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Protagonist Therapeutics (PTGX) investor relations material
Protagonist Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary6 Nov, 2025
Executive summary
Focused on peptide therapeutics for inflammatory, immunomodulatory, and hematology disorders, with lead assets icotrokinra and rusfertide in advanced Phase 3 development and major regulatory filings in 2025; commercialization targeted for 2026.
NDA for icotrokinra (oral IL-23R antagonist) submitted to FDA in July 2025 and MAA to EMA in September 2025 for moderate-to-severe plaque psoriasis; multiple Phase 3 trials ongoing in additional indications.
Rusfertide (injectable hepcidin mimetic) completed Phase 3 VERIFY trial in PV, met all primary and secondary endpoints, and received FDA Breakthrough Therapy designation in August 2025; NDA filing expected by year-end.
Significant pipeline progress with new clinical candidates PN-881 (oral IL-17 antagonist) and PN-477 (triple agonist for obesity) advancing toward clinical studies; first patient dosed in PN-881 Phase 1 trial in October 2025.
Financial highlights
License and collaboration revenue was $4.7M for Q3 2025, flat year-over-year; $38.6M for the nine months ended September 30, 2025, down from $263.8M in the prior year period due to large prior-year upfront payments.
Net loss for Q3 2025 was $39.3M ($(0.62) per share); net loss for the nine months was $85.8M ($(1.35) per share), compared to net income of $143.5M ($(2.34) per share) in 2024.
Research and development expenses increased 11% year-over-year in Q3 2025 to $40.0M, driven by preclinical and discovery programs; general and administrative expenses rose 10% to $11.1M.
Cash, cash equivalents, and marketable securities totaled $678.8M as of September 30, 2025, up from $559.2M at year-end 2024.
Outlook and guidance
Existing cash and investments expected to fund operations for at least the next 12 months and potentially through 2028.
Revenue in 2025 expected to be significantly lower than 2024 due to the absence of large upfront and milestone payments; future revenue dependent on regulatory milestones and commercialization.
NDA filing for rusfertide anticipated by year-end 2025; icotrokinra and rusfertide commercialization targeted for 2026; clinical study initiations for triple agonist programs expected in 2026.
Icotrokinra's expanded I&I indications strategy
Impact of rusfertide 52-week VERIFY data at ASH?
Timeline for PN-477 clinical study initiation
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Next Protagonist Therapeutics earnings date
Q4 202520 Feb, 2026
Next Protagonist Therapeutics earnings date
Q4 202520 Feb, 2026
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Frequently asked questions
Protagonist Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to discovering and developing innovative peptide-based therapeutic drugs aimed at addressing unmet medical needs. The company's focus encompasses a broad range of diseases, with a particular emphasis on rare and prevalent conditions where existing treatments are limited or inadequate. Protagonist Therapeutics' technology platform has produced a pipeline of promising drug candidates, including peptide-based drugs for hematology and blood disorders, as well as inflammatory and immunomodulatory diseases.
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