Geron Q2 2024 Earnings Report
Key Takeaways
Geron Corporation reported a net loss of $67.4 million, or $0.10 per share, for the second quarter of 2024. The company launched RYTELO commercially in the U.S. in June 2024. Total product revenue, net for the quarter was approximately $780,000.
U.S. commercial launch of RYTELO began in June 2024.
NCCN Guidelines were updated to include the use of RYTELO in both RS+ and RS- patients.
Approximately 70% enrollment achieved in the Phase 3 IMpactMF trial as of August 2024.
Expanded the dose level 4 cohort in the Part 1 dose-finding stage of the Phase 1 IMproveMF study.
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Forward Guidance
For fiscal year 2024, Geron expects total operating expenses to be in the range of approximately $270 million to $280 million. The company believes that its existing cash, cash equivalents, and marketable securities, together with projected revenues from U.S. sales of RYTELO, will be sufficient to fund its projected operating requirements into the second quarter of 2026. Geron plans to grow to a total of approximately 230-260 employees by year-end 2024.
Positive Outlook
- Existing cash, cash equivalents, and marketable securities will be sufficient to fund projected operating requirements into Q2 2026.
- Projected revenues from U.S. sales of RYTELO will contribute to funding operating requirements.
- Operating expenses expected to be in the range of approximately $270 million to $280 million for fiscal year 2024.
- Plan to grow to a total of approximately 230-260 employees by year-end 2024.
- Broad access to RYTELO for eligible patients is aimed.
Challenges Ahead
- Potential delays and other adverse impacts caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges.
- Regulatory authorities may not permit the further development of imetelstat on a timely basis, or at all, without any clinical holds.
- Future safety or efficacy results of imetelstat treatment may cause the benefit-risk profile of imetelstat to become unacceptable.
- Geron may seek to raise substantial additional capital in order to continue the development and commercialization of imetelstat.
- Failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials may impact commercialization of RYTELO or the continuation of the IMpactMF trial.