Full Press Release Details
Geron Corporation Reports Second
Quarter 2013 Financial Results
Investigator-Sponsored Trial in Myelofibrosis
Conference Call Scheduled for 4:30
p.m. EDT Today, August 8th
MENLO PARK, CA, August 8, 2013
Geron Corporation (Nasdaq: GERN) today
reported financial results for the second quarter ended June 30, 2013.
For the second quarter of 2013, the
company reported a net loss of $8.9 million, or $0.07 per share,compared to $18.3 million, or
$0.14 per share, for the comparable 2012 period. Net loss for the first
was $20.8 million, or $0.16 per share, compared to $37.1 million, or $0.29 per
comparable 2012 period. The company ended the second quarter of 2013 with $71.6
million in cash and investments.
Revenues for the second quarter of 2013
were $112,000, compared to $130,000 for the comparable 2012 period. Revenues for the first
six months of 2013 were $877,000, compared to $1.4 million for the comparable 2012
Total operating expenses for the second
quarter of 2013 were $9.1 million, compared to $18.6 million for the comparable 2012 period.
Research and development expenses for the second quarter of 2013
compared to $12.8 million for the comparable 2012 period. General and
administrative expenses for the second quarter of 2013 were $3.4 million, compared to
$5.8 million for the comparable 2012 period. Operating expenses for the 2013 second quarter
also included restructuring charges of $838,000 in connection with the company s
decisions to discontinue its discovery research programs and companion diagnostics program
based on telomere length, as well as close its research laboratory
its workforce from 64 to 44 positions.
Total operating expenses for the first six
months of 2013 were $21.8 million, compared to $38.8 million for the comparable 2012 period.
Research and development expenses for the first six months of 2013
compared to $27.9 million for the comparable 2012 period. General and
administrative expenses for the first six months of 2013 were $8.2 million, compared to
$10.9 million for the comparable 2012 period. The year-to-date operating expenses for 2013 also included
restructuring charges of $916,000.
The decrease in research and development
expenses for the three and six month periods ending June 30, 2013, compared to the same
periods in 2012, primarily reflected reduced personnel-related costs resulting from the recent restructurings,
lower costs for the manufacturing of imetelstat and GRN1005 drug
reduced clinical trial expenses with the wind-down of the imetelstat trials in metastatic
advanced non-small cell lung cancer and GRN1005 trials in patients with brain
metastases. The decrease in general and administrative expenses for the three and six
month periods ending June 30, 2013, compared to the same periods in 2012, primarily reflected
reduced personnel-related costs resulting from the recent restructurings and lower legal costs associated
with the company s patent portfolio.
Non-cash operating expenses, which primarily
included stock-based compensation and depreciation, were approximately $1.6 million and $3.2
million for the three and six month periods ended June 30, 2013, respectively, compared to $2.1
million and $4.4 million for the comparable 2012 periods.
Interest and other income for the second
quarter of 2013 amounted to $56,000, compared to $165,000 for the comparable 2012 period.
Interest and other income for the first six months of 2013 was
to $341,000 for the comparable 2012 period. The decline in interest and other
income primarily reflected the decrease in cash and investment balances. The company has
not incurred any impairment charges on its investment portfolio.
Trial in Essential Thrombocythemia. In June 2013, Geron
presented updated clinical results
from the Phase 2 trial of imetelstat in patients with essential thrombocythemia (ET) at the Congress of
the European Hematology Association (EHA). The data showed durable hematologic and molecular responses
in patients, suggesting that imetelstat inhibited, in a relatively selective manner, the progenitor cells
of a malignant clone believed to be responsible for the underlying disease. The Phase 2 trial of imetelstat
in ET is no longer enrolling new patients, but the company continues to treat and follow patients previously
enrolled in the trial. The rationale for studying imetelstat in ET was to provide proof-of-concept for
further development of imetelstat in a broader range of hematologic myeloid malignancies, including myelofibrosis
(MF), where there is a clear unmet medical need for a product that could be disease-modifying.
Investigator-Sponsored
Trial in Myelofibrosis. Based on data from the Phase 2 clinical trial
of imetelstat in patients with ET,
in November 2012, Dr. Ayalew Tefferi at Mayo Clinic initiated an investigator-sponsored trial
(IST) to evaluate the safety and efficacy of imetelstat in patients with myelofibrosis (MF) and to determine
an appropriate dose and schedule for further evaluation. The trial is an open-label
study in patients with primary
MF, post-essential thrombocythemia MF
or post-polycythemia vera MF who
have two to three risk factors
(intermediate-2) or four or more risk factors (high risk) as defined by the Dynamic International
Prognostic Scoring System Plus (DIPSS Plus) described by Gangat, et al, in the Journal of Clinical
Oncology (2011). The primary endpoint is overall response rate, which is defined by the proportion of patients
who are classified as responders having achieved either a clinical improvement, partial remission, or complete
remission according to the International Working Group for Myelofibrosis Research and Treatment
(IWG-MRT) criteria. Secondary endpoints
include reduction of spleen size, transfusion independence, safety
The investigator has provided the
following communications to Geron regarding the status of the IST in
Enrollment of the first cohort of 11 patients in
which the dose of imetelstat was given once every three weeks was completed at the end of March
Pre-specified criteria in the clinical protocol of at least two
responders in the first cohort were met to enable expanded
Enrollment of the second cohort of 11 patients in
which the dose intensity of imetelstat was increased to levels similar to those used in the
ET trial was completed at the end of May 2013;
Pre-specified criteria in the clinical protocol of at least two
responders in the second cohort were met to enable further expanded
Additional cohorts to enable continued testing of
the effect of different dosing intensities of imetelstat are being considered by the
A protocol amendment to add a new cohort of 11
patients with MF that has transformed into acute myelogenous leukemia, known as
was recently approved by the Mayo Clinic
Institutional Review Board.
Data from this IST, if positive, will
inform any future Geron-sponsored clinical trial in patients with MF.