Galena Biopharma Reports Year-End 2012 Financial Results
*Operating loss from continuing operations for the year ended December 31,
2012 was $21.2 million, including $1.8 million in stock-based
*NeuVax™ (nelipepimut-S or E75) Phase 3 PRESENT trial being conducted under
a Special Protocol Assessment (SPA) is currently enrolling in over 100
clinical sites worldwide.
*Phase 2b clinical trial with NeuVax in combination with Herceptin®
(trastuzumab; Genentech/Roche) has been initiated with first of 300
patients to study.
LAKE OSWEGO, Ore., March 12, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma
(Nasdaq:GALE), a biopharmaceutical company developing innovative, targeted
oncology treatments that address major unmet medical needs to advance cancer
care, today reported its financial results for the year ended December 31,
2012 and provided a business update.
"2012 was a transformational year of progress for Galena Biopharma. We are now
a fully focused oncology company with assets in all three phases of
development, including our ongoing Phase 3 trial with NeuVax™ currently
enrolling patients at over 100 sites globally," said Mark J. Ahn, Ph.D.,
President and Chief Executive Officer. "To start 2013, we are pleased to
announce that we have initiated our Phase 2b trial of NeuVax in combination
with Herceptin® (trastuzumab; Genentech/Roche) through a collaborative
Investigator Sponsored Trial."
*Lead product, NeuVax (nelipepimut-S or E75), is the first adjuvant breast
cancer vaccine to enter pivotal Phase 3 clinical trials. NeuVax consists
of the synthetic E75 peptide derived from the HER2 oncogene product
combined with the immune stimulant granulocyte macrophage-colony
stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic
(CD8+) T cells in a highly specific manner to target cells expressing any
level of HER2. Based on promising Phase 2 results, Galena initiated a
randomized, multi-national Phase 3 trial entitled PRESENT (Prevention of
Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to
Intermediate HER2 Expression with NeuVax™ Treatment). The Phase 3 study is
being conducted under a Special Protocol Assessment (SPA) granted by the
FDA, and is currently enrolling in over 100 clinical sites worldwide.
*Multiple data presentations of NeuVax at major clinical and scientific
meetings demonstrate the safety and efficacy of the vaccine to prevent
recurrence in women with HER2 negative breast cancer (low-to-intermediate
expression, IHC levels of 1+ or 2+ and a FISH rating of less than 2.0).
*Final Phase 2 trial data were presented at the 35^th Annual CTRC-AACR
San Antonio Breast Cancer Symposium (SABCS). The combined SN-33 (Node
Positive) and SN-34 (Node Negative) Intent-to-treat (ITT) population
continued to demonstrate an excellent safety and efficacy profile. Phase
2 HER2 IHC 1+/2+ patients from SN-33 established the Phase 3 patient
population. After establishing statistical significance at the 36-month
Landmark Analysis, or the same endpoint as the ongoing Phase 3 trial,
the 60-month Landmark Analysis demonstrated a 5.6% recurrence rate with
NeuVax vs. a 25.9% recurrence rate in the control arm—a recurrence
reduction of 78.4%. Booster inoculations, which are included in the
PRESENT trial, were shown to be well-tolerated and appear to maintain
long-term peptide-specific immunity and reduce disease recurrence rates.
In the Phase 1/2 trial, boosted patients have lower recurrence rates and
improved disease-free survival compared to patients who did not receive
*At the 27^th Annual Meeting of the Society for Immunotherapy of Cancer
(SITC), data showed that vaccine treated patients were more likely to
show a decrease in Circulating Tumor Cells (CTCs) than control patients.
CTCs are cells that have detached from the primary breast tumor and
circulate in the bloodstream, and may then cause the growth of
additional tumors (metastases) in different tissues. In 16/26 NeuVax
treated patients with at least two CTC measurements, the CTCs decreased
during the time of treatment, corresponding with an increase in the
patients' E75-specific CD8+ cytotoxic T-lymphocytes (killer T-cells) and
an increase in their delayed type hypersensitivity (DTH) reactions. DTH
is the measurable signal on the skin that the patient is immunologically
responding to the vaccine. None of these patients had a recurrence of
their cancer during the five-year follow-up period.
*Solidified three key collaborations to advance NeuVax.
*Signed an agreement with a subsidiary of Teva Pharmaceutical Industries
Limited for the commercialization of NeuVax in Israel. Under the
agreement, Teva Israel will assume responsibility for regulatory
registration in Israel, provide financial support for local development,
and will commercialize the product in the region. Israel is the location
of at least four clinical trial sites for the PRESENT study.
*Announced a partnership with Leica Biosystems to develop a companion
diagnostic for HER2 screening in women with breast cancer. Leica's Bond
Oracle™ HER2 IHC System companion diagnostic will be used to support the
selection of the appropriate patients for the NeuVax PRESENT study. Data
will be presented at the 2013 American Society of Clinical Oncology
(ASCO) Annual Meeting in June.
