NEWARK, Calif., Nov. 4, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today reported its financial
results for the third quarter ended September 30, 2020, and provided a corporate
update.
"The three clinical assets PTG-300, PN-943 and PTG-200, all
discovered through our peptide technology platform, continue to
make progress in Phase 2 clinical proof-of-concept studies,"
commented Dinesh V. Patel, Ph.D.,
Protagonist President and Chief Executive Officer. "We look forward
to sharing updated clinical data in December from our Phase 2 study
of PTG-300 in patients with polycythemia vera and see significant
opportunity for PTG-300 to address unmet needs and improve upon the
current standards of care."
Dr. Patel continued, "We are moving forward with our ongoing
Phase 2 clinical programs with the oral alpha-4-beta-7 integrin
antagonist PN-943 in patients with ulcerative colitis, and the oral
interleukin-23 receptor antagonist PTG-200 in patients with Crohn's
disease. In addition, we're encouraged by the steady progress in
our ongoing collaboration with Janssen, and recently announced the
selection of two additional oral interleukin-23 receptor
antagonists, PN-235 and PN-232, for advancement into clinical
development. These candidates provide several strategic options for
development in multiple indications."
Product Development and Corporate Update
PTG-300: Subcutaneous Injectable Hepcidin Mimetic for
Polycythemia Vera and Other Blood Disorders
- Five presentations have been accepted for the American Society
for Hematology (ASH) Annual meeting, taking place in a virtual
format from December 5-8, 2020. Two
posters and one oral presentation are related to PTG-300 and
polycythemia vera and two posters describe the hepcidin mimetic
mechanism of action and a hepcidin mimetic for oral delivery.
- In October, PTG-300 was granted orphan designation by the
European Medicines Agency for the treatment of polycythemia
vera.
- Complete enrollment of 50 patients in the PTG-300 polycythemia
vera study is expected in mid-2021.
- A pivotal study of PTG-300 in the treatment of polycythemia
vera is expected to begin in the second half of 2021 pending dialog
with regulatory authorities.
- An open-label proof-of-concept study of PTG-300 in patients
with hereditary hemochromatosis is in progress and results are
expected in 2021.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory
Bowel Disease
- Protagonist has dosed patients in a global, randomized,
double-blind, placebo-controlled Phase 2 study (the "IDEAL Study")
evaluating safety, tolerability and efficacy of PN-943 in
approximately 150 patients with moderate to severe ulcerative
colitis.
- In light of the global COVID-19 pandemic, Protagonist has
suspended guidance on a timeline for study completion.
Oral IL-23 Receptor Antagonists (Janssen Biotech and Protagonist
Collaboration)
- Protagonist Therapeutics and Janssen Biotech are jointly
conducting the development of PTG-200 (JNJ-67864238) through
completion of a Phase 2 clinical proof of concept study in the
treatment of Crohn's disease.
- Two additional oral peptide IL-23 receptor antagonist
candidates from the collaboration agreement with Janssen Biotech,
PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186), have been selected
for advancement into clinical development. A Phase 1 study of
PN-235 is expected to begin in the fourth quarter of 2020.
Financial Update
- During the third quarter of 2020, the Company issued 333,000
shares through its at-the-market (ATM) program and raised
$6.4 million; shares were sold at an
average price of $19.65 per
share.
- The Company also reported sales of an additional 918,000 shares
through its ATM program during October
2020, raising $18.9 million,
at an average price of $21.03 per
share.
Financial Results
- Cash, cash equivalents and marketable securities as of
September 30, 2020, were $200.0 million. Protagonist estimates sufficient
financial resources from its cash, cash equivalents, marketable
securities and access to its debt facility to fund its currently
planned operating and capital expenditures through mid-2023.
- License and collaboration revenues were $13.1 million and $23.0
million for the three and nine months ended September 30, 2020, respectively, in comparison
to $4.1 million and $(2.5) million reported for the same periods of
2019. The increase in revenue in the third quarter of 2020 compared
to 2019 was related to an estimate update for services completed
versus remaining services to be performed under the Janssen
collaboration agreement. This revised estimate accelerated our
overall performance percentage completion under the current
accounting performance obligation, coupled with continued delivery
of Protagonist's services under the ongoing collaboration. The
increase in year-over-year revenue was also related to a previously
reported 2019 one-time cumulative adjustment related to the
application of revenue recognition principles following the
May 2019 amendment of the Janssen
Biotech collaboration agreement that had reduced revenue by
$9.4 million for the nine months
ended September 30, 2019.
- Research and Development (R&D) expenses for the
three and nine months ended September 30,
2020, were $16.0 million and
$55.0 million, respectively, as
compared to $17.3 million and
$49.1 million for the same periods of
2019. 2020 expenses were primarily related to advancing our
clinical development including the ongoing Phase 2 clinical trial
for polycythemia vera with PTG-300, PN-943 Phase 2 study in
ulcerative colitis, and the IL-23 receptor antagonist research
collaboration activities with Janssen Biotech.
- General and Administrative (G&A) expenses for the
three and nine months ended September 30,
2020, were $4.9 million and
$13.6 million, respectively, as
compared to $4.0 million and
$11.6 million for the same periods of
2019. The increases were primarily related to professional fees,
insurance costs and salary related expenses to support the growth
in operations.
