NEWARK, Calif., Nov. 6, 2019 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today reported its financial
results for the third quarter ended September 30, 2019, and provided a corporate
update.
"The progress of our three clinical candidates shows the
strength and versatility of the Protagonist peptide engineering
platform," commented Dinesh V.
Patel, Ph.D., Protagonist President and Chief Executive
Officer. "These maturing assets reflect our steady transition
toward becoming a fully integrated company. In addition to the
ongoing Phase 2 study in beta-thalassemia, we continue to explore
the full potential of the hepcidin mimetic PTG-300 as one product
with multiple clinical applications. We recently dosed the first
patient in a Phase 2 open-label study for the potential treatment
of polycythemia vera. We are on track to initiate a Phase 2 study
with PTG-300 in hereditary hemochromatosis, and we expect an
investigator sponsored study in myelodysplastic syndrome to begin
in early 2020. In the portfolio of inflammatory bowel disease
product candidates comprised of oral gut-restricted peptides, we
plan to begin a Phase 2 study with the alpha-4-beta-7 integrin
antagonist PN-943 in patients with ulcerative colitis in the second
quarter of 2020, on the basis of a completed Phase 1 study. We also
recently dosed the first patient in a Phase 2 study of oral
interleukin-23 receptor antagonist PTG-200, partnered with Janssen
Biotech, with results from this study expected in 2021. Finally, we
continue to maintain a strong financial position, with available
cash, investments and access to an established debt facility to
support the development of pipeline assets through year-end
2021."
Product Development and Corporate Update:
PTG-300
- Preliminary Phase 2 results from the ongoing study of PTG-300
for the treatment of beta-thalassemia are expected in the fourth
quarter of 2019.
- An abstract relating to pre-clinical studies of hepcidin
mimetic PTG-300 has been accepted for presentation at the American
Society for Hematology (ASH) Annual meeting, taking place
Dec. 7-10 in Orlando, Fla.
- The Company is planning to initiate a Phase 2 study in patients
with hereditary hemochromatosis, a third indication of development
for PTG-300, by early 2020.
- An investigator-sponsored study of PTG-300 in patients with
myelodysplastic syndromes, which represents a fourth potential
indication for PTG-300, is expected to begin in early 2020.
PTG-943
- Protagonist announced results from the multiple ascending dose
(MAD) part of the Phase 1 study of PN-943 with two weeks of daily
administration, demonstrating sustained target engagement and
additional confirmation of superior target engagement as compared
with the first generation oral alpha-4-beta-7 integrin antagonist
PTG-100.
- Clinical data from the Phase 1 study of oral alpha-4-beta-7
integrin antagonist PN-943 were presented at the American College
of Gastroenterology (ACG) Annual Scientific Meeting.
- The Company plans to initiate a Phase 2 study of PN-943 for the
treatment of ulcerative colitis in the second quarter of 2020.
PTG-200 (JNJ-67864238)
- Data from the Phase 1 study of PTG-200, an oral peptide IL-23
receptor antagonist partnered with Janssen Biotech, were recently
presented at the United European Gastroenterology Week conference
and the American College of Gastroenterology (ACG) Annual
Scientific Meeting.
- The first patient has been dosed in a Phase 2 study of PTG-200
(also referenced as JNJ-67864238) in patients with moderate to
severe Crohn's disease. Protagonist Therapeutics and Janssen
Biotech are jointly conducting the development of PTG-200 through
completion of Phase 2 clinical proof of concept in the treatment of
Crohn's disease.
Financing
- During the third quarter of 2019, the Company issued 1.9
million shares through its at-the-market (ATM) program and raised
$23.9 million, at an average price of
$12.44 per share.
- The Company recently announced it has entered into a four-year
debt facility with MidCap Financial and Silicon Valley Bank
providing access to an aggregate principal amount up to
$50 million to support the ongoing
Protagonist clinical development programs and related general
corporate purposes.
Financial Results
Protagonist reported a net loss of $16.4
million and $59.7 million,
respectively, for the third quarter and first nine months of 2019,
as compared to a net loss of $8.7
million and $25.1 million,
respectively, for the same periods of 2018. The increase in net
loss for the third quarter of 2019 as compared to the prior year
period was driven primarily by increased research and development
(R&D) costs related to advancing its products in various
clinical trials. The increase in net loss for the first nine months
of 2019 as compared to the prior year period was driven primarily
by the previously reported application of revenue accounting
principles following the May 2019
Amendment to the Janssen collaboration agreement where the Company
re-assessed overall timelines as well as re-estimated completed and
remaining services, including a cumulative one-time adjustment of
$9.4 million reported in the second
quarter of 2019, and an increase in R&D costs related to
advancing its products is various clinical trials. The net loss for
the third quarter and first nine months of 2019 includes non-cash
stock-based compensation of $2.2
million and $6.2 million,
respectively, as compared to $2.0
million and $4.8 million,
respectively, for the same periods of 2018.
