Cytokinetics Reports Fourth Quarter 2019 Financial Results
GALACTIC-HF Continuing Following Second Planned Interim Analysis;
Top-line Results for GALACTIC-HF Expected in Q4 2020
Company Provides 2020 Financial Guidance;
More Than Two Years of Cash Runway Based on 2020 Guidance
“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
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 Cardiologymeeting 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.
- 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.
- We raised
$120.5 millioncapital through a convertible note offering in November 2019. The convertible note carries a 4% coupon rate, a 27.5% convert premium, and matures in November 2026.
Revenues for the three and twelve months ended
Research and development expenses for the three and twelve months ended
General and administrative expenses for the three and twelve months ended
2020 Financial Guidance
The company also announced financial guidance for 2020. The company anticipates cash revenue will be in the range of
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2019 results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
Senior Vice President, Corporate Communications, Investor Relations
|Condensed Consolidated Statements of Operations|
|(in thousands except per share data)|
|Three Months Ended
|Research and development revenues||$||5,212||$||9,377||$||26,868||$||26,368|
|Research and development||18,334||23,278||86,125||89,135|
|General and administrative||10,584||7,558||39,610||31,282|
|Total operating expenses||28,918||30,836||125,735||120,417|
|Non-cash interest expense on liability related to sale of future royalties||(5,533||)||(4,740||)||(20,737||)||(17,767||)|
|Interest and other income, net||1,330||900||4,535||4,191|
|Net loss before income taxes||(30,640||)||(26,469||)||(121,692||)||(106,289||)|
|Income tax benefit||—||—||—||—|
|Net loss per share — basic and diluted||$||(0.52||)||$||(0.48||)||$||(2.11||)||$||(1.95||)|
|Weighted-average shares in net loss per share — basic and diluted||59,133||54,689||57,575||54,420|
|Condensed Consolidated Balance Sheets|
|Cash and short term investments||$||225,112||$||198,731|
|Other current assets||8,640||8,943|
|Total current assets||233,752||207,674|
|Property and equipment, net||4,530||3,204|
|Operating lease right-of-use assets and other assets||8,882||300|
|LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)|
|Accounts payable and accrued liabilities||$||20,283||$||19,521|
|Current portion of long-term debt||—||2,607|
|Short-term lease liability||4,616||—|
|Other current liabilities||1,124||66|
|Total current liabilities||26,023||22,194|
|Term loan, net||45,052||39,806|
|Convertible notes, net||84,205||—|
|Liability related to the sale of future royalties, net||143,276||122,473|
|Long-term lease liability||2,195||771|
|Commitments and contingencies|
|Stockholders’ equity (deficit):|
|Additional paid-in capital||853,341||768,703|
|Accumulated other comprehensive income||679||500|
|Total stockholders’ equity (deficit)||(10,937||)||25,934|
|Total liabilities and stockholders’ equity (deficit)||$||289,814||$||211,178|
|(1) Derived from the audited financial statements, included in the company's Annual Report on Form 10-K for the year ended
Source: Cytokinetics, Incorporated