Cytokinetics, Inc. Reports Second Quarter 2017 Financial Results
Results Expected from VITALITY-ALS, Our Phase 3 Clinical Trial of Tirasemtiv, in Q4 2017
CK-2127107 Advancing in Four Clinical Trials Under Our Collaboration with Astellas
Omecamtiv Mecarbil Phase 3 Clinical Trial Proceeding on Plan in GALACTIC-HF Under Our Collaboration with
“We made key progress during the second quarter in anticipation of results from VITALITY-ALS expected later this year and recently initiated two additional clinical trials of CK-2127107 – one in ALS and one in elderly people with frailty under our collaboration with Astellas – underscoring the broad potential of fast skeletal muscle troponin activation across multiple diseases and conditions of impaired muscle function and weakness,” said
Recent Highlights and Upcoming Milestones
Skeletal Muscle Program
tirasemtiv (fast skeletal muscle troponin activator)
- Continued conduct of VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS) and enrollment in VIGOR-ALS (Ventilatory Investigations in Global Open-Label Research in ALS), an open-label extension clinical trial designed to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who have completed participation in VITALITY-ALS.
- Conducted clinical, regulatory, non-clinical and other activities intended to support potential regulatory filings and registration of tirasemtiv in
North Americaand Europe.
- Conducted manufacturing, market research, market access and other commercial readiness activities in support of potential registration and commercialization of tirasemtiv in
North Americaand Europe.
- Expect to continue to enroll patients who complete VITALITY-ALS into VIGOR-ALS throughout 2017.
- Expect results from VITALITY-ALS in Q4 2017.
CK-2127107 (next generation fast skeletal muscle troponin activator)
- Announced that the
Office of Orphan Products Development of the U.S. Food and Drug Administration( FDA) has granted orphan drug designation to CK-2127107 for the potential treatment of spinal muscular atrophy (SMA).
- Recently announced data relating to patient baseline characteristics and the reasons for patient screen failure, both from the first cohort of the Phase 2 clinical trial of CK-2127107 in patients with SMA, presented at the CureSMA 2017 Annual
SMA Conferencein Orlando, FL.
- Recently announced the start of a Phase 1b, double-blind, randomized, placebo-controlled, multiple dose, two-period crossover study to assess the effect of CK-2127107 on measures of physical function in elderly adults with limited mobility. This study is being conducted by Astellas, in collaboration with
- Recently announced the start of FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS). This Phase 2 clinical trial 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 CK-2127107.
- Expect to complete enrollment of Cohort 2 of the Phase 2 clinical trial of CK-2127107 in patients with SMA in 2017.
- Expect data from the Phase 2 clinical trial of CK-2127107 in patients with SMA in Q1 2018.
- Expect Astellas to continue enrollment in a Phase 2 clinical trial of CK-2127107 in patients with COPD in 2017.
Cardiac Muscle Program
omecamtiv mecarbil (cardiac muscle myosin activator)
- Announced that results from the dose escalation phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, were presented in a Rapid Fire Abstract Presentation at Heart Failure 2017, the annual congress of the
Heart Failure Associationof the European Society of Cardiology.
- Continued to activate sites and enroll patients 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 which is being conducted by
Amgen, in collaboration with Cytokinetics.
- Recently announced topline data from a Phase 2 clinical trial of omecamtivmecarbil in Japanese patients with chronic heart failure. The trial met its pharmacokinetic primary endpoint and demonstrated statistically significant improvements in systolic ejection time (SET).
- Expect continued enrollment of patients with chronic heart failure in GALACTIC-HF throughout 2017.
- Continued research activities under our joint research program with
Amgendirected 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. In addition, company scientists continued independent research activities directed to our other muscle biology programs.
- Expect to nominate at least one potential drug candidate from research programs for development in 2017.
$83 millionin net proceeds, after deducting underwriting discounts and commissions, from an underwritten public offering of 6,049,000 shares of common stock including the underwriter’s exercise of their overallotment option. Morgan Stanley LLCacted as the sole underwriter of the offering.
- Raised an additional
$12 millionfrom sales of common stock through an at-the-market equity vehicle.
- Received an additional
$11 millionfrom the exercise of warrants issued in connection with our June 2012equity offering.
- Announced that
Cytokineticshas been selected for addition to the S&P SmallCap 600 GICS Biotechnology Sub-Industry Index.
- Announced with
The ALS Association(ALSA) the continuation of our partnership in the fight against ALS which includes Cytokinetics’ renewal of its Gold Level Sponsorship of the National Walks to Defeat ALS® and Premier Level National ALS Advocacy Conference Sponsorship as well as Platinum Level Sponsorship for initiatives led by The ALS Association Golden West Chapter.
Revenues for the three and six months ended
Research and development expenses for the three and six months ended
General and administrative expenses for the three and six months ended
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s second quarter results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share data)|
|Three Months Ended||Six Months Ended|
|Research and development, grant and other|
|License revenues from related parties||4,942||1,950||6,388||5,923|
|Research and development||19,809||9,723||39,098||23,256|
|General and administrative||8,438||7,090||16,553||13,931|
|Total operating expenses||28,247||16,813||55,651||37,187|
|Interest and other income (expense), net||(3,887||)||(600||)||(6,503||)||(1,101||)|
|Net loss per share – basic and diluted||$||(0.60||)||$||(0.29||)||$||(1.22||)||$||(0.61||)|
|Weighted average shares used in computing net loss per share – basic and diluted||48,218||39,666||44,910||39,629|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents||$||100,711||$||66,874|
|Short term investments||211,340||89,375|
|Other current assets||4,945||2,360|
|Total current assets||316,996||158,633|
|Property and equipment, net||3,268||3,637|
|Liabilities and stockholders' equity|
|Deferred revenue, current||$||7,942||$||8,060|
|Other current liabilities||23,117||25,198|
|Total current liabilities||31,059||33,258|
|Deferred revenue, non-current||15,067||15,000|
|Liability related to sale of future royalties||96,657||-|
|Other non-current liabilities||2||142|
|Total liabilities and stockholders' equity||$||340,630||$||170,142|
|(1) Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2016.
Diane WeiserVice President, Corporate Communications, Investor Relations (650) 624-3000