Conference Call
Scheduled for 4:30 p.m. EST Today, November 7th
MENLO PARK, Calif., November
7, 2013 -- Geron Corporation (Nasdaq: GERN) today reported
financial results for the third quarter ended September 30,
2013.
For the third quarter of 2013, the company
reported a net loss of $8.3 million, or $0.06 per share, compared
to $16.0 million, or $0.13 per share, for the comparable 2012
period. Net loss for the first nine months of 2013 was $29.1
million, or $0.23 per share, compared to $53.0 million, or $0.42
per share, for the comparable 2012 period. The company ended the
third quarter of 2013 with $67.0 million in cash and
investments.
Revenues for the third quarter of 2013 were
$181,000, compared to $636,000 for the comparable 2012 period.
Revenues for the first nine months of 2013 were $1.1 million,
compared to $2.0 million for the comparable 2012 period. The
decrease in revenues for the three and nine month periods ending
September 30, 2013, compared to the same periods in 2012, primarily
reflects the recognition of a license payment from GE Healthcare
UK, Limited in the third quarter of 2012 and termination of the
company's license agreement with Asia Biotech Corporation in
December 2012. The license agreement with GE Healthcare UK, Limited
was transferred to Asterias Biotherapeutics, Inc. upon the closing
of the divestiture of the company's stem cell assets.
Total operating expenses for the third quarter of
2013 were $8.9 million, compared to $16.5 million for the
comparable 2012 period. Research and development expenses for the
third quarter of 2013 were $5.3 million, compared to $11.7 million
for the comparable 2012 period. General and administrative expenses
for the third quarter of 2013 were $3.5 million, compared to $4.8
million for the comparable 2012 period.
Total operating expenses for the first nine months
of 2013 were $30.7 million, compared to $55.3 million for the
comparable 2012 period. Research and development expenses for the
first nine months of 2013 were $18.1 million, compared to $39.6
million for the comparable 2012 period. General and administrative
expenses for the first nine months of 2013 were $11.6 million,
compared to $15.7 million for the comparable 2012 period.
Operating expenses for the 2013 third quarter and
year-to-date periods also included restructuring charges of
$116,000 and $1.0 million, respectively, related to the company's
decisions in April 2013 to discontinue its discovery research
programs and companion diagnostics program based on telomere
length, as well as close its research laboratory facility and
reduce its workforce.
The decrease in research and development expenses
for the three and nine month periods ending September 30, 2013,
compared to the same periods in 2012, primarily reflects reduced
personnel-related costs resulting from recent restructurings, lower
manufacturing costs for drug products and reduced clinical trial
expenses in connection with the wind-down of the imetelstat trials
in metastatic breast cancer and 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 nine month
periods ending September 30, 2013, compared to the same periods in
2012, primarily reflects reduced personnel-related costs resulting
from recent restructurings, lower costs for consulting services and
reduced costs for legal services associated with the company's
patent portfolio.
Non-cash operating expenses, which primarily
included stock-based compensation and depreciation, were
approximately $1.4 million and $4.6 million for the three and nine
month periods ended September 30, 2013, respectively, compared to
$2.0 million and $6.4 million for the comparable 2012 periods.
Interest and other income for the third quarter of
2013 amounted to $699,000, compared to $140,000 for the comparable
2012 period. Interest and other income for the first nine months of
2013 was $836,000, compared to $481,000 for the comparable 2012
period. The increase in interest and other income for the three and
nine month periods ending September 30, 2013, compared to the same
periods in 2012, primarily reflects a net gain on the sale of
excess laboratory equipment in connection with the closure of the
company's research laboratory facility, partially offset by a
decline in interest income due to lower cash and investment
balances in 2013. The company has not incurred any impairment
charges on its investment portfolio.
Company Events
Investigator-Sponsored Trial in
Myelofibrosis. 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", which means that they have achieved either a
clinical improvement (CI), partial remission (PR) or complete
remission (CR), consistent with the criteria of the 2013
International Working Group for Myeloproliferative Neoplasms
Research and Treatment (IWG-MRT). Secondary endpoints include
reduction of spleen size, improvement in anemia or inducement of
red blood cell transfusion independence, safety and
tolerability.
The investigator has informed Geron that more than
fifty patients have been enrolled in the IST. Enrollment of the
first 11 patients in the first cohort of MF patients (Cohort A) in
which the dose of imetelstat is given once every three weeks was
completed at the end of March 2013 and the pre-specified criteria
in the clinical protocol of at least two responders in the first 11
patients were met to enable expanded enrollment. Enrollment of the
first 11 patients of the second cohort of MF patients (Cohort B)
in which imetelstat was given weekly for four weeks, followed
by one dose every three weeks, was completed in May 2013 and the
pre-specified criteria in the clinical protocol of at least two
responders in the first 11 patients were met to enable expanded
enrollment. In addition, the investigator has informed the company
that enrollment has commenced in additional cohorts to evaluate the
safety and efficacy of imetelstat using different dosing
algorithms, as well as to evaluate imetelstat in different patient
populations, including patients with MF that has transformed into
AML, or blast-phase MF, and certain subpopulations of
myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN),
or MDS.
Certain preliminary data from patients enrolled in
Cohort A and Cohort B of the ongoing IST have been selected for
presentation in an oral session at the 55th American Society of
Hematology (ASH) Annual Meeting and Exposition to be held in New
Orleans, Louisiana from December 7-10, 2013. The presentation is
scheduled to occur on Monday, December 9, 2013 at 4:45 p.m. CST.
The preliminary data selected by the investigator was submitted as
an abstract by the investigator to ASH in August 2013.
John A. Scarlett, Geron's Chief Executive Officer
commented, "Pending additional input from regulators, investigators
and other experts, as well as further potential insights from the
ongoing IST, we expect to initiate a Geron-sponsored, multi-center
trial of imetelstat in MF in the first half of 2014."
Completion of Divestiture of
Human Embryonic Stem Cell Assets. On October 1, 2013, the
transaction to divest Geron's human embryonic stem cell assets
pursuant to the terms of the previously announced Asset
Contribution Agreement that was entered into in January 2013 with
BioTime, Inc. and BioTime's subsidiary, Asterias Biotherapeutics,
Inc. (formerly known as BioTime Acquisition Corporation) was
completed.
Conference Call
At 4:30 p.m. EST on November 7, 2013, Geron's
management will host a conference call to discuss the company's
third quarter results and recent events.
Participants can access the conference call live
via telephone by dialing 877-303-9139 (U.S.); 760-536-5195
(international). The passcode is 95357406. A live audio-only
webcast is also available at
http://edge.media-server.com/m/p/a6skpm7i/lan/en. The audio webcast
of the conference call will be available for replay approximately
one hour following the live broadcast through December 8, 2013.
About Geron
Geron is a clinical stage biopharmaceutical
company developing a first-in-class telomerase inhibitor,
imetelstat, in hematologic myeloid malignancies. For more
information about Geron, visit www.geron.com.
Use of Forward-Looking
Statements
Except for the historical information contained
herein, this press release contains forward-looking statements made
pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Investors are cautioned that
statements in this press release regarding Geron's plans or
expectations for or of: (a) initiation or timing of a
Geron-sponsored, multi-center trial of imetelstat in myelofibrosis
and (b) clinical development plans or success of imetelstat,
including imetelstat possibly having applicability for the
treatment of any hematologic myeloid malignancies, including
myelofibrosis, constitute forward-looking statements. These
statements involve risks and uncertainties that can cause actual
results to differ materially from those in such forward-looking
statements. These risks and uncertainties, include without
limitation, those risks and uncertainties inherent in the
development of potential therapeutic products, including without
limitation, that: since the data in the ASH abstract is preliminary
data, additional and updated safety and efficacy data from the IST
and other clinical trials may be negative; institutional review
boards or regulatory agencies may cause delays or prohibit any
clinical trials for imetelstat; there may be a shortage of drug
supply; the company may not have adequate financial resources;
clinical trial collaborators may not be willing to participate in a
clinical trial; there may be critical regulatory, commercial,
competitive, technical or scientific challenges; results from the
IST may not mean that imetelstat has applicability for the
treatment of myelofibrosis or any other hematologic myeloid
malignancies; there may be limitations on freedom to operate
arising from intellectual property of others; and it may not be
possible to protect Geron's intellectual property rights.
