Full Press Release Details
Press Release Dated May 9, 2017
Geron Corporation Reports
First Quarter 2017 Financial Results and Recent Events
Calif., May 9, 2017 -- Geron Corporation (Nasdaq: GERN) today reported
financial results for the first quarter ended March 31, 2017 and recent events.
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
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
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
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.
Non-clinical data on
imetelstat was presented as a poster by Janssen at the 2017 annual meeting of
the American Association for Cancer Research 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 i metelstat 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.
Geron s Annual Meeting of
Stockholders will be held at 4:00 p.m. PDT / 7:00 p.m. EDT today, May 9, 2017.
Further information about the Annual Meeting is available on Geron s website at
www.geron.com on the homepage and in the Investors section under Events.
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
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 FDA for IMerge; (iv) that Janssen
will evaluate more mature data including overall survival for IMbark; (v)
potential outcomes of any data reviews conducted by Janssen for IMbark; (vi) any
future presentation of data from current clinical trials of imetelstat by
Janssen at a medical conference; (vii) the safety and efficacy of imetelstat; (viii) that if Janssen decides to proceed with the Phase 3 portion of
IMerge, the clinical trial will be opened for patient enrollment in the fourth
quarter of 2017; and (ix) other statements that are not historical facts,
constitute forward-looking statements. These statements involve risks and
uncertainties that can cause actual results to differ materially from those in
such forward-looking statements. These risks and uncertainties, include, without