Cytokinetics, Inc. Reports First Quarter 2018 Financial Results
Completed Enrollment in Phase 2 Study of Reldesemtiv in Patients with SMA;
Data Expected in Q2 2018
Preparing to Initiate Second Phase 3 Clinical Trial of Omecamtiv Mecarbil
“In the first quarter of 2018 we made progress advancing our muscle biology directed drug candidates in mid- and late-stage clinical trials across diseases and conditions of impaired muscle function,” said
Recent Highlights and Upcoming Milestones
Cardiac Muscle Program
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 is proceeding towards 50 percent completion with patients randomized to date having a risk profile consistent with the trial design. The Data Monitoring Committee for GALACTIC-HF has been meeting regularly and reviewing data arising from the trial; there have been no major changes to the trial following these reviews. We expect to complete enrolling patients with chronic heart failure in GALACTIC-HF in approximately one year.
- Continued protocol development, feasibility assessments, regulatory interactions and other readiness activities for a second Phase 3 clinical trial of omecamtiv mecarbil. This trial is intended to evaluate the potential effect of omecamtiv mecarbil on exercise performance in patients with heart failure and is planned to be conducted by
Cytokineticsin collaboration with Amgen. We are finalizing preparations to ensure readiness to begin this trial on a timeframe to be agreed soon.
Skeletal Muscle Program
tirasemtiv (fast skeletal muscle troponin activator (FSTA))
- Convened an advisory board of ethicists, patient advocates, trial investigators and experts in pre-approval access to assess whether and how best to continue providing tirasemtiv to those people living with ALS currently in VIGOR-ALS, the open-label extension clinical trial following VITALITY-ALS. Informed by our advisory board, we decided to close VIGOR-ALS and transition patients who wish to remain on tirasemtiv to a Managed Access Program (MAP).
- The manuscript, “Respiratory Measures in Amyotrophic Lateral Sclerosis,” published online in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
- The manuscript, “VITALITY-ALS, a Phase III Trial of Tirasemtiv, a Selective Fast Skeletal Muscle Troponin Activator, as a Potential Treatment for Patients with Amyotrophic Lateral Sclerosis: Study Design and Baseline Characteristics,” published online in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
reldesemtiv (CK-2127107, next-generation FSTA)
- Completed enrollment of 70 patients in our Phase 2 clinical trial of reldesemtiv which is designed to assess its effect on multiple measures of muscle function in both ambulatory and non-ambulatory patients with SMA. This trial is being conducted by
Cytokineticsin collaboration with Astellas. We expect results to be presented on June 16at the 2018 Annual Cure SMA Conference.
- 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. This trial has enrolled over 150 patients toward the objective of 445 patients and is being conducted by
Cytokineticsin collaboration with Astellas. We expect results from this clinical trial in Q4 2018.
- Continued patient enrollment in the Phase 2 clinical trial of reldesemtiv in patients with chronic obstructive pulmonary disease (COPD) which is designed to assess its effect on physical function. This trial, designed to enroll 40 patients, is nearing completion and is being conducted by Astellas in collaboration with
Cytokinetics. We expect results from this clinical trial in 2H 2018.
- Continued site activation and patient enrollment in the Phase 1b clinical trial of reldesemtiv in elderly subjects with limited mobility which is designed to assess its effect on measures of physical function. This trial is being conducted by Astellas in collaboration with
Cytokinetics. We expect Astellas will conduct an interim analysis of data arising from this trial in Q4 2018.
- Continued collaboration activities under our joint research program with Astellas directed to the discovery of next-generation skeletal muscle activators.
- Continued independent research activities directed to our other muscle biology programs.
- Continued to advance development compounds under our collaborations with
Amgenand Astellas. We expect to advance one of these potential drug candidates to Phase 1 in 2018.
- Continued IND-enabling studies for our unpartnered cardiac sarcomere directed compound. We expect to advance this potential drug candidate to Phase 1 in 2018.
- Announced progress against our Vision 2020 initiatives designed to advance and expand our pipeline of muscle biology directed drug candidates in late-stage development to address urgent needs of people living with conditions characterized by impaired muscle function and weakness.
- Announced that
Robert Califf, M.D., has been appointed to the company’s Board of Directors. Dr. Califf is the Vice Chancellor for Health Data Science at Duke Healthand Director of the Duke University Center for Health DataScience. He is also serving as an advisor to the senior management team at Verily Life Sciences, a subsidiary of Alphabet, Inc.(parent company to Stanford University.
- Joined the global initiative to raise awareness of Rare Disease Day®, an international campaign led by the
European Organisation for Rare Diseases(EURORDIS) and the National Organization for Rare Disorders(NORD), dedicated to elevating the public understanding of rare diseases.
Annual Stockholders' Meeting
Cytokinetics’ Annual Stockholders’ Meeting will be held on
Revenues for the first quarter of 2018 consisted of revenues from our collaboration with Astellas, including research and development revenues of
Research and development expenses fell to
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s first 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, unaudited)
|Three Months Ended|
|March 31, 2018||March 31, 2017|
|Research and development, grant and other revenues, net||$||3,585||$||2,707|
|Research and development||22,135||19,289|
|General and administrative||9,264||8,115|
|Total operating expenses||31,399||27,404|
|Non-cash interest expense on liability related to sale of future royalties||(4,129||)||(2,307||)|
|Interest and other income, net||842||436|
|Net loss per share - basic and diluted||$||(0.56||)||$||(0.62||)|
|Weighted-average shares used to compute net loss per share — basic and diluted||54,062||41,578|
Condensed Consolidated Balance Sheets
|March 31, 2018||December 31, 2017(1)|
|Cash and short term investments||$||251,454||$||268,891|
|Other current assets||20,885||5,404|
|Total current assets||272,339||274,295|
|Property and equipment, net||3,156||3,568|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||30,469||$||22,645|
|Deferred revenue, current||7,842||9,572|
|Other current liabilities||235||227|
|Total current liabilities||38,546||32,444|
|Long-term debt, net||31,954||31,777|
|Liability related to the sale of future royalties, net||108,792||104,650|
|Deferred revenue, non-current||—||15,000|
|Other long-term liabilities||1,035||1,097|
|Additional paid-in capital||757,405||755,526|
|Accumulated other comprehensive income||489||343|
|Total stockholders’ equity||99,599||109,842|
|Total liabilities and stockholders’ equity||$||279,926||$||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