- Lead product, NeuVax™ (nelipepimut-S), reached global site enrollment milestone for Phase 3 PRESENT trial; and commenced enrolling a Phase 2b in combination with Herceptin®.
- Completed Abstral® product acquisition in the U.S., with launch targeted in the 4th Quarter of 2013.
- Operating loss from continuing operations for the quarter ended March 31, 2013 of $6.6 million.
- Cash & marketable securities of $27.2 million, with a subsequent debt financing of $10 million—and outstanding tranche of another $5 million.
LAKE OSWEGO, Ore., May 9, 2013 (GLOBE NEWSWIRE) -- 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.
A video accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=18614
"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."1Q, 2013 Highlights
- Lead product, NeuVax (nelipepimut-S), 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 U.S. Food and Drug Administration (FDA), and is currently enrolling in over 125 clinical sites worldwide.
- A randomized, multicenter investigator-sponsored, 300 patient Phase 2b clinical trial began enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).
- Received the 2013 Global Frost & Sullivan Award for New Product Innovation for NeuVax. In March 2013, independent research firm, Frost & Sullivan, recognized Galena Biopharma with the 2013 Global Frost & Sullivan Award for New Product Innovation. Each year, Frost & Sullivan presents this award to the company that has developed an innovative element in a product by leveraging leading-edge technologies. The award recognizes the value-added features/benefits of the product and the increased ROI it offers customers, which, in turn, increases customer acquisition and overall market penetration potential.
- NeuVax mechanism of action video now available at http://www.neuvax.com/how-neuvax-works/ . The video can also be viewed on the www.galenabiopharma.com website.
- Acquired Abstral® (fentanyl) Sublingual Tablets in U.S., a Novel, Best-in-Class Treatment Approved for Breakthrough Cancer Pain. In March 2013, Galena acquired Abstral from Orexo AB (ORX.ST), an emerging specialty pharmaceutical company based in Sweden. Abstral was approved by the FDA in 2011, and is an important new 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. BTcP has been shown to affect as many as 40%-80% of cancer patients, with reported episodes of four per day and a median duration of 30 minutes. The innovative Abstral formulation delivers the analgesic power of micronized fentanyl in a sublingual tablet, which dissolves under the tongue within seconds. Abstral provides rapid relief of BTcP, predictable dosing, and is convenient and easy to use. It is the transmucosal immediate-release fentanyl (TIRF) market leader in Europe, and Galena expects to launch the drug into the $400 million U.S. market for TIRFs in in the fourth quarter of 2013.
- Strengthened the management team and expanded the Board of Directors with experts in oncology commercialization.
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.
- 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.