Cytokinetics Reports Second Quarter 2019 Financial Results
Completed Enrollment in GALACTIC-HF with More than 8,200 Heart Failure Patients
Results from Phase 1 Study of CK-274 to be Presented at HFSA in
“During the second quarter, we made progress across the breadth of our pipeline, with particular emphasis on our investigational medicines for cardiovascular diseases of muscle dysfunction,” said
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. In
July 2019we announced the completion of patient enrollment in GALACTIC-HF, having enrolled over 8,200 patients in 35 countries. We expect GALACTIC-HF to continue throughout 2019 and the next planned interim analysis in the first half of 2020.
- Continued conduct of 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. 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 a 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)
- 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). Results from the Phase 1 study have been accepted for presentation at the 23rd Annual
Heart Failure Society of America (HFSA) Scientific Meetingin Philadelphiain September 2019.
- Received feedback from
FDAregarding the design of a planned Phase 2 clinical trial of CK-274 and made preparations for the start of that trial which we expect to begin in the fourth quarter of this year.
- Presented preclinical data at the American Heart Association’s Basic Cardiovascular Sciences (BCVS) 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 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) at the
American Academy of Neurology71st Annual Meeting in Philadelphia. 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). Patients on all dose groups of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with larger and clinically meaningful differences emerging over time. 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, the ALSFRS-R total score in patients who received reldesemtiv declined less than patients who received placebo (p = 0.01). 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.
- Continued to analyze results from FORTITUDE-ALS to inform the design of a potential Phase 3 trial and registration program that may begin in 2020.
- Concluded a Phase 1 study of reldesemtiv in healthy volunteers designed to assess higher doses and related plasma exposures than were evaluated in the prior Phase 2 study of patients with SMA. We are evaluating the data from the study to inform the design of potential future clinical trials.
- Presented data from two preclinical studies of reldesemtiv at the 2019 Annual
Cure SMA Conferencein Anaheim, CA, showing that the addition of reldesemtiv to treatment with SMN upregulators (nusinersen and SMN-C1, an analogue to risdiplam) significantly increased muscle force in a mouse model of spinal muscular atrophy (SMA).
- 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’ research activities through 2019.
- Continued independent research activities directed to our other muscle biology research programs.
- We are currently in discussions with Astellas regarding amending the terms of our collaboration agreement, including, for reldesemtiv, the level of potential funding and share of commercial returns, as well as which company would be responsible for development and commercialization.
- Announced the continuation of our partnership with
The ALS Associationin the fight against ALS with renewal of 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, including grant funding for care services for people living with ALS in the San Francisco Bay Area.
Revenues for the three and six months ended June 30, 2019 were $7.1 million and $15.6 million, respectively, compared to $6.2 million and $11.5 million for the corresponding periods in 2018. The increase in revenues for the three and six month ended
Research and development expenses for the three and six months ended June 30, 2019 increased to $24.0 million and $47.6 million, respectively compared to $21.6 million and $43.7 million for the same periods in 2018, respectively due to increased spending related to METEORIC-HF and the development of CK-274, offset in part by reduced spending for reldesemtiv as well as for tirasemtiv, following suspension of development of tirasemtiv in late 2017.
General and administrative expenses for the three and six months ended June 30, 2019 increased to $9.8 million and
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s second quarter 2019 results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
Vice President, Corporate Communications, Investor Relations
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended||Six Months Ended|
|June 30, 2019||June 30, 2018||June 30, 2019||June 30, 2018|
|Research and development revenues||$||7,137||$||4,680||$||15,601||$||8,265|
|Research and development||24,017||21,582||47,562||43,717|
|General and administrative||9,836||8,046||19,273||17,310|
|Total operating expenses||33,853||29,628||66,835||61,027|
|Non-cash interest expense on liability related to the sale of future royalties||(5,064||)||(4,338||)||(9,883||)||(8,467||)|
|Interest and other income||1,044||1,126||2,185||1,968|
|Net loss per share — basic and diluted||$||(0.56||)||$||(0.51||)||$||(1.09||)||$||(1.07||)|
|Weighted-average shares in net loss per share — basic and diluted||57,648||54,293||56,242||54,178|
Condensed Consolidated Balance Sheets
|June 30, 2019||December 31, 2018(1)|
|Cash and short term investments||$||172,868||$||198,731|
|Other current assets||12,083||8,943|
|Total current assets||184,951||207,674|
|Property and equipment, net||2,945||3,204|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||17,022||$||19,521|
|Current portion of long-term debt||-||2,607|
|Short-term lease liability||4,538||—|
|Other current liabilities||399||66|
|Total current liabilities||21,959||22,194|
|Long-term debt, net||44,473||39,806|
|Liability related to the sale of future royalties, net||132,388||122,473|
|Long-term lease liability||4,294||—|
|Other long-term liabilities||—||771|
|Additional paid-in capital||799,088||768,703|
|Accumulated other comprehensive income||761||500|
|Total stockholders’ equity||(4,896||)||25,934|
|Total liabilities and stockholders’ equity||$||198,218||$||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