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spk01: Good afternoon and welcome, ladies and gentlemen, to CytoKinetics' third 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 the listen-only mode. At the company's request, we will open the call for questions and answers after the presentation. We will allow for up to two questions per participant. I will now turn the call over to Joanna Siegel Fatto Kinetics Senior Manager of Corporate Communications and Investor Relations. Please go ahead.
spk08: Good afternoon, and thanks for joining us on the call today. Robert Blum, our President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Then, Fatty Maleth, our EVP of Research and Development, will provide an update on Omicamp and McCarble, including recently presented additional analyses from Galactic HF, as well as an update on our ongoing next steps with the FDA. Next, Stuart Kupfer, our SPP and Chief Medical Officer, will provide an update on our development program for Affy-Campden by recapping the results from Cohort 1 and 2 of Redwood HCM, elaborating on continuing activities in Redwood HCM, and reviewing the design of Sequoia HCM, our planned Phase 3 clinical trial of Affy-Campden in patients with obstructive HCM. He will also speak to initial progress in Courage ALS, our ongoing phase three clinical trial of real deceptive in patients with ALS. Then, Andrew Kalos, our EVP and Chief Commercial Officer, will discuss our go-to-market strategy for Omicamp and McCarble and our cardiovascular franchise development plans for the commercialization of Affy Campton. Robert Wong, our VP and Chief Accounting Officer, will provide a financial overview for the past quarter And Ching Jha, our SVP and Chief Financial Officer, will discuss strategic planning, our financial outlook, and corporate development strategies before Robert Blum will provide concluding thoughts and expected key milestones for the remainder of 2021. Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Our actual results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings, including our current report regarding our third quarter 2021 financial results filed on Form 8K today. We undertake no obligation to update any forward-looking statements after this call. Now, I will turn the call over to Robert.
spk11: Thank you, Joanna, and thanks again to everyone for joining us on the call today. We had a very productive third quarter marked by meaningful progress across all of our later stage programs, most notably our sharing positive results from our Phase II clinical trial, Redwood HCM, which demonstrated the efficacy and safety of afecamptin, our next-in-class drug candidate, in patients with obstructive hypertrophic cardiomyopathy. As we've said, these results met our high expectations for this trial, and we received positive feedback from the physician community. Stuart will elaborate more on these results in a moment. During the third quarter, we were also pleased to complete enrollment in cohort three of Redwood HCM, which, as you'll recall, enrolled patients also on desipiramide, a medication often prescribed to patients with more severe HCM. We expect to share the results from cohort three in the first quarter of 2022. Following previous interactions with FDA from which we received feedback on our planned trial design, we continue to advance activities in preparation for Sequoia HCM, the phase three clinical trial of athecampin in patients with obstructive HCM. As we recently presented, and as Stuart will elaborate, this trial was designed to potentially demonstrate a significant improvement in exercise capacity and evaluate safety in a broad population of patients with symptomatic obstructive HCM. We're working with sites around the world, including many who participated in Redwood HCM who are enthusiastic about also participating in Sequoia HCM. and we look forward to starting this trial soon. Moving now to our heart failure program, we continued activities supportive of our plans to submit an MDA for Omicamp to McCarble, and we remain on track towards our goal of submission in this fourth quarter of this year. Fatty will have more to say about that in a moment. Additionally, as outlined in our recent Analyst and Investor Day, we're making significant progress in refining and executing the our go-to-market strategies for Omicamp to McCarvel across several work streams that Andrew will elaborate on in a moment. These commercial readiness activities represent a tremendous scope of work from our growing commercial organization and supporting our go-to-market strategies, as well as our intention to build a cardiovascular business franchise by leveraging common denominators and synergies across our business, inclusive of our plans both for the potential launch of omicamptomacarbal and a potential future launch of aficamptin. As Fadi will discuss, in the third quarter, we presented additional results from Galactic HF, highlighted by an analysis of black patients enrolled in Galactic HF, showing that the treatment effect of omicamptomacarbal in black patients was consistent with the treatment effect in the overall population, and also similar to the effect observed in white patients in the trial. This finding is important due to the fact that black patients tend to have a higher risk of heart failure and often have worse outcomes. Additionally, an analysis of the severe heart failure subgroup in galactic HF was published in the Journal of the American Medical Association Cardiology, illuminating a larger treatment effect when compared to the overall population of patients studied. This important manuscript was accompanied by an editorial suggesting recognition of a new classification for a group of severe heart failure patients whose still prevailing high unmet need represents an increasing patient population with heart failure that contributes more and more to the clinical and the economic burden of this disease. Finally, We were pleased in the most recent quarter to begin enrolling patients in Courage ALS, our phase three clinical trial of rel-deceptive in patients with ALS. The results from the phase two clinical trial, Fortitude ALS, were deemed compelling by investigators and physicians who treat patients with ALS. And our advancement to phase three is an exciting and important step forward for this program, as is aligned with our dedication to the ALS communities. The ALS communities are more assertively seeking new medicines, and the FDA and public policymakers seem to be increasingly responding to these louder calls for action. It is an incredibly important time for our company. We're building our teams and capabilities as we're now on the precipice of a powerful transformation from an R&D company into one that is also a commercial organization. It has always been our strategic vision to ourselves deliver on the promise of our science, and we're closer now to that than ever before. These are exciting times to be sure, but how we execute on those plans will matter. Robert will speak to our current financials, and Ching will comment on our progress and prospects in continuation of our long-standing practice to diversify our access to capital through both partnering and structured financings, as is informed by annual strategic planning. With that, I'll turn the call over now to Fatih to elaborate on developments related to Omicampt of McCarble.
