Nexvet Biopharma (Nasdaq:NVET), a veterinary biologics developer,
today announced its financial results for the three and nine-month
periods ended March 31, 2016.
Recent company highlights
include:
- Advanced clinical development and regulatory preparations for
ranevetmab (NV-01), for the control of pain associated with
osteoarthritis in dogs
- Completed enrollment of 126 cats in a pilot field safety and
efficacy study of NV-02, for the control of pain associated with
osteoarthritis in cats
- Announced anti-PD-1 program for canine cancer under United
States Department of Agriculture (USDA) jurisdiction, with new
candidates showing binding and potent inhibition of canine
PD-1
“I am pleased with the progress achieved during the
quarter. Certainly, maintaining the development timelines for our
lead product candidates is the top priority as we advance internal
and partnered programs utilizing our proprietary PETization
platform to create compelling treatments for unmet medical needs in
dogs and cats. I’m also encouraged by the progress we’ve made in
bringing our manufacturing facility, BioNua, on-line as managing
in-house manufacturing is an essential component of our business
strategy,” commented Dr. Mark Heffernan, Nexvet’s Chief Executive
Officer.
An important accomplishment during the quarter was
the successful completion of a pilot field study for ranevetmab,
the Company's anti-nerve growth factor (NGF) monoclonal antibody
(mAb) therapy in development for the control of pain associated
with osteoarthritis in dogs. This pilot field study was designed to
evaluate a combination of doses and routes of administration to
complement the pivotal safety and efficacy study for ranevetmab.
In November of 2015, Nexvet announced that the completed
pivotal study of ranevetmab demonstrated safety and efficacy (p≤
0.038 for the primary endpoint) when administered by subcutaneous
(SC) injection, once a month for three months. Results from the
most recent pilot study confirmed ranevetmab’s safety and efficacy
in a field study evaluating a range of dosages and treatment
regimens (SC and intravenous administration) in an additional
population of 176 dogs. The Target Animal Efficacy submission for
ranevetmab is scheduled for submittal to the United States Food and
Drug Administration’s Center for Veterinary Medicine by the end of
the second calendar quarter of 2016.
During the period, the Company also completed
enrollment for its pilot field safety and efficacy study of NV-02
for the control of pain associated with osteoarthritis in cats.
This study remains on course to deliver initial data in the second
calendar quarter of 2016. If supportive of further development, the
data will inform the design of a pivotal safety and efficacy study
for NV-02, to commence later this year.
Throughout the quarter, Nexvet continued to prepare
the BioNua manufacturing facility in Tullamore, Ireland to become
fully operational in mid-2016. Preparation of Chemistry,
Manufacturing and Controls (CMC) materials has begun for ranevetmab
and NV-02, inclusive of transitioning materials and processes from
former contract manufacturers. A team of 20 process scientists,
quality assurance personnel and support staff has been assembled,
and the facility has obtained state-of-the-art large-scale
disposable bioreactors, purification systems, UF/DF systems and
support equipment which has been fully commissioned in preparation
for manufacturing veterinary mAbs. In addition, facility upgrades
have been made and a Good Manufacturing Practice facility ramp-up
protocol has been initiated.
During the quarter, Nexvet advanced its anti-tumor
necrosis factor (TNF) programs, having identified new, highly
potent and neutralizing PETized dog and cat mAbs against this
target. TNF is a focus of the Company’s programs in chronic
inflammation, as targeting TNF has delivered several of the
best-selling anti-inflammatory drugs in human medicine. Nexvet’s
proof-of-concept studies demonstrated that NV-08 (a canine TNF
receptor fusion protein) produced an anti-inflammatory effect in
dogs; the Company’s new anti-TNF mAbs will progress into
proof-of-concept and will replace the receptor fusion protein
candidates (including NV-08) due to a more favorable target product
profile based on their longer half-life and anticipated need for
less frequent dosing.
