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Protagonist Reports Third Quarter 2025 Financial Results and Provides Corporate Update

PTGX
  • Protagonist Therapeutics reported Q3 2025 financial results with cash, cash equivalents, and marketable securities totaling $678.8 million as of September 30, 2025, providing a runway through at least the end of 2028.
  • The company submitted an NDA for icotrokinra to the U.S. FDA in July 2025, followed by an EMA application in September 2025 for moderate to severe plaque psoriasis in adults and adolescents.
  • Rusfertide received Breakthrough Therapy Designation from the U.S. FDA for Polycythemia Vera, with four presentations planned at the ASH meeting in December 2025, including 52-week VERIFY Phase 3 study results.
  • An NDA filing for rusfertide by partner Takeda Pharmaceuticals is expected in Q4 2025.
  • The first patient was dosed in the Phase 1 trial for PN-881, a first-in-class oral IL-17 peptide antagonist.
  • IND-enabling studies are progressing for triple-GLP/GIP/GCG agonists PN-477sc (clinical initiation anticipated mid-2026) and PN-477o (clinical initiation anticipated late 2026).
  • An oral hepcidin development candidate is expected to be nominated by the end of 2025.
  • License and collaboration revenue was $4.7 million for the three months ended September 30, 2025, and $38.6 million for the nine months ended September 30, 2025.
  • Research and development expenses increased to $40.0 million for the quarter and $112.9 million for the nine months ended September 30, 2025, compared to prior year periods.
  • The company reported a net loss of $39.3 million ($0.62 per share) for the quarter and $85.8 million ($1.35 per share) for the nine months ended September 30, 2025.
  • Johnson & Johnson expanded the ICONIC program for icotrokinra to include psoriatic arthritis, ulcerative colitis, and Crohn's disease indications.
  • New clinical data for icotrokinra in ulcerative colitis showed 31.7% clinical remission and 38.1% endoscopic improvement at Week 28 of the ANTHEM-UC study.
  • Long-term 52-week data for icotrokinra in psoriasis demonstrated high rates of clearance in high-impact body areas at the Fall Clinical Dermatology Conference.