spk16: Thanks, Robert. As you mentioned, results from additional analyses of galactic HF presented during the quarter at the Heart Failure Society of America Annual Scientific Meeting reinforced that outcomes with Omicamptib, McCarbell, and black patients enrolled in galactic HF were consistent with the overall population. And like the overall study results, were driven primarily by reduction in heart failure hospitalizations and heart failure events. The treatment effect in black patients was also similar compared to white patients. Galactic HF enrolled the most black patients among recent heart failure trials, and of patients enrolled in the U.S., 29% were black, which is important not only because black patients have historically been underrepresented in clinical research, but also because they have a higher risk of heart failure and suffer worse outcomes. This disparity in outcomes is complex. but it's encouraging to see that the potential benefit of treatment with omicamptive McCarble remains consistent in this group. Expanding on the theme of higher risk patients with heart failure, three weeks ago, a manuscript entitled Assessment of Omicamptive McCarble for the Treatment of Patients with Severe Heart Failure was published in JAMA Cardiology. Following on the heels of the initial data presentation in late June at Heart Failure 2021, an international congress of the European Society of Cardiology. The analysis by Dr. Michael Felker and co-authors looked at the treatment effect of omicamptomacarbal on the primary composite endpoint in patients from galactic HF, classified as having severe heart failure based on modified criteria from the Heart Failure Association of the European Society of Cardiology Advanced Heart Failure Position Statements. Patients in this subgroup had NYHA class 3-4 symptoms, EFs of less than or equal to 30%, and hospitalization for heart failure within the prior six months. Approximately 30% of patients enrolled in galactic HF met these criteria and had event rates that were approximately twice those of patients without severe heart failure. In this post-hoc analysis, those with severe heart failure who received omicamptomacarbal experienced a significant treatment benefit for the primary endpoint with a hazard ratio of 0.80, whereas patients without severe heart failure had no significant treatment benefit with a hazard ratio of 0.99. The results for cardiovascular death were qualitatively similar. Patients with heart failure that was severe experienced a trend towards treatment benefit from omicamptomacarbal, while patients without severe heart failure did not. Omicamps of McCarville was equally well tolerated in patients with and without severe heart failure with no significant changes in blood pressure, renal function, or potassium compared to placebo. Accompanying this manuscript was an editorial authored by Drs. Clyde Yancey, Adrian Hernandez, and Greg Fonarow titled Identifying Treatments for Stage C2 Heart Failure, in which Stage C2 is proposed as a new addition to the currently defined four stages of heart failure, A through D, and as would encapsulate these severe heart failure patients who may be a priority for additional impactful therapy. This high unmet need was a focus of our panel discussion at our recent Analyst and Investor Day. Despite the availability and adherence to guideline-directed medical therapy, or GDMT, patients with worsening heart failure still have high event rates, As we heard from Drs. Alana Morris and Tarek Hamad, who are both specialists in heart failure at major academic medical centers, it can be a challenge to get patients on GDMT because many are unable to tolerate their medications due to side effects. With Omicams and MoCarbo, we have the potential add-on therapy with a novel mechanism of action that could be used as a complement to and alongside existing therapies without increasing cardiac mortality. Physician feedback has indicated that their view is positive towards the clinical utility of omicamptomacarbal as an additional therapeutic option with a good safety and tolerability profile, and that there is a clear need for therapy like omicamptomacarbal to fit into regular practice. Moving on, we completed enrollment in meteoric HF at the end of the second quarter, and we continued conduct of the trial in the third quarter. This trial will provide insight as to how Omicamps and McCarville could benefit another key aspect of improving the lives of people with heart failure, which is to improve their exercise capacity. A common concern of patients with heart failure is their inability or difficulty with everyday tasks, but current treatments have little to no impact on exercise capacity and stamina. We expect to complete Meteoric HF this year, and look forward to reporting results in early 2022. Also in the third quarter, we conducted meetings with FDA to support the preparation and submission of our new drug application, or NDA, for omicamptomacarbone. We completed a pre-NDA meeting, which confirmed the suitability for submission of content related to chemistry, manufacturing and controls, clinical pharmacology, and the non-clinical program, as well as the format of data sets, the integrated summary of safety, and other components of the NDA. We also had a meeting with FDA to discuss the assay for plasma concentrations of omicamptomicarbol in terms of its potential need to guide dosing, as well as the regulatory pathway for its implementation. In sum, these meetings provided guidance to some of the content of our NDA, which is on track for submission this quarter. As we approach our goal of submitting our NDA to the FDA, we also continued simultaneously growing the scope and reach of our medical affairs activities by hiring therapeutic area lead medical directors and deploying additional field-based medical scientists. We have developed a compliant framework for an investigator-sponsored studies program, which is timely as we've started to receive requests for potential collaborative activities. The team's working on finalizing their scientific platform for Omicamps of McCarville, which forms the basis for communications with medical professionals. We also initiated vendor selection for the development of a medical contact center to be prepared to respond to requests for medical information or direct questions to the proper personnel for a response. With that, I'll turn the call over to Stuart to provide an update on Apicampton and Reldisemptive.
spk06: Thanks, Fatty. During the third quarter in September, we presented the full results from cohorts one and two of Redwood HCM, the phase two clinical trial of apicampin at the Heart Failure Society of America Annual Scientific Meeting in Denver. As we've mentioned, the results were positive and support our advancing apicampin to phase three, which I'll touch on in a moment. As we previously shared, in Redwood HCM treatment with apicampin for 10 weeks, resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular outflow tract, or LVOT, pressure gradient and the average post-vowel salve LVOT gradient. The majority of patients treated with apicampin, 79% in cohort one and 93% in cohort two, achieved the target goal of treatment defined as resting gradient less than 30 millimeters of mercury and post-Valsalva gradient less than 50 millimeters of mercury at week 10, compared to 8% for placebo. These reductions in LBOT gradient were dose-dependent, with patients achieving greater reductions of LBOT gradient with increasing doses of Avocampus. Reductions in LBOT gradient occurred within two weeks of initiating treatment, were maximized within two to six weeks of the start of dose titration, and were sustained until the end of treatment at 10 weeks. Reversibility of LBOT gradient and LB ejection fraction reductions were observed after discontinuation of apicampin, with levels returning to baseline at the end of the two-week washout period. Patients also experienced statistically significant reductions in NT-proBNP, and treatment with apicampin was associated with an improvement in New York Heart Association functional class, with a substantial number of patients improving by at least one class. As previously stated, treatment with apicampin was well-tolerated. The incidence of adverse events was similar between treatment arms, and there were no treatment-related serious adverse events. Importantly, there were no treatment interruptions or discontinuations. Dr. Marty Marin, director of the Hypertrophic Cardiomyopathy Center at Tufts University School of Medicine, who presented the results of Redwood HCM at HFSA, underscored the potential clinical utility of apicampin based on the elimination of arresting LVOT gradients in nearly all patients. Dr. Marin further commented on the substantial improvement in heart failure symptoms, rapid onset and reversibility of effect, the ability to use precise echo-guided titration, and the lack of dosing interruptions for low ejection fractions. At the conference, we also received a positive reaction from physicians who manage patients with HCM and expressing their enthusiasm about the results and for medication that potentially could be used for patients who have symptomatic obstructive HCM and are not responding to current standard of care therapies. Overall, we're very encouraged by the results so far and their potential translation to clinical practice. During the quarter, we also completed enrollment in cohort three of Redwood HCM in which patients with obstructive HCM who are receiving disapiramide as background therapy are treated with apicampin in an open-label