Nexvet Biopharma (Nasdaq:NVET) today announced its financial
results for the three and six month periods ended December 31,
2016.
Recent highlights:
- Initiated pivotal field efficacy and safety studies of
frunevetmab, the Company’s anti-nerve growth factor monoclonal
antibody (anti-NGF mAb) in development for the control of pain
associated with osteoarthritis in cats
- Entered into a research collaboration with Genentech
- Successfully completed preliminary in vivo immunogenicity,
pharmacokinetic and safety studies for the Company’s canine
anti-PD-1 immuno-oncology program
- Delivered first clinical-scale production of ranevetmab, the
Company’s canine anti-NGF mAb candidate, at the Company’s
wholly-owned manufacturing facility (BioNua)
- Signed a licensing agreement with Pfizer regarding certain
anti-NGF mAb patents
“This was an important period of progress for the Company as we
initiated pivotal clinical studies for frunevetmab, continued to
advance our chemistry, manufacturing and controls (CMC) activities,
and entered into a collaboration with Genentech, our first such
agreement with a dedicated human biotech company utilizing our
PETization platform,” commented Mark Heffernan, Chief Executive
Officer of Nexvet.
In December 2016, the Company announced it had treated the first
cat in the frunevetmab pivotal field efficacy and safety study.
This study is a placebo-controlled, randomized, double-blinded
study with a target enrolment of 250 cats with osteoarthritis at
approximately 20 clinical sites around the United States. Enrolled
cats will be randomly assigned to receive frunevetmab or placebo at
a 2:1 ratio. Each cat will receive three doses, with each dose
given 28 days apart. This study has received protocol concurrence
from the Center for Veterinary Medicine (CVM) at the United States
Food and Drug Administration (FDA) and will utilize a comparison of
owner-assessed responses, before and after treatment, as its
primary endpoint.
The pivotal target animal safety study, which commenced in late
October 2016, is examining the safety of frunevetmab in cats
according to standard International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH) guidance and a protocol concurred with the CVM.
Nexvet expects to report data from both studies in the fourth
quarter of calendar 2017.
In support of the Company’s planned frunevetmab CMC technical
section submission to the CVM, a third 200 liter batch of
frunevetmab was produced during the quarter at BioNua, the
Company’s wholly-owned manufacturing facility, which is also being
prepared for commercial manufacturing of Nexvet’s products. A first
200 liter batch of ranevetmab was also successfully produced during
the quarter.
In November 2016, the Company entered into a research
collaboration with Genentech, a member of the Roche Group,
involving use of the Company’s PETization platform.
During the quarter, Nexvet also successfully completed
preliminary pharmacokinetic, immunogenicity and safety studies for
its anti-PD-1 program in dogs. In human medicine, blocking the
interactions of programmed cell death protein 1 (PD-1) and
programmed cell death-ligand 1 (PD-L1) has resulted in approved
therapies with attractive safety profiles that demonstrate efficacy
against multiple tumor types.
Since December 31, 2016
In February 2017, the Company entered into a license agreement
with Pfizer Inc. (“Pfizer”), pursuant to which the Company received
a non-exclusive license to certain patents in the Pfizer portfolio
for anti-NGF antibodies. The Company has agreed to pay Pfizer a
$1.0 million upfront license fee, and may pay Pfizer (i) additional
amounts based on regulatory and sales milestones and (ii) a low,
single-digit royalty based on net sales of the Company’s anti-NGF
product candidates for the life of the relevant patents.
Financial Results
As of December 31, 2016, Nexvet had cash of
$20.5 million.
Three months ended December 31, 2016
For the three months ended December 31, 2016, Nexvet reported a
net loss of $5.4 million, compared to $5.7 million for
the three months ended December 31, 2015. Net loss per share
attributable to ordinary shareholders (basic and diluted) for the
three months ended December 31, 2016 was $0.46, compared to $0.49
for the three months ended December 31, 2015.
The net loss of $5.4 million for the three months ended
December 31, 2016 included operating expenses of $5.2 million,
reflecting $3.8 million in research and development expenses
and $1.4 million in general and administrative expenses. Other
expense of $0.3 million comprised an exchange loss of $1.0 million,
offset by research and development income of $0.5 million and
government grant income of $0.2 million.
The net loss of $5.7 million for the three months ended December
31, 2015 included operating expenses of $5.6 million, reflecting
$3.8 million in research and development expenses and $1.8 million
in general and administrative expenses. Other expense of $0.1
million comprised an exchange loss of $0.6 million offset by
research and development income of $0.5 million.
Six months ended December 31, 2016
For the six months ended December 31, 2016, Nexvet reported a
net loss of $10.5 million, compared to $9.7 million for the six
months ended December 31, 2015. Net loss per share attributable to
ordinary shareholders (basic and diluted) for the six months ended
December 31, 2016 was $0.90, compared to $0.84 for the six months
ended December 31, 2015.
The net loss of $10.5 million for the six months ended December
31, 2016 included operating expenses of $10.9 million, reflecting
$7.2 million in research and development expenses and $3.7 million
in general and administrative expenses. Other income of $0.4
million comprised research and development income of $1.0 million
and a government grant income of $0.4 million, offset by an
exchange loss of $1.0 million.
The net loss of $9.7 million for the six months ended December
31, 2015 included operating expenses of $11.2 million, reflecting
$7.5 million in research and development expenses and $3.7 million
in general and administrative expenses. Other income of $1.5
million comprised research and development income of $1.0 million
and an exchange gain of $0.5 million.
About Nexvet
(www.nexvet.com)
Nexvet is a clinical-stage biopharmaceutical company 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 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 conducts
manufacturing in Ireland.
