On August 5, 2026 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the second quarter ended June 30, 2026 and provided a corporate update.
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"The second quarter of 2026 marked a defining growth phase for Protagonist with a successful commercial launch of ICOTYDE through our strategic partner and accelerating momentum across our internal R&D pipeline. ICOTYDE is quickly becoming a paradigm-shifting oral therapy for patients with moderate-to-severe plaque psoriasis, and rusfertide is approaching an FDA decision that could establish it as a first-in-class erythrocytosis targeted medicine for patients with polycythemia vera," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "Equally exciting is the decision to advance our wholly-owned oral IL-17 antagonist PN-881 into a comprehensive Phase 2b psoriasis program, based on the strongly supportive pharmacokinetic results from the Phase 1 study. Behind PN-881, we have a maturing set of diverse assets moving toward clinical studies in obesity, hematology and immunology. These are the results of years of disciplined investment in differentiated science and mark the beginning, not the culmination, of a new phase of value creation as we continue to advance our peptide platform and clinical pipeline."
Second Quarter 2026 Recent Developments and Upcoming Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV)
· As announced on March 2nd, the NDA for rusfertide was accepted by the FDA and granted Priority Review in Q1 2026, with a PDUFA goal date in August 2026.
· Takeda holds exclusive worldwide development and commercialization rights to rusfertide following Protagonist’s opt-out election in April 2026. As previously disclosed, this triggered a $200 million payment to Protagonist, with an additional $200 million opt-out fee and a separate $75 million milestone due upon FDA approval of rusfertide. The opt-out election also increased downstream economics payable to Protagonist, including up to $775 million in sales milestone payments and tiered worldwide royalties ranging from 14% to 29%. At $1.5 billion in annual net sales, the weighted-average royalty rate is approximately 21%, with the 29% tier applying to annual sales above $1.5 billion. Protagonist continues to work closely with Takeda as the FDA completes its review. In addition to Priority Review, rusfertide has received Breakthrough Therapy designation, Orphan Drug designation, and Fast Track designation from the FDA for polycythemia vera.
· On June 1, Protagonist announced four presentations of Phase 3 VERIFY and long-term rusfertide data at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, including patient-reported outcome data from VERIFY and long-term efficacy and safety data from the REVIVE and THRIVE studies.
ICOTYDE (Icotrokinra): Oral IL-23 Receptor Antagonist
· On March 18, Protagonist announced that Johnson & Johnson received U.S. FDA approval of ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The approval triggered a $50 million milestone payment to Protagonist in the first quarter of 2026. The second quarter of 2026 represents ICOTYDE’s first full quarter of commercial sales.
· Under the collaboration with Johnson & Johnson, Protagonist remains eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as 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 the incremental annual sales above $4 billion. ICOTYDE is the first and only FDA-approved targeted oral peptide for moderate-to-severe plaque psoriasis.
Wholly-Owned Clinical and Discovery Programs
· PN-881 (oral IL-17 antagonist peptide): Pharmacokinetic data from the Phase 1 study supports the decision to advance PN-881 into a comprehensive Phase 2 psoriasis program, with initiation expected in early Q1 2027.
o PN-881 achieved 24-hour Ctrough levels significantly higher than prospectively targeted IC90 (IL-17AA, IL-17FF, IL-17AA+FF) values with once-daily oral dosing1
· PN-477 (triple GLP1/GIP/GCG agonist peptide for obesity): Phase 1 study with the injectable (sc) PN-477 has begun, and initiation of a Phase 1 study with the oral (o) formulation of PN-477 is anticipated in first half of 2027.
· PN-458o (dual GLP/GIP agonist peptide): IND-enabling studies are ongoing with Phase 1 initiation anticipated in the second half of 2027.
· PN-8047 (oral small molecule hepcidin functional mimetic): IND-enabling studies are ongoing, with Phase 1 initiation anticipated in Q1 2027.
· Discovery: The Company continues to advance high-priority discovery programs including an oral IL-4Rα antagonist and amylin-based mono- and poly-agonists.
Second Quarter 2026 Financial Results
· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2026, were $849.5 million as compared to $646.0 million as of December 31, 2025.
Three Months Ended Six Months Ended
June 30, June 30,
(in thousands, except per share amounts) 2026 2025 2026 2025
License and collaboration revenue $ 213,475 $ 5,546 $ 269,843 $ 33,867
Research and development expense $ 42,061 $ 37,036 $ 88,800 $ 72,929
General and administrative expense $ 12,648 $ 10,551 $ 25,925 $ 22,289
Income tax expense $ 2,265 $ 172 $ 763 $ 172
Net income (loss) $ 162,849 $ (34,771 ) $ 166,632 $ (46,426 )
Basic earnings (loss) per share $ 2.47 $ (0.55 ) $ 2.54 $ (0.73 )
Diluted earnings (loss) per share $ 2.29 $ (0.55 ) $ 2.35 $ (0.73 )
License and Collaboration Revenue: License and collaboration revenue of $213.5 million for second quarter of 2026 consisted primarily of (i) $192.4 million related to proportional recognition of the initial $200.0 million opt-out payment received from Takeda and (ii) $21.1 million for ongoing development services, including post opt-out wind down services, and rusfertide clinical supplies provided by us under the Takeda Collaboration Agreement and other revenues.
License and collaboration revenue of $269.8 million for six months ended June 30, 2026 consisted primarily of (i) $192.4 million related to proportional recognition of the initial $200.0 million opt-out payment received from Takeda, (ii) $27.4 million for ongoing development services, including post opt-out wind down services, and rusfertide clinical supplies provided by us under the Takeda Collaboration Agreement and other revenues, and (iii) a $50.0 million milestone earned from JNJ in Q1 2026 upon FDA approval of ICOTYDE.
License and collaboration revenue of $5.5 million for second quarter of 2025 consisted of (i) $5.0 million related to the initial transaction price of the Takeda collaboration agreement for development services provided by us, and (ii) $0.5 million related to the proportional recognition of the $25 million milestone earned in Q1 2025 but receivable following completion of the VERIFY clinical study report. License and collaboration revenue of $33.9 million for the six months ended June 30, 2025 consisted of: (i) $23.4 million related to proportional recognition of the $25 million milestone earned in Q1 2025 but payable following completion of the VERIFY clinical study report, and (ii) $10.5 million allocated to development services provided by us under the agreement 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 research and development expenses to increase significantly in the second half of 2026 compared to the first half of 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-477sc, 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 $162.8 million, or $2.47 per basic share and $2.29 per diluted share, for the second quarter of 2026 as compared to net loss of $34.8 million, or $0.55 per basic and diluted share, for the second quarter of 2025. Net income was $166.6 million, or $2.54 per basic share and $2.35 per diluted share, for the six months ended June 30, 2026 as compared to net loss of $46.4 million, or $0.73 per basic and diluted share, for the six months ended June 30, 2025.
(Press release, Protagonist, AUG 5, 2026, View Source [SID1234669728])