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Mar 31, 2024
Geron Q1 2024 Earnings Report
Geron reported financial results and business highlights for the first quarter of 2024.
Key Takeaways
Geron reported a net loss of $55.4 million, or $0.09 per share, for the first quarter of 2024. As of March 31, 2024, the Company had approximately $465 million in cash and marketable securities.
The FDA ODAC voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS in March.
Geron is actively preparing for a successful launch of imetelstat in the U.S., including onboarding its sales force in April.
The Phase 3 IMpactMF clinical trial is ongoing, with the interim analysis now expected in early 2026 and the final analysis expected in early 2027.
As of March 31, 2024, the Company had approximately $465 million in cash and marketable securities.
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CapyFin.com Forward Guidance
The Company expects total operating expenses to be in the range of approximately $270 million to $280 million for fiscal year 2024. Existing cash, cash equivalents, and current and noncurrent marketable securities, together with projected revenues from U.S. sales of imetelstat, if approved, potential proceeds from the exercise of our outstanding warrants, and potential future drawdowns under our loan facility, will be sufficient to fund our projected operating requirements into the second quarter of 2026.
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
- Build out of our commercial organization to support the potential U.S. commercial launch of imetelstat in the U.S.
- Increases in headcount in preparation for transition to a commercial-stage company
Challenges Ahead
- Potential delays and other adverse impacts caused by 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 has demonstrated sufficient safety, efficacy and clinical benefit in IMerge Phase 3 to enable regulatory approval
- Whether any future safety or efficacy results of imetelstat treatment cause the benefit-risk profile of imetelstat to become unacceptable
- Whether regulatory authorities require an additional clinical trial for approval of imetelstat in TD LR-MDS, or post-approval