On November 5, 2026 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.
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"The third quarter was a defining period for Protagonist, with FDA approval of MIMRYLO, our second approval this year for a first-in-class peptide drug, and the continued strong commercial launch of ICOTYDE under our collaboration with Johnson & Johnson," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "MIMRYLO reflects years of disciplined scientific dedication and clinical execution, and together with ICOTYDE, provides immensely important validation both of our innovative expertise in peptide therapeutics and of the successful pharma-biotech partnership model we have built around these two approved drugs. The partnerships are fueling an accelerating revenue engine, which provides the flexibility to fund the next generation of wholly owned programs emerging from our platform, and to return meaningful capital to shareholders through a share repurchase program."
Third Quarter 2026 Recent Developments and Upcoming Milestones
MIMRYLO (rusfertide): Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera
· On August 28, Protagonist announced that its partner Takeda received U.S. Food and Drug Administration (FDA) approval of MIMRYLO for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is the first and only hepcidin mimetic peptide therapy approved for this indication. On September 30, 2026, MIMRYLO was also approved in the United Arab Emirates. Protagonist discovered MIMRYLO and had primary responsibility for its clinical development through its New Drug Application ("NDA") filing in December 2025.
· The FDA approval of MIMRYLO triggered $275 million in payments to Protagonist, consisting of a $200 million opt-out payment and a $75 million approval milestone.
· Following Protagonist’s April 2026 opt-out election, Takeda holds exclusive worldwide development and commercialization rights to MIMRYLO. Protagonist is eligible to receive tiered royalties ranging from 14% to 29% on worldwide net sales, corresponding to an approximately 21% weighted-average royalty rate at $1.5 billion in annual net sales. Protagonist is eligible for up to an additional $875 million in potential future milestone payments.
· On October 13, 2026, results from the pivotal Phase 3 VERIFY study were published in the Journal of Clinical Oncology. The article is available here.
ICOTYDE (Icotrokinra): Oral IL-23 Receptor Antagonist
· During the third quarter, ICOTYDE received regulatory approvals in China, Japan and the European Union for the treatment of psoriasis, following U.S. FDA approval in March 2026. ICOTYDE is the first and only targeted oral peptide designed to precisely block the IL-23 receptor.
· On October 14, 2026, results from the Phase 2 ANTHEM-UC study were published in the New England Journal of Medicine. The article is available here.
· The third quarter of 2026 represents ICOTYDE’s second full quarter of U.S. commercial sales. Under the collaboration with Johnson & Johnson, Protagonist receives tiered royalties ranging from 6% to 10% on global net sales, with an approximate 7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier applying to incremental annual sales above $4 billion. Protagonist is eligible for up to an additional $580 million in potential future milestone payments.
· In September and October 2026, Johnson & Johnson presented two-year Phase 3 results from the ICONIC-TOTAL and ICONIC-LEAD studies. The results demonstrated sustained responses through Week 112 and a continued favorable safety profile in adults and adolescents with plaque psoriasis, including patients with disease affecting high-impact and difficult-to-treat areas.
· ICOTYDE is also in development for additional immune-mediated diseases, including psoriatic arthritis, ulcerative colitis and Crohn’s disease.Wholly-Owned Clinical and Discovery Programs
· PN-881 (oral IL-17 antagonist peptide for immune-mediated disease): The Phase 1 study of PN-881 has been completed. PN-881 achieved 24-hour trough concentrations several-fold above prospectively targeted IC90 values for IL-17AA, IL-17FF and IL-17AA+FF with once-daily oral dosing and was generally well tolerated, with no serious adverse events. Protagonist plans to initiate a comprehensive Phase 2b dose range-finding study in patients with plaque psoriasis in early Q1 2027. Phase 1 data are expected to be presented at a future medical meeting.
· PN-477 (triple GLP-1/GIP/GCG agonist peptide for obesity): In the subcutaneously administered PN-477sc Phase 1 SAD study we observed positive dose-related pharmacokinetic, pharmacodynamic and clinical activity. Based on these highly encouraging findings, the Company has made a strategic decision to prioritize the orally administered PN-477o clinical development program. Initiation of a Phase 1 study of oral PN-477o is anticipated in the first half of 2027.
· PN-458o (dual GLP-1/GIP agonist peptide for obesity): IND-enabling studies are ongoing, with Phase 1 initiation anticipated in the second half of 2027.
