Full Press Release Details
Geron Corporation Reports
First Quarter 2016 Financial Results and Recent Events
Conference Call Scheduled
for 4:30 p.m. EDT Today, May 5
Calif., May 5, 2016 -- Geron Corporation (Nasdaq: GERN) today reported
financial results for the first quarter ended March 31, 2016 and recent events.
First Quarter 2016 Results
For the first quarter of 2016,
the company reported operating revenues of $749,000 and operating expenses of
$9.8 million compared to $537,000 and $10.0 million, respectively, for the
comparable 2015 period. Revenues for the first quarter of 2016 and 2015 included
royalty and license fee revenues under various non-imetelstat agreements.
Operating expenses in the first quarter of 2015 included restructuring charges
of $406,000 in connection with the
company s organizational resizing announced in March 2015. Net loss for the first
quarter of 2016 was $8.8 million, or $0.06 per share, compared to $9.3 million,
or $0.06 per share, for the comparable 2015 period. The company ended the first
quarter of 2016 with $141.9 million in cash and investments.
Research and development
expenses for the first quarter of 2016 and 2015 were $5.0 million for each
period. Research and development
expenses for 2016 primarily reflect the net result of higher costs for the company s proportionate share of clinical development
expenses under the imetelstat collaboration with Janssen Biotech, Inc.
(Janssen), partially offset by lower personnel related expenses as a result of
the 2015 organizational resizing. The company expects research and development
expenses to increase during the remainder of the year as the clinical
development of imetelstat continues in collaboration with Janssen.
General and administrative
expenses for the first quarter of 2016 were $4.8 million compared to $4.6
million for the comparable 2015 period. The increase in general and
administrative expenses primarily reflects the net result of higher non-cash
stock-based compensation expense, partially offset by lower personnel related
costs due to the 2015 organizational resizing.
Interest and other income for
the first quarter of 2016 was $256,000 compared to $149,000 for the comparable
2015 period. The increase in interest and other income in 2016 compared to 2015
primarily reflects higher yields on
the company s marketable securities portfolio.
Recent Company Events
Clinical Development by
| Clinical data on imetelstat safety and efficacy from patients with a form of MDS known as refractory anemia with ring sideroblasts (MDS-RARS) enrolled as part of the Mayo Clinic Pilot Study were published online in the Blood Cancer Journal in March. The full text paper is available online at http://www.nature.com/bcj/. The data, previously presented at the American Society of Hematology annual meeting in December 2015, included nine patients enrolled in the study cohort, classified as having either IPSS intermediate-1 or intermediate-2 risk disease. Six of nine (66.7%) patients had prior treatment with ESAs. Three of the eight (37.5%) patients who were dependent on red blood cell transfusions at study entry became transfusion independent, defined as not requiring transfusions for at least eight weeks. The median duration of transfusion independence was 28 weeks (range: nine weeks to 37 weeks). | ||
| Two poster presentations by Janssen and academic collaborators describing non-clinical data on imetelstat were made at the 2016 annual meeting of the American Association for Cancer Research in April: | ||
| Impact of hypomethylating agents on hTERT expression and synergistic effect in combination with imetelstat, a telomerase inhibitor, in AML cell lines (Abstract #2731) Data presented described non-clinical results that treating acute myeloid leukemia (AML) cell lines with imetelstat enhanced the effects of agents currently used for the treatment of AML. These data extend the rationale from prior non-clinical studies for the potential use of imetelstat in hematologic myeloid malignancies, such as AML, including in combination with standard therapies. | ||
| Myelosuppression in patients treated with the telomerase inhibitor imetelstat is not mediated through activation of toll-like receptors (Abstract #2732) Data presented described results from non-clinical studies that provide further evidence for potential on-target mechanisms of telomerase inhibition by imetelstat underlying the reduction in platelets observed in previously conducted imetelstat clinical trials. |
The posters are available on
the Presentations & Publications page of Geron s website at www.geron.com/presentations.
At 4:30 p.m. EDT on May 5,
2016, Geron s management will host a conference call to discuss the company s
first quarter results as well as
Participants can access the
conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195
(international). The passcode is 97998290. A live audio-only webcast is also
available at http://edge.media-server.com/m/p/8839g3n8/lan/en. The audio webcast
of the conference call will be available for replay approximately one hour
following the live broadcast through June 5, 2016.
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) the conduct and
continuation of IMbarkTM and IMergeTM and other potential
activities under the collaboration agreement with Janssen; (ii) the safety and
efficacy of imetelstat; (iii) the current timelines, milestones and designs of
IMbarkTM and IMergeTM, including planned reviews and
analyses of clinical data; (iv) that the data from Abstract #2731 extend the rationale from prior non-clinical studies for the potential use of imetelstat in hematologic myeloid malignancies, such as AML, including in combination with standard therapies; (v) that the data from Abstract #2732 provide further evidence for potential on-target mechanisms of telomerase inhibition by imetelstat underlying the reduction in platelets observed in previously conducted imetelstat clinical trials; (vi) financial projections and expectations; and (vii) 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
limitation, risks and uncertainties related to: (i) the uncertain,
time-consuming and expensive product development and regulatory process,
including whether Geron and Janssen will succeed in overcoming all of the
clinical safety and efficacy, technical, scientific, manufacturing and
regulatory challenges in the development and commercialization of imetelstat;
(ii) regulatory authorities permitting the current clinical trials to continue
to proceed and potential clinical trials to begin or continue to proceed;
(iii) Janssen s ability to enroll patients in a timely manner, or at all, in any of the current
or potential clinical trials of imetelstat; (iv) the ability of Geron
and Janssen to protect and maintain
intellectual property rights for imetelstat; (v) Geron s dependence on Janssen for the development,
regulatory approval, manufacture and commercialization of imetelstat, including
the risks that if Janssen were to breach or terminate the collaboration
agreement or otherwise fail to successfully develop and commercialize imetelstat
and in a timely manner, or at all, Geron would not obtain the anticipated
financial and other benefits of the collaboration agreement with Janssen and the
clinical development or commercialization of imetelstat could be delayed or
terminated; (vi) whether imetelstat is safe and efficacious, and whether any
future efficacy or safety results may cause the benefit/risk profile of
imetelstat to become unacceptable; (vii) whether imetelstat can be applied to
any or to multiple hematologic malignancies; and (viii) Geron s need for future capital. Additional information on the above risks and uncertainties and additional risks,
uncertainties and factors that could cause actual results to differ materially
from those in the forward-looking
statements are contained in Geron s periodic reports filed with the Securities and Exchange Commission under the heading Risk Factors, including
Geron s quarterly report on Form 10-Q for the quarter ended
March 31, 2016. Undue reliance should not be placed on forward-looking
statements, which speak only as of the date they are made, and the facts and
assumptions underlying the forward-looking statements may change. Except as
required by law, Geron disclaims any obligation to update these forward-looking
statements to reflect future information, events or circumstances.