Full Press Release Details
Galena Biopharma Reports Year-End 2012 Financial Results
Lake Oswego, Oregon, March 12, 2013 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
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 31, 2011.
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
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 (OTCBB: RXII), 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
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 (CTL) 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.
Forward-Looking Statements
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 release.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF EXPENSES
(Amounts in thousands, except share and per share data)
| Year Ended December 31, 2012 | Year Ended December 31, 2011 | |||||||
| Expenses: | ||||||||
| 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 diluted | ||||||||
| Continuing operations | $ | (0.53 | ) | $ | (0.09 | ) | ||
| Discontinued operations | $ | (0.03 | ) | $ | (0.22 | ) | ||
| Net loss | $ | (0.56 | ) | $ | (0.32 | ) | ||
| Weighted average shares outstanding basic and diluted | 62,480,666 | 36,334,413 |
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
| December 31, 2012 | December 31, 2011 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| 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 | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 4,014 | $ | 5,139 | ||||
| Current maturities of capital lease obligations | 6 | 35 | ||||||
| Convertible notes payable, current | 500 | |||||||
| Fair value of warrants potentially settleable in cash | 10,964 | 3,746 | ||||||
| Current contingent purchase price consideration, current | 935 | 1,782 | ||||||
| Total current liabilities | 15,919 | 11,202 | ||||||
| Capital lease obligations, net of current maturities | 51 | 32 | ||||||
| Deferred tax liability, non-current | 5,053 | 5,053 | ||||||
| Contingent purchase price consideration, long term | 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 |
Toll free: +1 (855) 855-GALE (4253), ext. 109