manner. This cohort will further inform the potential inclusion of the small but important patient population in our planned phase three trial. In addition, during the third quarter, we continued enrolling patients in Redwood HCM OLE the open-label extension trial of Redwood HCM. With the positive results in hand from Redwood HCM, we have been actively engaging in startup activities for Sequoia HCM, our planned phase three clinical trial of Affey-Campden in patients with obstructive HCM. At our Analyst and Investor Day meeting in October, we presented the design of the trial, which I'll recap at a high level now. Sequoia HCM is a randomized, double-blind, placebo-controlled international clinical trial designed to evaluate apicampin in patients with symptomatic obstructive HCM on background medical therapy for 24 weeks. The primary objective is to evaluate the change from baseline to week 24 in peak oxygen uptake, or peak VO2, measured by cardiopulmonary exercise testing, or CPET, which is a measure of exercise capacity. Among the secondary objectives, we are investigating the change in Kansas City cardiomyopathy questionnaire clinical symptom score and New York Heart Association functional class at week 12 to evaluate a potentially early improvement in heart failure symptoms and again at week 24. We plan to randomize 270 patients in a one-to-one ratio to apicampin or placebo in addition to standard of care. Each patient will receive up to four escalating doses of apicampin or placebo with dose optimization based on achievement of echocardiographic targets. The starting dose will be 5 milligrams once daily, escalating to 10, 15, or 20 milligrams once daily as needed to achieve target gradients. These four doses were selected based on the results from Redwood HCM to facilitate selection of the optimal dose for each patient and maximize the individual benefit-risk profile. Study startup activities, regulatory filings, and IRB submissions are underway, with the first site initiations already completed. Drug product availability in early 2022 will enable the commencement of screening and enrollment of the first patients in this trial. In anticipation of enrolling patients with obstructive HCM from China in Sequoia HCM, We continue to collaborate closely with our partner, Jixing Pharmaceutical. Jixing recently completed a phase one study evaluating single and multiple doses of apicampin in healthy Chinese subjects. The pharmacokinetic results were similar to those observed in the Caucasian populations enrolled in our phase one study of apicampin conducted in the U.S. and similarly showed dose-proportional pharmacokinetics with a safety and tolerability profile comparable to placebo. The results of this study support submission of a clinical trial application and enrollment of patients with obstructive HCM in China. On the neuromuscular front, as Robert mentioned, during the third quarter, we began enrolling patients in COURAGE-ALS, the Phase III clinical trial of rel-deceptive in ALS. Courage ALS will enroll approximately 555 patients with ALS randomized two-to-one to receive REL-deceptive or placebo for 24 weeks, followed by a 24-week period in which all patients will receive REL-deceptive. The primary endpoint is a change from baseline to 24 weeks in ALS FRS-R, a functional rating scale that indicates the progression of ALS. As we design Courage ALS, we incorporated feedback from patients and caregivers to remove key barriers to clinical trial participation and to help make the patient experience less burdensome. We are also working to provide continued access to relative incentive for all patients who complete Courage ALS, as well as patients who have previously participated in our ALS trial, reflective of our goal to ensure ethical and equitable access for patients who are in need. With that, I will turn the call over to Andrew to discuss our progress against the go-to-market strategy for Omicamptive McCarvel.
spk10: Thanks, Stuart. During the third quarter, we advanced our go-to-market strategy for Omicamptive McCarvel, and we were pleased to present it at our recent analyst investor day. There are a few highlights to the strategy I'd like to review on today's call. First, our go-to-market strategy is based on a gated build, with a planned total investment to be titrated over time as de-risking events occur. such as NDA submission, NDA filing, and approval by the FDA. To illustrate, we have around 10 to 15 percent of our planned commercial FTEs in place today, and we will have less than one-third of the total number in place post-NDA submission. This level of commercial hires are sufficient for launch preparation. As Robert mentioned, we've hired a seasoned team to implement this go-to-market strategy, and we now have our full leadership team in place, as well as our account manager team, who call in payers, and nearly all of our marketing organizations. The go-to-market strategy is based on four key pillars, insights, education, access, and support. Insight speaks to having a very deep understanding of who the worsening heart failure patient is, where they are treated, and who the cardiologists are who treat them. Education means that if Omicamp of McCarvel is approved, then we need to ensure that cardiologists clearly understand the data supporting our label, including the evidence supporting omicampium and carbol's potential benefit for the subset of patients who have worsening heart failure. Access speaks to our plans to have affordable co-pays for most patients as soon as possible after launch. And finally, support entails the programs that we will have and provide for patients, like co-pay support for commercial patients, patient assistance program, and educational services. To support our goal of commercial of affordable access, our payer account management team has met with every major payer in the third quarter. We have introduced our team and our company while engaging payers in a mutual understanding of the unmet need and heart failure. To further support access, our health economics and outcome research colleagues continue to advance outcomes research with a goal of multiple publications in 2022. These publications are targeted documenting the value of Omicamp and McCarville as illustrated by meaningful reductions in resource utilization, intensity, and cost. As we are preparing for the potential launch of Omicamp and McCarvel, we are simultaneously building our cardiovascular franchise strategy towards our plans for the potential launch of Epicampin, keeping in mind our corporate goal of bringing multiple medicines to market in the next several years. This strategy relies on several synergies. First, in the cardiologists who treat these patients, There is an 85% overlap between the cardiologists who treat patients with heart failure and ACM. Cost efficiency is another synergy where we will share field sales, field medical, shared services, and systems across the entire organization. Once we have established relationships and built systems to support the launch of Omicamp and McCarvel, we are well positioned to accelerate and streamline the potential launch of Apicanthin. It is an incredibly exciting time to be working at Cytokinetics. As we continue to grow our team and advance our plans, it remains important for us to remember the driving force behind this motivation, patience, and the clear unmet need in both heart failure and HCM. And with that, I'll turn it over to Robert Wong, who will provide an update to our financials.
spk14: Thanks, Andrew. I'll provide an update on cash, revenue, and spending, and then Ching will review our financial outlook and corporate development strategies. More details on our actual results for the third quarter 2021 are included in the press release, which we released earlier this afternoon. We ended the third quarter with approximately $668.9 million in cash and investment. Our revenue in third quarter of 2021 came primarily from our recognizing a $5 million milestone from Zhijing Pharmaceuticals in anticipation of the start of Sequoia HCM. our third quarter 2021 R&D expenses increased to $48.4 million from $24.2 million in the third quarter of 2020, primarily due to increases in spending for our clinical development activities for our cardiac muscle inhibitor programs. In addition, we incurred transition costs related to the termination of our collaboration with Amgen and our purchase from Amgen of approximately $7.3 million of materials including manufactured quantities of the active pharmaceutical ingredient for Omicamp and McCarville, thereby completing our purchase commitment. More than 70% of our R&D expenses were attributable to our cardiovascular program, as expected, given activity related to transitions from our collaborations with Amgen, the purchase manufactured quantities of active pharmaceutical ingredients, ongoing activities associated with Meteoric HF, and also our cardiac myosin inhibitor program, including the ongoing activities associated with Redwood HCM and startup activities related to Sequoia HCM. The remainder of our expenses were attributable to our early research and skeletal muscle program activity. Our third quarter 2021 G&A expenses were $26.2 million, up from $12.3 million in the third quarter of 2020, due primarily to an increase in outside spending in anticipation of our potential commercial launch of Omicamp and McCarble in 2022, personnel-related costs, including stock-based compensation, and facilities costs related to our new building. And now, Ching will review our financial outlook and corporate development strategies.
