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 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 (
tage, Node-Positive Breast Cancer with Low to Intermediate HER2
reatment) study. The Phase 3 trial is ongoing and additional information on the study can be found at the recently updated website
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.