Full Press Release Details
Galena Biopharma Reports Third Quarter 2012 Financial Results
Lake Oswego, Oregon, November 13, 2012 Galena Biopharma, Inc. (NASDAQ: GALE), a biotechnology company focused on developing
innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, today reported its financial results for the quarter ended September 30, 2012 and provided a business update.
We have made significant progress in accelerating patient enrollment in the NeuVax Phase 3 PRESENT trial, said Mark J. Ahn, Ph.D.,
President and Chief Executive Officer. We have strengthened our team and intellectual property, and have opened 40 sites in North America and started opening an additional 40 sites in Western and Eastern Europe, Russia, Ukraine and Israel as
planned. 2013 will be a significant year of operational and business development milestones for the company.
Financial Highlights
Net loss for the three months ended September 30, 2012 was $6.3 million, or $0.09 per basic and diluted share,
versus a net loss of $5.5 million, or $0.13 per basic and diluted share for the three months ended September 30, 2011. Net loss for the nine months ended September 30, 2012 was $31.2 million, or $0.52 per basic and diluted share, versus a
net loss of $13.0 million, or $0.39 per basic and diluted share, for the nine months ended September 30, 2011.
continuing operations for the three months ended September 30, 2012 was $5.5 million, including $0.4 million in non-cash stock based compensations charges, compared with $3.4 million for the three months ended September 30, 2011, including
$0.7 million in non-cash stock based compensation charges. For the nine months ended September 30, 2012, operating loss from continuing operations was $15.6 million, including $1.3 million in non-cash stock based compensation charges, compared
with $8.9 million, including $2.1 million in non-cash stock based compensation charges, for the nine months ended September 30, 2011. There was no loss from discontinued operations for the three months ended September 30, 2012, as compared
to $1.6 million for the three months ended September 30, 2011. Loss from discontinued operations was $1.6 million for the nine months ended September 30, 2012 as compared to $5.9 million for the nine months ended September 30, 2011.
The period to period changes in net loss, loss from continued operations and loss from discontinued operations are primarily driven by Galena s ongoing, late-stage trial for its NeuVax product candidate and the spin-off of the former RXi
Pharmaceuticals subsidiary on April 27, 2012.
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 for the three months ended September 30, 2012 was $0.7 million versus other expense
of $0.4 million for the three months ended September 30, 2011. Other expense for the nine months ended September 30, 2012 was $13.9 million versus other income of $1.7 million for the nine months ended September 30, 2011.
As of September 30, 2012, Galena had cash and cash equivalents of $15.4 million, compared with cash and cash equivalents of $11.4 million as of
December 31, 2011. Galena also retains approximately 32.7 million shares of common stock of its former subsidiary, RXi Pharmaceuticals (OTCBB: RXII). The market value of the RXi shares held by Galena at September 30, 2012 was
approximately $3.6 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-S 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-S 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
According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually.
Of these women, about 75% test positive for HER2 (IHC 1+, 2+ or 3+). NeuVax targets approximately 50-60% of HER2-positive patients (IHC 1+/2+ or FISH <2.2) who 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(s) 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
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
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, 2011 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)
| Three | Three | Nine | Nine | |||||||||||||
| Months Ended | Months Ended | Months Ended | Months Ended | |||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | $ | 4,169 | $ | 1,367 | $ | 10,553 | $ | 1,757 | ||||||||
| General and administrative | 1,359 | 2,068 | 5,068 | 7,136 | ||||||||||||
| Operating loss | (5,528 | ) | (3,435 | ) | (15,621 | ) | (8,893 | ) | ||||||||
| Other income (expense), net | (733 | ) | (399 | ) | (13,953 | ) | 1,717 | |||||||||
| Net loss - continuing operations | (6,261 | ) | (3,834 | ) | (29,574 | ) | (7,176 | ) | ||||||||
| Net loss - discontinued operations | (1,641 | ) | (1,644 | ) | (5,898 | ) | ||||||||||
| Net loss | $ | (6,261 | ) | $ | (5,475 | ) | $ | (31,218 | ) | $ | (13,074 | ) | ||||
| Earnings per common share - basic and diluted | ||||||||||||||||
| Continuing operations | $ | (0.09 | ) | $ | (0.09 | ) | $ | (0.49 | ) | $ | (0.21 | ) | ||||
| Discontinued operations | $ | $ | (0.04 | ) | $ | (0.03 | ) | $ | (0.18 | ) | ||||||
| Net loss | $ | (0.09 | ) | $ | (0.13 | ) | $ | (0.52 | ) | $ | (0.39 | ) | ||||
| Weighted average shares outstanding - basic and diluted | 67,265,470 | 41,970,481 | 60,150,658 | 33,697,704 |
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
| September 30, | December 31, | |||||||
| 2012 | 2011 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,423 | $ | 11,433 | ||||
| Restricted cash | 101 | 101 | ||||||
| Prepaid expenses | 801 | 276 | ||||||
| Total current assets | 16,325 | 11,810 | ||||||
| Equipment and furnishings, net | 31 | 393 | ||||||
| In-process research and development | 12,864 | 12,864 | ||||||
| Goodwill | 5,898 | 5,898 | ||||||
| Deposits | 74 | 3 | ||||||
| Total assets | $ | 35,192 | $ | 30,968 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 4,222 | $ | 5,139 | ||||
| Current maturities of capital lease obligations | 6 | 35 | ||||||
| Convertible notes payable, current | 500 | |||||||
| Fair value of warrants potentially settleable in cash | 4,904 | 3,746 | ||||||
| Current contingent purchase price consideration | 925 | 1,782 | ||||||
| Total current liabilities | 10,057 | 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 | 5,866 | 4,569 | ||||||
| Total liabilities | 21,027 | 20,856 | ||||||
| Stockholders equity | 14,165 | 10,112 | ||||||
| Total liabilities and stockholders equity | $ | 35,192 | $ | 30,968 |
Toll free: +1 (855) 855-GALE (4253), ext. 109