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Sep 30, 2020
Cytokinetics Q3 2020 Earnings Report
Reported positive topline results from GALACTIC-HF, showing a reduction in cardiovascular death or heart failure events and made progress on pipeline, advancing CK-274 in REDWOOD-HCM.
Key Takeaways
Cytokinetics reported net loss of $3.2 million, or $0.05 per share, for the third quarter of 2020. Revenues increased to $41.7 million primarily due to license revenue from RTW transactions. The company's cash, cash equivalents, and investments totaled $451.2 million as of September 30, 2020.
GALACTIC-HF trial met primary composite endpoint of reduction in cardiovascular death or heart failure events.
Enrollment completed in Cohort 1 of REDWOOD-HCM.
Revenues for the third quarter were $41.7 million, primarily due to license revenue.
Cash, cash equivalents and investments totaled $451.2 million at September 30, 2020.
Cytokinetics
Cytokinetics
Forward Guidance
Cytokinetics is focused on advancing its muscle-directed drug candidates in clinical trials, including omecamtiv mecarbil, reldesemtiv and CK-274.
Positive Outlook
- Advancement of CK-274 in REDWOOD-HCM.
- Advancing a second cardiac myosin inhibitor into clinical development.
- Potential Phase 3 clinical trial and registration program for reldesemtiv in patients with ALS.
- Potential for FDA and other regulatory agency approval of omecamtiv mecarbil.
- Ability to earn milestone payments and royalties from Ji Xing Pharmaceuticals Limited in connection to the development and commercialization of CK-274 in certain Asian countries.
Challenges Ahead
- Need for additional funding and such additional funding may not be available on acceptable terms.
- Potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval.
- Patient enrollment for or conduct of clinical trials may be difficult or delayed.
- The FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials.
- Amgen’s decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and AMG 594.