Cytokinetics, Incorporated

Good afternoon and welcome ladies and gentlemen to cytokinetics fourth quarter 2023 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. We will allow for only one question per participant and ask that you adhere to this request. I will now turn the call over to Diane Weiser, Cytokinetic Senior Vice President of Corporate Communication and Investor Relations. 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. Patty Malek, EVP of R&D, will provide updates related to Appy Campton, focused to Sequoia HCM and Forest HCM. Stuart Kupfer, SVP and Chief Medical Officer, will provide additional updates for Affy Campton relating to Acacia HCM and Maple HCM and will also discuss CK586 and CK136. Andrew Kalos, EVP and Chief Commercial Officer, will speak about commercial readiness activities for Affy Campton. Robert Wong, VP and Chief Accounting Officer, will provide a financial overview of the past quarter And finally, Robert Blum will discuss our 2024 financial guidance and corporate development strategies before closing the call by reviewing expected key milestones for the year. 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 constitutes 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 fourth quarter 2023 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 fourth quarter of 2023 represented a transformational inflection point for our company as we turned the card on Sequoia HCM, our phase three clinical trial of afecamptin for the potential treatment of patients with hypertrophic cardiomyopathy, or HCM. The results exceeded our already high expectations. and we began 2024 firing on all cylinders with renewed commitments to preparing for regulatory interactions and submissions with urgency, executing on the broad clinical development program following behind Sequoia HCM, as well as activating the next phase of commercial readiness activities. On today's call, Fadi will discuss our plans for presentation and publication of primary and other results of Sequoia ACM, which will further elaborate on the efficacy and safety of our next-in-class cardiac myosin inhibitor. And as well, how we're moving swiftly to regulatory submissions across the globe And then Andrew will comment on how we're prudently planning for differentiated commercial positioning for our next-in-class opportunity. As important as Sequoia HCM is to our path to commercialization, there's much more in our pipeline that we believe will meaningfully unlock shareholder value as the company continues to mature. Stuart will provide an update on the progress of Maple HCM and Acasa HCM, the additional phase three clinical trials of afecamtin, which will provide an on-ramp to potentially expanding the utility of cardiac myosin inhibitors as a first-line treatment for obstructive HCM, as well as potentially provide a new treatment option for the growing number of patients with non-obstructive HCM. As you'll hear, there's been an increased enthusiasm and activity surrounding these trials on the heels of the positive results from Sequoia HCF. However, much still remains ahead of us to bring Afikampton to patients, but I'm confident in our ability to execute on our ambitious strategies. As you'll hear in more detail, we ended 2023 with a strong balance sheet thanks to reduced spending during the year. In the last quarter and earlier this year, we also added to our cash balance with an infusion of capital from our at the market or ATM equity vehicle. We're pleased to be reporting our financial guidance today with approximately two years of cash runway when accounting for both our cash on hand and cash available to us. And despite projecting an increase in our expected operating expenses in 2024. Recently, we announced the retirement of Ching Jha from his position as CFO in order to attend to his personal health. Ching's departure is unrelated to our business prospects and on mutually good terms with the company. On behalf of our senior leadership team, we support his decision for his well-being and we express our gratitude for his many contributions to our company. Ching built a strong team that many of you may know, including Robert Wong, VP and Chief Accounting Officer, as well as Matt Yang, VP of Corporate Finance and FP&A. Together with the teams they have assembled, we're confident that Ching's departure will have minimal impact to day-to-day financial operations. Libby Schneiders, our SVP of Business Development, who has served our company for well over 20 years, continues to lead business development, so we do not foresee any impact on that front. Furthermore, in anticipation of Ching having to attend to his health in the fourth quarter of 2023, we brought on a seasoned consultant who previously served as CFO of a public biopharma company and who has extensive experience in financial planning and structured finance transactions. He'll continue to work with me through this transition as we've already initiated a national search for Ching's replacement who we expect will bring international commercial and capital allocation experience compatible with maturing operations. Cytokinetics is looking ahead to a bright future in 2024 and also beyond, and as we turn the page towards potential commercialization of the first medicine arising from our pioneering and leading muscle biology research, with more to come as we continue to prosecute our R&D programs. We're fortunate to be where we are today, but it is not by coincidence. It's a result of meticulous planning, risk mitigation, strategic foresight, perseverance, and dedication. We're building a specialty cardiology company, leading with Affey Campton as the foundation, and we have the pipeline, the passion, and the people to make happen that vision, as we believe will further reward shareholders. With that, I'll turn the call over to Fatty, please.