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Dec 31, 2023
Geron Q4 2023 Earnings Report
Reported business highlights and financial results.
Key Takeaways
Geron Corporation reported its Q4 and Full Year 2023 financial results, highlighting progress with imetelstat and preparation for potential commercialization. The company's financial resources are projected to fund operations into the third quarter of 2025, with $378.1 million in cash, cash equivalents, and marketable securities as of December 31, 2023.
Reported positive top-line results from the pivotal IMerge Phase 3 clinical trial evaluating imetelstat in patients with TD LR-MDS.
The FDA accepted the New Drug Application (NDA) for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes.
Achieved fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating imetelstat versus best available therapy (BAT) in patients with intermediate-2 or high-risk Myelofibrosis (MF).
Geron projects that its existing financial resources will be sufficient to fund its projected operating expenses into the third quarter of 2025.
Geron
Geron
Forward Guidance
Geron expects total operating expenses for fiscal year 2024 to be in the range of approximately $270 million to $280 million. Subject to approval of imetelstat in the U.S., Geron plans to grow to a total of approximately 270 employees by year-end 2024.
Positive Outlook
- Costs to support regulatory processes with the FDA and EMA in 2024
- Continued support of ongoing clinical trials
- Manufacturing of commercial inventory of imetelstat
- Continued build out of our commercial organization to support the potential U.S. commercial launch of imetelstat
- Continued increases in headcount in preparation for transition to a commercial-stage company
Challenges Ahead
- Non-cash items such as stock-based compensation expense
- Amortization of debt discounts and issuance costs
- Depreciation and amortization
- Interest payments on outstanding debt