NEWARK, Calif., Aug. 6, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) today reported financial results
for the second quarter ended June 30,
2020, and provided an update on clinical development
programs.
"We have succeeded in bringing three differentiated candidates
from de novo discovery into Phase 2 development," commented
Dinesh V. Patel, Ph.D., Protagonist
President and Chief Executive Officer. "Each of these candidates
has unique attributes that address specific unmet needs in diverse
diseases, such as blood disorders with PTG-300 and inflammatory
bowel disease with PTG-200 and PN-943. The hepcidin mimetic PTG-300
makes use of the iron homeostasis mechanism of a natural hormone
and has demonstrated potential in the treatment of polycythemia
vera. We expect to initiate a pivotal study for PTG-300 in 2021
after discussions with the regulatory agencies. PN-943 and PTG-200
are both oral, gut-restricted candidates for the potential
treatment of inflammatory bowel disease. PTG-200 is an IL-23
receptor antagonist partnered with Janssen and is currently in a
Phase 2 Crohn's study. We recently initiated screening of patients
for our Phase 2 study of PN-943 in ulcerative colitis. Finally, we
are well financed and recently raised $122
million through a successful secondary offering and use of
our ATM program, which enables us to support planned operations
through mid-2023."
Product Development and Corporate Update
PTG-300: Injectable Hepcidin Mimetic for Polycythemia Vera and
Other Blood Disorders
- Initial Phase 2 results reported in May
2020 in patients with polycythemia vera demonstrated
clinically meaningful dose related control of hematocrit levels on
individual patient basis.
- In June 2020, PTG-300 received
U.S. Food and Drug Administration (FDA) Orphan Drug Designation for
the treatment of polycythemia vera.
- Protagonist plans to host a webinar featuring presentations on
clinical needs and market research on the potential opportunity for
PTG-300 in polycythemia vera. The "PTG-300 Opportunity Update"
webinar will be conducted Sept. 11,
2020. Details for participation will be publicly announced
prior to the event.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory
Bowel Disease
- Protagonist has initiated screening of prospective subjects 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 active ulcerative colitis. Patients will be randomized in
one of three arms (150 mg twice daily, 450 mg twice daily, or
placebo) for 12 weeks of oral dosing followed by an extended
treatment period of 40 weeks. During the extended treatment period
all subjects will receive PN-943. The primary endpoint of the study
is proportion of subjects achieving clinical remission at week 12
(as defined by rectal bleeding, stool frequency and endoscopic
subscores of the Adapted Mayo Score) in the 450 mg twice daily
treatment arm as compared to placebo. Secondary endpoints include
additional clinical and safety assessments, as well as
pharmacokinetic and pharmacodynamic measurements, and biomarker
measurements related to disease activity.
Oral IL-23 Receptor Antagonists (Janssen Biotech and Protagonist
Collaboration)
- Janssen Biotech is conducting a global Phase 2 study of PTG-200
(or JNJ-67864238) in moderate-to-severe Crohn's disease.
- Joint research efforts are underway to identify
second-generation oral IL-23 receptor antagonists for multiple
indications.
Financial Update
- During May 2020, the Company
successfully raised $105.7 million
net of underwriting and offering expenses in an oversubscribed
secondary offering issuing 8,050,000 shares at $14.00 per share.
- During the second quarter of 2020, the Company issued 1.2
million shares through its at-the-market (ATM) program and raised
$16.8 million, at an average price of
$14.02 per share.
Financial Results
- Cash, cash equivalents and marketable securities as of
June 30, 2020, were $208.7 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 $6.2 million and $9.9
million for the second quarter and six months ended 2020,
respectively, in comparison to $(8.2)
million and $(6.6) million
reported for the same periods of 2019. The increase in revenue was
due mainly to the 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 three and six months ended June 30,
2019.
- Research and Development ("R&D") expenses for the
three and six months ended June 30,
2020, were $20.3 million and
$39.0 million, respectively, as
compared to $19.4 million and
$31.8 million for the same periods of
2019. These variances were primarily due to increased activities in
advancing our ongoing clinical trial for polycythemia vera with
PTG-300, preparedness for PN-943 Phase 2 study in ulcerative
colitis, and our IL-23 receptor antagonist research collaboration
activities with Janssen Biotech.
- General and Administrative ("G&A") expenses for the
three and six months ended June 30,
2020, were $4.2 million and
$8.8 million, respectively, as
compared to $3.9 million and
$7.6 million for the same periods of
2019. The increases were primarily due to increases in salaries,
insurance expense and professional services to support the growth
in our operations.
