Friday, April 28, 2017
Savara Inc., a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases, today announced the closing of its previously announced merger with Mast Therapeutics, Inc. (NYSE MKT: MSTX), under which the stockholders of Savara have become the majority owners of Mast, and the operations of Mast and Savara have combined. The post-merger company, named Savara Inc., is based in Austin, TX and features three inhaled product candidates, each in advanced stages of clinical development. The company will be led solely by Savara's current management team. Two independent members of the Mast board remain on the post-merger board together with all five members of the Savara board. Savara's common stock will commence trading on April 28th, 2017 on the Nasdaq Capital Market under the trading symbol "SVRA".
"Savara's transition to the public market marks a significant milestone for us, and serves as testament to the determination of our team as well as the support of our investors to date," stated Rob Neville, Chairman and CEO of Savara. "Savara's team is passionate about helping those who suffer from rare and debilitating lung diseases and will dynamically pursue opportunities to develop impactful products to treat such conditions. We believe Savara presents an attractive business opportunity with our pipeline of unique products with considerable market potential, as well as significant value-driving clinical milestones."
Savara began the development of AeroVanc in 2010 and is now in preparation for a pivotal Phase 3 study. In July 2016, Savara acquired Serendex Pharmaceuticals adding Molgradex to its pipeline. Molgradex is currently in Phase 2/3 development. With the closing of the Mast merger, Savara adds the Aironite program to its pipeline (also known as AIR001). Savara intends to continue its growth strategy focused on indication expansion, strategic development partnerships and product acquisitions.
In connection with the closing of the merger, Mast effected a 1 for 70 reverse split of its common stock. Post-merger and post-reverse split, Savara has approximately 15 million shares of common stock issued and outstanding with prior Savara stockholders collectively owning approximately 77% of the combined company, and prior Mast stockholders collectively owning approximately 23% of the combined company. Prior to the merger closing, Savara stockholders exercised certain previously issued warrants to purchase Savara shares and invested additional capital into the company, resulting in aggregate net proceeds of approximately $4 million.
Savara's pipeline now includes:
• Molgradex, an inhaled nebulized GM-CSF to treat pulmonary alveolar proteinosis (PAP) currently in Phase 2/3 development;
• AeroVanc, an inhaled dry-powder vancomycin to treat chronic methicillin-resistant Staphylococcus aureus (MRSA) pulmonary infection in cystic fibrosis (CF) in preparation for a pivotal Phase 3 study; and
• Aironite, an inhaled nebulized sodium nitrite solution to treat heart failure with preserved ejection fraction (HFpEF) currently in Phase 2 development.
Select Development Milestones
• Completing negotiations with the U.S. Food and Drug Administration (FDA) on the requirements for a pivotal clinical study of Molgradex in the U.S. in Q2/2017;
• Initiating a pivotal Phase 3 study of AeroVanc in Q3/2017;
• Announcing an indication expansion strategy of Molgradex for the treatment of a rare lung infection in Q3/2017;
• Announcing top-line results from a Phase 2/3 study of Molgradex, expected to be registration-enabling in Europe and Japan, in Q1/2018; and
• Announcing results from an ongoing Phase 2 study of Aironite being conducted by the Heart Failure Clinical Research Network in H1/2018.
