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Mar 31, 2022
Geron Q1 2022 Earnings Report
Reported financial results for the first quarter of 2022.
Key Takeaways
Geron Corporation reported a net loss of $30.1 million, or $0.09 per share, for the first quarter of 2022. As of March 31, 2022, the Company had $178.0 million in cash and marketable securities.
Top-line results from IMerge Phase 3 trial in lower risk MDS continue to be expected in early January 2023.
Started the Phase 1 IMproveMF Study in Frontline MF in May 2022.
Current and projected financial resources expected to be sufficient to reach planned milestones through Year-End 2023.
The successful financing in April adds to current financial resources, as well as provides access to additional capital upon the potential exercise of warrants in the future.
Geron
Geron
Forward Guidance
Geron continues to expect total GAAP operating expenses in 2022 to be approximately $155 million to $165 million and non-GAAP operating expenses in 2022 to be approximately $140 million to $150 million.
Positive Outlook
- Preparatory activities for top-line results from the IMerge Phase 3 clinical trial and readiness for potential regulatory filings and commercialization of imetelstat in lower risk MDS.
- Continued conduct of IMerge and IMpactMF and commencement of new clinical studies associated with the imetelstat pipeline expansion strategy.
- Finalizing validation batches of imetelstat at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes.
- Projected increases in headcount.
- Sufficient to fund Geron’s projected level of operations, which includes preparatory activities for potential U.S. commercial launch of imetelstat in lower risk MDS, until the end of 2023.
Challenges Ahead
- Whether the current or evolving effects of the COVID-19 pandemic and/or the Russia/Ukraine conflict cause global economic and financial disruptions that materially and adversely impact Geron’s business and business prospects, its financial condition and the future of imetelstat
- Whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic and/or the Russia/Ukraine conflict, and overcomes all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for, and to meet the expected timelines and planned milestones
- Whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds
- Whether imetelstat is demonstrated to be safe and efficacious in IMerge Phase 3 and IMpactMF to enable regulatory approval
- Whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable