Cytokinetics, Incorporated

Good afternoon, and welcome, ladies and gentlemen, to Cytokinetics' second quarter 2024 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 to questions after the presentation. We will allow for only one question per participant. I will now turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Please go ahead.

Good afternoon, and thanks for joining us on the call today. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Thaddee Malik, EVP of R&D, will provide updates related to Sequoias HCM and the ongoing clinical trials program for Afikampton. Chris Murray, SVP, Regulatory Affairs and Quality, will provide an update from our recent interactions with FDA and EMA and the progress of our planned regulatory filings. Andrew Kalos, EVP and Chief Commercial Officer, will address commercial readiness activities for Affy Campton. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates regarding Omicampton-McCarbell CK586 and our earlier stage development pipeline. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview of the second quarter and review our updated financial guidance for 2024. And finally, Robert will review our corporate development strategies and review expected upcoming milestones. 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 2024 financial results filed on Form 8K that was furnished to the SEC 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 for joining us on the call today. The second quarter was marked by significant progress and notable achievements across our later stage clinical development programs built on the foundation of cardiac myosin modulation, as well as a significant strengthening of our balance sheet and capital structure, enabling continued execution of the potential commercial launch of Afikampen, as well as further advancement of our pipeline. In May, we were pleased to present the primary results from Sequoia HCM in a late-breaking clinical trial session at the European Society of Cardiology's Heart Failure 2024 Congress in Lisbon. As Fatih will elaborate, these results met our already high expectations. The safety and efficacy profile of afecamptin that has emerged from sequoia HCM points to a potentially category-expanding opportunity as a next-in-class cardiac myosin inhibitor for patients with HCM. During the quarter, we continued our dialogue with FDA ahead of our planned submission of an NDA. We participated in a productive Type B meeting with FDA to discuss potential strategies related to safety monitoring and risk mitigation for Affy Campton. We are pleased at how these discussions went and we're moving forward as planned. Chris Murray, SVP of Regulatory Affairs and Quality, has joined us today to provide an update on our regulatory interactions globally. With respect to Omicampt of McCarble, over the past year we conducted numerous analyses of the results from Galactic HF We spoke with regulators on several occasions and we conferred with heart failure experts on the unmet need and the potentially unique role that Omicamptive may play in treating patients with heart failure, all together while we evaluated our potential next steps. What we found was a compelling opportunity for Omicamp to McCarville to address a large and growing population of people with severe heart failure who have limited treatment options and are at increased risk of hospitalization. With high adjacency to HCM in terms of treating physicians, we believe we can deliver a high return on investment by advancing Omicamp to McCarville with minimal increased commercial costs following the launch of Affecampton. And again, should the confirmatory phase three clinical trial of Omicampton read out positively. Furthermore, alongside CK586, we see a synergistic opportunity from both an R&D and commercial standpoint to build a sustainable specialty cardiovascular franchise for patients and to further unlock and to potentially maximize value for shareholders. Overall, We're proud to highlight an extensive development program for Affy-Campden with multiple potential label-expanding clinical trials ongoing, plus later stage development programs in adjacent specialty cardiology indications, with more still to come arising from our pioneering muscle biology research. We're carving out a specialty cardiology niche anchored in the foundation of our Myosin platform and with our sights set on improving the lives of patients while also enhancing shareholder value. And with that, I'll turn the call over to Fatty, please.