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CORRECTION: Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

PTGX
  • Protagonist Therapeutics submitted an NDA for rusfertide to the FDA with potential approval & launch in 2026.
  • The company expects to exercise its right to opt-out of the 50:50 profit & loss sharing arrangement with Takeda for rusfertide in a 90-day window opening in Q2 2026.
  • A U.S. regulatory decision for ICOTYDE (icotrokinra) is anticipated in 2026 with a potential commercial launch if approved.
  • Phase 3 enrollment completion for icotrokinra in psoriasis & psoriatic arthritis studies is expected in 2026.
  • Completion of the PN-881 Phase 1 study is expected by mid-2026.
  • The pre-clinical pipeline expanded with novel wholly-owned candidates: PN-477 (triple GLP-GIP-GCG agonist), PN-458 (dual GLP-GIP agonist), & PN-8047 (oral hepcidin functional mimetic).
  • Additional high-priority discovery programs include IL-4Rα & amylin.
  • Cash, cash equivalents, & marketable securities totaled $646 million as of December 31, 2025, providing a runway through at least end of 2028.
  • License & collaboration revenue decreased to $7.4 million for Q4 2025 & $46.0 million for the full year 2025 due to lower milestone achievements compared to prior periods.
  • Research & development expenses increased by $11.5 million in Q4 2025 & $21.2 million for the full year 2025 primarily due to drug discovery & pre-clinical costs.
  • The company reported a net loss of $44.4 million for Q4 2025 & $130.1 million for the full year 2025.