Cytokinetics, Incorporated

And welcome, ladies and gentlemen, to CytoKinetics' third quarter 2022 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 up to two questions per participant. I will now turn the call over to Diane Weiser, CytoKinetics Senior Vice President of Corporate Communications 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 a brief overview of the quarter and recent developments. Fatih Malik, EVP of R&D, will provide updates related to Omicampton McCarville and Appycampton. Andrew Kalos, EVP and Chief Commercial Officer, will review commercialization planning activities for Omicampton McCarbell and our specialty cardiology franchise strategy related to Affy Campton. Stuart Kupfer, SVP and Chief Medical Officer, will provide an update on real deceptive. Robert Wong, VP and Chief Accounting Officer, will provide a financial overview of the past quarter. And Ching Jha, SVP and Chief Financial Officer, will discuss our financial outlook and corporate development. Then finally, Robert Blum will provide closing comments and review expected upcoming key 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 2022 financial results, filed on Form 8-K 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. We made good progress in the third quarter, and we approached the end of the year in a strong financial position, with important progress achieved across the company and for our programs. Most notably, during the quarter, we advanced planning for the potential launch of Omicamp and McCarville, subject to FDA approval, potentially next year. Over recent months, we continued productive engagement with FDA as it continues review of our NDA, And we expect the late cycle review to occur later in this quarter in advance of the advisory committee meeting. Engaging constructively with FDA represents a key priority. And as such, our teams have been very focused on preparations that will continue for the next several weeks as we ready for our participation in this important meeting. We also advanced regulatory preparations for Omicamp to McCarville outside of the United States. we remain on track to submit a marketing authorization application to the European Medicines Agency before the end of the year, which aligns with our go-to-Europe strategy. For Afikampton, we continued conduct of Sequoia HCM, we completed patient screening in cohort four of Redwood HCM, and we furthered our startup activities for the second phase three trial of Afikampton as monotherapy. a phase three trial for which we expect to activate sites by year end and with enrollment to begin next year. During the quarter, we also shared results from two analyses of the open label extension trial of Affy-Campden, which both add to our understanding of the potential benefit of longer-term treatment with Affy-Campden, and in particular support our rationale for advancing the program to elaborate on the potential for Affy-Campden as could be monotherapy. For rel-deceptive, we were pleased that the DMC, or Data Monitoring Committee, recommended that Courage ALS continue following their review of unblinded data from the trial. As you know, our commitment to this unrelenting disease is longstanding, and it remains of utmost importance to us to conduct rigorous clinical research to fully understand the potential efficacy and safety of rel-deceptive. Patient enrollment continues to encourage ALS as that trial progresses towards its second interim analysis expected next year. It's an exciting and also busy time for all of us at cytokinetics, but as you'll hear today, we are positioned well as we continue to transform and mature our company. We eagerly anticipate next month's advisory committee, our PDUFA date in February, and numerous other corporate milestones across our early stage and later stage pipeline, as you will now hear more. With that, I'll turn the call over to Fatih.