Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update.

"In 2025, Protagonist reached new heights with multiple successful Phase 3 outcomes and two NDA filings of our partnered assets, ICOTYDE and rusfertide," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "We see the next 12 to 24 months as a period of significant growth and value creation for Protagonist, driven by a combination of the anticipated regulatory and commercial milestones and royalties from ICOTYDE and rusfertide and the continued advancement of our robust R&D pipeline comprised of the oral IL-17 peptide antagonist, our obesity dual and triple agonists, and our oral hepcidin functional mimetic. We are well equipped to fund all our internal wholly owned programs to clinical proof-of-concept with the cash on hand and potential revenue from the partnered assets."

Fourth Quarter 2025 Recent Developments and Upcoming Milestones

Rusfertide

Under the terms of its License and Collaboration Agreement with Takeda Pharmaceuticals USA, Inc., Protagonist has the right to opt out of the 50:50 profit and loss sharing arrangement in the U.S. during the 90-day period beginning 120 days after filing of a New Drug Application with the FDA for Rusfertide for polycythemia vera. We currently expect to exercise that right in the second quarter of 2026.

ICOTYDETM (Icotrokinra)

A U.S. regulatory decision is anticipated in 2026, followed by commercial launch this year, if FDA approval is granted.

Primary endpoint enrollment completion is expected in 2026 for:

The Phase 3 ICONIC-ASCEND multicenter, randomized, double-blind, placebo-controlled, and ustekinumab active comparator-controlled study to evaluate the efficacy and safety of icotrokinra for the treatment of participants with moderate to severe plaque psoriasis (NCT06934226).

The Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of icotrokinra for the treatment of biologic-naïve participants with active psoriatic arthritis (NCT06878404).

Clinical Programs

The Company expects its Phase 1 study of PN-881 to be complete by mid-2026, informing subsequent clinical development plans.

Discovery Programs

Recently, Protagonist announced two new wholly owned development candidates:

PN-458, a novel dual GLP-GIP agonist for obesity, and

PN-8047, an oral hepcidin functional mimetic complementing rusfertide, an injectable hepcidin mimetic.

Additionally, the Company added IL-4Rα and amylin as high-priority discovery programs to further expand and strengthen its pipeline.

Fourth Quarter and Full Year 2025 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of December 31, 2025, were $646.0 million as compared to $559.2 million in the previous year.

Revenue: License and collaboration revenue is derived from the Company's License and Collaboration Agreement with JNJ, (the "JNJ Agreement"), and its License and Collaboration Agreement with Takeda (the "Takeda Agreement").

License and collaboration revenue decreased by $163.2 million from $170.6 million for the fourth quarter of 2024 to $7.4 million for the fourth quarter of 2025. License and collaboration revenue decreased by $388.4 million from $434.4 million for the full year 2024 to $46.0 million for the full year 2025. The decrease in revenue was primarily attributable to lower milestone and collaboration revenue, which is highly variable and dependent upon factors such as the timing of when regulatory and sales milestones are achieved, if at all, and the accounting for any upfront payments associated with any existing or new agreements.

License and collaboration revenue of $7.4 million for the fourth quarter of 2025 was comprised of development services we provided during the period under the Takeda Agreement. License and collaboration revenue of $170.6 million for the fourth quarter of 2024 included (i) achievement of a non-refundable $165.0 milestone under the JNJ Agreement, and (ii) development services we provided during the period under the Takeda Agreement.

License and collaboration revenue of $46.0 million for the full year 2025 was comprised of (i) proportional recognition of a $25.0 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period under the Takeda agreement. License and collaboration revenue of $434.4 million for the full year 2024 included (i) $254.1 million of the $300.0 million initial transaction price for the Takeda Agreement allocated to the rusfertide license upon effectiveness of the agreement, (ii) achievement of a non-refundable $165.0 milestone under the JNJ Agreement earned in Q4 24, and (iii) development services we provided during the period under the Takeda Agreement.

Research and Development Expenses: Increased by $11.5 million and $21.2 million for the fourth quarter and full year 2025, respectively, from the prior year periods. The increases were due primarily to increases in drug discovery and pre-clinical research expenses, including expenses related to our IL-17 product candidate PN-881 and our obesity product candidates.

General and Administrative Expenses: Increased by $2.5 million for the three months ended December 31, 2025, from the prior year period primarily due to increases in professional services and personnel-related expenses. The increase of $1.4 million for the full year 2025 as compared to the prior year was primarily due to increases in professional services and personnel-related expenses, partially offset by $4.6 million in one-time advisory and legal fees in 2024 related to the Takeda Agreement.

Net (Loss) Income: Net loss was $44.4 million, or $0.69 per basic share and diluted share, for the fourth quarter of 2025 as compared to net income of $131.7 million, or $2.11 per basic share and $1.98 per diluted share, for the fourth quarter of 2024. Net loss was $130.1 million, or $2.05 per basic share and diluted share, for the full year 2025, as compared to net income of $275.2 million, or $4.47 per basic share and $4.23 per diluted share, for the full year 2024.

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