spk15: Thanks, Robert. As is our annual practice, we recently conducted a comprehensive strategic planning process with subsequent presentation and discussion with our board. This year, the strategic plan was focused to prioritizing on our expanding clinical pipeline to ensure that we focus on R&D programs that leverage our core competencies and competitive advantages in muscle biology and also address high unmet need opportunities that may afford high return on investment potential. In addition, we pressure tested plans to enrich our research pipeline with external collaborations that could complement and strengthen our internal innovation. Lastly, we focused in this year's strategic planning process to critically evaluating and reformulating our cardiovascular and neuromuscular business franchise strategies that should continually capitalize on life cycle management of our most advanced drug candidates Omicanton-Macarbo, Effie-Kempton, and Rowdy Center. To recap our cash position, we ended the third quarter with approximately $669 million in cash, which includes $297 million raised in Q3 through an equity offering net of expenses. Therefore, our pro forma cash at year-end 2021 is expected to be in the range of $600 to $610 million, which represents more than three years of cash runway using our revised net cash utilization guidance of $195 to $215 million in 2021. With the potential commercial launch of Omicams and Carbo and the funding of two Phase III clinical trials, Sequoia HCM and Courage ALS, we do expect our 2022 and 2023 cash burn rate to increase relative to 2021 spending. And we will provide guidance on this in our fourth quarter earnings call plan to occur in early 2022. As we have stated, we continue to seek ways to strengthen our balance sheet. And in the third quarter, we have advanced partnering and structure financing discussions aligned with our corporate development strategy. During the quarter, we continue our discussions with potential co-development and co-commercialization partners for Omicam and Carbo as well as Epicampton with priority attention to business development in Asia and other complimentary geographies where we don't intend to go to market ourselves. Our plan is to preserve North American and potentially European rights for development and commercialization for both Omicampton-McCarbo and FD Camden. In parallel, we have also been advancing discussions with multiple entities and funds with shared interests related to structured financings, including royalty monetization and structured debt deals. To further support the commercial launch of Omicampton-McCarbo, and our continued and expanded development objectives for Epicampton. Our goal is to complete these deals in the fourth quarter, which could enable us to end the year with two to three years of forward cash runway, even as we expect the spending in 2022 and 2023 to be higher than our expected spending this year. As you know, we have always built our business on a strong financial foundation and we have an established history of making non-equity diluted deals to support our continued growth and progress. With transactions expected to close this quarter, we believe we are positioned financially and strategically to execute the potential launch of Omnicantum and Carvel and continue to advance our pipeline and business franchise strategies. And with that, I'll turn the call back over to Robert Bonds.
spk11: Thank you, Ching. Within our vision 2025 that we set forth in 2020, we laid out several goals, including achieving regulatory approvals for at least two drugs arising from our pipeline and expanding our discovery platforms. Over the past quarter, in addition to the clinical, regulatory, and commercial progress we made, we also engaged in activities to broaden our research footprint in the years to come. Thinking even beyond 2025, we continue to forge ahead as leaders in muscle biology with focus to populations of high unmet need. In the next year, you'll be hearing more about our activities as we've extended our muscle biology focus from the biomechanics of muscle contractility to the energetics, growth, and metabolism of muscle with novel mechanism drug candidates advancing in development. While much of our focus has been on our programs in cardiovascular disease, as you heard with our Start Encourage ALS, our commitment to the ALS communities remains strong. Along these lines, we also recently donated data from our completed clinical trials in ALS to the PROACT database, which stands for Pooled Resource Open Access ALS Clinical Trials. PROACT is available to members of the research community, and it contains over 10,000 de-identified clinical patient records from multiple completed clinical trials, providing a powerful tool to advance research in the ALS field, and also to gather observations related to disease progression and epidemiologic data. We will be donating data from three completed trials in ALS, benefit ALS, Vitality ALS, and Fortitude ALS, which represents data from almost 600 patients. We're pleased to be working with the ALS Association, with Prize for Life, and with the Neurologic Clinical Research Institute at Mass General to share these data with the ALS communities to which we are all together so importantly dedicated. Further, demonstrating our commitment to patient communities During the quarter, we renewed our partnership with CURE-SMA to increase education, awareness, public policy, and fundraising for spinal muscular atrophy. And we also announced the fourth annual Cytokinetics Communications Fellowship Grants Program, which will award a total of $100,000 in grants to patient advocacy organizations in heart failure, in HCM, in ALS, and in SMA. to support increased capacity in communications and outreach. As we near the end of 2021, we look back on our very gratifying progress and achievements, and we look ahead to what may be a watershed year for our company. We expect to end 2021 with two distinct programs advancing in phase three clinical trials, with our first potential medication moving towards a potential approval and commercial launch, and all of that happening on the foundation of continued innovations in muscle biology directed to patients who rely upon us and in areas for which our leadership offers hope for diseases associated with muscle dysfunction and weakness. We look forward to providing more updates on our continued progress, and we welcome your questions and feedback. Now let me recap our expected milestones for the remainder of 2021. For Omicampton-McCarbell, we expect to submit an NDA to the FDA in this fourth quarter of this year. We also expect to complete the conduct of meteoric HF by year end with results expected in early 2022. For Affycampton, we expect to continue with study startup with regulatory filings with IRB submissions and site readiness activities all together for Sequoia HCM. And with availability of drug product in early 2022, we anticipate commencement of screening and enrollment of the first patients in that trial. And for rel-deceptive, we expect to complete enrollment of Courage ALS throughout the remainder of this year. And for our ongoing research, we expect to advance new muscle-directed compounds and to conduct IND-enabling studies and to potentially advance one to two potential drug candidates into clinical development over the next year. Operator, with that update, we can now open the call up to questions, please.
spk01: To ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Dane Leon with Raymond James.
spk05: Hello, Dane. Great. Hi, Robert and team. Thank you for taking the questions, and congratulations on all the updates. Just two for me, if you will. Firstly, can you give us any more color in terms of the scale and scope of the Sequoia HCM study as we think about, one, modeling expenses, And two, time to run the study. Is it fair to use the EXPLORER HCM study as a similar proxy and scale and scope for the patients required in enrollment? And then my second question would be just to drill down a little bit more on the submission for OMA-CAMPTIV. I know it's been asked before, but in terms of updating your communications back and forth with the FDA, any additional color in terms of the scope or scale of the label as it relates to baseline left ventricular ejection fraction? Thank you.
