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Cytokinetics Inc
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Good afternoon, and welcome, ladies and gentlemen, to Cytokinetics’ First Quarter 2021 Conference Call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company’s request, we will open the call for questions-and-answers after the presentation.
I will 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 recent developments. Then Fady Malik, our EVP of Research and Development, will provide an update on omecamtiv mecarbil, including progress following a recent meeting with FDA and what to expect from upcoming analyses from GALACTIC-HF, the positive Phase 3 clinical trial of omecamtiv mecarbil as well as recent activities related to METEORIC-HF, the second Phase 3 clinical trial of omecamtiv mecarbil.
Next, Stuart Kupfer, our SVP and Chief Medical Officer, will provide an update on our cardiac myosin inhibitor program with focus to REDWOOD-HCM, the Phase 2 clinical trial of CK-274. Then Robert Wong, our VP and Chief Accounting Officer will provide a financial overview for the past quarter; and Ching Jaw, our SVP and Chief Financial Officer, will discuss our financial outlook and corporate development strategies before Robert Blum then returns to provide concluding thoughts and expected key milestones for the remainder of 2021. We also have a new team member on today’s call Andrew Callos, our Chief Commercial Officer who joined Cytokinetics during the quarter and who you will hear in upcoming calls.
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 including our current reports regarding our first quarter 2021 financial results filed on Form 8-K today. We undertake no obligation to update any forward-looking statements after this call.
And now, I will turn the call over to Robert.
Thank you, Diane, and thanks again to everyone for joining us on the call today. We had a productive first quarter and are feeling increasingly more optimistic as our nation reemerges towards new normalcies in the coming months with widespread vaccinations for COVID-19. We continue to wish you and your family’s good health and wellbeing.
We’re also optimistic about Cytokinetics and our pipeline, our progress, and our prospects. In the first quarter, we executed well against our plans and are firing on all cylinders. With priority to advancing our industry-leading cardiovascular drug candidates directed to muscle, focusing to both REDWOOD-HCM and METEORIC-HF, as well as advancing regulatory and commercial readiness work streams in support of omecamtiv mecarbil. Toward that end, I’m very pleased to introduce the newest member of our leadership team, Andrew Callos. Andrew joined us as our Chief Commercial Officer, and we’re thrilled to have him on board at a key time for our company, as we turn the corner towards commercialization and transition to be a forward integrated biopharmaceutical company.
Andrew brings relevant commercial and operational experience from cardiovascular specialty care and rare disease markets. He had a long tenured and successful career at Pfizer and at Wyeth Pharmaceuticals where he oversaw U.S. and international pharmaceutical business franchises. Most recently, Andrew served as Regional President and General Manager North America for Pfizer’s Upjohn Business Unit.
And prior to that role, and during his over 20 years at Pfizer and predecessor companies, he held leadership positions including as Vice President U.S. Cardiology & Metabolic Marketing overseeing the commercialization of Eliquis in the United States. Andrew also served as Vice President and Head of Inflammation Marketing Europe and Vice President Global Commercial Development for Rare Diseases. As you can see, his experience is a perfect fit for Cytokinetics, and he has quickly come up to speed and contributed to the many commercial planning work streams that had already been underway prior to his arrival.
Andrew joins us to lead a team of similarly expert commercial colleagues at Cytokinetics who are experienced in cardiovascular and neuromuscular specialty care markets. And as we proceed to finalize our go-to-market planning for omecamtiv mecarbil and CK-274, you’ll be hearing more from Andrew and his team about our plans including at an Investor Day to be scheduled later this year. On the regulatory front as previously communicated, during the first quarter, we convened an FDA meeting to review the Phase 3 clinical trial results from GALACTIC-HF. And we’re now proceeding towards additional interactions with FDA and other regulatory authorities. Fady will elaborate in a moment, but suffice it to say we’re pleased with the level of engagement and the feedback that we received from FDA and we believe GALACTIC-HF can stand on its own as a pivotal trial in a planned NDA submission.
We’re now proceeding towards our goal of an NDA submission for omecamtiv mecarbil in the second half of 2021. We also advanced our go-to-market planning with work streams focused on market research, brand positioning, supply chain manufacturing and logistics, market access, health economics and outcomes research, customer engagement and other commercial infrastructure to inform our future investment and execution strategies and anticipation of a potential commercial launch of omecamtiv mecarbil in the United States in 2022.
Ching will elaborate later in this call on our financials, our cash runway and our deal objectives to support our go-to-market strategy. We also made significant strides advancing our cardiac myosin inhibitor program during the quarter, focusing on the completion of REDWOOD-HCM, our ongoing Phase 2 clinical trial of CK-274 in patients with symptomatic obstructive hypertrophic cardiomyopathy. As Stuart will elaborate in the first quarter, we opened and promptly completed enrollment in Cohort 2 and more recently opened enrollment to Cohort 3.
In addition, this morning, we announced that we also activated the first site in the open-label extension study for patients who completed REDWOOD-HCM. This high proficiency execution underscores the urgency of our activities in this program given the high unmet need among patients with hypertrophic cardiomyopathy. Based on data from the interim analysis of Cohort 1 that we announced in December, we plan to engage FDA in this quarter and prepare for a Phase 3 clinical trial expected to begin before year end. We’re also advancing medical and new product planning activities directed to specialty care cardiologists in high volume heart failure hospitals that overlap with high volume HCM centers of excellence given the many synergies between our cardiac myosin modulators and planning.
And with that, I’ll turn the call over now to Fady to elaborate on developments related to omecamtiv mecarbil.
Thanks, Robert. During the first quarter, we advanced omecamtiv mecarbil forward in several important ways. First, we met with FDA to review the top line results of GALACTIC-HF that Type C meeting met our expectations in terms of engagement and feedback. We now intend to proceed to file an NDA later this year based on results from GALACTIC-HF and the rest of the development program.
