Submission of NDA for Omecamtiv Mecarbil on Track to Occur in Q4 2021
Start-Up Activities Underway for SEQUOIA-HCM
Enrollment Complete in Cohort 3 of REDWOOD-HCM; Results Expected in Q1 2022
SOUTH SAN FRANCISCO, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2021. Net loss for the third quarter was $76.1 million, or $0.95 per share, compared to net loss for the third quarter of 2020 of $3.2 million, or $0.05 per share. Cash, cash equivalents and investments totaled $668.9 million at September 30, 2021.
“During the third quarter we were pleased to deliver against several key milestones across our late-stage pipeline, including our sharing positive results from REDWOOD-HCM and conducting start-up activities for SEQUOIA-HCM, our Phase 3 trial of aficamten. In parallel, we were pleased to start COURAGE-ALS, our Phase 3 trial of reldesemtiv while also advancing towards our goal of submitting the NDA for omecamtiv mecarbil,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Moreover, after recently outlining our go-to-market strategy for omecamtiv mecarbil in the U.S., we are forging ahead to execute on those plans, supported by a strong and growing commercial organization with focus to building a cardiovascular franchise. All of this is occurring alongside an expansion of our research programs with the objective to support a sustainable pipeline of innovation.”
Q3 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Continued activities supportive of our plans to submit a New Drug Application (NDA) for omecamtiv mecarbil, which remains on track to occur in Q4 2021.
- Results from additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Denver, CO, showing that the effect of treatment with omecamtiv mecarbil in Black patients was consistent with the overall population and with white patients.
- Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. We expect to complete METEORIC-HF by year end and report results in early 2022.
- Advanced our go-to-market-strategy and commercial readiness activities. We completed the hiring of our commercial senior leadership and payer account management teams and grew our U.S. marketing organization. In addition, we advanced key activities in preparation for potential commercial launch including refinement of product positioning, development of a product educational campaign, updating the sizing and deployment strategy for our U.S. sales team, U.S. pricing, and our product value proposition.
- Expanded our Medical Affairs organization with the hiring of therapeutic area lead Medical Directors and deployment of additional field-based Medical Scientists. We initiated vendor selection for the development of a Medical Contact Center and continued organizing the framework for the Investigator Sponsored Study Program.
- The manuscript entitled “Assessment of Omecamtiv Mecarbil for the Treatment of Patients with Severe Heart Failure” was published in JAMA Cardiology.
- The manuscript entitled “Characteristics and Outcomes of Patients with Heart Failure with Reduced Ejection Fraction After a Recent Worsening Heart Failure Event” was published in the Journal of the American Heart Association.
aficamten (cardiac myosin inhibitor)
- Announced positive results from Cohorts 1 and 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) demonstrating that treatment with aficamten for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular outflow tract pressure gradient (LVOT-G) and the average post-Valsalva LVOT-G. A large majority of patients treated with aficamten achieved the target goal of treatment, defined as resting gradient