spk11: Sure. Good question. So, I'll start and turn it over to Fatty. He may also ask Stuart to elaborate. I don't think we're going to provide any specific financial guidance with regard to sequoia. It may be premature to do that until we start dosing patients. But certainly, we could give you some things to hold on to with regard to your projections. For instance, what might be our expectations in terms of time for enrollment and duration of the study? I hope that can be helpful. And certainly, you know already the number of patients we aim to enroll. So why don't I turn it over to Fadi first to talk to you about how we think it's going to enroll, the number of sites, the number of countries, things like that. And then most likely, once we start dosing, Presumably, that'll be in early 2022. We'll be in a better position to point to how we think it's going to be affecting our spending. And then we'll come back to your second question.
spk16: All right. Thanks, Robert. You know, I think we plan to enroll approximately 270 patients into Sequoia, which is a little bit more than was enrolled in Explorer. I think, you know, the size and scope are comparable, and certainly the number of sites and things like that. We will probably go to a few more sites than they did in Explorer, you know, nearly a dozen countries, and, you know, well over north of 80 sites, I think, ultimately, when we get the study fully up and going. So our plan is to push hard and to... enroll this as quickly as possible. But there are certain, I think, limitations in terms of study startup and things like that that are hard to press. Once we have sites up and going, I think it actually will enroll very rapidly.
spk11: So then your second question related to the NDA and how we're approaching what could be that which is contained within the NDA indication statement and otherwise, in particular around ejection fraction and As we've stated, we do believe that patients with EFs less than 30% are seemingly benefiting a great deal more than other patients in galactic, and we do think that it's in the interest of omicamptomacarbal and patients with heart failure that that's where the label should point. So we are hopeful that that data including graphics, could be included in the label ultimately upon potential approval, but that's obviously going to be subject to FDA review. But based on conversations we've been having, and Fatty can elaborate, we do feel encouraged that that would be supportive and consistent with other things the FDA has done. Fatty, anything you want to add?
spk16: No, I mean, I think we've had those discussions with FDA, and obviously what ends up in the label will be the outcome of the negotiations at the time that we negotiate the label. But in general, I think they're supportive of the concept that the label should indicate where the benefit of the drug is concentrated. And that provides physicians with the information needed to best use the drug. And in that context, the EF is obviously an important indicator.
spk11: And not only the label, I might suspect that that could ultimately inform how Omicampt and McCarville could be incorporated into guidelines also. And you got a sense of that from some of the publications that Fadi referred to in his statements.
spk05: Excellent. Thank you very much and congratulations. Thanks, Jane.
spk01: Your next question comes from the line of Joe Penginnis with HC Wainwright.
spk02: Hello, Joe. Hey, everybody. Good afternoon. Thanks for taking the questions. I wanted to focus my first question on the concept that you guys are really in an important execution and logistics time for the company. So with that said, I'll even go off of one of Stuart's comments, and Robert, you said it too, about drug availability for Sequoia early next year and executing courage as well. Do you feel you've had to plan anything ahead? above and beyond for these studies, no matter what it is, including drug availability, based on any anticipated issues around the global supply chain problems that we're seeing right now?
spk11: Very good question, and I think that might be the first time on one of these earnings calls that we really did get a question about the supply chain. It's an area of intense focus for us right now, as we're not only embarking on these large phase three studies, but we're readying for the supply of Omicamptive into the marketplace. And obviously, had we still been partnered with Amgen, that would be something we'd have relied on them for. But now it's our responsibility. And we are executing well on contracts, as well as conversion of drug substance to drug product and the like. And the study startup activities for Sequoia are proceeding nicely. we moved very swiftly from having completed cohorts one and two, reading out the results, having meetings with FDA, and readying to start Sequoia, all of that occurring in a relatively short timeframe. So it seems like things are going well that way, both in support of clinical trials and also commercialization. But we are building the supply chains at the same time we're executing on how the delivery of drug product into clinical trials is occurring. So it's something that I think is going to be continuing to be a focus for senior management as that is enabling of our success. And to this point, the good news is we're working with some of the same contract manufacturing organizations with whom we have longstanding relationships with, and there may also be opportunities to consolidate programs amongst them so that we're working with them for more than one program. And, you know, we're focused to small molecule drug candidates. And in that way, it's not like we're dealing with an incredibly novel way of approaching supply. But at the same time, we have to ensure capacity and deliverable timelines. And that's what we're focused towards. Fatty, anything you want to add to that?
spk16: No, I think you summed it up. I think, you know, we've been able to continue to advance drug supplies for our studies and things like that. I think the real, you know, major constraint has to do with, you know, spare capacity in the supply chain. There's just a lot of it's been squeezed out. So you have to be careful about how you plan things.
spk11: And what I might also say is Andrew and his team are very focused to the handoff between the manufacturers and then the logistics associated with distribution and all of the activities in connection with ensuring patients get reliable sources of drug as well. And that speaks to potential patient hub services and other things like that. Over time, I expect you'll hear more about that from Andrew too.
spk02: That's very, very helpful. Thank you. And then I guess two smaller questions. One, maybe for Ching, you know, on the financial side, you had this $7.3 million cost, you know, to pay Amgen for drug product for Omicamptive. Just curious what might still be outstanding there going into the future or if that expense is essentially done. And then second, if I heard Fatty correct when he was discussing the future from a captive as well, I could have sworn I heard him say potential ISTs. So that sounded like an interesting tease there. So I'm curious what kind of studies you might be looking at. Thank you.
spk16: Yeah, I mean, I haven't really... Oh, go ahead, Shane. You go first.
spk15: Yeah, I'll go first, Fatty. So in regards to the... payment that we pay Amgen, the $7.3 million this quarter is the last of those payments. As we stated in our press release, for the nine months ended September 30th, 2021, we have paid them $14.6 million. So that was the total amount. And this $7.3 was the last of the payments.
spk16: Thanks. And I think just in regards to investigator sponsor initiated studies, you know, we've begun to receive proposals. Obviously, we'll vet them and decide which ones we can support, things like that. They fall under a fairly broad range of interests that people have, you know, really outside, some of them outside of the heart failure population that we studied in GALACTIC, some of them within, but I think we'll elaborate more on those as we begin to to see them through. Sure. Understood.
spk02: Thank you very much.
spk11: Thank you.
spk01: Your next question comes from the line of Yasmeen Rahami with Piper Sandler.
spk11: Hello, Yasmeen.
