Cytokinetics, Inc. Reports Third Quarter 2018 Financial Results
METEORIC-HF Advancing to Trial Initiation
FORTITUDE-ALS on Track to Complete Enrollment by Year End
Phase 1 Clinical Studies of CK-274 and AMG 594 To Start in Q4
"With five programs advancing in development, we were pleased to report progress of our expanded pipeline of muscle biology directed potential medicines as recently outlined at our R&D Day," said
Recent Highlights and Upcoming Milestones
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Continued patient enrollment in 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. Enrollment has surpassed 70 percent completion with over 5,800 patients randomized to date having the high-risk profile intended by the trial design. We expect completion of patient enrollment in GALACTIC-HF to occur during the first half of 2019. We also expect that GALACTIC-HF will have accrued a sufficient number of events to enable the Data Monitoring Committee to conduct a first interim analysis for the trial, the design of which is tied to the potential for futility, in the first half of 2019.
- Conducted readiness activities in advance of the initiation of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv MecarbilRelated to Increased Contractility in Heart Failure). METEORIC-HF is a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment.
Cytokineticsis working together with Amgentowards the objective of starting METEORIC-HF by the end of 2018.
AMG 594 (cardiac troponin activator)
- Continued pre-clinical development of AMG 594 and filed an IND in collaboration with
Amgen. AMG 594 is a novel, first-in-class, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. In preclinical models, AMG 594 increases myocardial contractility by binding to cardiac troponin through an allosteric mechanism that sensitizes the cardiac sarcomere to calcium. Based on preclinical data, AMG 594 may offer differentiated efficacy and dose-related convenience relative to omecamtiv mecarbil.
- We expect that
Amgenwill initiate a Phase 1 program for AMG 594 before the end of the year to assess its safety, tolerability, pharmacokinetics and its potential to increase cardiac function in healthy volunteers.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Continued pre-clinical development and filed an IND for CK-274. CK-274 is a novel, oral, small molecule cardiac myosin inhibitor that company scientists discovered independent of its collaborations. CK-274 arose from an extensive next-generation chemical optimization program conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into best-in-class potential in clinical development. In preclinical models, CK-274 reduces myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site preventing myosin from entering a force producing state.
- We expect to initiate a Phase 1 program for CK-274 before the end of the year to assess its safety, tolerability, pharmacokinetics and its effect on cardiac function in healthy volunteers.
Skeletal Muscle Program
reldesemtiv (next-generation FSTA)
- Announced that additional results from the Phase 2 clinical study of reldesemtiv in patients with spinal muscular atrophy (SMA) were presented by
John W. Day, M.D., Ph.D., Professor of Neurology and Pediatrics (Genetics), Stanford Universityat the 2018 Muscle Study Group Scientific Meeting in Oxford, UK, showing sustained increases in 6MWD and MEP four weeks after discontinuation of study drug.
- Continued site activation and patient enrollment in 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 which is designed to assess the change from baseline in percent predicted slow vital capacity and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. FORTITUDE-ALS has enrolled over 400 patients toward the objective of 445 patients in the trial and is being conducted by
Cytokineticsin collaboration with Astellas. We expect to complete enrollment in FORTITUDE-ALS in Q4 2018 with results from this clinical trial expected in the first half of 2019.
- With Astellas, announced the Phase 2 clinical trial of reldesemtiv in patients with chronic obstructive pulmonary disease (COPD), which was designed to assess its effect on physical function, did not meet the primary endpoint and did not demonstrate a statistically significant treatment difference in any of the secondary endpoints. Adverse events were similar between groups receiving reldesemtiv and placebo.
- With Astellas, announced that an interim analysis of the Phase 1b clinical trial of reldesemtiv in elderly subjects with limited mobility, which was designed to assess its effect on measures of physical function, was recently conducted. The Data Monitoring Committee determined that the pre-defined criteria for lack of efficacy of reldesemtiv had been met; Astellas has proceeded to notify investigators to halt further enrollment in the trial.
- Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA) into IND-enabling studies under our collaboration with Astellas.
- Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators. The companies are continuing their joint research program with Astellas providing sponsorship of
Cytokinetics'activities through 2019.
- Continued independent research activities directed to our other muscle biology research programs.
- Announced that
The ALS Association Golden West Chapteris the inaugural recipient of the Cytokinetics Communications Fellowship, an annual grant from the company intended to support increased capacity and community engagement for nonprofit organizations.
Revenues for the three and nine months ended
Research and development expenses for the third quarter of 2018 decreased to
General and administrative expenses for the three and nine months ended
Conference Call and Webcast Information
An archived replay of the webcast will be available via
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, unaudited)
|Three Months Ended||Nine Months Ended|
|September 30, 2018||September 30, 2017||September 30, 2018||September 30, 2017|
|Research and development, milestone, grant and other revenues, net||$||8,726||$||5,862||$||16,991||$||6,680|
|Research and development||21,391||24,947||65,858||64,045|
|General and administrative||7,164||9,657||23,724||26,210|
|Total operating expenses||28,555||34,604||89,582||90,255|
|Non-cash interest expense on liability related to sale of future royalties||(4,559||)||(3,906||)||(13,026||)||(9,918||)|
|Interest and other income, net||1,323||779||3,291||1,828|
|Net loss per share — basic and diluted||$||(0.40||)||$||(0.60||)||$||(1.47||)||$||(1.82||)|
|Weighted-average shares in net loss per share — basic and diluted||54,626||53,719||54,329||47,879|
Condensed Consolidated Balance Sheets
|September 30, 2018||December 31, 2017(1)|
|Cash and short term investments||$||210,310||$||268,891|
|Other current assets||16,959||5,404|
|Total current assets||227,269||274,295|
|Property and equipment, net||2,687||3,568|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||17,676||$||22,645|
|Deferred revenue, current||—||9,572|
|Current portion of long-term debt||3,778||—|
|Other current liabilities||38||227|
|Total current liabilities||21,492||32,444|
|Long-term debt, net||38,127||31,777|
|Liability related to the sale of future royalties, net||117,718||104,650|
|Deferred revenue, non-current||—||15,000|
|Other long-term liabilities||874||1,097|
|Additional paid-in capital||765,970||755,526|
|Accumulated other comprehensive income||447||343|
|Total stockholders' equity||52,068||109,842|
|Total liabilities and stockholders' equity||$||230,279||$||294,810|
(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