GERN- CC29th & 2011 Second Quarter Financial Results and Events
MENLO PARK, Calif., Jul 28, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN)
today reported financial results for the three and six months ended June 30,
2011.
For the second quarter of 2011, the company reported a net loss of $21.1 million,
or $0.17 per share, compared to $17.0 million, or $0.18 per share, for the
comparable 2010 period. Net loss for the first six months of 2011 was $45.5
million, or $0.37 per share, compared to $33.7 million, or $0.35 per share, for
the comparable 2010 period. The company ended the quarter with $192.2 million in
cash and investments.
Revenues for the second quarter of 2011 were $462,000, compared to $1.0 million
for the comparable 2010 period. Revenues for the first six months of 2011 were
$2.0 million, compared to $1.9 million for the comparable 2010 period. Revenues
for the second quarter and year-to-date periods of 2011 and 2010 included funding
from collaboration agreements and royalty and license fee revenues under various
agreements.
Interest and other income for the second quarter of 2011 amounted to $287,000,
compared to $194,000 for the comparable 2010 period. Interest and other income
for the first six months of 2011 was $583,000, compared to $396,000 for the
comparable 2010 period which reflects the increase in cash and investment
balances. The company has not incurred any impairment charges on its marketable
debt securities portfolio.
Total operating expenses for the second quarter of 2011 were $21.9 million,
compared to $17.9 million for the comparable 2010 period. Research and
development expenses for the second quarter of 2011 were $16.5 million, compared
to $13.4 million for the comparable 2010 period. General and administrative
expenses for the second quarter of 2011 were $5.3 million, compared to $4.5
million for the comparable 2010 period.
Total operating expenses for the first six months of 2011 were $47.7 million,
compared to $35.3 million for the comparable 2010 period. Research and
development expenses for the first six months of 2011 were $33.3 million,
compared to $26.9 million for the comparable 2010 period. General and
administrative expenses for the first six months of 2011 were $14.4 million,
compared to $8.3 million for the comparable 2010 period.
Research and development expenses increased for the three and six month periods
ending June 30, 2011, compared to the same periods in 2010, as a result of higher
clinical drug product purchases and increased clinical trial expenses related to
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 GRNOPC1 Phase
1 trial and the initiation of the GRN1005 Phase 2 clinical trials in patients
with brain metastases. General and administrative expenses increased for the
three and six month periods ending June 30, 2011, compared to the same periods in
2010, primarily due to higher non-cash stock-based compensation expense.
Second Quarter 2011 Highlights:
GRNOPC1 Phase 1 Clinical Trial in Spinal Cord Injury
-- Geron was awarded $25.0 million by the California Institute for Regenerative
Medicine (CIRM) to support the clinical development of GRNOPC1, Geron's cell
therapy containing oligodendrocyte progenitor cells derived from human embryonic
stem cells (hESCs), currently in a Phase 1 trial in patients with spinal cord
injury. This is the first funding ever awarded by CIRM to support a clinical
trial since the agency was established in 2004. CIRM funding will provide
matching support in the form of a product-backed loan for clinical trial costs,
non-clinical studies, analytical development and the manufacture of cells for
clinical trials.
-- A second subject was enrolled and received GRNOPC1 in the ongoing Phase 1
clinical trial in patients with spinal cord injury. GRNOPC1 was administered by
investigators at Northwestern Memorial Hospital and Northwestern University
Feinberg School of Medicine, one of the seven participating clinical sites open
to patient enrollment.
-- Early data from the first two patients in the Phase 1 clinical trial showed no
safety concerns with no serious adverse events. The data included Day 180
follow-up assessments of the first patient to receive GRNOPC1. The data were
presented at the 2011 International Conference on Spinal Cord Medicine and
Rehabilitation and at the 2011 Spine Symposium, which was held as part of The
American Spinal Injury Association (ASIA) Annual Scientific Meeting.
-- Based on the early safety data from the Phase 1 clinical trial, Geron received
clearance from the FDA to expand the eligibility criteria to allow inclusion of a
wider range of patients. Patients with injuries resulting in a neurological level
of T11, which represent a substantial proportion of thoracic injuries, are now
eligible for the trial in addition to injuries between spinal segments T3 and T10
in the original criteria. The FDA also allowed the 30-day stagger between
enrollment of patients in the trial to be reduced to 10 days.
