Press release
Geron Corporation Reports First Quarter 2023 Financial Results and Business Highlights
Planned submission of U.S. New Drug Application on track for June 2023 Additional data and analyses from IMerge Phase 3 expected to be presented at upcoming
About this update from Geron Corporation
[{"type":"text","content":"\nPlanned submission of U.S. New Drug Application on track for June 2023\n\n\nAdditional data and analyses from IMerge Phase 3 expected to be presented at upcoming medical meetings further strengthen differentiating qualities of imetelstat\n\n\nPreparations for potential commercial launch in the U.S. ongoing\n\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 business updates and financial results for the first quarter of 2023.\n\n\n“We believe that imetelstat has a compelling commercial value proposition and is well-positioned to become a standard of care in lower risk MDS, based on unprecedented broad durability of transfusion independence in the IMerge Phase 3 trial and high unmet need in this patient population,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are on track to submit a New Drug Application in the U.S. next month and are preparing for a potential U.S. commercial launch in the first half of 2024. Further, we are planning to submit a Marketing Authorization Application in the EU in the second half of 2023 and preparing for an EU commercial launch by the end of 2024.”\n\n\nDr. Scarlett also noted, “We also continue to make progress on recruiting and enrolling patients into IMpactMF, the first and only Phase 3 study of JAK inhibitor relapsed/refractory myelofibrosis patients with a primary endpoint of overall survival. If this trial is successful, we expect imetelstat to become a transformational agent for these patients.”\n\n\nDr. Scarlett added, “As of the end of the quarter, we had over $400 million on the balance sheet, which we believe provides the financial resources to operate the company through the end of the third quarter of 2025. This means we expect to launch in lower risk MDS without being compromised by lack of funding, while also supporting IMpactMF and our other ongoing earlier stage programs.”\n\n\nFinancial Resources to Support Potential Commercial Launch of Imetelstat in Lower Risk Myelodysplastic Syndromes (MDS)\n\n\nAs of March 31, 2023, the Company had $409.2 million in cash and marketable securities. In January 2023, the Company closed an underwritten public offering of common stock a...