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Jun 30, 2023
Geron Q2 2023 Earnings Report
Progressed business significantly with NDA submission and strengthened imetelstat's value proposition.
Key Takeaways
Geron Corporation reported business highlights and financial results for the second quarter of 2023, highlighted by the submission of a New Drug Application (NDA) to the FDA for imetelstat in lower risk myelodysplastic syndromes (MDS). The company's financial resources of approximately $400 million are expected to fund a potential successful launch and support the first year of launch.
Submitted New Drug Application (NDA) to the FDA based on results from IMerge Phase 3 in lower risk myelodysplastic syndromes (MDS).
Presented new data and analyses from IMerge Phase 3 at ASCO and EHA reporting robust durability of transfusion independence, evidence of disease-modifying activity and favorable fatigue patient-reported outcomes in imetelstat-treated lower risk MDS patients versus placebo.
Initiated Expanded Access Protocol (EAP) in June 2023, making imetelstat available to clinicians and patients prior to potential FDA approval.
Achieved >40% enrollment in IMpactMF, Geron’s Phase 3 trial of imetelstat in patients with myelofibrosis (MF) relapsed/refractory to JAK-inhibitors.
Geron
Geron
Forward Guidance
Geron projects its existing financial resources plus potential future proceeds from remaining warrants outstanding and estimated revenues from commercialization will be sufficient to fund its projected operating requirements through the end of 2025. For fiscal year 2023, under GAAP the Company expects total expenses to be in the range of $210 to $220 million, and non-GAAP total expenses to be in the range of $200 to $210 million.
Positive Outlook
- Potential U.S. commercial launch in lower risk MDS expected in first half of 2024
- Approximately $400 million on the balance sheet as of the end of the quarter
- Financial resources to fund a potential successful launch
- Financial resources to support the first year of launch
- IMpactMF has registrational intent
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
- Geron may seek to raise substantial additional capital in order to complete the development and commercialization of imetelstat