Cytokinetics, Incorporated

Good afternoon and welcome, ladies and gentlemen, to CytoKinetics' third quarter 2021 conference call. At this time, I would like to inform you that this call is being recorded and that all participants are in the 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 Joanna Siegel Fatto Kinetics Senior Manager 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 begin with an overview of the quarter and recent developments. Then, Fatty Maleth, our EVP of Research and Development, will provide an update on Omicamp and McCarble, including recently presented additional analyses from Galactic HF, as well as an update on our ongoing next steps with the FDA. Next, Stuart Kupfer, our SPP and Chief Medical Officer, will provide an update on our development program for Affy-Campden by recapping the results from Cohort 1 and 2 of Redwood HCM, elaborating on continuing activities in Redwood HCM, and reviewing the design of Sequoia HCM, our planned Phase 3 clinical trial of Affy-Campden in patients with obstructive HCM. He will also speak to initial progress in Courage ALS, our ongoing phase three clinical trial of real deceptive in patients with ALS. Then, Andrew Kalos, our EVP and Chief Commercial Officer, will discuss our go-to-market strategy for Omicamp and McCarble and our cardiovascular franchise development plans for the commercialization of Affy Campton. Robert Wong, our VP and Chief Accounting Officer, will provide a financial overview for the past quarter And Ching Jha, our SVP and Chief Financial Officer, will discuss strategic planning, our financial outlook, and corporate development strategies before Robert Blum will provide concluding thoughts and expected key milestones for the remainder of 2021. 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 2021 financial results filed on Form 8K today. We undertake no obligation to update any forward-looking statements after this call. Now, I will turn the call over to Robert.

Thank you, Joanna, and thanks again to everyone for joining us on the call today. We had a very productive third quarter marked by meaningful progress across all of our later stage programs, most notably our sharing positive results from our Phase II clinical trial, Redwood HCM, which demonstrated the efficacy and safety of afecamptin, our next-in-class drug candidate, in patients with obstructive hypertrophic cardiomyopathy. As we've said, these results met our high expectations for this trial, and we received positive feedback from the physician community. Stuart will elaborate more on these results in a moment. During the third quarter, we were also pleased to complete enrollment in cohort three of Redwood HCM, which, as you'll recall, enrolled patients also on desipiramide, a medication often prescribed to patients with more severe HCM. We expect to share the results from cohort three in the first quarter of 2022. Following previous interactions with FDA from which we received feedback on our planned trial design, we continue to advance activities in preparation for Sequoia HCM, the phase three clinical trial of athecampin in patients with obstructive HCM. As we recently presented, and as Stuart will elaborate, this trial was designed to potentially demonstrate a significant improvement in exercise capacity and evaluate safety in a broad population of patients with symptomatic obstructive HCM. We're working with sites around the world, including many who participated in Redwood HCM who are enthusiastic about also participating in Sequoia HCM. and we look forward to starting this trial soon. Moving now to our heart failure program, we continued activities supportive of our plans to submit an MDA for Omicamp to McCarble, and we remain on track towards our goal of submission in this fourth quarter of this year. Fatty will have more to say about that in a moment. Additionally, as outlined in our recent Analyst and Investor Day, we're making significant progress in refining and executing the our go-to-market strategies for Omicamp to McCarvel across several work streams that Andrew will elaborate on in a moment. These commercial readiness activities represent a tremendous scope of work from our growing commercial organization and supporting our go-to-market strategies, as well as our intention to build a cardiovascular business franchise by leveraging common denominators and synergies across our business, inclusive of our plans both for the potential launch of omicamptomacarbal and a potential future launch of aficamptin. As Fadi will discuss, in the third quarter, we presented additional results from Galactic HF, highlighted by an analysis of black patients enrolled in Galactic HF, showing that the treatment effect of omicamptomacarbal in black patients was consistent with the treatment effect in the overall population, and also similar to the effect observed in white patients in the trial. This finding is important due to the fact that black patients tend to have a higher risk of heart failure and often have worse outcomes. Additionally, an analysis of the severe heart failure subgroup in galactic HF was published in the Journal of the American Medical Association Cardiology, illuminating a larger treatment effect when compared to the overall population of patients studied. This important manuscript was accompanied by an editorial suggesting recognition of a new classification for a group of severe heart failure patients whose still prevailing high unmet need represents an increasing patient population with heart failure that contributes more and more to the clinical and the economic burden of this disease. Finally, We were pleased in the most recent quarter to begin enrolling patients in Courage ALS, our phase three clinical trial of rel-deceptive in patients with ALS. The results from the phase two clinical trial, Fortitude ALS, were deemed compelling by investigators and physicians who treat patients with ALS. And our advancement to phase three is an exciting and important step forward for this program, as is aligned with our dedication to the ALS communities. The ALS communities are more assertively seeking new medicines, and the FDA and public policymakers seem to be increasingly responding to these louder calls for action. It is an incredibly important time for our company. We're building our teams and capabilities as we're now on the precipice of a powerful transformation from an R&D company into one that is also a commercial organization. It has always been our strategic vision to ourselves deliver on the promise of our science, and we're closer now to that than ever before. These are exciting times to be sure, but how we execute on those plans will matter. Robert will speak to our current financials, and Ching will comment on our progress and prospects in continuation of our long-standing practice to diversify our access to capital through both partnering and structured financings, as is informed by annual strategic planning. With that, I'll turn the call over now to Fatih to elaborate on developments related to Omicampt of McCarble.