Cytokinetics, Incorporated

Good afternoon and welcome, ladies and gentlemen, to Cytokinetics' first 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 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, 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 Affie Campton, focused to Sequoia HCM, Forrest HCM, and recent interactions with FDA. Stuart Kupfer, SVP and Chief Medical Officer, will provide additional updates regarding the ongoing clinical trials of Afikampton, Maple HCM, and Acacia HCM, and will also discuss progression of CK586 and our emerging pipeline. Andrew Callows, EVP and Chief Commercial Officer, will speak about commercial readiness activities for Afikampton. Sung Lee, our new EVP and Chief Financial Officer, is with us today, but just listening alongside us. as this is his first day at cytokinetics. Robert Wong, VP and Chief Accounting Officer, will provide a financial overview of the past quarter. And finally, Robert Blum will review our 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 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 contained in our SEC filings, including our current report regarding our first 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. In the first quarter, we made substantial progress executing on our muscle biology-focused portfolio anchored by the broad development program of Affy-Campden. On the heels of positive top-line results from Sequoia HCM, our pivotal phase three clinical trial of Affy-Campden in patients with obstructive hypertrophic cardiomyopathy, we are running at full throttle in preparation for an ambitious set of presentations and publications scheduled to occur over the course of the year. In addition, we are laser focused on regulatory submissions in the second half of the year, continued conduct of the ongoing clinical trials program, accelerating our commercial readiness activities and further expanding our pipeline. While top line results of Sequoia HCM announced last December included a comprehensive high level view of the safety and efficacy of Affy Campton, a priority of ours is to present more fully the results from Sequoia HCM at a major medical meeting. Recently, we announced that that forum will be the European Society of Cardiology's Heart Failure 2024 Congress in Lisbon next week, Monday, May 13, where we will have three late-breaking clinical trial presentations related to Sequoia HCM. Along with the primary results, we have two other late-breakers with data from additional analyses from Sequoia HCM on which fatty will elaborate. He will also lay out the steady stream of presentations and publications that we anticipate sharing related to Affy Campton throughout 2024, as we believe will nicely elaborate on its next-in-class profile. During the first quarter, we also engaged meaningfully with FDA ahead of our planned submission of an NDA for Affy Campton in the third quarter of this year. We convened two meetings with FDA in the month of February including a first meeting to review the results of Sequoia HCM and a second pre-NDA meeting to cover specific topics related to our submission. We are pleased with the agency's feedback and we look forward to additional discussions to occur this quarter, which will address specific questions we are posing relating to potential REMS scenarios. We've also been preparing for our planned submission of an MAA with EMA expected in the fourth quarter of this year. Moreover, in 2024, many other work streams and activities were pushed into the next phase of execution, notably commercial readiness activities, which Andrew will speak about in more detail. And while Sequoia HCM represents the forward edge of the Phase III development program for Affy-Campden, We now have two other ongoing Phase III clinical trials evaluating Afikampton, which each represent additional opportunities to expand the clinical evidence use case and hopefully reach more patients in need. Of course, we're also continuing our ongoing open-label extension study, FOREST-HCM, to collect longer-term data on the safety and efficacy of Afikampton. And as Stuart will elaborate, Maple HCM, the phase three clinical trial of afecamptin, as monotherapy compared to metoprolol as monotherapy, is expected to complete enrollment in the third quarter. This trial will provide an evidence-driven answer to the question clinicians are beginning to ask with the emergence of cardiac myosin inhibitors. That is, which drug do we initiate first? Maple HCM may be an important opportunity for afecamptin as we hope it may inform a critical change in treatment practice, as could be outlined in emerging guidelines. Stuart will also share an update on ACASIA-HCM, our Phase III clinical trial of afikamtin in patients with non-obstructive HCM. And he'll also describe a third late-stage clinical trial called CEDAR-HCM, which is now open to enrollment in a pediatric population of patients with OHCM. we're especially pleased to maintain a strong financial position at the end of the first quarter alongside of our maturing R&D programs. As I'll speak to in more detail later in this call, we believe that we are in an advantage position in terms of our options for accessing diversified capital to further fuel our science for the benefit of patients and to deliver increasing shareholder value. And lastly, We were pleased to recently announce that we had finalized our search for a new CFO. And as you hopefully saw from the 8K we issued, I'm pleased to welcome Sung Lee to our team. When we began our search, we had several key criteria for the ideal candidate, including previous experience in both large and mid-sized biopharma companies, global commercial finance experience, and a track record of innovative financing deals. Sung brings all of that and more, and we couldn't be happier to have him join our team. Prior to cytokinetics, Sung was CFO of Veer Biotechnology and also Morphosis AG and Sangamo Therapeutics. Previously, he built his career expertise over 14 years at Gilead, where he served in various roles, obtaining leadership expertise in tax, accounting, operations, and IR. You will hear from Sung on our Q2 earnings call, and for those of you who don't already know him, you'll soon have a chance to meet him at upcoming conferences and one-on-one meetings. And with that, I'll turn the call over to Fatih, please.