Cytokinetics Reports First Quarter 2020 Financial Results
Top-line Results for GALACTIC-HF Expected in Q4 2020
Ended Q1 with More Than Two Years of Going Forward Cash Based on 2020 Guidance
“While we face challenges due to the COVID-19 pandemic, we believe we are on track to achieve our key strategic objectives in 2020, in particular, the sharing of top-line results from GALACTIC-HF, expected in the fourth quarter of this year,” 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, following the second and final planned interim analysis, which considered pre-specified criteria for futility and superiority. We expect top-line results in Q4 2020. GALACTIC-HF is being conducted by Amgen in collaboration with
- Published patient baseline characteristics and demographics from GALACTIC-HF during the
Virtual American College of Cardiology69th Annual Scientific Session together with the World Congress of Cardiology(ACC.20/WCC Virtual). Patients enrolled in the trial represent a population at risk for heart failure events despite being well-treated in accordance with international guidelines.
- Announced the publication of a manuscript relating to the design of GALACTIC-HF in the
Journal of American College of Cardiology: Heart Failure (JACC: HF).
- 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, in Q1. In response to the COVID-19 pandemic, Cytokinetics and Amgen recently agreed to temporarily suspend enrollment in METEORIC-HF to protect the safety and health of clinical trial participants and healthcare professionals. Clinical site start-up activities are continuing to be prioritized with an objective to activate new sites throughout
North Americaand Europe. We believe enrollment may be completed by the end of Q4 2020 if enrollment can be reactivated by the end of Q2 2020. METEORIC-HF is being conducted by Cytokineticsin collaboration with Amgen.
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 in Q1. In response to the COVID-19 pandemic, Amgen and Cytokinetics recently agreed to temporarily suspend enrollment in the Phase 1 study of AMG 594 to protect the safety and health of clinical study participants and healthcare professionals. This Phase 1 study is being conducted by Amgen in collaboration with
- Presented preclinical data at the Keystone Symposium “Charting a New Course for Heart Failure: From Discovery to Data,” showing that AMG 594 selectively increases calcium sensitivity of cardiac muscle fibers and increased cardiac contractility.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Prepared for and started REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (HCM). REDWOOD-HCM started in Q1 2020 and will continue through 2020. In response to the COVID-19 pandemic,
Cytokineticsrecently temporarily suspended enrollment in REDWOOD-HCM, to protect the safety and health of clinical study participants and healthcare professionals. Clinical site start-up activities are continuing to be prioritized with an objective to activate new sites throughout North Americaand Europe. We believe data from the first cohort of patients enrolled in REDWOOD-HCM can be available in 2H 2020 if enrollment in the first cohort can be completed by mid-year.
- Presented preclinical data at the
Biophysical Society64th Annual Meeting demonstrating that CK-274 has a distinct binding site on cardiac myosin, and selectively reduces cardiac myosin activity in vitro.
CK-271 (CK-271, second cardiac myosin inhibitor)
- Submitted IND and plan to start Phase 1 study of CK-271 in Q2 2020.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
- Convened a Type C meeting with FDA and continued regulatory interactions with FDA and EMA in Q1. In addition, we conducted additional feasibility and other planning activities in preparation for the potential advancement of reldesemtiv to a Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS). We do not expect that the COVID-19 pandemic will affect 2020 objectives relating to this program.
- Received European Orphan Designation for reldesemtiv for the potential treatment of ALS from the
European Medicines Agency(EMA).
- Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA. We expect to continue the conduct of IND-enabling studies of CK-601 in 2020.
- Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators.
- Continued independent research activities directed to our other muscle biology research programs.
- Unveiled Cytokinetics’ Vision 2025, “Leading with Science, Delivering for Patients,” articulating the company’s five-year key imperatives enabling
Cytokineticsto be the leading muscle biology biopharmaceutical company that meaningfully improves the lives of patients with diseases of impaired muscle function through access to novel medicines arising from our research.
- Joined with the
European Organisation for Rare Diseases(EURORDIS) and the National Organization for Rare Disorders(NORD) to recognize Rare Disease Day®, an international campaign elevating the public understanding of rare diseases.
- Awarded Cytokinetics Communications Fellowship Grants to patient advocacy organizations serving the heart failure, HCM, ALS and SMA communities to support increased capacity in communications, awareness building and community engagement.
- Entered into agreements with Astellas, which, taken together, amend and restate our research, development and commercialization collaboration agreement with Astellas in follow up to the previously disclosed agreement in principle which now provide, amongst other terms, that:
Cytokineticshas exclusive control and responsibility for the development and commercialization of reldesemtiv, CK-601 and other fast skeletal regulatory activator (FSRA) compounds. Astellas agreed to pay certain costs which may be incurred in connection with Cytokinetics’ potential Phase 3 clinical trial of reldesemtiv in ALS. Astellas has agreed to non-cash contributions to Cytokineticsincluding the transfer of its inventories of active pharmaceutical ingredient of reldesemtiv and CK-601 and the continued conduct of ongoing stability studies at its cost. Cytokineticswill pay Astellas a low- to mid- single digit royalty on sales of reldesemtiv in certain countries.
- Astellas extended the joint research program at
Cytokineticsthrough 2020, with a minimum of fifteen (15) research FTE’s being supported by Astellas, and has exclusive rights to co-develop and commercialize skeletal sarcomere activators (other than FSRA compounds) in all indications, subject to certain Cytokinetics’ development and commercialization rights; Cytokineticsmay co-promote and conduct certain commercial activities in the U.S., Canadaand/or Europe.
Revenues for the first quarter of 2020 decreased to
Research and development expenses for the first quarter 2020 decreased to
General and administrative expenses for the first quarter of 2020 increased to
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s first quarter 2020 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”).
Senior Vice President, Corporate Communications, Investor Relations
|Condensed Consolidated Statements of Operations|
|(in thousands except per share data)|
|Three Months Ended|
|Research and development revenues||$||3,825||$||8,464|
|Research and development||21,738||23,545|
|General and administrative||12,449||9,437|
|Total operating expenses||34,187||32,982|
|Non-cash interest expense on liability related to the sale of future royalties||(5,689||)||(4,819||)|
|Interest and other income||723||1,141|
|Net loss per share — basic and diluted||$||(0.66||)||$||(0.54||)|
|Weighted-average number of shares used in computing net loss per share — basic and diluted||59,270||54,821|
|Condensed Consolidated Balance Sheets|
|Cash and short term investments||$||220,706||$||225,112|
|Other current assets||5,232||8,640|
|Total current assets||225,938||233,752|
|Property and equipment, net||5,162||4,530|
|Operating lease right-of-use assets and other assets||8,972||8,882|
|LIABILITIES AND STOCKHOLDERS’ DEFICIT|
|Accounts payable and accrued liabilities||$||13,204||$||20,283|
|Short-term lease liability||5,030||4,616|
|Other current liabilities||2,507||1,124|
|Total current liabilities||20,741||26,023|
|Term loan, net||45,340||45,052|
|Convertible notes, net||85,455||84,205|
|Liability related to the sale of future royalties, net||148,983||143,276|
|Long-term lease liability||1,774||2,195|
|Commitments and contingencies|
|Additional paid-in capital||857,038||853,341|
|Accumulated other comprehensive income||1,613||679|
|Total stockholders’ deficit||(45,711||)||(10,937||)|
|Total liabilities and stockholders’ deficit||$||256,582||$||289,814|
Source: Cytokinetics, Incorporated