Press release
Geron Corporation Reports Second Quarter 2022 Financial Results
Top-Line Results from IMerge Phase 3 Trial in Lower Risk MDS Continue to be Expected in Early January 2023 Current and Projected Financial Resources Expected
About this update from Geron Corporation
[{"type":"text","content":"\nTop-Line Results from IMerge Phase 3 Trial in Lower Risk MDS Continue to be Expected in Early January 2023\n\nCurrent and Projected Financial Resources Expected to Support Planned Milestones and Operations Through Middle of 2024\n\nConference Call Scheduled for 4:30 p.m. ET Today\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGeron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results for the second quarter of 2022 and key upcoming expected milestones.\n\n“We continue to focus intently on our plans for a catalyst-rich next two years, during which we expect to transform Geron from a development stage to commercial company,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “Our plan to disclose Phase 3 top-line results in lower risk MDS remains on track for early January 2023. Assuming positive top-line results, U.S. and EU regulatory submissions are also planned in the first and second half of 2023, respectively. In addition, we expect to continue the stage-gated buildout of our commercial capabilities and key talent across our organization to support a potential commercial U.S. launch of imetelstat in the first half of 2024.”\n\n“In order to maintain a strong balance sheet, we also recently amended our existing loan facility to secure up to $50 million in additional non-dilutive capital, which we expect to be available in 2023,” Dr. Scarlett continued. “With these potential added debt proceeds, we believe our current and projected financial resources will be sufficient to fund our expected level of operations until the middle of 2024.”\n\nKey Upcoming Expected Milestones\n\nLower Risk Myelodysplastic Syndromes (MDS)\n\n\nTop-line results from IMerge Phase 3 in early January 2023\n\n\nNew Drug Application submission in the U.S. in the first half of 2023\n\n\nMarketing Authorization Application submission in the EU in the second half of 2023\n\n\nU.S. approval and commercial launch in the first half of 2024\n\n\nMyelofibrosis\n\n\nOpen remaining selected IMpactMF Phase 3 clinical sites by year-end 2022\n\n\nIMpactMF interim analysis in 2024\n\n\nPipeline expansion in additional indications and treatment combinations\n\n\nStart IMpress investigator-led study...