Cytokinetics, Inc. Reports Third Quarter 2017 Financial Results
VITALITY-ALS Proceeding towards Planned Database Lock and Read-out in Q4;
Commercial Planning and Preparations for Potential Regulatory Submissions Underway
CK-2127107 Advancing in Four Mid-Stage Clinical Trials Under Collaboration with Astellas
First Patient Recently Dosed in
“We are proud of the key milestones we recently achieved in preparation for the planned release of results from VITALITY-ALS, and potential regulatory filings and commercialization of tirasemtiv in
Recent Highlights and Upcoming Milestones
Skeletal Muscle Program
tirasemtiv (fast skeletal muscle troponin activator)
- Completed dosing of patients in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), our Phase 3 clinical trial of tirasemtiv in patients with ALS.
- Continued enrollment in VIGOR-ALS (Ventilatory Investigations in Global Open-Label Research in ALS), an open-label clinical trial designed to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who have completed participation in VITALITY-ALS.
- Conducted clinical, regulatory, non-clinical and other activities intended to support potential regulatory filings and registration of tirasemtiv in
North Americaand Europe.
- Conducted manufacturing, logistical planning, market research, market access and other commercial readiness activities intended to support potential registration and commercialization of tirasemtiv in
North Americaand Europe.
- Proceeding to collection of final data from VITALITY-ALS and clinical trial database lock in Q4 2017. We plan to conduct analyses of data from VITALITY-ALS and present results from this clinical trial on
December 8, 2017at the 28th International Symposium on ALS/MND in Boston.
- Expect to continue to enroll patients who complete VITALITY-ALS into VIGOR-ALS throughout 2017.
CK-2127107 (next-generation fast skeletal muscle troponin activator)
- Announced the start of a Phase 1b, double-blind, randomized, placebo-controlled, multiple dose, two-period crossover study to assess the effect of CK-2127107 on measures of physical function in elderly adults with limited mobility. This study is being conducted by Astellas, in collaboration with
- Announced the start of FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS). This Phase 2 clinical trial is designed to assess the change from baseline in the percent predicted slow vital capacity (SVC) and other measures of skeletal muscle function after 12 weeks of treatment with CK-2127107 in patients with ALS. This trial is being conducted by
Cytokinetics, in collaboration with Astellas.
- “Reasons for Screen Failures and Baseline Characteristics of Randomized Patients from the First Cohort of the Phase 2 Clinical Trial of CK-2127107 in Patients with SMA,” presented by
Stacy Rudnicki, M.D., Director, Clinical Research, Cytokinetics, at the Cure SMA 2017 Annual SMA Conferencein Orlando, FL.
- Expect to complete enrollment of Cohort 2 of the Phase 2 clinical trial of CK-2127107 in patients with SMA in 2017.
- Expect data from the Phase 2 clinical trial of CK-2127107 in patients with SMA in Q1 2018.
- Expect Astellas to continue enrollment in a Phase 2 clinical trial of CK-2127107 in patients with COPD in 2017.
- Expect Astellas to continue enrollment in a Phase 1b clinical trial of CK-2127107 in adults with limited mobility in 2017.
- Expect to continue enrollment in FORTITUDE-ALS, a Phase 2 clinical trial of CK-2127107 in patients with ALS in 2017.
Cardiac Muscle Program
omecamtiv mecarbil (cardiac muscle myosin activator)
- Announced that the Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with heart failure met its pharmacokinetic primary endpoint and demonstrated statistically significant improvements in systolic ejection time (SET), a secondary endpoint.
- Announced that the first patient has been dosed in
Japanin 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 which is being conducted by Amgen, in collaboration with Cytokinetics. Coincident with patient dosing in Japan, Cytokineticsearned a $10 millionmilestone payment from Amgen.
- Announced that additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, were presented by
John Teerlink, M.D., Professor of Clinical Medicine at the University of California San Franciscoand Director of Heart Failure at the San Francisco Veterans Affairs Medical Centers in a Rapid Fire Abstracts Presentation at the 21st Annual Heart Failure Society of America Scientific Meetingin Dallas, TX.The results suggest that omecamtiv mecarbil may produce similar results with regard to cardiac function, heart rate, biomarkers and adverse events in patients with ischemic and non-ischemic heart failure due to left ventricular systolic dysfunction.
- Continued to enroll patients in GALACTIC-HF, the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil, conducted by
Amgen, in collaboration with Cytokinetics.
- Expect continued enrollment of patients with chronic heart failure in GALACTIC-HF throughout 2017.
- Continued research activities under our joint research program with
Amgendirected to the discovery of next-generation cardiac muscle activators and under our joint research program with Astellas directed to the discovery of next-generation skeletal muscle activators. In addition, company scientists continued independent research activities directed to our other muscle biology programs.
- Expect to nominate at least 2 compounds from ongoing Research programs (partnered and unpartnered) as potential drug candidates by the end of 2017.
Revenues for the three and nine months ended
Total research and development expenses for the three and nine months ended
General and administrative expenses for the three and nine months ended
The Company also announced updated financial guidance for 2017. The Company anticipates cash research and development expenses will be in the range of
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s third quarter 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”).
Vice President, Corporate Communications, Investor Relations
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,||September 30,||September 30,|
|Research and development, grant and other|
|Research and development||24,947||17,865||64,045||41,121|
|General and administrative||9,657||7,217||26,210||21,149|
|Total operating expenses||34,604||25,082||90,255||62,270|
|Operating (loss) income||(28,424||)||33,965||(76,869||)||10,999|
|Interest and other income (expense), net||(3,933||)||(603||)||(10,436||)||(1,703||)|
|Net (loss) income||$||(32,357||)||$||33,362||$||(87,305||)||$||9,296|
|Net (loss) income per share – basic||$||(0.60||)||$||0.84||$||(1.82||)||$||0.23|
|Net (loss) income per share – diluted||$||(0.60||)||$||0.77||$||(1.82||)||$||0.22|
|Weighted average shares used in computing net (loss) income
per share – basic
|Weighted average shares used in computing net (loss) income
per share – diluted
Condensed Consolidated Balance Sheets
|September 30,||December 31,|
|Cash and cash equivalents||$||116,320||$||66,874|
|Short term investments||191,247||89,375|
|Other current assets||4,420||2,360|
|Total current assets||321,987||158,633|
|Property and equipment, net||3,294||3,637|
|Liabilities and stockholders' equity|
|Deferred revenue, current||$||9,570||$||8,060|
|Other current liabilities||32,787||25,198|
|Total current liabilities||42,357||33,258|
|Deferred revenue, non-current||15,872||15,000|
|Liability related to sale of future royalties||100,575||-|
|Other non-current liabilities||-||142|
|Total liabilities and stockholders' equity||$||326,313||$||170,142|
(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