NEWARK, Calif., May 7, 2020 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) today reported its financial
results for the first quarter ended March
31, 2020, and provided an update on clinical development
programs.
"Based on the highly promising and consistent clinical responses
achieved to date, we are pleased to announce polycythemia vera as
the first indication for a pivotal study of PTG-300," commented
Dinesh V. Patel, Ph.D., Protagonist
President and Chief Executive Officer. "With an orphan drug
development regulatory path forward, we are focused on rapidly
advancing PTG-300 as a first-in-class non-cytoreductive hepcidin
hormone mimetic agent for this indication with significant unmet
need. With a highly focused development effort forward with
PTG-300 for polycythemia vera, and deferring PN-943 Phase 2
initiation due to the current COVID-19 environment, we have reduced
our operational expenditures and now have an additional six months
of cash runway estimated to extend through mid-2022."
Product Development Update
PTG-300: Injectable Hepcidin Mimetic
- Initial Phase 2 results in patients with polycythemia vera from
an ongoing study demonstrated that treatment with PTG-300 at
individualized doses ranging from 10 mg to 80 mg for up to 28 weeks
controlled hematocrit levels. All patients were phlebotomy free
(except a single phlebotomy due to an unintended dose interruption
in a patient who remains on study). Administration of PTG-300 was
well tolerated and the safety profile was generally similar with
results of prior studies, with injection site reactions and bruise
as the only adverse events related to or possibly related to
treatment. Results are available as of the May 1, 2020, cutoff date.
- The results of the PTG-300 beta-thalassemia Phase 2 study will
be presented at an upcoming medical conference in the second
quarter of 2020.
- Protagonist will redirect the majority of its PTG-300 efforts
to the polycythemia vera indication, while also continuing its
exploration of PTG-300 in hereditary hemochromatosis. The Company
is discontinuing clinical development for PTG-300 in
beta-thalassemia and myelodysplastic syndromes.
PTG-200 (JNJ-67864238): Oral IL-23 Receptor Antagonist for
Inflammatory Bowel Disease
- In collaboration with Janssen Biotech, we initiated a Phase 2
global study for PTG-200 (or JNJ-67864238) in moderate-to-severe
Crohn's disease in the fourth quarter of 2019. Because of the
global COVID-19 pandemic, guidance has been currently suspended on
a timeline for study completion.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory
Bowel Disease
- A Phase 2 study of PN-943 in approximately 150 patients with
moderate-to-severe ulcerative colitis is currently planned.
- In light of the global COVID-19 pandemic, Protagonist continues
to review all aspects of the planned Phase 2 study and is currently
suspending guidance on a timeline for study initiation. The Company
is maintaining readiness to initiate the study as soon as
conditions allow for safe accrual of subjects for the global
study.
Financial Results
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of March 31, 2020, were $117.5 million. Due to the focusing of efforts on
polycythemia vera and the delay in PN-943 trial initiation caused
by the ongoing global COVID-19 pandemic and a related internal
reorganization, the company believes its adjusted operating plans
now provide sufficient financial resources from its cash, cash
equivalents, marketable securities and access to its debt facility
to fund its currently planned operating and capital expenditures
through mid-2022. The company will continue to monitor events
closely and may further adjust its operating plans as
warranted.
- License and Collaboration Revenue: License and
collaboration revenue of $3.6 million
for the first quarter of 2020 increased in comparison to
$1.6 million reported for the same
period of 2019. License and collaboration revenue is generally
earned over time as services are provided under the
collaboration.
- Research and Development ("R&D") Expenses: R&D
expenses for the first quarter 2020 were $18.8 million as compared to $12.4 million for the same period of 2019. The
increase was primarily due to increased clinical development costs
related to PTG-300, PN-943 and our IL-23 receptor antagonist
collaboration with Janssen Biotech to develop PTG-200 and the
related research collaboration efforts.
- General and Administrative ("G&A")
Expenses: G&A expenses for the first quarter 2020
were $4.6 million, as compared to $3.8 million for
the same period of 2019. The increase was primarily due to
increases in salaries, employee-related expenses and professional
services to support the growth in our operations.
- Net Loss: The first quarter 2020 net loss was
$20.1 million, or a net loss of
$0.72 per share, as compared to a net
loss of $14.1 million, or a net loss
of $0.58 per share, for the same period of 2019.
Conference Call and Webcast Information
Protagonist will host a conference call at 5 p.m. EDT / 2 p.m.
