NEWARK, Calif., March 12, 2019 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today reported its financial
results for the fourth quarter and full year ended December 31, 2018, and provided a corporate
update on its clinical development programs.
"We continue to advance three different clinical development
candidates discovered from our proprietary peptide engineering
platform and have sufficient financial resources to support these
programs and reach important milestones through the end of 2020,"
commented Dinesh V. Patel, Ph.D.,
Protagonist President and Chief Executive Officer. "We are pleased
to have initiated a global Phase 2 trial of PTG-300 for the
treatment of beta thalassemia and expect preliminary results in the
second half of 2019. Based on the broad applicability of the
mechanism of action of PTG-300, we see strong potential for its
development in multiple indications, and plan to initiate a second
indication for PTG-300 in the second half of the year. With our
partner, Janssen Biotech, we are working towards filing a U.S.
Investigational New Drug (IND) application in the first half of
2019 to support a global Phase 2 study of PTG-200 in Crohn's
patients. In addition, we are moving forward with the development
of our oral, gut-restricted alpha-4-beta-7 integrin antagonist,
PN-943, for the treatment of inflammatory bowel disease. Safety,
pharmacokinetic, and pharmacodynamic results from the Phase 1 study
of PN-943 in healthy volunteers are expected in the first half of
2019."
Product Development Update:
PTG-300
- The Company announced the initiation of dosing in the TRANSCEND
study, a single-arm, open-label global Phase 2 study of PTG-300, an
injectable hepcidin mimetic, in patients with transfusion-dependent
or non-transfusion dependent beta thalassemia. Preliminary
results from this Phase 2 trial are expected in the second half of
2019.
- The Company expects to begin clinical development of PTG-300 in
a second indication in the second half of 2019.
- The Company received Orphan Drug Designation from the European
Medicines Agency for PTG-300. PTG-300 had previously received
Orphan Drug Designation and Fast Track Designation from the U.S.
FDA.
PTG-200
- Top-line results from a Phase 1 study of PTG-200, an oral
peptide IL-23 receptor antagonist partnered with Janssen Biotech,
demonstrated that the drug was well tolerated, with no serious
adverse events or dose-limiting toxicities observed.
- Protagonist and Janssen Biotech are working towards filing a
U.S. IND application to support a global Phase 2 clinical study in
patients with Crohn's disease. This IND filing would trigger a
milestone payment from Janssen Biotech of $25 million under the exclusive license and
collaboration agreement between Janssen Biotech and Protagonist
(Janssen License and Collaboration Agreement). The U.S. IND filing
is expected in the first half of 2019.
PN-943
- Protagonist announced initiation of dosing in a Phase 1 study
of PN-943, which is being developed as a potential novel oral
therapy for patients with inflammatory bowel disease. The study
will evaluate safety, pharmacokinetics, and pharmacodynamic
readouts of target engagement as measured by blood receptor
occupancy in healthy volunteers. Top-line results from this Phase 1
study are expected in the first half of 2019.
- The Phase 1 data will inform the design of a Phase 2 study of
PN-943 in patients with ulcerative colitis, with an expected U.S.
IND filing in late 2019.
- Preclinical research findings of PN-943 have been accepted for
oral presentation on Sunday, May 19,
2019, at the Digestive Diseases Week conference in
San Diego.
Financial Results
Protagonist reported a net loss of $13.9
million and $38.9 million,
respectively, for the fourth quarter and full year 2018, as
compared to a net loss of $3.1
million and $37.0 million,
respectively, for the same periods of 2017. The increase in net
loss for the fourth quarter of 2018 as compared to the prior year
period was driven primarily by numerous factors such as nearing the
end of the revenue recognition phase of the $50.0 million upfront payment received from
Janssen in 2017, a net decrease in license and collaboration
revenue affected by an increase in variable consideration and the
additional time required to deliver the services to Janssen, and
increases in research and development (R&D) expenses. The
increase in net loss for the full year 2018 as compared to the
prior year was driven primarily by increases in R&D and general
and administrative (G&A) expenses, partially offset by an
increase in license and collaboration revenue and higher interest
income. The net loss for the fourth quarter and full year 2018
included non-cash stock-based compensation of $2.1 million and $6.9
million, respectively, as compared to $1.2 million and $4.2
million, respectively, for the same periods of 2017.
License and collaboration revenue was $2.4 million and $30.9
million, respectively, for the fourth quarter and full year
2018, as compared to $11.3 million
and $20.1 million, respectively, for
the same periods of 2017. The decrease in license and collaboration
revenue for the fourth quarter of 2018 as compared to the prior
year period was primarily related to nearing the end of the revenue
recognition phase of the $50.0
million upfront payment received from Janssen in 2017
coupled with the additional estimated time remaining to complete
our increased compound supply services under the Janssen License
and Collaboration Agreement. Protagonist estimates these services
will be completed during the first half of 2019 compared to the
previous estimate of end of 2018. The increase in license and
collaboration revenue for the full year of 2018 as compared to the
prior year was primarily driven by a full year of services
performed under the Janssen License and Collaboration Agreement
during 2018, compared to five months of revenue during 2017
following the signing of the agreement. The Company has determined
that the transaction price of the Janssen License and Collaboration
Agreement was $60.7 million at
December 31, 2018, an increase in
variable consideration of $6.8
million from the transaction price of $53.9 million at December
31, 2017.
