Galena Biopharma Enters Merger Agreement With SELLAS Life Sciences

Galena Biopharma, Inc. and SELLAS Life Sciences Group Ltd recently announced they have entered into an all stock definitive merger agreement under which SELLAS will merge into and become an indirect, wholly owned subsidiary of Galena. The combined company will be renamed SELLAS Life Science Group, Inc. The merger will result in a combined company focused on the development of novel treatments for cancer.

The combined company will feature a late-stage pipeline led by novel immunotherapies targeting a broad range of indications in hematology and solid tumors. SELLAS licenses the rights to its lead asset, galinpepimut-S, (GPS), a novel WT1 antigen-targeting immunotherapy. GPS is initially being developed for the treatment of acute myeloid leukemia (AML) and is Phase 3-ready in this setting. SELLAS has also successfully completed a Phase 2 study of GPS in malignant pleural mesothelioma (MPM), and its end-of-Phase 2 meetings with the US FDA for GPS in both indications. For both AML and MPM, SELLAS has been granted orphan drug designation from the FDA and the European Medicines Agency (EMA) and been given FDA fast-track status. In addition, SELLAS is currently conducting two Phase 2 trials of GPS in multiple myeloma, as well as a combination trial in ovarian cancer with nivolumab (OPDIVO; Bristol-Myers Squibb), and is currently preparing for additional combination trials for GPS in combination with another checkpoint inhibitor. Galena’s lead immunotherapy program, NeuVax (nelipepimut-S), is currently in three, Phase 2 investigator-sponsored clinical trials in breast cancer, and these trials will remain ongoing. Galena’s other development programs, GALE-401, a controlled release version of anagrelide that is Phase 3-ready, and GALE-301/GALE-302, an earlier stage cancer immunotherapy program targeting folate binding protein, are currently being evaluated for potential internal development or strategic partnership.

“This transaction with Galena is an important step for SELLAS and the advancement of our lead product candidate, GPS, through important development milestones,” said Dr. Angelos Stergiou, SELLAS’s Chief Executive Officer. “We believe GPS has the potential to benefit a wide range of cancer patients and become an important piece of the cancer immunotherapy treatment landscape as both a monotherapy and in combination with other agents, particularly checkpoint inhibitors. NeuVax strengthens our platform and may provide important value inflections as the clinical trials progress. The combined pipeline, with significant near term milestones, creates multiple development and partnering opportunities to create value as these programs evolve.”

Stephen F. Ghiglieri, Galena’s Interim Chief Executive Officer and Chief Financial Officer, added “Following a thorough review of strategic alternatives and extensive search for a merger partner, we selected SELLAS due to the depth of their cancer immunotherapy pipeline, which is clearly complementary to Galena’s development programs. In evaluating many alternatives, SELLAS stood out in terms of its vision, strategic alignment with Galena’s cancer immunotherapy programs, and near-term opportunity for value creation for our shareholders. We are encouraged by the GPS data generated to date and the potential advancement of that program into clinical trials in several indications. I, and our board of directors, believe that patients and our shareholders have the opportunity to benefit greatly from the clinical development efforts that the combined companies will undertake.”

On January 31, 2017, Galena announced the initiation of a process to explore a range of strategic alternatives focused on maximizing shareholder value. After a thorough review of available alternatives, and extensive diligence and negotiation with SELLAS, Galena’s board of directors unanimously approved to enter into a definitive merger agreement with SELLAS.

Under the terms of the merger agreement, existing SELLAS shareholders will receive newly issued shares of Galena common stock. On a pro forma basis, assuming completion of the proposed merger, Galena stock and warrant holders are expected to own approximately 32.5%, and SELLAS shareholders will own approximately 67.5% of the combined company.

The transaction has also been unanimously approved by the SELLAS board of directors and a majority of SELLAS shareholders have agreed to vote in favor of the transaction. The proposed merger is expected to close in the fourth quarter of 2017, subject to the approval of Galena stockholders and other customary closing conditions.

Galena’s financial advisor for the transaction is Canaccord Genuity Inc. and Galena’s legal counsel are Paul Hastings LLP and BeesMont Law Limited. SELLAS’ financial advisor for the transaction is Guggenheim Securities, and SELLAS’ legal counsels are Cooley LLP and Conyers Dill & Pearman.

Galinpepimut-S is a WT1 antigen-targeting immunotherapy. The WT1 antigen is one of the most widely expressed cancer antigens in multiple malignancies. Galinpepimut-S is a multi-peptide product with heteroclitic-modifications that enhance the immunity and duration of the immune response against the WT1 antigen independent of a patient’s underlying genetics (HLA types) and elicits CD4 and CD8 immune responses with clinical efficacy and favorable safety profile.

SELLAS Life Sciences Group Ltd is a late-stage biopharmaceutical company focused on the development of novel cancer immunotherapies and therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S, is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center that targets a broad spectrum of hematologic cancers and solid tumor indications. Galinpepimut-S is expected to enter pivotal, Phase 3 clinical trials in patients with AML and is also in various development phases in multiple myeloma and ovarian cancer, and additional indications are expected as a monotherapy or in combination with other immuno-oncology agents. SELLAS recently received orphan drug designations from the FDA, as well as the EMA, for galinpepimut-S in AML and MPM; as well as fast track designation for AML and MPM from the FDA.

SELLAS was founded in 2012 and is currently headquartered in Hamilton, Bermuda, with additional operating offices in New York City, NY. For more information, visit www.sellaslifesciences.com.

Galena Biopharma, Inc. is a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs. Galena’s pipeline consists of multiple mid-to-late-stage clinical assets led by its hematology asset, GALE-401, and its novel cancer immunotherapy programs including NeuVax™ (nelipepimut-S) and GALE-301/GALE-302. For more information, visit www.galenabiopharma.com.