Imetelstat
-- The joint ASCO/AACR session at the 2011 ASCO Annual Meeting was titled,
"Telomeres and Telomerase in Cancer," highlighting the importance of telomerase
as a target for developing novel cancer therapies. Imetelstat, Geron's telomerase
inhibitor drug currently in Phase 2 clinical trials in four different cancers,
was featured in a presentation by Kathy D. Miller, M.D., Associate Professor and
Sheila D. Ward Scholar at the Indiana University Melvin and Bren Simon Cancer
Center and lead investigator of the company's ongoing Phase 2 study in patients
with breast cancer. The special session also included a presentation by the
session co-chair, Elizabeth H. Blackburn, Ph.D., joint-winner of the 2009 Nobel
Prize in Physiology or Medicine for her discoveries in the field of telomere
biology and telomerase, and a former Geron collaborator.
-- At the Jefferies 2011 Global Healthcare Conference in New York City in June,
an update on the Phase 2 clinical program was provided. Patient enrollment in the
two larger randomized clinical trials of imetelstat in patients with non-small
cell lung cancer and breast cancer is proceeding ahead of projections.
Senior Management Appointments
-- Melanie I. Nallicheri joined Geron as Senior Vice President, Corporate
Development. In her role, Ms. Nallicheri is responsible for overall strategic
planning, development of business plans, product/market competitive analyses,
commercialization strategies and pharmaceutical company alliances across
programs.
-- A number of appointments were made within the senior management team to
reflect Geron's clinical development stage and focus. Stephen Kelsey, M.D., was
appointed Executive Vice President, Head of Research & Development and Chief
Medical Officer; Jane Lebkowski, Ph.D., became Senior Vice President and Geron's
Chief Scientific Officer; and Melissa Kelly Behrs was appointed to Senior Vice
President, Strategic Portfolio Management.
Conference Call
At 8:00 a.m. PDT/11:00 a.m. EDT on July 29, 2011, David L. Greenwood, Geron's
president, will host a conference call to discuss the company's second quarter
and year-to-date results.
Participants can access the conference call live via telephone by dialing
800-591-6944 (U.S.); 617-614-4910 (international). The passcode is 38893153. 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 webcast
of the conference call will be available for replay approximately one hour
following the live broadcast through August 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 (BBB). 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.
Use of Forward-Looking Statements
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
quarterly report on Form 10-Q for the quarter ended March 31, 2011. 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 ENDEDSIX MONTHS ENDED
JUNE 30,JUNE 30,
----------------------------------------------------------
(In thousands, except share and2011201020112010
------------------------------------------
per share data)
Revenues from collaborative agreements$150$225$300$450
License fees and royalties3127761,6671,469
------------------------------------------
Total revenues4621,0011,9671,919
Operating expenses:
Research and development16,54413,38933,29926,934
General and administrative5,3344,48814,4408,338
------------------------------------------
Total operating expenses21,87817,87747,73935,272
------------------------------------------
Loss from operations(21,416)(16,876)(45,772)(33,353)
Unrealized gain on derivatives, net240172279230
Interest and other income287194583396
Losses recognized under equity method investment(168)(496)(503)(892)
Interest and other expense(31)(25)(64)(52)
----------- ------------ ------------- ------------ --
Net loss$(21,088)$(17,031)$(45,477)$(33,671)
== =========== ==== ========== ==== =========== ==== ========== ==
Basic and diluted net loss per share$(0.17)$(0.18)$(0.37)$(0.35)
== =========== ==== ========== ==== =========== ==== ========== ==
Shares used in computing basic and diluted net loss per share124,579,19096,712,059123,838,95995,862,080
== =========== ==== ========== ==== =========== ==== ========== ==
CONDENSED CONSOLIDATED BALANCE SHEETS
JUNE 30,DECEMBER 31,
(In thousands)20112010
-------------------------
(Unaudited)(Note 1)
Current assets:
Cash, restricted cash and cash equivalents$32,812$46,764
Current marketable securities119,756140,599
Other current assets4,6267,654
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Total current assets157,194195,017
Noncurrent marketable securities39,59233,911
Property and equipment, net2,5143,088
Deposits and other assets1,0301,568
--------------
$ 200,330$ 233,584
===== ============= =======
Current liabilities$9,270$40,849
Stockholders' equity191,060192,735
--------------
$ 200,330$ 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., 650-473-7765
Investor and Media Relations
info@geron.com |