R&D expenses for the third quarter and first nine months of
2019 were $17.3 million and
$49.1 million, respectively, as
compared to $12.1 million and
$45.2 million, respectively, for the
same periods of 2018. The increases in R&D expenses were
primarily due to increased clinical development costs related to
PTG-300 and PN-943, offset by lower cost related to pre-clinical
and discovery expenses and other clinical development expenses.
General and administrative (G&A) expenses for the third
quarter and first nine months of 2019 were $4.0 million and $11.6 million, respectively, as compared to
$3.4 million and $10.2 million, respectively, for the same periods
of 2018. The increases in G&A expenses were primarily due to
increases in salaries and employee-related expenses driven by an
increase in headcount and professional services expenses to support
growth in operations.
Protagonist ended the third quarter with $137.7 million in cash, cash equivalents and
marketable securities, and $10
million of the debt facility was funded at closing in
October 2019. The Company expects
cash, cash equivalents and marketable securities, and access to its
debt facility will be sufficient to fund its planned operating and
capital expenditures through year-end 2021.
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 drugs to transform existing
treatment paradigms for patients with significant unmet medical
needs. PTG-300 is an injectable hepcidin mimetic in development for
the treatment of iron overload anemia and related rare blood
diseases. PTG-200 is an oral, gut-restricted interleukin-23
receptor specific antagonist peptide in Phase 2 clinical
development for the potential treatment of inflammatory bowel
disease. The Company has a worldwide license and collaboration
agreement with Janssen Biotech for the clinical development of
PTG-200. PN-943 is an oral, gut-restricted alpha-4-beta-7 integrin
specific antagonist peptide in clinical development for the
potential treatment of inflammatory bowel disease, with ulcerative
colitis as the initial intended indication.
Protagonist is headquartered in Newark, California. 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 of PTG-300 as a
possible treatment for polycythemia vera and beta-thalassemia, the
potential of PTG-200 and PN-943 as possible treatments for
inflammatory bowel disease, the initiation of and enrollment of
patients in our clinical trials, the results of clinical trials and
the outlook for our other programs. In some cases, you can
identify these statements by forward-looking words such as "plan,"
"will," "expect," "potential," 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, 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.
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 quarterly period ended September 30,
2019, 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
|
(In thousands,
except share and per share data)
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
License and
collaboration revenue - related party
|
$
4,141
|
$
6,117
|
|
$
(2,488)
|
$
28,572
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
17,293
|
12,145
|
|
49,092
|
45,249
|
General and
administrative
|
4,015
|
3,361
|
11,642
|
10,180
|
|
|
|
|
|
Total operating
expenses
|
21,308
|
15,506
|
60,734
|
55,429
|
|
|
|
|
|
Loss from
operations
|
(17,167)
|
(9,389)
|
(63,222 )
|
(26,857)
|
Interest income and
other, net
|
656
|
654
|
1,989
|
1,798
|
|
|
|
|
|
Loss before income
tax benefit
|
(16,511)
|
(8,735 )
|
(61,233)
|
(25,059)
|
Income tax
benefit
|
102
|
--
|
1,547
|
--
|
|
|
|
|
|
Net loss
|
$
(16,409)
|
$ (8,735
)
|
$
(59,686)
|
$
(25,059)
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.61)
|
$
(0.38 )
|
$
(2.36)
|
$
(1.15)
|
|
|
|
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
26,956,957
|
22,912,279
|
25,315,512
|
21,750,562
|
|
|
|
|
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
|
December
31,
|
|
|
|
2019
|
|
|
2018
|
|
Condensed
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
Cash, cash
equivalents and available-for-sale securities
|
|
$
|
137,692
|
|
|
$
|
128,853
|
|
Working
capital
|
|
$
|
113,247
|
|
|
$
|
111,345
|
|
Total
assets
|
|
$
|
154,627
|
|
|
$
|
139,472
|
|
Deferred revenue –
related party
|
|
$
|
38,678
|
|
|
$
|
8,223
|
|
Accumulated
deficit
|
|
$
|
(200,160)
|
|
|
$
|
(140,474)
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/protagonist-therapeutics-reports-third-quarter-2019-financial-results-300953248.html
SOURCE Protagonist Therapeutics, Inc.