SAN FRANCISCO, Aug. 7, 2017 /PRNewswire/ -- Kindred
Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company
focused on saving and improving the lives of pets, today announced
financial results for the second quarter ended June 30, 2017 and provided updates on its
programs.
"We continue to look forward to our two upcoming approvals and
launches. The commercial preparations for the launches are
proceeding well and the feedback from the top opinion leaders on
both of our products has been very positive," stated Richard Chin, M.D., President and CEO of
KindredBio. "We are continuing to make excellent progress across
our pipeline, and are pleased to announce the completion of our
state-of-the art, full cGMP biologics plant in California. In addition, the recent purchase
of the 180,000-square foot manufacturing plant in Kansas will allow us to meet the anticipated
market demand for our deep pipeline of biologics."
Development and Corporate Updates
- KindredBio continues to expect approval of Mirataz™
(mirtazapine transdermal ointment) for the management of weight
loss in cats in the second half of 2017, assuming the Food and Drug
Administration (FDA) finds the submissions acceptable. Preparations
for the commercial launch of Mirataz are on track, with the drug's
launch expected shortly after approval. The Company has received
approval of its efficacy technical section and has responded to
comments from the FDA regarding the Chemistry, Manufacturing and
Controls (CMC) technical section and the safety technical section.
In addition, the Company submitted a formal non-rolling New Animal
Drug Application (NADA) with a standard six-month review by the
FDA. Regulatory approval is subject to the typical risks inherent
in such a process.
Mirataz is expected to be the
first FDA-approved product for the management of weight loss in
cats, a serious and potentially fatal condition that is the leading
cause of visits to the veterinarian for cats.
- KindredBio continues to expect approval of Zimeta™ (dipyrone
injection) for the control of pyrexia (fever) in horses. The
Company now expects the approval either in the second half of 2017
or in early 2018, depending upon the FDA review timelines. The
change in timing, should it occur, is due to a revision of the
proposed labeling and is not expected to affect approvability or
require generation of additional data. Preparations for the
commercial launch of Zimeta remain on track, with the drug's launch
anticipated shortly after approval. The Company has received
approval of its efficacy technical section and has responded to FDA
comments regarding the CMC and safety technical sections.
Regulatory approval is subject to the typical risks inherent in
such a process.
The Company executed a commercial
manufacturing agreement with Corden Pharma S.p.A for the
manufacture of Zimeta for an initial 3-year term with an automatic
renewal period of 2 years upon the conclusion of the initial term.
The agreement provides for production to supply KindredBio's
initial launch and future commercial campaigns upon regulatory
approval, with capabilities to grow alongside demand.
Zimeta is expected to be the first
FDA-approved product for the control of fever in horses, a
significant unmet medical condition that affects millions of horses
each year.
- The pivotal effectiveness trial for the oral form of Zimeta
(dipyrone oral gel) is ongoing and over halfway through enrollment.
The Company has also initiated the target animal safety study.
Results of the pivotal study are expected before the end of
2017.
Zimeta Oral, which is an oral gel,
is expected to expand use of the drug and build upon the success of
Zimeta IV.
- The pilot field study of the enhanced version of epoCat™
(feline recombinant erythropoietin) for the control of
non-regenerative anemia in cats has been completed and has
demonstrated efficacy. In addition, the PK data from the study
suggest that the molecule may have sufficiently long half-life to
allow for once monthly dosing. The Company plans to initiate a
pilot effectiveness study with the molecule in Q3 2017.
Anemia is a common condition in
older cats which is often associated with chronic kidney disease,
resulting in decreased levels of endogenous erythropoietin. epoCat
is a recombinant protein that has been specially engineered by
KindredBio with a prolonged half-life compared to endogenous feline
erythropoietin.
- The first pilot field study of KIND-014 for the treatment of
equine gastric ulcers has been completed. Based on the positive
study results, the Company has optimized its formulation and
expects to initiate the next pilot safety study in Q3 2017 and
pilot effectiveness field study in Q4 2017.
- A pilot field study assessing oral tolerability and
palatability of KIND-015 for the management of clinical signs
associated with equine metabolic syndrome has been completed. The
lead formulation is well tolerated and 90-95% palatable with no
signs of oral toxicity. The Company expects to initiate a pilot
efficacy study in Q3 2017.
