& the Paul Harvey...Geron Corporation Reports 2011 First Quarter Financial Results and Highlights
MENLO PARK, Calif., Apr 27, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN)
today reported financial results for the three months ended March 31, 2011.
For the first quarter of 2011, the company reported operating revenues of $1.5
million and operating expenses of $25.9 million, compared to $918,000 and $17.4
million, respectively, for the comparable 2010 period. Net loss for the first
quarter of 2011 was $24.4 million, or $0.20 per share, compared to $16.6 million,
or $0.18 per share, for the comparable 2010 period. The company ended the quarter
with $207.3 million in cash and investments.
Revenues for the first quarter of 2011 and 2010 included funding from
collaboration agreements and royalty and license fee revenues under various
agreements. Interest and other income for the first quarter of 2011 amounted to
$296,000, compared to $202,000 for the comparable 2010 period.
Research and development expenses for the first quarter of 2011 were $16.8
million, compared to $13.5 million for the comparable 2010 period. The increase
in research and development expenses reflected higher drug purchases and
increased clinical trial expenses for initiation and enrollment of four oncology
Phase 2 clinical trials of imetelstat and the Phase 1 clinical trial for GRNOPC1
in patients with spinal cord injury. The company expects research and development
expenses to increase in the future with the continued enrollment in the
imetelstat Phase 2 trials and the planned initiation of the GRN1005 Phase 2
clinical trials in the second half of 2011 in patients with brain metastases.
General and administrative expenses for the first quarter of 2011 were $9.1
million, compared to $3.9 million for the comparable 2010 period. The increase in
general and administrative expenses reflects costs related to the management
transition, primarily non-cash stock-based compensation expense, and higher legal
costs for the financing-related class action and derivative litigation against
the company. All such cases have now been voluntarily dismissed.
First Quarter 2011 Highlights:
a-Geron scientists and collaborators at The Hospital for Sick Children
and the University of Toronto published preclinical data in Clinical
Cancer Research demonstrating that the company's telomerase
inhibitor drug, imetelstat, selectively targets cancer stem cells in
pediatric tumors of neural origin. Preclinical studies have now
shown imetelstat to have activity against cancer stems cells from
all nine tumor types tested, spanning adult, pediatric, solid,
liquid, epithelial and non-epithelial derived cancers. The findings
support the rationale for conducting an investigator sponsored
clinical trial in pediatric tumors.
a-The first patient was enrolled in a single-agent Phase 2 clinical
trial to evaluate the activity of imetelstat in patients with
essential thrombocythemia (ET), a chronic disorder arising in blood
stem cells in the bone marrow. All four clinical trials in Geron's
Phase 2 program for imetelstat have been initiated. The trials
include two large randomized clinical trials in non-small cell lung
cancer (NSCLC) and breast cancer and two single arm studies in
multiple myeloma and ET.
a-A Geron collaborator from the University of Washington Medical
School presented preclinical study data showing positive effects of
GRNCM1 in a small animal model of acute heart damage. The results
suggest that GRNCM1 positively impacts cardiac function through
several mechanisms, leading to overall increased cardiac output and
decreased arrhythmias in the acute infarct setting. Geron is
developing GRNCM1 for the treatment of myocardial disease.
a-Geron hosted a webcast analyst and investor meeting on March 29 to
discuss the company's oncology programs.
The presentation provided an update on the Phase 2 clinical program
for the company's telomerase inhibitor drug (imetelstat sodium -
GRN163L). Enrollment for the two large randomized trials in NSCLC
and breast cancer was reported as ahead of projections.
The Phase 2 clinical development plan for the recently in-licensed
peptide-conjugated paclitaxel derivative designed to penetrate the
blood-brain barrier (GRN1005) was outlined for the first time. Geron
is planning for the GRN1005 Phase 2 program to initiate at the end
of 2011 in patients with brain metastases. Additional studies in
primary brain tumors are under discussion.
a-Geron hosted a webcast analyst and investor meeting on April 19 to
discuss the company's cell therapy products derived from its human
embryonic stem cell platform. The presentation included new data on
GRNOPC1 (oligodendrocyte progenitors), GRNCM1 (cardiomyocytes) and
GRNIC1 (immature islet cells).
Safety data from the Phase 1 clinical trial of GRNOPC1 in subacute,
complete, thoracic spinal cord injury were presented for the first
time. The first patient to be enrolled in the study has completed
the Day 180 follow-up visit with a clean safety profile showing no
Serious Adverse Events (SAEs) and no Adverse Events (AEs) related to
the injection procedure or GRNOPC1 (two mild AEs related to
immunosuppressive drug included nausea and low magnesium). No
significant change in neurological status and no adverse changes or
evidence of cavitation on MRI has been observed. Immune monitoring
showed no evidence of immune responses to GRNOPC1 through Day 90 (30
days after withdrawal of immunosuppressive drug).
