NEWARK, Calif., March 10, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today reported its financial
results for the fourth quarter and full year ended December 31, 2019, and provided an update on its
clinical development programs.
"We are pleased to have made great progress in 2019, creating
multiple opportunities to execute on our clinical development plans
with three platform-generated therapeutic candidates," commented
Dinesh V. Patel, Ph.D., Protagonist
President and Chief Executive Officer. "Our priorities for 2020
include evaluating PTG-300 in multiple blood disorders with the
intent of selecting the first clinical indication for a pivotal
study, continuing Phase 2 development of PTG-200 with our partner
Janssen Biotech, and advancing PN-943 into Phase 2 development in
ulcerative colitis. Our financial position provides us with
sufficient resources through the end of 2021 which should enable us
to reach definitive conclusions for all of the ongoing clinical
proof of concept studies."
Product Development Update
PTG-300: Injectable Hepcidin Mimetic for Blood
Disorders
- The Company is conducting Phase 2 proof of concept studies with
PTG-300 in patients with beta-thalassemia, polycythemia vera and
hereditary hemochromatosis.
- In December 2019, the Company
reported observations of dose-related reductions from high baseline
serum iron and transferrin saturation (TSAT) levels in the ongoing
open-label TRANSCEND Phase 2 study of PTG-300, supporting continued
evaluation with additional dose regimens and longer follow-up time
periods.
- An investigator-sponsored study of PTG-300 in patients with
myelodysplastic syndromes, a fourth potential indication for
PTG-300, is expected to begin in the first half of 2020.
PTG-200 (JNJ-67864238): Oral IL-23 Receptor Antagonist for
Inflammatory Bowel Disease
- Protagonist Therapeutics and Janssen Biotech are jointly
conducting the development of PTG-200 (or JNJ-67864238) through
completion of a Phase 2a study in patients with moderate-to-severe
Crohn's disease, with the anticipation of completion in the first
half of 2021.
- Protagonist achieved milestones leading to payments from
Janssen Biotech of $25 million
received in 2019 triggered by the decision to advance PTG-200 in a
Phase 2a study and expansion of the existing collaboration
agreement, and $5 million received in
early 2020 on the nomination of a second-generation oral IL-23
receptor antagonist.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist
for Inflammatory Bowel Disease
- Results from a Phase 1 study of PN-943 demonstrated a sustained
and superior target engagement as compared with the
first-generation oral alpha-4-beta-7 integrin antagonist PTG-100.
These results were highlighted in an oral presentation at the 2019
Digestive Disease Week conference.
- The Company plans to initiate a Phase 2 study in patients with
ulcerative colitis in the second quarter of 2020, with topline data
expected in the second half of 2021.
- Preclinical research findings on PN-943 were presented on
February 14, 2020, at the 15th
Congress of the European Crohn's and Colitis Organization (ECCO) in
Vienna.
- Preclinical research findings for PN-943 have been accepted for
presentation at the 2020 Digestive Disease Week conference taking
place May 2-5, 2020, in Chicago.
Financial Results
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of December 31, 2019 were $133.0 million. The Company expects current cash,
cash equivalents and marketable securities and access to its debt
facility to be sufficient to fund its planned operating and capital
expenditures through year-end 2021.
- License and Collaboration Revenue: License and
collaboration revenue of $2.7 million
for the fourth quarter of 2019 was in line with $2.4 million for the same period of 2018. License
and collaboration revenue for the full year 2019 was $0.2 million, compared to $30.9 million for 2018. The Company recognized
$9.6 million of license and
collaboration revenue for the full year 2019, which was offset by
the one-time cumulative adjustment related to the application of
revenue recognition principles following the May 2019 amendment of the Janssen Biotech
collaboration agreement that reduced the revenue by $9.4 million for the year, resulting in net
revenue recognition of $0.2 million
for the full year 2019.
- Research and Development ("R&D") Expenses: R&D
expenses for the fourth quarter and full year 2019 were
$15.9 million and $65.0 million, respectively, as compared to
$14.2 million and $59.5 million, respectively, for the same periods
of 2018. The increases were primarily due to increased clinical
development costs related to PTG-300 and PN-943, offset in part by
lower clinical development costs related to PTG-200 and
PTG-100.
- General and Administrative ("G&A")
Expenses: G&A expenses for the fourth quarter and full
year 2019 were $4.1 million and $15.7 million,
respectively, as compared to $3.5 million and $13.7
million, respectively, for the same periods of 2018. The increases
were primarily due to increases in salaries and employee-related
expenses driven by increased headcount and professional services to
support the growth in our operations.
- Net Loss: The fourth quarter net loss was
$17.5 million, or a net loss of
$0.63 per share, and the full year
2019 net loss was $77.2 million, or a
net loss of $2.98 per share.
