NEWARK, Calif., Nov. 3, 2021 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company")
today reported its financial results for the third quarter ended
September 30, 2021 and provided a
corporate update.
"We are excited to share the substantial progress made thus far
in all of our clinical programs, highlighted by the presentation of
proof-of-concept data on rusfertide in hereditary hemochromatosis
at the upcoming AASLD meeting, and the new rusfertide data in
polycythemia vera, which will be presented by the year's end," said
Dinesh V. Patel, Ph.D., President
and Chief Executive Officer. "We were very pleased that the FDA
reached a swift resolution regarding the clinical hold placed on
rusfertide, and we are in the process of resuming all rusfertide
clinical studies. Additionally, we are highly encouraged with the
rate of enrollment in the Phase 2 study of our oral alpha-4-beta-7
integrin antagonist PN-943, for ulcerative colitis, an indication
with a large patient population and unmet treatment need. We
maintain our guidance of a data readout in Q2 2022, and in
anticipation of this, we are excited that Dr. Scott Plevy has joined our team as Executive
Vice President and Therapeutic Head, Gastroenterology. As a
renowned gastroenterologist, Dr. Plevy will oversee the clinical
development of PN-943 and other future programs focused on
gastrointestinal diseases. Finally, our oral IL-23 receptor
antagonist program, in partnership with Janssen, continues to make
demonstrated progress, with PN-235 now advancing into a Phase 2
study in psoriasis in early 2022."
Third Quarter 2021 Recent Developments and Upcoming
Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for
Polycythemia Vera (PV) and Other Blood Disorders
- On October 11, 2021, Protagonist
announced that the U.S. Food and Drug Administration (FDA) removed
the full clinical hold on rusfertide's clinical studies after the
Company provided the FDA with all requested information, including
the individual patient clinical safety reports, updated the
investigator brochure and patient informed consent forms, conducted
a comprehensive review of the most recent safety database, and
added new safety and stopping rules in the study protocols. This
was in response to the Company receiving a communication from the
FDA that Protagonist's clinical studies for rusfertide had been
placed on clinical hold on September 17,
2021. Protagonist has been working closely with study
investigators and clinical trial sites to resume enrollment and
dosing of patients in ongoing clinical trials with rusfertide.
- An abstract highlighting new, preliminary data from a Phase 2
proof-of-concept study in hereditary hemochromatosis (HH) has been
selected for oral presentation by Dr. Kris
Kowdley, from the Liver Institute Northwest in Seattle. These data will be presented on
November 13, 2021 at The Liver
Meeting® 2021, hosted by the American Association for the Study of
Liver Diseases (AASLD).
- The Company intends to report updated data from the Phase 2
study of rusfertide in polycythemia vera (PV) by the end of
2021.
- The Company is on track to initiate the Phase 3 study of
rusfertide in PV in Q1 2022.
- The Company resolved its collaboration agreement dispute with
Zealand Pharma, reducing future development and sales milestone
payments and royalties owed to Zealand for rusfertide under the
companies' 2012 collaboration agreement. Under the new terms of the
agreement, future development and sales milestone payments (other
than $2.5 million in near-term
milestones) and royalties for rusfertide have been reduced by 50
percent. Milestones and royalty payments will be due for sales and
milestones achieved by either Protagonist or any future rusfertide
licensee or partner. Protagonist will also make a $1.5 million payment to Zealand in August 2022.
PN-943: Oral, gut-restricted, alpha-4-Beta-7 Integrin
Antagonist for Ulcerative Colitis
- We are continuing to see steady progress in the enrollment and
execution of the Phase 2 IDEAL study of PN-943 in ulcerative
colitis. This study includes a 12-week induction period and a
40-week open label extension. Topline data from the 12-week
induction period is expected in the second quarter of 2022.
- Scott Plevy, M.D., renowned
expert in translational and clinical research in gastroenterology
and immunology, was appointed Executive Vice President and
Therapeutic Head, Gastroenterology, and he will oversee clinical
operations and development of Protagonist's ongoing and future
programs in gastrointestinal diseases, including PN-943.
Oral IL-23 Receptor Antagonists (collaboration between
Janssen Biotech, Inc. and Protagonist)
- Following a pre-specified interim analysis criteria, a
portfolio decision was made to stop further development of the
first-generation IL-23 receptor antagonist (IL-23R) candidate
PTG-200 (JNJ-67864238), in favor of continued development of the
two second generation candidates PN-235 (JNJ-77242113) and PN-232
(JNJ-75105186) with superior product profiles. In particular:
-
- The Phase 1 study of PN-235 is completed, and a Phase 2
study in psoriasis is anticipated to initiate in early 2022.
- The Phase 1 study with PN-232 is under progress with study
completion expected by mid-2022.
- Additional development in IBD is expected to initiate in
2022.
- Protagonist will earn a $25
million milestone in connection with the initiation of the
first Phase 2 study of a second-generation candidate, and a
$10 million milestone in connection
with the initiation of the second Phase 2 study of a
second-generation candidate. Protagonist remains eligible for
up to approximately $900
million in development-related milestone payments, in addition
to the $87.5M in milestones already
earned.
- Protagonist received a $7.5
million milestone payment from Janssen, triggered by the
completion of the clinical data collection Phase 1 activities for
PN-235 (JNJ-2113).
Third Quarter 2021 Financial Results
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of September 30, 2021, were $352.5 million. The Company expects current cash,
cash equivalents and marketable securities to be sufficient to fund
its planned operating and capital expenditures through 2024.
- License and Collaboration Revenue: License and
collaboration revenues were $10.3
million and $18.7 million for
the three and nine months ended September
30, 2021, respectively, as compared to $13.1 million and $23.0
million reported for the same periods of 2020. The Company
recognized $8.0 million as a
cumulative catch-up amount during the three months ended
September 30, 2021, following the
amendment of its collaboration agreement for the development of
IL-23 receptor antagonist assets with Janssen Biotech. This
cumulative catch-up was primarily the result of an acceleration of
our cumulative performance completed under our obligation,
following the amendment to the collaboration which reduced the
remaining services the Company is responsible to conduct. We are
nearing completion of our remaining services to be provided to
Janssen under the collaboration, in particular, both the ongoing
Phase 1 trials in PN-235 and PN-232, are expected to be complete in
the fourth quarter of 2021 and second quarter 2022, respectively.
Revenue for the prior year's third quarter of 2020 also included an
estimate update for services completed versus remaining services to
be performed under the Janssen collaboration agreement which
accelerated revenue recognition.
- Research and Development ("R&D") Expenses: R&D
expenses for the three and nine months ended September 30, 2021, were $37.0 million and $87.6
million, respectively, as compared to $16.0 million and $55.0
million, respectively, for the same periods of 2020. The
increases were primarily due to additional costs associated to
advancing our clinical trials with our pipeline assets rusfertide
and PN-943, as well as our second-generation IL-23 receptor
antagonist assets under the Janssen collaboration (PN-235 and
PN-232). The increases also relate 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. Following the amendment to the Zealand
collaboration agreement we also recorded $4.0 million in the quarter ended September 30, 2021 in R&D expense related to
these collaboration payments.
- General and Administrative ("G&A") Expenses: G&A
expenses for the three and nine months ended September 30, 2021, were $7.3 million and $19.9
million, respectively, as compared to $4.9 million and $13.6
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 three and nine months ended September 30, 2021, were $4.8 million and $11.4
million, respectively, as compared to $1.8 million and $5.9
million, respectively, for the same periods of 2020. SBC
increases included in R&D and G&A expenses are primarily
attributable to the addition of new employees and related stock
grants in support of the Company's continued growth coupled with
the increase in the Company's stock price at grant date which is
used in the SBC expense calculation.
- Net Loss: The third quarter 2021 net loss was
$33.8 million, or a net loss of
$0.70 per share, and the nine months
ended September 30, 2021, net loss
was $88.6 million, or a net loss of
$1.94 per share, compared to the
third quarter of 2020 net loss of $7.8
million, or a net loss of $0.21 per share, and the nine months ended
September 30, 2020, net loss of
$47.3 million, or a net loss of
$1.45 per share.
