Updates from Galena Biopharma (GALE)

MissionIR would like to highlight Galena Biopharma (NASDAQ: GALE), focused on developing and commercializing targeted oncology treatments to address major unmet medical needs and advance cancer care. The company’s peptide vaccine immunotherapies harness the patient’s own immune system to identify and destroy cancer cells. Utilizing peptide immunogens has many clinical advantages, including an excellent safety profile and long-lasting protection through immune system activation and convenient delivery.

In the company’s news,

Galena Biopharma has moved forward with its Phase IIb trial of NeuVax (nelipepimut-S or E75) combined with Herceptin as an adjuvant treatment in HER2 1+/2+ breast cancer patients. An investigator is conducting the trial in collaboration with the company.

Roche Holding subsidiary Genentech is responsible for providing Herceptin for the trial at no charge. Galena began enrolling patients in the trial in March 2013. The trial has been designed to randomize 300 breast cancer patients (1:1) – node positive or negative – who are disease-free following standard of care, comparing NeuVax plus Herceptin vs. Herceptin alone with a primary endpoint of disease-free survival (DFS) at 24 months.

Galena also recently reported data from its ongoing Phase I/IIa trial of FPB (folate binding protein or E-39) in ovarian cancer (OC) and endometrial cancer (EC). FBP is overexpressed in more than 90% of OC and EC, compared with limited expression in nonmalignant tissues, which is a feature that makes the drug a good immunotherapy target. Galena uses FBP (plus GM-CSF) as an adjuvant treatment for preventing cancer recurrence in high-risk OC and EC. Enrollment in the study begun in February 2012, and 20 patients have been enrolled to date. FBP-treated patients had an 11.1% recurrence, while untreated patients had a 27.3% occurrence – representing a 59% reduction.

Galena’s Abstral (fentanyl) sublingual tablets, which are indicated for managing breakthrough pain in cancer patients 18 years and older who are already receiving and are tolerant to opioid therapy, is projected to contribute $1.5 million in revenue in 2013 and $8.2 million in 2014. This is contrasted with management’s guided revenues of $1.5 million to $3 million in 2013 and $8 million to $12 million in 2014. The company’s 10-year DCF values NeuVax at $4/share and Abstral at $1/share. At this stage, Galena is not assigning a market value to FBP. The company believes its long-term risk-reward profile is favorable.

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Forward-Looking Statement:

This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.