NEWARK, Calif., Nov. 6, 2017 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (NASDAQ: PTGX) today reported its financial
results for the third quarter and nine months ended September 30, 2017 and provided an update on the
company's recent achievements.
"We recently reported positive preliminary Phase I results for
PTG-300, our hepcidin mimetic in development for the potential
treatment of anemia and iron overload related blood disorders,
including rare diseases such as beta-thalassemia and
myelodysplastic syndromes (MDS). These results, coupled with the
encouraging Phase I results achieved for PTG-100 in 2016 and the
recent partnership with Janssen for PTG-200, all provide validation
for our novel peptide platform," said Dinesh Patel, president and chief executive
officer. "We plan to continue to execute on our strategy of
optimizing our peptide technology platform and applying it to the
discovery and development of drugs that address unmet medical needs
and offer strong differentiation against existing treatments."
Recent Pipeline Achievements
- PTG-300: The company reported preliminary results from a
Phase 1 clinical trial of PTG-300, the company's hepcidin mimetic,
which demonstrated pharmacodynamic proof-of-concept in normal
healthy volunteers. This data indicated that PTG-300 demonstrated a
dose-related reduction in serum iron, which persisted beyond 72
hours at higher dose levels. PTG-300 showed a dose-dependent
increase in blood drug levels and was well tolerated with no
serious adverse events or dose-limiting toxicities. The company
expects to report final top-line results from the complete study in
the fourth quarter of 2017.
- PTG-100: The ongoing Phase 2B trial in ulcerative
colitis patients remains on track to report interim futility
analysis in early 2018 and top-line results in the second half of
2018. In parallel, the company is making all the preparations
needed to support Phase 3 development.
- PTG-200: The company closed a license and collaboration
agreement with Janssen Biotech, Inc. for clinical development of
PTG-200. PTG-200 is expected to enter a Phase 1 clinical trial in
the fourth quarter of 2017.
Recent Corporate Finance Events
- The company completed a public offering of 3,530,000 shares of
its common stock at a price to the public of $17.00 per share. The gross proceeds from the
offering, before underwriting discounts and commissions and
offering costs, were approximately $60
million. The underwriters have an option until November 10, 2017 to purchase up to an additional
529,500 shares at the price to the public, less underwriting
discounts and commissions.
- The closing of the license and collaboration agreement with
Janssen Biotech, Inc. resulted in an upfront payment of
$50 million to the company. The
company will also be eligible to receive up to an additional
$940 million in development,
regulatory, and sales milestones.
Third Quarter 2017 Financial Results
Protagonist reported a net loss attributable to common
stockholders of $4.8 million and
$33.9 million, respectively, for
the third quarter and first nine months of 2017, as compared to a
net loss attributable to common stockholders of $7.4
million and $26.5 million,
respectively, for the same periods of 2016. The decrease in net
loss for the third quarter of 2017 as compared to the prior year
period was driven primarily by license and collaboration revenue
recognized during the current quarter, partially offset by
increases in research and development (R&D) expenses and
general and administrative (G&A) expenses. The increase in net
loss for the first nine months of 2017, as compared to the prior
year period, was driven primarily by increases in R&D expenses
and G&A expenses, partially offset by license and collaboration
revenue recognized during the current quarter. The net loss for the
third quarter and first nine months of 2017 includes non-cash
stock-based compensation of $1.2
million and $3.1 million,
respectively, as compared to $0.4
million and $0.6 million,
respectively, for the same periods of 2016.
License and collaboration revenue for the third quarter and
first nine months of 2017 was $8.8
million and consisted of revenue from activities performed
under the agreement with Janssen Biotech, Inc. Pursuant to
changes in accounting guidance for revenue recognition adopted by
Protagonist during the quarter, the $50
million upfront payment from Janssen, which was recorded as
deferred revenue, is being recognized based on proportional
achievement of Protagonist's performance obligations as measured by
actual costs incurred relative to total budgeted costs. These
performance obligations are expected to be completed during the
second half of 2018. Protagonist will evaluate the measure of
performance each reporting period and, if necessary, adjust that
measure and related revenue recognition. Protagonist did not
recognize any license and collaboration revenue prior to the third
quarter of 2017.
