NEWARK, Calif., Aug. 8, 2017 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today reported its financial
results for the second quarter and six months ended June 30, 2017.
"Protagonist achieved several significant milestones during the
second quarter, most notably the signing of a major license and
collaboration agreement with Janssen for PTG-200, our pre-clinical
stage oral interleukin-23 receptor (IL-23R) antagonist for
inflammatory bowel diseases (IBD)," said Dinesh V. Patel, Ph.D., President and Chief
Executive Officer of Protagonist Therapeutics. "In addition to the
strategic advantages this major partnership provides us, it has
also extended our financial runway, enabling us to advance our
clinical pipeline of innovative peptide drugs and expand the
utility of our technology platform."
Pipeline Highlights:
PTG-200:
- Protagonist granted Janssen exclusive, worldwide rights to
PTG-200, a first-in-class oral peptide IL-23R antagonist currently
in pre-clinical development and expected to enter phase 1 studies
in the second half of 2017. The terms of the agreement
included a $50.0 million upfront
payment, which we expect to receive in the third quarter of
2017. Protagonist can also potentially receive up to an
additional $940.0 million in clinical
development, regulatory approval, and sales milestones. Protagonist
and Janssen will co-develop and co-fund PTG-200 through Phase 2
clinical development. Protagonist will receive double-digit tiered
royalties on future net sales and retains the option to co-detail
PTG-200 in the United States, if
PTG-200 receives regulatory approval.
- A new U.S. patent, No. 9,624,268, providing composition of
matter protection for PTG-200 and covering the use of oral peptide
inhibitors of IL-23R to treat IBD, was issued.
- Protagonist was awarded a Phase 2 Small Business Innovation
Research Grant from the National Institute of Diabetes and
Digestive and Kidney Diseases of the National Institutes of Health.
This grant provides up to $1.3
million of funding over two years to support the development
of biomarkers useful in the clinical development of anti-IL23R
agents for the treatment of IBD, including PTG-200.
PTG-100:
- The company is advancing the clinical proof-of-concept and dose
optimization global Phase 2b trial in ulcerative colitis (UC)
patients with alpha-4-beta-7 integrin specific antagonist peptide
PTG-100. PTG-100 is being developed as a potential oral targeted
therapy for IBD and related indications. Based on current
enrollment rates, the interim analysis is now expected in early
2018; top-line results are still anticipated for the second half of
2018.
PTG-300:
- Protagonist has initiated a Phase 1 clinical study of PTG-300,
an injectable hepcidin mimetic peptide discovered using the
company's proprietary technology platform, in normal healthy
volunteers. PTG-300 is being developed as a potential
treatment for patients with chronic iron overload in rare diseases
such as beta-thalassemia. The Phase 1 single ascending dose study
is evaluating the safety, tolerability, and pharmacokinetics of
PTG-300 in normal healthy volunteers. In addition, the effect of
PTG-300 on baseline serum iron levels will be analyzed to evaluate
pharmacodynamics-based clinical proof-of-concept. The results of
this study are anticipated in the second half of 2017.
Corporate Highlights:
- The company appointed Rusty
Williams, M.D., Ph.D., current President and Chief Executive
Officer of Five Prime Therapeutics, to the Protagonist Board of
Directors. Dr. Williams is a member of the National Academy
of Sciences and an industry veteran having served in critical roles
at various companies such as Chiron Corporation, COR Therapeutics,
and Daiichi Research Center.
Financial Results
Protagonist reported a net loss attributable to common
stockholders of $15.0 million and
$29.1 million, respectively, for
the second quarter and first six months of 2017, as compared to a
net loss attributable to common stockholders of $7.3
million and $19.1 million,
respectively, for the same periods of 2016. The increase in
net loss for both the second quarter and year-to-date periods were
driven primarily by research and development (R&D) expenses
related to the accelerated progression to Phase 1 initiation of
PTG-300; PTG-100 clinical trial and development activities; and
other preclinical studies and discovery research efforts in support
of Protagonist's pipeline; as well as general and administrative
(G&A) expenses for operations. The net loss for the
second quarter and first six months of 2017 includes non-cash
stock-based compensation of $1.0
million and $1.8 million,
respectively, as compared to $0.1
million and $0.2 million,
respectively, for the same periods of 2016.
R&D expenses for the second quarter and first six months of
2017 were $12.0 million and $23.3
million, respectively, as compared to $5.7
million and $11.3 million,
respectively, for the same periods of 2016. The increases in
R&D expenses were primarily due to increased PTG-100 clinical
trial and development activities, which included Phase 2 clinical
trial site start-up activities, contract manufacturing costs, and
pre-clinical and clinical development studies for other product
candidates, including PTG-300. R&D expenses for the
second quarter and year-to-date periods also included an increase
in employee-related expenses due to an increase in R&D
personnel.
G&A expenses for the second quarter and first six months of
2017 were $3.1 million and $6.1
million, respectively, as compared to $1.4
million and $2.8 million,
respectively, for the same periods of 2016. The increases in
G&A expenses were primarily due to an increase in
employee-related expenses primarily due to an increase in headcount
to support the growth of our operations, consulting and
professional service fees, and other administrative expenses.
Protagonist ended the second quarter with $64.5
million in cash, cash equivalents and investments. With
the additional funding from the Janssen collaboration, including
the $50.0 million upfront milestone
payment the company expects to receive in the third quarter of
2017, the company expects to have sufficient financial resources to
fund operations until the middle of 2019.
