COVID-19 Action Plan
Our top priority is the health and well-being of our employees, clinical trial participants, business and community partners.
Continuing Clinical Trials
GALACTIC-HF: The study record for GALACTIC-HF was recently updated on www.clinicaltrials.gov to reflect an Estimated Study Completion Date of August 7, 2020. Cytokinetics expects results from GALACTIC-HF in Q4 2020. GALACTIC-HF is being conducted by Amgen in collaboration with Cytokinetics.
METEORIC-HF: In consultation with the DMC, Cytokinetics and Amgen have agreed to temporarily suspend enrollment in METEORIC-HF to protect the safety and health of clinical trial participants and healthcare professionals. For enrolled subjects, Cytokinetics is working closely with clinical sites to monitor study visits and is taking certain steps to mitigate potential risk associated with the COVID-19 pandemic by enabling remote study visits and home delivery of investigational product to ensure study continuity and integrity. Cytokinetics continues to enable site start-up activities with an objective to activate over 50 new sites throughout North America and Europe.
AMG 594: Amgen and Cytokinetics have agreed to suspend enrollment in the Phase 1 study of AMG 594 to protect the safety and health of clinical study participants and healthcare professionals as well as reduce the burden on the healthcare systems fighting COVID-19. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics.
REDWOOD-HCM: Screening and enrollment of patients in REDWOOD-HCM have slowed in response to the COVID-19 pandemic. Cytokinetics has temporarily suspended enrollment in REDWOOD-HCM to protect the safety and health of clinical trial participants and healthcare professionals. We have been engaging sites to enable patient-specific plans for dispensation of investigational product and accommodations for potential remote visits.
We believe that we have manufactured adequate supplies of drug substance and investigational product to complete ongoing trials as well as to support planned clinical trials into 2021 and we do not expect delays to clinical trials due to manufacturing or supply-chain issues.
Engaging in Ongoing Discussions with Regulatory Authorities
We are continuing interactions with regulatory authorities. The FDA recently released a guidance document regarding the conduct of clinical trials that provides helpful information to sponsors of clinical trials.
Supporting our Workforce and our Community
We have taken steps to ensure the safety and wellbeing of employees and their families and to comply with guidance from federal, state and local authorities. We have instituted a mandatory work-from-home policy for most of our employees and have implemented support programs and made technology resources available to employees with the objective to minimize disruption to business operations. The policy permits designated employees to attend to certain essential business and corporate activities, including key research and other laboratory activities. For these employees, we have established safety guidelines to limit the number of employees onsite and to ensure physical distancing, and the regular conduct of appropriate disinfection cleanings in our facilities.
Overall Business Outlook
We believe that the fundamentals of our business remain intact and we are on track to achieve our key strategic objectives for 2020. We recently announced that we ended 2019 with cash, cash equivalents and investments totaling $267.7 million representing more than two years of cash runway based on 2020 financial guidance. We continue to assess the potential impact to our business given the ongoing nature of the COVID-19 pandemic and will provide further updates as needed.