Cytokinetics Reports Fourth Quarter 2018 Financial Results
Company Provides 2019 Financial Guidance and Expected Milestones
Reduced Operating Expenses vs. 2018; Over Two Years of Cash Based on Current Burn Rate
Interim Analysis for GALACTIC-HF on Track for 1H 2019
Results from FORTITUDE-ALS Expected in Q2 2019
“We had a productive fourth quarter 2018 highlighted by the expansion of our clinical pipeline of muscle-directed investigational medicines and the advancement of our wholly-owned cardiac myosin inhibitor which we are developing for the potential treatment of patients with hypertrophic cardiomyopathies,” said
Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Continued 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 nearing 90 percent completion with over 7,000 patients randomized to date having the high-risk profile intended by the trial design. GALACTIC-HF is being conducted by
Amgen in collaboration withCytokinetics .
- Opened METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv MecarbilRelated to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. 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. METEORIC-HF is being conducted by
Cytokinetics in collaboration withAmgen .
AMG 594 (cardiac troponin activator)
- Began dosing in 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 .
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Continued enrollment in a 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).
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
- Received feedback from the
U.S. Food and Drug Administration that the Six Minute Walk Test is an acceptable primary endpoint for a potential registration program for reldesemtiv in ambulatory patients with SMA.
- Completed 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 designed to assess the change from baseline in the percent predicted slow vital capacity and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. This Phase 2 trial is being conducted by
Cytokinetics in collaboration with Astellas.
- Announced data from FORTITUDE-ALS at the 29th International Symposium on ALS/MND in
Glasgow, Scotland ,UK , including patient baseline characteristics and demographics. Baseline characteristics of patients enrolled in FORTITUDE-ALS are similar to those of other recent large clinical trials in ALS, including BENEFIT-ALS and VITALITY-ALS.
- Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA, 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.
Corporate
- Convened an R&D Day to provide an update on our expanded pipeline of muscle-directed drug candidates.
Financials
Revenues for 2018 included
Research and development expenses decreased to
General and administrative expenses decreased to
2019 Financial Guidance
The company also announced financial guidance for 2019. The company anticipates cash revenue will be in the range of
2019 Corporate Milestones
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Expect to complete patient enrollment in GALACTIC-HF in the first half of 2019.
- Expect the Data Monitoring Committee to conduct a first interim analysis for GALACTIC-HF, the design of which is tied to the potential for futility, in the first half of 2019.
- Expect to continue patient enrollment in METEORIC-HF through 2019.
AMG 594 (cardiac troponin activator)
- Expect the continued conduct of the Phase 1 study of AMG 594 through 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Expect data from a Phase 1 study of CK-274 in the second half of 2019.
Skeletal Muscle Program
reldesemtiv (next-generation FSTA)
- Expect results from FORTITUDE-ALS in Q2 2019.
- Expect to continue joint research program with Astellas through 2019.
- Expect to continue independent research activities directed to our other muscle biology research programs through 2019.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2018 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. (
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 December 31, | Years Ended December 31, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Revenues: | |||||||||||||||
Research and development, milestone, grant and other revenues, net | $ | 9,377 | $ | (5,234 | ) | $ | 26,368 | $ | 4,569 | ||||||
License revenues | — | 5,216 | 5,133 | 8,799 | |||||||||||
Total revenues | 9,377 | (18 | ) | 31,501 | 13,368 | ||||||||||
Operating expenses: | |||||||||||||||
Research and development | 23,278 | 26,250 | 89,135 | 90,296 | |||||||||||
General and administrative | 7,558 | 10,259 | 31,282 | 36,468 | |||||||||||
Total operating expenses | 30,836 | 36,509 | 120,417 | 126,764 | |||||||||||
Operating loss | (21,459 | ) | (36,527 | ) | (88,916 | ) | (113,396 | ) | |||||||
Interest expense | (1,170 | ) | (670 | ) | (3,797 | ) | (3,016 | ) | |||||||
Non-cash interest expense on liability related to sale of future royalties | (4,740 | ) | (4,061 | ) | (17,767 | ) | (13,980 | ) | |||||||
Interest and other income, net | 900 | 774 | 4,191 | 2,602 | |||||||||||
Net loss | $ | (26,469 | ) | $ | (40,484 | ) | $ | (106,289 | ) | $ | (127,790 | ) | |||
Net loss per share | $ | (0.48 | ) | $ | (0.75 | ) | $ | (1.95 | ) | $ | (2.59 | ) | |||
Weighted-average shares in net loss per share | 54,689 | 53,929 | 54,420 | 49,404 |
Condensed Consolidated Balance Sheets
(in thousands)
December 31, 2018 | December 31, 2017(1) | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and short term investments | $ | 198,731 | $ | 268,891 | ||||
Other current assets | 8,943 | 5,404 | ||||||
Total current assets | 207,674 | 274,295 | ||||||
Long-term investments | — | 16,518 | ||||||
Property and equipment, net | 3,204 | 3,568 | ||||||
Other assets | 300 | 429 | ||||||
Total assets | $ | 211,178 | $ | 294,810 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued liabilities | $ | 19,521 | $ | 22,645 | ||||
Deferred revenue, current | — | 9,572 | ||||||
Current portion of long-term debt | 2,607 | — | ||||||
Other current liabilities | 66 | 227 | ||||||
Total current liabilities | 22,194 | 32,444 | ||||||
Long-term debt, net | 39,806 | 31,777 | ||||||
Liability related to the sale of future royalties, net | 122,473 | 104,650 | ||||||
Deferred revenue, non-current | — | 15,000 | ||||||
Other long-term liabilities | 771 | 1,097 | ||||||
Total liabilities | 185,244 | 184,968 | ||||||
Stockholders’ equity: | ||||||||
Common stock and additional paid-in capital | 768,758 | 755,580 | ||||||
Accumulated other comprehensive income | 500 | 343 | ||||||
Accumulated deficit | (743,324 | ) | (646,081 | ) | ||||
Total stockholders’ equity | 25,934 | 109,842 | ||||||
Total liabilities and stockholders’ equity | $ | 211,178 | $ | 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