Cytokinetics Reports First Quarter 2019 Financial Results
GALACTIC-HF Continues Following Interim Analysis for Futility;
METEORIC-HF Opened to Enrollment
Phase 1 Data for CK-274 Expected in Q3 2019;
Planning Underway for Potential Progression to Phase 2
FORTITUDE-ALS Demonstrates Patients on All Doses of Reldesemtiv Declined Less Than Patients on Placebo for SVC and ALSFRS-R, With Clinically Meaningful Differences Emerging Over Time
“We are pleased with the progress made across our pipeline of muscle-directed investigational medicines during the first quarter of 2019,” said
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 first planned interim analysis for futility. We expect screening in this event-driven trial to complete in the second quarter of 2019.
- Opened METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv MecarbilRelated to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil, to enrollment. METEORIC-HF is a 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. We expect to continue enrollment of METEORIC-HF throughout 2019.
John Teerlink , M.D., Professor of Clinical Medicine,University of California San Francisco and Director of Heart Failure,San Francisco Veterans Affairs Medical Center , presented additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) at theAmerican College of Cardiology’s 68th Annual Scientific Session. The results of a post hoc subgroup analysis of the COSMIC-HF data showed that, between 32 patients with atrial fibrillation (AF) and 117 patients without AF, there were no statistically significant differences in the effects of treatment with omecamtiv mecarbil on cardiac function, including systolic ejection time and stroke volume, as well as ventricular volumes, heart rate, and NT-proBNP.
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 a joint research program with
Amgen . This Phase 1 study is being conducted byAmgen in collaboration withCytokinetics . We expect the conduct of this study to continue throughout 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Continued conduct of the Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-274 in healthy adult subjects. CK-274 is a wholly-owned, novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM). We expect results from this study in the third quarter of 2019 and are preparing for potential progression of CK-274 to Phase 2 in the second half of 2019.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
- Results from 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), were presented during a platform presentation at the
American Academy of Neurology 71st Annual Meeting inPhiladelphia onSunday, May 5, 2019 .
- FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). Similar analyses of ALSFRS-R and slope of the Muscle Strength Mega-Score yielded p values of 0.09 and 0.31, respectively. While the dose-response analyses for the primary and secondary endpoints did not achieve statistical significance at the level of 0.05, in a post-hoc analysis pooling the doses together, patients who received reldesemtiv in FORTITUDE-ALS declined less than patients who received placebo. The trial showed effects favoring reldesemtiv across dose levels and timepoints with clinically meaningful magnitudes of effect observed at 12 weeks for the primary and secondary endpoints. The differences between reldesemtiv and placebo in SVC and ALSFRS-R total score observed after 12 weeks of treatment were still evident at follow-up, four weeks after the last dose of study drug.
- Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA), under our collaboration with Astellas.
- Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; Astellas is sponsoring Cytokinetics’ activities through 2019.
- Continued independent research activities directed to our other muscle biology research programs.
Corporate
- Joined the
European Organisation for Rare Diseases (EURORDIS) and theNational Organization for Rare Disorders (NORD) to recognize Rare Disease Day®, an international campaign elevating the public understanding of rare diseases.
Financials
Revenues for the first quarter of 2019 increased to
Research and development expenses for the first quarter of 2019 increased to
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s first quarter 2019 results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
About
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn,
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
Contact:
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
| Three Months Ended | ||||||||
| March 31, 2019 | March 31, 2018 | |||||||
| Revenues: | ||||||||
| Research and development revenues | $ | 8,464 | $ | 3,585 | ||||
| License revenues | — | 1,683 | ||||||
| Total revenues | 8,464 | 5,268 | ||||||
| Operating expenses: | ||||||||
| Research and development | 23,545 | 22,135 | ||||||
| General and administrative | 9,437 | 9,264 | ||||||
| Total operating expenses | 32,982 | 31,399 | ||||||
| Operating loss | (24,518 | ) | (26,131 | ) | ||||
| Interest expense | (1,170 | ) | (863 | ) | ||||
| Non-cash interest expense on liability related to sale of future royalties | (4,819 | ) | (4,129 | ) | ||||
| Interest and other income, net | 1,141 | 842 | ||||||
| Net loss | $ | (29,366 | ) | $ | (30,281 | ) | ||
| Net loss per share — basic and diluted | $ | (0.54 | ) | $ | (0.56 | ) | ||
| Weighted-average shares in net loss per share — basic and diluted | 54,821 | 54,062 | ||||||
Condensed Consolidated Balance Sheets
(in thousands)
| March 31, 2019 | December 31, 2018(1) | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and short term investments | $ | 176,622 | $ | 198,731 | ||||
| Other current assets | 9,778 | 8,943 | ||||||
| Total current assets | 186,400 | 207,674 | ||||||
| Property and equipment, net | 3,175 | 3,204 | ||||||
| Other assets | 9,036 | 300 | ||||||
| Total assets | $ | 198,611 | $ | 211,178 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 15,491 | $ | 19,521 | ||||
| Current portion of long-term debt | 6,212 | 2,607 | ||||||
| Short-term lease liability | 4,499 | — | ||||||
| Other current liabilities | 75 | 66 | ||||||
| Total current liabilities | 26,277 | 22,194 | ||||||
| Long-term debt, net | 36,382 | 39,806 | ||||||
| Liability related to the sale of future royalties, net | 127,308 | 122,473 | ||||||
| Long-term lease liability | 5,272 | — | ||||||
| Other long-term liabilities | — | 771 | ||||||
| Total liabilities | 195,239 | 185,244 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock | 55 | 55 | ||||||
| Additional paid-in capital | 775,401 | 768,703 | ||||||
| Accumulated other comprehensive income | 606 | 500 | ||||||
| Accumulated deficit | (772,690 | ) | (743,324 | ) | ||||
| Total stockholders’ equity | 3,372 | 25,934 | ||||||
| Total liabilities and stockholders’ equity | $ | 198,611 | $ | 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