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Dec 31, 2021
Geron Q4 2021 Earnings Report
Geron reported fourth quarter and full year 2021 financial results, highlighting progress in imetelstat development and upcoming milestones.
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.