Geron Corporation (NASDAQ:GERN) has announced its financial results for the three months ended September 30, 2020, in which it ended with $247 million in cash, cash equivalents and investments. According to current planning assumptions, Geron expects the financial resources to be adequate for funding operations up to 2022.
Geron reports progress in imetelstat clinical program
John Scarlett, Geron’s CEO and Chairman said that in Q3, the company executed imetelstat program’s clinical, regulatory and publication plans. Geron continues to advance enrolment of the IMerge Phase 3 clinical study and startup activities for the anticipated Phase 3 clinical study in refractory myelofibrosis named IMpactMF. Scarlett added that during the quarter, the company secured orphan drug designation in Europe in lower risk MDs. Geron published IMerge Phase 2 results in the Journal of Clinical Oncology. The CEO confirmed that the company strengthened its balance sheet through a loan facility that offers additional financial flexibility, thus supporting imetelstat development plans in the future.
Geron expects to complete enrolment in the IMerge study in Q1 2021. Scarlett pointed out that the second wave of COVID-19 is causing unpredictable impact and uncertainty on the company’s clinical study activities. The uncertainty may push enrolment into Q2 2021 but provided the study finalizes enrolment in 1H 2020 the company plans to release topline IMerge results in 2H 2020.
IMpactMF study to commence enrolment in Q1 2021
Scarlett also confirmed that based on clinical sites feedback, the company expected the planned IMpactMF study to open for enrolment and screening in Q1 2021. The final analysis for OS will be event-driven and will occur after over 50% of enrolled patients in the study have died. Also, the interim OS analysis will happen after around 70% of the projected number of events for final analysis have taken place.
Geron’s cash position shows net proceeds of around $140 million from its public offering in May and $24 million in initial proceeds from a $75 million facility closed in Q3 2020. The facility is available through 2022 in three tranches subject to some clinical, regulatory and financial milestones.