Dr. Schwartz concluded, "I would also like to address our recent financial offering that allowed us to secure our cash balance for the year. While our ongoing, anticipated cash burn including current and planned clinical trials is expected to be between $11 to 13 million per quarter, we will also have non-recurring expenses as a result of the previously announced commercial divesture and settlement of the outstanding litigation. As such, it was important for us to enhance our balance sheet ahead of our expected milestones to ensure the company remains financially strong over the course of 2016."2016 Outlook: Galena expects to achieve a number of key milestones this year across its novel cancer immunotherapy programs. Effective immunotherapy treatment is associated with high numbers of cytotoxic T-Cells (CTLs), and it has been shown that increasing tumor specific CTLs is critical for overcoming many of the challenges associated with some of the current immunotherapy treatments. Galena's peptide based vaccines, NeuVax and GALE-301/302, have demonstrated, in multiple trials, they can effectively induce, activate and expand CTLs. Galena's vaccines harness the power of the patient's immune system to seek out and destroy any residual, or occult, cancer cells via their proven mechanism of action stimulating T-Cell proliferation and expansion. The Company's current programs are designed to prevent recurrence in breast, gastric, and ovarian cancers in the adjuvant setting where patients have relatively healthy immune systems. As the number of cancer survivors continues to grow, preventing recurrence of the disease becomes more important as metastatic tumors are most often fatal. Employing this approach, the company is currently engaged in multiple clinical trials with NeuVax and GALE-301/302 combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena's lead development asset, NeuVax, has several milestones upcoming for 2016:
- The pivotal, Phase 3 PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study is fully enrolled and is expected to reach two key milestones in the first half of the year. In the first quarter, the trial should see the 70 th patient event, which is defined as a recurrence or death from any cause. Once this occurs, the Independent Data Safety and Monitoring committee will evaluate the data and provide the company with the safety and futility interim analysis. This analysis is expected in the second quarter.
- The company expects to initiate a Phase 2 trial in patients with Ductal Carcinoma in Situ (DCIS) in the first quarter. This trial is being run in partnership with the National Cancer Institute.
- For the Phase 2b randomized, combination trial with NeuVax and trastuzumab, Galena expects to present interim safety data as well as patient immunology data on the A24 and A25 Human Leukocyte Antigen (HLA) status in the fourth quarter.
- Initiate a randomized, Phase 2b trial in ovarian cancer in the second half of this year based upon promising data from two ongoing trials: the GALE-301 Phase 2a clinical trial and the GALE-301/GALE-302 Phase 1b trial.
- Present GALE-301/302 booster data in the second quarter.
- Present GALE-301 Phase 2a, two-year data in the fourth quarter.
About Galena BiopharmaGalena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena's development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company's pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax is currently in a pivotal, Phase 3 clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers and in a Phase 1b given sequentially with GALE-302. For more information, visit 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 the development of Galena's product candidates, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates or that otherwise relate to future periods . 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, 2014 and most recent Quarterly Reports on Form 10-Q 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. NeuVax is a trademark of Galena Biopharma, Inc.
Contact:Remy Bernarda SVP, Investor Relations & Corporate Communications(925) 498-7709 email@example.com