- Enrollment recently completed in the second stage of the pilot
field study of KIND-011, an anti-TNF monoclonal antibody targeting
sick or septic foals.
- The pilot field study of atopic dermatitis in dogs, to assess
safety and efficacy of several anti-cytokine antibodies, has been
completed. The initial pilot safety and PK studies of anti-IL31,
anti-IL17 and SINK have been completed and all the molecules were
well tolerated. The Company plans on initiating additional pilot
efficacy studies shortly.
- The Company has completed its state-of-the art, full cGMP
biologics plant in California. The
facility is believed to be one of the first in the world dedicated
to veterinary biologics.
In addition, the Company closed
escrow on the acquisition of a manufacturing facility in
Elwood, Kansas. The facility
includes approximately 180,000 square feet with clean rooms,
utility, equipment and related quality documentation suitable for
small molecule and biologics manufacturing.
- KindredBio was added to the Russell 2000 Index, effective
June 23, 2017.
- On July 12, 2017 KindredBio
raised $21 million in net cash
proceeds from a public offering of 3,000,000 shares of its common
stock at a price of $7.50 per share.
The net proceeds will be used for the expansion of its commercial
infrastructure in anticipation of future product approvals and
launches, for expansion of its manufacturing capacity, the
development of its therapeutic candidates, and for other general
corporate and working capital purposes.
Second Quarter and Six Month 2017 Financial Results
For the quarter ended June 30,
2017, KindredBio reported a net loss of $6.8 million or $0.29 per share, as compared to a net loss of
$4.9 million or $0.25 per share for the same period in 2016. For
the six months ended June 30, 2017,
the net loss was $13.3 million or
$0.59 per share, as compared to a net
loss of $11.0 million or $0.55 per share for the same period in 2016.
Total research and development expenses for the three and six
months ended June 30, 2017 were
$3.9 million and $7.6 million, respectively, compared to
$3.2 million and $6.6 million for the same periods in 2016.
Stock-based compensation expense included in research and
development expense was $0.4 million
and $0.8 million for the three and
six months ended June 30, 2017 as
compared to $0.4 million and
$0.7 million for the same periods in
2016. The increase in research and development expenses in 2017
compared to 2016 was primarily due to higher field trial and
material costs including formulation development costs associated
with the advancement of the Company's pipeline, as well as
consulting expenses.
Total general and administrative expenses were $3.1 million and $5.9
million for the three and six months ended June 30, 2017 compared to $1.9 million and $3.9
million for the same periods in 2016. The increase in
general and administrative expenses in 2017 was due to higher
headcount and related expenses as the Company begins to expand its
commercial organization, as well as higher stock based compensation
expense and other corporate expenses. Stock-based
compensation expense included in general and administrative expense
was $0.9 million and $1.7 million for the three and six months ended
June 30, 2017 as compared to
$0.5 million and $1.0 million for the same periods in 2016.
As of June 30, 2017, KindredBio
had $74.5 million in cash, cash
equivalents and investments, compared with $57.8 million as of December 31, 2016. Net cash used in operating
activities for the first six months in 2017 was approximately
$11.4 million, offset by $29.0 million of net cash proceeds from the sale
of securities in conjunction with an At Market Issuance Sales
Agreement with FBR Capital Markets & Co. The Company also
invested approximately $0.9 million
in capital expenditures for the build-out of its GMP biologics
manufacturing facility. In addition, in July
2017, the Company completed an underwritten public offering
of its common stock resulting in net cash proceeds of $21.0 million.
For the 2017 calendar year, the Company reiterates its previous
guidance for operating expenses to be in the range of $30 million to $32 million, excluding the impact
of stock-based compensation expense and the impact of acquisitions,
if any. The Company's anticipated expenditures for the remainder of
the year include the build-out of a small commercial team, and
preparations for distribution, commercial scale-up and
manufacturing for Mirataz and Zimeta. Additionally, KindredBio
plans to focus on the development of its pipeline candidates, as
well as the necessary manufacturing requirements for its biologics
program.
Webcast and Conference Call
KindredBio will host a conference call and webcast today at
4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. Interested parties may
access the call by dialing toll-free (855) 433-0927 from the US, or
(484) 756-4262 internationally, and using conference ID 56145078.
The call will be webcast live at
http://edge.media-server.com/m/p/manjktch A replay will also
be available at that link for 30 days.