R&D expenses for the third quarter and first nine months of
2017 were $11.2 million and $34.5
million, respectively, as compared to $5.6
million and $16.9 million,
respectively, for the same periods of 2016. The increases in
R&D expenses were primarily due to increased PTG-100 and
PTG-300 clinical trial and development activities, which included
clinical trial activities, contract manufacturing costs, and
pre-clinical and clinical development studies for other product
candidates, and PTG-200 activities related to the agreement with
Janssen Biotech, Inc. R&D expenses for the third 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 third quarter and first nine months of
2017 were $2.6 million and $8.7
million, respectively, as compared to $1.6
million and $4.4 million,
respectively, for the same periods of 2016. The increases in
G&A expenses were primarily due to an increase in
employee-related expenses mainly due to an increase in headcount to
support the growth of our operations, professional service fees and
consulting, and other administrative expenses.
Protagonist ended the second quarter with $104.9
million in cash, cash equivalents and investments. With
the additional funding from the Janssen agreement and proceeds from
the $60 million public equity
offering completed on October 16,
2017, the company expects to have sufficient financial
resources to fund operations through 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 the treatment of moderate-to-severe ulcerative colitis.
PTG-200, a potential first-in-class oral Interleukin-23 receptor
antagonist in development for the treatment of IBD, initially
Crohn's disease, is currently in pre-clinical development and is
expected to enter a Phase 1 clinical trial before the end of 2017.
The company recently announced it has entered into a worldwide
agreement with Janssen Biotech, Inc. 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 for the potential treatment of
anemia and iron overload disorders, including rare diseases such as
beta-thalassemia and MDS. 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, research and development and capital resources. 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 September 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
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
License and
collaboration revenue - related party (1)
|
$
8,781
|
|
$
—
|
|
$
8,781
|
|
$
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
11,168
|
|
5,561
|
|
34,457
|
|
16,882
|
General and
administrative
|
2,593
|
|
1,577
|
|
8,708
|
|
4,387
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
13,761
|
|
7,138
|
|
43,165
|
|
21,269
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(4,980)
|
|
(7,138)
|
|
(34,384)
|
|
(21,269)
|
Interest
income
|
155
|
|
54
|
|
479
|
|
93
|
Change in fair value
of redeemable convertible preferred stock tranche and warrant
liabilities
|
—
|
|
—
|
|
—
|
|
(4,719)
|
Other
expense
|
—
|
|
—
|
|
—
|
|
(34)
|
|
|
|
|
|
|
|
|
Net loss
|
$
(4,825)
|
|
$
(7,084)
|
|
$
(33,905)
|
|
$
(25,929)
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(4,825)
|
|
$
(7,377)
|
|
$
(33,905)
|
|
$
(26,487)
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
(0.29)
|
|
$
(0.87)
|
|
$
(2.01)
|
|
$
(8.62)
|
|
|
|
|
|
|
|
|
Weighted-average
shares used to compute net loss per share attributable to common
stockholders, basic and diluted
|
16,911,575
|
|
8,483,189
|
|
16,851,672
|
|
3,071,456
|
|
|
|
|
|
|
|
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
|
December
31,
|
|
|
2017
|
|
|
2016
|
Consolidated
Balance Sheet Data:
|
|
|
|
|
|
Cash, cash
equivalents and available-for-sale securities
|
|
$
|
104,902
|
|
|
$
|
87,749
|
Working
capital
|
|
$
|
45,457
|
|
|
$
|
76,809
|
Total
assets
|
|
$
|
110,415
|
|
|
$
|
93,990
|
Deferred revenue –
related party (1)
|
|
$
|
41,739
|
|
|
$
|
-----
|
Accumulated
deficit
|
|
$
|
(98,498)
|
|
|
$
|
(64,593)
|
Total stockholders'
equity
|
|
$
|
57,836
|
|
|
$
|
87,555
|
|
|
|
|
|
|
|
|
(1)
|
Effective July 1,
2017, the Company adopted Financial Accounting Standards Board
Accounting Standards Codification Topic 606, Revenue from
Contracts with Customers, using the full retrospective
transition method. The company had no effective contracts within
the scope of this guidance prior to July 1, 2017, and the adoption
had no impact on the Company's financial position, results of
operations or liquidity prior to July 1, 2017.
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/protagonist-therapeutics-reports-third-quarter-2017-financial-results-and-provides-corporate-update-300550274.html
SOURCE Protagonist Therapeutics, Inc.