Full Press Release Details
Corporation Reports Fourth Quarter and Annual 2009 Financial Results and
MENLO PARK, Calif.--(BUSINESS WIRE)--February 25, 2010--Geron
Corporation (Nasdaq: GERN) today reported financial results for the
fourth quarter and year ended December 31, 2009.
Fourth Quarter 2009 and Year End Results
Net loss applicable to common stockholders for the fourth quarter of
2009 was $18.4 million or $(0.20) per share, compared to $17.6 million
or $(0.22) per share for the comparable 2008 period. For fiscal 2009,
the company had net loss applicable to common stockholders of $70.4
million or $(0.80) per share, compared to $62.0 million or $(0.79) per
share for fiscal 2008.
In the fourth quarter of 2009, the company had revenues of $605,000,
compared to $544,000 for the comparable 2008 period. For fiscal 2009,
the company had revenues of $1.7 million, compared to $2.8 million for
fiscal 2008. Revenues in 2009 and 2008 reflected royalty and license fee
revenue and collaboration funding under various agreements. Revenues in
2008 also included receipt of a $1.5 million milestone payment.
Interest and other income for the fourth quarter of 2009 was $246,000,
compared to $1.0 million for the comparable 2008 period. For fiscal
2009, interest and other income was $1.4 million, compared to $5.5
million for fiscal 2008 which reflects the lower interest rate
environment during 2009. The company has not incurred any impairment
charges on its marketable securities portfolio.
In the fourth quarter of 2009, the company had operating expenses of
$19.0 million, compared to $18.2 million for the comparable 2008 period.
Research and development expenses for the fourth quarter of 2009 were
$15.3 million, compared to $14.2 million for the comparable 2008 period.
Research and development expenses increased primarily due to higher
non-cash compensation expense for equity-based awards. General and
administrative expenses for the fourth quarter of 2009 were $3.6
million, compared to $4.0 million for the comparable 2008 period.
For fiscal 2009, the company had operating expenses of $72.0 million,
compared to $69.8 million for fiscal 2008. Research and development
expenses for fiscal 2009 were $57.6 million, compared to $53.7 million
for fiscal 2008. Overall research and development expenses increased in
fiscal 2009 primarily as a result of hiring additional personnel and
increased clinical trial costs. General and administrative expenses for
fiscal 2009 were $14.3 million, compared to $16.2 million for fiscal
Clinical Development
Five presentations were given on Geron's telomerase inhibitor,
imetelstat sodium (GRN163L), at the American Association for Cancer
Research annual meeting. The presentations focused on the activity of
imetelstat sodium against cancer stem cells from non-small cell lung,
breast, pancreatic, prostate and pediatric neural tumors.
The U.S. Food and Drug Administration (FDA) placed Geron's IND
(Investigational New Drug application) for GRNOPC1, a cell therapy for
neurologically complete, subacute spinal cord injury, on clinical hold
after the company notified the agency of additional preclinical animal
study data. The data showed a higher frequency of cysts than had been
seen in numerous foregoing preclinical studies with clinical grade
GRNOPC1, including the IND-enabling studies. The characteristics of the
cysts were similar to what was observed in previous studies:
non-proliferative, confined to the injury site, smaller than the injury
cavity and not associated with adverse clinical outcomes.
Geron will complete a confirmatory preclinical study using GRNOPC1 that
has been characterized by new markers and assays, as agreed upon in
discussions with the FDA. As part of the ongoing plan to advance
clinical development to cervical patients, Geron had already initiated
this preclinical study in an animal model of cervical injury.
In discussions with the company, the FDA has advised that it concurs
with Geron that positive data from this study can be used to support
both release of the clinical hold related to Geron's pending IND and
expansion of the clinical trial to cervical patients.
Interim data were presented from the ongoing trial of imetelstat
sodium (GRN163L), a telomerase inhibitor drug, in patients with
refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer Therapeutics.
The data showed that current patient exposures to imetelstat are
exceeding the levels that have been associated with efficacy in several
models of human cancers and that telomerase inhibition has been observed
in tissue samples from patients, while minimizing hematological
toxicities through an alternative dosing schedule.
Interim data were presented from the Phase II trial of GRNVAC1, an
autologous dendritic cell vaccine targeting telomerase, in patients with
acute myelogenous leukemia (AML) at the 51st Annual Meeting of the
American Society of Hematology. The data showed that the endpoints of
safety and tolerability have been met. In addition, in the study a
number of high risk patients have entered the extended boost phase of
the vaccination regimen. These patients have been in remission for a
period ranging from four months to nearly two years. Analyses of minimal
residual disease by qPCR of WT-1, a tumor gene associated with
differentiation and proliferation of AML, showed that the 14 patients
who remain in complete remission are negative for WT-1.
Geron scientists published data in the journal Regenerative
Medicine demonstrating that dendritic cells (DCs) scalably
manufactured from human embryonic stem cells (hESCs) exhibit the normal
functions of naturally occurring human DCs found in the bloodstream.
These findings support the use of hESC-derived DCs in therapeutic
vaccine applications for cancer and other diseases.
Geron collaborators published data in Stem Cells showing
that oligodendrocyte progenitor cells (OPCs) derived from hESCs, when
transplanted into a rodent model of cervical spinal cord injury, reduced
tissue damage within the lesion and improved recovery of locomotor
function. These data provide preclinical proof-of-concept for the use of
GRNOPC1, Geron's hESC-derived oligodendrocyte progenitor product, in
patients with cervical spinal cord injuries.
Business Development, Finance and Intellectual Property
On February 19, 2009, Geron completed a public offering of 7,250,000
shares of the company's common stock at a public offering price of $6.60
per share. Total net proceeds after offering expenses were $45.9 million.