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Dec 31, 2022
Geron Q4 2022 Earnings Report
Reported business updates, upcoming milestones and financial results.
Key Takeaways
Geron Corporation reported a net loss of $42.6 million for the fourth quarter of 2022 and ended the year with $173.1 million in cash and marketable securities. The company is focused on completing regulatory submissions for imetelstat in lower risk MDS and preparing for its potential commercial launch in the U.S.
Positive top-line results were reported for IMerge Phase 3.
The company plans to complete and submit a U.S. New Drug Application (NDA) and a European Marketing Authorization Application (MAA) for imetelstat in lower risk MDS in 2023.
Geron is implementing operational items needed to prepare for potential commercial launch of imetelstat in lower risk MDS in the U.S.
Progress continues to be made on recruiting and enrolling patients into IMpactMF, the imetelstat Phase 3 trial in relapsed/refractory MF.
Geron
Geron
Forward Guidance
For fiscal year 2023, Geron expects total expenses to be between $210 million and $220 million under GAAP, and non-GAAP total expenses to be between $200 million and $210 million.
Positive Outlook
- Costs to support planned regulatory submissions in 2023
- Continued support of ongoing clinical trials
- Manufacturing commercial inventory of imetelstat
- Preparations for potential U.S. commercial launch of imetelstat in lower risk MDS
- Projected increases in headcount
Challenges Ahead
- The financial guidance reflects projected increases in interest payments on outstanding debt.
- The company is facing increasing interest rates.
- The company anticipates higher personnel-related expenses for additional headcount.
- The company is incurring costs for commercial preparatory activities.
- The company's portion of settlement costs related to class action and derivative lawsuits is increasing expenses.