NEWARK, Calif., Aug. 7, 2019 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today reported financial results
for the second quarter ended June 30,
2019, and provided a corporate update.
"We continue to make great progress in advancing our three
clinical assets in diverse disease areas and are pleased with our
cash runway scenario, which we expect will provide operating
capital through mid-2021," commented Dinesh
V. Patel, Ph.D., Protagonist President and Chief Executive
Officer. "In addition to the ongoing study of hepcidin mimetic
PTG-300 in patients with beta-thalassemia, we expect to initiate a
Phase 2 study in the third quarter in patients with polycythemia
vera (PV), a rare myeloproliferative disease with limited treatment
options. Given the central role of hepcidin in iron homeostasis and
erythropoiesis, we view PTG-300 as a one product portfolio with
potential applications in multiple blood disorders. We also intend
to initiate a Phase 2 study in patients with hereditary
hemochromatosis, and we expect that an investigator-sponsored trial
in patients with myelodysplastic syndromes will begin in early
2020. These indications rely on different aspects of iron biology
that comprise the central mechanism of PTG-300 and offer the
advantage of allowing evaluation in small clinical studies with
objective endpoints. We are also pleased with the successful
completion of the Phase 1 study of our oral alpha-4-beta-7 integrin
antagonist PN-943 in normal healthy volunteers, and are advancing
PN-943 toward a Phase 2 study in patients with ulcerative colitis.
Finally, our oral IL-23 receptor antagonist PTG-200, partnered with
Janssen, is moving forward in a Phase 2 study in patients with
Crohn's disease."
Corporate and Product Development Updates:
Financing
- During the second quarter of 2019, the Company issued 921,684
shares through its at-the-market (ATM) program and raised
$10.5 million, at an average of
$11.44 per share.
- The Company also reported sales of an additional 1.2 million
shares through its ATM program during July
2019, raising $15.0 million,
or $12.64 per share.
- The additional funding is expected to extend the Company's cash
runway through mid-2021 as it advances its three clinical
programs.
- As of July 31, 2019, the Company
had $22.1 million remaining available
for sale under its ATM financing facility.
PTG-300
- Protagonist is conducting the Phase 2 TRANSCEND study, a
single-arm, open label, study of PTG-300, an injectable hepcidin
mimetic, in the treatment of patients with transfusion-dependent as
well as non-transfusion dependent beta-thalassemia. Initial results
from this Phase 2 trial are expected in the fourth quarter of 2019,
with final topline data expected in the first half of 2020.
- Protagonist plans to initiate a Phase 2 study of PTG-300 in
patients with polycythemia vera in the third quarter of 2019.
- The Company is working toward the initiation of a clinical
study in early 2020 of PTG-300 in the treatment of hereditary
hemochromatosis, a third indication of development for
PTG-300.
- An investigator-sponsored study of PTG-300 in patients with
myelodysplastic syndromes is also expected to begin in early
2020.
PTG-200
- In May 2019, Protagonist expanded
its collaboration with Janssen Biotech to include the discovery of
second generation oral IL-23 receptor antagonists, with Protagonist
receiving a $25 million milestone
payment following the signing of the expanded agreement.
Protagonist also received research funding supporting full-time
equivalent employees.
- Protagonist and Janssen are jointly conducting the development
of PTG-200 through completion of a Phase 2 proof-of-concept study
in Crohn's disease. Protagonist and Janssen Biotech completed the
filing of a U.S. Investigational New Drug (IND) application to
support the global Phase 2 clinical study with initiation expected
in the fourth quarter of 2019.
PN-943
- In May 2019, Protagonist
announced results of the single ascending dose part of the first
clinical study of PN-943. The Company also recently announced
results from the multiple ascending dose part of the study.
Administration of PN-943 was found to be safe and well tolerated,
and results of target engagement as measured by blood receptor
occupancy were supportive of the higher potency of PN-943 as
compared to the first generation antagonist, PTG-100. The PN-943
Phase 1 data has guided the design of a Phase 2 study of PN-943 in
patients with ulcerative colitis, with study initiation expected in
early 2020.
- Preclinical and early clinical research findings from the
single ascending dose study describing the properties of PN-943,
including high potency relative to PTG-100, were detailed in an
oral presentation in May 2019 at the
Digestive Diseases Week Conference in San
Diego.
Financial Results
Protagonist reported a net loss of $29.2
million and $43.3 million,
respectively, for the second quarter and first six months of 2019,
as compared to a net loss of $8.7
million and $16.3 million,
respectively, for the same periods of 2018. The increase in net
loss for both the second quarter and year-to-date periods was
driven primarily by the application of revenue accounting
principles following the May 2019
Amendment to the Janssen collaboration agreement. The Company
reported an adjustment to revenue of $(8.2)
million which decreased the booked license and collaboration
revenue in the second quarter. Application of the accounting
principles required the Company to re-assess overall timelines as
well as re-estimate completed and remaining services following the
Collaboration Agreement amendment, leading to the revenue
adjustment. The Company also determined that the accounting
transaction price had increased to $109.2
million as of June 30, 2019,
following the Amendment, from $60.6
million as of March 31, 2019.
