFrEF. And importantly, the commercial operations we're building to support omecamtiv mecarbil, funded largely by Amgen can be leveraged to commercialize CK-274 if successful in North America and Europe. And furthermore, our recent transactions with RTW and Ji Xing 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 reldesemtiv to a Phase 3 clinical trial in patients with ALS and we engaged with clinical experts and patient advocates and help 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 long-standing partnership with the ALS Association in the fight against ALS. 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 omecamtiv mecarbil, 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 AMG 594, a Phase 1 study of AMG 594 is now complete with data analyses ongoing. Amgen and Cytokinetics are discussing next steps in the development program. For CK-274 we expect to complete enrollment in the first cohort of REDWOOD-HCM, and to have data to inform progress to the trial to the second cohort by the end of 2020. For CK 271 we expect to initiate a Phase 1 study in Q3 2020. For reldesemtiv 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. And operator, with that we can now open up the call please to questions.

[Operator Instructions] Your first question comes from the line of Dane Leone, with Raymond James.

Hi Dane.

Questions, so maybe starting with me, we've gotten questions in from the investment community posted deal on to some for just trying to think strategically from your point of view, as you advance 271, how you would manage two assets with similar [indiscernible] 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 from me would just be anything you can give us for setting the table on the REDWOOD-HCM 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 would want investors to focus on as well? Thank you.

Sure, I'll start and then turn it over to Fady and maybe Fady will turn it over to Stuart. 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 our lead compounds backups follow-ons and diversify 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 CK-274, we're committed to, as you've heard, obstructive and nonobstructive as well as, as we're considering HFPEF. And as far as CK-271 is concerned, it really depends on the profile, things we'll learn about CK-274, but also CK-271, 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. Well, 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 REDWOOD in order to inform the second cohort.

Yes, I think you covered the first question, Robert, 271 I think that's the data come out of its Phase 1 trial and as we start to see more data on 274 we will begin to form strategy with those two compounds. With regard to REDWOOD-HCM, maybe I'll turn it over to Stuart and he has been very closely overseeing the progress of that study and to discuss what our strategy will be towards the end of the year in terms of data and next steps.

Yes, thank you, Fady. So as we mentioned, we plan to have 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, we're 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 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. 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 the signs and symptoms other pharmacodynamic endpoints like NT-proBNP. So, the totality of the data from the 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 of our planning in cohort 2.

Great, I just want to clarification on my first question, sorry. I think, investors are just trying to understand whether there was anything preclusive legally within the RTW agreement from 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 CK-271 as we see fit, so we have no intention right now. Right now CK-271 still needs to be characterized in Phase 1 as the CK-274 in Phase 2. So our goal is to be advancing multiple compounds forward as I 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 subtypes 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 of Jeff Hung with Morgan Stanley.

Hi Jeff, thanks.

Hey, thanks for taking the questions. You indicated that AMG 594 Phase 1 is complete. When might we get data from the - and are you likely to move forward in only one indication or is it likely that you'll proceed in parallel in multiple indications like CK-274? And then I have a followup.

Yes, very good question. So we're right now in the process of receiving and evaluating and analyzing those data, and that's the process that is really just at its beginnings. 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 be encompassing of many different indications, recognizing that as a cardiac muscle activator there are many different directions we could go, both to 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 is still at the paper and pencil exercise level.

And so when you said later this year is that when we might see aspects of the Phase 1 data, or...

Yes, I suspect that as we will 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 CK-271 in humans, so maybe if you can talk about the differences in the profile from the preclinical data between CK-271 and CK-274? Thank you.

Fady, do you want to take that?

I can take that. Yes, I mean pre-clinically CK-274 and then CK-271 have similar mechanisms of action. Primarily there are differences, a little bit, in terms of the deepness of the exposure response relationship between two molecules, and also their pharmacokinetic are a bit different pre-clinically as well, which is the reason that we advanced it, and to get a little diversity of PK and PKTV [ph] in the clinic, and use the excellent form advancement of our - this mechanism of action in patients as well as provide the opportunity to split indications or other things that we might think about.

