NEWARK, Calif., Aug. 4, 2021 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company")
today reported its financial results for the second quarter ended
June 30, 2021, and an overview of
recent company progress.
"The second quarter of 2021 was one of enormous progress,
achievement, and growth for our Company," said Dinesh V. Patel, Ph.D., President and Chief
Executive Officer. "In April, we announced completion of enrollment
for our Phase 2 study of rusfertide in polycythemia vera, data from
which supported the U.S. Food and Drug Administration's
Breakthrough Therapy Designation. In mid-June, we shared updated
results from this Phase 2 study in an oral presentation at the
European Hematology Association's 2021 Virtual Congress. This data,
from 63 patients, continues to demonstrate rusfertide's potential
as the first-in-class, non-cytoreductive treatment option for this
disease. The durability of effect and symptom improvements observed
provided further support for the advancement of rusfertide into
Phase 3 clinical development, expected to commence in early
2022."
Dr. Patel continued, "Looking ahead to the remainder of this
year and into early 2022, Protagonist has multiple catalysts in
view and underway. We intend to announce a third indication for
rusfertide, beyond polycythemia vera and hereditary
hemochromatosis. We look forward to sharing, for the first time,
data from our clinical proof-of-concept study of rusfertide in
hereditary hemochromatosis. In the fourth quarter, we are excited
to share data from the completed Phase 2 study of rusfertide in
polycythemia vera, meanwhile preparing diligently for the Phase 3
study. Finally, we remain intensely engaged in the successful
execution of our Phase 2 study of PN-943 in ulcerative colitis and
intend to share data from this study in the second quarter of
2022."
Second Quarter 2021 Recent Developments and Upcoming
Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for
Polycythemia Vera (PV) and Other Blood Disorders
- Completed enrollment in the Phase 2 study of rusfertide in
PV.
- Reported updated results from the Phase 2 study of rusfertide
in PV at the European Hematology Association (EHA) 2021 Virtual
Congress, which was selected for an oral presentation. The Company
expects to report further updated data in PV by the end of
2021.
- Secured Breakthrough Therapy Designation from the FDA for
rusfertide in PV.
- Plan to announce third indication beyond PV and hereditary
hemochromatosis (HH) by the end of 2021.
- Intend to report preliminary data from Phase 2 proof-of-concept
study in HH by the end of 2021.
- On track to commence Phase 3 study of rusfertide in PV in early
2022.
PN-943: Oral, gut-restricted, alpha-4-Beta-7 Integrin
Antagonist for Ulcerative Colitis
- Announced significant progress in the enrollment and execution
of the Phase 2 study of PN-943 in ulcerative colitis, revising
guidance in anticipation of a sooner-than-expected data readout of
the completed study. The Company expects to report results of the
completed study in the second quarter of 2022.
Oral IL-23 Receptor Antagonists (Janssen Biotech and
Protagonist Collaboration)
- As disclosed in July 2021, the
oral IL-23 receptor antagonists collaboration between Janssen
Biotech and Protagonist has advanced and expanded through an
amendment to the original agreement.
- The amended agreement provides for Janssen to lead worldwide
development, manufacturing, and commercialization, and also
broadens the range of indications contemplated for these drug
candidates. Protagonist's development and expense obligations are
now limited to the ongoing PTG-200 Phase 2a study in Crohn's
disease and to the ongoing Phase 1 studies investigation PN-232 and
PN-235.
- Under the amended agreement, Protagonist remains eligible for
approximately $900M in future
milestone payments, in addition to the $80M in payments already received under the
original agreement.
- The Phase 1 study of PN-235, the first of the second-generation
oral IL-23 receptor antagonists included in the Janssen
collaboration, is in progress, with study completion expected in
the fourth quarter of 2021.
- Announced the dosing of the first human subject in a Phase 1
study of PN-232, the second of the second-generation oral IL-23
receptor antagonist peptides included in the collaboration with
Janssen.
Second Quarter 2021 Financial Results
Financial Update
- In the second quarter of 2021, Protagonist announced the
commencement and closing of an underwritten public offering of
3,503,311 shares of its common stock, including 456,953 shares sold
pursuant to the underwriters' option to purchase additional shares,
at a price to the public of $37.75
per share. Aggregate gross proceeds to Protagonist from the
offering were approximately $132.2
million, before deducting underwriting discounts and
commissions and offering expenses.
Financial Results
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of June 30, 2021 were $380.4
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 $2.3
million and $8.5 million for
the three and six months ended June 30,
2021, respectively, in comparison to $6.2 million and $9.9
million reported for the same periods of 2020. The revenue
was lower in the second quarter and year to date 2021 compared to
the prior year due primarily to the Company delivering a lower
amount of collaboration related services during 2021 when compared
to 2020. This follows as the Company in 2021 is now nearing
completion of its remaining service obligations being provided
under the collaboration. In particular, we are near the end of both
the ongoing phase 1 trials in PN-235 & PN-232, which are
expected to be completed in the fourth quarter of 2021 and early
2022, respectively.
