Cytokinetics Reports Third Quarter 2019 Financial Results
Enrollment Completed in GALACTIC-HF with More than 8,200 Heart Failure Patients;
Second Interim Analysis Expected in Q1 2020
Data from Phase 1 Study of CK-274 Support Progression;
Phase 2 Clinical Trial in Patients with Obstructive Hypertrophic Cardiomyopathy to Begin in Q4 2019
Faster Progressing Patients Receiving Reldesemtiv in FORTITUDE-ALS Experienced Slower Decline
in ALSFRS-R and Greater Difference from Placebo than Slower Progressing Patients
“In the third quarter of 2019, we achieved major milestones in both our cardiovascular and neuromuscular programs representing progress on key priorities across our pipeline of muscle-directed therapies,” said
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Completed 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. GALACTIC-HF enrolled over 8,200 patients in 35 countries. We expect GALACTIC-HF to continue throughout 2019 and the second planned interim analysis of GALACTIC-HF to occur in the first quarter of 2020.
- Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related 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. We expect to continue enrollment of METEORIC-HF throughout 2019.
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 our joint research program with
Amgen. This Phase 1 study is being conducted by Amgenin collaboration with Cytokinetics. We expect the conduct of this study to continue throughout 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Presented data from the Phase 1 study of CK-274 at the
Heart Failure Societyof America’s 23rd Annual Scientific Meeting in Philadelphia. The study met its primary and secondary objectives to assess the safety and tolerability of single and multiple oral doses of CK-274, describe the pharmacokinetics of CK-274 and its pharmacodynamic effects as measured by echocardiography, as well as to characterize the PK/PD relationship with regards to cardiac function. These data support the advancement of CK-274 into a Phase 2 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM) which is expected to begin in Q4 2019.
- Presented preclinical data at the American Heart Association’s Basic Cardiovascular Sciences Scientific Sessions in
Bostondemonstrating that CK-274 produces exposure related effects on cardiac contractility in healthy animals and mouse models of HCM and support the therapeutic hypothesis relating to onset of action and reversibility.
Skeletal Muscle Program
reldesemtiv (next-generation, fast skeletal muscle troponin activator (FSTA))
- Presented post-hoc analyses from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), at the 2019 Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting in
Clearwater Beach, FL.The analyses demonstrated that, in the combined middle and faster progressing tertiles of patients, the decline in the ALSFRS-R total score from baseline to week 12 in patients who received any dose of reldesemtiv was significantly smaller than the decline on placebo, while no significant difference between reldesemtiv and placebo was observed in slower progressing patients.
- Held regulatory interactions and conducted feasibility and other planning activities in preparation for the potential advancement of reldesemtiv to a Phase 3 trial in patients in ALS in 2020.
- Received European Orphan Designation for reldesemtiv for the potential treatment of spinal muscular atrophy (SMA) by the
European Medicines Agency(EMA).
- Announced the publication of “Fast Skeletal Muscle Troponin Activator CK-2066260 Increases Fatigue Resistance by Reducing the Energetic Cost of Muscle Contraction,” in
The Journal of Physiology, demonstrating that a FSTA can decrease skeletal muscle fatigue by increasing the metabolic efficiency of muscle contraction. CK-2066260 is a preclinical FSTA tool compound.
- 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; Astellas is sponsoring Cytokinetics’ research activities through 2019.
- Continued independent research activities directed to our other muscle biology research programs.
- We and Astellas have agreed in principle to revise the terms of our collaboration agreement so that
Cytokineticswould have the exclusive right to develop and commercialize all FSTAs, including reldesemtiv and CK-601. Astellas’ future contributions would be to provide partial co-funding for certain Phase 3 clinical trial costs for reldesemtiv in ALS and to provide other in-kind support. In exchange, Astellas would receive a low- to mid- single digit royalty on reldesemtiv to be payable by Cytokinetics. We have also agreed in principle to extend our joint research program for another year with Astellas sponsoring research at Cytokineticsthrough 2020.
- The above agreements in principle are non-binding and contingent upon our finalizing amendments to our collaboration agreement and, absent such agreement, the terms of the existing agreement remain in place.
- Announced the continuation of our partnership with Cure SMA to increase education, awareness, public policy and fundraising for SMA. The partnership includes support for several of Cure SMA’s national initiatives as well as local community events.
- Announced a call for proposals for the second annual Cytokinetics Communications Fellowship Grant program. The program provides
$100,000in grants to five selected patient advocacy organizations serving the ALS, heart failure, HCM, or SMA communities, and is intended to support increased capacity in communications, awareness building and community engagement.
Revenues for the three and nine months ended
Research and development expenses for the three and nine months ended
General and administrative expenses for the three and nine months ended
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s third quarter 2019 results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
Vice President, Corporate Communications, Investor Relations
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended||Nine Months Ended|
|September 30, 2019||September 30, 2018||September 30, 2019||September 30, 2018|
|Research and development revenues||$||6,055||$||8,726||$||21,656||$||16,991|
|Research and development||20,229||21,391||67,791||65,858|
|General and administrative||9,753||7,164||29,026||23,724|
|Total operating expenses||29,982||28,555||96,817||89,582|
|Non-cash interest expense on liability related to the sale of future royalties||(5,321||)||(4,559||)||(15,204||)||(13,026||)|
|Interest and other income||1,020||1,323||3,205||3,291|
|Net (loss) income before income taxes||(29,573||)||(22,017||)||(91,052||)||(79,821||)|
|Income tax benefit||-||-||-||-|
|Net loss per share — basic and diluted||$||(0.50||)||$||(0.40||)||$||(1.60||)||$||(1.47||)|
|Weighted-average shares in net loss per share — basic and diluted||58,640||54,626||57,050||54,329|
Condensed Consolidated Balance Sheets
|September 30, 2019||December 31, 2018(1)|
|Cash and short term investments||$||166,039||$||198,731|
|Other current assets||10,496||8,943|
|Total current assets||176,535||207,674|
|Property and equipment, net||3,615||3,204|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||16,551||$||19,521|
|Current portion of long-term debt||-||2,607|
|Short-term lease liability||4,577||—|
|Other current liabilities||389||66|
|Total current liabilities||21,517||22,194|
|Long-term debt, net||44,762||39,806|
|Liability related to the sale of future royalties, net||137,726||122,473|
|Long-term lease liability||3,257||—|
|Other long-term liabilities||—||771|
|Additional paid-in capital||813,729||768,703|
|Accumulated other comprehensive income||719||500|
|Total stockholders’ equity||(19,869||)||25,934|
|Total liabilities and stockholders’ equity||$||187,393||$||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