Conference Call and Webcast Information
Protagonist executives will host a conference call at
4:30 p.m. EDT/1:30 p.m. PDT today. To access the live call,
dial 1-844-515-9178 (U.S./Canada)
or 1-614-999-9313 (international) and refer to conference ID number
5591627. A live and archived webcast of the call will also be
accessible in the Investors section of the Company's website at
www.protagonist-inc.com.
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 address significant unmet
medical needs and transform existing treatment paradigms for
patients. The Company currently has three different assets in
various stages of clinical development. All three were discovered
through the use of the Company's peptide technology platform.
PTG-300 is an injectable hepcidin mimetic in development for the
potential treatment of iron overload and related blood disorders,
including hereditary hemochromatosis and rare diseases such as
beta-thalassemia and polycythemia vera. PTG-200 is an orally
delivered, gut-restricted interleukin-23 receptor specific
antagonist peptide in Phase 2 clinical development for the
potential 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 clinical development of PTG-200. PN-943 is an orally delivered,
gut-restricted alpha-4-beta-7 integrin specific antagonist peptide
in clinical development for the potential treatment of inflammatory
bowel disease, with a Phase 2 ulcerative colitis study expected to
commence in the second quarter of 2020.
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 clinical
programs, the potential of PTG-300 as a possible treatment
for beta-thalassemia, polycythemia vera, hereditary
hemochromatosis and myelodysplastic syndromes, our plans for future
clinical trials, the potential of PTG-200 and PN-943 as possible
treatments for inflammatory bowel disease, the initiation and
availability of results of our clinical trials and 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 "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, and 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 Annual Report on Form 10-K for the year ended
December 31, 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.
Consolidated
Statements of Operations
(In
thousands, except share and per share data)
|
|
|
|
For the Three
Months Ended
December 31,
|
|
|
For the Year
Ended
December 31,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and
collaboration revenue - related party
|
$
|
2,719
|
|
$
|
2,353
|
|
$
|
231
|
|
$
|
30,925
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development (1)
|
|
15,911
|
|
|
14,248
|
|
|
65,003
|
|
|
59,497
|
|
General and
administrative (1)
|
|
4,107
|
|
|
3,517
|
|
|
15,749
|
|
|
13,697
|
|
Total
operating expenses
|
|
20,018
|
|
|
17,765
|
|
|
80,752
|
|
|
73,194
|
|
Loss from
operations
|
|
(17,299)
|
|
|
(15,412)
|
|
|
(80,521)
|
|
|
(42,269)
|
|
Interest
income
|
|
679
|
|
|
748
|
|
|
2,813
|
|
|
2,566
|
|
Interest
expense
|
|
(167)
|
|
|
--
|
|
|
(169)
|
|
|
--
|
|
Other income
(expense), net
|
|
142
|
|
|
--
|
|
|
(1)
|
|
|
(20)
|
|
Loss before income
taxes
|
|
(16,645)
|
|
|
(14,664)
|
|
|
(77,878)
|
|
|
(39,723)
|
|
Income tax (expense)
benefit
|
|
(856)
|
|
|
799
|
|
|
691
|
|
|
799
|
|
Net loss
|
$
|
(17,501)
|
|
$
|
(13,865)
|
|
$
|
(77,187)
|
|
$
|
(38,924)
|
|
Net loss per common
share, basic and diluted
|
$
|
(0.63)
|
|
$
|
(0.57)
|
|
$
|
(2.98)
|
|
$
|
(1.74)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
|
27,610,696
|
|
|
24,186,356
|
|
|
25,894,024
|
|
|
22,364,515
|
|
|
(1) Amounts include non-cash stock-based compensation
expense as follows (in thousands):
|
|
|
|
For the Three
Months Ended
December 31,
|
|
|
For the Year
Ended
December 31,
|
Stock-based
compensation
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
1,113
|
|
$
|
1,000
|
|
$
|
4,350
|
|
$
|
3,424
|
General and
administrative
|
|
1,047
|
|
|
1,072
|
|
|
4,003
|
|
|
3,495
|
Total stock-based
compensation expense
|
$
|
2,160
|
|
$
|
2,072
|
|
$
|
8,353
|
|
$
|
6,919
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
$
|
133,017
|
|
$
|
128,853
|
Working
capital
|
$
|
109,905
|
|
$
|
111,345
|
Total
assets
|
$
|
154,917
|
|
$
|
139,472
|
Long-term debt,
net
|
$
|
9,794
|
|
$
|
--
|
Deferred revenue -
related party
|
$
|
41,530
|
|
$
|
8,223
|
Accumulated
deficit
|
$
|
(217,661)
|
|
$
|
(140,474)
|
Total stockholders'
equity
|
$
|
79,964
|
|
$
|
112,515
|
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SOURCE Protagonist Therapeutics, Inc.