In April 2016, the Company announced the successful
PETization of fully canine mAbs against programmed cell death
protein 1 (PD-1). The anti-PD-1 program is based on mAbs identified
by Nexvet’s research and development collaborator, Zenoaq (Nippon
Zenyaku Kogyo Co., Ltd.), a leading Japanese animal health company.
The program has demonstrated binding and potent inhibition of
canine PD-1, and will now enter further safety, pharmacokinetic and
immunogenicity studies. The USDA’s Center for Veterinary Biologics
has confirmed jurisdiction over the regulatory path for this
program, providing an opportunity for conditional licensure*.
*About conditional licensure
Conditional licensure allows for market entry in
the U.S. of a product on a comparatively rapid basis, under certain
conditions, after a demonstration of purity, safety and a
reasonable expectation of efficacy. While a conditional licensure
is in place, the license holder continues to develop efficacy data
in order to apply for full approval.
Third Quarter 2016 Financial
Results
As of March 31, 2016, Nexvet had cash of
$37.2 million.
For the three months ended March 31, 2016, Nexvet
reported a net loss of $5.8 million, compared to
$2.7 million for the three months ended March 31, 2015. Net
loss per share attributable to ordinary shareholders (basic and
diluted) for the three months ended March 31, 2016 was $0.50,
compared to $0.36 for the three months ended March 31, 2015.
The net loss of $5.8 million for the three
months ended March 31, 2016 included operating expenses of
$6.0 million, reflecting $4.3 million in research and
development expenses and $1.7 million in general and
administrative expenses. Other income comprised $0.2 million,
principally research and development income of $0.4 million
offset by an exchange loss of $0.3 million.
The net loss of $2.7 million for the three
months ended March 31, 2015 included operating expenses of
$5.1 million, reflecting $2.7 million in research and
development expenses and $2.4 million in general and
administrative expenses. Other income comprised $2.4 million,
principally research and development income of $1.0 million
and an exchange gain of $1.3 million.
For the nine months ended March 31, 2016, Nexvet
reported a net loss of $15.4 million, compared to $7.4 million
for the nine months ended March 31, 2015. Net loss per share
attributable to ordinary shareholders (basic and diluted) for the
nine months ended March 31, 2016 was $1.34, compared to
$2.30 for the nine months ended March 31, 2015.
The net loss of $15.4 million for the nine
months ended March 31, 2016 included operating expenses of
$17.1 million, reflecting $11.8 million in research and
development expenses and $5.3 million in general and
administrative expenses. Other income comprised $1.7 million,
principally research and development income of $1.4 million,
an exchange gain of $0.2 million and interest income of $0.1
million.
The net loss of $7.4 million for the nine
months ended March 31, 2015 included operating expenses of
$15.1 million, reflecting $7.4 million in research and
development expenses and $7.7 million in general and
administrative expenses. Other income comprised $7.7 million,
principally research and development income of $2.7 million,
an exchange gain of $4.6 million and government grant income
of $0.4 million.
The increased operating expenses for both the three
and nine month periods ended March 31, 2016, compared to the
corresponding periods in 2015, primarily reflect research and
development costs associated with building our team, particularly
within our manufacturing facility, and conducting field studies of
our lead programs, offset by a reduction in general and
administrative costs primarily due to incurring costs in 2015
associated with preparation for our initial public offering and
Irish reorganization.
About Nexvet
(www.nexvet.com)
Nexvet is a veterinary biologics developer focused
on transforming the therapeutic market for companion animals, such
as dogs and cats, by developing and commercializing novel,
species-specific biologics. Nexvet’s proprietary PETization™
platform is designed to rapidly design monoclonal antibodies (mAbs)
that are recognized as “self” or “native” by an animal’s immune
system, a property Nexvet refers to as “100% species-specificity.”
Nexvet’s product candidates also build upon the safety and efficacy
data from clinically tested human therapies, thereby reducing
clinical risk and development cost.
Nexvet is leveraging diverse global expertise and
incentives to build a vertically integrated biopharmaceutical
company, which conducts drug discovery in Australia, conducts
clinical development in the United States and Europe and
is growing its biomanufacturing capabilities in Ireland.