- Net loss for the three and six months ended June 30, 2020, was $19.4
million and $39.5 million or a
net loss of $0.59 per share and
$1.31 per share, respectively, as
compared to a net loss of $29.2
million and $43.3 million, or
a net loss of $1.18 per share and
$1.77 per share, 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. The Company currently has three clinical-stage assets.
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. The Company has a worldwide license and collaboration
agreement with Janssen Biotech, Inc., for the development of
PTG-200. 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 for our ongoing
clinical programs, our plans for future clinical trials, the
potential of PTG-300 as a possible treatment for polycythemia
vera and other blood disorders, the potential of PTG-200 and PN-943
as possible treatments for inflammatory bowel disease, the
potential of a pivotal study for PTG-300 in 2021, the potential of
our Phase 2 study of PN-943 in ulcerative colitis, the
initiation and availability of results of our clinical trials, the
sufficiency of our financial resources, our ability to fund our
clinical trials, 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 "potential," "expect,"
"plan," "estimate," "will," 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 Biotech, 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
and risks related to the global COVID-19 pandemic and actions taken
to slow its spread. 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 period ended June 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)
|
|
|
June 30,
2020
|
|
December 31,
2019
|
Cash, cash
equivalents and marketable securities
|
$
|
208,665
|
|
|
$
|
133,017
|
|
Working
capital
|
182,106
|
|
|
109,905
|
|
Total
assets
|
224,980
|
|
|
154,917
|
|
Long-term debt,
net
|
--
|
|
|
9,794
|
|
Deferred revenue -
related party
|
34,014
|
|
|
41,530
|
|
Accumulated
deficit
|
(257,162)
|
|
|
(217,661)
|
|
Total stockholders'
equity
|
167,485
|
|
|
79,964
|
|
PROTAGONIST
THERAPEUTICS, INC.
|
Condensed
Consolidated Statements of Operations
|
(Amounts in
thousands except share and per share data)
|
(unaudited)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenue:
|
|
|
|
|
|
|
|
License and
collaboration revenue - related party
|
$
|
6,217
|
|
|
$
|
(8,189)
|
|
|
$
|
9,864
|
|
|
$
|
(6,629)
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
20,257
|
|
|
19,355
|
|
|
39,025
|
|
|
31,799
|
|
General and
administrative (1)
|
4,177
|
|
|
3,863
|
|
|
8,753
|
|
|
7,627
|
|
Total operating
expenses
|
24,434
|
|
|
23,218
|
|
|
47,778
|
|
|
39,426
|
|
Loss from
operations
|
(18,217)
|
|
|
(31,407)
|
|
|
(37,914)
|
|
|
(46,055)
|
|
Interest
income
|
207
|
|
|
641
|
|
|
733
|
|
|
1,372
|
|
Interest
expense
|
(209)
|
|
|
--
|
|
|
(452)
|
|
|
--
|
|
Loss on early
repayment of debt
|
(585)
|
|
|
--
|
|
|
(585)
|
|
|
--
|
|
Other income
(expense), net
|
512
|
|
|
(37)
|
|
|
22
|
|
|
(39)
|
|
Loss before income
taxes
|
(18,292)
|
|
|
(30,803)
|
|
|
(38,196)
|
|
|
(44,722)
|
|
Income tax (expense)
benefit
|
(1,129)
|
|
|
1,629
|
|
|
(1,305)
|
|
|
1,445
|
|
Net loss
|
$
|
(19,421)
|
|
|
$
|
(29,174)
|
|
|
$
|
(39,501)
|
|
|
$
|
(43,277)
|
|
Net loss per common
share, basic and diluted
|
$
|
(0.59)
|
|
|
$
|
(1.18)
|
|
|
$
|
(1.31)
|
|
|
$
|
(1.77)
|
|
Weighted-average
shares used to compute net loss per share,
basic and diluted
|
|
32,799,691
|
|
|
|
24,662,779
|
|
|
30,251,805
|
|
|
24,481,186
|
|
|
|
|
|
|
|
|
|
(1)Amounts
include non-cash stock-based compensation
expense as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Research and
development
|
$
|
1,026
|
|
|
$
|
977
|
|
|
$
|
2,092
|
|
|
$
|
2,100
|
|
General and
administrative
|
970
|
|
|
1,036
|
|
|
1,952
|
|
|
1,892
|
|
Total stock-based
compensation expense
|
$
|
1,996
|
|
|
$
|
2,013
|
|
|
$
|
4,044
|
|
|
$
|
3,992
|
|
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SOURCE Protagonist Therapeutics, Inc.