On March 3, 2020 Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the fourth quarter and full year 2019. Net loss for the fourth quarter was $30.6 million or $0.52 per share and net loss for the year 2019 was $121.7 million, or $2.11 per share. Net loss for the fourth quarter of 2018 was $26.5 million, or $0.48 per share and net loss for the year 2018 was $106.3 million, or $1.95 per share. Cash, cash equivalents and investments totaled $267.7 million at December 31, 2019.
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"We had a productive fourth quarter of 2019 which positions us well to deliver against our Vision 2025 that we recently announced pointing towards commercialization of our novel drug candidates, doubling our development pipeline and expanding the breadth of our muscle biology focused research," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "In 2020, we look forward to reaching several key milestones, including sharing top-line results of GALACTIC-HF and completing enrollment in METEORIC-HF, both alongside continued preparations for the potential commercialization of omecamtiv mecarbil and the development of a co-promotion plan in collaboration with Amgen. We are also advancing our pipeline of cardiac myosin inhibitors, including CK-274 in REDWOOD-HCM and CK-271 which we expect to enter Phase 1 soon. We began 2020 with a strong balance sheet enabling our continued execution on key objectives that we believe will empower us to deliver on the promise of our science for patients."
Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
Continued conduct of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil, following the recently completed second and final planned interim analysis, which considered pre-specified criteria for futility and superiority. We expect top-line results in Q4 2020.
Announced the publication of a manuscript relating to the design of GALACTIC-HF in the Journal of American College of Cardiology: Heart Failure (JACC: HF).
Expect presentation of baseline characteristics from GALACTIC-HF at the American College of Cardiology meeting in March 2020.
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 enrollment in METEORIC-HF in 2020.
Presented results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) at the American Heart Association’s Scientific Sessions in Philadelphia. In this post-hoc analysis, patients with heart failure with reduced ejection fraction (HFrEF) treated with omecamtiv mecarbil, in addition to previously reported improvements in cardiac contractility measures (including systolic function, or pumping action of the heart), measures of diastolic function were not different from placebo and, for some measures, trended toward improvement.
AMG 594 (cardiac troponin activator)
Continued conduct of the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under our joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics. We expect to complete the SAD/MAD cohorts of the study in 2H 2020.
CK-3773274 (CK-274, cardiac myosin inhibitor)
Prepared for and started REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (HCM). REDWOOD-HCM started in Q1 2020 and will continue through 2020. We expect data from the first cohort of patients enrolled in REDWOOD-HCM to be available in 2H 2020.
CK-271 (CK-271, second cardiac myosin inhibitor)
We expect to file an IND and begin a Phase 1 study of CK-271 in 1H 2020.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
Presented subgroup analyses of FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS) at the 30th International Symposium on ALS/MND in Perth, Australia, showing that the effect of reldesemtiv on patients with ALS was similar whether or not patients were also receiving edaravone and/or riluzole.
Received Orphan Designation for reldesemtiv for the potential treatment of ALS by the U.S. Food and Drug Administration (FDA).
Held regulatory interactions and conducted feasibility and other planning activities in preparation for the potential advancement of reldesemtiv to a Phase 3 trial in patients with ALS. We expect to continue to engage with regulatory and reimbursement authorities in 2020 in preparation for the potential trial.
Pre-Clinical Development and Ongoing Research
Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA, under our collaboration with Astellas. We expect to continue the conduct of IND-enabling studies of CK-601 in 2020.
Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators.
Continued independent research activities directed to our other muscle biology research programs.
Corporate
We raised $120.5 million capital through a convertible note offering in November 2019. The convertible note carries a 4% coupon rate, a 27.5% convert premium, and matures in November 2026.
Financials
Revenues for the three and twelve months ended December 31, 2019 were $5.2 million and $26.9 million, respectively, compared to $9.4 million and $31.5 million for the corresponding periods in 2018. The decrease in revenues for the three and twelve months ended December 31, 2019 was due primarily to the winding down of FORTITUDE-ALS in addition to a lack of license revenue in 2019. License revenues in the fourth quarter and twelve months of 2018 were related to the Phase 2 trial of reldesemtiv in spinal muscular atrophy completed in 2018.
Research and development expenses for the three and twelve months ended December 31, 2019 were $18.3 million and $86.1 million, respectively compared to $23.3 million and $89.1 million for the same periods in 2018, respectively. The changes were primarily due to reduced spending for reldesemtiv as well as tirasemtiv following suspension of development of tirasemtiv in late 2017 offset by increased spending related to METEORIC-HF and the development of CK-274.
General and administrative expenses for the three and twelve months ended December 31, 2019 increased to $10.6 million and $39.6 million, respectively, from $7.6 million and $31.3 million for the same periods in 2018, respectively, due primarily to an increase in outside legal counsel and personnel related costs including stock-based compensation.
2020 Financial Guidance
The company also announced financial guidance for 2020. The company anticipates cash revenue will be in the range of $18 to $22 million, operating expenses will be in the range of $120 to $130 million, and net cash utilization will be approximately $105 to $115 million.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2019 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 8698309.
An archived replay of the webcast will be available via Cytokinetics’ website until March 17, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 8698309 from March 3, 2020 at 7:30 PM Eastern Time until March 17, 2020.