Aviragen Therapeutics, Inc. (NASDAQ:AVIR) today announced its
financial results for the three month period ended September
30, 2016, which is the first quarter of the Company's 2017 fiscal
year, and also provided an update on recent corporate developments.
“Throughout the last quarter and in recent
weeks, we have made significant progress advancing each of our
Phase 2 antiviral clinical programs. Most notably, I am pleased to
announce the completion of enrollment in the SPIRITUS Phase 2b
trial of vapendavir for the treatment of HRV infections in moderate
and severe asthmatic patients as well as the Phase 2a RSV challenge
study of BTA585. We look forward to announcing top-line data from
both of these trials in the coming months,” commented Joseph M.
Patti, PhD, President and Chief Executive Officer of Aviragen
Therapeutics.
Recent Corporate Highlights
Announced Completion of Enrollment in
the SPIRITUS Phase 2b Trial of Vapendavir for the Treatment of
Human Rhinovirus (HRV) Infections. Today, the Company
announced completion of patient enrollment in the Phase 2b trial of
vapendavir for the treatment of HRV infections in moderate and
severe asthmatics. Given the 35 day follow up for each patient, the
last patient is expected to complete the study in early December.
Top-line data are expected approximately eight weeks after the last
patient completes the study. The primary endpoint of SPIRITUS is
the change from baseline to study day 14 measured by an asthma
control questionnaire (ACQ)-6 total score. The secondary endpoints
are focused on safety and tolerability, and lung function
assessments.
Announced Completion of Enrollment in
the Phase 2a RSV Challenge Study of BTA585. Today, the
Company announced the completion of patient enrollment in the final
cohort (600 mg bid) in the Phase 2a trial in healthy volunteers
intranasally challenged with RSV. Top-line data from this
trial is expected around the end of the year.
Presented BTA585 Phase 1a and 1b Data at
ID Week 2016. Pharmacokinetic (PK) and safety data from a
Phase 1 single ascending dose and multiple ascending dose study
with BTA585 were presented in New Orleans at the annual ID Week in
October 2016. The clinical data from 85 healthy volunteers
demonstrated that BTA585 was generally well tolerated and there was
a low incidence of adverse events with the most common being
headache, nausea, and chromaturia. BTA585 plasma Cmax was rapidly
achieved at approximately one hour following oral dosing, exposure
was dose-proportional, there was no accumulation of BTA585 over the
duration of dosing and the half-life (T1/2) was approximately five
to six hours. Additionally, dosing of BTA585 with a high fat
meal did not adversely affect the PK.
Hosted Key Opinion Leader (KOL) Meeting
on HRV Infections. In October 2016, the Company hosted a
KOL breakfast focused on the significant burden of HRV infections
in at-risk patient populations. The meeting featured keynote
presentations from Dr. Frederick G. Hayden, Professor Emeritus
of Infectious Diseases and International Health at the
University of Virginia School of Medicine, and Dr. Sebastian
L. Johnston, Professor of Respiratory Medicine and Allergy
at Imperial College London and Director of
the Wellcome Trust Centre for Respiratory Infection.
Reported Data from the Vapendavir Phase
1 Bioavailability Trial. In August 2016, the Company
completed a single-center, open-label, three-period comparative
bioavailability study in healthy volunteers to assess the
comparability of the vapendavir phosphate salt capsule, and two new
formulations of vapendavir free base in the forms of an oral
suspension and tablet. Results showed that the
bioavailability of the oral suspension and tablet formulations were
comparable to the capsule form of vapendavir. The oral suspension
formulation is intended to enable the conduct of future pediatric
trials, and the tablet formulation will allow an increase in
manufacturing scale appropriate for Phase 3 trials and commercial
development.
Financial Results for the Three Month
Period Ended September 30, 2016
The Company reported a net loss of $10.0 million
for the three month period ended September 30, 2016, as compared to
a net loss of $6.6 million in the same quarter of the prior fiscal
year. Basic and diluted net loss per share was $0.26 for the three
month period ended September 30, 2016, as compared to a basic and
diluted net loss per share of $0.17 in the same period in 2015. The
major components of net loss in both periods are detailed
below.
