Cytokinetics, Incorporated

Good afternoon, and welcome to Cytokinetics' third 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. Patty Malek, EVP of R&D, will provide updates related to the clinical development program for Apti-Campden. Andrew Kalos, EVP and Chief Commercial Officer, will address commercial readiness activities for Apti-Campden. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates regarding Omicampton McCarble, CK586, and our earlier stage development pipeline. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview of the third quarter. 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 third 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 to all for joining us today. As we communicated just a few weeks ago at our Investor and Analyst Day, we made significant progress across our pipeline in the third quarter. Most importantly, we completed the rolling submission and submitted our new drug application to the FDA for Afikampton. This is an exciting milestone for cytokinetics as well as the physician and patient communities. and it brings us one step closer to hopefully bringing Afikampton to patients suffering from obstructive HCM. It reflects a tremendous amount of work from our colleagues for which we're especially grateful. While we have requested priority review of the submission, our base case is standard review. The next step will be the expected announcement of filing acceptance and assigned PDUFA date. During Q3, We also supported Corsell, formerly Zhijing, in filing the NDA in China for Affy Campton for obstructive HCM, which we're pleased to announce today was recently accepted for filing. Meanwhile, our commercial preparations for the potential approval and launch of Affy Campton in the United States are dialing up according to plan. As Andrew will elaborate, we're executing pre-launch activities, including recently launching an HCM disease awareness campaign for healthcare professionals. In addition, we selected third-party external partners to support education, distribution, and patient support, all together forming a bespoke patient experience. and we refined sales territory configurations as well as sales training and recruiting programs in the United States, while we also concurrently hired our initial geographic and functional team leaders in Europe. During the quarter, we continued to present and publish additional data from Sequoia HCM, further strengthening the evidence supporting its potential next-in-class safety and efficacy profile. As Fadi will elaborate, The additional analyses show that treatment with Afikampton is associated with improvements in exercise capacity, gradients, symptoms, biomarkers, cardiac structure, and function, as well as favorable cardiac remodeling. Together, these analyses expand in meaningful ways on the overall profile of Afikampton and are enabling of the positioning that we foresee for a next-in-class cardiac myosin inhibitor that we believe can expand the category and activate broader adoption. Beyond Affy-Campden, we prepared to start two new clinical trials from within our emerging specialty cardiology franchise, COMET-HF, the confirmatory Phase III clinical trial of Omicamptib-Macarbo, and AMBER-Hef-Pef, the Phase II clinical trial of CK586. As Stuart will share, each of Omicampt and McCarble and CK586 offers an opportunity to expand our specialty cardiology franchise by targeting underserved populations at opposite ends of the spectrum of heart failure, those with severely reduced ejection fraction and those with supernormal ejection fraction. Finally, while our specialty cardiology franchise remains our top priority, Our research dedicated to novel muscle directed therapies has continued within our labs in South San Francisco and our long standing innovation and muscle biology continues with another promising drug candidate called CK 089 readying to begin a first in human study. CK089 is a fast skeletal muscle troponin activator, which we believe may have potential therapeutic application to a specific type of muscular dystrophy. You'll be hearing more about how we have applied lessons learned with prior fast skeletal troponin activators to our next level plans for CK089, as it will soon begin clinical development in this fourth quarter. Where we stand today at Sato Kinetics is a reflection of thoughtful planning, strategic positioning, and prudent capital deployment, all in service of realizing the full potential of our muscle biology platform. We are not a company expecting to simply build for the success of a single drug candidate. Instead, we're focused on building momentum across our pipeline and planning for our future by prosecuting a portfolio of multiple muscle-directed drug candidates designed to address diseases of high unmet need. By doing so, we hope to impact the lives of both patients as well as return meaningful value to shareholders in enduring ways. With that, I'll turn the call over to Fatih, please.