Cytokinetics Reports Fourth Quarter 2021 Financial Results

Commercial Launch Readiness Activities Underway for Omecamtiv Mecarbil in Advance of PDUFA Date of November 30, 2022

SEQUOIA-HCM Open to Enrollment; Development Program for Aficamten Expanding in 2022

Company Provides 2022 Financial Guidance; More Than 2 Years of Cash Runway

SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2021. Net loss for the fourth quarter was $30.6 million or $0.36 per share and the net loss for the year 2021 was $215.3 million or $2.80 per share. Net loss for the fourth quarter of 2020 was $43.9 million or $0.62 per share and net loss for the year 2020 was $127.3 million or $1.97 per share. Cash, cash equivalents and investments totaled $623.7 million at December 31, 2021. This cash balance does not include $150 million in proceeds received from transactions executed in late 2021 and early 2022.

“In the fourth quarter of last year and in early January we were pleased to execute two important transactions, comprising the licensing of omecamtiv mecarbil in China as well as funding for long-term capital supportive of the commercial launch of omecamtiv mecarbil and the further development of aficamten. In the fourth quarter we also continued to build our commercial infrastructure remaining prudent to spending gated to key de-risking events, such as the recent acceptance of the New Drug Application for omecamtiv mecarbil by the U.S. Food and Drug Administration,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “As we look ahead to what may be a pivotal year for our company, we believe that we are in a strong financial position to expand the development program for aficamten and advance our pipeline of early drug candidates while we also deliver on the promise of muscle biology by responsibly transforming from a R&D focused company to one that is also commercial.”

Q4 and Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

• The U.S. Food and Drug Administration (FDA) accepted and filed our New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF). The NDA was assigned standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.
• Continued building our commercial infrastructure and capabilities and engaged in product launch readiness activities for omecamtiv mecarbil in the U.S. Key launch readiness activities in Q4 focused to market access, distribution strategy, campaign development, pricing, field force size, structure and territory boundaries. Furthermore, the recent NDA filing has triggered additional investments in systems, training programs, supply chain and logistics as we continue to plan for a potential launch.
• Continued to expand our therapeutic Medical Scientists team and began development of our Managed Healthcare Medical Science Liaison team. We completed vendor selection for the Medical Contact Center and finalized design of our Investigator Sponsored Study Program.
• Announced topline results of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with HFrEF. METEORIC-HF evaluated the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET). There was no effect on the primary endpoint of change in peak oxygen uptake (pVO2) on CPET from baseline to Week 20 in patients treated with omecamtiv mecarbil compared to placebo. Adverse events, including major cardiac events, were similar between the treatment arms, and the safety profile of omecamtiv mecarbil was consistent with prior clinical trials, including GALACTIC-HF. The results from METEORIC-HF will be presented at the American College of Cardiology 71st Annual Scientific Session & Expo in Washington, D.C., as part of a Late Breaking Clinical Trial session on Sunday, April 3, 2022.
• Presented results from additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) at the American Heart Association (AHA) Scientific Sessions 2021 showing that treatment with omecamtiv mecarbil was associated with a significant reduction in the risk of stroke.

aficamten (cardiac myosin inhibitor)

• Opened enrollment in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM). SEQUOIA-HCM is a Phase 3 randomized, placebo-controlled, double-blind, multi-center clinical trial designed to evaluate aficamten in patients with symptomatic obstructive HCM on background medical therapy for 24 weeks. The primary endpoint is the change in pVO2 measured by CPET from baseline to week 24. SEQUOIA-HCM is expected to enroll 270 patients, randomized on a 1:1 basis to receive aficamten or placebo in addition to standard-of-care treatment. Each patient will receive up to four escalating doses of aficamten or placebo based on echocardiographic guidance alone.
• Announced positive topline results from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), which enrolled patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract gradient (LVOT-G) of ≥50 mmHg whose background therapy included disopyramide and in the majority a beta-adrenergic blocker. Results showed that substantial reductions in the average resting LVOT-G as well as the post-Valsalva LVOT-G (defined as resting gradient