Cytokinetics, Incorporated

Good afternoon and welcome ladies and gentlemen to cytokinetics third quarter 2020 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. 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. our President and Chief Executive Officer will kick off the call with a recap of our top-line results from Galactic HF and an overview of our progress during the quarter. Then, Fady Malik, our EVP of Research and Development, will provide perspective on the top-line results, what we can expect from presentations at AHA, and an update on Meteoric HF, the second Phase III clinical trial of Omicamptive McCarble. Next, Stuart Kupfer, our SVP and Chief Medical Officer, will update on recent progress with CK274, our cardiac myosin inhibitor, which is a subject of Redwood HCM, as well as CK271, our additional cardiac myosin inhibitor. Then Robert Wong, our VP and Chief Accounting Officer, will provide a financial overview for the quarter, and Ching Jha, our SVP and Chief Financial Officer, will discuss strategic planning and our financial outlook before Robert Blum provides concluding thoughts on the company's path forward and expected key milestones for the remainder of the year. 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. 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. I'll begin with our most recent news. A few weeks ago, we were pleased to announce top-line results of Galactic HF, which demonstrated treatment with omicamptamicarbol achieved the primary composite efficacy endpoint of the trial. and demonstrated statistically significant effect to reduce the risk of cardiovascular death or heart failure related events compared to placebo in patients treated with standard of care and with a p-value less than 0.05. Galactic HF is a large scale over 8,000 patient international trial. The first phase three trial to test this novel mechanism and Admittedly, we in Amgen swung for the fences with this Phase III outcomes trial and the overall development program for omicamptomicarbol. We had hopes of hitting a home run for patients with heart failure by decreasing heart failure events, reducing cardiovascular mortality, improving quality of life, and extending patient stamina and endurance. And while results from Galactic HF may have fallen short of our most ambitious goals, Expectations by Missing on the First Secondary Endpoint of Cardiovascular Death Alone, we believe the results, as already communicated, put us in potential scoring positions by hitting on the primary efficacy endpoint and by demonstrating balance safety across treatment arms. Considering the novel mechanism of action of Omicampton-McCarvel and the scope and scale of Galactic HF, Having enrolled patients in 35 countries, both inpatients and outpatients, and patients well maintained on standard of care, we believe there's a lot more to the results of this trial as will be illuminated by the presentation of the primary result at the upcoming AHA scientific sessions next week. Already, Galactic HF has revealed to be a very important clinical trial for heart failure patients. and the heart failure community. Because we now have evidence that increasing contractility can safely improve meaningfully relevant outcomes important to physicians, patients and payers. And of course, this is an important outcome for cytokinetics and our employees and shareholders. A major event for us, in fact, having committed over 15 years to the clinical development of omicamptamicarbol and more recently, the commercial readiness for the potential launch of our first-in-class cardiac myosin activator. We are now immersed in ongoing analyses of data from Galactic HF and discussions about potential next steps with Amgen as well as with members of the Academic Executive Committee of the trial. Together, we're continuing to conduct pre-specified and supplemental analyses suggested by the top line results in preparation for the late breaking presentation to be given by Dr. John Tierling at AHA, as well as other activities to follow. We look forward to our ability to discuss these results in more detail very soon. Following Dr. Tierling's presentation at AHA, Stotokinetics will convene a publicly available investor and media call with Dr. Tierling and others from the executive committee of the trial to review the results in the context of the high clinical unmet need for patients with heart failure as well as the growing economic burden of the disease. Recognizing we can't say too much more prior to the presentation at AHA, Fady will review the top line results in a moment and put them into the context of the trial design. will also provide an update on progress in Meteoric HF, the second phase three clinical trial of omicamptamicarbol. Turning to our cardiac myosin inhibitor program, we continue to make progress and look forward to advancing Redwood HCM to its cohort two by year end. Much like in heart failure, HCM patients are in great need of novel therapies to address the underlying contractile dysfunction of their disease. And we're working with urgency to progress our program on the heels of our licensing deal with Zhijing Pharmaceuticals and our royalty deals with RTW. Stuart will provide more details on progress for this program in a moment. And finally, during the third quarter, we continued readiness activities in preparation for the potential start of a Phase III clinical trial of rel-deceptive in patients with ALS. And to remind you, we've communicated that we would make a decision regarding potential advancement of rel-deceptive to Phase III following the review of results of Galactic HF, and that decision has not been made. It's still forthcoming. We will have more clarity on our plans following the presentation of results of Galactic HF at AHA, as well as upon the conclusion of ongoing internal planning and budgeting and also discussions to be convened with our board later this quarter. And with that, I'll turn the call now over to Fady to elaborate on developments related to Omicamp and McCarville.