We had an opportunity to hear from FDA as those matters that we should be prepared to address and finalizing the NDA filing. We are now preparing for additional discussions with FDA during the second quarter, including another plan Type C meeting that we expect to further inform our filing strategy. At this next meeting, we plan to share additional analyses of GALACTIC-HF and request FDA feedback that can inform labeling and our NDA submission. We expect still further interactions, including a potential pre-NDA meeting and are pleased to have multiple opportunities to engage FDA ahead of our goal to submit an NDA in the second half of the year.
I’ll remind you that our planned NDA submission will be based on the results of GALACTIC-HF in combination with the rest of the development program comprising over 30 clinical trials and as informed by prior regulatory discussions. In parallel with these activities, we continue to conduct METEORIC-HF, our second Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with the reduced ejection fraction. And METEORIC-HF, we’re investigating the potential effects of omecamtiv mecarbil to improve exercise tolerance in patients with heart failure, which may provide a benefit for these patients struggling to perform daily activities.
Screening is now nearly closed and we’re on track to complete randomization of patients into METEORIC in this second quarter. We expect top line results to be available in early 2022. If the findings for METEORIC are positive, we expect that data from that trial would be submitted in a supplemental filing as would be expected to follow a potential FDA approval and commercial launch.
I’d like to acknowledge the efforts of the study team, investigators and study coordinators for their successful commitment to accomplish this milestone during an unprecedented pandemic. During the quarter, we received confirmation the data from a secondary analysis of GALACTIC-HF assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to ejection fraction at baseline will be presented by Dr. John Teerlink in a late breaking clinical trial session at the American College of Cardiology 70th Annual Scientific Session.
We can’t say more about these data. So as not to break embargo policies, but suffice it to say, we believe it will further advance the understanding of which patients in GALACTIC-HF achieved the greatest benefit from treatment with omecamtiv mecarbil on top of standard of care. The executive committee of GALACTIC-HF in collaboration with Cytokinetics has been working on several additional secondary analyses from which data will be forthcoming later this year at medical meetings and in manuscripts to further elaborate on the results of GALACTIC-HF and inform its potential use.
We believe that these additional analyses will be very informative as to how omecamtiv mecarbil performed in GALACTIC and illuminate key learning. Given the dynamics of the heart failure treatment setting, it’s incumbent on us to best understand how to frame these data and what can hopefully be an approvable submission for this first-in-class cardiac myosin activator, which reduced the risk of heart failure events in its pivotal trial.
To that point, in the last quarter, we continued market research activities to better define and refine the potential target product profile of omecamtiv mecarbil and understand where it may best fit in the treatment armamentarium, particularly given the new entries available to clinicians and their patients. As we’ve said before, it’s an exciting time in the treatment of heart failure, where there are still tremendous unmet need, and we remain enthusiastic that omecamtiv mecarbil may provide a welcome addition in the battle to better manage this high prevalence progressive disease, particularly among more severe patients who have exhausted guidelines directed therapy, and still suffered debilitating symptoms or at high risk for heart failure hospitalization.
We also had opportunity to engage with a large number of KOLs during the quarter with a significant majority of them providing positive views regarding omecamtiv mecarbil. And importantly, pointing out that it could potentially fill a key need among a more severely ill patient population that is more at risk of hospitalization and re-hospitalization. Common themes included an understanding that biologically it stands to reason that those patients with more impaired cardiac systolic function may benefit more from this novel mechanism therapy, this designed to act directly on muscle and improve cardiac function and performance. As well as the potential to add omecamtiv mecarbil to standard of care, given its favorable tolerability and safety profile as we observed in GALACTIC-HF, and which it’s addition to standard of care did not adversely affect blood pressure or renal function.
And finally, during the past quarter, we’re pleased to conduct an inaugural meeting of our heart failure patient advisory council. This is a group of passionate patients and caregivers with whom we’ve been meeting regularly to inform understanding to the patient experience, disease journey, and unmet needs. These insights will be instrumental in designing patient support services, educational materials, and guiding the development of our heart failure directed pipeline.
We’re grateful to the participants. From our first engagement, we are confident this group will be valuable to our patient-centric activities. As we’ve indicated, Cytokinetics is committed to advancing omecamtiv mecarbil as a key priority in 2021. Doing that as required extensive attention to wind down activities and our collaboration with Amgen included amongst these projects are managing the transfer of the integrated safety database and reported – related reporting obligations, receipt of regulatory documents and assuming responsibility for manufacturing. Transitioning these many work streams from a 15-year collaboration is not trivial. And our team at Cytokinetics has been very busily attending to these issues to ensure smooth and orderly handoffs.
Naturally, we have prioritized omecamtiv mecarbil and are therefore de-prioritizing the further development of our cardiac troponin activator, CK-136 formerly referred to as AMG 594, which will be deferred for the rest of 2021. We plan to continue its development in the future as we continue to build out in advance our pipeline and look to expand our emerging cardiovascular product franchise.
And with that, I’ll turn the call over to Stuart.
Thanks, Fady. During the quarter, we made significant progress within our cardiac myosin inhibitor program focus on the advancement of CK-274. I’ll begin with an update on REDWOOD-HCM, the Phase 2 clinical trial of CK-274 and patients with obstructive HCM, including a highlighting recent and upcoming regulatory interactions, and then touch on preclinical data recently presented at the American Chemical Society Annual Meeting.
During the first quarter in REDWOOD-HCM, we dosed the first patient and also completed full enrollment in Cohort 2, which is examining the safety and tolerability of doses of 10, 20 and 30 milligrams of CK-274 versus placebo. Dosing of CK-274 is individually titrated by echocardiography at weeks two, four and six with dosing optimized on the basis of target reductions in LVOT gradients, while maintaining a normal ejection fraction.
Overall, the treatment duration is 10 weeks with an echocardiogram to examine reversibility of effect two weeks after the last dose. We remain on track to report top line results from both Cohort 1 and Cohort 2 mid-year as well as to begin to plan Phase 3 clinical trial by year end. Earlier this week, we announced the opening of Cohort 3 of REDWOOD-HCM. Cohort 3 is intended to examine the safety and tolerability of CK-274 in patients whose background therapy includes disopyramide, a medication that a sometime use in patients with symptoms refractory to first-line medical therapy, and that has been excluded in most trials of HCM intervention today.
