Aviragen Therapeutics, Inc. (NASDAQ:AVIR) today announced its
financial results for the three month period ended December
31, 2016, which is the second quarter of the Company's 2017 fiscal
year, and also provided an update on recent corporate developments.
“In looking to the 2017 calendar year, we have both
near-term events and a broad vision driving the development of our
antiviral pipeline. In the coming weeks, we have a key data readout
from our lead program, vapendavir, that we feel could be a
significant value-creating event for the Company. We are very
committed to the advancement of our pipeline and are confident of
its potential to address considerable unmet clinical needs for
patients with limited therapeutic options,” commented Joseph M.
Patti, PhD, President and Chief Executive Officer of Aviragen
Therapeutics. “We remain opportunistic in seeking out new
indications within our current pipeline and plan to initiate a
Phase 2 study of vapendavir for the treatment of rhinovirus
infections in hematopoietic stem cell transplant patients this
quarter.”
Upcoming Corporate Milestones
Data Readout from Phase 2b SPIRITUS
Trial. This month the Company expects to report results
from the Phase 2b SPIRITUS trial of vapendavir for the treatment of
rhinovirus (RV). The primary endpoint of this multi-center,
randomized, double-blind, placebo-controlled dose-ranging study 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, lung function assessments
such as forced expiratory volume in one second (FEV1), incidence of
asthma exacerbations, assessments of the severity and duration of
cold symptoms measured by the Wisconsin Upper Respiratory
Symptom Survey-21 (WURSS-21) and virological assessments.
Initiation of Phase 2 Trial of Vapendavir
for Treatment of RV Infections in
Hematopoietic Stem Cell Transplant
(HSCT)
Patients. In the first quarter of 2017, the
Company expects to initiate a Phase 2 trial of vapendavir for the
treatment of RV infections in HSCT patients. The primary endpoint
of the trial will be time-weighted average change from baseline to
end of treatment visit in RV viral load. Secondary endpoints will
include mortality, rate of progression of RV in upper respiratory
tract infection to lower respiratory tract infection, duration of
RV shedding in HSCT subjects, and proportion with hospitalization
and hospitalization time.
Corporate Update
Reported Data from the Phase 2a RSV
Challenge Study of BTA585. Yesterday, the Company
announced top-line data from its double-blind, placebo-controlled
Phase 2a study of BTA585 in adults challenged intranasally with
respiratory syncytial virus (RSV). The data indicated there
was not a significant reduction in the primary endpoint, which was
viral load. The data suggested biological activity on several of
the endpoints, however, the considerable variability in viral load
among the cohorts and the small number of subjects that became
infected with RSV likely impacted the ability to detect a
significant difference between the groups. The safety profile of
BTA585 was favorable and consistent across treatment groups. These
safety results, together with the other clinical data and the
recently completed non-clinical studies, will form the basis for
the Company’s interaction with the FDA to discuss lifting the
clinical hold on BTA585’s Investigational New Drug application.
Dr. Patti continued, “For BTA585, we plan to
determine the best path forward based on our review of the full
data set from the challenge study and our interactions with the
FDA, and expect to be able to update you on our plans next
quarter.”
Financial Results for the Three Month
Period Ended December 31, 2016
The Company reported a net loss of $9.1 million for
the three month period ended December 31, 2016, as compared to a
net loss of $6.5 million in the same quarter of the prior fiscal
year. Basic and diluted net loss per share was $0.24 for the three
month period ended December 31, 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 increased to $3.8 million for the
three month period ended December 31, 2016 from $1.7 million in the
same period in 2015 mainly due to non-cash royalty revenue related
to the sale of certain royalty rights for Inavir® in Japan to
HealthCare Royalty Partners III, L.P. in April 2016.
Research and development expense increased to $10.2
million for the three month period ended December 31, 2016 from
$6.3 million in the same period in 2015. The $3.9 million increase
largely reflected additional clinical trial activity and higher
clinical and manufacturing costs associated with our three Phase 2
clinical trials that were ongoing during the quarter.
General and administrative expense was $2.1 million
for both the three month period ended December 31, 2016 and the
same period in 2015.
Non-cash implied interest expense was $0.5 million
for the three month period ended December 31, 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 $49.2 million in cash, cash
equivalents, and short-term investments as of December 31,
2016.
Conference Call and Webcast
Information
Aviragen Therapeutics will host a conference call
today to review these second 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 60561525. 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
four Phase 2 clinical programs: vapendavir, an oral treatment for
rhinovirus (RV) upper respiratory infections in moderate-to-severe
asthmatics; vapendavir for the treatment of RV infections in
hematopoietic stem cell transplant patients; BTA585, an oral fusion
protein inhibitor in development for the treatment of respiratory
syncytial virus infections; and BTA074, a topical antiviral
treatment 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 readout from the Phase 2
SPIRITUS trial and the timing of the initiation of a Phase 2 trial
in hematopoietic stem cell transplant patients, the timing of the
FDA response to our request to lift clinical hold, and the timing
to announce our plans for BTA585. 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® is a registered trademark.
Inavir® is a registered trademark of Daiichi Sankyo Company,
Ltd.