R&D expenses were $14.2
million and $59.5 million,
respectively, for the fourth quarter and full year 2018, as
compared to $11.7 million and
$46.2 million, respectively, for the
same periods of 2017. The increases in R&D expenses were
primarily due to costs related to contract manufacturing and the
preparation for and conduct of clinical trials for our product
candidates. R&D expenses for the fourth quarter and full year
2018 included increases in salaries and employee-related expenses
due to an increase in R&D personnel.
G&A expenses for the fourth quarter and full year 2018
were $3.5 million and $13.7 million, respectively,
as compared to $3.1 million and $11.8 million,
respectively, for the same periods of 2017. The increases in
G&A expenses were primarily due to increases in salaries and
employee-related expenses to support the growth of our
operations.
Interest income for the fourth quarter and full year 2018
was $0.7 million and $2.5 million, respectively, as
compared to $0.5 million and $0.9 million,
respectively, for the same periods of 2017. The increase in
interest income is primary the result of the increasing interest
rate environment during 2018.
Protagonist ended 2018 with $128.9
million in cash, cash equivalents and investments.
Protagonist expects to have sufficient financial resources to fund
operations to the end of 2020.
Conference Call and Webcast Information
Protagonist executives will host a conference call at
4:30 p.m. EDT 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 9688334. The call will also be
webcast and will be accessible from "Events & Presentations" in
the Investors section of the Company's website at
www.protagonist-inc.com. A replay will be available on the
Company's website approximately two hours after the call and will
remain available for 60 days.
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 for the potential
treatment of anemia and iron overload related to rare blood
diseases with an initial focus on beta thalassemia. PTG-200 is an
oral peptide interleukin-23 receptor antagonist in development for
the treatment of Crohn's disease. The company has entered into a
worldwide license and collaboration agreement with Janssen Biotech
for the clinical development of PTG-200. PN-943 is an oral,
gut-restricted alpha-4-beta-7 integrin antagonist peptide in
development for the treatment of inflammatory bowel disease.
Protagonist is headquartered in Newark, California, with pre-clinical and
clinical staff in California and
discovery operations in both California and Brisbane, Queensland, Australia. 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 initiation and availability of results of our
clinical trials and the sufficiency of our financial resources. 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, 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. We discuss many of these risks in greater detail
under the heading "Risk Factors" contained in our Annual Report on
Form 10-K for the year ended December 31,
2018, filed with the Securities and Exchange Commission. 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
December 31,
|
|
Year Ended
December 31,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
License and
collaboration revenue - related party
|
$
2,353
|
|
$
11,282
|
|
$
30,925
|
|
$
20,063
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
14,248
|
|
11,724
|
|
59,497
|
|
46,181
|
General and
administrative
|
3,517
|
|
3,071
|
|
13,697
|
|
11,779
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
17,765
|
|
14,795
|
|
73,194
|
|
57,960
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(15,412)
|
|
(3,513 )
|
|
(42,269 )
|
|
(37,897)
|
Interest
income
|
748
|
|
461
|
|
2,546
|
|
940
|
|
|
|
|
|
|
|
|
Loss before income
tax benefit
|
(14,664)
|
|
(3,052 )
|
|
(39,723)
|
|
(36,957)
|
Income tax
benefit
|
799
|
|
--
|
|
799
|
|
--
|
|
|
|
|
|
|
|
|
Net loss
|
$
(13,865)
|
|
$ (3,052
)
|
|
$
(38,924)
|
|
$
(36,957)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.57)
|
|
$
(0.15 )
|
|
$
(1.74)
|
|
$
(2.09)
|
|
|
|
|
|
|
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
24,186,356
|
|
20,195,519
|
|
22,364,515
|
|
17,694,505
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2018
|
|
|
2017
|
|
Consolidated
Balance Sheet Data:
|
|
|
|
|
|
|
Cash, cash
equivalents and available-for-sale securities
|
|
$
|
128,853
|
|
|
$
|
155,459
|
|
Working
capital
|
|
$
|
111,345
|
|
|
$
|
108,392
|
|
Total
assets
|
|
$
|
139,472
|
|
|
$
|
163,734
|
|
Deferred revenue –
related party
|
|
$
|
8,223
|
|
|
$
|
31,752
|
|
Accumulated
deficit
|
|
$
|
(140,474))
|
|
|
$
|
(101,550))
|
|
Total stockholders'
equity
|
|
$
|
112,515
|
|
|
$
|
120,632
|
|
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SOURCE Protagonist Therapeutics, Inc.