Cytokinetics, Incorporated

Good afternoon and welcome, ladies and gentlemen, to Cytokinetic's second quarter 2021 conference call. At this time, I'd like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company's request, we will open the call for questions and answers after the presentation, and we will allow for up to two questions per participant. I will now turn the call over to Diane Wiser, Cytokinetic's Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.

Good afternoon, and thanks, everyone, 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. Ben Fatty-Malik, our EVP of Research and Development, will provide an update on Omicamptomacarbal, including the secondary analyses from Galactic HF, our positive phase III clinical trial of Omicamptomacarbal, as well as recent interactions and next steps with the FDA. Next, Andrew Kalos, our EVP and Chief Commercial Officer, will provide an update on progress towards our go-to-market strategy for Omicampton McCarble and how those plans intersect with our franchise development strategies and our future plans for the commercialization of Affy Campton, or CK274. Then, Stuart Kupfer, our SVP and Chief Medical Officer, will provide an update on our development program for Affy Campton with focus to recently announced results from Redwood HCM, our positive Phase II clinical trial. Next, 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 our financial outlook and corporate development strategies before Robert Blum will return to provide concluding thoughts and expected 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 second quarter 2021 financial results filed on Form 8K. 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 to everyone for joining us on the call today. We had a productive second quarter, which has continued with intensity more recently as we've delivered against multiple milestones across our cardiovascular and also our neuromuscular development programs. In the past few quarters, we've made tremendous progress on the clinical development front, punctuated by positive Phase III results from Galactic, positive Phase II results from Redwood HCM, completion of enrollment in Meteoric HF, and initiation of Courage ALS, the Phase III clinical trial of rel-deceptive in patients with ALS. Looking forward, we're preparing for our first NDA submission. and executing well against commercial readiness objectives while also advancing three distinct late-stage development programs, all expected to be in Phase III clinical trials by the fourth quarter. This is an extraordinary achievement for any company, much less one of our size, but it's a testament to our focus, our innovation, our resilience, our resourcefulness, and our disciplined strategic corporate development. Importantly, progress across our pipeline also catalyzed our recent equity offering, which fortified our balance sheet and which is expected at year-end to have us with over $600 million. This will ensure a strong financial position as we pass through key milestones in building a sustainable and durable business anchored in our industry-leading muscle biology focus. As Fatty will elaborate... New analyses from Galactic HF reinforce previous results, which reinforce that patients with higher risk factors, underscoring more severe heart failure, derived greater treatment benefit from omicamptamicarbol when added to standard of care. And they augur well for a defined, clearly identifiable target patient population. These patients remain amongst the toughest to treat despite the availability of guideline-directed medical therapy. And based on continued feedback from the healthcare professional community, we believe omicamptomacarbal may fill an unmet need in the treatment armamentarium. As you'll hear more in recent months, we've conducted several additional interactions with FDA towards our goal of submitting an NDA for omicamptomacarbal in this second half of the year. And Concurrently, under Andrew's leadership, our commercialization strategy is also taking further shape. We have active work streams progressing across every element of our go-to-market strategy, including product positioning, market research, value proposition development, market access, and manufacturing and other logistics scale-up. Turning to another underserved cardiovascular patient population, we were pleased to share top-line results of Redwood HCM, which met our high expectations for this dose-ranging trial and our next-in-class objectives. As pioneers in the science of modulating cardiac myosin, it's rewarding to see that the physiochemical properties that we prioritized in optimizing afikampton are translating into clinically meaningful results for patients. With positive results from Redwood HCM now in hand, we have received constructive FDA feedback from our recent type C and end of phase two interactions, supportive of progression into our phase three trial intended to get underway in the fourth quarter of 2021. With enthusiastic clinical trial sites across North America and Europe, we anticipate high interest for enrollment and we'll provide updates as the trial gets underway. And finally, with clarity on a submission strategy for Omicamptive McCarble, as well as positive results from Redwood HCM supporting a Phase III trial and a reinforced balance sheet, earlier this week, we announced the start of COURAGE-ALS, our Phase III clinical trial of rel-deceptive in patients with ALS. And as a reminder, Under the terms of our amended collaboration agreement with Astellas, cytokinetics now controls development and commercialization of rel-deceptive, and Astellas will contribute $12 million toward the conduct of this trial. We feel fortunate to be at a major turning point in our corporate development. The promise of modulating contractile proteins that drive muscle contractility is being realized with our positive clinical trial programs, and we're grateful to our shareholders for continuing to believe in the potential of this platform so that we may deliver to patients first-in-class and next-in-class drug candidates that may improve their health span and also overall quality of life. And with that, I'll turn the call over to Fadi to elaborate on recent developments related to Omicampt of McCarble.