Merged Company to Focus on Development of
Antiviral Vaccines and Therapeutics Based on Proprietary
Delivery Technology Platform
Aviragen Therapeutics, Inc. (NASDAQ:AVIR), a company focused on the
discovery and development of direct-acting antivirals to treat
infections that have limited therapeutic options, and Vaxart, Inc.,
a privately-held, clinical-stage company focused on developing oral
recombinant vaccines based on its proprietary delivery platform
that allows for administration by tablet rather than by injection,
announced today that the companies have entered into a definitive
merger agreement. The merger will result in a combined company,
Vaxart, Inc., focused on developing orally-delivered therapeutics
and prophylactics to address a variety of viral infections.
“We are thrilled with the prospect of combining forces with
Aviragen, which will create a deep pipeline of antiviral products
and allow Vaxart to accelerate development of the promising vaccine
candidates that are based on our proprietary oral delivery
platform,” said Wouter Latour, M.D., Chief Executive Officer of
Vaxart. “This transaction gives us the opportunity to build on the
positive Phase 2 challenge study results we announced recently for
our influenza oral tablet vaccine, as well as the excellent results
we obtained in the safety and immunogenicity studies with our
norovirus vaccine. Additionally, it will provide us access to
Aviragen’s antiviral assets, including their BTA074 Phase 2 program
for the treatment of condyloma caused by HPV, which is on track to
complete enrollment this quarter and to report top-line safety and
efficacy data in the second quarter of 2018.”
“We believe our oral vaccine programs are significantly
de-risked based on the positive clinical outcome of the
BARDA-funded H1N1 influenza Phase 2 challenge study which
serves as proof of concept for our technology platform as a
whole,” continued Latour, “and we look forward to taking our
norovirus vaccine into a Phase 2 challenge study next.
Norovirus is the leading cause of acute viral gastroenteritis in
the United States, causing frequent outbreaks across the
population, and we believe our oral tablet vaccine would be the
optimal approach to address this unmet medical need.”
The Vaxart technology platform has been engineered for the
delivery of a wide range of oral vaccines, initially targeting
norovirus, human papilloma virus (HPV), respiratory syncytial
virus, and influenza, using a convenient and room
temperature-stable tablet, which eliminates the need for injection.
In clinical studies to date, Vaxart vaccines consistently
generated broad systemic and local immune responses that could
provide important advantages in preventing infection, as well as
robust T cell responses that we believe are essential to obtain a
therapeutic benefit in chronic viral infection and cancer.
“After a comprehensive review of strategic alternatives, we are
delighted to announce this transaction with Vaxart, which will
complement Aviragen’s focus on infectious diseases and position us
to create both near and long-term value for our stockholders,” said
Joseph M. Patti, Ph.D., President and Chief Executive Officer
of Aviragen Therapeutics. “Vaxart is well-funded to advance
its norovirus and HPV antiviral vaccine programs, and together with
BTA074, the combined companies are poised to provide meaningful
value-creating data readouts.”
Today, Vaxart will be announcing positive results from the
company’s Phase 1b open-label, dose-ranging study assessing the
safety and immunogenicity of VXA-G1.1-NN, Vaxart’s norovirus oral
tablet vaccine, in 60 healthy adult volunteers. VXA-G1.1-NN met
both the primary and secondary endpoints for safety and
immunogenicity in the clinical trial. Based on the favorable
clinical data, a Phase 2 norovirus challenge study is expected to
begin in the second half of 2018. To date, Vaxart has dosed more
than 300 adult volunteers with its vaccines for norovirus,
respiratory syncytial virus and influenza.
About the Transaction
The exchange ratio in the merger agreement was determined by
assigning $60 million in value to Aviragen for its financial and
clinical assets and $90 million in value for Vaxart’s assets. On a
pro forma basis, after giving effect to the number of shares of
Aviragen common stock issued in the merger, Vaxart’s
securityholders will own approximately 60% of the combined company
and Aviragen securityholders will own approximately 40% of the
combined company, subject to certain potential adjustments as
described in the merger agreement. The transaction has been
approved by the board of directors of both companies. The merger is
expected to close in the first quarter of 2018, subject to the
approval of the stockholders of each company as well as other
customary conditions. Wouter Latour, M.D., will serve as Chief
Executive Officer of the combined company.
Upon the closing of the transaction, the name of the combined
company will become Vaxart, Inc. and shares of the combined are
expected to continue trading on NASDAQ under the proposed ticker
symbol “VXRT.”
Stifel, Nicolaus & Company, Incorporated is acting as
financial advisor to Aviragen, and Dechert LLP is serving as legal
counsel to Aviragen. Cooley LLP is serving as legal counsel to
Vaxart.
Aviragen will reduce its workforce by six to a total of 10
full-time employees, who will remain on board to complete the
BTA074 Phase 2 clinical trial and assist with the transition of
duties to the Vaxart management team.
Aviragen and Vaxart management will host a conference call this
morning, Monday, October 30, 2017 at 8:30 a.m.
EDT to discuss the planned merger. To participate in the
conference call, please dial (877) 312-5422 (United States) or
(253) 237-1122 (international) and refer to conference ID number
6295889. A replay of the conference call can be accessed under the
Investors section of Aviragen's website
at www.aviragentherapeutics.com and on the Vaxart website at
www.vaxart.com.
