Loading...
•
Jun 30, 2021
Geron Q2 2021 Earnings Report
Reported updates on the IMerge Phase 3 trial in lower risk MDS and financial results for the second quarter ended June 30, 2021.
Key Takeaways
Geron Corporation reported a net loss of $29.6 million, or $0.09 per share, for the second quarter of 2021. As of June 30, 2021, the Company had $239.1 million in cash and marketable securities, expected to fund operations through the end of the first quarter of 2023. Enrollment in IMerge Phase 3 reached 91%, with top-line results expected in the first quarter of 2023.
IMerge Phase 3 trial in lower risk MDS achieved 91% of planned enrollment.
Top-line results for IMerge Phase 3 accelerated to the first quarter of 2023.
First patient dosed in IMpactMF Phase 3 clinical trial in Refractory Myelofibrosis.
Cash and marketable securities totaled $239.1 million as of June 30, 2021.
Geron
Geron
Forward Guidance
Geron expects to fully enroll IMerge Phase 3 in the fourth quarter of 2021 and anticipates top-line results in the first quarter of 2023. The company plans to grow to approximately 80 to 85 employees by year-end 2021 and expects its financial resources to fund operations through the end of the first quarter of 2023.
Positive Outlook
- IMerge Phase 3 is expected to be fully enrolled in the fourth quarter of 2021.
- Top-line results for IMerge Phase 3 are expected in the first quarter of 2023.
- Financial resources are expected to fund operations through the end of the first quarter of 2023.
- Company plans to grow to 80-85 employees by year-end 2021.
- The clinical cut-off date for the primary analysis could occur three months earlier than originally planned
Challenges Ahead
- Potential delays and adverse impacts caused by the current or evolving effects of the COVID-19 pandemic.
- Challenges related to enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing, and regulatory aspects.
- Risk of regulatory authorities not permitting further development of imetelstat or placing clinical holds.
- Uncertainty regarding imetelstat's safety and efficacy in IMerge Phase 3 and IMpactMF for regulatory approval.
- Potential for future efficacy or safety results to cause an unacceptable benefit-risk profile for imetelstat.