Revenue decreased to $0.1 million for the
three month period ended September 30, 2016 from $1.7 million in
the same period in 2015 due to a $1.6 million reduction in royalty
revenues, reflecting no government stockpiling orders of the flu
product Relenza® for the three month period ended September 30,
2016. The Company currently receives a 7% royalty on sales of
Relenza® in the U.S. and in certain other countries. However, in
October 2016, the U.S. Court of Appeals for the Federal Circuit
Decision Board upheld the Patent Office’s rejection of claims in
U.S. Patent Application 08/737,141 relating to the method of
prevention and treatment of influenza by inhalation of zanamivir
(Relenza®). The Company is working with its partner to determine
possible next steps in the prosecution of the patent
application.
Research and development expense increased to
$7.6 million for the three month period ended September 30, 2016
from $5.5 million in the same period in 2015. The $2.1 million
increase largely reflected higher clinical and manufacturing costs
associated with our ongoing trials.
General and administrative expense was $2.2
million for both the three month period ended September 30, 2016
and the same period in 2015, as higher consulting and professional
fees were fully offset by decreased personnel costs.
Non-cash implied interest expense was $0.4
million for the three month period ended September 30, 2016 related
to the royalty interest sale in April 2016. There was no
non-cash implied interest expense for the same period in
2015.
The Company held $58.3 million in cash, cash
equivalents, and short-term investments as of September 30,
2016.
Conference Call and Webcast
Information
Aviragen Therapeutics will host a conference
call today to review these first quarter fiscal 2017 financial
results, as well as provide a general update on the Company, via a
webcast and conference call at 4:30 p.m. ET. To access the
conference call, please dial (877) 312-5422 (domestic) or (253)
237-1122 (international) and refer to conference ID number 8654317.
A live audio webcast of the call and the archived webcast will be
available in the Investors section of the Company’s website at
http://www.aviragentherapeutics.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. The
Company has three product candidates in active clinical
development: vapendavir, an oral treatment for human rhinovirus
(HRV) upper respiratory infections in moderate-to-severe asthmatics
currently being evaluated in the Phase 2b SPIRITUS trial; BTA585,
an oral fusion protein inhibitor in Phase 2 development for the
treatment and prevention of respiratory syncytial virus (RSV)
infections; and BTA074, a topical antiviral treatment in Phase 2
development for condyloma caused by human papillomavirus types 6
& 11. For additional information about the Company, please
visit www.aviragentherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve known and unknown risks and
uncertainties concerning Aviragen Therapeutics’ business,
operations and financial performance. Any statements that are not
of historical facts may be deemed to be forward-looking statements,
including the timing of top-line data readouts on our Phase 2 HRV
and RSV programs, and the use of vapendavir tablets or capsules in
future studies and commercialization. Various important factors
could cause actual results, performance, events or achievements to
materially differ from those expressed or implied by
forward-looking statements, including: the Company, the U.S. Food
and Drug Administration (FDA) or a similar regulatory body in
another country, a data safety monitoring board, or an
institutional review board delaying, limiting, suspending or
terminating the clinical development of any of the Company's
product candidates at any time for a lack of efficacy, safety,
tolerability, regulatory or manufacturing issues, or any other
reason whatsoever; the Company's ability to secure, manage and
retain qualified third-party clinical research, data management and
contract manufacturing organizations upon which it relies to assist
in the design, development, implementation and execution of the
clinical development of all its product candidates and those
organizations’ ability to successfully execute their contracted
responsibilities; the Company’s ability to comply with applicable
government regulations in various countries and regions in which we
are conducting, or expect to conduct, clinical trials; and other
cautionary statements contained elsewhere in this press release and
in our Annual Report on Form 10-K and our other reports filed with
the Securities and Exchange Commission. There may be events in the
future that the Company is unable to predict, or over which it has
no control, and the Company’s business, financial condition,
results of operations and prospects may change in the future. The
Company may not update these forward-looking statements more
frequently than quarterly unless it has an obligation under U.S.
