Full Press Release Details
Geron Announces Removal
of Full Clinical Hold on Imetelstat IND
2014 Third Quarter and
Year-to-Date Financial Results Also Reported
November 3, 2014 Geron
Corporation (Nasdaq: GERN) announced today that the U.S. Food and Drug
Administration (FDA) has removed the full clinical hold on Geron s
investigational new drug (IND) application for imetelstat. In addition, the FDA
stated that Geron s proposed clinical development plan for imetelstat that is
focused on high-risk myeloid malignancies, such as myelofibrosis (MF), is
acceptable. The FDA acknowledged that the company does not intend to conduct
further studies in, or develop imetelstat for, the treatment of essential
thrombocythemia (ET) or polycythemia vera, which is consistent with the
company s plans as originally disclosed in April 2013.
To address the full clinical
hold, the FDA required Geron to provide follow-up information from
imetelstat-treated patients who experienced liver function test (LFT)
abnormalities until such abnormalities resolved to normal or baseline. Geron
obtained clinical follow-up information from patients in the previously ongoing
company-sponsored Phase 2 trials in ET and multiple myeloma (MM). These data
were submitted to the FDA as part of the company s complete response. The
company s analysis of these data concluded that in the ET trial LFT
abnormalities resolved to normal or baseline in 14 of 18 follow-up patients. For
the remaining four ET patients, at the time of the data cut-off, three patients
showed improvement in LFT abnormalities and one patient had unresolved LFT
abnormalities. Currently, two of the remaining four ET patients continue in
follow-up. In the MM trial, LFT abnormalities resolved to normal or baseline in
all nine follow-up patients. In addition, no emergent hepatic adverse events
were reported during follow-up for either study.
The FDA also requested
information regarding the reversibility of liver toxicity after chronic
imetelstat administration in animals. The company submitted data from its
previously conducted non-clinical toxicology studies, which included a six-month
study in mice and a nine-month study in cynomolgus monkeys. In these studies, no
clinical pathology changes indicative of hepatocellular injury were observed,
and no clear signal of LFT abnormalities were identified.
With the lift of the full
clinical hold, a multi-center Phase 2 clinical trial in MF is projected to begin
in the first half of 2015.
Geron's management plans to
provide an update on the company and development plans for imetelstat at the
Stifel Healthcare Conference. The audio and slide presentation will be webcast
and is scheduled to occur at 1:50 p.m. Eastern Time on Wednesday, November 19,
For the third quarter of 2014,
the company reported a net loss of $9.5 million, or $0.06 per share, compared to
$8.3 million, or $0.06 per share, for the comparable 2013 period. Revenues for
the third quarter of 2014 were $160,000 compared to $181,000 for the comparable
2013 period. The company ended the third quarter of 2014 with $142.5 million in
cash and investments.
Total operating expenses for
the third quarter of 2014 were $10.1 million compared to $8.9 million for the
comparable 2013 period. Research and development expenses for the third quarter
of 2014 were $6.0 million compared to $5.3 million for the comparable 2013
period. General and administrative expenses for the third quarter of 2014 were
$4.1 million compared to $3.5 million for the comparable 2013 period. Operating
expenses for the 2013 third quarter also included restructuring charges of
$116,000 in connection with the company s decisions to discontinue its discovery
research programs and close its research laboratory facility in the second
The increase in research and
development expenses for the third quarter of 2014, compared to the same period
in 2013, primarily reflected higher costs for the manufacturing of imetelstat.
The increase in general and administrative expenses for the third quarter of
2014, compared to the same period in 2013, was primarily the net result of
higher non-cash stock-based compensation expense and increased legal costs
associated with the purported securities lawsuits and derivative lawsuit filed
against the company, partially offset by reduced patent costs and transaction
fees associated with the stem cell divestiture which closed in October 2013.
Interest and other income for
the third quarter of 2014 amounted to $91,000 compared to $699,000 for the
comparable 2013 period. The decrease in interest and other income for the third
quarter of 2014, compared to the same period in 2013, was primarily the net
result of a gain on the sale of excess laboratory equipment in connection with
the closure of the company s research laboratory facility in 2013, partially
offset by higher interest income due to increased cash and investment balances
with the receipt of net cash proceeds from the underwritten public offering the
company completed in February 2014.
Nine Months Ended 2014
Net loss for the first nine
months of 2014 was $26.7 million, or $0.18 per share, compared to $29.1 million,
or $0.23 per share, for the comparable 2013 period. Revenues for the first nine
months of 2014 were $1.0 million compared to $1.1 million for the comparable
Total operating expenses for
the first nine months of 2014 were $28.3 million compared to $30.7 million for
the comparable 2013 period. Research and development expenses for the first nine
months of 2014 were $16.4 million compared to $18.1 million for the comparable
2013 period. General and administrative expenses for the first nine months of
2014 were $11.9 million compared to $11.6 million for the comparable 2013
period. Year-to-date operating expenses for 2013 also included restructuring
charges of $1.0 million.
The decrease in research and
development expenses for the first nine 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 company s discovery research programs, partially offset by higher costs for
the manufacturing of imetelstat. The increase in general and administrative
expenses for first nine months of 2014, compared to the same period in 2013, was
primarily the net result of higher non-cash stock-based compensation expense and
increased legal costs associated with the purported lawsuits, partially offset