About Protagonist Therapeutics
Protagonist Therapeutics is a clinical-stage biopharmaceutical
company with a proprietary technology platform which is utilized to
discover and develop novel peptide-based drugs to address
significant unmet medical needs. Its primary focus is on developing
potential first-in-class oral targeted therapy-based peptide drugs
that work by blocking biological pathways that are currently
targeted by marketed injectable antibody drugs. Protagonist's
initial lead peptide product candidates, PTG-100 and PTG-200, are
based on this approach, and the company believes these candidates
have the potential to transform the existing treatment paradigm for
inflammatory bowel disease (IBD), consisting primarily of
ulcerative colitis and Crohn's disease.
PTG-100, a potential first-in-class oral peptide alpha-4-beta-7
integrin antagonist, is currently in a global Phase 2b clinical
trial for treatment of moderate-to-severe ulcerative colitis.
PTG-200, a first-in-class oral Interleukin-23 receptor antagonist
for potential treatment of IBD, initially Crohn's disease, is
currently in pre-clinical development and is expected to enter a
Phase 1 clinical study in the second half of 2017. The company
recently announced it has entered into a worldwide collaboration
with Janssen Biotech to co-develop and commercialize PTG-200 for
all indications, including IBD.
In addition to PTG-100 and PTG-200, the company is developing an
injectable hepcidin mimetic PTG-300 as a potential orphan drug for
the treatment of rare diseases such as beta-thalassemia.
PTG-300 is currently being studied in a Phase 1 clinical trial.
Protagonist is headquartered in Newark, California with its pre-clinical and
clinical staff in California, and
discovery operations both in California and in Brisbane, Queensland, Australia. For further
information, please visit http://www.protagonist-inc.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include
statements regarding our intentions or current expectations
concerning, among other things, the potential for our programs, our
collaborations, the initiation and availability of results of our
clinical trials, enrollment in our clinical trials, contract
manufacturing, capital resources, the possibility of obtaining
orphan drug designation, and the potential for eventual regulatory
approval of our product candidates. In some cases, you can identify
these statements by forward-looking words such as "anticipate,"
"believe," "may," "will," "expect," or the negative or plural of
these words or similar expressions. Forward-looking
statements are not guarantees of future performance and are subject
to risks and uncertainties that could cause actual results and
events to differ materially from those anticipated, including, but
not limited to, our history of net operating losses, our reliance
on third parties and uncertainty regarding our ability to achieve
profitability, our ability to develop and commercialize our product
candidates, our ability to earn milestone payments under our
collaboration agreement with Janssen, our ability to use and expand
our programs to build a pipeline of product candidates, our ability
to obtain and maintain regulatory approval of our product
candidates, our ability to operate in a competitive industry and
compete successfully against competitors that have greater
resources than we do, and our ability to obtain and adequately
protect intellectual property rights for our product
candidates. We discuss many of these risks in greater
detail under the heading "Risk Factors" contained in our quarterly
report on Form 10-Q for the quarter ended June 30, 2017, to be filed with the Securities
and Exchange Commission. Forward-looking statements are not
guarantees of future performance, and our actual results of
operations, financial condition and liquidity, and the development
of the industry in which we operate, may differ materially from the
forward-looking statements contained in this press release. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
PROTAGONIST
THERAPEUTICS, INC.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
(In thousands,
except share and per share data)
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
12,007
|
|
$
5,696
|
|
$
23,289
|
|
$
11,321
|
General and
administrative
|
3,124
|
|
1,395
|
|
6,115
|
|
2,810
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
15,131
|
|
7,091
|
|
29,404
|
|
14,131
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(15,131)
|
|
(7,091)
|
|
(29,404)
|
|
(14,131)
|
Interest
income
|
152
|
|
27
|
|
324
|
|
39
|
Change in fair value
of redeemable convertible preferred stock tranche and warrant
liabilities
|
—
|
|
—
|
|
—
|
|
(4,719)
|
Other
expense
|
—
|
|
(34)
|
|
—
|
|
(34)
|
|
|
|
|
|
|
|
|
Net loss
|
$
(14,979)
|
|
$
(7,098)
|
|
$ (29,080)
|
|
$ (18,845)
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(14,979)
|
|
$
(7,323)
|
|
$ (29,080)
|
|
$ (19,110)
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
(0.89)
|
|
$
(19.07)
|
|
$
(1.73)
|
|
$
(56.90)
|
|
|
|
|
|
|
|
|
Weighted-average
shares used to compute net loss per share attributable to common
stockholders, basic and diluted
|
16,875,627
|
|
383,910
|
|
16,821,225
|
|
335,855
|
|
|
|
|
|
|
|
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2017
|
|
|
2016
|
|
Consolidated
Balance Sheet Data:
|
|
|
|
|
|
|
Cash, cash
equivalents and available-for-sale securities
|
|
$
|
64,492
|
|
|
$
|
87,749
|
|
Working
capital
|
|
$
|
59,760
|
|
|
$
|
76,809
|
|
Total
assets
|
|
$
|
70,479
|
|
|
$
|
93,990
|
|
Accumulated
deficit
|
|
$
|
(93,673)
|
|
|
$
|
(64,593)
|
|
Total stockholders'
equity
|
|
$
|
61,030
|
|
|
$
|
87,555
|
|
|
|
|
|
|
|
|
|
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/protagonist-therapeutics-reports-second-quarter-2017-financial-results-and-business-highlights-300501497.html
SOURCE Protagonist Therapeutics, Inc.