In Cohort 3, patients will receive CK-274 in open-label fashion over a 10-week period with individualized dose titration of 5, 10 or 15 milligrams once daily. This cohort is not being conducted to further refine the dosing strategy that we intend to study in Phase 3, but instead Cohort 3 is expected to provide important data to inform the potential inclusion of disopyramide treated patients in our planned Phase 3 clinical trial.
Additionally, this morning, we announced that we have activated the first site in REDWOOD-HCM OLE, open-label extension study that is designed to assess the long-term safety and tolerability of CK-274 in patients with symptomatic obstructive HCM. Eligible patients will have completed their participation at Redwood-HCM. Primarily, we will evaluate long-term safety as assessed by the incidence of adverse events and left ventricular ejection fraction less than 50%. Secondary endpoints include measures of the long-term effects of CK-274 on left ventricular outflow tract gradient and assessments of steady state pharmacokinetics.
The open-label extension study will also include a cardiac MRI sub-study to assess changes in cardiac morphology function and fibrosis. All enrolled patients will receive CK-274 and use a similar echocardiography guided dose titration to individually optimized dose as has been employed in Redwood-HCM.
During the last quarter, we also made progress under our collaboration with Ji Xing Pharmaceuticals with initiation of a Phase 1 clinical study of CK-274 in healthy participants in China. This aligns with our shared objective for the inclusion of China in a global Phase 3 clinical trial planned to begin later this year.
We are pleased to see that our colleagues at Ji Xing are operating with the same sense of urgency as we are to enable advancement of CK-274 into a global registration program. From a regulatory perspective, we were also pleased to recently receive orphan drug designation from the FDA for CK-274 and symptomatic HCM encompassing, both obstructive and non-obstructive patients. This underscores a significant unmet need and patients who continue the separate symptoms that can severely impact their quality of life. The few treatment options available to them and no currently approved medical therapies.
In the first quarter, we also prepared for regulatory interactions, including Type C and end of Phase 2 meetings with the FDA, as well as with EMA for scientific advice. The first of these next level meetings is planned to occur in the second quarter and will inform how we approach an end of Phase 2 meeting that is expected to occur in the third quarter.
Finally, last month, data related to the optimization of CK-274, including the first disclosure of its chemical structure were presented at the American Chemical Society Spring 2021 Virtual Meeting. This scientific presentation highlighted the preclinical characterization of CK-274 and focused on key compound characteristics, including this half-life, the shallow dose response relationship and lack of meaningful cytochrome P450 interactions.
Furthermore, data were presented from genetic models of HCM, in which CK-274 reduced fractional shortening and LVOT peak gradient in a dose related manner. These results highlight the success of the chemical optimization program conducted at Cytokinetics, which was intentionally focused on designing key compound characteristics to enable flexible, safe and timely dosing adjustments in clinical practice.
We now look forward to results from both Cohorts 1 and 2 of Redwood-HCM, which will elucidate how these next generation physicochemical properties of CK-274 may translate into important clinical effects in patients with obstructive HCM.
And with that, I’ll turn it over to Robert Wong, who will 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 financial outlook and corporate development strategies looking forward. More details on our actual results for the first quarter 2021 are included in the press release, which we released earlier this afternoon. We ended the first quarter with approximately $460 million in cash and investments.
Our revenues in Q1 2021 came primarily from our strategic alliances with Amgen and Astellas. Our first quarter 2021 R&D expenses increase to $31.6 million from $21.7 million in the first quarter of 2020, primarily due to increases in spending on our skeletal muscle program and clinical development activities for our cardiac myosin inhibitor programs.
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 to our skeletal and early research activities. Our first quarter 2021 G&A expenses were $15.6 million up from $12.4 million in Q1 2020, due to higher personnel related costs, including stock-based compensation and higher commercial readiness spending.
And now, Ching will review our planning and corporate development strategy.
Thanks, Robert. As we ended the first quarter was approximately $460 million in cash. We look to our financial guidance for 2021 and believe we have over two years of forward cash runway. We have also indicated that we may revise financial guidance based on finalizing commercial planning activities related to omecamtiv mecarbil and a potential product launch in 2022.
During the quarter, we delve deeply into commercial planning and are developing a comprehensive go-to-market strategy, which will be presented to our board to gain alignment on the overall approach and investment requirements. The strategy comprises key elements, such as market assessment, brand strategy, market access, commercial organizational structure, customer facing and digital engagement strategies, supply chain, information systems and projected sales, spending and return on investment.
As we advance these strategies in support of potential launch of omecamtiv mecarbil, we are focusing on the most efficient and high yield investments to enable the commercialization of omecamtiv mecarbil in 2022, but also equipped Cytokinetics to be best prepared for potential expansion of our cardiovascular pipeline and the commercialization of CK-274. The foundation we build for omecamtiv mecarbil will be leveraged to support the planned product launch for CK-274, which will assume file.
As part of this planning process, we are engaging in industry benchmarking exercises to understand best practices to optimize our approach to franchise development, especially in a post-pandemic world. Executing on our commercial strategies and plans may result in our incurring significant additional expenses that were not included in our current financial guidance.
We expect that some or all of those potential expenses could be covered by our accessing additional capital through strategic partnerships with near-term cash infusions or buy equity and or debt financing, if deemed appropriate. Finally, as we have previously discussed, we are advancing a two-fold corporate development strategy in 2021.
Firstly, to seek a development and commercialization partner for omecamtiv mecarbil and CK-274 in complimentary geographies to that, where we intended to go-to-market ourselves. So those additional geographies, we are currently engaged in potential partnering discussions in Japan and Europe.
Secondly, to see potential royalty monetization and/or structure financing deals in order to support the commercial launch of omecamtiv mecarbil and CK-274. During the first quarter, we’ve had encouraging and productive interactions with potential partners to advance this strategy and we look forward to continuing those discussions as may result in a deal or deals in the second half of the year.
Cytokinetics has always gain access to capital through a diverse array of transaction types. And we continue to believe that our path to commercialization will be served by our continuing monetization of our leadership in muscle pharmacology.