Federal securities laws to do so.
|
AVIRAGEN THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(in millions, except per share
amounts) |
|
|
September 30, 2016 |
|
June 30, 2016 |
|
(unaudited) |
|
(audited) |
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
45.9 |
|
|
$ |
49.7 |
|
Short-term investments |
|
12.4 |
|
|
|
19.3 |
|
Accounts receivable, net of
allowance |
|
0.6 |
|
|
|
0.7 |
|
Prepaid and other current
assets |
|
3.9 |
|
|
|
2.7 |
|
Total current assets |
|
62.8 |
|
|
|
72.4 |
|
Non-current assets: |
|
|
|
Property and equipment, net |
|
0.3 |
|
|
|
0.3 |
|
Total non-current assets |
|
0.3 |
|
|
|
0.3 |
|
Total assets |
$ |
63.1 |
|
|
$ |
72.7 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
1.6 |
|
|
$ |
3.9 |
|
Accrued expenses |
|
5.6 |
|
|
|
3.6 |
|
Short-term note payable |
|
0.4 |
|
|
|
0.4 |
|
Liabilities related to sale of
future royalties, net of deferred financing costs |
|
1.2 |
|
|
|
1.3 |
|
Total current liabilities |
|
8.8 |
|
|
|
9.2 |
|
Non-current
liabilities: |
|
|
|
Long-term note payable, net of
current portion |
|
0.3 |
|
|
|
0.3 |
|
Liabilities related to sale of
future royalties, net of deferred financing costs and current
portion |
|
17.2 |
|
|
|
16.8 |
|
Other long-term liabilities, net of
current portion |
|
0.2 |
|
|
|
0.2 |
|
Total liabilities |
|
26.5 |
|
|
|
26.5 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.10 par value;
5,000,000 shares authorized and none issued and outstanding as of
September 30, 2016 and June 30, 2016 |
|
- |
|
|
|
- |
|
Common stock, $0.10 par value;
200,000,000 shares authorized 38,640,487 shares issued and
outstanding at September 30, 2016 and June 30, 2016 |
|
3.9 |
|
|
|
3.9 |
|
Additional paid-in capital |
|
158.0 |
|
|
|
157.6 |
|
Accumulated other comprehensive
income |
|
19.0 |
|
|
|
19.0 |
|
Accumulated deficit |
|
(144.3 |
) |
|
|
(134.3 |
) |
Total stockholders’ equity |
|
36.6 |
|
|
|
46.2 |
|
Total liabilities and stockholders’
equity |
$ |
63.1 |
|
|
$ |
72.7 |
|
|
|
|
AVIRAGEN THERAPEUTICS, INC. |
|
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
(in millions, except per share amounts) |
|
|
(unaudited) |
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
|
2016 |
|
|
2015 |
|
|
|
Revenue: |
|
|
|
|
Royalty revenue and milestones |
$ |
0.1 |
|
$ |
1.7 |
|
|
|
Total revenue |
|
0.1 |
|
|
1.7 |
|
|
|
|
|
|
|
|
Operating expense: |
|
|
|
|
Research and development |
|
7.6 |
|
|
5.5 |
|
|
|
General and administrative |
|
2.2 |
|
|
2.2 |
|
|
|
Foreign exchange loss (gain) |
|
(0.1 |
) |
|
0.7 |
|
|
|
Total operating
expense |
|
9.7 |
|
|
8.4 |
|
|
|
Loss from operations |
|
(9.6 |
) |
|
(6.7 |
) |
|
|
|
|
|
|
|
Non-operating income: |
|
|
|
|
Non-cash interest expense on
liability related to sale of future royalties |
|
(0.4 |
) |
|
- |
|
|
|
Interest income (expense), net |
|
- |
|
|
0.1 |
|
|
|
Total non-operating income
(expense) |
|
(0.4 |
) |
|
0.1 |
|
|
|
|
|
|
|
|
Loss before tax |
|
(10.0 |
) |
|
(6.6 |
) |
|
|
Income tax benefit |
|
- |
|
|
- |
|
|
|
Net loss |
$ |
(10.0 |
) |
$ |
(6.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share |
$ |
(0.26 |
) |
$ |
(0.17 |
) |
|
|
Diluted loss per
share |
$ |
(0.26 |
) |
$ |
(0.17 |
) |
|
|
|
|
|
|
|
Basic weighted-average
shares outstanding |
|
38,640,487 |
|
|
38,624,227 |
|
|
|
Diluted weighted-average
shares outstanding |
|
38,640,487 |
|
|
38,624,227 |
|
|
|
|
|
|
|
|
Contacts:
Mark Colonnese
Executive Vice President and Chief Financial Officer
Aviragen Therapeutics, Inc.
(678) 221-3381
mcolonnese@aviragentherapeutics.com
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
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