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Protagonist Reports Third Quarter 2022 Financial Results and Provides Corporate Update Continued execution of Phase 3 VERIFY study of rusfertide in polycythemia vera Arturo Molina, M.D., M.S. named Chief Medical Officer,

Key Takeaway: Third Quarter 2022 Financial Results and Provides Corporate Update Continued execution of Phase 3 VERIFY study of rusfertide in polycythemia vera Arturo Molina, M.D., M.S. named Chief Medical Officer, providing medical, clinical development, and strategic leadership to the ru

Full Press Release Details

Third Quarter 2022 Financial Results and Provides Corporate Update
Continued execution of Phase 3 VERIFY study
of rusfertide in polycythemia vera
Arturo Molina, M.D., M.S. named Chief Medical
Officer, providing medical, clinical development, and strategic leadership to the rusfertide clinical development program
Three rusfertide poster presentations to be
shared at the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH) in December
Calif., Nov. 8, 2022 - Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or
"the Company") today reported financial results for the third quarter ended September 30, 2022 and provided a corporate
"Continued execution
of the Phase 3 VERIFY global clinical development program of rusfertide in polycythemia vera remains our top corporate priority,"
said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Rusfertide has the potential to transform the
current treatment paradigm for PV, dramatically improving patients' lives. The enthusiasm we have observed around rusfertide, among
patients and physicians alike, reinforces our commitment to advancing this important drug candidate as rapidly as possible."
Dr. Patel continued, "We
are pleased to have recently announced a new Chief Medical Officer, Dr. Arturo Molina, a renowned hematologist-oncologist and a
successful drug developer. Dr. Molina will focus on providing medical and operational leadership to our rusfertide clinical development
Janssen-partnered asset, PN-235 (JNJ-77242113), an oral peptide interleukin 23 receptor (IL-23R) antagonist, is currently in
multiple Phase 2 clinical studies to assess safety and efficacy in moderate-to-severe plaque psoriasis. We look forward to
decision-driving results from these studies in the first half of next year. With important pending readouts for both rusfertide and
PN-235, we expect the first half of 2023 to be a period of potential transformational value creation for Protagonist."
Third Quarter 2022 and Recent Developments
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia
Vera (PV) and Other Potential Indications
Title: VERIFY: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera
Session Name: 634. Myeloproliferative Syndromes: Clinical
and Epidemiological: Poster I
Session Date: Saturday, December 10, 2022
Presentation Time: 5:30 PM - 7:30 PM CT.
Title: Subgroup Analysis of Adverse Events Following Rusfertide Dosing in REVIVE: A Phase 2 Study of Patients with Polycythemia Vera
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 11, 2022
Presentation Time: 6:00 PM - 8:00 PM CT.
Analog-PN23114 as a Hepcidin Mimetic Provides Efficacy Benefits in Conjunction with Phlebotomy in Mouse Model for Hereditary Hemochromatosis
Session Name: 102. Iron Homeostasis
and Biology: Poster II
Session Date: Sunday, December 11, 2022
Presentation Time: 6:00 PM - 8:00 PM CT.
PN-235: Oral IL-23 Receptor Antagonist
PN-943: Oral, Gut-Restricted, alpha-4-beta-7
Integrin Antagonist for Ulcerative Colitis (UC)
Management and Operational Updates
Third Quarter 2022 Financial Results
Therapeutics is a biopharmaceutical company with peptide-based new chemical entities rusfertide and PN-235 in advanced stages of clinical
development, both derived from the Company's proprietary technology platform. Rusfertide, a mimetic of the natural hormone hepcidin,
is the Company's lead drug candidate currently in a global Phase 3 stage of development. The VERIFY (Phase 3) and REVIVE (Phase
2) studies of rusfertide in polycythemia vera are ongoing. Protagonist owns all marketing rights to rusfertide.
has partnered with Janssen Biotech, Inc. on the development of PN-235 (JNJ-77242113) in moderate-to-severe psoriasis and inflammatory
bowel disease. PN-235 is currently in multiple studies in psoriasis, led by Janssen.
is headquartered in Newark, California. For more information on Protagonist, please visit the Company's website at www.protagonist-inc.com.
Cautionary Note on Forward-Looking Statements
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 expectations regarding enrollment in the rusfertide VERIFY Phase 3 trial, the potential benefits of rusfertide to patients, timing
of PN-235 clinical trials and potential milestones related to PN-235, and our expected cash runway. 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, delays
or difficulties in enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate
our compounds or product candidates are unsafe or ineffective, dependence on third parties to conduct clinical studies and manufacture
our products, our ability to earn milestone payments under our collaboration agreement with Janssen Biotech, the impact of the
current COVID-19 pandemic on our discovery and development efforts, the impact of the ongoing military conflict in Ukraine and Russia
on any future studies, 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
Jami Taylor - j.taylor@ptgx-inc.com
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Amounts in thousands except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2022 2021 2022 2021
License and collaboration revenue - related party $ - $ 10,286 $ 26,581 $ 18,740
Operating expenses:
Research and development (1) 25,402 36,956 96,331 87,633
General and administrative (1) 6,901 7,256 25,107 19,936
Total operating expenses 32,303 44,212 121,438 107,569
Loss from operations (32,303 ) (33,926 ) (94,857 ) (88,829 )
Interest income 1,157 122 1,809 321
Other expense, net (86 ) - (151 ) (136 )
Net loss $ (31,232 ) $ (33,804 ) $ (93,199 ) $ (88,644 )
Net loss per share, basic and diluted $ (0.64 ) $ (0.70 ) $ (1.90 ) $ (1.94 )
Weighted-average shares used to compute net loss per share, basic and diluted 49,107,639 47,987,184 48,971,329 45,705,782
PROTAGONIST THERAPEUTICS, INC.
Stock-based Compensation (Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2022 2021 2022 2021
Research and development $ 3,858 $ 2,611 $ 11,290 $ 6,241
General and administrative 2,092 2,164 7,400 5,130
Total stock-based compensation expense $ 5,950 $ 4,775 $ 18,690 $ 11,371
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
September 30, December 31,
2022 2021
Cash, cash equivalents and marketable securities $ 267,437 $ 326,900
Working capital 239,863 296,720
Total assets 282,174 347,695
Deferred revenue-related party - 1,601
Accumulated deficit (502,561 ) (409,362 )
Total stockholders' equity 243,616 300,021
Last updated: Nov 8, 2022