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Protagonist Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update $165.0 million icotrokinra (formerly JNJ-2113) milestone earned in Q4 2024, received in January 2025 PN-881, a potenti

Key Takeaway: Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update million icotrokinra (formerly JNJ-2113) milestone earned in Q4 2024, received in January 2025 a potential best-in-class oral IL-17 receptor antagonist peptide nominated as a development ca

Full Press Release Details

Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
million icotrokinra (formerly JNJ-2113) milestone earned in Q4 2024, received in January 2025
a potential best-in-class oral IL-17 receptor antagonist peptide nominated as a development candidate in Q4 2024
Topline results for rusfertide Phase 3 VERIFY clinical trial in polycythemia vera expected in March 2025
Topline results for icotrokinra Phase 2b ANTHEM clinical trial in moderate to severe ulcerative colitis expected in March 2025
cash equivalents, and marketable securities of $559.2 million as of December 31, 2024, combined with $165.0 million milestone payment,
anticipated to provide cash runway through at least end of 2028
Calif., February 21, 2025 - Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the
Company") today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate
is quickly approaching multiple late-stage transformational events expected in the first quarter of this year, including the topline
results from the VERIFY Phase 3 study of rusfertide in polycythemia vera and from the ANTHEM Phase 2b ulcerative colitis study of icotrokinra",
said Dinesh V. Patel, Ph.D., the Company's President and CEO. "In addition, we look forward to progressing oral IL-17 peptide
antagonist PN-881 in clinical studies and nominating new development candidates from the oral obesity and oral hepcidin programs
this year. We are fortunate to be in a strong cash position, enabling the flexibility to progress these early-stage peptide drug candidates
independently into pre-clinical and clinical proof-of-concept studies over the coming years."
Worldwide License and Collaboration
Agreement for Rusfertide with Takeda
articles published in the New England Journal of Medicine ("NEJM") in February 2024
Icotrokinra: Oral IL-23 Receptor
ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
of PN-881, a potential best-in-class oral peptide IL-17 antagonist development candidate; additional discovery programs announced
of a $165.0 million milestone
the terms of the icotrokinra license and collaboration agreement with JNJ, as amended in November 2024, the Company earned a $165.0
million milestone during Q4 2024. The $165.0 million was received in January 2025.
and Upcoming Milestones
VERIFY (NCT05210790)
ANTHEM (NCT06049017)
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
Fourth Quarter and Full Year 2024
Cash, Cash Equivalents,
and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2024, were $559.2 million as compared
to $341.6 million in the previous year.
Three Months Ended Twelve Months Ended
December 31, December 31,
(in thousands, except per share amounts) 2024 2023 2024 2023
License and collaboration revenue $ 170,638 $ 60,000 $ 434,433 $ 60,000
Research and development expense $ 34,904 $ 28,899 $ 138,128 $ 120,161
General and administrative expense $ 8,954 $ 8,052 $ 43,462 $ 33,491
Net income (loss) $ 131,674 $ 27,335 $ 275,188 $ (78,955 )
Basic earnings (loss) per share $ 2.11 $ 0.45 $ 4.47 $ (1.39 )
Diluted earnings (loss) per share $ 1.98 $ 0.44 $ 4.23 $ (1.39 )
and collaboration revenue is derived from the Company's License and Collaboration Agreement with Johnson & Johnson
(JNJ), as amended in November 2024 (the "JNJ Agreement"), and its Worldwide License and Collaboration Agreement for
Rusfertide with Takeda which became effective in March 2024 (the "Takeda Agreement"). Total License and collaboration
revenue increased by $374.4 million from $60.0 million for the year ended December 31, 2023, to $434.4 million for the year ended
December 31, 2024. The increase was attributable to:
Research and Development
("R&D") Expenses: Increased by $6.0 million and $18.0 million for the fourth quarter and full year 2024, respectively,
from the prior year periods. The increases were due primarily to increases in drug discovery and pre-clinical research expenses.
General and Administrative
("G&A") Expenses: Increased by $0.9 million for the three months ended December 31, 2024, from the prior year period
primarily due to an increase in stock-based compensation. The increase of $10.0 million for the full year 2024 as compared to the prior
year was primarily due to $4.6 million in one-time advisory and legal fees related to the Takeda Collaboration Agreement and an increase
of $4.4 million in stock-based compensation and other personnel-related expenses.
Net income was $131.7 million, or $2.11 per basic share and $1.98 per diluted share, for the fourth quarter of 2024 as compared to net
income of $27.3 million, or $0.45 per basic and $0.44 per diluted share, for the fourth quarter of 2023. Net income was $275.2 million,
or $4.47 per basic share and $4.23 per diluted share, for the full year 2024, as compared to a net loss of $(79.0) million, or ($1.39)
per share, for the full year 2023.
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 New Drug Application submissions to the FDA
potentially in 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 JNJ Innovative Medicines ("JNJ"), formerly Janssen
Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R
collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ 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 into in 2024 under which the Company remains primarily responsible
for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically
and commercially validated targets, including IL-17 oral peptide antagonist PN-881, oral hepcidin program, and oral obesity 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/.
Note on Forward-Looking Statements
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 rusfertide, the timing of icotrokinra
and rusfertide clinical trials, and timing of developments and announcements in our discovery 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
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Statements of Operations
in thousands except share and per share data)
Three Months Ended Twelve Months Ended
December 31, December 31,
2024 2023 2024 2023
License and collaboration revenue $ 170,638 $ 60,000 $ 434,433 $ 60,000
Operating expense:
Research and development (1) 34,904 28,899 138,128 120,161
General and administrative (1) 8,954 8,052 43,462 33,491
Total operating expense 43,858 36,951 181,590 153,652
Income (loss) from operations 126,780 23,049 252,843 (93,652 )
Interest income 6,853 4,242 26,315 14,898
Other income (expense), net 31 44 250 (201 )
Income (loss) before income tax expense 133,664 27,335 279,408 (78,955 )
Income tax expense 1,990 - 4,220 -
Net income (loss) $ 131,674 $ 27,335 $ 275,188 $ (78,955 )
Net income (loss) per share, basic $ 2.11 $ 0.45 $ 4.47 $ (1.39 )
Net income (loss) per share, diluted $ 1.98 $ 0.44 $ 4.23 $ (1.39 )
Weighted-average shares used to compute net income (loss) per share, basic 62,328,468 60,387,606 61,566,989 56,763,559
Weighted-average shares used to compute net income (loss) per share, diluted 66,406,817 61,796,205 65,077,722 56,763,559
includes non-cash stock-based compensation expense.
Three Months Ended Twelve Months Ended
December 31, December 31,
2024 2023 2024 2023
Research and development $ 5,322 $ 3,890 $ 20,919 $ 17,061
General and administrative 3,771 2,711 16,635 12,232
Total stock-based compensation expense $ 9,093 $ 6,601 $ 37,554 $ 29,293
Consolidated Balance Sheet Data
December 31, December 31,
2024 2023
Cash, cash equivalents and marketable securities $ 559,165 $ 341,617
Working capital 544,243 334,303
Total assets 744,725 357,951
Deferred revenue 30,567 -
Accumulated deficit (340,522 ) (615,710 )
Total stockholders' equity 675,295 336,677
Last updated: Feb 21, 2025