Full Press Release Details
Corporation Reports 2011 Second Quarter Financial Results and Events
MENLO PARK, Calif.--(BUSINESS WIRE)--July 28, 2011--Geron Corporation
(Nasdaq: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
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.
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