On May 9, 2017 Geron Corporation (Nasdaq:GERN) reported financial results for the first quarter ended March 31, 2017 and recent events (Press release, Geron, MAY 9, 2017, View Source [SID1234518962]).

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First Quarter 2017 Results

For the first quarter of 2017, the company reported operating revenues of $537,000 and operating expenses of $8.0 million compared to $749,000 and $9.8 million, respectively, for the comparable 2016 period. Revenues for the first quarter of 2017 and 2016 included royalty and license fee revenues under various non-imetelstat license agreements. Net loss for the first quarter of 2017 was $7.2 million, or $0.05 per share, compared to $8.8 million, or $0.06 per share, for the comparable 2016 period. The company ended the first quarter of 2017 with $121.7 million in cash and investments.

Research and development expenses for the three months ended March 31, 2017 and 2016 were $3.4 million and $5.0 million, respectively, and largely reflect the company’s proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen). Higher research and development expenses in 2016 were primarily due to start-up costs for the initiation of IMerge, the Phase 2/3 trial in myelodysplastic syndromes being conducted by Janssen, in which the first patient was dosed in January 2016.

General and administrative expenses for the three months ended March 31, 2017 and 2016 were $4.7 million and $4.8 million, respectively. The decrease in general and administrative expenses in 2017 compared to 2016 primarily reflects reduced consulting costs.

Interest and other income for the three months ended March 31, 2017 and 2016 were $332,000 and $256,000, respectively. The increase in interest and other income in 2017 compared to 2016 primarily reflects higher yields on the company’s marketable securities portfolio.

"As a result of the second internal data reviews that were completed in April for the imetelstat clinical trials in myelodysplastic syndromes and myelofibrosis, both trials are continuing unmodified. For IMerge, the next step is a decision regarding the Phase 3 portion of the trial. If Janssen decides to move forward, we expect the Phase 3 portion to be open to patient enrollment in the fourth quarter. For IMbark, we expect Janssen to evaluate maturing data from the trial during the next year, including an assessment of overall survival," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "We continue to be pleased by the commitment to imetelstat shown by our colleagues at Janssen. Their conduct of these internal data reviews has highlighted to us the care and professional development expertise they are applying to this innovative drug."

Recent Company Events

Imetelstat Clinical Development

The telomerase inhibitor imetelstat is being evaluated in two ongoing clinical trials, IMerge and IMbark, as conducted by Janssen under the terms of an exclusive worldwide license and collaboration agreement. IMerge is a Phase 2/3 clinical trial designed to evaluate imetelstat in transfusion dependent patients with IPSS low or intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). IMbark is a Phase 2 clinical trial designed to evaluate two dose levels of imetelstat in patients with intermediate-2 or high risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor.

In April 2017, the second internal data reviews of IMerge and IMbark were completed. Based on these reviews, the Joint Steering Committee determined the following:

Both trials continue unmodified, and patients remaining in the treatment phases may continue to receive imetelstat.

The safety profile of imetelstat in both trials was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified.

For IMerge, the benefit/risk profile of imetelstat in the Phase 2 patients supports continued development in lower risk MDS. A data package and proposed design refinements to the Phase 3 component of the trial are planned to be provided to the FDA. In addition, the Phase 2 data from IMerge are expected to be submitted for consideration for presentation at a medical conference in the future.

For IMbark, the current results suggest clinical benefit and a potential overall survival benefit associated with imetelstat treatment in relapsed or refractory MF. Enrollment of new patients to the trial remains suspended because the total number of patients enrolled to date is adequate to assess longer-term outcome measures, including overall survival, when the data are fully matured.
Geron expects further decisions by Janssen on the development of imetelstat will be informed by maturing efficacy and safety data from the trials, feedback from health authorities, and the totality of imetelstat program information, including an assessment of the evolving treatment landscapes in MDS and MF and the potential application of imetelstat in multiple hematologic malignancies.

Poster Presentation

Non-clinical data on imetelstat was presented as a poster by Janssen at the 2017 annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April:

Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia (Abstract #1101)

Data presented described non-clinical results of imetelstat’s activity in combination with venetoclax, a selective BCL-2 inhibitor. In acute myeloid leukemia (AML) cell lines, telomerase expression and activity were decreased by imetelstat and further reduced in combination with venetoclax. In addition, imetelstat enhanced apoptosis induced by venetoclax in AML cell lines and AML patient samples. Combining imetelstat with venetoclax in an AML mouse model prolonged survival, with four of ten mice alive approximately 80 days after treatment was stopped.
The poster is available on Geron’s website at www.geron.com/presentations.