Geron Reports Four Imetelstat Data Presentations at Virtual Edition of the European Hematology Association (EHA) Annual Congress - Seite 2

The conclusions of the oral presentation are as follows:

• Meaningful and durable transfusion independence (TI):
  ° High rates of TI and HI-E: 42% 8-week TI rate and 68% HI-E rate
  ° Durable TI and HI-E: Median duration of TI is 20 months and median duration of HI-E is 21 months
  ° TI across multiple patient subtypes: ringed sideroblast positive (RS+) and RS-, high and very high transfusion burden
  
  
• Potential disease-modifying activity:
  ° 29% of patients transfusion free for more than 1 year
  ° 75% of 8-week TI responders had a hemoglobin rise of > 3g/dL from pretreatment level
  ° Reduction in variant allele frequency (VAF) of SF3B1 mutation correlated with shorter time to TI and duration of TI
  
  
• No new safety signal identified:
  ° Reversible cytopenias, without significant clinical consequences were most frequent adverse events

The slide presentation is available on Geron’s website at www.geron.com/r-d/publications.

Ongoing IMerge Phase 3 Clinical Trial

The IMerge Phase 3 clinical trial is a double-blind, randomized, placebo-controlled clinical trial with registration intent. The trial is designed to enroll approximately 170 patients with lower risk transfusion dependent MDS who are relapsed or refractory to an ESA, have not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and who are non-del(5q). The trial was opened for screening and enrollment in August 2019. As of the end of April 2020, approximately 68% of planned clinical sites for the IMerge Phase 3 trial were open for enrollment. Geron expects to complete patient enrollment by the end of the first quarter of 2021. Under current assumptions, the Company expects top-line results to be available in the second half of 2022.

New Analyses of Data from IMbark Phase 2 Clinical Trial in Intermediate-2 or High-risk Myelofibrosis

“Taken together, we believe the three EHA poster presentations reporting new analyses of IMbark Phase 2 data substantiate the OS outcome observed in IMbark and indicate potential disease-modifying activity of imetelstat in yet another hematologic indication,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “These analyses also provide further support for our planned Phase 3 clinical trial in refractory MF, which is expected to open for enrollment in the first quarter of 2021.”