On March 16, 2017 Mast Therapeutics, Inc. (NYSE MKT: MSTX) reported it has set a date for a special meeting of its stockholders to vote on matters related to the proposed merger with Savara Inc. (Savara), a privately-held, 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 (Press release, Mast Therapeutics, MAR 16, 2017, View Source [SID1234518206]).

The special meeting will be held at 9:00 a.m., local time, on April 21, 2017 at 3611 Valley Centre Drive, Suite 500, San Diego, California 92130. Mast’s stockholders of record as of the close of business on March 13, 2017 are entitled to receive notice of, and to vote at, the special meeting.

The merger has been unanimously approved by the boards of directors of both companies and the board of directors of Mast unanimously recommends that its stockholders vote "FOR" the special meeting proposals described in the proxy statement/prospectus/information statement declared effective by the Securities and Exchange Commission on March 15, 2017, a copy of which will be provided to Mast stockholders of record as of March 13, 2017. The proposed merger is expected to close promptly after the Mast special meeting scheduled for April 21, 2017, subject to the approval of the stockholders of each company and the satisfaction or waiver of the other closing conditions in the merger agreement between the companies.

The combined company would advance a pipeline of novel inhalation therapies for the treatment of diseases with significant unmet medical needs, featuring three product candidates, each in advanced stages of clinical development:

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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;

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Molgradex, an inhaled nebulized GM-CSF to treat pulmonary alveolar proteinosis (PAP) currently in Phase 2/3 development; and

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AIR001, an inhaled nebulized sodium nitrite solution to treat heart failure with preserved ejection fraction (HFpEF) currently in Phase 2 development.

Select Anticipated Upcoming Development Milestones

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Closing of proposed merger in Q2/2017.

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Initiate a pivotal Phase 3 study of AeroVanc in Q3/2017.

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Complete 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 Q3/2017.

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Announce strategy related to Molgradex program expansion for the treatment of a rare lung infection in 2017.

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Announce top-line results from Phase 2/3 study of Molgradex, expected to be registration-enabling for the treatment of PAP in Europe and Japan, in Q1/2018.

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Announce results from ongoing Phase 2 study of AIR001 for the treatment of HFpEF being conducted by the Heart Failure Clinical Research Network in Q1/2018.

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On March 16, 2017 Provecs Medical GmbH, a cancer immunotherapy company developing novel treatments to modulate the tumor microenvironment, reported the closing of a partnership with oncology pharma company Medac Gesellschaft für klinische Spezialpräparate mbH (Press release, Provecs Medical, MAR 16, 2017, View Source [SID1234571468]). The partners aim to develop, manufacture and market Provec’s cancer immunotherapy lead product Immunalon for the treatment of urinary bladder cancer. Immunalon is being developed for the treatment of a wide range of solid cancers, including urinary bladder cancer. Financial details were not disclosed.

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The collaboration combines Medac´s marketing expertise in oncology and hematology with Provecs´ development know-how, which is based on its proprietary ENVIRO technology platform for innovative immunotherapeutics.

ENVIRO is a unique, patented adenoviral platform for the targeted delivery of up to four biologicals combined in one product to the tumor site. This multivalent approach is designed to reprogram the barriers between the immune system and cancer by addressing up to four immune checkpoints simultaneously. Immunalon is Provecs Medical´s lead compound based on ENVIRO.

"It is known today that the activation and inhibition of immune cells is regulated by a wealth of molecules called checkpoint molecules," said Dr. Frank Schnieders, CEO of Provecs Medical. "Tumors establish control over checkpoints to deactivate immune cells directed against the cancer. We also know that blocking these inhibitory checkpoint molecules partially restores the immune system’s ability to control and sometimes eliminate cancer cells. Existing treatments are directed against single checkpoints only and therefore show limited efficacy. We are convinced that addressing up to four checkpoints with our ENVIRO approach makes it much more difficult for tumor cells to escape elimination."

Provecs achieved ex-vivo proof-of-concept for Immunalon using its EXVIRO platform, a unique primary cancer tissue platform for ex-vivo therapy simulation as well as pharmacodynamics and pharmacokinetics studies. This 3D tissue culture system uses patient-derived human cancer tissues to study the tumor microenvironment in its spatial context without disrupting the cellular relationships. Provecs is now developing a first-in-man study concept for Immunalon in a second indication.

"We are seeking partners for the development of Immunalon in other solid cancer indications with high medical need and a lack of standard therapies," Schnieders added.

On March 16, 2017 Elasmogen Ltd, developer of soloMERTM biologics, reported that it has received a Biomedical Catalyst Grant from the UK’s innovation agency, Innovate UK and matching investment from Deepbridge Capital and Scottish Investment Bank (the investment arm of Scottish Enterprise) totalling £1.2 M (Press release, Elasmogen, MAR 16, 2017, View Source [SID1234637761]). The funding will be used to develop ELN-21 and ELN-22, the companies’ next generation biologics for topical treatment of ocular disease. Current treatments for ocular diseases such as uveitis and macular degeneration require either systemic dosing or direct injection into the eye. soloMERs are Elasmogen’s proprietary humanized versions of shark VNARs, the smallest naturally occurring binding domains. The small size (11 kDa) and highly robust nature of soloMERs make them ideal for delivering topically applied sight saving therapies while reducing systemic side effects and eliminating the need for injections. "We have recently completed our proof of concept trials demonstrating the ability to deliver therapeutic concentrations of soloMERs to the back of the eye by topical delivery," said Elasmogen CEO Caroline Barelle. "Winning the Biomedical Catalyst grant along with the new investment will allow us to build on these results and prepare our anti-inflammatory and anti-autoimmune soloMERs for phase 1 clinical trials." "Use of corticosteroids for treatment of ocular inflammation carries the risk of significant side effects including glaucoma and cataracts," said John Forrester Clinical Professor of Ophthalmology, The Lions Eye Institute, Australia and University of Aberdeen, Scotland. "A fast acting, topically applied biologic that can reach all parts of the eye would provide significant benefit to uveitis and other ocular disease patients." Kerry Sharp, Head of the Scottish Investment Bank said, "We are pleased to be able to support Elasmogen, initially through our High-Growth Spinout Programme which helps researchers to take their ideas and inventions from the lab to the global marketplace, and now through matched investment from the Scottish Venture Fund. The company has made significant technical progress in a short space of time and its sight-saving auto-immune therapies have the potential to make a notable social, as well as commercial, impact. We look forward to working with Deepbridge Capital to further support and nurture the exciting opportunity presented by Elasmogen."

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XBiotech has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, XBiotech, 2017, MAR 16, 2017, View Source [SID1234521576]).

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DURECT has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, DURECT, 2018, MAR 15, 2017, View Source [SID1234525998]).

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