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galena biopharma inc (GALE) Key Developments

Galena Biopharma, Inc. - Special Call

To discuss the company's responses to the recommendations and provide an update on Abstral(fentanyl) sublingual tablets and the status of NeuVax (nelipepimut-S) enrollment

Galena Biopharma, Inc. Presents at EBD Group's Biopharm America 2014 Conference, Sep-22-2014

Galena Biopharma, Inc. Presents at EBD Group's Biopharm America 2014 Conference, Sep-22-2014 . Venue: Boston Marriott Copley Place, 110 Huntington Avenue, Boston, MA 02116, United States.

Galena Biopharma Provides Update on Phase 2 Clinical Trial

Galena Biopharma, Inc. announced the first patient has been dosed in the GALE-401, or Anagrelide Controlled Release (CR), Phase 2 Clinical Trial. The Phase 2 study will treat patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET). Based on discussions with the U.S. Food and Drug Administration (FDA) and pending a successful development program, Galena would pursue approval via the 505(b)(2) regulatory pathway. The Phase 2 trial is an open-label, single-arm, multicenter study of GALE-401 in 20 patients with MPN-related thrombocytosis. The goals of the study are to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to assess safety and tolerability, and to measure blood levels of the drug. The primary efficacy endpoint will be the proportion of subjects who achieve a complete or partial platelet response for at least four weeks during the first six months of treatment. MPNs encompass a family of diseases including essential thrombocythemia, polycythemia vera, primary myelofibrosis, and chronic myelogenous leukemia. The active ingredient immediate release version of anagrelide has been shown to reduce excessive platelet counts and has been approved by the FDA for treating high platelet counts in patients with MPNs. Anagrelide CR is Galena's new formulation of anagrelide that releases the active ingredient more slowly over time than currently marketed versions of this drug, and is therefore absorbed more slowly into the bloodstream.

Galena Biopharma, Inc. Announces Management Changes

Galena Biopharma, Inc. announced that Mark W. Schwartz, Ph.D., has been appointed as president and chief executive officer, effective immediately. Dr. Schwartz was previously Galena's executive vice president and chief operating officer. He replaces Mark J. Ahn, Ph.D. who has resigned as the president and CEO and as a director of the company to pursue other long held personal and professional goals. It is expected that Dr. Schwartz will also be appointed to Galena's board of directors. Dr. Schwartz brings more than 30 years of experience in the biotechnology and life science industry and was appointed executive vice president and chief operating officer in 2011 following Galena's acquisition of Apthera, Inc. where he served as the company's president and chief executive officer. Prior to Apthera, Dr. Schwartz served for five years as president and CEO of Bayhill Therapeutics.

Galena Biopharma, Inc. Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014; Provides Cash Flow Guidance for the Third Quarter 2014

Galena Biopharma, Inc. announced unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company announced net revenue was $2,331,000 compared to $0 a year ago. Operating loss was $15,783,000 compared to $7,986,000 for the same period a year ago. Loss before income taxes was $19,941,000 compared to $8,056,000 for the same period a year ago. Net loss was $19,941,000 compared to $9,597,000 for the same period a year ago. Net loss was $9,597,000 compared to $196,000 for the same period a year ago. Basic and diluted net loss per share was $0.17 compared to $0.11 for the same period a year ago. From a cash flow perspective, the company spent $13 million in operating activities compared to $8 million last quarter. For the six months, the company announced net revenue was $4,504,000 compared to $0 a year ago. Operating loss was $27,632,000 compared to $14,597,000 for the same period a year ago. Loss before income taxes was $22,477,000 compared to $20,111,000 for the same period a year ago. Net loss from continuing operations was $18,890,000 compared to $23,313,000 for the same period a year ago. Net loss was $22,477,000 compared to $18,890,000 for the same period a year ago. Basic and diluted net loss per share was $0.19 compared to $0.23 for the same period a year ago. The company, moving forward, expect net operating cash burn to stabilize in the range of $8 million to $10 million per quarter, due to factors including NeuVax Phase III completing enrollment, increasing profitability from commercial operations and expectation that a majority of ongoing legal fees will be reimbursed from insurance carrier.

 

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