Thank you.

Your next question comes from Jason Butler with JMP securities.

Hi Jason.

Jason, your line is open.

Jason, are you there? Operator, it 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 line of Charles Duncan with Cantor.

Hi, Charles.

Hi Robert and team. COVID be darned. You guys have made a lot of progress, congratulations. I had a quick question on omecamtiv timing and then on strategy. First of all, regarding omecamtiv timing, Fady did a great job laying out, kind of what to expect, but I'm kind of wondering in terms of 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 meeting, a pre-NDA meeting with the agency before say mid first quarter of next year?

Fady, I will turn that over to you and I'll elaborate afterwards.

Sure. Hi Charles. You know I think I can say that Amgen and Cytokinetic has 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. So I think you would see the results are supportive and the path forward looks clear. I think you would see us moving forward to an NDA filing quite early quite rapidly. There isn’t really anything I would say that is other than the result that needs to be in our hands in order to progress an NDA filing.

Yes 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 are working diligently on preparing study reports and ensuring that they all get quality controlled. It's 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 has a Fast Track Designation as you know and that could be enabling of 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 quick question on strategy in Asia. I know you updated the partnership couple 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?

Sure. So, the collaboration we have with Amgen is a worldwide collaboration includes China. 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 sublicense to Servier in Europe and other Commonwealth independent states to be enabling 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. It spans all countries. And that's under the commercialization oversight of a joint commercialization committee. Our co-promotion role 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. Hope that helps.

Okay, it does. I like the pun. Last question for Ching. Ching, you were laying out cash position at the end of this year. And I'm not sure if you misspoke, or I miss heard, more likely the latter, that at the end of 2021 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 miss hear that?

No, Charles, what I heard, what I said it was, in 2020 was more than $500 million. I didn't say anything about 2021.

Okay. That's, that's clear. But you did mention milestones and potentially royalties in next 12 to 18 months, correct?

Yes, yes, that that is correct. And that's associated with omecamtiv mecarbil, if GALACTIC were to be positive.

Got it. Thanks for the clarification.

Thank you, Charles.

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

Hello, Joe.

Hello guys. This is Manuela calling for Joe Pantginis. Thanks for taking the question. I have a couple, I was wondering if you can give us a little bit more color on the results of the analyses you are, the marketing analysis you are performing and the commercialization activities. With like, 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 the – who is going to get Mavacamten [ph] first?

Sure. 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 the following, 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. 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 that also provide advantages and pay dividends down the road for us in connection with our interest with regards to CK-274 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.

Got it? Thank you. And regarding, speaking of Amgen, I saw on clinicaltrials.gov that Amgen has opened a post trial access study where all the committee's 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 a longer term follow-up trial, like I was wondering what you're trying to achieve with this longer term?

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.

Yes.

Yes, there so many 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 a post trial access 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 return to those countries where it's a requirement.

Got it. Thank you very much.

Your next question comes from the line of Ted Tenthoff with Piper Sandler.

Great, thank you very much. Sorry about the noise in the background. Thanks Stu for the update on cardio. I'm going to ask about reldesemtiv and just see if we can have any updates there? What the latest is with CK, with Astellas? Thanks.

Pardon me, I was on mute. 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 3 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 circled with HTAs and 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 recognizing that we haven't committed to do the trial yet, as 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.

Great, I can appreciate that. Thank you very much.

Thank you.

Your next question comes from a line of Salim Syed with Mizuho.

Hello, Salim.

Hey guys, this is Dennis staying on for Salim. Thanks for taking the questions and congrats on all the progress. I have two questions if I may and the first question is on 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 revasc, 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? And then my second question is on HCM specifically, how are you thinking about the opportunity in Europe? How did the EMA think about the Phase 3 endpoints and if something like peak feel to like, the right endpoint? And thanks for taking the questions.

