Full Press Release Details
Galena Biopharma Reports First Quarter 2013 Financial Results
Lake Oswego, Oregon, May 9, 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 quarter ended March 31, 2013 and provided a business update.
We envision a day when breast cancer survivors can live free from fear of disease recurrence, and are focused on advancing NeuVax in both our Phase
3 PRESENT study and Phase 2b combination trial, said Mark J. Ahn, Ph.D., President and Chief Executive Officer. Also, with the acquisition of FDA-approved Abstral, I am more excited than ever about our prospects as we further accelerate
into a commercial company. Over the past two months, the Abstral team has made significant progress by transferring the New Drug Application two months ahead of schedule and reaching several regulatory, manufacturing, and clinical milestones, as we
drive towards commercial launch in the fourth quarter of this year.
First Quarter 2013 Financial Highlights
Operating loss for the quarter ended March 31, 2013 was $6.6 million, including $0.4 million in stock-based compensation charges, compared with an operating loss of $4.4 million for the quarter ended
March 31, 2012, which includes $0.7 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. These charges for the quarter ended March 31, 2013 were $5.4 million versus $19.1 million for the
quarter ended March 31, 2012.
Net loss (including both continued operations and discontinued operations) for the quarter ended
March 31, 2013 was $9.3 million, or $0.11 per basic and diluted share, versus a net loss of $24.8 million, or $0.52 per basic and diluted share, for the quarter ended March 31, 2012.
As of March 31, 2013, Galena had cash, cash equivalents and marketable securities of $27.2 million, compared with $35.6 million as of
December 31, 2012. Our marketable securities consist of approximately 33.5 million shares of common stock in RXi Pharmaceuticals (OTCBB: RXII), with a market value of approximately $9.7 million and $2.7 million at March 31, 2013 and
December 31, 2012, respectively. On May 8, Galena completed a debt financing of $15 million to fund the purchase and launch of Abstral, of which $10 million was drawn immediately.
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 (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 PRESENT trial is ongoing and additional information on the study can be
found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin (trastuzumab; Genentech/Roche).
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 Abstral (fentanyl) Sublingual Tablets
(fentanyl) Sublingual Tablets are an important new treatment option for inadequately controlled breakthrough cancer pain (BTcP) which impact 40%-80% of cancer patients. Abstral is approved by the FDA, and is a sublingual (under the tongue)
fentanyl tablet indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The innovative
Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a more convenient sublingual tablet which rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes,
and matches the duration of the entire pain episode.
About Galena Biopharma
Galena Biopharma, Inc. (NASDAQ: GALE) is a Portland, Oregon-based biopharmaceutical company developing 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 progress of patient enrollment in our clinical trials, as well as statements about expectations, plans and prospects for the commercialization of Abstral and 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 and Quarterly Report on Form 10-Q for the three months ended March 21, 2013 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 (unaudited)
(Amounts in thousands, except share and per share data)
| Three Months Ended March 31, 2013 | Three Months Ended March 31, 2012 | |||||||
| Expenses: | ||||||||
| Research and development | $ | 5,081 | $ | 2,664 | ||||
| General and administrative | 1,530 | 1,746 | ||||||
| Operating loss | (6,611 | ) | (4,410 | ) | ||||
| Other income (expense), net | (5,444 | ) | (19,130 | ) | ||||
| Pretax loss from continuing operations | (12,055 | ) | (23,540 | ) | ||||
| Income tax benefit | (2,762 | ) | ||||||
| Net loss from continuing operations | (9,293 | ) | (23,540 | ) | ||||
| Discontinued operations | (1,221 | ) | ||||||
| Net loss | $ | (9,293 | ) | $ | (24,761 | ) | ||
| Earnings per common share basic and diluted | ||||||||
| Continuing operations | $ | (0.11 | ) | $ | (0.49 | ) | ||
| Discontinued operations | $ | $ | (0.03 | ) | ||||
| Net loss | $ | (0.11 | ) | $ | (0.52 | ) | ||
| Weighted average shares outstanding basic and diluted | 83,002,323 | 47,967,499 |
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
| March 31, 2013 (unaudited) | December 31, 2012 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,481 | $ | 32,807 | ||||
| Restricted cash | 102 | 101 | ||||||
| Marketable securities | 9,709 | 2,678 | ||||||
| Prepaid expenses | 210 | 535 | ||||||
| Total current assets | 27,502 | 36,121 | ||||||
| Equipment and furnishings, net | 27 | 29 | ||||||
| In-process research and development | 12,864 | 12,864 | ||||||
| Abstral rights | 15,086 | |||||||
| Goodwill | 5,898 | 5,898 | ||||||
| Deposits | 74 | 74 | ||||||
| Total assets | $ | 61,451 | $ | 54,986 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 9,601 | $ | 4,014 | ||||
| Current maturities of capital lease obligations | 6 | 6 | ||||||
| Fair value of warrants potentially settleable in cash | 15,843 | 10,964 | ||||||
| Current contingent purchase price consideration, current | 929 | 935 | ||||||
| Total current liabilities | 26,379 | 15,919 | ||||||
| Capital lease obligations, net of current maturities | 51 | 51 | ||||||
| Deferred tax liability, non-current | 5,053 | 5,053 | ||||||
| Contingent purchase price consideration, long term | 6,656 | 6,207 | ||||||
| Total liabilities | 38,139 | 27,230 | ||||||
| Stockholders equity | 23,312 | 27,756 | ||||||
| Total liabilities and stockholders equity | $ | 61,451 | $ | 54,986 |
Senior Director, Communications