About Kindred Biosciences
Kindred Biosciences is a pre-commercialization stage
biopharmaceutical company focused on saving and improving the lives
of pets. Its mission is to bring to pets the same kinds of safe and
effective medicines that human family members enjoy. The Company's
strategy is to identify compounds and targets that have already
demonstrated safety and efficacy in humans and to develop
therapeutics based on these validated compounds and targets for
dogs, cats and horses. The Company has a deep pipeline of novel
drugs and biologics in development across many therapeutic
classes.
For more information or to download the corporate presentation,
visit www.KindredBio.com/LearnMore. Stay connected with KindredBio
on Facebook at www.Facebook.com/KindredBio.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including, but not limited to,
statements regarding our expectations about the trials, regulatory
approval, manufacturing, distribution and commercialization of our
current and future product candidates, and statements regarding our
anticipated revenues, expenses, margins, profits and use of
cash.
These forward-looking statements are based on our current
expectations. These statements are not promises or guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results to be materially
different from any future results expressed or implied by the
forward-looking statements. These risks include, but are not
limited to, the following: our limited operating history and
expectations of losses for the foreseeable future; the absence of
significant revenue from our product candidates for the foreseeable
future; our potential inability to obtain any necessary additional
financing; our substantial dependence on the success of our lead
product candidates, which may not be successfully commercialized
even if they are approved for marketing; the effect of competition;
our potential inability to obtain regulatory approval for our
existing or future product candidates; our dependence on third
parties to conduct some of our development activities; our
dependence upon third-party manufacturers for supplies of our
product candidates; uncertainties regarding the outcomes of trials
regarding our product candidates; our potential failure to attract
and retain senior management and key scientific personnel;
uncertainty about our ability to develop a satisfactory sales
organization; our significant costs of operating as a public
company; our potential inability to obtain patent protection and
other intellectual property protection for our product candidates;
potential claims by third parties alleging our infringement of
their patents and other intellectual property rights; our potential
failure to comply with regulatory requirements, which are subject
to change on an ongoing basis; the potential volatility of our
stock price; and the significant control over our business by our
principal stockholders and management.
For a further description of these risks and other risks that we
face, please see the risk factors described in our filings with the
U.S. Securities and Exchange Commission (the SEC), including the
risk factors discussed under the caption "Risk Factors" in our
Annual Report on Form 10-K and any subsequent updates that may be
contained in our Quarterly Reports on Form 10-Q filed with the SEC.
As a result of the risks described above and in our filings with
the SEC, actual results may differ materially from those indicated
by the forward-looking statements made in this press release.
Forward-looking statements contained in this press release speak
only as of the date of this press release and we undertake no
obligation to update or revise these statements, except as may be
required by law.
Contact
Russell Radefeld
KindredBio
russell.radefeld@kindredbio.com
(650) 701-7904
Kindred
Biosciences, Inc.
|
Condensed
Consolidated Statements of Operations
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
3,866
|
|
3,161
|
|
7,646
|
|
6,598
|
|
General and
administrative
|
3,056
|
|
1,865
|
|
5,899
|
|
3,885
|
|
Restructuring
costs
|
-
|
|
-
|
|
-
|
|
655
|
|
|
Total operating costs
and expenses
|
6,922
|
|
5,026
|
|
13,545
|
|
11,138
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(6,922)
|
|
(5,026)
|
|
(13,545)
|
|
(11,138)
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
155
|
|
79
|
|
286
|
|
131
|
Net loss
|
$
(6,767)
|
|
$
(4,947)
|
|
$
(13,259)
|
|
$
(11,007)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.29)
|
|
$
(0.25)
|
|
$
(0.59)
|
|
$
(0.55)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used to calculate basic
|
|
|
|
|
|
|
|
|
and diluted net loss
per share
|
23,409
|
|
19,865
|
|
22,467
|
|
19,851
|
|
|
|
|
|
|
|
|
|
|
Selected
Consolidated Balance Sheet Data
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December
31,
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
74,548
|
|
$
57,807
|
|
|
|
|
|
|
Total
assets
|
78,877
|
|
61,576
|
|
|
|
|
|
|
Stockholders'
equity
|
76,269
|
|
57,680
|
|
|
|
|
|
|
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SOURCE Kindred Biosciences, Inc.