Geron Corporation Reports First Quarter 2017 Financial Results and Recent Events
First Quarter 2017 Results
For the first quarter of 2017, the company reported operating revenues of
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Interest and other income for the three months ended
“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
Recent Company Events
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.
- 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.
Non-clinical data on imetelstat was presented as a poster by Janssen at the 2017 annual meeting of the
- 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.
Annual Meeting of Stockholders
Geron’s Annual Meeting of Stockholders will be held at
Due to the timing of the Annual Meeting this year, Geron management will not be hosting a separate first quarter conference call.
Geron is a biopharmaceutical company supporting the clinical stage development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) continued development of imetelstat by Janssen for MDS in the Phase 3 portion of IMerge and continued conduct by Janssen of IMbark and/or IMerge; (ii) data that suggest clinical benefit and potential overall survival benefit of imetelstat in MF; (iii) a planned data package will be provided to the
Financial table follows.
|CONDENSED STATEMENTS OF OPERATIONS|
|Three Months Ended March 31,|
|(In thousands, except share and per share data)||2017||2016|
|License fees and royalties||$||537||$||749|
|Research and development||3,374||5,033|
|General and administrative||4,657||4,793|
|Total operating expenses||8,031||9,826|
|Loss from operations||(7,494||)||(9,077||)|
|Interest and other income||332||256|
|Interest and other expense||(21||)||(21||)|
|Basic and diluted net loss per share:|
|Net loss per share||$||(0.05||)||$||(0.06||)|
|Shares used in computing net loss per share||159,161,550||158,896,038|
|CONDENSED BALANCE SHEETS|
|March 31,||December 31,|
|Cash, cash equivalents and restricted cash||$||15,129||$||13,078|
|Current marketable securities||84,432||102,035|
|Other current assets||7,002||999|
|Total current assets||106,563||116,112|
|Noncurrent marketable securities||22,126||13,954|
|Property and equipment, net||158||183|
Note 1: Derived from audited financial statements included in the company’s annual report on Form 10-K for the year ended
Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 firstname.lastname@example.org email@example.com