Galena Biopharma, Inc. (NASDAQ:GALE) announced an update on the status of the Company and its most advanced clinical development program.
Galena’s primary focus is the evaluation of strategic alternatives initiated in the first quarter of this year. With the support of Canaccord Genuity, Galena has had extensive interactions with numerous companies to explore options for monetizing some or all of its clinical development programs through a license or sale of the assets, and/or transforming the Company via a sale, merger, reverse merger, or business combination with another company. While Galena is working through its strategic alternatives process, management has significantly reduced the staffing levels and certain operational expenses to preserve cash, although work remains ongoing to advance its two core clinical programs, GALE-401 and NeuVax™ (nelipepimut-S), and maintain their value.
For NeuVax, Galena continues to support the ongoing investigator sponsored studies, and today provided an update on the Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ patients in combination with trastuzumab. According to the latest report from the clinical research organization (CRO) conducting the trial, the study is nearly fully enrolled with 293 of the 300 patients enrolled to date. At the current pace, the CRO expects enrollment of the final 7 patients over the next few weeks with the interim analysis performed by the Data Safety Monitoring Board to occur six months after the final patient is enrolled.
Separately, Galena filed an S-1 registration statement (post effective amendment to S-3 on Form S-1) today to address our current S-3 ineligibility. The purpose of the S-1 registration statement, as filed, is to register currently outstanding warrants as we had notified warrant holders that we would update the ineffective S-3 through such a filing. All of the warrants are out of the money.
“While I am relatively new to Galena, I understand the road many of our shareholders have traveled in their investment with the Company, and I am very focused on seeking the best possible outcome from our strategic process that will maximize the opportunity for a financial return,” stated Stephen F. Ghiglieri, Interim Chief Executive Officer and Chief Financial Officer. “Given the challenges that Galena has faced, we are diligently addressing all aspects of our business and proactively removing potential impediments to executing a transaction. Reducing our expenses and simplifying our capital structure is paramount for us as we work to successfully complete the strategic alternative process. To that end, I want to thank our shareholders for the ratification vote we received on July 6, 2017, as it helps to clarify the capital structure of the Company and should enable us to complete our strategic alternatives process.”
Mr. Ghiglieri continued, “Thus far, we have had initial interest in potential transactions from a number of companies. Though this process is still evolving, we are committed to updating the market as key events unfold. My goal is to find the best available option, or options, for the Company and our assets to bring value to our shareholders. We appreciate the patience and continued support from our shareholders during this period.”
Shares of Galena closed yesterday at $0.555, down $0.01 or -1.77%. GALE has a 1-year high of $11.18 and a 1-year low of $0.52. The stock’s 50-day moving average is $0.57 and its 200-day moving average is $0.86.
On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on April 20, Berenberg Bank analyst Batuhan Karabekir assigned a Buy rating on GALE, with a price target of $7.90, which represents a potential upside of 1323% from where the stock is currently trading. Separately, on March 15, Raymond James’ Reni Benjamin maintained a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Batuhan Karabekir and Reni Benjamin have a yearly average loss of -5.0% and -7.6% respectively. Karabekir has a success rate of 0% and is ranked #3355 out of 4598 analysts, while Benjamin has a success rate of 38% and is ranked #4402.
Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs. It focuses on identifying and advancing therapeutic opportunities to improve cancer care from direct treatment of the disease to the reduction of its debilitating side effects. Its products include Abstral sublingual tablets and Zuplenz oral soluble film.