Sure. I think I’ll ask Fady to answer both of those, please.

Sure. The, with regard to the first question, the data that support in effect in both ischemic and non-ischemic cardiomyopathy comes from GALACTIC, I mean from COSMIC were that the effective omecamtiv mecarbil in those patients subgroups. And, which essentially to our very similar effects on the measures of improvements in cardiac function. The changes in volumes, changes in NT-proBNP, while there are fewer muscle cells potentially in patients that have ischemic cardiomyopathy, just you have to recall there, there's generally still lots of viable myocardium, myocardium that is left hypertrophies and gets bigger. And so you can still augment their function in response to a drawback omecamtiv mecarbil 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 are you thinking about it in terms of Phase 3? How does the EMA think about Phase 3 endpoints, is there something like [indiscernible], like a proper endpoint?

It's a good question. And I think, from – it just still a bit early for us to comment on what EMA may think about endpoints in Phase 3, we're planning we have engaged them initially, and we plan to engage them more deeply in the coming months, can we plan for Phase 3 that would be conducted both in Europe and the U.S. There's clearly a guidance that comes out of Europe functional improvements in patients with heart failure or with HCM or certainly possible [ph] endpoint. And it's maybe a question of how you define function or symptoms. And, right now I think we're still in the phase of learning, what their vision or what their opinions on that are.

Got it. Thank you.

Thank you.

[Operator Instructions] Our next question comes from the line of Chad Messer with Needham.

Hi, Chad.

Hi, thanks for taking my question and congratulations on all the, 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 omecamtiv data, but have you guys, so well positioned with the rest of the pipeline going into that is truly fantastic.

No, news for a very long time, Chad. So it's gratifying, I know, to be able to share this with you and looking forward to the results later in the year to be sure.

Likewise, 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 having 10 drugs in development by the end, which, given how prolific your drug discovery engine has been, it's, aggressive, but certainly feasible. And I know in your corporate deck you kind of talk about, branching out away from your focus on contractility, to muscle energy and metabolism. You learned a couple weeks ago that you've been working on inhibitors of skeletal protein parasites, all this stuff, can you maybe speak broadly to some of these areas? And what kinds of, what kinds of conditions you can address by going after the new biology?

It's a very good question. And I'll start but better for you to hear from Fady on this. 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'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 medicines. 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 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've been speaking about. For the compounds that are in clinical trials. Reldesemtiv by itself could be a pipeline in and of itself, in which at this point we've really been focused to, as 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 still should remain within our cardiovascular neuromuscular vertical. So we're going to continue to invest in pipeline, cardiovascular and neuromuscular. And as we found 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 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 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, as many as 10 developmental programs by 2025.

Thanks, Robert. Chad it’s a very good question. And, as Robert said, we've been leveraging the biology of sarcomere for nearly 20 years now, and it's developed a pipeline of activators of cardiac muscle, inhibitors of cardiac muscle, activators of skeletal muscle and 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, we have a lot of programs in that area now. And as we're thinking of how can we move to another important feature of muscle, which is how does muscles generate energy and muscle is chock full of mitochondria, it's critical for heart health and fellow [ph] muscle health. Obviously, mitochondria are not muscle specific, but there are certainly muscle specific applications of mitochondrial biology. And we're going to, we've already been doing this for a while, 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 the 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 play to an aging demographic. And that's where we see our business constantly evolving.

Yes. 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 fitting preclinical compounds into a new company that you incubate in exchange for equity and royalties. I have this sneaking suspicion this is something that could work out for you.

Well, thank you for noticing 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.

Yes, let's see if it works again.

Thank you, Chad.

Okay. Operator Your next question comes from the line of Jason Butler with JMP securities.

Hey Jason, welcome back. Jason, can you hear us?

Jason, 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. 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, still maintaining good fiscal discipline, 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 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.