spk09: Hi, Robert. Thank you so much for taking my questions. But I have two questions for you. Maybe the first place to start is, A lot of our investors have been sort of surprised by the FDA recently by some of the actions that were taken and created sort of a nervous Nelly situation. So I guess the question for you is, especially over the last few months as you've been interacting with the FDA, what's sort of their tone, their body language, their enthusiasm towards you? So if you could just elaborate sort of the You know, how does discussions blend? I think that could be really important, and then I have a follow-up question.
spk11: Sure. So what I'll say is oftentimes in these situations, biotech companies talk about having a pre-NDA meeting. They submit an NDA. It gets filed or doesn't get filed, and then they await approval. In our case, over the last year, we've had many interactions with FDA, both in person before COVID shut that down and then also subsequently by Zoom interactions and otherwise through written exchange of documents. I found FDA to be very accessible and very interactive with us and providing guidance that informs both the formatting and the content of our planned NDA submission. So I'm very encouraged by the level of engagement as should hopefully support our submission that would hopefully align with interest for approval. We've had all of our questions satisfactorily answered in order to provide for us now to go through the final mechanics of an NDA submission in order to get that done this quarter.
spk09: Thank you, Robert, for the answer. And maybe a follow-up question is maybe giving me some insight when you speak with cardiologists, whether these are in private practice, whether it is at the hospital setting, sort of the level of appreciation they have for omicamptive in terms of a novel mechanism of action. Does it click right away when they know that it's the first myotrope, being able to really, being able to improve cardiac contractility. I think that might be really important, like how important is the novelty of its mode of action for driving adoption and their enthusiasm beyond, obviously, the outstanding data from black to nature.
spk11: So it's a little too early to talk about adoption, of course, in that as much as not approved, but certainly based on ad boards and interactions with key opinion leaders that have been driven out of medical affairs and also market research, as is driven out of our commercial group, we're getting very positive vibes about how the novelty of the mechanism may translate into potential future adoption. Maybe I'll turn it over to Fadi first to speak about some of those activities that he's overseen, and then I'll turn to Andrew as well.
spk16: Yeah, I mean, I think the physician community certainly understands where this could play a role, and it's been finding a drug that can improve cardiac function safely and have benefit for patients has been a longstanding goal in this field. If you listen to our Investor Day presentation, I think you might hear some of the enthusiasm in the two discussions we had, but it was similar amongst many ad boards that we conducted both in the U.S. and in Europe. And, you know, I think even as we go out to other stakeholders in the process, you know, we're sensing their enthusiasm for something that is new, but on the other hand, we understand how it works and it's rational. You know, it's rational as to why you might use it.
spk10: This is Andrew. The only thing I would add is that when we talk with physicians, They're excited by the mechanism, not for the mechanism alone, but it's a reason to believe relative to the data and the evidence that we produced. So when they look at the mechanism and the evidence and the unmet need are very well aligned, they are running out of options when patients can't tolerate guideline-directed medical therapy. They are running out of options when they need products that could be an add-on that's neutral on kidney, neutral on blood pressure, in worsening patients. And when you talk about the add-on and those type of effects, they get very excited and a good reason to believe then kind of closing is a mechanism. So we're getting a lot of enthusiasm for a very specific subset of patients relative to the product.
spk09: Thank you for the answer.
spk11: Thank you.
spk01: Your next question comes from the line of Jeff Hung with Morgan Stanley.
spk04: Hey, Jeff. Hey, Robert. Thanks for taking the question. Previously indicated that meetings with payers on Omicamp and McCarvel have been largely introductory. Just curious if you have any updates that you can provide on payer feedback.
spk11: Sure. I'll turn it over to Andrew to address that.
spk10: Sure. So, appreciate the question. So, we've interacted with, you know, as I mentioned, we've hired all of our account managers. as well as a leader of that team. Many of them have existing relationships with all the major payers. We've interacted with the major payers, and it's really more about introduction, who is cytokinetics, and then making sure we align well on how they think about heart failure, how do they manage heart failure, what are their challenges, and what are their needs. So we've had those kind of baseline discussions, and then where we'll go next is, you know, per FDA regs is kind of a pre- approval information exchange, and we'll start doing that in coming weeks. So the feedback has been, well, they do like that we can clearly identify those patients relative to benefit in EF, so then therefore that could indicate where they would target us from a prior authorization point of view, which is acceptable to us, because that gives us access to a very specific population. that greatly benefits from all the captains. So hopefully that gives you a color of our interactions in the third quarter.
spk11: The other thing to add is there's a lot more forthcoming that you'll see in the published literature in 2022 that underscores the economic burden of heart failure, especially for those with worsening heart failure and where there could be opportunity for a new mechanism therapy like Omicamp to Bacarbo based on results from Galactic to make a dent in that for payers. And payers are clearly aware of the economic burden associated with their management of heart failure patients. They're aware especially of the high Medicare percentage of these patients for which they're oftentimes penalized when these patients are readmitted. So a novel mechanism therapy that could reduce heart failure-related events, primarily hospitalizations, would be something that would catch their attention. And that's something that we'll continue to investigate as could be supportive of our plans for Omicamptive.
spk04: Great. Thanks. I think I may have misheard, but did you say that you expect enrollment of COURAGE to be completed this year? Otherwise, any updates on estimated timing or when you might be better able to gauge the pace of enrollment to estimate that time? Yeah. Thanks.
spk11: Yeah, what I said or meant to say was that enrollment continues through this year, but also intended next year also. We expect that we'll enroll patients sufficient to enable a first interim analysis next year, the timing of which is still to be defined, but We expect that were it to pass through that interim analysis, hopefully it will, the study would continue through next year. So, no, it's not intended to complete enrollment this year. Okay. Thank you. Thank you, Jeff.
spk01: Your next question comes from the line of Akash Tiwari with Jefferies.
spk11: Hello, Akash.
spk07: Hey, Robert. So, thanks so much for taking my questions. Can you talk about what drove your decision to look at exercise capacity as your primary endpoint for Sequoia, not the composite endpoint that MAVA had? Why may exercise capacity be a more useful endpoint both for the agency and clinicians? And additionally, have you heard any feedback from either the FDA or KOLs on the need for long-term outcomes data post-approval for afikantin? Thank you.
spk11: Why don't we turn first to Stuart to address the first question, and then maybe Fatty and Stuart the second question.
spk06: Thank you, Robert. So we focused on, you know, evaluating functional improvement in patients with destructive HEM, comparing at the Camden versus placebo. And with respect to the fact that these patients have very poor, you know, exercise tolerance, we focus on one of the most rigorous objective measurements of exercise capacity, and that is, you know, clearly peak VO2 as well as other parameters using cardiopulmonary exercise testing. And so, you know, rather than combining this with, say, a more subjective component of a composite endpoint, we really wanted to zero in on what we thought was the most sort of critical and quantitative measurement and objective measurement of exercise capacity. And having said that, we will be evaluating other endpoints, these secondary endpoints that, you know, evaluate, you know, symptomatic improvements such as the Kansas City cardiomyopathy questionnaire and New York Heart Association functional class, et cetera. So those other kind of, I'll say, more traditional endpoints we will be evaluating in Sequoia.
