Full Press Release Details
Protagonist Reports First
Quarter 2025 Financial Results and Provides Corporate Update
Positive top line results
from rusfertide Phase 3 VERIFY trial in polycythemia vera (PV) announced; full data selected for oral presentation during plenary session
be held June 2nd at 8AM EDT to discuss rusfertide data presented at ASCO
dataset from Phase 3 ICONIC-LEAD trial with icotrokinra in patients with moderate-to-severe plaque psoriasis (PsO) presented at the 2025
AAD Meeting in March; data from adolescent subset presented at World Congress of Pediatric Dermatology in April
top line results from icotrokinra Phase 2b ANTHEM trial in moderately to severely active ulcerative colitis (UC) announced in March, data
to be presented at medical conference later in 2025
Cash, cash equivalents
and marketable securities of $697.9 million as of March 31, 2025, anticipated to provide cash runway through at least end of 2028
Calif., May 6, 2025 - Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the
Company") today reported financial results for the first quarter ended March 31, 2025,
and provided a corporate update.
"Protagonist is off to a very strong
2025 with multiple transformational events in the first quarter for our two late-stage partnered assets, rusfertide and icotrokinra which
are progressing to NDA filings by year end," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "We look
forward to presenting data from rusfertide's Phase 3 VERIFY study at a plenary session at ASCO on June 1st. We're
very pleased with the highly positive results from the icotrokinra Phase 2b ANTHEM study in ulcerative colitis which lay the foundation
for additional studies in both UC and Crohn's. We are continuing to increasingly focus on advancement of our pre-clinical candidates
including the oral IL-17 antagonist PN-881, as well as additional candidates emerging from our oral anti-obesity and oral hepcidin programs.
We are fortunate to be in a very strong cash position, allowing us to independently and rapidly progress our early-stage pipeline into
value-creating clinical safety and proof-of-concept studies starting with PN-881 in 2025."
Quarter 2025 Recent Developments and Upcoming Milestones
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood
Abstract accepted for presentation
at the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO).
International Investors:1-412-317-6026
webcast link for the event can be found here: https://viavid.webcasts.com/starthere.jsp?ei=1718556&tp_key=360d3b714d
A replay of the presentation
will be available on the Company's Investor Relations Events and Presentations webpage following the event.
| o | Study met primary endpoint with a significantly higher proportion of clinical responders 1 on rusfertide compared to placebo during weeks 20-32 (p<0.0001) | |
| o | Study met all four key secondary endpoints (weeks 0-32) |
1 A responder is a patient who completed weeks 0-32 of
the study, was not phlebotomy eligible and did not receive a phlebotomy during weeks 20-32. To meet phlebotomy eligibility, patients
in the study were required to have: confirmed hematocrit 45% that was 3% higher than their baseline hematocrit value, or hematocrit
Icotrokinra (JNJ-2113): Oral IL-23 Receptor Antagonist
First Quarter 2025 Financial Results
| Three Months Ended | ||||||||
| March 31, | ||||||||
| (in thousands, except per share amounts) | 2025 | 2024 | ||||||
| (Unaudited) | ||||||||
| License and collaboration revenue | $ | 28,321 | $ | 254,953 | ||||
| Research and development expense | $ | 35,893 | $ | 33,734 | ||||
| General and administrative expense | $ | 11,738 | $ | 14,910 | ||||
| Income tax expense | $ | -- | $ | 3,326 | ||||
| Net (loss) income | $ | (11,655 | ) | $ | 207,340 | |||
| Basic (loss) earnings per share | $ | (0.19 | ) | $ | 3.41 | |||
| Diluted (loss) earnings per share | $ | (0.19 | ) | $ | 3.26 |
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 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 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 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/.
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
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 | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| License and collaboration revenue | $ | 28,321 | $ | 254,953 | ||||
| Operating expense: | ||||||||
| Research and development (1) | 35,893 | 33,734 | ||||||
| General and administrative (1) | 11,738 | 14,910 | ||||||
| Total operating expense | 47,631 | 48,644 | ||||||
| (Loss) income from operations | (19,310 | ) | 206,309 | |||||
| Interest income | 7,573 | 4,376 | ||||||
| Other income (expense), net | 82 | (19 | ) | |||||
| (Loss) income before income tax expense | (11,655 | ) | 210,666 | |||||
| Income tax expense | - | 3,326 | ||||||
| Net (loss) income | $ | (11,655 | ) | $ | 207,340 | |||
| Net (loss) income per share, basic | $ | (0.19 | ) | $ | 3.41 | |||
| Net (loss) income per share, diluted | $ | (0.19 | ) | $ | 3.26 | |||
| Weighted-average shares used to compute net (loss) income per share, basic | 62,963,806 | 60,855,689 | ||||||
| Weighted-average shares used to compute net (loss) income per share, diluted | 62,963,806 | 63,595,328 |
includes non-cash stock-based compensation expense.
(Unaudited, in thousands)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Research and development | $ | 7,991 | $ | 5,288 | ||||
| General and administrative | 5,811 | 4,064 | ||||||
| Total stock-based compensation expense | $ | 13,802 | $ | 9,352 |
PROTAGONIST THERAPEUTICS, INC.
Selected Condensed Consolidated Balance Sheet
(Unaudited, In thousands)
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents and marketable securities | $ | 697,877 | $ | 559,165 | ||||
| Working capital | 570,748 | 544,243 | ||||||
| Total assets | 742,132 | 744,725 | ||||||
| Deferred revenue | 25,071 | 30,567 | ||||||
| Accumulated deficit | (352,177 | ) | (340,522 | ) | ||||
| Total stockholders' equity | 689,052 | 675,295 |