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Galena Biopharma Reports Second Quarter 2013 Financial Results

  • Galena to generate sales revenue in 2013 with significant progress towards Abstral® commercial launch in the fourth quarter.
  • NeuVax™ (nelipepimut-S) Phase 3 PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study enrolling patients in 11 countries and over 130 sites worldwide.
  • Net operating loss for the quarter ended June 30, 2013 was $7.9 million.

LAKE OSWEGO, Oregon, Aug. 8, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company commercializing and developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the three months and six months ended June 30, 2013 and provided a business update.

"We have made rapid progress towards successfully commercializing Abstral®," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "While the NeuVax™ PRESENT trial continues its enrollment and our other development programs advance, Galena has now evolved into a fully integrated biopharmaceutical company. Building our capabilities allows us to seize opportunities to better serve patients and increase shareholder value."

2Q 2013 Highlights
  • Significant progress towards U.S. commercialization of Abstral® (fentanyl) Sublingual Tablets. Abstral is an important treatment option for inadequately controlled breakthrough cancer pain (BTcP) in patients 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 of micronized fentanyl in a sublingual tablet, which dissolves under the tongue in seconds, provides rapid relief in minutes, and lasts the entire duration of the breakthrough pain episode. Key milestones towards Abstral commercialization have included:
  • Scaled up commercial operations with field leadership, field sales and account management teams in preparation for the official fourth quarter Abstral launch.
  • Abstral now available commercially nationwide. Galena has secured stocking and distribution partnerships with major wholesalers and specialty distributors, and Abstral is available to patients and health care professionals at pharmacies nationwide. Established broad and easy access to patient assistance programs to ensure efficient and timely patient access to Abstral treatment.
  • Data presentation at the American Pain Society 32 nd Annual Scientific Meeting outlined Abstral's sublingual Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program that served as a model for the current shared TIRF REMS program utilized by all products in the class. The TIRF REMS program is intended to minimize the risk of misuse, abuse, addiction and overdose. The U.S. Food and Drug Administration (FDA) has standardized key components of the REMS program to facilitate the adoption of a single shared system.
  • NeuVax™ (nelipepimut-S) presentation at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting showed durable response rates from the previously completed Phase 1/2 trial. NeuVax works by stimulating the body's own immune system via cytotoxic T lymphocytes (CTLs) to seek out and destroy micrometastatic cancer cells that may be circulating in a patient's body after their cancer treatment. The data demonstrated a correlation between the NeuVax-specific CTLs stimulated by the vaccine and a reduction in breast cancer recurrence in the women treated, further confirming the NeuVax mechanism of action.
  • Our lead product, NeuVax, is enrolling patients in two key trials. 
  • NeuVax is the first adjuvant breast cancer vaccine to enter pivotal Phase 3 clinical trials. Galena is currently enrolling its randomized, multi-national Phase 3 trial entitled PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment). The study is being conducted under a Special Protocol Assessment (SPA) granted by the FDA, and is currently enrolling in over 130 clinical sites worldwide.
  • A randomized, multicenter investigator-sponsored, 300 patient Phase 2b clinical trial is enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).
  • We strengthened the management team and expanded the Board of Directors with experts in oncology commercialization.
  • Christopher S. Lento joined Galena as its Vice President of Sales and Commercial Operations to launch Abstral. Mr. Lento has 20 years of experience in senior level positions managing the sales, business development and operations at major healthcare companies including Genentech BioOncology, Altos Solutions, Abraxis Bioscience (acquired by Celgene Corporation), and US Oncology Network.
  • William L. Ashton joined the Company's Board of Directors in May 2013. Mr. Ashton is a senior executive with more than twenty-eight years of experience in biotechnology and pharmaceutical leadership and management. Most recently, at Amgen, Inc., he served as Vice President of Corporate and Government Affairs and Vice President of Sales, and was directly responsible for product launches, as well as interaction with key government agencies including the Centers for Medicare and Medicaid Services. After retiring from Amgen, Mr. Ashton joined the University of the Sciences in Philadelphia where he currently serves as Associate Provost and Senior Vice President of Strategic Business Development, Founding Dean, Mayes College of Healthcare Business and Policy, and Assistant Professor of Pharmaceutical Business.

Second Quarter 2013 Financial Highlights

Operating loss for the three months ended June 30, 2013 was $7.9 million, including $0.5 million in stock-based compensation charges, compared with an operating loss of $5.7 million for the three months ended June 30, 2012, which includes $0.2 million in stock-based compensation charges. For the six months ended June 30, 2013, operating loss from continuing operations was $14.6 million compared with $10.1 million for the six months ended June 30, 2012.

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