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, today announced
the completion of patient enrollment in its Phase 2 CT4 clinical
trial evaluating teslexivir (BTA074) for the treatment of
condyloma. The Company expects to report top-line data from this
trial in the second quarter of 2018.
“The enrollment and randomization of over 210 patients in the
CT4 trial represents a significant milestone in the development of
teslexivir,” said Joseph Patti, Ph.D., President and Chief
Executive Officer of Aviragen. “We believe the direct-acting
antiviral mechanism of action of teslexivir has the potential to
both enhance clearance rates and reduce condyloma recurrence rates
compared with currently approved treatments.”
CT4 is a Phase 2 double-blind, randomized, multi-center,
placebo-controlled trial designed to evaluate the safety,
tolerability and efficacy of teslexivir 5% gel in male and female
patients with condyloma, or anogenital warts. Patients were
randomized 2-to-1 (teslexivir to placebo gel) and dosed twice daily
for up to 16 weeks. The primary efficacy endpoint is the complete
clearance rate for baseline anogenital warts from the commencement
of therapy to the end of the treatment period. Secondary efficacy
endpoints include various efficacy assessments of clearance and
wart area reduction for both baseline warts and post-baseline
emergent warts, as well as the assessment of condyloma recurrence
over a 3 month follow-up period, in patients who experience
clearance.
Teslexivir is a topical antiviral agent that is a potent and
selective inhibitor of the interaction between two essential viral
proteins, E1 and E2, an interaction that is a necessary step for
Human Papilloma Virus (HPV) 6 and 11 DNA replication and thus viral
production. HPV types 6 and 11 are responsible for more than
90% of anogenital condyloma.
About Condyloma (Anogenital Warts)
Condyloma infections from HPV represent the most frequent viral
sexually transmitted disease in adults worldwide. In the United
States, approximately one to two percent of sexually active adults
between the ages of 15 to 49 develop condyloma as the primary
clinical manifestation of HPV infection. Currently available
treatments for anogenital warts typically are divided into two
categories, ablative/destructive therapies and topical therapies.
Existing topical therapies are associated with significant mucosal
toxicities manifesting as erosions and ulcerations, which can
result in therapy discontinuation. Ablative options can be painful
and scarring, and can lead to sexual dysfunction. Another
significant limitation with current therapies is a high incidence
of recurrence after successful primary treatment.
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 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®. Aviragen recently announced plans to merge with Vaxart,
Inc., a privately-held clinical-stage company focused on developing
oral recombinant vaccines from its proprietary delivery platform.
For additional information, please visit
www.aviragentherapeutics.com.
Aviragen Therapeutics® is a registered trademark. Relenza® is a
registered trademark ofGlaxoSmithKline Pharmaceuticals, Ltd., and
Inavir® is a registered trademark of Daiichi Sankyo Company,
Ltd.
Forward-Looking Statements
This communication contains forward-looking statements
(including within the meaning of Section 21E of the United States
Securities Exchange Act of 1934, as amended, and Section 27A of the
United States Securities Act of 1933, as amended) concerning
Aviragen, Vaxart, the Merger and other matters. These
statements may discuss goals, intentions and expectations as to
future plans, trends, events, results of operations or financial
condition, or otherwise, based on current beliefs of the management
of Aviragen, as well as assumptions made by, and information
currently available to, management. Forward-looking
statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions, and
include words such as “may,” “will,” “should,” “would,” “expect,”
“anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,”
“intend,” and other similar expressions among others. Statements
that are not historical facts are forward-looking statements.
Forward-looking statements are based on current beliefs and
assumptions that are subject to risks and uncertainties and are not
guarantees of future performance. Actual results could differ
materially from those contained in any forward-looking statement as
a result of various factors, including, without limitation: the
timing of the availability of top-line data from the Phase 2 CT4
trial of teslexivir; the potential of teslexivir to both enhance
clearance rates and reduce condyloma recurrence rates compared with
currently approved treatments; the risk that the conditions to the
closing of the Merger are not satisfied, including 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; potential adverse reactions or
changes to business relationships resulting from the announcement
or completion of the Merger; provisions in certificate of
incorporation, bylaws and laws of Delaware containing provisions
that could delay or discourage a change in control of the Company;
and legislative, regulatory, political and economic developments.
The foregoing review of important factors that could cause actual
events to differ from expectations should not be construed as
exhaustive and should be read in conjunction with statements that
are included herein and elsewhere, including the risk factors
included in Aviragen’s most recent Annual Report on Form 10-K, and
Aviragen’s recent Quarterly Report on Form 10-Q and Current Reports
on Form 8-K filed with the SEC. Aviragen can give no assurance that
the conditions to the Merger will be satisfied. Except as required
by applicable law, Aviragen undertakes no obligation to revise or
update any forward-looking statement, or to make any other
forward-looking statements, whether as a result of new information,
future events or otherwise.
No Offer or Solicitation
This communication is not intended to and does not constitute an
offer to sell or the solicitation of an offer to subscribe for or
buy or an invitation to purchase or subscribe for any securities or
the solicitation of any vote in any jurisdiction pursuant to the
Merger or otherwise, nor shall there be any sale, issuance or
transfer of securities in any jurisdiction in contravention of
applicable law. No offer of securities shall be made except
by means of a prospectus meeting the requirements of Section 10 of
the United States Securities Act of 1933, as amended. Subject to
certain exceptions to be approved by the relevant regulators or
certain facts to be ascertained, the public offer will not be made
directly or indirectly, in or into any jurisdiction where to do so
would constitute a violation of the laws of such jurisdiction, or
by use of the mails or by any means or instrumentality (including
without limitation, facsimile transmission, telephone and the
internet) of interstate or foreign commerce, or any facility of a
national securities exchange, of any such jurisdiction.
Important Additional Information Will be Filed with the
SEC
In connection with the proposed transaction between Aviragen and
Vaxart, Aviragen intends to file relevant materials with the SEC,
including a registration statement that will contain a proxy
statement and prospectus. AVIRAGEN URGES INVESTORS AND STOCKHOLDERS
TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT AVIRAGEN, THE MERGER AND RELATED MATTERS. Investors and
shareholders will be able to obtain free copies of the proxy
statement, prospectus and other documents filed by Aviragen with
the SEC (when they become available) through the website maintained
by the SEC at www.sec.gov. In addition, investors and
shareholders will be able to obtain free copies of the proxy
statement, prospectus and other documents filed by Aviragen with
the SEC by contacting Aviragen Therapeutics, Inc., 2500 Northwinds
Parkway, Suite 100, Alpharetta, Georgia 30009, Attention: Corporate
Secretary or delivered via e-mail to
investors@aviragentherapeutics.com. Investors and
stockholders 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.
Participants in the Solicitation
Aviragen and Vaxart, and each of 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 in connection with the Merger. Information about
Aviragen’s directors and executive officers is included in
Aviragen’s 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. Additional
information regarding these persons and their interests in the
Merger will be included in the proxy statement relating to the
Merger when it is filed with the SEC. These documents can be
obtained 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
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