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Dec 31, 2020
Geron Q4 2020 Earnings Report
Geron reported financial results and operational highlights.
Key Takeaways
Geron Corporation reported a net loss of $23.8 million for the fourth quarter of 2020. The company ended the year with $260 million in cash and marketable securities, expected to fund operations until the end of 2022.
IMerge Phase 3 achieved 65% enrollment, with full enrollment expected in the second half of 2021 and top-line results available from the end of 2022 to the first half of 2023.
IMpactMF opened for screening and enrollment in December 2020, with event-driven analyses projected for 2024 (interim) and 2025 (final).
Preparations have begun for the future submission of an NDA for imetelstat in lower risk MDS, with a potential commercial launch in 2024.
New analyses of IMbark Phase 2 data support overall survival (OS) outcome and disease-modifying potential of imetelstat.
Geron
Geron
Forward Guidance
Geron provided financial guidance for fiscal year 2021, expecting operating expenses to range from $108 to $112 million and planning to grow to a total of approximately 80 to 85 employees by year-end 2021.
Positive Outlook
- Costs for the two ongoing Phase 3 clinical trials.
- Producing validation batches of imetelstat at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes.
- Preparatory activities for NDA and commercial readiness.
- Sufficient cash to fund operations until the end of 2022.
- Majority of new hires will be research and development personnel.
Challenges Ahead
- Operating expense burn expected to range from $108 to $112 million.
- COVID-19 pandemic may cause delays in clinical site openings, patient screening, and enrollment.
- Normalization of clinical site operations remains uncertain and unpredictable.
- Enrollment in IMpactMF is expected to be slower due to competing trials and constrained site personnel resources.
- The fluid and dynamic nature of the pandemic continues to create uncertainty and unpredictability on our clinical trial activities.