Recent Updates
Recently added Catalysts
PTGX

Protagonist Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update Resumption of the Phase 2 study of rusfertide in polycythemia vera now underway, following swift removal of the FDA clin

Key Takeaway: Protagonist Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update Resumption of the Phase 2 study of rusfertide in polycythemia vera now underway, following swift removal of the FDA clinical hold concept data for rusfertide in hereditary hemo

Full Press Release Details

Protagonist Therapeutics
Reports Third Quarter 2021 Financial Results and Provides Corporate Update
Resumption of the Phase
2 study of rusfertide in polycythemia vera now underway, following swift removal of the FDA clinical hold
concept data for rusfertide in hereditary hemochromatosis to be presented at The Liver Meeting hosted by the American
Association for the Study of Liver Diseases
psoriasis indication, Phase 2 study initiation planned for early 2022
NEWARK, Calif., November 3, 2021-Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") today reported its financial results for the
third quarter ended September 30, 2021 and provided a corporate update.
"We are excited to share the substantial
progress made thus far in all of our clinical programs, highlighted by the presentation of proof-of-concept data on rusfertide in hereditary
hemochromatosis at the upcoming AASLD meeting, and the new rusfertide data in polycythemia vera, which will be presented by the year's
end," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer. "We were very pleased that the FDA reached a swift
resolution regarding the clinical hold placed on rusfertide, and we are in the process of resuming all rusfertide clinical studies. Additionally,
we are highly encouraged with the rate of enrollment in the Phase 2 study of our oral alpha-4-beta-7 integrin antagonist PN-943, for ulcerative
colitis, an indication with a large patient population and unmet treatment need. We maintain our guidance of a data readout in Q2 2022,
and in anticipation of this, we are excited that Dr. Scott Plevy has joined our team as Executive Vice President and Therapeutic Head,
Gastroenterology. As a renowned gastroenterologist, Dr. Plevy will oversee the clinical development of PN-943 and other future programs
focused on gastrointestinal diseases. Finally, our oral IL-23 receptor antagonist program, in partnership with Janssen, continues to make
demonstrated progress, with PN-235 now advancing into a Phase 2 study in psoriasis in early 2022."
Third Quarter 2021 Recent Developments
and Upcoming Milestones
Rusfertide: Subcutaneous Injectable Hepcidin
Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
PN-943: Oral, gut-restricted, alpha-4-Beta-7
Integrin Antagonist for Ulcerative Colitis
Oral IL-23 Receptor Antagonists (collaboration
between Janssen Biotech, Inc. and Protagonist)
The Phase 1 study with PN-232 is under progress with study completion expected by mid-2022.
Additional development in IBD is expected to initiate in 2022.
Third Quarter 2021 Financial Results
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 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. 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 is targeting ulcerative colitis as the initial indication.
The Company has a worldwide license
and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds in development
include PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates. The Phase 1 study of PN-235
is completed, and Janssen is expected to initiate a Phase 2 study in psoriasis in Q1 2022. The phase 1 study with PN-232, the second 2nd
generation candidate, is under progress with study completion expected by mid-2022. Additional research in IBD is expected to initiate
Protagonist 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 Company's clinical development
program for rusfertide. 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
Investors: Kevin Murphy - protagonist@argotpartners.com
Media: Joshua R. Mansbach - protagonist@argotpartners.com
PROTAGONIST THERAPEUTICS,
Condensed Consolidated Statements of Operations
(Amounts in thousands except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
License and collaboration revenue - related party $ 10,286 $ 13,114 $ 18,740 $ 22,978
Operating expenses:
Research and development (1) 36,956 15,995 87,633 55,020
General and administrative (1) 7,256 4,891 19,936 13,644
Total operating expenses 44,212 20,886 107,569 68,664
Loss from operations (33,926 ) (7,772 ) (88,829 ) (45,686 )
Interest income 122 87 321 820
Interest expense - (19 ) - (471 )
Loss on early repayment of debt - - - (585 )
Other expense, net - (59 ) (136 ) (37 )
Loss before income tax expense (33,804 ) (7,763 ) (88,644 ) (45,959 )
Income tax expense - - - (1,305 )
Net loss $ (33,804 ) $ (7,763 ) $ (88,644 ) $ (47,264 )
Net loss per share, basic and diluted $ (0.70 ) $ (0.21 ) $ (1.94 ) $ (1.45 )
Weighted-average shares used to compute net loss per share, basic and diluted 47,987,184 37,386,881 45,705,782 32,647,524
PROTAGONIST THERAPEUTICS,
Stock-based Compensation (Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
Research and development $ 2,611 $ 1,006 $ 6,241 $ 3,098
General and administrative 2,164 882 5,130 2,834
Total stock-based compensation expense $ 4,775 $ 1,888 $ 11,371 $ 5,932
PROTAGONIST THERAPEUTICS,
Selected Consolidated Balance Sheet Data
September 30, December 31,
2021 2020
Cash, cash equivalents and marketable securities $ 352,470 $ 307,809
Working capital 288,531 275,365
Total assets 373,175 324,468
Deferred revenue-related party 2,241 14,477
Accumulated deficit (372,455 ) (283,811 )
Total stockholders' equity 329,660 279,606
Last updated: Nov 3, 2021