About Protagonist
Protagonist Therapeutics is a biopharmaceutical company with
multiple peptide-based investigational new chemical entities in
different stages of development, all derived from the Company's
proprietary technology platform.
Protagonist's pipeline includes rusfertide (PTG-300), an
investigational, injectable hepcidin mimetic currently in a Phase 2
proof-of-concept clinical trial for polycythemia vera (PV), a Phase
2 study in PV subjects with high hematocrit levels, and a Phase 2
study for hereditary hemochromatosis. The Company plans to initiate
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 a Phase 2 study in adults with moderate to
severe active ulcerative colitis (UC). 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
IL-23 receptor antagonists. Compounds in development include PN-235
and PN-232, both second-generation oral interleukin-23 receptor
antagonist candidates. The Phase 1 study of PN-235 is
completed, and Janssen is expected to initiate a Phase 2 study in
psoriasis in Q1 2022. The phase 1 study with PN-232, the second 2nd
generation candidate, is under progress with study completion
expected by mid-2022. Additional research in IBD is expected to
initiate in 2022.
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 Company's clinical development
program for rusfertide. 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
|
(Unaudited)
|
(Amounts in
thousands except share and per share data)
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
License and
collaboration revenue - related party
|
|
$
|
10,286
|
|
$
|
13,114
|
|
$
|
18,740
|
|
$
|
22,978
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development (1)
|
|
|
36,956
|
|
|
15,995
|
|
|
87,633
|
|
|
55,020
|
General and
administrative (1)
|
|
|
7,256
|
|
|
4,891
|
|
|
19,936
|
|
|
13,644
|
Total operating
expenses
|
|
|
44,212
|
|
|
20,886
|
|
|
107,569
|
|
|
68,664
|
Loss from
operations
|
|
|
(33,926)
|
|
|
(7,772)
|
|
|
(88,829)
|
|
|
(45,686)
|
Interest
income
|
|
|
122
|
|
|
87
|
|
|
321
|
|
|
820
|
Interest
expense
|
|
|
—
|
|
|
(19)
|
|
|
—
|
|
|
(471)
|
Loss on early
repayment of debt
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(585)
|
Other expense,
net
|
|
|
—
|
|
|
(59)
|
|
|
(136)
|
|
|
(37)
|
Loss before income
tax expense
|
|
|
(33,804)
|
|
|
(7,763)
|
|
|
(88,644)
|
|
|
(45,959)
|
Income tax
expense
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,305)
|
Net loss
|
|
$
|
(33,804)
|
|
$
|
(7,763)
|
|
$
|
(88,644)
|
|
$
|
(47,264)
|
Net loss per share,
basic and diluted
|
|
$
|
(0.70)
|
|
$
|
(0.21)
|
|
$
|
(1.94)
|
|
$
|
(1.45)
|
Weighted-average
shares used to compute
net loss per share, basic and diluted
|
|
|
47,987,184
|
|
|
37,386,881
|
|
|
45,705,782
|
|
|
32,647,524
|
|
(1)
Amount includes non-cash stock-based compensation
expense.
|
PROTAGONIST
THERAPEUTICS, INC.
|
Stock-based
Compensation (Unaudited)
|
(In
thousands)
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Research and
development
|
$
|
2,611
|
|
$
|
1,006
|
|
$
|
6,241
|
|
$
|
3,098
|
General and
administrative
|
|
2,164
|
|
|
882
|
|
|
5,130
|
|
|
2,834
|
Total stock-based
compensation expense
|
$
|
4,775
|
|
$
|
1,888
|
|
$
|
11,371
|
|
$
|
5,932
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
September
30,
|
|
December
31,
|
2021
|
2020
|
Cash, cash
equivalents and marketable securities
|
$
|
352,470
|
|
$
|
307,809
|
Working
capital
|
|
288,531
|
|
|
275,365
|
Total
assets
|
|
373,175
|
|
|
324,468
|
Deferred
revenue-related party
|
|
2,241
|
|
|
14,477
|
Accumulated
deficit
|
|
(372,455)
|
|
|
(283,811)
|
Total stockholders'
equity
|
|
329,660
|
|
|
279,606
|
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SOURCE Protagonist Therapeutics, Inc.