Geron Q2 2020 Earnings Report
Key Takeaways
Geron Corporation reported a net loss of $15.8 million, or $0.06 per share, for the second quarter of 2020. The company is focusing on the development of Imetelstat and expects to fund its development plans into the second half of 2022.
Advanced with a Phase 3 clinical trial in refractory MF after a successful meeting with the FDA.
Reported clinically meaningful transfusion independence with longer durability from IMerge Phase 2 trial in lower risk MDS.
Raised additional capital expected to sufficiently fund development plans into the second half of 2022.
European Commission granted orphan drug designation to Imetelstat for MDS.
Geron
Geron
Forward Guidance
Geron expects to complete patient enrollment in the first quarter of 2021 and have top-line results in the second half of 2022 for IMerge. The company expects to begin patient screening and enrollment in the first quarter of 2021, 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 for the planned Phase 3 clinical trial in refractory MF. Geron’s 2020 operating expense range will be $70-75 million.
Positive Outlook
- Patient enrollment for IMerge is expected to be completed by the end of the first quarter of 2021.
- Top-line results for IMerge are expected in the second half of 2022.
- Patient screening and enrollment for the Phase 3 clinical trial in refractory MF is expected to begin in the first quarter of 2021.
- Funds are expected to be sufficient for operations into the second half of 2022.
- Imetelstat may have disease-modifying activity.
Challenges Ahead
- Potential delays or interruptions associated with COVID-19 could impact trial timelines.
- The evolving effects of the COVID-19 pandemic could materially and adversely impact Geron’s business and business prospects.
- There are risks and uncertainties related to the development and commercialization of Imetelstat.
- Geron needs to raise substantial capital in order to complete the development and commercialization of Imetelstat.
- There could be failures or delays in manufacturing sufficient quantities of Imetelstat.