MILPITAS, Calif., Nov. 14, 2016 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (NASDAQ: PTGX) today reported its financial
results for the quarter ended September 30,
2016 and provided an update on the company's recent
achievements.
"Protagonist has accomplished several important milestones since
the start of 2016, including reporting encouraging results from the
Phase 1 clinical trial of PTG-100 and the successful completion of
our initial public offering," said Dinesh
V. Patel, Ph.D., Protagonist President and Chief Executive
Officer. "The IPO has provided us with the financial resources
needed to rapidly advance the development of our pipeline of
innovative peptide therapeutics."
"We anticipate commencing a Phase 2b trial for PTG-100 in
ulcerative colitis by year-end 2016 and reporting full results by
mid-2018. We are also planning to advance two additional
peptide drug candidates into Phase 1 clinical testing in 2017.
These include PTG-200, our oral IL-23 receptor antagonist for the
treatment of Crohn's disease, and PTG-300, an injectable Hepcidin
mimetic, for iron overload disorders," Dr. Patel concluded.
Recent Achievements
- Completed IPO, upsizing from initial target of $70 million to $90 million, with total gross
proceeds of $93 million including
partial exercise of underwriters' option to purchase additional
shares. The company raised $83.6
million, net of underwriting discounts, commissions and
offering costs, from the sale of 7.8 million shares of common
stock.
- Successfully completed a Phase 1 clinical trial of PTG-100, the
company's oral peptide alpha-4-beta-7 antagonist, in healthy
volunteers in Australia. Clinical
data from this study was presented at United European
Gastroenterology Week, on October 17
in Vienna, Austria.
- Received SBIR funding for development of injectable hepcidin
mimetics for treatment of iron overload disorders.
- Strengthened board of directors with appointment of
William D. Waddill, Calithera Chief
Financial Officer.
- U.S. Investigational New Drug (IND) application submitted to
support Phase 2 development of PTG-100 in ulcerative colitis is now
active.
Third Quarter 2016 Financial Results
Research and development expenses were $5.6 million for the third quarter of 2016,
compared to approximately $3.2
million for the same period of 2015, an increase of
$2.4 million. The increase was
primarily due to increased expenses for contract consultants,
contract manufacturing and other activities for PTG-100 clinical
trials and other product candidate studies, as well as increases in
salaries and employee related expenses.
General and administrative expenses were $1.6 million for the third quarter of 2016
compared to $0.9 million for the same
period in 2015, an increase of $0.7
million. The increase was primarily due to increased
salaries and employee-related expenses and increases in
professional fees.
Net loss for the quarter ended September
30, 2016 was $7.1 million or
$0.87 per common share, compared to a
net loss of $3.4 million or
$12.79 per common share for the same
period in 2015. As of September 30,
2016, Protagonist had approximately $98.5 million of cash and cash equivalents,
short-term investments and short-term restricted cash.
About Protagonist Therapeutics
Protagonist Therapeutics is a clinical-stage biopharmaceutical
company with a proprietary technology platform focused on
discovering and developing peptide-based new chemical entities to
address significant unmet medical needs. Its primary focus is on
developing first-in-class oral peptide drugs that specifically
target biological pathways also targeted by currently marketed
injectable antibody drugs. Compared to injectable antibody drugs,
Protagonist's oral peptides offer targeted delivery to the
gastrointestinal (GI) tissue compartment, potential for improved
safety due to minimal exposure in the blood, improved convenience
and compliance, and potentially an opportunity for earlier
introduction of targeted therapy for inflammatory bowel disease
(IBD). Protagonist's initial lead peptide product candidates,
PTG-100 and PTG-200, are based on this approach, and the company
believes they have the potential to transform the existing
treatment paradigm for IBD, a GI disease consisting primarily of
ulcerative colitis and Crohn's disease.
PTG-100, a potential first-in-class oral alpha-4-beta-7 integrin
antagonist that is being developed initially for moderate-to-severe
ulcerative colitis, has now completed a phase 1 clinical trial in
normal healthy volunteers. PTG-200, a potential
first-in-class oral Interleukin-23 receptor antagonist is being
developed initially for moderate-to-severe Crohn's disease and is
currently in IND-enabling studies.
The company has a peptide technology platform that enables the
discovery of oral and injectable peptides that can be utilized
against a diverse set of targets and diseases including, but not
confined to the GI. In addition to PTG-100 and PTG-200, the company
is engaged in the discovery and development of injectable hepcidin
mimetics, including one lead compound from this program, PTG-300,
which is currently in pre-clinical development. These mimetics have
potential utility for the treatment of iron overload disorders,
such as transfusion dependent beta-thalassemia and hereditary
hemochromatosis (HH), each of which may qualify PTG-300 for orphan
drug designation.
