Cytokinetics, Incorporated

Good afternoon and welcome, ladies and gentlemen, to Cytokinetic's first quarter 2021 conference call. At this time, I'd 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. I'll now like to turn the call over to Diane Wiser, 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, our President and Chief Executive Officer, will kick off the call with an overview of the quarter and recent developments. Then, Fatih Malik, our EVP of Research and Development, will provide an update on Omicamp and McCarble, including progress following a recent meeting with FDA and what to expect from upcoming analyses from Galactic HF, the positive Phase III clinical trial of Omicamp and McCarble, as well as recent activities related to meteoric HF, the second phase three clinical trial of Omicamptomacarbol. Next, Stuart Kupfer, our SVP and chief medical officer, will provide an update on our cardiac myosin inhibitor program with focus to Redwood HCM, the phase two clinical trial of CK274. Then, Robert Wong, our VP and chief accounting officer, will provide a financial overview for the past quarter, and Ching Jia, our SVP and chief financial officer, will discuss our financial outlook and corporate development strategies before Robert Blum then returns to provide concluding thoughts and expected key milestones for the remainder of 2021. We also have a new team member on today's call, Andrew Kalos, our chief commercial officer who joined cytokinetics during the quarter and who you will hear in upcoming calls. 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 2021 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 again to everyone for joining us on the call today. We had a productive first quarter and are feeling increasingly more optimistic as our nation reemerges towards new normalcies in the coming months with widespread vaccinations for COVID-19. We continue to wish you and your families good health and well-being. We're also optimistic about cytokinetics in our pipeline, our progress, and our prospects. In the first quarter, we executed well against our plans and are firing on all cylinders, with priority to advancing our industry-leading cardiovascular drug candidates directed to muscle, focusing to both Redwood HCM and Meteoric HF, as well as advancing regulatory and and commercial readiness work streams in support of Omicampto McCarble. Toward that end, I'm very pleased to introduce the newest member of our leadership team, Andrew Kalos. Andrew joined us as our chief commercial officer and we're thrilled to have him on board at a key time for our company as we turn the corner towards commercialization and transition to be a forward integrated biopharmaceutical company. Andrew brings relevant commercial and operational experience from cardiovascular specialty care and rare disease markets. He had a long tenured and successful career at Pfizer and at Wyeth Pharmaceuticals, where he oversaw U.S. and international pharmaceutical business franchises. Most recently, Andrew served as regional president and general manager North America for Pfizer's Upjohn business unit. And during his over 20 years at Pfizer and predecessor companies, he held leadership positions, including as Vice President US Cardiology and Metabolic Marketing, overseeing the commercialization of Eliquis in the United States. Andrew also served as Vice President and Head of Inflammation Marketing Europe and Vice President Global Commercial Development for Rare Diseases. As you can see, his experience is a perfect fit for cytokinetics, and he has quickly come up to speed and contributed to the many commercial planning work streams that had already been underway prior to his arrival. Andrew joins us to lead a team of similarly expert commercial colleagues at cytokinetics who are experienced in cardiovascular and neuromuscular specialty care markets. And as we proceed to finalize our go-to-market planning, for Omicamptive McCarble and CK274. You'll be hearing more from Andrew and his team about our plans, including at an investor day to be scheduled later this year. On the regulatory front, as previously communicated, during the first quarter, we convened an FDA meeting to review the phase three clinical trial results from Galactic HF. And we're now proceeding towards additional interactions with FDA and other regulatory authorities. Fatih will elaborate in a moment, but suffice it to say, we're pleased with the level of engagement and the feedback that we received from FDA, and we believe Galactic HF can stand on its own as a pivotal trial in a planned NDA submission. We're now proceeding towards our goal of an NDA submission for Omicamp to McCarville in the second half of 2021. We also advanced our go-to-market planning with work streams focused on market research, brand positioning, supply chain manufacturing and logistics, market access, health economics and outcomes research, customer engagement, and other commercial infrastructure to inform our future investment and execution strategies in anticipation of a potential commercial launch of Omicampt and McCarble in the United States in 2022. Ching will elaborate later in this call on our financials, our cash runway, and our deal objectives to support our go-to-market strategy. We also made significant strides advancing our cardiac myosin inhibitor program during the quarter, focusing on the completion of Redwood HCM, our ongoing Phase II clinical trial of CK274 in patients with symptomatic obstructive hypertrophic cardiomyopathy. As Stuart will elaborate, in the first quarter, we opened and promptly completed enrollment in cohort two and more recently opened enrollment to cohort three. In addition, this morning, we announced that we also activated the first site in the open label extension study for patients who completed Redwood HCM. This high proficiency execution underscores the urgency of our activities in this program given the high unmet need among patients with hypertrophic cardiomyopathy. Based on data from the interim analysis of cohort one that we announced in December, we plan to engage FDA in this quarter and prepare for a phase three clinical trial expected to begin before year end. We're also advancing medical and new product planning activities directed to specialty care cardiologists in high-volume heart failure hospitals that overlap with high-volume HCM centers of excellence, given the many synergies between our cardiac myosin modulators and planning. And with that, I'll turn the call over now to Fatty to elaborate on developments related to omicamptive macabre.