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(unaudited) |
(in thousands, except share and per share
amounts) |
|
|
|
March 31, 2016 |
|
June 30, 2015 |
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash |
|
$ |
37,162 |
|
|
$ |
52,033 |
|
Other income receivable |
|
|
1,813 |
|
|
|
3,301 |
|
Prepaid expenses and other |
|
|
768 |
|
|
|
607 |
|
Total current assets |
|
|
39,743 |
|
|
|
55,941 |
|
Noncurrent assets |
|
|
|
|
Other income receivable |
|
|
55 |
|
|
|
— |
|
Prepaid expenses |
|
|
139 |
|
|
|
163 |
|
Total noncurrent assets |
|
|
194 |
|
|
|
163 |
|
Property, plant and
equipment, net |
|
|
4,235 |
|
|
|
549 |
|
Intangible assets,
net |
|
|
42 |
|
|
|
19 |
|
Total assets |
|
$ |
44,214 |
|
|
$ |
56,672 |
|
Liabilities and
Shareholders’ Equity |
|
|
|
|
Current
liabilities |
|
|
|
|
Accounts payable |
|
$ |
1,549 |
|
|
$ |
658 |
|
Accrued expenses and other
liabilities |
|
|
3,278 |
|
|
|
2,352 |
|
Deferred grant income |
|
|
280 |
|
|
|
— |
|
Deferred lease incentive |
|
|
23 |
|
|
|
23 |
|
Total current liabilities |
|
|
5,130 |
|
|
|
3,033 |
|
Noncurrent
liabilities |
|
|
|
|
Accrued expenses and other
liabilities |
|
|
67 |
|
|
|
— |
|
Deferred grant income |
|
|
55 |
|
|
|
— |
|
Deferred lease incentive |
|
|
44 |
|
|
|
61 |
|
Total noncurrent liabilities |
|
|
166 |
|
|
|
61 |
|
Total liabilities |
|
$ |
5,296 |
|
|
$ |
3,094 |
|
Commitments and
contingencies (Note 11) |
|
|
|
|
Shareholders’
equity |
|
|
|
|
Ordinary shares, $0.125 nominal
value per share, 100,000,000 shares authorized as of March 31, 2016
and June 30, 2015—11,563,133 and 11,406,916 shares issued and
outstanding as of March 31, 2016 and June 30, 2015,
respectively |
|
$ |
1,445 |
|
|
$ |
1,426 |
|
Euro deferred shares, €100 nominal
value per share, 400 shares authorized as of March 31, 2016 and
June 30, 2015—400 shares issued and outstanding as of March 31,
2016 and June 30, 2015 |
|
|
13 |
|
|
|
13 |
|
Additional paid-in capital |
|
|
81,626 |
|
|
|
80,275 |
|
Accumulated other comprehensive
loss |
|
|
(5,115 |
) |
|
|
(4,481 |
) |
Accumulated deficit |
|
|
(39,051 |
) |
|
|
(23,655 |
) |
Total shareholders’ equity |
|
|
38,918 |
|
|
|
53,578 |
|
Total liabilities and shareholders’
equity |
|
$ |
44,214 |
|
|
$ |
56,672 |
|
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS |
(unaudited) |
(in thousands, except share and per share
amounts) |
|
|
|
Three Months EndedMarch
31, |
|
|
Nine Months EndedMarch
31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
25 |
|
Total revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
25 |
|
Operating
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
4,260 |
|
|
|
2,679 |
|
|
|
11,775 |
|
|
|
7,444 |
|
General and
administrative |
|
|
1,680 |
|
|
|
2,430 |
|
|
|
5,329 |
|
|
|
7,688 |
|
Total operating expenses |
|
|
5,940 |
|
|
|
5,109 |
|
|
|
17,104 |
|
|
|
15,132 |
|
Loss from
operations |
|
|
(5,940 |
) |
|
|
(5,109 |
) |
|
|
(17,104 |
) |
|
|
(15,107 |
) |
Other Income
(Expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development income |
|
|
418 |
|
|
|
1,011 |
|
|
|
1,441 |
|
|
|
2,693 |
|
Government grant
income |
|
|
- |
|
|
|
84 |
|
|
|
4 |
|
|
|
403 |
|
Exchange (loss)
gain |
|
|
(259 |
) |
|
|
1,341 |
|
|
|
151 |
|
|
|
4,595 |
|
Interest income |
|
|
36 |
|
|
|
5 |
|
|
|
112 |
|
|
|
38 |
|
Net loss |
|
$ |
(5,745 |
) |
|
$ |
(2,668 |
) |
|
$ |
(15,396 |
) |
|
$ |
(7,378 |
) |
Net loss per share
attributable to ordinary shareholders, basic and diluted |
|
$ |
(0.50 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.34 |
) |
|
$ |
(2.30 |
) |
Weighted-average
ordinary shares outstanding, basic and diluted |
|
|
11,559,056 |
|
|
|
7,474,478 |
|
|
|