Protagonist is headquartered in Milpitas, 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,
plans, timing and the availability of results of our clinical
trials 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 "may," "will," "continue,"
"anticipate," "intend," "could," "project," "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 and uncertainty regarding our
ability to achieve profitability, our ability to develop and
commercialize our product candidates, 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 inability to operate in a competitive industry and
compete successfully against competitors that have greater
resources than we do, our reliance on third parties, 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, 2016 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,
|
|
2016
|
2015
|
2016
|
2015
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
$
5,561
|
$
3,158
|
$
16,882
|
$
7,638
|
General and
administrative
|
1,577
|
863
|
4,387
|
2,155
|
|
|
|
|
|
Total operating
expenses
|
7,138
|
4,021
|
21,269
|
9,793
|
|
|
|
|
|
Loss from
operations
|
(7,138 )
|
(4,021 )
|
(21,269 )
|
(9,793 )
|
Interest
income
|
54
|
1
|
93
|
2
|
Change in fair value
of redeemable convertible preferred stock tranche and warrant
liabilities
|
—
|
571
|
(4,719 )
|
426
|
Other
expense
|
—
|
—
|
(34 )
|
—
|
|
|
|
|
|
Net loss
|
$
(7,084 )
|
$ (3,449
)
|
$ (25,929
)
|
$ (9,365
)
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(7,377 )
|
$ (3,485
)
|
$ (26,487
)
|
$ (9,401
)
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
(0.87 )
|
$ (12.79
)
|
$
(8.62 )
|
$ (38.32
)
|
|
|
|
|
|
Weighted-average
shares used to compute net loss per share attributable to common
stockholders, basic and diluted
|
8,483,189
|
272,409
|
3,071,456
|
245,298
|
|
|
|
|
|
PROTAGONIST
THERAPEUTICS, INC. Condensed Consolidated Balance
Sheets (In thousands, except share data)
|
|
|
September 30,
2016
|
December 31,
2015
|
Assets
|
(Unaudited)
|
(Audited)
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
96,024
|
$
4,055
|
Restricted
cash
|
10
|
10
|
Available-for-sale
securities
|
2,499
|
7,868
|
Research and
development tax incentive receivable
|
1,944
|
715
|
Prepaid expenses and
other current assets
|
1,768
|
1,558
|
|
|
|
Total current
assets
|
102,245
|
14,206
|
Property and
equipment, net
|
564
|
609
|
Other
assets
|
34
|
30
|
|
|
|
Total
assets
|
$ 102,843
|
$
14,845
|
|
|
|
Liabilities
Redeemable Convertible Preferred Stock and Stockholders' Equity
(Deficit)
|
|
|
Current
liabilities:
|
|
|
Accounts
payable
|
$
2,335
|
$
1,247
|
Accrued expenses and
other payables
|
3,014
|
1,879
|
|
|
|
Total current
liabilities
|
5,349
|
3,126
|
Redeemable
convertible preferred stock tranche liability
|
—
|
1,643
|
Redeemable
convertible preferred stock warrant liability
|
—
|
480
|
|
|
|
Total
liabilities
|
5,349
|
5,249
|
|
|
|
Commitments and
contingencies
|
|
|
Redeemable
convertible preferred stock, $0.00001 par value: 0 and 126,374,911
shares authorized as of September 30, 2016 (unaudited) and
December 31, 2015, respectively; 0 and 77,185,117 shares
issued and outstanding as of September 30, 2016 (unaudited)
and December 31, 2015, respectively; redemption value of
$41,538 as of December 31, 2015
|
—
|
36,996
|
Stockholders' equity
(deficit):
|
|
|
Preferred stock,
$0.00001 par value, 10,000,000 and 0 shares authorized as of
September 30, 2016 (unaudited) and December 31, 2015,
respectively; and no shares issued and outstanding as of
September 30, 2016 (unaudited) and December 31,
2015
|
—
|
—
|
Common stock, $0.00001
par value, 90,000,000 and 160,000,000 shares authorized as of
September 30, 2016 (unaudited) and December 31, 2015, respectively;
16,714,453 and 272,409 shares issued and outstanding as of
September 30, 2016 (unaudited) and December 31, 2015,
respectively
|
—
|
—
|
Additional paid-in
capital
|
150,863
|
118
|
Accumulated other
comprehensive loss
|
(24 )
|
(102 )
|
Accumulated
deficit
|
(53,345)
|
(27,416 )
|
|
|
|
Total stockholders'
equity (deficit)
|
97,494
|
(27,400 )
|
|
|
|
Total liabilities,
redeemable convertible preferred stock and stockholders' equity
(deficit)
|
$ 102,843
|
$
14,845
|
|
|
|
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SOURCE Protagonist Therapeutics, Inc.