Geron Q3 2021 Earnings Report
Key Takeaways
Geron Corporation reported its Q3 2021 financial results, including a net loss of $26.7 million, and summarized key highlights from its Investor Event, where the company emphasized the disease-modifying activity of Imetelstat and its potential in treating hematologic malignancies.
Imetelstat shows strong evidence of disease-modifying activity.
Phase 3 development programs in lower risk MDS and refractory MF are underway.
New programs are expanding potential indications and combination opportunities for Imetelstat.
Company estimates potential peak revenue of more than $3 billion for imetelstat from the United States and the five largest countries in the European Union.
Geron
Geron
Forward Guidance
Geron anticipates several key milestones and developments in the near future, including the availability of top-line results from the IMerge Phase 3 trial, the opening of the first clinical site for IMproveMF, the initiation of IMpress and TELOMERE trials, and the availability of preliminary results from the preclinical program in lymphoid malignancies.
Positive Outlook
- Top-line results from IMerge Phase 3 are expected at the beginning of January 2023.
- Interim analysis for IMpactMF is expected in 2024, and the final analysis in 2025.
- The first clinical site for IMproveMF is expected to open in the first half of 2022.
- IMpress is expected to begin in the first half of 2022.
- TELOMERE is expected to begin in the first half of 2022.
Challenges Ahead
- The COVID-19 pandemic could materially and adversely impact Geron’s business and business prospects.
- Geron faces potential delays and other adverse impacts caused by the COVID-19 pandemic.
- Regulatory authorities may not permit the further development of imetelstat on a timely basis, or at all, without any clinical holds.
- Future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable.
- There may be failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials in a timely manner.