Cytokinetics, Incorporated

Good afternoon and welcome, ladies and gentlemen, to Cytokinetic's second 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 up to one question per participant. I will now turn the call over to Diane Wiser, 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 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, Redwood HCM, and Forest HCM. Steve Heitner, VP Clinical Research and Therapeutic Area Lead, Cardiovascular, is filling in for Stuart Kupfer today and will provide additional updates for Affy Campton relating to Maple HCM and speak to the expected start of Acacia HCM. Andrew Kalos, EVP and Chief Commercial Officer, will speak about commercial readiness activities for Affy Campton and its 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 revised spending guidance for 2023. Finally, Robert Blum will provide an update on our early clinical programs and his closing comments 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 second 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. We made substantial progress in the second quarter, not only by advancing and broadening the development program for Affy-Campton, but also by making further strides in our earlier stage specialty cardiovascular pipeline. As Fatty and Steve will elaborate, our comprehensive clinical trials development program for Affy-Campton is firing on all cylinders. During the quarter, we completed enrollment in Sequoia HCM We began Maple HCM and we prepared to start Acacia HCM, the phase three clinical trial of afecamtin in patients with non-obstructive HCM. We have accelerated the timeline for this trial and we now expect to open the trial to patient enrollment next month. It's notable that very soon we will have three ongoing phase three clinical trials for afecamtin plus the open label extension. which is a testament to our corporate reprioritization and the excellent work of our dedicated regulatory, technical operations, clinical research and operations teams, as well as the high level enthusiasm and diligence of our clinical site investigators and their staffs. Now that enrollment in Sequoia HCM is complete, study conduct is progressing and we remain on track to share top line results by the end of this year. This trial has progressed through the dose escalation phase for all patients, and we're monitoring key metrics in blinded data, such as patients' randomized baseline characteristics, standard deviation around endpoints, early terminations, and missing data. And I'm pleased to report that across all of these measures, Sequoia HCM is proceeding well and meeting or exceeding our trial design assumptions. Moreover, alongside our preparations for the reporting on top line results, our regulatory, supply chain, and commercial readiness teams have been actively engaging in numerous activities, including go-to-market plans that build towards potential approvals and commercialization of AFI Campton. Andrew will elaborate on some of those plans shortly. While Afikampton may be top of mind, in parallel, our clinical research activities continue to push forward on other fronts as well. In the second quarter, we advanced CK586, a second cardiac myosin inhibitor, into a Phase I study. We continued the Phase I study of CK136, our cardiac troponin activator, and we continued non-clinical research and IND-enabling activities towards our goal of submitting one to two new INDs over the next one to two years. Moreover, in response to corporate setbacks earlier in 2023, and as we telegraphed on our last earnings call, we have reduced operating spending by approximately 15% relative to our initial 2023 financial guidance. with a heightened focus on our priorities and pipeline, including preparations for the potential approval and commercialization of AFI Campton. That's all going to enable us to further extend our cash runway. Ching will provide more details and updated financial guidance for 2023 later in this call. As you will hear today, we're moving forward with momentum into the second half of the year with a broad early and late stage pipeline ongoing research and a stronger financial foundation, giving us conviction and confidence in achieving our goals for the rest of the year, as well as setting us up well afterwards. With that, I'll now turn the call over to Fatih.