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
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 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.
Annual Meeting of Stockholders
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.
About Geron
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 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 limitation, risks and uncertainties
related to: (i) whether Janssen decides to initiate the Phase 3
portion of IMerge and to continue to conduct IMerge and/or IMbark;
(ii) whether imetelstat is safe and efficacious and will succeed in
IMbark and/or IMerge by overcoming all of the clinical safety and
efficacy, technical, scientific, manufacturing and regulatory
challenges; (iii) whether health authorities permit IMbark and/or
IMerge to continue to proceed under the existing protocols or any
amendments thereto; (iv) Janssen’s ability to collect additional
and more mature data from current clinical trials of 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) any future efficacy or safety results from any
clinical trial of imetelstat may cause the benefit/risk profile of
imetelstat to become unacceptable; and (vii) patent coverage of
imetelstat enables Janssen to successfully commercialize
imetelstat. Additional information on the above-stated 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, 2017. 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.
Financial table follows.
GERON CORPORATION |
CONDENSED STATEMENTS OF
OPERATIONS |
(UNAUDITED) |
|
|
|
Three Months Ended March 31, |
(In thousands, except
share and per share data) |
|
2017 |
|
|
2016 |
|
|
|
|
Revenues: |
|
|
License
fees and royalties |
$ |
537 |
|
$ |
749 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
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 |
) |
Net loss |
$ |
(7,183 |
) |
$ |
(8,842 |
) |
|
|
|
|
|
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, |
(In thousands) |
|
2017 |
|
2016 |
|
(Unaudited) |
(Note 1) |
Current assets: |
|
|
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 |
|
$ |
128,847 |
$ |
130,249 |
|
|
|
|
|
Current
liabilities |
$ |
11,596 |
$ |
7,869 |
Stockholders’
equity |
|
117,251 |
|
122,380 |
|
$ |
128,847 |
$ |
130,249 |
Note 1: Derived from audited financial
statements included in the company’s annual report on Form 10-K for
the year ended December 31, 2016.
CONTACT:
Anna Krassowska, Ph.D.
Investor and Media Relations
650-473-7765
investor@geron.com
media@geron.com
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