AUSTIN, Texas, April 27, 2017 /PRNewswire/ -- Savara Inc.
(NASDAQ: SVRA), 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.
Conference Call and Webcast
Savara will hold a conference call on Tuesday May 2nd, 2017, at 4:30 p.m. Eastern Time / 3:30 p.m. Central Time to provide an overview and
business update. Interested parties may access the conference
call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from
Canada, and (412) 542-4127 from
outside the U.S. and should request the Savara Inc. Call. A live
webcast of the conference call will be available online from the
Investors section of Savara's website at
http://www.savarapharma.com/investors/events/. Replays of the
webcast will be available on Savara's website for 30 days and a
telephone replay will be available through May 9th, 2017 by dialing (877)
344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere
outside the U.S. and entering replay access code 10104600.
About Savara
Savara Inc. is 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. Savara's pipeline comprises AeroVanc, a Phase 3 ready
inhaled vancomycin, Molgradex, a Phase 2/3 stage inhaled
granulocyte-macrophage colony-stimulating factor, or GM-CSF and
Aironite, an inhaled nebulized sodium nitrite solution to treat
HFpEF. Savara's strategy involves expanding its pipeline of
best-in-class products through indication expansion, strategic
development partnerships and product acquisitions, with the goal of
becoming a leading company in its field. Savara's management team
has significant experience in orphan drug development and pulmonary
medicine, in identifying unmet needs, creating and acquiring new
product candidates, and effectively advancing them to approvals and
commercialization. More information can be found at
www.savarapharma.com. (Twitter: @SavaraPharma)
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 Securities and
Exchange Commission including the most recent Form 8-K filed on
April 27, 2017, other filings on Form
8-K, the Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and the
Registration Statement on Form S-4 related to the Mast/Savara
merger. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. Savara undertakes any obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as may be
required by law.
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SOURCE Savara Inc.