(This release updates the release that posted earlier on February 25, 2026 to update the sub headlines.) NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this year PN-881 Phase 1 completion expecte ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-37852 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol Name of each exchange on whi ...

Financial Performance - License and collaboration revenue decreased by $163.2 million from $170.6 million in Q4 2024 to $7.4 million in Q4 2025, and decreased by $388.4 million from $434.4 million in 2024 to $46 million in 2025[12] - The net loss for Q4 2025 was $44.4 million, or $0.69 per share, compared to a net income of $131.7 million, or $2.11 per share, in Q4 2024[14] - Protagonist's total operating expenses for 2025 were $204.1 million, compared to $181.6 million in 2024[20] - Total stockholders' equity decreased to $614,707,000 in 2025 from $675,295,000 in 2024, a decline of approximately 9%[24] - The accumulated deficit increased to $(470,671,000) in 2025 from $(340,522,000) in 2024, indicating a worsening financial position[24] Cash and Assets - Protagonist reported cash, cash equivalents, and marketable securities of $646 million as of December 31, 2025, up from $559.2 million in the previous year[2] - Cash, cash equivalents, and marketable securities as of December 31, 2025, were $646,002,000, up from $559,165,000 in 2024, indicating a 16% increase[24] - Total assets decreased to $668,188,000 in 2025 from $744,725,000 in 2024, a decline of approximately 10%[24] - Deferred revenue significantly decreased to $9,550,000 in 2025 from $30,567,000 in 2024, a reduction of about 69%[24] Research and Development - Research and development expenses increased by $11.5 million in Q4 2025 compared to the prior year, primarily due to drug discovery and pre-clinical research expenses[11] - Research and development expenses for Q4 2025 were $6,121,000, up from $5,322,000 in Q4 2024, representing a 15% increase[22] - The Phase 1 study of PN-881 is expected to be completed by mid-2026, informing future clinical development plans[6] - Protagonist's pipeline includes new candidates PN-477, PN-458, and PN-8047, expanding its focus on obesity and hepcidin mimetics[2] Future Outlook - Protagonist expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda in Q2 2026[1] - The company anticipates a U.S. regulatory decision for ICOTYDE™ in 2026, with a potential launch this year if approved[1] - The company projects a cash runway through at least the end of 2028 based on current cash reserves[2] Expenses - General and administrative expenses for Q4 2025 were $4,580,000, compared to $3,771,000 in Q4 2024, reflecting a 21% increase[22] - Total stock-based compensation expense for Q4 2025 was $10,701,000, an increase of 18% from $9,093,000 in Q4 2024[22]

NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this year PN-881 Phase 1 completion expected by mid- 2026 NEWARK, CALIFORNIA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasda ...

Core Insights - Protagonist Therapeutics, a clinical-stage biotech company, reported significant insider selling by director William D. Waddill, who sold 20,000 shares for approximately $1.7 million, despite the company's strong stock performance [1][2]. Company Overview - Protagonist Therapeutics focuses on peptide therapeutics to address unmet medical needs in hematology and immunology, particularly for patients with rare blood disorders and inflammatory diseases [5]. - As of February 14, 2026, the company's stock price was $81.49, with a market capitalization of $5.09 billion, revenue of $209.22 million, and net income of $45.91 million [4]. Transaction Details - The sale of 20,000 shares is five times larger than Waddill's recent median sell transaction of 4,000 shares, indicating a significant move [7]. - The transaction occurred when the stock was priced at $83.68, reflecting a 123.8% increase over the previous twelve months [7][8]. Market Context - Protagonist highlighted its projected growth at the J.P. Morgan Healthcare Conference, with two key pharmaceutical products in advanced clinical development, supported by major firms like Johnson & Johnson [8]. - Despite the insider selling, Wall Street analysts predominantly rate Protagonist's stock as a "strong buy," with a high price-to-earnings ratio of 113.15, suggesting strong growth expectations [6].