This has been influenced predominantly by the $25 million milestone payment received from
Janssen in the second quarter along with additional research
funding and other research and development (R&D) services. The
remaining revenue of $64.9 million
will be recognized as the Company performs services related to
PTG-200 development as well as new services related to the R&D
activities for second generation product candidates.
The net loss for the second quarter and first six months of 2019
includes non-cash stock-based compensation of $2.0 million and $4.0
million, respectively, as compared to $1.6 million and $2.8
million, respectively, for the same periods of 2018.
Amounts reported in the category of license and collaboration
revenue were $(8.2) million and
$(6.6) million for the second quarter
and first six months of 2019, respectively, and contained the
cumulative catch-up revenue accounting adjustment following the
amendment to the Janssen Collaboration Agreement. This is compared
to license and collaboration revenue of $11.7 million and $22.5
million for the second quarter and first six months of 2018,
respectively.
R&D expenses for the second quarter and first six months of
2019 were $19.4 million and
$31.8 million, respectively, as
compared to $17.7 million and
$33.1 million, respectively, for the
same periods of 2018. The increases in R&D expenses in the
second quarter from the same period a year ago are primarily due to
increased costs related to preparation for and conduct of clinical
trials for our product candidates PTG-300 and PN-943. R&D
expenses for the quarter also included an increase in salaries and
employee-related expenses.
G&A expenses for the second quarter and first six months of
2019 were $3.9 million and
$7.6 million, respectively, as
compared to $3.2 million and
$6.8 million, respectively, for the
same periods of 2018. The increases in G&A expenses were
primarily due to increases in salaries and employee-related
expenses primarily due to an increase in headcount and consulting
and professional services expenses to support growth in
operations.
Protagonist ended the second quarter of 2019 with $126.1 million in cash, cash equivalents and
investments. Protagonist forecasts having sufficient financial
resources to fund operations through mid-2021.
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 transform existing
treatment paradigms for patients with significant unmet medical
needs. PTG-300 is an injectable hepcidin mimetic in development for
the treatment of iron overload anemia and related rare blood
diseases. PTG-300 is currently in a global Phase 2 study in
beta-thalassemia. PTG-200 is an oral, gut-restricted interleukin-23
receptor specific antagonist peptide in clinical development for
the potential treatment of inflammatory bowel disease. The Company
has a worldwide license and collaboration agreement with Janssen
Biotech for the clinical development of PTG-200 and a Phase 2 study
in Crohn's disease is expected in fourth quarter of 2019. PN-943 is
an oral, gut-restricted alpha-4-beta-7 integrin specific antagonist
peptide in clinical development for the potential treatment of
inflammatory bowel disease, with ulcerative colitis as the initial
intended indication.
Protagonist is headquartered in Newark, California. For further information,
please visit http://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, our cash runway and the
availability of results of our clinical trials. 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 agreement with Janssen, 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. 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 three and six months ended June
30, 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)
|
|
|
Three Months
Ended June
30,
|
|
Six Months
Ended June
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
License and
collaboration revenue - related party
|
$
(8,189)
|
|
$
11,674
|
|
$
(6,629)
|
|
$
22,455
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
19,355
|
|
17,735
|
|
31,799
|
|
33,103
|
General and
administrative
|
3,863
|
|
3,178
|
|
7,627
|
|
6,820
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
23,218
|
|
20,913
|
|
39,426
|
|
39,923
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(31,407)
|
|
(9,239 )
|
|
(46,055 )
|
|
(17,468)
|
Interest
income
|
604
|
|
576
|
|
1,333
|
|
1,144
|
|
|
|
|
|
|
|
|
Net loss before
income tax benefit
|
(30,803)
|
|
(8,663 )
|
|
(44,722)
|
|
(16,324)
|
Income tax
benefit
|
1,629
|
|
--
|
|
1,445
|
|
--
|
|
|
|
|
|
|
|
|
Net loss
|
$
(29,174)
|
|
$ (8,663
)
|
|
$
(43,277)
|
|
$
(16,324)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(1.18)
|
|
$
(0.41 )
|
|
$
(1.77)
|
|
$
(0.77)
|
|
|
|
|
|
|
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
24,662,779
|
|
21,207,234
|
|
24,481,186
|
|
21,160,076
|
|
|
|
|
|
|
|
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2019
|
|
|
2018
|
|
Consolidated
Balance Sheet Data:
|
|
|
|
|
|
|
Cash, cash
equivalents and available-for-sale securities
|
|
$
|
126,101
|
|
|
$
|
128,853
|
|
Working
capital
|
|
$
|
103,998
|
|
|
$
|
111,345
|
|
Total
assets
|
|
$
|
148,105
|
|
|
$
|
139,472
|
|
Deferred revenue –
related party
|
|
$
|
41,567
|
|
|
$
|
8,223
|
|
Accumulated
deficit
|
|
|
(183,751)
|
|
|
$
|
(140,474)
|
|
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SOURCE Protagonist Therapeutics, Inc.