Cytokinetics, Incorporated

Good afternoon and welcome, ladies and gentlemen, to Cytokinetic's first 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 one question per participant. I will now turn the call over to Diane Weiser, Cytokinetic's 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 an overview of the quarter and recent developments. Thaddee Malik, EVP of R&D, will provide updates related to Affecampton and other drug candidates comprising our early stage pipeline. Stuart Kupfer, SVP and Chief Medical Officer, will provide further updates on the development program for Affecampton. Andrew Kalos, EVP and Chief Commercial Officer, will speak further about commercial preparation activities for AFCampton and the market opportunity. 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 strategies. Finally, Robert Blum will provide closing comments and review expected key milestones for 2023. 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 first 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. While we began the first quarter with a clinical stage program directed to the potential treatment of ALS, We ended the quarter acknowledging that we can no longer commit to that opportunity. In the best interest of the science and the shareholders, we must own that reality and rededicate to that which ultimately holds the greatest promise for patients. Toward that end, I want to emphasize our confidence in and priority commitment to our specialty cardiovascular pipeline of novel cardiac muscle directed drug candidates. Despite the disappointment related to ALS, in the first quarter of 2023, significant progress was made across our cardiovascular pipeline with particular focus to Affy-Campden and its broad development program. As Fatty and Stuart will elaborate, screening in Sequoia HCM, our pivotal phase three clinical trial in patients with obstructive HCM, is expected to close tomorrow, enabling enrollment to conclude in a few weeks and the readout of results in the fourth quarter of this year, as planned. We also recently reported data from cohort four of Redwood HCM, as well as 48-week data from Forest HCM, both providing compelling evidence for our next-in-class cardiac myosin inhibitor. Finally, we made progress towards expanding development for afecamtin with the plan to soon start Maple HCM, the active comparator phase three trial versus metoprolol, and continued preparations for our planned Phase III clinical trial of Afikampton in nonobstructive HCM. As you know, during the quarter, we also received a complete response letter from the FDA for Omikampton McCarble. We're continuing to engage with FDA and are planning to meet with FDA this quarter to discuss their feedback and to better understand what may be our options going forward. We expect to provide an update when we have something more meaningful to report. In the meantime, we're pressing forward toward potential international approvals for Omicamptive McCarvel. In Europe, we're engaging EMA in its review of the MAA and are preparing to respond to day 120 questions. And in China, the Center for Drug Evaluation of the National Medical Products Administration is reviewing the NDA submission for Omicamptive McCarvel. As I previously mentioned, during the first quarter, We also announced that Courage ALS, the phase three clinical trial of rel-deceptive met criteria for futility at the second planned interim analysis. Our dedication to the ALS community over the last decade has been a hallmark of our commitment to novel muscle-directed medicines, and we're disappointed that we'll not be able to move forward a drug candidate for patients with this grievous disease. Given the data from the interim analysis, we proceeded to conclude study conduct at Courage ALS and we're completing closeout activities in both this trial as well as the open label extension study during this second quarter. We plan to present full results from Courage ALS at a medical meeting later this year. The trial was designed and conducted with scientific integrity and in the interest of people living with ALS, and we hope it may serve as a blueprint for how to conduct rigorous patient-centric clinical research. While we're certainly very disappointed in this outcome for Courage ALS, it affords us an opportunity to realize certain savings in 2023, which we believe can extend our cash runway and enable us to reallocate resources to further increase our focus on AFI Campton. Previously, over 60% of our R&D budget was already devoted to Affy Campton, but with savings we now expect in 2023, an even higher proportion of our total spending will now be dedicated to Affy Campton. Ching will elaborate further on our expected 2023 spending in a moment. So while the first quarter brought some unexpected setbacks, we remain as committed as ever to our mission to bring forward new medicines for patients with diseases of high unmet need. Our late stage as well as our early stage pipeline of potential cardiovascular medicines provide a solid path forward, fortified by our strong balance sheet to support continued execution in the interest of all of our stakeholders. And with that, I'll turn the call over to Fatty.