Geron Q4 2021 Earnings Report
Key Takeaways
Geron Corporation reported a net loss of $32.0 million for the fourth quarter of 2021, compared to a net loss of $23.8 million for the same period in 2020. The company ended the year with $212.7 million in cash and marketable securities, expected to fund operations through Q1 2023. Key milestones include anticipated top-line results from the IMerge Phase 3 trial in early January 2023 and a planned interim analysis from the IMpactMF trial in 2024.
Net loss for Q4 2021 was $32.0 million, or $0.10 per share, compared to $23.8 million, or $0.07 per share, for Q4 2020.
Revenues for Q4 2021 were $1.0 million compared to $50,000 for the same period in 2020.
The company ended 2021 with $212.7 million in cash and marketable securities.
Top-line results from IMerge Phase 3 trial in lower risk MDS are expected in early January 2023.
Geron
Geron
Forward Guidance
Geron expects total operating expenses for fiscal year 2022 to be in the range of $155 million to $165 million (GAAP) and $140 million to $150 million (non-GAAP).
Positive Outlook
- Preparatory activities for top-line results in lower risk MDS.
- NDA and commercial readiness activities.
- Two ongoing Phase 3 clinical trials and new clinical studies expanding the pipeline.
- Finalizing validation batches of imetelstat at contract manufacturers.
- Projected increases in headcount.
Challenges Ahead
- Potential delays and adverse impacts caused by the COVID-19 pandemic and/or the Russia/Ukraine conflict.
- Enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges.
- Whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds.
- Whether imetelstat is demonstrated to be safe and efficacious in IMerge Phase 3 and IMpactMF to enable regulatory approval.
- Whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable.