NEWARK, Calif., Feb. 28, 2022 /PRNewswire/ -- Protagonist
Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company")
today reported financial results for the fourth quarter and full
year ended December 31, 2021 and
provided a corporate update.
"This past quarter and the year leading up to it has been a
transformational period for Protagonist," said Dinesh V. Patel, Ph.D., President and Chief
Executive Officer of Protagonist. "Today, we are closer than ever
to fulfilling the potential of three diverse strategies reflected
in our robust pipeline: (1) moving rusfertide into a Phase 3
registrational study for a rare disease indication like
polycythemia vera, (2) completing enrollment for PN-943 Phase 2
proof-of-concept study in a common and prevalent disease like
ulcerative colitis, and (3) enabling our partner, Janssen, to
progress PN-235 into a Phase 2b study
in plaque psoriasis and potentially other indications in
inflammatory bowel diseases in the later part of the year. Each of
these three assets and their potential to treat diverse diseases
represent a multi-billion-dollar opportunity for Protagonist."
Dr. Patel continued: "In the last quarter and year, we have
demonstrated exceptional strength of execution in progressing our
assets further in clinical development. For rusfertide in PV, we
announced updated Phase 2 data at EHA and ASH, and recently
unveiled the design of our Phase 3 VERIFY study, which is set to
initiate this quarter. With great anticipation, we look forward to
the topline data readout from the Phase 2 IDEAL study of PN-943 in
ulcerative colitis in the second quarter of this year. We're very
pleased that the 240-patient Phase 2b
study of PN-235 in plaque psoriasis has initiated, with the first
patient dosed recently. Looking ahead, we plan to continue to
demonstrate our strength of execution across all current and
emerging assets in our pipeline, thereby maximizing the
opportunities ahead of us for substantial value creation this
year."
Fourth Quarter 2021 Recent Developments and Upcoming
Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for
Polycythemia Vera (PV) and Other Blood Disorders
- Most recent data from the ongoing Phase 2 REVIVE study of
rusfertide in PV were presented at the American Society of
Hematology (ASH) December 2021 Annual
Meeting. Findings from the open label portion of this study
continued to demonstrate rusfertide's ability to markedly reduce
the need for therapeutic phlebotomies (TP) in a majority of PV
patients, along with additional observed effects including rapid,
sustained, and durable hematocrit (HCT) control.
- Also at ASH 2021, the Company presented results from the
PACIFIC Phase 2 study of rusfertide for PV patients with high HCT
levels. Data demonstrated that post-induction, weekly rusfertide
treatment rapidly controlled HCT levels without the need for
TP.
- Protagonist is preparing to initiate the VERIFY study, a
pivotal Phase 3 clinical trial of rusfertide for 250 patients
living with PV, in Q1 2022. The design of the upcoming clinical
trial was also presented at ASH in December
2021.
- Data from an open-label Phase 2 clinical trial of rusfertide in
HH were presented at The Liver Meeting in November 2021, hosted by the American Association
for the Study of Liver Diseases. This data demonstrated
rusfertide's ability to reduce phlebotomy rates and other
biomarkers associated with the disease in the study population. The
Company plans to identify potential target sub-populations and next
steps in 1H 2022 to advance the program.
PN-943: Oral, gut-restricted, alpha-4-beta-7 Integrin
Antagonist for Ulcerative Colitis (UC)
- PN-943 is currently being evaluated in moderate-to-severe UC in
the Company's Phase 2 IDEAL study. The clinical trial has completed
its target enrollment of 150 patients, and the Company plans to
share topline results from the study, including data from the
12-week induction period, in Q2 2022.
PN-235: Oral IL-23 Receptor Antagonist
- A Phase 2b study of PN-235
(JNJ-77242113) in participants with moderate-to-severe plaque
psoriasis (FRONTIER 1) initiated in early 2022, sponsored by
Janssen Biotech (Janssen). PN-235 is a second-generation oral
peptide IL-23 receptor antagonist being developed under the
worldwide license and collaboration agreement with Janssen. PN-235
is also expected to advance into Phase 2 clinical studies in
inflammatory bowel diseases in 2H 2022. The Company will earn a
$25 million milestone in connection
with the dosing of a third patient in FRONTIER 1. Protagonist is
also eligible for a $10 million
milestone in connection with the start of the second
indication-based Phase 2 study.
Fourth Quarter 2021 Financial Results
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of December 31, 2021 were $326.9 million. The Company expects current cash,
cash equivalents and marketable securities to be sufficient to fund
its planned operating and capital expenditures through 2024. Our
cash forecast will be updated following the PN-943 Phase 2 study UC
data readout in the second quarter of 2022.
- License and Collaboration Revenue: License and
collaboration revenue was $8.6
million for the fourth quarter of 2021 compared to
$5.7 million for the same period of
2020. The increase was primarily due to an increase in services
provided to Janssen under the collaboration agreement during 2021
related to PN-232 and PN-235 as the company nears completion of the
services to be performed. License and collaboration revenue for the
full year 2021 was $27.4 million
compared to $28.6 million for 2020.
The full year 2021 collaboration revenue included a cumulative
catch-up amount of $8.0 million
following the July 2021 amendment of
its collaboration agreement for the development of IL23-R assets
with Janssen. Revenue for the prior year 2020 included an update to
the forecast for remaining services to be completed under the
collaboration, which accelerated our overall percentage completion
under the accounting performance obligation and accelerated revenue
recognition.
- Research and Development ("R&D") Expenses: R&D
expenses for the fourth quarter and full year 2021 were
$38.4 million and $126.0 million respectively, as compared to
$19.5 million and $74.5 million, respectively, for the same periods
of 2020. The increases in 2021 were primarily due to the additional
costs associated with advancing rusfertide and PN-943 through Phase
2 studies and our preparations for future Phase 3 clinical study
initiations, as well as expenses related to our Phase 1 studies for
our second-generation IL23-R antagonist assets under the Janssen
collaboration. R&D expenses also increased due to higher
research spending and employee related costs, including stock-based
compensation expenses following recent hiring in support of our
advancing research and development programs.
- General and Administrative ("G&A") Expenses: G&A
expenses for the fourth quarter and full year 2021 were
$7.3 million and $27.2 million, respectively, as compared to
$5.0 million and $18.6 million for the same periods of 2020. The
increases were primarily related to professional fees, insurance
costs and employee compensation related expenses, including
stock-based compensation expenses, supporting the growth in our
operations.
- Stock-based Compensation ("SBC") Expenses: SBC expenses
for the fourth quarter and full year ended December 31, 2021 were $5.0 million and $16.4
million, respectively, as compared to $2.0 million and $7.9
million, respectively, for the same periods of 2020. The
increases in 2021 (included in R&D and G&A expenses above)
were primarily attributable to awards granted to new employees
hired to support the Company's continued growth and an increase in
the Company's stock price at the grant dates during 2021.
- Net Loss: The fourth quarter 2021 net loss was
$36.9 million, or a net loss of
$0.77 per share, and for the year
ended December 31, 2021, net loss was
$125.6 million, or a net loss of
$2.71 per share, compared to the
fourth quarter of 2020 net loss of $18.9
million, or a net loss of $0.48 per share, and for the year ended
December 31, 2020, net loss of
$66.2 million, or a net loss of
$1.92 per share.
About Protagonist
Protagonist Therapeutics is a biopharmaceutical company with
multiple peptide-based new chemical entities in different stages of
clinical development, all derived from the Company's proprietary
technology platform.
Protagonist's pipeline includes rusfertide, an investigational,
injectable hepcidin mimetic currently in the REVIVE Phase 2
proof-of-concept clinical trial for polycythemia vera (PV), the
PACIFIC Phase 2 study in PV subjects with high hematocrit levels,
and a recently completed Phase 2a study for hereditary
hemochromatosis. The Company is actively initiating VERIFY, a
single, global Phase 3 randomized, placebo-controlled trial
evaluating the efficacy and safety of a once weekly, subcutaneously
self-administered dose of rusfertide.
The Company is also evaluating an orally delivered,
gut-restricted alpha-4-beta-7 integrin specific antagonist peptide
(PN-943), currently in the IDEAL Phase 2 study in adults with
moderate to severe active ulcerative colitis. The Company is
targeting ulcerative colitis as the initial indication.
The Company has a worldwide license and collaboration agreement
with Janssen Biotech, Inc., for the development of oral peptide
interleukin-23 receptor (IL23-R) antagonist PN-235 (JNJ-77242113).
Under the collaboration, Janssen is advancing PN-235 into FRONTIER
1, a Phase 2b study in plaque
psoriasis and is expected to advance at least one new Phase 2
clinical study in inflammatory bowel disease.
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 Company's clinical development
programs for rusfertide and PN-943, the potential benefits of
rusfertide in PV patients and the clinical development of PN-235.
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 agreements, 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 most recently
filed periodic reports on Form 10-K and Form 10-Q 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
|
(Amounts in
thousands except share and per share data)
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
License and
collaboration revenue - related party
|
|
$
|
8,617
|
|
$
|
5,650
|
|
$
|
27,357
|
|
$
|
28,628
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development (1)
|
|
|
38,373
|
|
|
19,486
|
|
|
126,006
|
|
|
74,506
|
General and
administrative (1)
|
|
|
7,260
|
|
|
4,994
|
|
|
27,196
|
|
|
18,638
|
Total operating
expenses
|
|
|
45,633
|
|
|
24,480
|
|
|
153,202
|
|
|
93,144
|
Loss from
operations
|
|
|
(37,016)
|
|
|
(18,830)
|
|
|
(125,845)
|
|
|
(64,516)
|
Interest
income
|
|
|
122
|
|
|
80
|
|
|
443
|
|
|
900
|
Interest
expense
|
|
|
—
|
|
|
(127)
|
|
|
—
|
|
|
(598)
|
Loss on early
repayment of debt
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(585)
|
Other expense,
net
|
|
|
(13)
|
|
|
(9)
|
|
|
(149)
|
|
|
(46)
|
Loss before income
tax expense
|
|
|
(36,907)
|
|
|
(18,886)
|
|
|
(125,551)
|
|
|
(64,845)
|
Income tax
expense
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,305)
|
Net loss
|
|
$
|
(36,907)
|
|
$
|
(18,886)
|
|
$
|
(125,551)
|
|
$
|
(66,150)
|
Net loss per share,
basic and diluted
|
|
$
|
(0.77)
|
|
$
|
(0.48)
|
|
$
|
(2.71)
|
|
$
|
(1.92)
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
|
|
48,154,171
|
|
|
39,605,193
|
|
|
46,322,910
|
|
|
34,396,446
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Amount includes
non-cash stock-based compensation expense.
|
PROTAGONIST
THERAPEUTICS, INC.
|
Stock-based
Compensation
|
(In
thousands)
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Research and
development
|
$
|
2,755
|
|
$
|
1,023
|
|
$
|
8,996
|
|
$
|
4,121
|
General and
administrative
|
|
2,269
|
|
|
944
|
|
|
7,399
|
|
|
3,778
|
Total stock-based
compensation expense
|
$
|
5,024
|
|
$
|
1,967
|
|
$
|
16,395
|
|
$
|
7,899
|
|
|
|
|
|
|
|
|
|
|
|
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
December
31,
|
|
December
31,
|
2021
|
2020
|
Cash, cash
equivalents and marketable securities
|
$
|
326,900
|
|
$
|
307,809
|
Working
capital
|
|
296,720
|
|
|
275,365
|
Total
assets
|
|
347,695
|
|
|
324,468
|
Deferred
revenue-related party
|
|
1,601
|
|
|
14,477
|
Accumulated
deficit
|
|
(409,362)
|
|
|
(283,811)
|
Total stockholders'
equity
|
|
300,021
|
|
|
279,606
|
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SOURCE Protagonist Therapeutics, Inc.