AIR001 developer Mast Therapeutics will merge with AeroVanc and Molgradex developer Savara, the companies have announced. Savara’s current management team will lead the combined company, which will be called Savara Inc and which will trade under a new stock ticker symbol. After the merger, current Savara stockholders will own ~76% of the combined company, and current Mast shareholders will own ~24%.
In September 2016, Mast announced that it was dropping its vepoloxamer development program to concentrate exclusively on the development of AIR001 sodium nitrite inhalation solution for patients with heart failure with preserved ejection fraction (HFpEF) and for pulmonary arterial hypertension (PAH). AIR001 is currently in Phase 2 development; the companies say that they expect to announce results from an ongoing Phase 2 study in the first quarter of 2018.
In March 2016, Savara announced that it had raised $20 million for Phase 3 development of its AeroVanc vancomycin DPI for the treatment of MRSA lung infections in CF patients. A pivotal Phase 3 study is expected to begin in the 3rd quarter of 2017.
in June 2016, Savara announced that it had acquired Serendex and its Molgradex inhaled granulocyte-macrophage colony-stimulating factor (molgramostim) for the treatment of autoimmune pulmonary alveolar proteinosis (PAP). Molgradex is currently in Phase 2/3 development, with top-line results from an ongoing study in Europe and Japan expected in the first quarter of 2018. The companies say that negotiations with the FDA for a pivotal study of Molgradex in the US are ongoing, with initiation of the study expected in the third quarter of 2017.
Current Mast Therapeutics CEO Brian M. Culley commented, “Following an extensive review of strategic alternatives and a thorough process, the Mast Board of Directors chose to combine with Savara because we believe the proposed merger provides an attractive opportunity for our shareholders to obtain value appreciation from a diversified pipeline and positions the company for more rapid short- and long-term growth via a triad of late-stage clinical assets with important forthcoming milestones. We are excited for the prospects of the combined company and believe that Savara’s management team is well equipped to advance the pipeline toward regulatory approvals and commercialization in the US and EU.”
Savara Chairman and CEO Rob Neville said, “This merger is transformative for Savara and marks our second transaction in a year, each expanding Savara’s pipeline of inhaled therapies for serious and life-threatening diseases. AeroVanc and Molgradex are orphan-designated product candidates in late-stage development, and we see Mast’s AIR001 program potentially adding significant value to our pipeline with a modest capital outlay in 2017. We believe the favorable risk profile of our product candidates combined with their market potential provides a unique opportunity for Savara to become the next breakout company in orphan pulmonary diseases.”
Read the Mast Therapeutics and Savara press release.