- Research and Development ("R&D") Expenses: R&D
expenses for the three and six months ended June 30, 2021 were $26.4
million and $50.7 million,
respectively, as compared to $20.3
million and $39.0 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.
- General and Administrative ("G&A") Expenses: G&A
expenses for the three and six months ended June 30, 2021 were $6.7
million and $12.7 million,
respectively, as compared to $4.2
million and $8.8 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.
- Net Loss: The second quarter 2021 net loss was
$30.8 million, or a net loss of
$0.69 per share, and the six months
ended June 30, 2021 net loss was
$54.8 million, or a net loss of
$1.23 per share, compared to the
second quarter of 2020 net loss of $19.4
million, or a net loss of $0.59 per share, and the six months ended
June 30, 2020 net loss of
$39.5 million, or a net loss of
$1.31 per share.
About Protagonist Therapeutics
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 discovery 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. Based on the feedback
provided by the FDA and EU regulatory authorities, 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 has a worldwide license and collaboration agreement
with Janssen Biotech, Inc., for the development of oral peptide
IL-23 receptor antagonists. Compounds included in this agreement
are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered,
gut-restricted, interleukin-23 receptor specific antagonist peptide
in a Phase 2 clinical trial for Crohn's disease. PN-235 and PN-232,
both second-generation oral interleukin-23 receptor antagonist
candidates, are currently in Phase 1 studies.
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, potential benefits of rusfertide
for the treatment of PV, and commencement or completion of clinical
trials and announcements of clinical data. 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
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
License and
collaboration revenue - related party
|
|
$
|
2,265
|
|
$
|
6,217
|
|
$
|
8,454
|
|
$
|
9,864
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development (1)
|
|
|
26,432
|
|
|
20,257
|
|
|
50,677
|
|
|
39,025
|
General and
administrative (1)
|
|
|
6,715
|
|
|
4,177
|
|
|
12,680
|
|
|
8,753
|
Total operating
expenses
|
|
|
33,147
|
|
|
24,434
|
|
|
63,357
|
|
|
47,778
|
Loss from
operations
|
|
|
(30,882)
|
|
|
(18,217)
|
|
|
(54,903)
|
|
|
(37,914)
|
Interest
income
|
|
|
97
|
|
|
207
|
|
|
199
|
|
|
733
|
Interest
expense
|
|
|
—
|
|
|
(209)
|
|
|
—
|
|
|
(452)
|
Loss on early
repayment of debt
|
|
|
—
|
|
|
(585)
|
|
|
—
|
|
|
(585)
|
Other (expense)
income, net
|
|
|
(57)
|
|
|
512
|
|
|
(136)
|
|
|
22
|
Loss before income
tax expense
|
|
|
(30,842)
|
|
|
(18,292)
|
|
|
(54,840)
|
|
|
(38,196)
|
Income tax
expense
|
|
|
—
|
|
|
(1,129)
|
|
|
—
|
|
|
(1,305)
|
Net loss
|
|
$
|
(30,842)
|
|
$
|
(19,421)
|
|
$
|
(54,840)
|
|
$
|
(39,501)
|
Net loss per share,
basic and diluted
|
|
$
|
(0.69)
|
|
$
|
(0.59)
|
|
$
|
(1.23)
|
|
$
|
(1.31)
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
|
|
44,964,637
|
|
|
32,799,691
|
|
|
44,546,172
|
|
|
30,251,805
|
|
(1)
Amount includes non-cash stock-based compensation
expense.
|
Stock-based
Compensation (Unaudited)
|
(In
thousands)
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Research and
development
|
$
|
2,155
|
|
$
|
1,026
|
|
$
|
3,630
|
|
$
|
2,092
|
General and
administrative
|
|
1,781
|
|
|
970
|
|
|
2,966
|
|
|
1,952
|
Total stock-based
compensation expense
|
$
|
3,936
|
|
$
|
1,996
|
|
$
|
6,596
|
|
$
|
4,044
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
June
30,
|
|
December
31,
|
2021
|
2020
|
Cash, cash
equivalents and marketable securities
|
$
|
380,402
|
|
$
|
307,809
|
Working
Capital
|
|
328,845
|
|
|
275,365
|
Total
assets
|
|
404,232
|
|
|
324,468
|
Deferred
revenue-related party
|
|
2,009
|
|
|
14,477
|
Accumulated
deficit
|
|
(338,651)
|
|
|
(283,811)
|
Total stockholders'
equity
|
|
357,447
|
|
|
279,606
|
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SOURCE Protagonist Therapeutics, Inc.