About Aviragen Therapeutics
Aviragen Therapeutics is focused on the discovery and
development of the next generation of direct-acting antivirals to
treat infections that have limited therapeutic options and affect a
significant number of patients globally. It has three Phase 2
clinical stage compounds: BTA074 (teslexivir), an antiviral
treatment for condyloma caused by human papillomavirus types 6 and
11; vapendavir, a capsid inhibitor for the prevention or treatment
of rhinovirus (RV) upper respiratory infections; and BTA585
(enzaplatovir), a fusion protein inhibitor in development for the
treatment of respiratory syncytial virus infections. Aviragen also
receives royalties from marketed influenza products, Relenza® and
Inavir®. For additional information, please visit
www.aviragentherapeutics.com.
Aviragen Therapeutics® is a registered trademark. Relenza® is a
registered trademark of GlaxoSmithKline Pharmaceuticals, Ltd.,
and Inavir® is a registered trademark of Daiichi Sankyo Company,
Ltd.
About Vaxart
Vaxart is a clinical-stage company developing a range of oral
recombinant vaccines based on its proprietary delivery platform.
Vaxart vaccines are administered using convenient room
temperature-stable tablets that can be stored and shipped without
refrigeration and eliminate risk of needle-stick injury. Its
development programs are oral tablet vaccines designed to protect
against norovirus, seasonal influenza and respiratory syncytial
virus (RSV), as well as a therapeutic vaccine for human
papillomavirus (HPV), Vaxart’s first immuno-oncology indication.
For more information, please visit www.vaxart.com.
Forward-Looking Statements
This press release contains forward-looking
statements about Aviragen Therapeutics, Inc. and Vaxart Inc., and
their respective businesses, business prospects, strategy and
plans, including but not limited to statements regarding
anticipated preclinical and clinical drug development activities,
timelines and market opportunities; Vaxart being well-funded to
advance its programs; the combined companies being poised to
provide meaningful value-creating data readouts; Vaxart’s oral
tablet vaccine being the optimal approach to address the unmet
medical need relating to norovirus; the combined company’s ability
to accelerate development of Vaxart’s vaccine candidates and
generate near and long-term value for stockholders; and the
anticipated closing date of the merger. All statements other than
statements of historical facts included in this press release are
forward looking statements. The words “anticipates,” “may,”
“can,” “plans,” “believes,” “estimates,” “expects,” “projects,”
“intends,” “likely,” “will,” “should,” “to be,” and any similar
expressions or other words of similar meaning are intended to
identify those assertions as forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties that could cause actual results to differ materially
from those anticipated, including, without limitation: the risk
that the conditions to the closing of the merger are not satisfied,
the failure to timely or at all obtain stockholder approval for the
merger; uncertainties as to the timing of the consummation of the
merger and the ability of each of Aviragen and Vaxart to consummate
the merger; risks related to Aviragen’s ability to correctly
estimate its operating expenses and its expenses associated with
the merger; risks related to the market price of Aviragen’s common
stock relative to the exchange ratio; the ability of Aviragen or
Vaxart to protect their respective intellectual property rights;
competitive responses to the merger; unexpected costs, charges or
expenses resulting from the merger; and potential adverse reactions
or changes to business relationships resulting from the
announcement or completion of the merger. The vaccine candidates
that Vaxart develops may not progress through clinical development
or receive required regulatory approvals within expected timelines
or at all. In addition, future clinical trials may not confirm any
safety, potency or other product characteristics described or
assumed in this press release and such vaccine candidates may not
successfully commercialized. Additional factors that may
cause actual results to differ materially from such forward-looking
statements include those identified under the caption “Risk
Factors” in the documents filed by Aviragen with the Securities and
Exchange Commission from time to time, including its Annual Reports
on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports
on Form 8-K. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
of this press release. Except to the extent required by applicable
law or regulation, neither Aviragen nor Vaxart undertakes any
obligation to update the forward-looking statements included in
this press release to reflect subsequent events or
circumstances.
Additional Information and Where to Find It
In connection with the proposed strategic merger, Aviragen
intends to file relevant materials with the Securities and Exchange
Commission (SEC), including a registration statement on Form S-4
that will contain a proxy statement and prospectus. Investors may
obtain the proxy statement/prospectus (when available), as well as
other filings containing information about Aviragen, free of
charge, from the SEC’s Web site (www.sec.gov). In addition,
investors and securityholders may obtain free copies of the
documents filed with the SEC by Aviragen by directing a written
request to: Aviragen Therapeutics, Inc. 2500 Northwinds Parkway,
Suite 100, Alpharetta, GA 30009, Attention: Corporate Secretary or
delivered via e-mail to investors@aviragentherapeutics.com.
Investors and securityholders are urged to read the proxy
statement, prospectus and the other relevant materials when they
become available before making any voting or investment decision
with respect to the merger.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended.
Participants in the Solicitation
Aviragen and Vaxart and their respective directors and executive
officers and certain of their other members of management and
employees may be deemed to be participants in the solicitation of
proxies from the stockholders of Aviragen in connection with the
proposed transaction. Information regarding the special interests
of these directors and executive officers in the merger will be
included in the proxy statement/prospectus referred to above.
Additional information regarding the directors and executive
officers of Aviragen is also included in Aviragen Annual Report on
Form 10-K for the year ended June 30, 2017, filed with the SEC on
September 1, 2017, and the Form 10-K/A filed with the SEC on
October 20, 2017. These documents are available free of charge from
the sources indicated above.
Contacts
Mark ColonneseExecutive Vice President and Chief Financial
OfficerAviragen Therapeutics, Inc.(678)
221-3381
mcolonnese@aviragentherapeutics.com
Beth DelGiaccoStern Investor Relations, Inc.(212)
362-1200beth@sternir.com
John HarlandChief Financial OfficerVaxart Inc.(650) 550
3500jharland@vaxart.com
Katie HoganWCG/W2O Group415-658-9745khogan@wcgworld.com
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