Full Press Release Details
Second Quarter 2025 Financial Results and Provides Corporate Update
for icotrokinra for the treatment of adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO)
submitted to U.S. FDA in July
Phase 2b trial data of icotrokinra in ulcerative colitis scheduled for an oral presentation at the 33rd United European Gastroenterology
Week (UEGW) on October 7th
3 VERIFY trial data set of rusfertide in polycythemia vera (PV) presented during plenary session at ASCO; U.S. NDA filing on track for
cash equivalents and marketable securities of $673.0 million as of June 30, 2025, anticipated to provide cash runway through at
Calif., August 6, 2025 - Protagonist Therapeutics (Nasdaq: PTGX)
("Protagonist" or "the Company") today reported financial results for the second quarter ended June 30,
2025, and provided a corporate update.
far, 2025 has been a year of breakthrough accomplishments for Protagonist, as we saw rusfertide the topic of the prestigious ASCO Plenary
Session in May, the announcement of an oral and injectable triple agonist anti-obesity peptide development candidate in June, and most
recently the first ever NDA filing of icotrokinra for psoriasis last month," said Dinesh V. Patel, Ph.D., the Company's President
and CEO. "Over the coming months, we look forward to the NDA filing of rusfertide for polycythemia vera, and advancing our wholly
owned early-stage assets PN-881 and PN-477 into clinical and IND-enabling studies respectively."
Quarter 2025 Recent Developments and Upcoming Milestones
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood
Icotrokinra (JNJ-2113): Oral IL-23 Receptor Antagonist
April 10th, data from the adolescent cohort of the Phase 3 ICONIC-LEAD study
in moderate-to-severe plaque psoriasis was presented as a late-breaking abstract at the 2025 World Congress of Pediatric Dermatology
Pipeline: First-in-Class Oral IL-17 Peptide Antagonist (PN-881) & GLP-1, GIP, & GCG Triple
Second Quarter 2025 Financial Results
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| (in thousands, except per share amounts) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| (Unaudited) | ||||||||||||||||
| License and collaboration revenue | $ | 5,546 | $ | 4,167 | $ | 33,867 | $ | 259,120 | ||||||||
| Research and development expense | $ | 37,036 | $ | 33,520 | $ | 72,929 | $ | 67,254 | ||||||||
| General and administrative expense | $ | 10,551 | $ | 9,440 | $ | 22,289 | $ | 24,350 | ||||||||
| Net (loss) income | $ | (34,771 | ) | $ | (30,616 | ) | $ | (46,426 | ) | $ | 176,724 | |||||
| Basic (loss) earnings per share | $ | (0.55 | ) | $ | (0.50 | ) | $ | (0.73 | ) | $ | 2.89 | |||||
| Diluted (loss) earnings per share | $ | (0.55 | ) | $ | (0.50 | ) | $ | (0.73 | ) | $ | 2.77 |
License and collaboration revenue of $5.5 million and $4.2
million for the second quarter of 2025 and 2024, respectively, was comprised of development services we provided under the Takeda collaboration
and collaboration revenue of $33.9 million for the six months ended June 30, 2025 was comprised of (i) proportional recognition
of a $25 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period. License and
collaboration revenue of $259.1 million for the six months ended June 30, 2024 included (i) $254.1 million of the $300.0
million initial transaction price for the Takeda collaboration agreement allocated to the rusfertide license upon effectiveness of the
agreement, and (ii) development services we provided during the period.
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
an NDA submission for rusfertide expected by end of 2025. Icotrokinra (formerly, JNJ-2113), a first-in-class investigational targeted
oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") is licensed to J&J 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 in 2024 under which the Company remains primarily responsible for
development through NDA filing. The Company also has a number of pre-clinical stage drug discovery programs addressing biologically and
commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and the oral hepcidin
information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://www.protagonist-inc.com/.
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 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 press release.
Investor Relations Contact
Media Relations Contact
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PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Amounts in thousands except share and per share
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| License and collaboration revenue | $ | 5,546 | $ | 4,167 | $ | 33,867 | $ | 259,120 | ||||||||
| Operating expense: | ||||||||||||||||
| Research and development (1) | 37,036 | 33,520 | 72,929 | 67,254 | ||||||||||||
| General and administrative (1) | 10,551 | 9,440 | 22,289 | 24,350 | ||||||||||||
| Total operating expense | 47,587 | 42,960 | 95,218 | 91,604 | ||||||||||||
| (Loss) income from operations | (42,041 | ) | (38,793 | ) | (61,351 | ) | 167,516 | |||||||||
| Interest income | 7,406 | 7,404 | 14,979 | 11,780 | ||||||||||||
| Other income, net | 36 | 97 | 118 | 78 | ||||||||||||
| (Loss) income before income tax expense (benefit) | (34,599 | ) | (31,292 | ) | (46,254 | ) | 179,374 | |||||||||
| Income tax expense (benefit) | 172 | (676 | ) | 172 | 2,650 | |||||||||||
| Net (loss) income | $ | (34,771 | ) | $ | (30,616 | ) | $ | (46,426 | ) | $ | 176,724 | |||||
| Net (loss) income per share, basic | $ | (0.55 | ) | $ | (0.50 | ) | $ | (0.73 | ) | $ | 2.89 | |||||
| Net (loss) income per share, diluted | $ | (0.55 | ) | $ | (0.50 | ) | $ | (0.73 | ) | $ | 2.77 | |||||
| Weighted-average shares used to compute net (loss) income per share, basic | 63,510,537 | 61,305,289 | 63,238,682 | 61,080,489 | ||||||||||||
| Weighted-average shares used to compute net (loss) income per share, diluted | 63,510,537 | 61,305,289 | 63,238,682 | 63,909,633 |
includes non-cash stock-based compensation expense.
(Unaudited, in thousands)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development | $ | 6,291 | $ | 5,097 | $ | 14,282 | $ | 10,385 | ||||||||
| General and administrative | 4,621 | 3,847 | 10,432 | 7,911 | ||||||||||||
| Total stock-based compensation expense | $ | 10,912 | $ | 8,944 | $ | 24,714 | $ | 18,296 |
PROTAGONIST THERAPEUTICS, INC.
Selected Condensed Consolidated Balance Sheet
(Unaudited, In thousands)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents and marketable securities | $ | 672,958 | $ | 559,165 | ||||
| Working capital | 567,019 | 544,243 | ||||||
| Total assets | 718,006 | 744,725 | ||||||
| Deferred revenue | 20,063 | 30,567 | ||||||
| Accumulated deficit | (386,948 | ) | (340,522 | ) | ||||
| Total stockholders' equity | 668,018 | 675,295 |