· PN-8047 (oral small molecule hepcidin functional mimetic for PV): IND-enabling studies are ongoing, with Phase 1 initiation anticipated in Q1 2027.
· Discovery: The Company continues to advance high-priority discovery programs for oral peptides, including an oral IL-4Rα antagonist and amylin-based mono- and poly-agonists.
Share Repurchase Program
· On September 8, Protagonist announced that its Board of Directors authorized a share repurchase program under which the Company may repurchase up to $300 million of its outstanding common stock. The Company intends to fund repurchases from its cash, cash equivalents and marketable securities, as well as royalties and other payments received under its collaboration arrangements with Takeda related to MIMRYLO and Johnson & Johnson related to ICOTYDE. The timing and amount of any repurchases will depend on market conditions, alternative capital deployment opportunities and other factors.
Third Quarter 2026 Financial Results
· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2026, were $834.6 million as compared to $646.0 million as of December 31, 2025.Three Months Ended Nine Months Ended
September 30, September 30,
(in thousands, except per share amounts) 2026 2025 2026 2025
License and collaboration revenue $ 274,410 $ 4,712 $ 544,253 $ 38,579
Research and development expense $ 41,274 $ 40,003 $ 130,074 $ 112,932
General and administrative expense $ 13,704 $ 11,130 $ 39,629 $ 33,419
Income tax expense $ 6,556 $ – $ 7,319 $ 172
Net income (loss) $ 220,015 $ (39,339 ) $ 386,647 $ (85,765 )
Basic earnings (loss) per share $ 3.32 $ (0.62 ) $ 5.88 $ (1.35 )
Diluted earnings (loss) per share $ 3.07 $ (0.62 ) $ 5.43 $ (1.35 )
· License and Collaboration Revenue: License and collaboration revenue was $274.4 million for the third quarter of 2026. This revenue was primarily driven by the proportional recognition of $266.6 million related to the $275.0 million earned from Takeda during the quarter. These payments, which were received in cash in October 2026, consisted of a further $200.0 million opt-out fee and a separate $75.0 million milestone triggered by the FDA approval of MIMRYLO. The remaining $7.8 million was derived from ongoing development services provided by us under the Takeda Collaboration Agreement, and other revenues.
· License and collaboration revenue was $544.3 million for the nine months ended September 30, 2026. This cumulative revenue consisted primarily of $460.5 million related to total proportional revenue recognized from Takeda during those nine months. Additionally, the nine-month revenue includes $33.8 million derived from ongoing development services provided by us under the Takeda Collaboration Agreement, a $50.0 million milestone earned from Johnson & Johnson in Q1 2026 upon FDA approval of ICOTYDE, and other revenues.
License and collaboration revenue of $4.7 million for the third quarter of 2025 was comprised of development services we provided under the Takeda collaboration agreement. License and collaboration revenue of $38.6 million for the nine months ended September 30, 2025, was comprised of (i) proportional recognition of a $25 million milestone earned from Takeda in Q1 2025, and (ii) development services we provided during the period.
· Research and Development ("R&D") Expense: The increases in R&D expense from the prior year periods were primarily due to our clinical development and pre-clinical discovery programs, partially offset by decreases in rusfertide expenses related to the Phase 3 VERIFY clinical trial. We expect our R&D expenses to increase for the remainder of the year as compared to the prior quarters in 2026. The increase is expected to be driven primarily by the advancement of PN-881 into a comprehensive Phase 2 psoriasis program, planned investments in clinical manufacturing and CMC activities, including at-risk expenditures to ensure readiness for other programs as they advance into clinical development (PN-477o, PN-458, PN-8047), additional pre-clinical discovery programs, as well as an increase in headcount and stock-based compensation expense.
· General and Administrative ("G&A") Expense: The increases in G&A expense from the prior year periods were primarily due to increases in stock-based compensation and other personnel-related expenses.
· Net Income (Loss): Net income was $220.0 million, or $3.32 per basic share and $3.07 per diluted share, for the third quarter of 2026 as compared to net loss of $39.3 million, or $0.62 per basic and diluted share, for the third quarter of 2025. Net income was $386.6 million, or $5.88 per basic share and $5.43 per diluted share, for the nine months ended September 30, 2026, as compared to net loss of $85.8 million, or $1.35 per basic and diluted share, for the nine months ended September 30, 2025.
(Press release, Protagonist, NOV 5, 2026, View Source [SID1234674321])