PDT today to provide a corporate update. Ronald Hoffman, M.D., Director of the
Myeloproliferative Diseases Program at The Icahn School of Medicine
at Mount Sinai, will join the call to present initial results for
PTG-300 in polycythemia vera. 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
4597494. A live and archived webcast will also be accessible in the
Investors section of the Company's website at
www.protagonist-inc.com.
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 therapeutics to address significant
unmet medical needs and transform existing treatment paradigms for
patients. The Company currently has three clinical-stage assets.
PTG-300 is an injectable hepcidin mimetic in development for the
treatment of polycythemia vera and hereditary hemochromatosis.
PTG-200 is an orally delivered, gut-restricted, interleukin-23
receptor specific antagonist peptide in development for the
treatment of inflammatory bowel disease, with Crohn's disease as
the initial indication. The Company has a worldwide license and
collaboration agreement with Janssen Biotech, Inc., for the
development of PTG-200. PN-943 is an orally delivered,
gut-restricted alpha-4-beta-7 integrin specific antagonist peptide
in development for the treatment of inflammatory bowel disease,
with ulcerative colitis as the initial targeted indication.
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 potential for our ongoing
clinical programs, our plans for future clinical trials, the impact
of the global COVID-19 pandemic, the potential of PTG-300 as a
possible treatment for polycythemia vera,
beta-thalassemia and hereditary hemochromatosis, the potential of
PTG-200 and PN-943 as possible treatments for inflammatory bowel
disease, the initiation and availability of results of our clinical
trials and the sufficiency of our financial resources, our ability
to fund our clinical trials, the initiation of and enrollment of
patients in our clinical trials, the results of clinical trials and
the outlook for our other programs. In some cases, you can identify
these statements by forward-looking words such as "plan,"
"estimate," "will," "potential," 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 Biotech, 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
and risks related to the global COVID-19 pandemic and actions taken
to slow its spread. 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 period ended March 31, 2020, 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)
(Unaudited)
|
|
|
|
Three Months
Ended
March 31,
|
|
|
2020
|
|
|
2019
|
|
|
|
|
|
|
|
|
License and
collaboration revenue - related party
|
$
|
3,647
|
|
$
|
1,560
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development (1)
|
|
18,768
|
|
|
12,444
|
|
General and
administrative (1)
|
|
4,576
|
|
|
3,764
|
|
Total operating
expenses
|
|
23,344
|
|
|
16,208
|
|
Loss from
operations
|
|
(19,697)
|
|
|
(14,648)
|
|
Interest
income
|
|
526
|
|
|
731
|
|
Interest
expense
|
|
(243)
|
|
|
-
|
|
Other income
(expense), net
|
|
(490)
|
|
|
(3)
|
|
Loss before income
taxes
|
|
(19,904)
|
|
|
(13,920)
|
|
Income tax
(expense)
|
|
(176)
|
|
|
(183)
|
|
Net loss
|
$
|
(20,080)
|
|
$
|
(14,103)
|
|
Net loss per common
share, basic and diluted
|
$
|
(0.72)
|
|
$
|
(0.58)
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
|
27,703,918
|
|
|
24,297,576
|
|
|
|
|
|
|
|
|
(1) Amounts include non-cash
stock-based compensation expense as follows (in
thousands):
|
|
|
|
Three Months
Ended
March 31,
|
Stock-based
compensation
|
|
2020
|
|
|
2019
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
1,066
|
|
$
|
1,122
|
|
General and
administrative
|
|
982
|
|
|
857
|
|
Total stock-based
compensation expense
|
$
|
2,048
|
|
$
|
1,979
|
|
PROTAGONIST
THERAPEUTICS, INC.
|
Selected
Consolidated Balance Sheet Data
|
(In
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
2020
|
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
$
|
117,513
|
|
$
|
133,017
|
Working
capital
|
$
|
89,614
|
|
$
|
109,905
|
Total
assets
|
$
|
134,901
|
|
$
|
154,917
|
Long-term debt,
net
|
$
|
9,832
|
|
$
|
9,794
|
Deferred revenue -
related party
|
$
|
39,045
|
|
$
|
41,530
|
Accumulated
deficit
|
$
|
(237,741)
|
|
$
|
(217,661)
|
Total stockholders'
equity
|
$
|
62,666
|
|
$
|
79,964
|
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SOURCE Protagonist Therapeutics, Inc.