Loading...
•
Sep 30, 2020
Geron Q3 2020 Earnings Report
Reported financial results for the third quarter ended September 30, 2020.
Key Takeaways
Geron Corporation reported a net loss of $19.7 million, or $0.06 per share, for the third quarter of 2020. As of September 30, 2020, the company had approximately $274 million in cash and investments, which is expected to be sufficient for operations until the end of 2022.
Advanced enrollment in the ongoing IMerge Phase 3 clinical trial and start-up activities for the upcoming Phase 3 clinical trial in refractory myelofibrosis (IMpactMF).
Secured European orphan drug designation in lower risk MDS.
Received acceptance for presentation of all ten abstracts submitted to the ASH Annual Meeting.
Strengthened balance sheet with a loan facility providing additional financial flexibility.
Geron
Geron
Forward Guidance
Geron expects its 2020 operating expense burn to range from $70 to $75 million. Enrollment in the IMerge Phase 3 trial is expected to be complete in the second quarter of 2021, with top-line results available in the second half of 2022. The IMpactMF Phase 3 clinical trial is expected to be open for screening and enrollment in the first quarter of 2021.
Positive Outlook
- IMpactMF will be open for screening and enrollment in the first quarter of 2021.
- The loan facility is available through the end of 2022 subject to the achievement of certain clinical, financial and regulatory milestones.
- Top-line results for IMerge will be available in the second half of 2022.
- Almost all of the new IMerge sites will be open for screening and enrollment by the end of 2020.
- Under current planning assumptions, for IMpactMF Geron expects to complete patient enrollment in the second half of 2022, conduct an interim analysis in the first half of 2023 and conduct a final analysis in the first half of 2024.
Challenges Ahead
- The recent resurgence of the COVID-19 pandemic is causing an uncertain and unpredictable impact on clinical trial activities.
- The trial will most likely be fully enrolled in the second quarter of 2021.
- The anticipated timing is subject to potential delays or interruptions associated with the evolving effects of the ongoing COVID-19 pandemic, which causes unpredictability when projecting future enrollment trends.
- Geron will need to raise substantial capital in order to complete the development and commercialization of imetelstat.
- Whether there are failures or delays in manufacturing sufficient quantities of imetelstat or other clinical trial materials in a timely manner, whether due to the current or evolving effects of the COVID-19 pandemic or otherwise.