Release
Savara Announces Closing Of Merger With Mast Therapeutics
"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
Savara began the development of AeroVanc in 2010 and is now in preparation for a pivotal Phase 3 study. In
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
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 andJapan , 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.
Conference Call and Webcast
Savara will hold a conference call on
About Savara
Forward Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements regarding dynamically pursuing opportunities to develop impactful products, Savara presenting an attractive business opportunity with a pipeline of unique products with considerable market potential, as well as significant value-driving clinical milestones, Savara's intent to continue its growth strategy focused on indication expansion, strategic development partnerships and product acquisitions, Savara's pipeline and select developmental milestones. Savara may not actually achieve any of the matters referred to in such forward looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs, the timing and ability of Savara to raise additional equity capital to fund continued operations; the ability to successfully develop Savara's product candidates, and the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Risks and uncertainties facing Savara are described more fully in Savara's filings with the
SOURCE
Savara Inc., Ioana C. Hone (ir@savarapharma.com), (512) 961-1891