*Based on encouraging results of a Phase 2a trial, a randomized,
multicenter investigator sponsored Phase 2b clinical trial has been
initiated with the first of 300 patients to study NeuVax in combination
with Herceptin® (trastuzumab; Genentech/Roche). "Trastuzumab has been a
breakthrough treatment for breast cancer patients and has clinically
validated the HER2 target, yet only addresses 25% of HER2 breast cancer
patients," stated COL George E. Peoples, MD, FACS, Director, Cancer
Vaccine Development Program; Deputy Director, United States Military
Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson
Cancer Center; Professor, Surgery, Uniformed Services University; Chief,
Surgical Oncology, Brooke Army Medical Center (BAMC). "The combination
use of NeuVax with Herceptin may expand the use of both products to the
remaining 50-60% of breast cancer patients with low-to-intermediate HER2
expression who are not eligible to receive Herceptin therapy.
Furthermore, this trial may provide confirmation data of a synergistic
effect of the combination that may also extend to those patients already
eligible for Herceptin."
*Received approval from the United States Adopted Names (USAN) Council for
nonproprietary name, "nelipepimut-S" (pronounced nel i pep' i mut) for
NeuVax. The USAN Council serves health professions of the United States by
selecting simple, informative and unique nonproprietary names for drugs by
establishing logical nomenclature classifications based on pharmacological
and/or chemical relationships.
*Issued two key patents:
*The U.S. Patent and Trademark Office issued a patent covering the use of
NeuVax for inducing immunity to breast cancer recurrence in HER2
negative patients (low-to-intermediate expression, IHC levels of 1+ or
2+ and a FISH rating of less than 2.0). The patent covers the use of
NeuVax for treating the Phase 3 target population of low-to-intermediate
(IHC 1+/2+) HER2 patients, and provides NeuVax exclusivity for this
indication until 2028, not including any patent term extensions.
*The Japan Patent Office issued a Folate Binding Protein (FBP) cancer
vaccine patent in Japan providing exclusivity until 2022. This
Composition of Matter and Treatment patent covers FBP peptide variants
for individual or expanded use in combination with the novel FBP
*Initiated a Phase 1/2 trial with Folate Binding Protein (E39), or FBP,
Targeted Peptide Vaccine in Ovarian and Endometrial Cancer Patients. FBP
is Galena's second targeted cancer vaccine, which contains the E39
peptide, an antigen that is over-expressed (20-80 fold) in more than 90%
of ovarian and endometrial cancers. Results on the Phase 1 portion of this
trial will be reported at the 2013 ASCO Annual Meeting in June.
*Significantly strengthened the management team and expanded the Company's
Scientific Advisory Board (SAB) with esteemed oncology experts.
*Rosemary Mazanet, M.D., Ph.D., joined Galena as Executive Vice President
and Chief Medical Officer, and Lynn Sutton, RN, MN, NP was appointed
Vice President, Clinical Operations.
*Joining the advisory board were: Hope S. Rugo, M.D., Clinical Professor
of Medicine in the Division of Hematology and Oncology at the University
of California San Francisco Helen Diller Family Comprehensive Cancer
Center; Gabriel N. Hortobagyi, M.D., F.A.C.P., Professor of Medicine and
Chairman of the Department of Breast Medical Oncology and holds the
Nellie B. Connally Chair in Breast Cancer Research at the University of
Texas MD Anderson Cancer Center; and Robert Figlin, M.D., F.A.C.P.,
Associate Director of the Academic Development Program and Director of
the Division of Hematology/Oncology at Cedars-Sinai's Samuel Oschin
Comprehensive Cancer Institute. Dr. Figlin is board-certified in both
medical oncology and internal medicine.
*Completed the Spin-Off of RXi Pharmaceuticals. One-for-one RXi
Pharmaceuticals stock dividend was paid to Galena stockholders as of the
payment date in April 2012. Galena retains a significant equity interest
in RXi (33.5 million shares of RXi common stock with a value of
approximately $9.0 million as of March 11, 2013), with potential to
receive up to $45 million in milestone payments.
Fiscal Year 2012 Financial Highlights
Operating loss from continuing operations (which excludes the discontinued
operations of RXi Pharmaceuticals) for the year ended December 31, 2012 was
$21.2 million, including $1.8 million in stock-based compensation charges,
compared with $12.5 million for the year ended December 31, 2011, including
$2.5 million in stock-based compensation charges.
Galena Biopharma also incurs income or expense due to non-cash charges related
to changes in the fair value estimates of the Company's warrant liabilities
and contingent purchase price liability, referred to as "Other income or
expense."Other expense, net, for the year ended December 31, 2012 was $13.2
million versus other income, net of $9.1 million for the year ended December
Loss from discontinued operations (RXi Pharmaceuticals) for the year ended
December 31, 2012 was $1.6 million, as compared to $8.0 million for the year
ended December 31, 2011. The year-to-year changes in net loss, loss from
continued operations and loss from discontinued operations are primarily
driven by Galena's ongoing clinical trials for its NeuVax product candidate
and the spin-off of the former RXi Pharmaceuticals subsidiary in April 2012.
