Geron (GERN) Q1 Loss Narrows Y/Y, Revenues Fall, Shares Down
Zacks Investment Research | May 10, 2018 09:52PM ET
Geron Corporation (NASDAQ:GERN) reported a loss of 4 cents per share for the first quarter of 2018, narrower than the year-ago loss of 5 cents.
Quarterly revenues fell 40.8% from the year-ago quarter to $0.32 million. Revenues comprised royalty and license fee revenues received under various non-imetelstat license agreements. The company stated that active non-imetelstat license agreements reduced in numbers and products sales from the licensees decreased.
Shares were down 5.5% in pre-market trading on May 11. However, so far this year, Geron’s shares have significantly outperformed the industry , rising 101.7%, against the industry’s decline of 11.3%.
Research and development (R&D) expenses declined 27.7% to $2.4 million. The decline was due to decreased stock-based compensation and lower costs for the proportionate share of clinical development costs for imetelstat under collaboration with Janssen, a subsidiary of Johnson & Johnson (NYSE:JNJ) .
General and administrative (G&A) expenses rose 14.1% to $5.3 million due to consulting costs and legal costs.
The company ended the quarter with $103.2 million in cash and investments compared with $109.2 million at the end of the fourth quarter.
Pipeline Update
Geron’s sole pipeline candidate, imetelstat, is being evaluated in two mid-stage studies – IMerge and IMbark – in myelodysplastic syndromes (“MDS”) and myelofibrosis (“MF”), respectively. Geron is conducting the studies in collaboration with J&J.
In December 2017, Geron presented preliminary data from part I of phase II/III IMerge study. Data showed that imetelstat achieved RBC transfusion-independence (RBC-TI – reduced or no requirement of RBC transfusion over a certain interval) in 54% of the patient population, who have not received prior treatment with either lenalidomide or a hypomethylating agent, for at least eight weeks. RBC-TI was achieved in 31% of the patients in the above subset for at least 24 weeks.
Based on this data, J&J expanded part I of the study to include 20 more patients in a refined MDS indication to confirm the clinical benefit and safety observed earlier. In October 2017, the FDA granted fast track designation to imetelstat based on data from part 1 of IMerge.
Meanwhile, the clinical benefit and a potential overall survival benefit observed during the third internal review in March 2018 supported continuation of the phase II IMbark study without modifications.
However, J&J is planning to amend the protocol of the study to allow long-term treatment of patients. The amendment will be based on a primary analysis of data from the study, which is expected in the second quarter of 2018. J&J will also notify Geron about continuation of the study based on this analysis, which is expected in the third quarter of 2018.
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