On May 2, 2019 Geron Corporation (Nasdaq: GERN) reported financial results for the first quarter ended March 31, 2019 (Press release, Geron, MAY 2, 2019, View Source [SID1234535556]). As of the quarter-end, the Company had approximately $170 million in cash and marketable securities, which is sufficient to support the commencement of late-stage development for imetelstat in lower risk myelodysplastic syndromes (MDS).
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"We continue to make good progress on our 2019 objectives," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We are on track to assume sponsorship of the IND for imetelstat by the end of the second quarter, as expected, which will enable us to open enrollment of the planned Phase 3 portion of IMerge by mid-year. In addition, our expanding in-house leadership and drug development team will support the accomplishment of our 2019 objectives and beyond."
First Quarter 2019 Results
For the first quarter of 2019, the Company reported a net loss of $10.1 million, or $0.05 per share, compared to $7.2 million, or $0.04 per share, for the comparable 2018 period.
Revenues for the first quarter of 2019 were $57,000 compared to $318,000 for the comparable 2018 period. Revenues for 2019 and 2018 included royalty and license fee revenues under various non-imetelstat license agreements. The decrease in revenues for the three months ended March 31, 2019 compared to the same period in 2018 primarily reflects a reduction in the number of active license agreements as a result of patent expirations on the underlying technology.
Total operating expenses for the first quarter of 2019 were $11.4 million compared to $7.8 million for the comparable 2018 period.
Research and development expenses for the first quarter of 2019 were $5.9 million compared to $2.4 million for the comparable 2018 period. The increase in research and development expenses for first quarter of 2019 compared to the same period in 2018 primarily reflects higher imetelstat development costs under the former collaboration agreement with Janssen Biotech, Inc. (Janssen) due to Geron’s payment responsibility increasing from 50% to 100% following the termination of the collaboration agreement; new costs for the imetelstat program transition from Janssen to Geron, including for consultants and the Company’s contract research organization (CRO); and increased expenses related to additional development headcount.
General and administrative expenses for the first quarter of 2019 were $5.5 million compared to $5.3 million for the comparable 2018 period. The increase in general and administrative expenses in the first quarter of 2019 compared to same period in 2018 primarily reflects recruitment expenses for new members for the Company’s board of directors.
Interest and other income for the first quarter of 2019 was $1.2 million compared to $394,000 for the comparable 2018 period. The increase in interest and other income for 2019 compared to 2018 primarily reflects higher yields on the Company’s marketable securities portfolio.
Conference Call for Imetelstat Program Update
In lieu of a first quarter conference call, Geron will host a conference call to provide an imetelstat program update at 9:00 a.m. ET on Thursday, May 16, 2019.
Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The conference ID is 1264477. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat include a Phase 2/3 trial called IMerge in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial called IMbark in Intermediate-2 or High-risk myelofibrosis. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent.