Geron Corp. : Geron Corporation Reports Fourth Quarter and Annual 2012
MENLO PARK, Calif., March 12, 2013 - Geron Corporation (Nasdaq: GERN) today
reported financial results for the fourth quarter and year ended December 31,
Fourth Quarter 2012 Results
Net loss for the fourth quarter of 2012 was $15.9 million, or $0.12 per share,
compared to $31.9 million, or $0.25 per share, for the comparable 2011 period.
Net loss for the fourth quarter of 2012 and 2011 included restructuring
charges of $2.7 million and $5.4 million related to the discontinuation of the
company's GRN1005 and stem cell programs, respectively. Net loss for the
fourth quarter of 2011 also included non-cash debt extinguishment charges of
$1.7 million resulting from the repayment of the loan to the California
Institute for Regenerative Medicine. The company ended 2012 with $96.3 million
in cash and investments.
In the fourth quarter of 2012, the company had revenues of $689,000, compared
to $251,000 for the comparable 2011 period. Revenues in both periods primarily
reflected license fees and royalties.
Interest and other income for the fourth quarter of 2012 was $2.6 million,
compared to $204,000 for the comparable 2011 period. In December 2012, the
company received $2.5 million in other income in connection with the
assignment of certain intellectual property related to the company's
telomerase activation technology.
In the fourth quarter of 2012, the company had operating expenses of $19.2
million, compared to $30.7 million for the comparable 2011 period. Research
and development expenses for the fourth quarter of 2012 were $11.8 million,
compared to $19.7 million for the comparable 2011 period. The decrease in
research and development expenses primarily was due to reduced scientific
supply costs and personnel-related costs as a result of the discontinuation of
the company's stem cell programs and reduced costs for the manufacturing of
imetelstat drug product resulting from the timing of manufacturing campaigns.
General and administrative expenses for the fourth quarter of 2012 were $4.7
million, compared to $5.5 million for the comparable 2011 period. The decrease
primarily was due to lower non-cash stock-based compensation expense.
Non-cash operating expenses for the fourth quarter of 2012 were approximately
$2.7 million, which primarily included stock-based compensation, write-downs
of excess lab equipment related to the GRN1005 program and expense for stock
issued for services. Non-cash operating expenses for the fourth quarter of
2011 were approximately $6.0 million, which primarily included stock-based
compensation, write-downs of excess lab equipment related to the company's
stem cell programs and expense for stock issued for services.
Year-End 2012 Results
For 2012, net loss was $68.9 million, or $0.54 per share, which included
restructuring charges of $2.7 million, compared to $96.9 million, or $0.78 per
share, for 2011, which included restructuring charges of $5.4 million and
non-cash debt extinguishment charges of $1.7 million.
Revenues for 2012 and 2011 were $2.7 million and $2.4 million, respectively,
reflecting funding under a collaborative agreement and license fees and
For 2012, interest and other income was $3.1 million, which included the
receipt of $2.5 million for the assignment of the company's telomerase
activation technology. Interest and other income was $1.0 million for 2011.
For 2012, the company had operating expenses of $74.5 million, compared to
$98.6 million for 2011. Research and development expenses for 2012 were $51.4
million, compared to $69.3 million for 2011. Overall, research and development
expenses decreased in 2012 as a net result of reduced scientific supply costs
and personnel-related costs due to the discontinuation of the company's stem
cell programs and reduced costs for the manufacturing of imetelstat drug
product resulting from the timing of manufacturing campaigns, partially offset
by higher costs for the company's GRN1005 program. General and administrative
expenses for 2012 were $20.4 million, compared to $23.8 million for 2011. The
decrease was primarily the net result of lower non-cash stock-based
compensation expense, partially offset by increased legal and consulting costs
associated with the company's intellectual property portfolio and the
divestiture of the company's stem cell programs.
Non-cash operating expenses for 2012 were approximately $9.1 million, which
primarily included stock-based compensation, depreciation, write-downs of
excess lab equipment related to the GRN1005 program and expense for stock
issued for services. Non-cash operating expenses for 2011 were approximately
$25.2 million, which primarily included stock-based compensation,
depreciation, write-downs of excess lab equipment related to the company's
stem cell programs and expense for stock issued for services.
*In December 2012, Geron reported positive clinical results from the Phase
2 trial of imetelstat, the company's first-in-class telomerase inhibitor,
in patients with essential thrombocythemia (ET) who did not respond to or
tolerate other therapies. ET is a chronic blood disorder that is
representative of a group of diseases known as myeloproliferative
neoplasms. The data, which showed durable hematologic and molecular
responses in patients treated with imetelstat, suggest a relatively
selective activity of imetelstat against the malignant progenitors driving
ET, and provide evidence to support a potential disease-modifying effect.
These findings were presented in an oral session at the 54th Annual
Meeting of the American Society of Hematology in Atlanta, GA, by Prof. Dr.
med. Gabriela M. Baerlocher of the University Hospital and University of
Bern, Switzerland, and a principal investigator of the trial.
The Phase 2 trial of imetelstat in ET was designed to provide
proof-of-concept for the potential use of the drug as a treatment for
hematologic myeloid malignancies, including myelofibrosis, myelodysplastic
syndromes and acute myelogenous leukemias. Based on the results from the
ET trial, Dr. Ayalew Tefferi at the Mayo Clinic has begun an
investigator-sponsored trial (IST) to evaluate the safety and efficacy of
imetelstat in patients with myelofibrosis and determine the optimal dose
and schedule for further evaluation. Geron is in the initial planning
stages of a company-sponsored trial in myelofibrosis, which will be
informed by data from the Mayo Clinic IST, if positive. In addition, Geron
intends to expand its directed program of ISTs in 2013 to other
hematologic myeloid indications, including acute myelogenous leukemias and
*In September, the company reported an unplanned interim analysis of its
randomized Phase 2 trial in advanced non-small cell lung cancer (NSCLC)
evaluating imetelstat as maintenance treatment following platinum-based
induction chemotherapy compared to observation. The analysis suggested a
modest trend of efficacy in favor of the imetelstat arm. Subsequently, in
December, the company reported the analysis of a pre-specified sub-group
of NSCLC patients based on a retrospective measurement of tumor telomere
length. This analysis suggested that patients whose tumors had short
telomeres at baseline experienced an increase in progression-free survival
when treated with imetelstat in comparison to patients in the control arm.
The treatment effect was not observed in imetelstat-treated patients whose
tumors had medium-to-long telomeres. The company has been refining and
evaluating candidate assays to prospectively measure telomere length in
individual patient tumor samples. The company recently completed an
updated analysis that included a more mature follow-up of clinical data
and a retest of patient tumor samples using a refined, prospective assay
to measure telomere length. In this analysis, the magnitude of the
treatment effect in patients whose tumors had short telomeres was not
reproduced. Geron is evaluating the impact of this updated analysis on its
plans for potential development of imetelstat in solid tumors,
includingNSCLC. Data from theNSCLC trialhave been accepted for
presentation at the American Association for Cancer Research annual
meeting to be held in April 2013.
*Andrew J. Grethlein, Ph.D., was appointed as Executive Vice President,
Technical Operations, and as a member of the executive management team.
Dr. Grethlein is a senior executive with over 20 years of biotechnology
industry experience. Dr. Grethlein is overseeing the Company's
manufacturing and quality functions. Dr. Grethlein previously served in a
similar capacity at Inspiration Biopharmaceuticals and was the Portfolio
Management Team Leader for Hematology at Ipsen S.A.
*Craig C. Parker was appointed as Senior Vice President, Corporate
Development, and as a member of the executive management team. Mr. Parker
has over 25 years experience in the science and business of the
biotechnology industry, and was most recently Senior Vice President,
Strategy and Corporate Development at Human Genome Sciences, Inc., until
its sale to Glaxo SmithKline in 2012.
*Olivia Bloom, formerly Vice President, Finance, Chief Accounting Officer
and Treasurer, was appointed as Senior Vice President, Finance, Chief
Financial Officer and Treasurer.
*Susan M. Molineaux, Ph.D., and Daniel M. Bradbury were appointed to the
company's board of directors. Dr. Molineaux joined the board's nominating
and corporate governance committee, and Mr. Bradbury joined the board's
audit committee. Dr. Molineaux has more than 20 years of biotechnology
industry experience and is currently serving as President of Calithera
Biosciences, Inc., which she co-founded in June 2010. Dr. Molineaux also
co-founded Proteolix, Inc. where she was responsible for leading the
development of Proteolix's second generation proteasome inhibitor,
carfilzomib (now marketed as Kryprolis), for the treatment of multiple
myeloma, from discovery through completion of clinical trials for
accelerated approval, until the company's acquisition by Onyx
Pharmaceuticals, Inc. in November 2009. Mr. Bradbury has nearly 30 years
of pharmaceutical and biotechnology industry experience. Mr. Bradbury
served as Chief Executive Officer of Amylin Pharmaceuticals, Inc., until
its acquisition by Bristol-Myers Squibb Company for approximately $7
billion in August 2012.
*In January 2013, Geron entered into an Asset Contribution Agreement with
BioTime, Inc. (BioTime) and BioTime's recently formed subsidiary, BioTime
Acquisition Corporation (BAC), that provides for the divestiture of
Geron's stem cell assets to BAC upon the closing of the transaction, which
is expected to occur no later than September 30, 2013.
Upon closing of the transaction, Geron will contribute to BAC its
intellectual property, cell lines and other assets related to Geron's
discontinued human embryonic stem cell programs, including the Phase 1
clinical trial in patients with acute spinal cord injury, as well as its
autologous cellular immunotherapy program. Geron will receive
approximately 6.5 million shares of Series A Common Stock of BAC.
Following the closing of the transaction, Geron will distribute the Series
A BAC Common Stock received from BAC to Geron's stockholders on a pro rata
basis (other than with respect to fractional shares and stockholders in
certain to-be-determined excluded jurisdictions, which will instead
receive cash on a pro rata basis).
At 9:00 a.m. ET on March 13th, Geron's management will host a conference call
to discuss the company's fourth quarter and year end results.
Participants can access the conference call via telephone by dialing
866-270-6057 (U.S.); 617-213-8891 (international). The passcode is 80790305. A
live audio-only webcast is also available at
http://edge.media-server.com/m/p/3328hz6w/lan/en. The audio webcast of the
conference call will be available for replay approximately one hour following
the live broadcast through April 12, 2013.
Geron is a biopharmaceutical company developing first-in-class therapies for
cancer, including its telomerase inhibitor, imetelstat, in clinical
development. 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) the reception of or dates to obtain or present
data or other results from any clinical trials, including the Mayo Clinic IST;
(b) clinical development plans or success of imetelstat, including imetelstat
possibly having applicability for the treatment of other progenitor
cell-driven hematologic malignancies, including myelofibrosis; (c)the future
development of imetelstat in solid tumors with short telomeres; and (d) the
closing of the BioTime/BAC transaction, 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: (a) regarding the
reception of or dates for the availability of data or other results - delays
in enrollment, delays caused by institutional review boards or regulatory
agencies, shortage of supply, dependence on clinical trial collaborators and
safety issues; (b) regarding clinical development plans or success of
imetelstat, including imetelstat possibly having applicability for the
treatment of other progenitor cell-driven hematologic malignancies, including
myelofibrosis, positive safety and efficacy data from the Mayo Clinic IST and
other clinical trials, including the ET clinical trial - those risks and
uncertainties inherent in the development of potential therapeutic products,
including without limitation, results from the ET trial may not mean that
imetelstat has applicability for the treatment of other progenitor cell-driven
hematologic malignancies, including myelofibrosis; technical and scientific
challenges; limitations on freedom to operate arising from intellectual
property of others and the protection of Geron's intellectual property rights;
(c) regarding the future development of imetelstat in solid tumors with short
telomeres - clinical, scientific,technical, and commercial challenges;
limitations on freedom to operate arising from intellectual property of others
and the protection of Geron's intellectual property rights; and (d) regarding
the closing of the BioTime/BAC transaction - the satisfaction of all the
closing conditions in the agreement. Additional information on the above risks
and uncertainties (a)-(d) and other 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'squarterly report on Form 10-Q for thequarter
endedSeptember 30, 2012. 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
Anna Krassowska, Ph.D.
Investor and Media Relations
Financial table follows.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED Year Ended
Three Months Ended December 31,
(In thousands, except 2012 2011 2012 2011
share and per share data)
Revenues from $- $- $- $300
License fees and royalties 689 251 2,709 2,138
Total revenues 689 251 2,709 2,438
Research and development 11,800 19,672 51,368 69,316
Restructuring charges 2,702 5,449 2,702 5,449
General and administrative 4,671 5,538 20,397 23,789
Total operating expenses 19,173 30,659 74,467 98,554
Loss from operations (18,484) (30,408) (71,758) (96,116)
Unrealized gain on 23 73 13 643
Interest and other income 2,616 204 3,097 1,024
Losses recognized under - - - (503)
equity method investment
Losses recognized from - (1,664) - (1,664)
Interest and other expense (18) (59) (233) (237)
Net loss $(15,863) $(31,854) $(68,881) $(96,853)
Basic and diluted net loss
Net loss per share $(0.12) $(0.25) $(0.54) $(0.78)
Shares used in computing 127,262,350 125,247,957 126,941,024 124,506,763
net loss per share
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, December 31,
(In thousands) 2012 2011
Cash, cash equivalents and restricted cash $22,857 $16,898
Current marketable securities 73,472 105,208
Other current assets 2,088 3,519
Total current assets 98,417 125,625
Noncurrent marketable securities - 32,133
Property and equipment, net 974 1,241
Deposits and other assets 410 1,048
Current liabilities $14,148 $13,444
Stockholders' equity 85,653 146,603
This announcement is distributed by Thomson Reuters on behalf of Thomson
The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.
Source: Geron Corp. via Thomson Reuters ONE
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