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Protagonist Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Corporate Update -- Regulatory guidance anticipated in the first half of 2021 for registrational clinical development plan of inves

Key Takeaway: Protagonist Therapeutics Reports Fourth Quarter and Full Results and Corporate Update -- Regulatory guidance anticipated in the first half of 2021 for registrational clinical development plan of investigational drug, rusfertide (PTG-300), for polycythemia -- Company expects t

Full Press Release Details

Protagonist Therapeutics Reports Fourth Quarter and Full
Results and Corporate Update
-- Regulatory guidance anticipated in
the first half of 2021 for registrational clinical development plan of investigational drug, rusfertide (PTG-300), for polycythemia
-- Company expects to share findings
from ongoing hereditary hemochromatosis study for rusfertide (PTG-300) in the second half of 2021 --
-- Strong cash position to fund planned
operations through the first half of 2024 --
-- Management to host conference call
today at 4:30 p.m. EST --
NEWARK, Calif., March 10,
2021 -- Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") (Nasdaq: PTGX) today reported
financial results and provided a corporate update for the fourth quarter and full year ended December 31, 2020.
year 2020 marked a significant period of growth for Protagonist as we focused on expanding the scope of our pipeline and advancing
different development molecules in multiple clinical programs and indications," commented Dinesh V. Patel, Ph.D., Protagonist
President and Chief Executive Officer. "In December, we released compelling interim data from our ongoing Phase 2 trial with
our most advanced candidate, rusfertide, which has received orphan drug designation and Fast Track designation for the treatment
of polycythemia vera, a rare disease that affects about 100,000 treated patients in the U.S. alone. In the first half of 2021,
we expect to complete our planned regulatory interactions and finalize the registrational clinical development plan, which represents
an important turning point for the Company as rusfertide has the potential to become
a new therapeutic treatment option for polycythemia vera patients. Continuing with the momentum of building our rusfertide portfolio,
we expect to announce initial results of the hereditary hemochromatosis proof-of-concept trial in the second half of 2021 and select
an additional indication for this candidate in 2021."
Dr. Patel added, "This
past year, we continued to make progress with our ongoing 150-patient, Phase 2 IDEAL trial in ulcerative colitis with the gut-restricted
alpha-4-beta-7 integrin blocker PN-943 and expect to complete this study in 2022. During the year, we also added two new clinical
development stage assets to the ongoing oral IL-23 receptor antagonist program with our partner, Janssen. With a strong cash position
through mid-2024, we look forward to focusing our capital to continue building value across our portfolio."
PRODUCT DEVELOPMENT AND
Disorders of Red Blood Cells
Rusfertide (PTG-300)
Investigational, injectable,
hepcidin mimetic discovered through our peptide technology platform. Hepcidin regulates iron homeostasis and controls the absorption,
storage, and distribution of iron in the body. Rusfertide is currently being evaluated for disorders associated with iron overload
and excessive erythrocytosis (red blood cell production).
Inflammatory Bowel Diseases
Investigational, orally
delivered, gut-restricted alpha-4-beta-7 specific integrin antagonist for inflammatory bowel diseases.
Oral IL-23 Receptor Antagonists
PTG-200; PN-235; PN-232
Investigational, orally
delivered, IL-23 receptor antagonists.
Conference Call and Webcast
access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (International) and refer to conference ID #: 7756175.
A live webcast of the call will also be accessible on the Investors section of the Company's website at www.protagonist-inc.com.
The replay will be available on the company's website approximately two hours after the call and will remain available for
About Protagonist Therapeutics
Protagonist Therapeutics is a clinical
stage biopharmaceutical company with multiple peptide-based new chemical entities in different stages of development. Rusfertide
(PTG-300) is an injectable hepcidin mimetic in a Phase 2 proof-of-concept clinical trial for polycythemia vera, and a separate
Phase 2 clinical study for hereditary hemochromatosis. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific
antagonist peptide in a 150 patient Phase 2 study for the potential treatment of inflammatory bowel disease, with ulcerative colitis
as the initial targeted indication. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist
peptide in a Phase 2 clinical trial for Crohn's disease. Two additional second-generation oral interleukin-23 receptor antagonist
candidates PN-235 and PN-232, are in early stages of clinical development. The Company has developed a proprietary technology
platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing
treatment paradigms.
is headquartered in Newark, California. For further information, please visit www.protagonist-inc.com.
Cautionary Note on Forward-Looking
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 timing of our discussions with regulatory authorities, our expectations regarding enrollment in, and announcement of data from,
our ongoing clinical trials and our plans to evaluate rusfertide for an additional indication. 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, 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 Annual Report on Form 10-K for the year ended December 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.
Condensed Consolidated Statements of Operations
(Amounts in thousands except share and per share data)
Three Months Ended Year Ended
December 31, December 31,
2020 2019 2020 2019
License and collaboration revenue - related party $ 5,650 $ 2,719 $ 28,628 $ 231
Operating expenses:
Research and development (1) 19,486 15,911 74,506 65,003
General and administrative (1) 4,994 4,107 18,638 15,749
Total operating expenses 24,480 20,018 93,144 80,752
Loss from operations (18,830 ) (17,299 ) (64,516 ) (80,521 )
Interest income 80 679 900 2,813
Interest expense (127 ) (167 ) (598 ) (169 )
Loss on early repayment of debt - - (585 ) -
Other (expense) income, net (9 ) 142 (46 ) (1 )
Loss before income tax (expense) benefit (18,886 ) (16,645 ) (64,845 ) (77,878 )
Income tax (expense) benefit - (856 ) (1,305 ) 691
Net loss $ (18,886 ) $ (17,501 ) $ (66,150 ) $ (77,187 )
Net loss per share, basic and diluted $ (0.48 ) $ (0.63 ) $ (1.92 ) $ (2.98 )
Weighted-average shares used to compute net loss per share, basic and diluted 39,605,193 27,610,696 34,396,446 25,894,024
include non-cash stock-based compensation expense.
Three Months Ended Year Ended
December 31, December 31,
2020 2019 2020 2019
Research and development $ 1,023 $ 1,113 $ 4,121 $ 4,350
General and administrative 944 1,047 3,778 4,003
Total stock-based compensation expense $ 1,967 $ 2,160 $ 7,899 $ 8,353
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
December 31, December 31,
2020 2019
Cash, cash equivalents and marketable securities $ 307,809 $ 133,017
Working capital 275,365 109,905
Total assets 324,468 154,917
Long-term debt, net - 9,794
Deferred revenue-related party 14,477 41,530
Accumulated deficit (283,811 ) (217,661 )
Total stockholders' equity 279,606 79,964
Last updated: Mar 10, 2021