Full Press Release Details
Galena Biopharma Reports First Quarter 2012 Financial Results
Lake Oswego, Oregon, May 14, 2012 Galena Biopharma (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 March 31, 2012 and provided an update on recent business developments.
Operating loss for the three months ended March 31, 2012 increased to $5.6 million, versus $5.2 million for the three months ended March 31, 2011. The
increase of $0.4 million in operating loss was due primarily to an increase of $1.5 million for research and development expense partially offset by a $1.1 million decrease in general and administrative expense. Net loss for the three months ended
March 31, 2012 was $24.8 million or $0.52 per share, versus a net loss of $3.8 million, or $0.19 per share, for the three months ended March 31, 2011. Other expense for the three months ended March 31, 2012 was $19.2 million, versus other income of
$1.4 million. The increase of $20.6 million in other expense was due primarily to an increase of $19.8 million in non-cash expense for the change in the fair value of warrants accounted for as a liability and an increase of $0.8 million in non-cash
expense related to the change in fair value of a contingent purchase price consideration liability.
As of March 31, 2012, the Company
had cash and cash equivalents of $8.7 million, compared with cash and cash equivalents of $11.4 million as of December 31, 2011. As of April 30, 2012, the Company s cash and cash equivalents totaled $24.9 million.
With additional funding from our April financing and the recent exercises of a majority of our outstanding warrants, we have approximately $25
million in cash to advance our late-stage cancer immunotherapy pipeline and have significantly simplified our capital structure, stated Mark J. Ahn, Ph.D., President and Chief Executive Officer. We are grateful for the support of our
shareholders throughout our transition over the past year, and we are tightly focused on accelerating our progress and building shareholder value. We continue to add investigational sites and accrue patients into our NeuVax Phase 3 PRESENT
trial, as well as advance clinical studies with both NeuVax in combination therapy and FBP.
Recent Business Highlights
About NeuVax (E75 + GM-CSF)
NeuVax consists of the E75 peptide derived from human epidermal growth factor receptor 2 (HER2) combined with the immune adjuvant 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. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months.
Based on a successful Phase 2 trial that achieved its primary endpoint of disease-free survival, the Food and Drug Administration granted NeuVax a Special Protocol Assessment 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 200,000 women in the U.S. are diagnosed with
breast cancer annually. Of these women, about 75% of them have breast cancer tissue that tests positive for some level of HER2 staining (IHC 1+, 2+ or 3+). Only 25% of all breast cancer patients, those with HER2 3+ disease, are eligible for
Herceptin (trastuzumab; Roche-Genentech), which had revenues of over $5 billion in 2010. NeuVax targets the 50%
of patients with tumors that stain low or intermediate for HER2 (HER2 1+ and 2+), who would not receive Herceptin after they successfully complete their surgery, adjuvant chemotherapy and radiation. This provides this large group of early stage
breast cancer patients an option for a HER2-targeted adjuvant treatment to maintain their disease-free status.
About Folate Binding
Protein (E39), or FBP
Folate Binding Protein (FBP) is a targeted vaccine aimed at preventing the recurrence of ovarian, endometrial, and
breast cancers. The FBP vaccine consists of the E39 peptide derived from the folate binding protein combined with the immune adjuvant granulocyte macrophage
colony stimulating factor (GM-CSF). FBP is over-expressed (20-80 fold) in more than 90% of ovarian and endometrial cancers, as well as 20 50% of breast, lung, colorectal, and renal cell
carcinomas. FBP has very limited tissue distribution and expression in non-malignant tissue, making it an ideal immunotherapy target.
cancer occurs in over 22,000 patients per year in the U.S. and is the most lethal gynecologic cancer. Although the incidence of ovarian cancer is only approximately 20% of that of breast cancer, the number of patients that die from ovarian cancer is
nearly 50% greater than the percentage of breast cancer patients who die from this disease. Endometrial cancer is the most common gynecologic cancer and occurs in over 46,000 women, with over 8,000 deaths in the U.S. annually. While many patients
respond to initial treatment and become clinically free of disease, the majority of these patients will relapse, and, once the disease recurs, the treatment options and successes drop dramatically.
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
possible benefits of the recent developments described above, 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 presentation.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF EXPENSES
(Amounts in thousands, except share and per share data)
| For the Three Months Ended March 31, 2012 | For the Three Months Ended March 31, 2011 | |||||||
| Research and development expense | $ | 3,671 | $ | 2,156 | ||||
| General and administrative expense | 1,939 | 3,119 | ||||||
| Operating loss | (5,610 | ) | (5,275 | ) | ||||
| Other income (expense), net | (19,151 | ) | 1,434 | |||||
| Net loss | $ | (24,761 | ) | $ | (3,841 | ) | ||
| Net loss per common share: | ||||||||
| Basic and diluted loss per share | $ | (0.52 | ) | $ | (0.19 | ) | ||
| Weighted average common shares outstanding: | ||||||||
| Basic and diluted | 47,967,499 | 20,316,170 |
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
| March 31, 2012 | December 31, 2011 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,701 | $ | 11,433 | ||||
| Restricted cash | 101 | 101 | ||||||
| Prepaid expenses | 290 | 276 | ||||||
| Total current assets | 9,092 | 11,810 | ||||||
| Equipment and furnishings, net | 351 | 393 | ||||||
| In-process research and development | 12,864 | 12,864 | ||||||
| Goodwill | 5,898 | 5,898 | ||||||
| Deposits | 3 | 3 | ||||||
| Total assets | $ | 28,208 | $ | 30,968 | ||||
| LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,581 | $ | 2,155 | ||||
| Accrued expenses and other current liabilities | 3,532 | 2,984 | ||||||
| Current maturities of capital lease obligations | 24 | 35 | ||||||
| Convertible notes payable | 500 | |||||||
| Fair value of warrants potentially settleable in cash | 20,357 | 3,746 | ||||||
| Current contingent consideration | 898 | 1,782 | ||||||
| Total current liabilities | 27,392 | 11,202 | ||||||
| Capital lease obligations, net of current maturities | 36 | 32 | ||||||
| Convertible notes payable, non-current | 1,000 | |||||||
| Deferred tax liability, non-current | 5,053 | 5,053 | ||||||
| Contingent consideration, net of current portion | 5,297 | 4,569 | ||||||
| Total liabilities | 38,778 | 20,856 | ||||||
| Stockholders (deficit) equity | (10,570 | ) | 10,112 | |||||
| Total liabilities and stockholders equity | $ | 28,208 | $ | 30,968 |
Toll free: +1 (855) 855-GALE (4253), ext. 109