Cytokinetics, Inc. Reports Fourth Quarter 2017 Financial Results
Company Provides 2018 Financial Guidance and Expected Milestones;
Reduced Operating Expenses vs. 2017; Over Two Years of Cash Based on Current Burn Rate
CK-2127107 Advancing in Four Clinical Trials Under Collaboration with Astellas;
Results Expected in 2018 with Data from Phase 2 Clinical Trial in Patients with SMA Anticipated in Q2
Enrollment in GALACTIC-HF on Track Under Collaboration with
Finalizing Plans for Second Phase 3 Clinical Trial in 2018
“We had a productive fourth quarter and begin the year with optimism for our growing pipeline of muscle biology directed drug candidates,” said
Recent Highlights and Upcoming Milestones
Cardiac Muscle Program
omecamtiv mecarbil (cardiac myosin activator)
- Continued site activation and patient enrollment in GALACTIC-HF, the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Enrollment is proceeding according to plan with patients that have the intended risk profile consistent with the trial design.
- Continued protocol development, feasibility assessments, regulatory interactions and other readiness activities for a second Phase 3 clinical trial of omecamtiv mecarbil. This trial which is intended to evaluate the potential of omecamtiv mecarbil to increase exercise performance in patients with heart failure is planned to be conducted by
Cytokinetics in collaboration withAmgen .
- Announced that a post-hoc responder analysis from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 clinical trial evaluating omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction, was presented by
John Teerlink , M.D. in an Abstract Rapid Fire Oral presentation at the American Heart Association Scientific Sessions. The proportion of patients achieving various thresholds in the percent reduction of NT-proBNP was larger in patients who received omecamtiv mecarbil than in patients who received placebo.
Skeletal Muscle Program
tirasemtiv (fast skeletal muscle troponin activator (FSTA))
- Announced the presentation of results from VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), the international Phase 3 clinical trial of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS), at the 28th International Symposium on ALS and Motor Neurone Disease (MND) in
Boston . The presentation, byJeremy Shefner , M.D., Ph.D., Lead Investigator of VITALITY-ALS, Professor and Chair of Neurology atBarrow Neurological Institute , and Professor and Executive Chair of Neurology atUniversity of Arizona ,Phoenix , followed our prior announcement that the trial did not meet the primary endpoint of change from baseline in slow vital capacity which was evaluated at 24 weeks following randomization or any of the secondary endpoints in the trial which were evaluated at 48 weeks.
- Continued treatment of patients 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. Currently, there are still over 100 patients who are receiving tirasemtiv in VIGOR-ALS.
CK-2127107, reldesemtiv (next-generation fast skeletal muscle troponin activator)
- Received final approval from the
World Health Organization and theUnited States Adopted Name Council for reldesemtiv to be used as the International Nonproprietary Name for CK-2127107.
- Continued conduct of 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 has enrolled over 60 patients toward the objective of 72 patients and is being conducted by
Cytokinetics in collaboration with Astellas.
- 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 the percent predicted slow vital capacity (SVC) and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. This trial has screened over 100 patients and enrolled nearly 90 patients toward the objective of 445 patients and is being conducted by
Cytokinetics in collaboration with Astellas.
- Continued site activation and 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 has enrolled over 30 patients towards the objective of 40 patients and is being conducted by Astellas in collaboration with
Cytokinetics .
- 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 has enrolled over 20 subjects towards the objective of 60 subjects and is being conducted by Astellas in collaboration with
Cytokinetics .
- Announced the publication of “CK-2127107 Amplifies Skeletal Muscle Response to Nerve Activation in Humans,” in Muscle & Nerve, which showed that reldesemtiv increased the force generated by the tibialis anterior muscle versus placebo in response to nerve stimulation in a dose, plasma concentration, and frequency-dependent manner. Single doses of reldesemtiv were well-tolerated in healthy volunteers up to 4000 mg. No serious adverse events were reported and adverse events were all mild or moderate.
- Advanced a next-generation cardiac muscle activator into development under our collaboration with
Amgen . This milestone triggered a$1 million payment fromAmgen toCytokinetics .
- Advanced a next-generation skeletal muscle activator into development under our collaboration with Astellas.
- Announced that
Cytokinetics is advancing an unpartnered cardiac sarcomere directed compound from research into IND-enabling studies in 2018.
- Continued collaboration activities under our joint research program with
Amgen directed 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.Cytokinetics and Astellas recently agreed to extend the joint research program through 2019.
- Company scientists continued independent research activities directed to our other muscle biology programs.
Financials
Revenues for the year ended
Research and development expenses for the three months and year ended
General and administrative expenses for the three months and year ended
2018 Financial Guidance
The Company also announced financial guidance for 2018. The company anticipates cash revenue will be in the range of
2018 Corporate Milestones
Cardiac Muscle Program
omecamtiv mecarbil (cardiac myosin activator)
- Expect to complete enrolling patients with chronic heart failure in GALACTIC-HF in approximately one year.