And with that, I’ll turn the call back over to Robert Blum.
Thank you, Ching. Before I provide an update on our expected milestones for the remainder of the year, I’d like to take a moment to remind you of the landscape upon, which Cytokinetics is operating, especially, as it relates to the overall clinical and economic burden of cardiovascular disease today.
Despite COVID taking well over 500,000 American lives, cardiovascular disease remains the leading killer of Americans, taking even more lives over the same timeframe. Clearly, the impact of cardiovascular disease to patients, caregivers and our healthcare system remains unacceptable. We’re gratified to be in a position to have the opportunity to make a meaningful impact with novel mechanism therapies that work unlike other available therapies and has may benefit millions of patients with various forms of heart failure. Phase 3 trials have demonstrated that modulating cardiac myosin either by its activation or its inhibition can translate into clinically meaningful effects on highly relevant registration endpoints.
We’re pleased to have pioneered the biopharmaceutical sciences directed to cardiac muscle and we’re excited to be preparing for commercialization activities in the same comprehensive and expert way in which we’re defining an entirely new cardiovascular pharmacology. As you’ve heard, it’s been a productive quarter and we’re energized by the transformation taking place at the company, as we advance plans for our first potential FDA approval and commercial launch, which we believe will set the table for achievement of our vision 2025. One goal of which is to secure two to three approvals for our potential medicines over the next few years.
Ching reviewed components and work streams related to our go-to-market strategy in support of the commercialization of omecamtiv mecarbil. During the quarter, we continued to conduct market research with physicians and payers to refine our target product profile and our understanding of patient journeys and treatment patterns related to the severe heart failure patient, who may benefit most from treatment with omecamtiv mecarbil.
We also began in earnest to lay down the design strategy for our commercial organization and our potential launch of omecamtiv mecarbil. These activities had begun under our collaboration with Amgen and now we’re being refined with that collaboration coming to an end later this month. As we develop the structure and customer engagement strategy for omecamtiv mecarbil, we’re keeping CK-274 close in mind, as we are intent to capitalize on a franchise approach to our business, much like we prioritized a portfolio approach to our focus to muscle biology.
I want to emphasize the high degree of overlap in high volume centers that specialize in both heart failure and HCM, both geographically, as well as institutionally. The investments we’re making in sales and marketing infrastructure to support the potential commercialization of omecamtiv mecarbil will be amortized over time and set the table for advancement and potential commercialization of CK-274.
In other words, the economies of scale and the synergies, we’ve seen in R&D over many years at Cytokinetics should also serve us well from a commercial standpoint, as we expect to build a cardiovascular drug franchise established on sustainable and growing revenues. While our priorities in 2021 are clearly focused on our cardiovascular programs, we’re also mindful that we need to continue to prepare for COURAGE-ALS, the Phase 3 clinical trial of reldesemtiv in patients with ALS.
ALS is another major area of high unmet need for patients and we maintain a commitment to opening this trial to potential enrollment once we have clarity on our go-to-market strategy with omecamtiv mecarbil and progression of CK-274 to Phase 3. During the quarter, we initiated clinical trial startup activities, including regulatory and institutional review board submissions for COURAGE-ALS in preparation for the potential start of the trial in the second half of the year.
In summary, as we round out the second quarter of 2021, we’ve remain enthusiastic about our prospects across the pipeline and our transformation to a fully integrated bio-pharmaceutical company. The second half of the year has us turning over several cards at Cytokinetics, most notably, the upcoming results of Redwood-HCM and the potential regulatory advancement of omecamtiv mecarbil.
With what we believe could be amongst the most promising cardiovascular pipelines. We’re taking strides to realize our mission of bringing potential medicines to people living with cardiovascular diseases of impaired muscle function that may improve their health span. At the same time, ingenuity and innovation remain a core focus of our research activities, which are also a key component of our vision 2025. In the next few years, to remind you, we expect to double our development pipeline to 10 therapeutic programs, as well as to expand our discovery platform from the biomachinery of muscle contractility to muscle energetics growth and metabolism.
We’re making good progress already and expect to select up to two more development compounds over the next year across our cardiac and skeletal programs to enter IND-enabling studies. And we look forward to elaborating on these promising R&D programs in our future calls.
Now, let me recap our expected milestones for 2021. For omecamtiv mecarbil, we expect to meet with the FDA in this second quarter to continue discussions related to our goal of an NDA submission in the second half of 2021. We expect randomization of patients with heart failure in METEORIC-HF to be completed in this second quarter of 2021 and we expect to refine our go-to-market strategy and our potential commercial launch plans in the second quarter of 2021 and through the remainder of this year. For CK-274, we expect to announce results from Cohorts 1 and 2 in REDWOOD-HCM by mid-year 2021.
We plan to engage regulatory authorities regarding our Phase 3 trial and development program in this second quarter and also continuing into the second half of 2021 and we expect to begin a potential Phase 3 clinical trial of CK-274 by the end of 2021. For reldesemtiv, we expect to continue conducting start-up activities for COURAGE-ALS and we may open the trial to enrollment in second half of 2021, again, subject to our plans relating to advancing omecamtiv mecarbil towards commercialization and CK-274 to a potential Phase 3 clinical trial in patients with obstructive HCM. And for our ongoing research, we expect to advance programs and conduct IND-enabling studies to potentially advanced one to two potential drug candidates in development in 2022.
Operator, with that, we can now open the call up to questions, please.
[Operator Instructions] Our first question comes from the line of Emanuela Branchetti with H.C. Wainwright.
Hello, Emanuela.
Good afternoon, guys. And thank you for taking my questions. Congratulations on the progress on our programs. You mentioned a discussion with the FDA omecamtiv going as expected. Could you please provide more color on what elements were discussed with the FDA and what still needs to be discussed before NDA submission?
Sure. I’m not sure we’re going to be able to do more than that, which we already mentioned on this call, but perhaps in summary, I’ll say that the first meeting was specifically intended to understand, if a GALACTIC-HF by itself without any other Phase 3 clinical trial could stand alone in support of an NDA filing. And we asked questions, it had discussion and we believe coming out of that call that we got the answer that we were looking for, which is that we can proceed this way, readying to file an NDA based on GALACTIC by itself. But that’s just the beginning of a series of FDA interactions that we had intended. And with that, I’ll turn it over to Fady to speak about some of the things we expect to be discussing in other FDA interactions, including an upcoming Type C meeting.
