Cytokinetics, Incorporated

Good afternoon and welcome, ladies and gentlemen, to Sata Kinetics' fourth quarter 2020 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 turn the call over to Diane Weiser, Sata Kinetics' 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 our 2021 priorities considering company performance in 2020. Then, Fatih Malik, our EVP of Research and Development, will provide a more detailed update on Omicamptomacarbals, including perspective on recently presented supplemental analyses from Galactic HF, the positive phase III clinical trial of Omicamptomacarbals, as well as progress on Meteoric HF, the second phase three clinical trial of Omicamptomacarbol. Next, Stuart Kupfer, our SVP and chief medical officer, will update on our cardiac myosin inhibitor program. Then 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 2021 financial guidance and corporate development strategies, before Robert Blum then returns to provide concluding thoughts on the year ahead and expected key milestones for 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 filed on Form 8K this morning. We undertake no obligation to update any forward-looking statements after this call. And now I will turn the call over to Robert.

Thanks, Diane. And thanks again to everyone for joining us on the call today. As we begin 2021, I hope you and your families are healthy and well. while we are all still in the throes of the COVID-19 pandemic. Despite the challenges of stay at home orders, clinical trial interruptions and restarts, and transitionings relating to our longest standing development and commercialization collaboration, we enter this year at the forefront of muscle biology research and with the most advanced pipeline in our company's history, a strong balance sheet and are now preparing for engagements with FDA towards what may be our first potential NDA filing, and as may set the stage for our first approved medicine. Following the positive phase three clinical trial results from Galactic HF, our immediate priority is to secure FDA feedback in order to provide clarity for potential regulatory submission of omicamptam carbol in the United States in the second half of 2021. We expect to meet with FDA in the next few weeks. Simultaneously, we will complete ongoing workstreams focused to product, market, and sales analyses to inform development of our go-to-market strategy and commercial readiness activities in the first half of the year. As we announced at the end of 2020, Worldwide development and commercialization rights to Omicamp and McCarville and CK136, formerly known as AMG594, are reverting to cytokinetics. While this was unexpected, we believe it affords cytokinetics freedom to operate as we chart our own commercial path forward and lay the groundwork for the cardiovascular franchise plans we unveiled last summer at our Analyst and Investor Day. With this in mind, we also expect to engage in business and corporate development activities this year to seek commercialization partners in Asia, in Europe, and possibly for co-promotion in the United States. These activities are already underway as we begin our outreach campaigns and Ching will elaborate on our overall corporate development approach in a moment. Additionally, this year, we will continue to prioritize the development of CK274, our next generation cardiac myosin inhibitor. In December, we announced that we completed an interim analysis of cohort one of Redwood HCM, our ongoing phase two clinical trial of CK274 in patients with symptomatic obstructive hypertrophic cardiomyopathy. That interim analysis informed progression to cohort two which opened to screening in December. And I'm pleased to announce today that we have now fully enrolled cohort two, and we expect to have top line results from both cohorts by mid-year 2021. As the year progresses, we will articulate our plans to advance CK274 potentially into phase three in the second half of the year. Stuart will provide details on the interim analysis and how we're currently thinking about the continuing development program. Though our priorities in 2021 will be focused to our cardiovascular programs, once we have clarity on our go-to-market strategy with Omicamp and McCarble and progression of CK274 to Phase III, we'll then consider opening Courage ALS to enrollment. That is our planned Phase III trial of rel-deceptive in patients with ALS, as may further expand our late stage pipeline. Our research engine continues to be productive despite the challenges posed by the current pandemic. Thanks to the dedication of our scientists, we anticipate advancing additional compounds, potential development candidates emerging from research into development in the coming one to two years. We expect to leverage our leadership expertise in muscle contractility to expand into other aspects of muscle function as may extend to the potential treatment of other serious yet adjacent diseases and conditions. And we'll have more to say about that later in the year. 2021 has the potential to be a transformational year for cytokinetics as we prepare to potentially submit our first MDA that could lead to the commercialization of our first medicine to treat patients with heart failure. And as we've articulated in our vision 2025, which we introduced early last year, our goal over the next five years is to achieve potential regulatory approvals for at least two drug candidates arising out of our pipeline and to drive towards sustainable product-driven revenues while we, in parallel, double our pipeline of development programs, and also plan to expand our discovery platform beyond muscle contractility. Based on our strong performance in 2020 and momentum already in 2021, we believe we're well on our way. With that, I'll turn the call over to Fatty to elaborate on developments related to Omicamp of McCarville.