AVIRAGEN THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(in millions, except per share amounts) |
|
December 31, 2016 |
|
June 30, 2016 |
|
(unaudited) |
|
(audited) |
ASSETS |
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
38.1 |
|
|
$ |
49.7 |
|
Short-term investments |
|
11.1 |
|
|
|
19.3 |
|
Accounts
receivable, net of allowance |
|
4.2 |
|
|
|
0.7 |
|
Prepaid
and other current assets |
|
2.8 |
|
|
|
2.7 |
|
Total
current assets |
|
56.2 |
|
|
|
72.4 |
|
Non-current
assets: |
|
|
|
Property
and equipment, net |
|
0.3 |
|
|
|
0.3 |
|
Total
non-current assets |
|
0.3 |
|
|
|
0.3 |
|
Total
assets |
$ |
56.5 |
|
|
$ |
72.7 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
3.4 |
|
|
$ |
3.9 |
|
Accrued
expenses |
|
5.6 |
|
|
|
3.6 |
|
Short-term note payable |
|
0.3 |
|
|
|
0.4 |
|
Liabilities related to sale of future royalties, net of deferred
financing costs |
|
1.2 |
|
|
|
1.3 |
|
Total
current liabilities |
|
10.5 |
|
|
|
9.2 |
|
Non-current
liabilities: |
|
|
|
Long-term
note payable, net of current portion |
|
0.2 |
|
|
|
0.3 |
|
Liabilities related to sale of future royalties, net of deferred
financing costs and current portion |
|
17.6 |
|
|
|
16.8 |
|
Other
long-term liabilities, net of current portion |
|
0.2 |
|
|
|
0.2 |
|
Total
liabilities |
|
28.5 |
|
|
|
26.5 |
|
Stockholders’
equity: |
|
|
|
Preferred
stock, $0.10 par value; 5,000,000 shares authorized and none issued
and outstanding as of December 31, 2016 and June 30, 2016 |
|
- |
|
|
|
- |
|
Common
stock, $0.10 par value; 200,000,000 shares authorized 38,640,487
shares issued and outstanding at December 31, 2016 and June 30,
2016 |
|
3.9 |
|
|
|
3.9 |
|
Additional paid-in capital |
|
158.5 |
|
|
|
157.6 |
|
Accumulated other comprehensive income |
|
19.0 |
|
|
|
19.0 |
|
Accumulated deficit |
|
(153.4 |
) |
|
|
(134.3 |
) |
Total
stockholders’ equity |
|
28.0 |
|
|
|
46.2 |
|
Total
liabilities and stockholders’ equity |
$ |
56.5 |
|
|
$ |
72.7 |
|
AVIRAGEN THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in millions, except per share amounts) |
(unaudited) |
|
|
Three Months Ended December 31, |
|
Six Months Ended December 31, |
|
|
2016 |
|
|
2015 |
|
|
|
2016 |
|
|
2015 |
|
Revenue: |
|
|
|
|
|
Royalty
revenue |
$ |
1.5 |
|
$ |
1.7 |
|
|
$ |
1.6 |
|
$ |
3.4 |
|
Non-cash
royalty revenue related to the sale of future royalties |
|
2.3 |
|
|
- |
|
|
|
2.3 |
|
|
- |
|
Total revenue |
|
3.8 |
|
|
1.7 |
|
|
|
3.9 |
|
|
3.4 |
|
|
|
|
|
|
|
Operating expense: |
|
|
|
|
|
Research
and development |
|
10.2 |
|
|
6.3 |
|
|
|
17.8 |
|
|
11.8 |
|
General
and administrative |
|
2.1 |
|
|
2.1 |
|
|
|
4.3 |
|
|
4.4 |
|
Foreign
exchange loss (gain), net |
|
0.1 |
|
|
(0.2 |
) |
|
|
- |
|
|
0.5 |
|
Total operating
expense |
|
12.4 |
|
|
8.2 |
|
|
|
22.1 |
|
|
16.7 |
|
Loss from
operations |
|
(8.6 |
) |
|
(6.5 |
) |
|
|
(18.2 |
) |
|
(13.3 |
) |
|
|
|
|
|
|
Non-operating income
(expense): |
|
|
|
|
|
Non-cash
interest expense on liability related to sale of future
royalties |
|
(0.5 |
) |
|
- |
|
|
|
(0.9 |
) |
|
- |
|
Interest
income, net |
|
0.1 |
|
|
- |
|
|
|
0.1 |
|
|
0.1 |
|
Total non-operating
income (expense) |
|
(0.4 |
) |
|
- |
|
|
|
(0.8 |
) |
|
0.1 |
|
|
|
|
|
|
|
Loss before tax |
|
(9.0 |
) |
|
(6.5 |
) |
|
|
(19.0 |
) |
|
(13.2 |
) |
Income tax expense |
|
0.1 |
|
|
- |
|
|
|
0.1 |
|
|
- |
|
Net loss |
$ |
(9.1 |
) |
$ |
(6.5 |
) |
|
$ |
(19.1 |
) |
$ |
(13.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per
share |
$ |
(0.24 |
) |
$ |
(0.17 |
) |
|
$ |
(0.49 |
) |
$ |
(0.34 |
) |
Diluted loss per
share |
$ |
(0.24 |
) |
$ |
(0.17 |
) |
|
$ |
(0.49 |
) |
$ |
(0.34 |
) |
|
|
|
|
|
|
Basic weighted-average
shares outstanding |
|
38,640,487 |
|
|
38,636,946 |
|
|
|
38,640,487 |
|
|
38,630,587 |
|
Diluted
weighted-average shares outstanding |
|
38,640,487 |
|
|
38,636,946 |
|
|
|
38,640,487 |
|
|
38,630,587 |
|
|
|
|
|
|
|
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
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Sep 2023 to Sep 2024