Yes, I’ll maybe just tackle that at a high level. I think there are many aspects of filing an NDA to try to get FDA input on before you go ahead and file the NDA, in terms of approaching labeling in terms of approaches to dosing and other things that we will examine with them, in terms of the program. That way we can put together a filing that think helps the line, what their feedback might be with our objectives.
And finally, there are number of technical matters that one has to settle with them in terms of data standards and other aspects of the program as one submits a filing. NDA filing is a very large undertaking and there are many details, which sometimes it helps to align on for you submit the documentation, so that you’re not having to sort through those things later.
Got it. Thank you. That’s very helpful. And switching over to REDWOOD-HCM, can you ask us maybe frame the expectation around the coming data? What should we specifically focus on, especially when considering potential comparisons with Phase 2 data being mavacamten.
Sure. So again, I’ll start and then turn it over to Fady and Stuart. As you know, we already reported on interim results from Cohort 1, we did that back at the end of last year. We had some pretty high expectations going into that. And I think admittedly, we believe that the interim Cohort 1 data exceeded those expectations in that a majority of patients achieved clinically meaningful responses at the low end of the planned dose response curve. And we did not have any of those patients have EFs fall below 50%. So we see that as ordering well for the completion of this study, both Cohort 1 and Cohort 2.
And as we are now completed with enrollment in Cohort 2, we’ll be preceding towards the database lock and the readout of those results. But as far as how that compares to another compound, keep in mind please that we’re running a different study. We’re not doing a head to head comparison. We are, however, looking at what we think are real world practice patterns here in this trial on top of background therapy compared to placebo where we think this can best inform Phase 3. And with that, I’ll turn it over to Fady and Stuart.
I think Robert covered most of it. I think I’ll just be brief in that the – we were quite pleased with the Cohort 1 results, I think, as we said, the majority of the patients in that cohort reached the target of where we would stop escalating drug therapy, but not everybody. And that was why we embarked on Cohort 2 to study somewhat higher doses and see if we could ensure that we had covered the top of the dose range.
So the data from Cohort 1 and 2 will inform the starting dose and obviously the top dose as well. And we’ll report those data in July, but I think the most important data are the effect of the drug on the left ventricular outflow tract gradient, the timing of its reduction and extent of its reduction, and all of those things should be pretty well laid out for you all, when we report the data in the middle of the year.
Got it. Thank you. And in regards to the enrollment of the circle REDWOOD-HCM, the beginning of this quarter was optional, if I remember correctly. Could you elaborate on the rationale behind combining CK-274 with disopyramide.
I’ll turn that over to Fady or Stuart, whoever wants to answer that.
Stuart, why don’t you take that question?
Right. So the rationale is, we’ve noticed is that patients with more advanced symptomatic obstructive HCM are sometimes treated with disopyramide, which can reduce cardiac contractility to some extent. But if there are patients despite being treated with some of the standard therapy, including disopyramide who still are suffering from symptoms related to HCM, they could benefit from a drug like CK-274, which of course is specifically designed to inhibit reduced cardiac contractility.
So there really is a potential advantage here for patients with sort of run out of options, so to speak and are further along in the natural history of disease, in terms of their disease severity. They could benefit from another medical intervention, such as CK-274 and that’s really our objective to explore that more severe patient population by adding to disopyramide treated patient.
Got it. Thank you for that. And it seems to be [indiscernible] open-label, would you expect to release data as the trial advances cut off before all patients have dosed?
I’m sorry. Stuart, can you take that.
Right. I’m sorry if I understood the question was about releasing data for Cohort 3. Was that the question?
Yes. Yes. What’s the timeline for that?
Well, let me say, first of all, the results from Cohort 1 and 2, essentially, it will inform our planning for Phase 3. So I just want to make it very clear that – those are the cohorts that are focused on our dose finding objectives. So that will eventually feed into our Phase 3 trial design. And we plan to start that study by the end of the year.
So Cohort – the conduct of Cohort 3 or the start of Phase 3 is not contingent on completion of Cohort 3. So having said that, we will release the results, essentially when we get to the point of completing that cohort. It will be likely later in the year. But again, it’s – we don’t have a specific meaning or timeline at the moment. And again, it’s not tied to starting our Phase 3 trial.
Yes, most likely this open-label extension will be generating data for a while and will be periodically reporting on its progress.
Got it. Thank you very much.
Thank you.
Your next question comes from the line of Charles Duncan with Cantor Fitzgerald.
Hey, Charles.
Hey, Robert and team, thanks for taking our question, and congrats on the forward progress with omecamtiv, very good productivity this quarter. I wanted to ask you a question about that recent FDA meeting. I know that you probably can’t give us details. But I’m just wondering, first of all, if you’ve received the meeting minutes yet. And secondly, do you feel like the FDA was most compelled by the efficacy that was seen or by the identification of the high burden and relatively underserved patient population, likely both. But where do you think their real interest was?
Good question. Firstly, with regard to the minutes, yes, and we have received them. With regard to your second question, I don’t think I can speak for FDA. But I think as you know, with a program that comprises over 30 clinical trials and a Phase 3 pivotal trial that is over 8,000 patients in 35 countries, it’s a rather robust data set that we have generated in connection with omecamtiv mecarbil over 15 years.
I don’t think the FDA is newly realizing the unmet need in heart failure. And you’ve seen how they’ve been leaning forward in connection with approvals in that space. Albeit, not medicines that directly impact cardiac muscle. And I think, while I can’t speak for FDA, we have had many, many, many listening sessions with opinion leaders since the GALACTIC results have been provided.
