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Sep 30, 2023
Geron Q3 2023 Earnings Report
Reported business highlights and financial results for the third quarter of 2023.
Key Takeaways
Geron Corporation reported $381.9 million in cash, cash equivalents, and marketable securities as of September 30, 2023. Revenues for the quarter were $164,000, and total operating expenses were $47.8 million. The company projects its financial resources will be sufficient to fund operating requirements through the end of Q3 2025.
Received FDA acceptance of the New Drug Application (NDA) for imetelstat for lower risk MDS with a PDUFA action date of June 16, 2024; FDA plans to hold an advisory committee meeting.
Submitted the Marketing Authorization Application (MAA) for imetelstat and received validation from the European Medicines Agency (EMA). Review expected to be completed by the end of 2024.
Presented data from the IMerge Phase 3 clinical trial at the Society of Hematologic Oncology Annual Meeting, with new analyses planned at the American Society of Hematology (ASH) Annual Meeting.
Appointed Michelle Robertson as Executive Vice President, Chief Financial Officer and Treasurer.
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CapyFin.com Forward Guidance
Geron expects total expenses in the range of approximately $200 million to $210 million for fiscal year 2023.
Positive Outlook
- Continued support of ongoing clinical trials, IMerge Phase 3, IMpactMF, ImproveMF, and the investigator-led Impress trial
- Preclinical studies in lymphoid malignancies and discovery research for a next generation telomerase inhibitor
- Manufacturing of commercial inventory of imetelstat
- Preparations for potential U.S. commercial launch of imetelstat in lower risk MDS
- Projected increases in headcount and interest payments on outstanding debt