CONDENSED CONSOLIDATED BALANCE SHEETS |
(unaudited) |
(in thousands, except share and per share
amounts) |
|
|
December 31, 2016 |
|
June 30, 2016 |
Assets |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash |
|
$ |
20,482 |
|
|
$ |
31,481 |
|
Other
income receivable |
|
|
1,265 |
|
|
|
2,201 |
|
Prepaid
expenses and other |
|
|
1,438 |
|
|
|
1,280 |
|
Total
current assets |
|
|
23,185 |
|
|
|
34,962 |
|
Noncurrent
assets |
|
|
|
Other
income receivable |
|
|
563 |
|
|
|
251 |
|
Prepaid
expenses and other |
|
|
108 |
|
|
|
129 |
|
Total
noncurrent assets |
|
|
671 |
|
|
|
380 |
|
Property,
plant and equipment, net |
|
|
5,083 |
|
|
|
4,908 |
|
Intangible
assets, net |
|
|
71 |
|
|
|
74 |
|
Total
assets |
|
$ |
29,010 |
|
|
$ |
40,324 |
|
Liabilities and Shareholders’ Equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
851 |
|
|
$ |
1,729 |
|
Accrued
expenses and other liabilities |
|
|
1,951 |
|
|
|
3,295 |
|
Deferred
income |
|
|
23 |
|
|
|
23 |
|
Total current
liabilities |
|
|
2,825 |
|
|
|
5,047 |
|
Noncurrent
liabilities |
|
|
|
Accrued
expenses and other liabilities |
|
|
72 |
|
|
|
104 |
|
Deferred
income |
|
|
23 |
|
|
|
37 |
|
Total
noncurrent liabilities |
|
|
95 |
|
|
|
141 |
|
Total
liabilities |
|
$ |
2,920 |
|
|
$ |
5,188 |
|
Commitments
and contingencies (Note 12) |
|
|
|
|
|
|
|
|
Shareholders’
equity |
|
|
|
|
|
|
|
|
Ordinary
shares, $0.125 nominal value per share, 100,000,000 shares
authorized as of December 31 and June 30, 2016—11,752,302 and
11,565,133 shares issued and outstanding as of December 31 and
June 30, 2016, respectively |
|
$ |
1,469 |
|
|
$ |
1,446 |
|
Euro
deferred shares, €100 nominal value per share, 400 shares
authorized as of September 30 and June 30, 2016—400 shares issued
and outstanding as of September 30 and June 30, 2016,
respectively |
|
|
13 |
|
|
|
13 |
|
Additional paid-in capital |
|
|
82,951 |
|
|
|
82,030 |
|
Accumulated other comprehensive loss |
|
|
(4,816 |
) |
|
|
(5,333 |
) |
Accumulated deficit |
|
|
(53,527 |
) |
|
|
(43,020 |
) |
Total
shareholders’ equity |
|
|
26,090 |
|
|
|
35,136 |
|
Total
liabilities and shareholders’ equity |
|
$ |
29,010 |
|
|
$ |
40,324 |
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
(unaudited) |
(in thousands, except share and per share
amounts) |
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Total
revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Operating
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
3,753 |
|
|
|
3,790 |
|
|
|
7,219 |
|
|
|
7,515 |
|
General and
administrative |
|
|
1,407 |
|
|
|
1,779 |
|
|
|
3,640 |
|
|
|
3,649 |
|
Total
operating expenses |
|
|
5,160 |
|
|
|
5,569 |
|
|
|
10,859 |
|
|
|
11,164 |
|
Loss from
operations |
|
|
(5,160 |
) |
|
|
(5,569 |
) |
|
|
(10,859 |
) |
|
|
(11,164 |
) |
Other Income
(Expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development income |
|
|
459 |
|
|
|
457 |
|
|
|
970 |
|
|
|
1,023 |
|
Government grant
income |
|
|
181 |
|
|
|
— |
|
|
|
356 |
|
|
|
4 |
|
Exchange (loss)
gain |
|
|
(953 |
) |
|
|
(618 |
) |
|
|
(1,034 |
) |
|
|
410 |
|
Interest income |
|
|
31 |
|
|
|
39 |
|
|
|
60 |
|
|
|
76 |
|
Net
loss |
|
$ |
(5,412 |
) |
|
$ |
(5,691 |
) |
|
$ |
(10,507 |
) |
|
$ |
(9,651 |
) |
Net loss per share
attributable to ordinary shareholders, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.49 |
) |
|
$ |
(0.90 |
) |
|
$ |
(0.84 |
) |
Weighted-average
ordinary shares outstanding, basic and diluted |
|
|
11,740,432 |
|
|
|
11,506,236 |
|
|
|
11,721,862 |
|
|
|
11,474,394 |
|
Comprehensive
Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,412 |
) |
|
$ |
(5,691 |
) |
|
$ |
(10,507 |
) |
|
$ |
(9,651 |
) |
Net gain (loss) in
foreign currency translation adjustments |
|
|
448 |
|
|
|
597 |
|
|
|
517 |
|
|
|
(844 |
) |
Total comprehensive
loss |
|
$ |
(4,964 |
) |
|
$ |
(5,094 |
) |
|
$ |
(9,990 |
) |
|
$ |
(10,495 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 (the “Exchange Act”). Forward looking statements consist of
all statements other than statements of historical fact, including
statements regarding our future results of operations and financial
position, ability to access financing on acceptable terms or at
all, results of any current or future pivotal 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
+61 417-351-272 (Aus.)
damian.lismore@nexvet.com
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