spk16: And your second question, you want to repeat that for me, Akash?
spk07: Yeah, absolutely. Absolutely. Have you heard any feedback, either from the FDA or KOLs, on the need for outcomes data post-approval for CK274? Thanks.
spk16: Yeah, you know, outcomes data, I think the regulators and KOLs appreciate that outcomes data are very hard to come by in a symptomatic, although, you know, very heavily burdened patient population environment. These patients, unlike traditional heart failure patients, don't get hospitalized. Their mortality rates are usually quite low and, you know, less than, well, you know, well under 5% per year. And so, you know, you can't really do an outcomes-based trial per se. And I think that's well understood based on the event rate. That said, I think that there's also a recognition that the therapy that is being developed for these patients is a lifelong therapy. And so, you know, having a good understanding of its safety long-term is important, and that's, you know, why we're conducting the open-label extension and plan, you know, at least five years of follow-up in patients that we enroll in that that roll out of either Redwood or Sequoia to enable us to, you know, better characterize the course of these patients who are being treated with afecampton.
spk11: You know, I think the advent of new pharmaceuticals is going to drive a better awareness of the outcomes associated with a diagnosis of HCM as could be modified with add-on therapy of afecampton or mavicampton. You're going to see, I think, increasingly publications arising out of registries that speak to the real-world evidence associated with these longitudinal studies. So we will be in a position to better understand what might be possible, and I do suspect that will play into ultimately the adoption of the category. But to your original question as to whether regulators are pushing for it, I don't think that's likely going to factor into the registration of these new medicines, at least not from what we've heard from FDA.
spk07: That's super helpful. And if I may just follow up here, can you talk about the importance of showing the FDA that patients are able to get stabilized onto a safe dose for this class of drugs? Is that something that the agency is focused on from a regulatory perspective? Thanks so much.
spk11: It's certainly something that we think is possible and achievable with Affy Campton, and we hope to be able to demonstrate that with Sequoia. If your question is pointed to, is that something FDA is pushing for because of their review of another product, that would not be appropriate for FDA to be signaling anything like that to us.
spk07: Understood. Thanks so much. I appreciate it.
spk01: Your next question comes from the line of Saleem Saeed with Mazuho.
spk11: Hello, Saleem.
spk17: Good afternoon, Robert and team, and congrats on all the progress. Just a couple from me, one on 274 and one on actually relative incentive. So on 274, look, so Robert, obviously the thesis here has gotten a lot more comfortable for a lot of long-only investors, right? And I'm curious, in your mind, what are the gating factors? When you think about the story, what are the gating factors here for 274 that are really stopping you from turning on the afterburners and starting to develop, have PATH, which as you know, is a large indication, more aggressively? And I guess we could also ask the same question for non-obstructive hypertrophic cardiomyopathy. And the second question on REL dissentives, so as we start to dig in here on the courage design, you guys are enrolling looks like ALS, FRS, total score 44 or less. But when we look at the Phase 2 data, the slow progressor, Tertile, which had a score of 41, didn't really show much of a difference between drug and placebo. So I'm curious how you guys are thinking about courage. Are you going to limit somehow the slow progressors that are entering the trial? Or how are you ensuring that when we get to futility that you haven't over-enrolled slow progressors, I guess is one way to ask it. Or how are you controlling that you're going to actually have enough medium or fast progressors that would show a larger benefit here potentially? according to the Phase II data. Thank you.
spk11: Sure. Both very good questions. Let's start with your first one around the development program for Affy-Campden. We've spent quite a bit of time over these last several months, once we saw the Redwood results, considering what might be our next steps beyond Sequoia HCM for Affy-Campden. And Fatty and Stuart and Steve and others here at Cytokinetics are considering a number of different trial designs as we would be expected to expand the development program in non-obstructive HCM and in HFPAF. It's premature for us to elaborate on them, but you should expect in 2022 to hear more about our plans that way. We intend to be pursuing the development of AFI-CAMPTN along both those lines and not in a linear way per se, but in parallel ways. that would be enabling of us to build on what we know for AFI Campton. I'm just not in a position to do that on today's call. But certainly as we plan for budgets for 2022 and goals and consider resources that we need to align in order to make that happen, that's very much in the forefront of our planning. Your second question related to Courage ALS in Alaska. Fatty, and Stuart to address. I think you might be misunderstanding a bit how we are designing the study. We are going to be prioritizing for those patients who are progressing, but they can elaborate.
spk16: Yeah, I think, you know, it's really an enrichment strategy, Salim, and so the entry criteria design is such a way to enrich for the medium and faster progressors. And I can turn it over to Stuart a little bit to describe how that works. But ultimately, you know, it's also something that we can monitor because you can look at progress, you can look at the, calculate the early progression rates in the study and ensure that you're enrolling the right patients in a blinded way. Stuart?
spk06: Yeah, so, Salim, I think you're referring to the post hoc analyses that were conducted with Fortitude ALS database, and while we observed trends of benefit in slow progressors, we observed greater magnitudes of benefit with respect to ALS-FRS-R in the medium and fast-progressing patients. And what we did was map that progression rate to critical entry criteria, particularly a maximum ALS-FRS-R of 44, as well as time from symptom onset of two years. And so if we apply those two main criteria, that enriches, as Patty mentioned, for population of faster-progressing patients, while not excluding slow progressors, but we'll have a larger proportion of medium and faster-progressing patients. And, you know, with that strategy, we anticipate that this will increase the sensitivity of detecting a beneficial treatment effect with relative symptoms.
spk17: Okay, got it. So this is more, you will be able to, in your view, do this based on entry criteria, not having to calculate during the trial based on blinded data?
spk06: That's correct, exactly.
spk17: Okay, thank you.
spk06: Thank you, Steve.
spk01: Your next question comes from the line of Jason Butler with JMP Securities.
spk12: Good afternoon, Jason. Hi, Robert. Thanks for taking the questions. Just wondering if you could talk a little bit more about the path for AfriCamp and in China. Is there data that you need beyond the completed PK study to open up the Sequoia trial to China? And then, you know, just to give us a sense of what proportion of patients in Sequoia you think could come from China. And then, you know, could Sequoia as a standalone support registration in China, or would you need additional data or an additional trial beyond that trial? Thanks.
