Geron preps for commercial launch of blood cancer therapy
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With its Q1 financials for 2023, Geron Corporation (NASDAQ:GERN) announced Thursday that the company is preparing for a potential commercial launch of its blood cancer therapy imetelstat ahead of its plans to submit a marketing application next month.
Early this year, Geron (GERN) announced that its IMerge Phase 3 clinical trial for imetelstat achieved key goals in lower-risk myelodysplastic syndromes (MDS).
The company is also enrolling patients to evaluate the treatment in high-risk myelofibrosis (MF) patients who are refractory to prior treatment with a JAK inhibitor.
“If this trial is successful, we expect imetelstat to become a transformational agent for these patients,” CEO John Scarlett remarked, adding that plans are also underway to submit a marketing application in the EU in H2 2023, expecting a commercial rollout by the end of 2024.
As for financials, Geron (GERN) reported $38.1M of net loss for the quarter, indicating a ~27% YoY rise as G&A and R&D expenses reached $12.9M and $27.2M with ~93% YoY and ~23% YoY growth, respectively.
Meanwhile, cash, cash equivalents, and restricted cash reached $113.1M marking a ~98% rise from 2022 year-end.
“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,” Dr. Scarlett added.
Geron (GERN) reaffirms its 2023 guidance for total expenses at $210M – $220M on a GAAP basis, including projections for planned regulatory submissions and the U.S. commercial launch of imetelstat.