Protagonist Therapeutics, Inc (PTGX)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 results were in line to slightly ahead of consensus: license & collaboration revenue was $4.712M vs S&P Global consensus of ~$4.136M*, and diluted EPS was ($0.62) vs consensus of ($0.64); R&D rose as preclinical programs ramped, widening the loss year over year .
  Estimates source: S&P Global
• Regulatory execution stayed strong: icotrokinra NDA (FDA) was submitted in July and MAA (EMA) in September; rusfertide received FDA Breakthrough Therapy Designation in August with a U.S. NDA filing expected by year-end and 52-week VERIFY data slated for ASH in December .
• Balance sheet remains a differentiator: cash, cash equivalents and marketable securities were $678.8M at 9/30/25, with management reiterating cash runway through at least end of 2028 .
• Investment updates: first subject dosed in Phase 1 PN‑881 (oral IL‑17 antagonist); PN‑477 (oral/subQ GLP‑1/GIP/GCG triple agonist) proceeding through IND‑enabling, with first clinical starts targeted for 2026 .
• Near-term stock catalysts: ASH VERIFY 52‑week rusfertide data (Dec), U.S. NDA filing for rusfertide by YE25, and ongoing reviews for icotrokinra in the U.S./EU .

What Went Well and What Went Wrong

What Went Well

• Multiple regulatory milestones: “NDA and EMA submissions for icotrokinra for psoriasis” and Breakthrough Therapy for rusfertide; management highlighted expanded JNJ development across PsA, UC, and Crohn’s, reinforcing broad opportunity .
  Quote: “2025 continues to be a highly productive year… We… eagerly await… rusfertide 52‑week VERIFY data at ASH… and the NDA filing… by year end.” – CEO Dinesh V. Patel .
• Pipeline advancement: first human dosed in PN‑881 Phase 1; PN‑477 (oral/subQ triple agonist) on track for mid/2H26 clinical starts; oral hepcidin development candidate expected by year end .
• Strong liquidity and runway: $678.8M of cash and securities and a reiterated runway through at least end of 2028 provide strategic flexibility amid increased discovery spend .

What Went Wrong

• Loss widened on higher discovery/preclinical spend: net loss ($39.3M) vs ($33.2M) YOY; R&D +11% YOY to $40.0M driven by PN‑881 and PN‑477 ramp; G&A +10% on professional services .
• Revenue base remains small and collaboration‑driven: Q3 revenue $4.712M (flat YOY) from Takeda development services; 2025 YTD revenue sharply below 2024 due to prior-year recognition of Takeda upfront and JNJ milestone .
• Regulatory/macro risks elevated: 10‑Q flags potential timing impacts from U.S. government shutdowns and FDA staffing/budget uncertainty; tariff policy changes also cited as potential cost/timing headwinds .

Financial Results

Note: Operating margins are computed from reported revenue and loss from operations in the cited filings.

KPIs

Estimates vs Actual (Q3 2025)

Estimates source: S&P Global*. Actuals from company filings .

Guidance Changes

Earnings Call Themes & Trends

Note: The full Q3 2025 earnings call transcript was not available in our corpus. Themes below reflect disclosures from the Q3 press release and 10‑Q.

Management Commentary

• “As icotrokinra and rusfertide move towards potential NDA approval and commercialization in 2026, we shift our attention to the next phase of assets… first subject in the Phase 1 trial of oral IL‑17 antagonist, PN‑881… PN‑477… progressing… and we remain on track to nominate a development candidate from the oral hepcidin program by year end.” – Dinesh V. Patel, President & CEO .
• “We, along with our partner Takeda, eagerly await the presentation of the rusfertide 52‑week VERIFY data at ASH… and the NDA filing for rusfertide by year end.” – Dinesh V. Patel .

Q&A Highlights

• The full Q3 2025 earnings call transcript was not accessible via our document tools; as a result, Q&A specifics (analyst topics, clarifications) cannot be verified here. We reviewed the 8‑K/press release and 10‑Q in full and reflected those disclosures above .

Estimates Context

• Q3 2025 results vs S&P Global consensus: revenue $4.712M vs $4.136M* and EPS ($0.62) vs ($0.64); estimate counts were 11 for revenue and 10 for EPS, indicating a reasonably covered print that landed essentially in line on EPS with a modest top-line beat .
  Estimates source: S&P Global

Where estimates may adjust:

• Increased confidence in 2026 revenue potential as regulatory timelines firm (icotrokinra U.S./EU submissions; rusfertide BTD and NDA timing), offset by higher discovery spend that may temper near-term EPS trajectories until approval/launch milestones are realized .

Key Takeaways for Investors

• Execution remains the core story: dual late‑stage assets progressed to regulatory filings/designations on schedule, with multiple 4Q25 catalysts (ASH data, rusfertide NDA) that can reset probabilities of success and timing assumptions .
• EPS/Revenue prints are less relevant near term given collaboration accounting; focus instead on milestone timing, deferred revenue burn, and regulatory inflection points as drivers of estimate revisions and share price .
• Discovery pipeline is moving from concept to clinic (PN‑881 first‑in‑human; PN‑477 tracking to 2026), justifying elevated R&D; this is a near‑term headwind to P&L but increases medium‑term option value .
• Liquidity is a competitive advantage: $678.8M cash/securities with runway through at least 2028 reduces financing risk through key regulatory and early launch phases .
• Risk watchlist: potential regulatory timing friction from U.S. government shutdown/FDA staffing and evolving tariff policies; monitor disclosures and timelines closely into/through 1H26 .
• Valuation anchor: 2026–2027 milestone/royalty/profit‑share scenarios (JNJ/Takeda) are increasingly real; ASH/NDA events will likely drive changes in sell‑side models (probability‑weighted launches, milestone recognition cadence) .
• Trading setup: positive ASH VERIFY 52‑week durability/safety and on‑time rusfertide NDA could be near‑term positive catalysts; any perceived review delays or weaker‑than‑expected ASH details could weigh on sentiment .

Footnote: All consensus estimate figures marked with an asterisk (*) are values retrieved from S&P Global.