Net loss (including both continued operations and discontinued operations
associated with RXi Pharmaceuticals) for the year ended December 31, 2012 was
$35.0 million, or $0.56 per basic and diluted share, versus a net loss of
$11.5 million, or $0.32 per basic and diluted share for the year ended
December 31, 2011.
As of December 31, 2012, Galena had cash, cash equivalents and marketable
securities of $35.5 million, compared with $11.4 million as of December 31,
2011. Galena retained approximately 33.5 million shares of common stock in
RXi Pharmaceuticals, which are reported as marketable securities at fair value
on the balance sheet. The market value of the RXi shares held by Galena at
March 11, 2013 was approximately $9.0 million.
About NeuVax™ (nelipepimut-S or E75)
NeuVax™ (nelipepimut-S) is the immmunodominant nonapeptide derived from the
extracellular domain of the HER2 protein, a well-established target for
therapeutic intervention in breast carcinoma. The nelipepimut sequence
stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to
HLA-A2/A3 molecules on antigen presenting cells (APC). These activated
specific CTLs recognize, neutralize and destroy, through cell lysis, HER2
expressing cancer cells, including occult cancer cells and micrometastatic
foci. The nelipepimut immune response can also generate CTLs to other
immunogenic peptides through inter- and intra-antigenic epitope spreading.
Based on a successful Phase 2 trial, which achieved its primary endpoint of
disease-free survival (DFS), the Food and Drug Administration (FDA) granted
NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention
of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to
Intermediate HER2 Expression with NeuVax Treatment) study. The Phase 3 trial
is ongoing and additional information on the study can be found at the
recently updated website www.neuvax.com.
According to the National Cancer Institute, over 230,000 women in the U.S. are
diagnosed with breast cancer annually. Of these women, only about 25% are HER2
positive (IHC 3+). NeuVax targets the approximately 50%-60% of these women who
are HER2 negative (IHC 1+/2+ or FISH < 2.2) and achieve remission with current
standard of care, but have no available HER2-targeted adjuvant treatment
options to maintain their disease-free status.
About Folate Binding Protein (FBP)
Folate Binding Protein (FBP) is highly over-expressed in breast, ovarian and
endometrial cancers and is a well-validated therapeutic target. FBP is the
source of immunogenic peptides like E39 that can stimulate cytotoxic T
lymphocytes (CTL) to recognize and destroy preclinical FBP-expressing cancer
cells. The FBP vaccine consists of the FBP peptide combined with the immune
adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena's
FBP vaccine, E39, is currently in a Phase 1/2 trial in two gynecological
cancers: ovarian and endometrial adenocarcinomas.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company that develops innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer care.For
more information please visit us at www.galenabiopharma.com.
The Galena Biopharma, Inc. logo is available at
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.Such statements include,
but are not limited to, statements about the preliminary results of the trends
in CTS in patients treated with NeuVax, as well as statements about
expectations, plans and prospects for the development of Galena's product
candidates.These forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including those identified under "Risk Factors"
in Galena's Annual Report on Form 10-K for the year ended December 31, 2012
filed with the SEC.Actual results may differ materially from those
contemplated by these forward-looking statements. Galena does not undertake to
update any of these forward-looking statements to reflect a change in its
views or events or circumstances that occur after the date of this press
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF EXPENSES
(Amounts in thousands, except share and per share data)
Year Ended Year Ended
December 31, 2012 December 31, 2011
Research and development $ 14,614 $ 3,851
General and administrative 6,585 8,635
Operating loss (21,199) (12,486)
Other income (expense), net (13,178) 9,079
Pretax loss - continuing operations (34,377) (3,407)
Income tax benefit (1,052) --
Loss from continuing operations (33,325) (3,407)
Net loss- discontinued operations (1,644) (8,078)
Net loss $ (34,969) $ 11,485
Earnings per common share - basic and
Continuing operations $ (0.53) $ (0.09)
Discontinued operations $ (0.03) $ (0.22)
Net loss $ (0.56) $ (0.32)
Weighted average shares outstanding – 62,480,666 36,334,413
basic and diluted
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
December 31, December 31,
Cash and cash equivalents $ 32,807 $ 11,433
Restricted cash 101 101
Marketable securities 2,678 --
Prepaid expenses 535 276
Total current assets 36,121 11,810
Equipment and furnishings, net 29 393
In-process research and development 12,864 12,864
Goodwill 5,898 5,898
Deposits 74 3
Total assets $ 54,986 $ 30,968
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 4,014 $ 5,139
Current maturities of capital lease 6 35
Convertible notes payable, current -- 500
Fair value of warrants potentially 10,964 3,746
settleable in cash
Current contingent purchase price 935 1,782
Total current liabilities 15,919 11,202
Capital lease obligations, net of current 51 32
Deferred tax liability, non-current 5,053 5,053
Contingent purchase price consideration, 6,207 4,569
Total liabilities 27,230 20,856
Stockholders' equity 27,756 10,112
Total liabilities and stockholders' equity $ 54,986 $ 30,968
CONTACT: Madeline Hatton
Toll free: +1 (855) 855-GALE (4253), ext. 109
IR Sense, LLC
+1 (503) 400-6995
Galena Biopharma, Inc.
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