And there is a very consistent theme running across those conversations, which is – this is an opportunity that we’ve been looking for in connection with a new mechanism therapy that binds directly to cardiac muscle enhances cardiac function, improves cardiac performance and can do so safely without risk of arrhythmias heart rate and where blood pressure and renal function are not compromised. So that’s what we believe omecamtiv mecarbil represents as could be complimentary to standard of care and keep in mind the results we saw in GALACTIC were on top of standard of care. And we believe that speaks to an opportunity set for omecamtiv mecarbil. And we discuss that with FDA and we were pleased with the feedback. I hope that answers your question.
Yes, absolutely. So it’s kind of the entire gestalt. But it does seem, like, they certainly considered the differentiated mechanism of action and potentially target product profile.
I think it’s important that, the FDA has been involved in a lot of public meetings with academics and biopharma, heart failure researchers, and trying to advance the field. You saw a couple of years ago, a guidance came out to reiterate their position on, what approvability for drugs and heart failure looks like, that you see many senior members of the FDA involved in these meetings. And I think that just reflects on recognition that there’s a tremendous unmet need here, despite the fact that we have existing therapies. And you can just even look at the event rates in GALACTIC, they exceed 30% and even higher than that in some sub-populations. So still a tremendous need, despite the therapies that we have.
Yes, makes sense. I know there’ll be a lot of questions on CK-274 from other analysts. So I’ll leave that to them. But I wanted to ask you about COURAGE-ALS, you mentioned being in a position to start that Phase 3, once you nailed down omecamtiv go-to-market and then potential moving to CK-274 into Phase 3. And I guess, I’m kind of wondering, what are the trigger points with regard to COURAGE-ALS, if you can share them with us that you’re waiting for to be able to operationalize that study.
Sure. Good question. So firstly, as you may recall, we presented the design for COURAGE-ALS late last year. And we’ve also commented on additional secondary analyses that lend support for ways we think we can enrich the response seen in four to two day or less has designed into that Phase 3 trial COURAGE-ALS. We’ve also announced that Astellas has agreed to provide co-funding of COURAGE-ALS in connection with their receipt of a low single-digit royalty on sales in certain countries. We’ve also announced that COURAGE-ALS is designed with interim analyses so that we can see if it is affirming the kind of activity that we designed and powered the study for based on what we saw in Phase 2. So we took certain steps to ready for the potential start of COURAGE-ALS, but we’re a small company and we have to maintain priority and focus.
So we wanted to make certain that we understood what would be the path forward for omecamtiv mecarbil and CK-274, before we commit to operationalizing COURAGE-ALS. And we laid out a couple of objectives or milestones. Firstly, we wanted to see the GALACTIC results, we’ve seen them. We wanted to understand if they could support an NDA filing and we believe that we have that feedback and that they do and we expect to file in second half of the year. But we also want to understand the go-to-market strategy and how that can return on investment, the timelines, the expenses, and the activities, and make certain that we’ve got our arms around that.
And we’re in the process of making that happen. We also wanted to understand CK-274 and what could be its path to Phase 3. So that’s partly answered by the fact that we’ve seen interim data from Cohort 1 and we’re engaging regulatory authorities. And we are preparing for potential Phase 3 later this year, but we haven’t seen enough yet from REDWOOD, in order to be committal to COURAGE-ALS.
So we want to see those data in order to be able to be in the best position to know that CK-274 has a path forward to Phase 3, and that can be moving forward, potentially in parallel with reldesemtiv in COURAGE-ALS in Phase 3. Imagine that will then be a company with a profile, omecamtiv going to market potentially in 2022 and two programs, one from each of our verticals in Phase 3 in 2022. We like that complexion. We think that’s in the interest of shareholders and in the interest of our science, that’s what we’ve been building towards. And if there’s anything that we’ve learned from the course of over 20 years at Cytokinetics is that there’s always advantage to having one up next a program up is in the interest of building a sustainable and durable company managing a portfolio enables us to build a franchise across both cardiac and skeletal muscle.
So we’re not there yet with COURAGE-ALS, we still have to turn over a few cards, but we’re getting there in the meantime, we’ve been conducting startup activities and getting mobilized. I hope that helps.
That does help, Robert. Thank you for the thoughtful answer and strategy and appreciate you taking our questions.
Sure.
Your next question with Salim Syed with Mizuho.
Hello, Salim.
Great. Hey, Robert. Hey, guys. Thanks for all the color and congrats on the progress. Just a couple from me if I can. Fady, did I hear you, right, that, did you say we’re getting the data for REDWOOD in July?
I think I said mid-year, in July, mid-year.
It is. But I thought you mentioned the month, is that – I just want to make sure, I didn’t mishear you.
I might have mentioned the month. I think we expect the data given the completion of enrollment and the completion of the anticipated study duration and things for it to read out sometime in July.
Yes. Given that, we still haven’t locked the database. We still are conducting the study. I’ve seen your notes and you’ve made certain calculations and projections on timing. What I can say is that we’re looking to mid-year and that’s still to be determined based on things still to happen.
Okay. Got it. Just to clarify on that. I mean, if you guys had finished enrollment for Cohort 2 in February, I believe, I think you guys announced that on the 25, specifically. Why wouldn’t you be able to lock the database two weeks – post the week 10 treatment duration? So at the last echo, why wouldn’t you be able to lock it then for Cohort 2 and present the data earlier? Is this any curiosity?
Salim, there’s actually a four-week period after a week 10. So there’s a two-week echo at week 12 and then there’s a two-week follow-up at week 14. There’s a period of time when all the echos have to be centrally read and adjudicated and the data need to be cleaned and all that sort of stuff. So the timeline is something that requires, includes database lock and core lab activities and so forth.
Okay, got it. And then just secondly, you guys are starting to discuss the Phase 3 for CK-274, and just wondering how you guys are planning to do this with mavacamten on the market and I think the PDUFA is in January of 2022. Are you guys contemplating the head-to-head versus mava or how are you guys exactly thinking about this with another HCM acid potentially on the market early part of 2022?
It’s a good question, but I don’t think it would be reasonable for us to be responding about that from the competitive positioning standpoint, recognizing that there could be a single pivotal trial, there could be more than one. We’re ultimately going to be deciding how best to position and frame a CK-274 in what will be a dynamic space.