11,502,409 |
|
|
|
3,204,434 |
|
Comprehensive
Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,745 |
) |
|
$ |
(2,668 |
) |
|
$ |
(15,396 |
) |
|
$ |
(7,378 |
) |
Net gain (loss) in
foreign currency translation adjustments |
|
|
210 |
|
|
|
(1,505 |
) |
|
|
(634 |
) |
|
|
(5,123 |
) |
Total comprehensive
loss |
|
$ |
(5,535 |
) |
|
$ |
(4,173 |
) |
|
$ |
(16,030 |
) |
|
$ |
(12,501 |
) |
|
Forward looking statements
This press release contains forward looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Forward looking statements consist of all
statements other than statements of historical fact, including
statements regarding our future results of operations and financial
position, results of any current or future pivotal safety and
efficacy study, future expenditures relating to our lead product
candidates, time for completion of any of our studies or facilities
upgrades, ability to develop our pipeline of product candidates,
business strategy, prospective products, ability to successfully
manufacture our own product candidates, ability to meet conditions
for the receipt of government grants, time for regulatory
submissions or ability to qualify for conditional licensure or
obtain product approvals, research and development costs, timing
and likelihood of success, plans and objectives of management for
future operations, and future results of current and anticipated
products. These statements relate to future events or to our future
financial performance and involve known and unknown risks,
uncertainties and other factors which may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward looking statements. The words “anticipate,” “assume,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “might,” “objective,” “plan,” “potential,” “predict,”
“project,” “position,” “seek,” “should,” “target,” “will,” “would,”
or the negative of these terms or other similar expressions are
intended to identify forward looking statements, although not all
forward looking statements contain these identifying words. These
forward looking statements are based on current expectations,
estimates, forecasts and projections about our business and the
industry in which we operate, and management’s beliefs and
assumptions are not guarantees of future performance or development
and involve known and unknown risks, uncertainties and other
factors. Factors that could cause actual results to differ
materially from our expectations expressed in this report include
those summarized under Risk Factors in our reports on Forms 10-Q
and 10-K and the other documents we file from time to time with the
Securities and Exchange Commission. Given these risks and
uncertainties, you should not place undue reliance on these forward
looking statements. Also, forward looking statements represent
management’s beliefs and assumptions only as of the date of this
press release. Except as required by law, we do not intend, and
undertake no obligation, to revise or update these forward looking
statements, or to update the reasons actual results could differ
materially from those anticipated in these forward looking
statements, even if new information becomes available in the
future.
Further information
Investors
Candice Knoll
Blueprint Life Science Group
+1 415-375-3340 Ext. 4
cknoll@bplifescience.com
Company
Damian Lismore
CFO, Nexvet Biopharma plc
+1 415-602-5544
+61 417-351-272 (Aus.)
damian.lismore@nexvet.com
Company
Damian Lismore
CFO, Nexvet Biopharma plc
+1 415-602-5544
+61 417-351-272 (Aus.)
damian.lismore@nexvet.com
Media
Jessica Burns
Berry & Company Public Relations
+1 212-253-8881
jburns@berrypr.com
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