Full Press Release Details
Geron Corporation Reports
Second Quarter 2014 Financial Results
Conference Call Scheduled
for 4:30 p.m. EDT Today, August 11th
Calif., August 11, 2014 -- Geron Corporation (Nasdaq: GERN) today reported
financial results for the second quarter ended June 30, 2014.
Second Quarter 2014 Results
For the second quarter of
2014, the company reported a net loss of $8.7 million, or $0.06 per share,
compared to $8.9 million, or $0.07 per share, for the comparable 2013 period.
Revenues for the second quarter of 2014 were $341,000 compared to $112,000 for
the comparable 2013 period. Interest and other income for the second quarter of
2014 amounted to $99,000 compared to $56,000 for the comparable 2013 period. The
company ended the second quarter of 2014 with $147.6 million in cash and
Total operating expenses for the second quarter of 2014 were $9.0
million compared to $9.1 million for the comparable 2013 period. Research and
development expenses for the second quarter of 2014 were $5.2 million compared
to $4.8 million for the comparable 2013 period. General and administrative
expenses for the second quarter of 2014 were $3.9 million compared to $3.4
million for the comparable 2013 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 close its
research laboratory facility.
The increase in research and development expenses
for the 2014 second quarter, compared to the same period in 2013, was primarily
the net result of higher costs for the manufacturing of imetelstat, partially
offset by reduced personnel-related and other research costs resulting from
previous restructurings and the discontinuation of the discovery research
programs. The increase in general and administrative expenses for the 2014
second quarter, compared to the same period in 2013, was primarily the net
result of higher non-cash stock-based compensation expense, partially offset by
lower patent costs and transaction expenses associated with the closing of the
stem cell divestiture in October 2013.
Six Months Ended 2014
Net loss for the first six
months of 2014 was $17.2 million, or $0.11 per share, compared to $20.8 million,
or $0.16 per share, for the comparable 2013 period. Revenues for the first six
months of 2014 were $815,000 compared to $877,000 for the comparable 2013
period. Interest and other income for the first six months of 2014 was $182,000
compared to $137,000 for the comparable 2013 period. The company has not
incurred any impairment charges on its investment portfolio.
Total operating expenses for
the first six months of 2014 were $18.2 million compared to $21.8 million for
the comparable 2013 period. Research and development expenses for the first six
months of 2014 were $10.4 million compared to $12.7 million for the comparable
2013 period. General and administrative expenses for the first six months of
2014 were $7.8 million compared to $8.2 million for the comparable 2013 period.
Year-to-date operating expenses for 2013 also included restructuring charges of
The decrease in research and
development expenses for the first six months of 2014, compared to the same
period in 2013, was primarily the net result of lower clinical trial expenses
with the wind-down of the imetelstat trials in solid tumors and GRN1005 trials
in patients with brain metastases and reduced personnel-related and other
research costs resulting from previous restructurings and the discontinuation of
the discovery research programs, partially offset by higher costs for the
manufacturing of imetelstat. The decrease in general and administrative expenses
for the first six months of 2014, compared to the same period in 2013, was
primarily the net result of lower patent costs and transaction expenses
associated with the closing of the stem cell divestiture in October 2013,
partially offset by higher non-cash stock-based compensation expense.
Recent Company Events
Clinical Hold on Myelofibrosis IST: In
June 2014, the U.S. Food and Drug Administration (FDA) removed the partial
clinical hold on the investigator-sponsored clinical trial of imetelstat in
myelofibrosis (Myelofibrosis IST). The partial clinical hold was placed in March
2014 due to a safety signal of hepatotoxicity that was identified in clinical
trials of imetelstat. In order to resolve the partial clinical hold, the
investigator, Dr. Ayalew Tefferi of Mayo Clinic, Rochester, Minnesota, was
required to provide follow-up information regarding reversibility of
hepatotoxicity for all patients who received imetelstat in the Myelofibrosis
IST. The investigator submitted a complete response to the FDA to seek release
of the partial clinical hold, and the FDA lifted the partial hold on June 11,
Sponsorship of Myelofibrosis IST and IND: In July 2014, Geron and Mayo Clinic entered into a
transfer agreement whereby the Investigational New Drug (IND) application for
imetelstat under which the Myelofibrosis IST has been conducted will be
transferred from Mayo Clinic to Geron. In addition, Geron will assume
sponsorship for the Myelofibrosis IST, and Dr. Ayalew Tefferi will remain as the
principal investigator for the study. The company and Mayo Clinic have agreed
that the IND and sponsorship responsibility for the conduct of the Myelofibrosis
IST will be transferred to Geron by September 30, 2014.
The Myelofibrosis IST
ceased enrolling patients in January 2014. Under Geron s sponsorship, the
patients remaining in the study which include patients with myelofibrosis
(MF), blast phase MF, and refractory anemia with ringed sideroblasts, a subtype
of the myelodysplastic syndromes (RARS-MDS) will continue to receive treatment
with imetelstat or continue in follow-up. Geron does not intend to enroll
additional patients in this study. The company plans to use the transferred data
and information from the Myelofibrosis IST to inform the design of Geron s
planned Phase 2 clinical trial in MF.
Update on Geron s Full
Clinical Hold: Geron s IND
for imetelstat remains on full clinical hold, affecting the company s clinical
trials in essential thrombocythemia or polycythemia vera and in multiple
myeloma. The company is working diligently to seek release of the full clinical
hold and is currently in the process of compiling preclinical and clinical
information from Geron-sponsored studies, as well as information available from
other imetelstat studies, such as the Myelofibrosis IST, regarding LFT
abnormalities and the incidence and reversibility of hepatotoxicity. Until the
FDA lifts the full clinical hold on Geron s IND, the company will be unable to
initiate any new clinical trials for imetelstat in the United States under that