New preclinical efficacy data on GRNCM1 from a study in a
chronically infarcted pig model showed statistically and clinically
significant functional improvement (ejection fraction) compared to
untreated controls. These are important data in an animal model with
a heart of similar size and structure to humans.
New preclinical efficacy data on GRNIC1 were reported showing the
restoration and maintenance of glucose control for up to 120 days in
a rodent model of Type 1 diabetes, compared to a lack of glucose
control leading to death of control animals within 20 days.
a-A new leadership structure was implemented through the appointment
of David L. Greenwood as President, Interim Chief Executive Officer
and a member of the Board of Directors, Hoyoung Huh, Ph.D., M.D., as
Executive Chairman of the Board and Alexander E. Barkas, Ph.D. as
Lead Independent Director.
Conference Call
At 8:00 a.m. PDT/11:00 a.m. EDT on April 28, 2011, David L. Greenwood, Geron's
president, will host a conference call to discuss the company's first quarter
results.
Participants can access the conference call via telephone by dialing 800-573-4840
(U.S.) or 617-224-4326 (international). The passcode is 23275594. If accessing
the conference call by telephone, please dial in at least 10 minutes early to
minimize any delay in joining the call. A live audio-only Webcast is also
available through a link that is posted on the events page in the investor
relations section of Geron's Web site at geron.com. The audio Web
broadcast of the conference call will be available for replay within 60 minutes
following the live broadcast through May 30, 2011.
About Geron
Geron is developing first-in-class biopharmaceuticals for the treatment of cancer
and chronic degenerative diseases. The company is advancing anti-cancer therapies
through multiple Phase 2 clinical trials in different cancers by targeting the
enzyme telomerase and with a compound designed to penetrate the blood-brain
barrier. The company is developing cell therapy products from differentiated
human embryonic stem cells for multiple indications, including central nervous
system (CNS) disorders, heart failure, diabetes and osteoarthritis, and has
initiated a Phase 1 clinical trial in spinal cord injury. For more information,
visit geron.com.
This news release may contain 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 potential
applications of Geron's telomerase, oncology, and human embryonic stem cell
technologies, including plans and expectations for future clinical development
and future operating results, constitute forward-looking statements that involve
risks and uncertainties, including, without limitation, risks inherent in the
development and commercialization of potential products, the uncertainty and
preliminary nature of clinical trial results or regulatory approvals or
clearances, need to raise additional capital, dependence upon collaborators and
protection of our intellectual property rights. Actual results may differ
materially from the results anticipated in these forward-looking statements.
Additional information on potential factors that could affect our results and
other risks and uncertainties are detailed from time to time in Geron's periodic
reports filed with the Securities and Exchange Commission, including Geron's
annual report on Form 10-K for the year ended December 31, 2010. Undue reliance
should not be placed on forward-looking statements, which speak only as of the
date they are made, and, except as required by law. Geron disclaims any
obligation to update these forward-looking statements to reflect future events or
circumstances.
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
THREE MONTHS ENDED
MARCH 31,
-----------------------------
(In thousands, except share and per share data)20112010
---------------------
Revenues from collaborative agreements$150$225
License fees and royalties1,355693
---------------------
Total revenues1,505918
Operating expenses:
Research and development16,75513,545
General and administrative9,1063,850
---------------------
Total operating expenses25,86117,395
---------------------
Loss from operations(24,356)(16,477)
Unrealized gain on fair value of derivatives3958
Interest and other income296202
Losses recognized under equity method investment(335)(396)
Interest and other expense(33)(27)
----------- ----------- -
Net loss$(24,389)$(16,640)
===== =========== == ========== =
Basic and diluted net loss per share$(0.20)$(0.18)
===== =========== == ========== =
Shares used in computing basic and diluted net loss per share123,098,72895,012,100
===== =========== == ========== =
CONDENSED CONSOLIDATED BALANCE SHEETS
MARCH 31,DECEMBER 31,
(In thousands)20112010
------------------
(Unaudited)(Note 1)
Current assets:
Cash, restricted cash and cash equivalents$36,204$46,764
Current marketable securities127,915140,599
Other current assets6,0847,654
------------------
Total current assets170,203195,017
Noncurrent marketable securities43,18633,911
Property and equipment, net2,7943,088
Deposits and other assets8371,568
------------------
$217,020$233,584
========= ================== =========
Current liabilities$9,363$40,849
Stockholders' equity207,657192,735
------------------
$217,020$233,584
========= ================== =========
Note 1:Derived from audited financial statements included in the
company's annual
report on Form 10-K for the year ended
December 31, 2010.
SOURCE: Geron Corporation
Geron Corporation
Anna Krassowska, Ph.D.
Investor and Media Relations
650-473-7765
info@geron.com |
