2023-05-11 09:01:23 ET
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.
More on Geron
- Geron hits three-month low as Goldman Sachs issues Neutral rating
- Geron: Updates Ahead Of Q1 2023 Earnings
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Geron preps for commercial launch of blood cancer therapy