Additional information on the above risks and uncertainties and
additional risks, uncertainties and factors that could cause actual
results to differ materially from those in the forward-looking
statements are contained in Geron's periodic reports filed with the
Securities and Exchange Commission under the heading "Risk
Factors," including Geron's quarterly report on Form 10-Q for the
quarter ended September 30, 2013. Undue reliance should not be
placed on forward-looking statements, which speak only as of the
date they are made, and the facts and assumptions underlying the
forward-looking statements may change. Except as required by law,
Geron disclaims any obligation to update these forward-looking
statements to reflect future information, events or
circumstances.
CONTACT:
Anna Krassowska, Ph.D.
Investor and Media Relations
650-473-7765
investor@geron.com
media@geron.com
Financial table follows.
GERON
CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(UNAUDITED)
|
THREE
MONTHS ENDED |
NINE MONTHS
ENDED |
|
SEPTEMBER
30, |
SEPTEMBER
30, |
(In thousands, except share and per share
data) |
2013 |
2012 |
2013 |
2012 |
|
|
|
|
|
Revenues: |
|
|
|
|
License fees and royalties |
$ |
181 |
$ |
636 |
$ |
1,058 |
$ |
2,020 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
5,338 |
|
11,684 |
|
18,066 |
|
39,568 |
Restructuring charges |
|
116 |
|
- |
|
1,032 |
|
- |
General and administrative |
|
3,460 |
|
4,829 |
|
11,643 |
|
15,726 |
Total operating expenses |
|
8,914 |
|
16,513 |
|
30,741 |
|
55,294 |
Loss from operations |
|
(8,733) |
|
(15,877) |
|
(29,683) |
|
(53,274) |
|
|
|
|
|
|
|
|
|
Unrealized loss on derivatives |
|
(208) |
|
(44) |
|
(207) |
|
(10) |
Interest and other income |
|
699 |
|
140 |
|
836 |
|
481 |
Interest and other expense |
|
(12) |
|
(172) |
|
(44) |
|
(215) |
Net loss |
$ |
(8,254) |
|
(15,953) |
$ |
(29,098) |
$ |
(53,018) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.06) |
$ |
(0.13) |
$ |
$(0.23) |
$ |
(0.42) |
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net |
|
|
|
|
|
|
|
|
loss per share |
|
128,293,074 |
|
127,236,993 |
|
128,146,333 |
|
126,833,916 |
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In thousands) |
SEPTEMBER
30, |
DECEMBER
31, |
|
2013 |
2012 |
|
(Unaudited) |
(Note
1) |
|
|
|
Current assets: |
|
|
Cash, restricted cash and cash equivalents |
$ |
10,386 |
$ |
22,857 |
Marketable securities |
|
56,617 |
|
73,472 |
Other current assets |
|
1,399 |
|
2,088 |
Total current assets |
|
68,402 |
|
98,417 |
|
|
|
|
|
Property and equipment, net |
|
116 |
|
974 |
Deposits and other assets |
|
195 |
|
410 |
|
$ |
68,713 |
$ |
99,801 |
|
|
|
|
|
Current liabilities |
$ |
6,837 |
$ |
14,148 |
Stockholders' equity |
|
61,876 |
|
85,653 |
|
$ |
68,713 |
$ |
99,801 |
Note 1:
Derived from audited financial statements
included in the company's Annual Report on Form 10-K for the year
ended December 31, 2012.
###
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announcement is distributed by Thomson Reuters on behalf of Thomson
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(i) the releases contained herein are protected by copyright and
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(ii) they are solely responsible for the content, accuracy and
originality of the
information contained therein.
Source: Geron Corp. via Thomson Reuters ONE
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