spk11: Yeah, so very good questions. We're still learning about what might be required, but it's our assumption that that we're going to be in a position to start Sequoia in China and, based on the phase one data, be enrolling China patients into the same study and as could be supportive of registration in China as well as outside of China, U.S., Europe, elsewhere. So that's the intention in the plan. Obviously, that's subject to regulatory interactions that are still to be had. But our partner, Zhijing, is very much on top of these things, and we're working very, very well. Stuart is leading much of that activity for cytokinetics. Stuart, anything more you want to add?
spk06: I think you've summarized it very well. We certainly rely on Zhijing for guidance. They have more expertise in China regarding the regulatory requirements. But as it has been laid out, we expect the Phase I data to support enrollment of patients in China in Sequoia HCM and that trial to support registration in China.
spk12: Great.
spk06: Thanks for taking the questions. Thank you.
spk01: Your next question comes from the line of Charles Duncan with Cantor Fitzgerald.
spk11: Hello, Charles.
spk13: Hello, Robert and team. Congratulations on a good year of progress. Thanks for taking my question. I had a couple of questions, one on OMI-CAMDIV and then another on REL Dissemptive. With regard to OMI-CAMDIV NDA filing, I guess I'm wondering, are you planning on press releasing the submission or the acceptance for review or filing, and then I guess I just need to clarify something. I think it was to Dane's question. Would you be filing for a broad label claim with data pointing to the patient, the cohort that had the greatest benefit, or would you limit the filing claim to that cohort?
spk11: Yeah, so I'll take those, and Patty may want to elaborate. With regard to the communications and the press release, we expect to be submitting an NDA in this quarter and we probably would not be communicating anything until such time as we have a read on its filability, whether it's filed or not filed by FDA. And then as to your second question, I'll ask Patty to speak regarding how we might approach the indication statement and where it might be the information containing the patients that benefited the most.
spk16: Yeah, you know, I think if you look at different indication statements, even recent ones, there are different approaches, but generally they reflect the patient population that was studied in the clinical trial at large. You know, you can see in the Entresto label after the Paragon data were added that there was an additional statement with regards to where the benefit was concentrated, i.e., in patients with below normal ejection fraction. So it may be that you could end up with a modifying statement in the indication. You certainly will have data in the clinical trial section that show the pre-specified subgroups, one of which was ejection fraction, as you know, and showed the benefit in the lower ejection fraction group, the NYHA 3-4 group. And, you know, and others across the subgroups that we had pre-specified. So there are different places in the label where the information may be contained. And ultimately, you know, it's hard to predict where we'll end up until we go through those discussions.
spk13: Okay, that's helpful. Consistent with what I kind of thought. Regarding meteoric, I think you mentioned that you'd complete the conduct of it yet this year. Can you give us some sense on timing to data? Could that be in the first half of the first quarter? And then can you confirm whether or not you think that that data would then be submitted to the agency and have any potential for impacting the review? It seems like it'd be pretty early in the review cycle, so likely not.
spk16: Yeah, you know, I think what we probably aren't going to give guidance with regards to first half or second half of the quarter with regards to meteoric. Conduct will wrap up this year, but it's really going to wrap up pretty late in the quarter. And then, of course, it's a complicated study because there's a lot of central lab work in terms of the CPET evaluations and so forth, and the data sets are relatively complex to integrate. So time and database lock may be not as swift as you might have in an event-based trial. But I think the... Other aspect of your question that you're going to have to remind me of again now. I got lost the track of it.
spk13: Just impact on review cycle timing.
spk16: Yeah, no, I think, you know, having the results in hand and early in the quarter is not going to, you know, obviously the FDA will see them as we release them and hope to see them presented, but they won't. we think impact the review. There will be, the safety data will be probably, you know, part of an update during the review cycle, but that's it.
spk13: Okay, and then going on to relaceptive, just one quick question regarding the conduct of that trial, and I think you mentioned in the previous set of questions, or a couple of before, that you're kind of enriching for faster-progressing patients And so I guess I'm wondering, are you explicitly asking for more bulbar onset versus limb onset patients? Seem like to be consistent with that, given that under two years since symptom presentation.
spk06: Stuart, do you want to take that? Yeah, no, we're not being that restrictive in terms of our enrollment. We're certainly enrolling patients. you know, in both categories, but as I mentioned before, major criteria to enrich for faster progressing patients based on that LSFRS score at baseline and the time since the onset.
spk13: Okay. Thanks for taking the questions.
spk06: Thank you. Thank you, Josh.
spk01: Your next question comes from the line of Rohit Manson with Needham and Company. Good afternoon.
spk03: Hi, good afternoon. This is Rohit on for Surge. Thanks for taking my question. Can you talk a bit about how the meteoric HF trial fits with the gold market strategy for Olmec Amtiv? Do you expect a label expansion or better payer reimbursement?
spk11: Sure. I'll ask Patty to speak to that, and maybe Andrew might want to add.
spk16: I think if Meteoric is positive, we would at some point submit for a supplemental NDA filing, an expansion of the label that would include the results of Meteoric. You know, the clinical benefit there is important to patients and certainly would be worth having in the label. That wouldn't come until after the primary approval of Omicamp and McCarble, and I think being that improving exercise capacity is something that is rarely shown with drugs that improve heart rate. That would be a unique feature of omicamptomacarbone should the trial be positive. Maybe I'll ask to turn it over to Andrew to see if he has anything else he wants to add there.
spk10: Sure. We're going to be negotiating access, you know, pre-approval, post-approval, and largely we'll be using the data from Galactic. If we have a positive meteoric trial, that certainly will enhance the benefit we could bring to patients, especially in capacity. It could enhance our value argument. If patients feel better, it could be more productive. So it's really going to depend on how the data read out and what the adjustments are to the label. But I wouldn't expect it to have a major impact on our overall access strategy or access levels.
spk11: What it does do is it reinforces the mechanism of as provides what could be differentiating benefits to patients beyond outcomes, this being a functional outcome. And in that way, it could reinforce the use of Omicam to Bacarbal. But I agree with Andrew, it's not likely to drive things. It might very much have effect to things like adherence and compliance of patients. and also how physicians might ultimately view the category.
spk03: Great. Thank you.
spk01: And there are no further questions in queue at this time. Robert, your closing remarks, please.
spk11: Thank you. Thanks very much to all the participants on our teleconference today. Thanks for your continued support and your interest in cytokinetics. We're pleased to be able to provide you updates with respect to our progress as well as our prospects. Obviously, a lot is going on at our company, and we're looking forward to continuing to execute well on our key milestones through the remainder of this year, and then peering into next year. As mentioned, it could be quite a transformational year 2022. We look forward to sharing with you all of those updates, and with that operator, we can conclude the call.
spk01: Thank you. This does conclude today's conference call. You may now disconnect.
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