- Expect to finalize plans and prepare to start the second Phase 3 trial of omecamtiv mecarbil.
Skeletal Muscle Program
CK-2127107 (reldesemtiv), (next-generation fast skeletal muscle troponin activator (FSTA))
- Expect results from a Phase 2 clinical trial of reldesemtiv in patients with SMA in Q2 2018.
- Expect results from a Phase 2 clinical trial of reldesemtiv in patients with ALS in 2H 2018.
- Expect results from a Phase 2 clinical trial of reldesemtiv in patients with COPD in 2H 2018.
- Expect results from a Phase 1b clinical trial of reldesemtiv in adults with limited mobility in 2H 2018.
- Expect to advance one development compound, under each of our collaborations with
Amgen and Astellas, into IND-enabling studies in 2018, one of which may proceed to Phase 1 this year.
- Expect to advance an unpartnered cardiac sarcomere directed compound through IND-enabling studies in 2018 to enable initiation of Phase 1 in 2018.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s fourth quarter results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
About
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
(650) 624-3000
Cytokinetics, Incorporated Condensed Consolidated Statements of Operations (in thousands, except per share data) (unaudited) |
|||||||||||||
Three Months Ended | Year Ended | ||||||||||||
December 31, | December 31, |
December 31, | December 31, | ||||||||||
2017 | 2016 |
2017 | 2016 | ||||||||||
Revenues: | |||||||||||||
License and research and development revenues from Astellas | $ | 5,216 | $ | 6,792 | $ | 20,733 | $ | 77,281 | |||||
Milestone revenues from Amgen | 1,000 | 26,667 | 11,000 | 26,667 | |||||||||
Research and development revenues from Amgen | - | 616 | 1,279 | 2,466 | |||||||||
Co-investment payments to Amgen | (6,250 | ) | (1,250 | ) | (20,000 | ) | (1,250 | ) | |||||
Grant and other revenues | 16 | 313 | 356 | 1,243 | |||||||||
Total revenues, net | (18 | ) | 33,138 | 13,368 | 106,407 | ||||||||
Operating Expenses: | |||||||||||||
Research and development | 26,250 | 18,775 | 90,296 | 59,897 | |||||||||
General and administrative | 10,259 | 6,675 | 36,468 | 27,823 | |||||||||
Total operating expenses | 36,509 | 25,450 | 126,764 | 87,720 | |||||||||
Operating (loss) income | (36,527 | ) | 7,688 | (113,396 | ) | 18,687 | |||||||
Interest expense | (670 | ) | (714 | ) | (3,016 | ) | (2,698 | ) | |||||
Non-cash interest expense on liability related to sale of royalties | (4,061 | ) | - | (13,980 | ) | - | |||||||
Interest and other income (expense), net | 774 | 183 | 2,602 | 464 | |||||||||
Net (loss) income | $ | (40,484 | ) | $ | 7,157 | $ | (127,790 | ) | $ | 16,453 | |||
Net (loss) income per share – basic | $ | (0.75 | ) | $ | 0.18 | $ | (2.59 | ) | $ | 0.41 | |||
Net (loss) income per share – diluted | $ | (0.75 | ) | $ | 0.16 | $ | (2.59 | ) | $ | 0.39 | |||
Weighted average shares used in computing net (loss) income per share – basic | 53,929 | 40,581 | 49,404 | 39,943 | |||||||||
Weighted average shares used in computing net (loss) income per share – diluted | 53,929 | 43,696 | 49,404 | 42,561 |
Cytokinetics, Incorporated Condensed Consolidated Balance Sheets (in thousands) |
||||||
December 31, | December 31, | |||||
2017 | 2016(1) | |||||
(unaudited) | ||||||
Assets | ||||||
Cash and cash equivalents | $ | 125,206 | $ | 66,874 | ||
Short term investments | 143,685 | 89,375 | ||||
Accounts receivable | 1,112 | 24 | ||||
Other current assets | 4,292 | 2,360 | ||||
Total current assets | 274,295 | 158,633 | ||||
Long-term investments | 16,518 | 7,672 | ||||
Property and equipment, net | 3,568 | 3,637 | ||||
Other assets | 429 | 200 | ||||
Total assets | $ | 294,810 | $ | 170,142 | ||
Liabilities and stockholders' equity | ||||||
Deferred revenue, current | $ | 9,572 | $ | 8,060 | ||
Other current liabilities | 22,872 | 25,198 | ||||
Total current liabilities | 32,444 | 33,258 | ||||
Long-term debt | 31,777 | 27,381 | ||||
Deferred revenue, non-current | 15,000 | 15,000 | ||||
Liability related to sale of future royalties | 104,650 | - | ||||
Other non-current liabilities | 1,097 | 142 | ||||
Stockholders’ equity | 109,842 | 94,361 | ||||
Total liabilities and stockholders' equity | $ | 294,810 | $ | 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