We do expect BMS should get approval for mavacamten in 2022, but we also believe that the trial that we expect to conduct at least the Phase 3 trial that we’ve been focused towards is one that should enroll, well, not only in the United States, but outside the United States. Our plan is to make this a global registration program. So I think it has the potential then to still enroll rapidly even as mavacamten may be approved in 2022, as far as the head-to-head or anything like that, I think it would be premature for us to speak to any of those issues.
Got it. Thanks so much, guys.
Thank you.
Your next question comes from the line of Ted Tentoff with Piper Sandler.
Hey Ted.
Great. Thanks very much. Hi guys. How are you? Thanks for the thorough update. I guess my question would be with respect to omecamtiv mecarbil. I was encouraged by that update. And one of those sort of and maybe it’s a little bit early to talk about this, but what do you see as sort of the market opportunity based on the results that were reported from GALACTIC? Thanks very much.
Sure. Good question. I’m going to tackle that, but I’ll also ask Andrew, who’s joined this call to speak about it also at a high level, because he brings a different perspective than some of us at Cytokinetics. We’ve been at this for 15 years on omecamtiv mecarbil in the clinic. And we admittedly are pretty close to the trees, but he can look at this from a forest viewpoint as well and given his expertise in specialty care cardiology markets, I think it’d be helpful for you to hear from him at least this first time.
What I’ll tell you is that there are over 6 million of patients today in the United States with heart failure. That number looks to be growing to 8 million to 9 million by 2030. If you consider that roughly half of those have heart failure with reduced ejection fraction, and you look at data cuts, how many have ejection fractions below 40, below 35, below 30, below 25. And you can get this from real world evidence. There are a large number of patients who fit the bill for that, which is comparable to how we pre-specified in GALACTIC patients above and below the median.
The median in GALACTIC was 28%, ejection fraction at 28%. There over 4,000 of those patients in GALACTIC. And they are symbolic, if you will of patients with more severe heart failure and other risk factors. And we’re looking at a combination of these risk factors as defines a patient population that’s in high unmet need of new therapy, despite a standard of care. So because this is cardiology, you’re talking about not thousands or tens of thousands, but hundreds of thousands of patients, and even over a million such patients. And that’s where we need to be smart about positioning and knowing where omecamtiv mecarbil may play a role in guideline directed therapy.
But maybe I’ll stop there and turn it over to Andrew to provide some of his perspective.
Thanks, Robert. So maybe just to build on what Robert said, while I’ve been fairly new to the team, we’ve been spending a lot of time on our go-to-market strategy and given the profile that Fady and Robert described and an add on therapy, we are concluding that there given the unmet need and the match to the profile of omecamtiv, that there are a numerous amount of patients that could benefit from the emerging profile of omecamtiv and that we could be very successful in commercializing it as well.
We’re currently designing and building what we think is the right size commercial organization and infrastructure that will enable us to focus on care settings where the majority of heart failure patients are treated of both community cardiology and hospitals. So getting those cardiologists in those two care settings activated on omecamtiv for that subset of patients is really what’s going to be critical to our success. And we feel again right size their organization, and in the right ROI that we certainly can be successful in this market.
Awesome. Thank you, guys.
Thank you, Ted.
Your next question comes from the line of Jeff Hung with Morgan Stanley.
Hello, Jeff. Jeff, you might be on mute.
Can you hear me?
Yes, we can hear you now.
Okay. Well. Hey everyone, and thanks for taking the question, and welcome, Andrew. So actually this is for Andrew, if he’s on the line. I guess before you joined Cytokinetics, what aspects of omecamtiv mecarbil or GALACTIC did you find most compelling? And now that you’re at the company, what are some of the improvements that you envision for the commercial efforts?
Sure, thanks for the welcome. I mean the biggest thing really is the science, the focus the company has on science and match with the unmet need from a patient point of view, really focusing on the muscle biology, cardiac myosin inhibitor, cardio myosin activators that really matches science and unmet need is really the foundation of what I thought was great for patients and great for an organization to be successful.
Coming to the company, now for a few months, I think what we really learned is that you have to make sure that you get access to drugs and you get cardiologists to really understand the evidence produced by a clinical trial like GALACTIC-HF and using this evidence really painting a picture for who the clear patient is that can benefit most from that, and then bringing the organization and the infrastructure in place with the right ROI and the rightsizing and structure for a company or a size kind of marrying these things together, access, drug profile, given the evidence in science and kind of our go-to-market strategy. I think that formula together will surely make us successful.
Thank you.
I know the question wasn’t directed to me, but we’ll have an opportunity not only to hear from Andrew, but also members of his team as we’ll have an Investor Day later this year. And we intend to layout our go-to-market strategy in significant detail. We’re not going to try to be that company that competes on every front, but rather instead, where do we think the mechanistic science, the evidence, and our ability to achieve a high ROI could distinguish Cytokinetics in a marketplace with a high unmet need both clinically and economically.
And don’t forget the economic piece of this, because as you’ve already seen in GALACTIC-HF, omecamtiv on top of standard of care translated into significant reductions in hospitalizations and re-hospitalizations, and those hospitals are having to eat those costs on patients readmitting within 30 and 60 days. And there’s a very compelling opportunity for a pharmacoeconomic argument here that we think makes a lot of sense to institutions and cardiologists that treat patients in those institutions. So more to follow on that, but recognizing that when we go forward to hopefully a launch of omecamtiv mecarbil, we’ll have laid out our rationale for others to also understand.
Great. Thanks.
Thank you.
Your next question comes from the line of Dane Leone with Raymond James.
Hello, Dane.
Hi, how’s it going? Congrats on all the progress.
Good, thanks. Thank you.
Just one for me, because it’s getting a bit late in the call. The – could you maybe just parse out because we’ve gotten a lot of questions in terms of what you’ve disclosed around REDWOOD today with Cohort 1 versus Cohort 2, and then the opening of Cohort 3 with disopyramide. Is it –maybe just to stay clearly is the purpose of the Cohort 3 combination study with disopyramide to satisfy with a lot of the clinical community? The highlight is potentially a deficiency of what was generated with mavacamten dataset. Or is there some angle that maybe you can get more efficacy out of the Cohort 1 dosing on in combination with disopyramide that would preclude necessity from dosing CK-274 higher to the doses that were used in Cohort 2. Thank you.