- Net loss for the three and nine months ended
September 30, 2020, was $7.8 million and $47.3
million or a net loss of $0.21
per share and $1.45 per share,
respectively, as compared to a net loss of $16.4 million and $59.7
million, or a net loss of $0.61 per share and $2.36 per share, respectively, for the same
periods of 2019.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical
company that utilizes a proprietary technology platform to discover
and develop novel peptide-based therapeutics to address significant
unmet medical needs and transform existing treatment paradigms for
patients. PTG-300 is an injectable hepcidin mimetic in development
for the treatment of polycythemia vera and other blood disorders.
PTG-200 is an orally delivered, gut-restricted, interleukin-23
receptor specific antagonist peptide in development for the
treatment of inflammatory bowel disease, with Crohn's disease as
the initial indication. In addition to PTG-200, two oral peptide
interleukin-23 receptor antagonist candidates from a collaboration
with Janssen Biotech, Inc., are in development and have been
selected for advancement into clinical studies. PN-943 is an orally
delivered, gut-restricted alpha-4-beta-7 integrin specific
antagonist peptide in development for the treatment of inflammatory
bowel disease, with ulcerative colitis as the initial targeted
indication.
Protagonist is headquartered in Newark, California. For further information,
please visit 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 of our product
candidates to improve standards of care, our ability to fund
operations into future periods, and our expectations regarding the
timing of the initiation of clinical trials. 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 ability to develop and commercialize our
product candidates, our ability to earn milestone payments under
our collaboration agreement with Janssen, the impact of the current
COVID-19 pandemic on our discovery and development efforts, 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. Additional information concerning these and other
risk factors affecting our business can be found in our periodic
filings with the Securities and Exchange Commission, including
under the heading "Risk Factors" contained in our Quarterly Report
on Form 10-Q for the quarter ended September
30, 2020, 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.
|
Selected
Consolidated Balance Sheet Data
|
(In
thousands)
|
(Unaudited)
|
|
|
September 30,
2020
|
|
December 31,
2019
|
Cash, cash
equivalents and marketable securities
|
$
|
199,999
|
|
|
$
|
133,017
|
|
Working
capital
|
165,588
|
|
|
109,905
|
|
Total
assets
|
217,320
|
|
|
154,917
|
|
Long-term debt,
net
|
--
|
|
|
9,794
|
|
Deferred revenue -
related party
|
20,877
|
|
|
41,530
|
|
Accumulated
deficit
|
(264,925)
|
|
|
(217,661)
|
|
Total stockholders'
equity
|
169,590
|
|
|
79,964
|
|
PROTAGONIST
THERAPEUTICS, INC.
|
Condensed
Consolidated Statements of Operations
|
(Amounts in
thousands except share and per share data)
|
(unaudited)
|
|
|
Three Months Ended
September
30,
|
|
Nine Months Ended
September
30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenue:
|
|
|
|
|
|
|
|
License and
collaboration revenue - related party
|
$
|
13,114
|
|
|
$
|
4,141
|
|
|
$
|
22,978
|
|
|
$
|
(2,488)
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
15,995
|
|
|
17,293
|
|
|
55,020
|
|
|
49,092
|
|
General and
administrative (1)
|
4,891
|
|
|
4,015
|
|
|
13,644
|
|
|
11,642
|
|
Total operating
expenses
|
20,886
|
|
|
21,308
|
|
|
68,664
|
|
|
60,734
|
|
Loss from
operations
|
(7,772)
|
|
|
(17,167)
|
|
|
(45,686)
|
|
|
(63,222)
|
|
Interest
income
|
87
|
|
|
762
|
|
|
820
|
|
|
2,134
|
|
Interest
expense
|
(19)
|
|
|
--
|
|
|
(471)
|
|
|
--
|
|
Loss on early
repayment of debt
|
--
|
|
|
--
|
|
|
(585)
|
|
|
--
|
|
Other expense,
net
|
(59)
|
|
|
(106)
|
|
|
(37)
|
|
|
(145)
|
|
Loss before income
taxes
|
(7,763)
|
|
|
(16,511)
|
|
|
(45,959)
|
|
|
(61,233)
|
|
Income tax (expense)
benefit
|
-
|
-
|
|
102
|
|
|
(1,305)
|
|
|
1,547
|
|
Net loss
|
$
|
(7,763)
|
|
|
$
|
(16,409)
|
|
|
$
|
(47,264)
|
|
|
$
|
(59,686)
|
|
Net loss per common
share, basic and diluted
|
$
|
(0.21)
|
|
|
$
|
(0.61)
|
|
|
$
|
(1.45)
|
|
|
$
|
(2.36)
|
|
Weighted-average
shares used to compute net loss per share,
basic and diluted
|
|
37,386,881
|
|
|
|
29,956,957
|
|
|
32,647,524
|
|
|
25,315,512
|
|
|
|
|
|
|
|
|
|
(1)Amounts
include non-cash stock-based compensation
expense as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
Three Months Ended
September
30,
|
|
Nine Months Ended
September
30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Research and
development
|
$
|
1,006
|
|
|
$
|
1,137
|
|
|
$
|
3,098
|
|
|
$
|
3,237
|
|
General and
administrative
|
882
|
|
|
1,064
|
|
|
2,834
|
|
|
2,956
|
|
Total stock-based
compensation expense
|
$
|
1,888
|
|
|
$
|
2,201
|
|
|
$
|
5,932
|
|
|
$
|
6,193
|
|
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SOURCE Protagonist Therapeutics, Inc.