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Protagonist Reports Third Quarter 2025 Financial Results and Provides Corporate Update Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S.

Key Takeaway: Protagonist Reports Third Quarter 2025 Financial Results and Provides Corporate Update Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S. FDA in July, the European Medicines Agency (EMA) applic

Full Press Release Details

Protagonist Reports Third
Quarter 2025 Financial Results and Provides Corporate Update
Following the NDA submission
for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S. FDA in July, the European Medicines
Agency (EMA) application was submitted in September
breakthrough designation for patients in Polycythemia Vera (PV) and the subject of four presentations including 52-week results of the
VERIFY Phase 3 Study at ASH, the 67th Annual American Society of Hematology (ASH) meeting in December
in the Phase 1 trial of PN-881, a first-in-class oral IL-17 peptide antagonist
IND-enabling studies
progressing as planned with triple-GLP/GIP/GCG agonists PN-477sc and PN-477o
Oral hepcidin development
candidate expected to be nominated by year end
Cash, cash equivalents
and marketable securities of $678.8 million as of September 30, 2025, anticipated to provide cash runway through at least end of
Calif., November 6, 2025 - Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist"
or "the Company") today reported financial results for the third quarter ended September 30, 2025, and provided a corporate
"2025 continues to be a highly productive
year with significant accomplishments in both partnered and wholly owned programs," said Dinesh V. Patel, Ph.D., the Company's
President and CEO. "In addition to the NDA and EMA submissions for icotrokinra for psoriasis, we are pleased to see our partner
Johnson and Johnson expand the ICONIC program into additional IL-23 pathway relevant and validated I&I indications, namely psoriatic
arthritis, ulcerative colitis, and Crohn's disease. We, along with our partner Takeda, eagerly await the presentation of
the rusfertide 52-week VERIFY data at ASH in December and the NDA filing for rusfertide by year end."
"As icotrokinra and rusfertide move towards potential NDA
approval and commercialization in 2026, we shift our attention to the next phase of assets emerging from our validated
discovery and development platform. We are pleased to report that the first subject in the Phase 1 trial of oral IL-17
antagonist, PN-881, is dosed. Additionally, the oral and subcutaneous triple GLP/GIP/GCG agonists, PN-477o and PN-477sc, are
progressing through IND-enabling studies as planned, and we remain on track to nominate a development candidate from the oral
hepcidin program by year end. I am very proud of the consistent innovation and execution capabilities of the Protagonist
Quarter 2025 Recent Developments and Upcoming Milestones
Oral IL-23 Receptor Antagonist
Rusfertide: Subcutaneous Injectable
Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
Discovery and Development Pipeline
Third Quarter 2025 Financial Results
Three Months Ended September 30, Nine Months Ended September 30,
(in thousands, except per share amounts) 2025 2024 2025 2024
(Unaudited)
License and collaboration revenue $ 4,712 $ 4,675 $ 38,579 $ 263,795
Research and development expense $ 40,003 $ 35,970 $ 112,932 $ 103,224
General and administrative expense $ 11,130 $ 10,158 $ 33,419 $ 34,508
Net (loss) income $ (39,339 ) $ (33,210 ) $ (85,765 ) $ 143,514
Basic earnings (loss) per share $ (0.62 ) $ (0.54 ) $ (1.35 ) $ 2.34
Diluted earnings (loss) per share $ (0.62 ) $ (0.54 ) $ (1.35 ) $ 2.22
Protagonist Therapeutics is a discovery through late-stage development
biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase
3 clinical development, with a New Drug Application (NDA) for icotrokinra submitted to the FDA in July, and the NDA submission for rusfertide
expected by end of 2025. Icotrokinra (formerly, JNJ-2113), is a first-in-class investigational targeted oral peptide that selectively
blocks the Interleukin-23 receptor ("IL-23R"), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson
company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R
collaboration, Protagonist was primarily responsible for the development of icotrokinra through Phase 1, with Johnson & Johnson
assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in
Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized
with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains
primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing
clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477,
and the oral hepcidin program.
information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://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
the potential benefits of icotrokinra and PN-881, and expectations regarding the icotrokinra and PN-881 development programs. 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 with Janssen and Takeda, 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 release.
Investor Relations Contact
Media Relations Contact
ENTENTE Network of Companies
+1 833 500 0061 ext 1
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Amounts in thousands except share and per share
Three Months Ended Nine Months Ended
September 30, September 30,
2025 2024 2025 2024
License and collaboration revenue $ 4,712 $ 4,675 $ 38,579 $ 263,795
Operating expense:
Research and development (1) 40,003 35,970 112,932 103,224
General and administrative (1) 11,130 10,158 33,419 34,508
Total operating expense 51,133 46,128 146,351 137,732
(Loss) income from operations (46,421 ) (41,453 ) (107,772 ) 126,063
Interest income 7,049 7,682 22,028 19,462
Other income, net 33 141 151 219
(Loss) income before income tax benefit (expense) (39,339 ) (33,630 ) (85,593 ) 145,744
Income tax benefit (expense) - 420 (172 ) (2,230 )
Net (loss) income $ (39,339 ) $ (33,210 ) $ (85,765 ) $ 143,514
Net (loss) income per share, basic $ (0.62 ) $ (0.54 ) $ (1.35 ) $ 2.34
Net (loss) income per share, diluted $ (0.62 ) $ (0.54 ) $ (1.35 ) $ 2.22
Weighted-average shares used to compute net (loss) income per share, basic 63,772,332 61,767,934 63,418,522 61,311,310
Weighted-average shares used to compute net (loss) income per share, diluted 63,772,332 61,767,934 63,418,522 64,611,941
includes non-cash stock-based compensation expense.
(Unaudited, in thousands)
Three Months Ended Nine Months Ended
September 30, September 30,
2025 2024 2025 2024
Research and development $ 6,019 $ 5,212 $ 20,301 $ 15,597
General and administrative 4,540 4,953 14,972 12,864
Total stock-based compensation expense $ 10,559 $ 10,165 $ 35,273 $ 28,461
PROTAGONIST THERAPEUTICS, INC.
Selected Condensed Consolidated Balance Sheet
(Unaudited, In thousands)
September 30, 2025 December 31, 2024
Cash, cash equivalents and marketable securities $ 678,820 $ 559,165
Working capital 541,482 544,243
Total assets 701,688 744,725
Deferred revenue 16,988 30,567
Accumulated deficit (426,287 ) (340,522 )
Total stockholders' equity 645,437 675,295
Last updated: Nov 6, 2025