That’s an interesting way of thinking about it. I hadn’t even thought about it that way. It very much is in order to inform the possible inclusion of other patients in Phase 3, but maybe Fady can speak more to that or Stuart.
Yes. I think I can’t really speak to the whole investigative communities thinking about this other than these are patients that have not had the opportunity to participate in trials. We’re about to conduct a fairly sizable trial in this area. And if there isn’t a need to exclude them, then why not include them. And so I think Cohort 3 is designed to give us the information regarding the safety of combining those two drugs so that we can do so in an informed manner.
Great. Thank you, guys.
Thank you.
Your next question comes from the line of Greg Suvannavejh with Goldman Sachs.
Hey Greg.
Hi team, this is Anna on for Greg. Just one quick question from us on CK-274 Cohort 3, and the chosen doses which had appeared to be a slightly lower than the other doses have been explored. If you could just provide some color on the decision around the doses chosen for Cohort 3, and perhaps if you can give us some color on what’s the magnitude of the effect size that you’re hoping to see with Cohort 3 versus what you saw previously in Cohort 1. Thanks.
Stuart, why don’t you go ahead and take that?
Right. So the – we’ve been discussing disopyramide has some impact on reducing cardiac contractility and given that effect, we want to essentially evaluate that patient population cautiously as you might expect. And so as we described in our December press release and the interim results of Cohort 1, we determined that those – that lower dose range was a safe tolerable. And so it was reasonable to evaluate the disopyramide treated patients using those doses that had already been qualified so to speak were known to be safe and well tolerated.
But an additional point is, and just as a just to reinforce the point is that CK-274 dosing is individualized for each patient, right. So and based on achieving target gradients while maintaining reasonably normal ejection fraction. And so it could be very well be that some patients treated disopyramide will be well controlled achieving their target gradients the lower dose range. And it still some patients may require higher doses, but in the end, and we’ll learn this in our Phase 3 trial that – what type of – for the most part, what sort of doses will be required, given the full dose range in Phase 3 and these disopyramide treated patients.
Okay, great. Thanks so much.
Thank you.
And your last question comes from the line of Akash Tewari with Wolfe Research.
Hello, Akash.
Hey guys, this is Andrew on for Akash. I just had a couple if I can. But first, can you kind of talk to us about how much relative reduction in contractility you guys need to alleviate kind of the outflow gradient. This is something that I believe we’re targeting fairly low on a dosing curve, call it, [indiscernible] or so. Could you speak to that? And then secondly, like in terms of average LVEF drops across the cohorts and across like any dose that you might bring forward, when we look at the averages from the mavacamten trials, if you guys are able to dose relatively higher up the dosing curve, given the shallower relationship. Is it fair to say that we could see a slightly higher average drop in EF? And then lastly, well, I know we don’t want to everybody’s going to look at these Phase 2 results and try and compare it back to mavacamten, given the design of the trial and the titration scheme. Is it fair to say that the better comparator is really the EXPLORER trial versus the Phase 2 pioneer? Thanks.
All good questions. I’ll turn it over to Fady and Stuart can probably handle these better than like…
So I’ll try and tackle them quickly as we’re getting shorter on time. I think in regards to your first question, it’s a little bit of an open matter is that ejection fraction you need to drop in order to maximize the effect on the gradient. I think it depends on the patient. These patients in general have the ejection fractions that are 70%, 75%. So they have quite a ways. They have a significant room to move in terms of trying to maximize the effect on the gradient. But it’s kind of sum it up. I think we were anticipating drops of 5 to 15 – range depending on the patient and the severity of their gradient.
I think the second question in terms of I’m remembering the third question now, but the second question had to do with, you want to remind me.
Yeah. If like – if the shallower PK/PD plays out, is it fair to say the average EF drop could be relatively higher? Is that suggestive that we could get relatively higher on the dosing curve?
Right. Yes, I think that’s an astute observation. The fall and ejection of 3%, 4%, 5% on average is pretty minimal in terms of again where these patients start. And so as I alluded to in the first question, if you can predictably push the dose a bit higher, maybe even potentially lower the ejection fraction a bit more, you’re still well in the normal range. But you may be able to achieve a greater effect in patients that have a more severe gradient.
That’s something that we’ll hopefully have some read on when we see the fullness of the data from REDWOOD-HF, HCM rather. And then I think in the last question, the answer is, I think the EXPLORER data in some ways, the echocardiographic data from EXPLORER probably a better comparator to REDWOOD-HCM in the sense that it’s a placebo-controlled trial patients who are on background therapy in their Phase 2 trial there they had withdrawn patients from background therapy. It was an open-label trial.
I think there are certainly differences between the two trials that really preclude a head-to-head with caution people from always trying to draw those comparisons in the absence of understanding the underlying variables. But in essence, I think probably EXPLORER would be more relevant to the Redwood experience.
Okay. Thank you.
Thank you.
And there are no further questions at this time.
Okay. Looks like we covered quite a lot of ground here in the presentation in the Q&A, so I’ll be brief. I want to thank everybody for their attention and for participation on 2021 earnings call, obviously a lot of good things going on at Cytokinetics. We’re approaching the remainder of the year with clear-eyed focus to execution on getting to the results of REDWOOD-HCM mid-year putting a good strategy for omecamtiv mecarbil and readying to build what we think can be a transformational time at Cytokinetics as we transition to our commercial phase with a potential 2022.
That is happening at the same time, we’re doubling down on research and development both our research platform expansion, and a doubling of our pipeline in clinical research. And we hope to be one of those companies that is establishing a franchise business. At the same time, we continue to innovate in science and bring forward a sustainable pipeline and make for a durable business. I look forward to keeping you updated on our progress. And we look forward to responding to other comments and questions over time.
With that operator, we can bring this call to a close.
Ladies and gentlemen, this does conclude today’s conference call. We thank you for your participation. You may now disconnect.