Company Overview - Protagonist Therapeutics is a clinical-stage biotechnology company focused on addressing unmet medical needs in hematology and immunology, particularly for patients with rare blood disorders and inflammatory diseases [5] - The company has a market capitalization of $5.11 billion, with a revenue of $209.22 million and a net income of $45.91 million for the trailing twelve months (TTM) [4] - Protagonist's stock experienced a significant price change of 120.48% over the past year, calculated using January 31, 2026, as the reference date [4] Recent Transaction - Arturo Molina, Chief Medical Officer of Protagonist Therapeutics, sold 9,514 shares on January 20, 2026, for approximately $784,700, marking the largest direct open-market sale by him to date [1][6] - Post-transaction, Molina retains 97,266 shares valued at approximately $8.11 million [2] Market Sentiment - The majority of Wall Street analysts rate Protagonist Therapeutics' stock as a "strong buy," indicating positive sentiment towards the company's growth potential [6] - The company is projected to experience significant growth within the next 12-24 months, supported by partnerships with large firms like Johnson & Johnson [7][8] - Protagonist's stock soared approximately 123% in 2025, reflecting strong institutional investor support [8]

Core Insights - Protagonist Therapeutics is poised for significant growth and value creation over the next 12 to 24 months, driven by two potential blockbuster drug approvals and launches, multiple clinical readouts, new discovery programs, and a strong cash position [3] Company Overview - Protagonist Therapeutics is participating in the 44th JPMorgan Healthcare Conference for the sixth consecutive year, indicating its established presence in the biotech sector [2] - The company is focused on completing a decade-long journey from concept to commercialization with two specific assets: icotrokinra, partnered with Johnson & Johnson, and rusfertide, partnered with Takeda [3] Development Pipeline - The company is highlighting its development candidates that target validated biological pathways, with differentiated assets aimed at addressing specific unmet medical needs across multiple indications [4]

Protagonist Therapeutics FY Conference Summary Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Event**: FY Conference at the 44th J.P. Morgan Healthcare Conference - **Date**: January 13, 2026 Key Points Industry and Market Context - Protagonist is positioned in the biopharmaceutical industry, focusing on innovative therapies for unmet medical needs, particularly in the areas of immunology and rare diseases [2][26] Core Assets and Development Pipeline - **Icotrokinra (Ico)**: - Partnered with Johnson & Johnson (J&J) - Aims to set a new standard of care in psoriasis and other IL-23-mediated indications - First and only oral IL-23 pathway blocker in late-stage development - Potential market opportunity exceeding $80 billion across four indications: psoriasis, psoriatic arthritis, ulcerative colitis (UC), and Crohn's disease [4][5][6] - Anticipated peak sales of over $10 billion [6] - **Rusfertide**: - Partnered with Takeda - A synthetic peptide mimetic of hepcidin, targeting polycythemia vera (PV) - Phase 3 VERIFY study results deemed practice-changing, with potential peak revenue of $1-$2 billion [10][11] - Fast-track status and breakthrough therapy designation expected to expedite approval [12] - **Emerging Assets**: - **PN-881**: An oral IL-17 antagonist, expected to enter Phase I studies [13][15] - **PN-8047**: An oral hepcidin functional mimetic, complementing Rusfertide, with Phase I initiation expected by year-end [16][17] - **PN-477**: A novel oral triple agonist for obesity, with IND-enabling studies ongoing [18][19] - **PN-458**: A new dual GLP-1/GIP agonist for obesity, enhancing the obesity portfolio [20] Financial Position - Protagonist ended Q3 2025 with approximately $679 million in cash, sufficient to fund operations through 2028 [21][22] - Revenue potential from partnered assets: - Icotide: Eligible for $600 million in future milestones and 6%-10% royalty range, averaging around 7.25% [22][23] - Rusfertide: Potential opt-out fee of $400 million, with royalties ranging from 14%-29% based on sales [24][25] Strategic Vision - Protagonist aims to maximize shareholder value while expanding its discovery pipeline, with aspirations to grow its market cap from $5 billion to $10-$20 billion [33] - The company emphasizes the importance of partnerships with pharmaceutical companies for scaling and expertise, particularly in the obesity space [34][46] Upcoming Catalysts - Anticipated commercial launches for Icotide and Rusfertide within the year [26] - Completion of pivotal studies and initiation of Phase II studies for emerging assets [26] Additional Insights - The company is focused on maintaining a balance between funding internal R&D and returning capital to shareholders through potential stock buybacks and dividends [34][35] - Protagonist is committed to expanding its pipeline with a focus on high-priority targets in immunology, including IL-4 [53] Conclusion Protagonist Therapeutics is at a pivotal growth stage, with a robust pipeline of innovative therapies and a strong financial position, poised for significant market impact in the coming years. The strategic partnerships and upcoming product launches are expected to drive value creation and enhance shareholder returns.

Core Viewpoint - Johnson & Johnson's (JNJ) first-in-class drug Icotrokinra has been submitted for market approval in China, targeting moderate to severe plaque psoriasis in adults and children aged 12 and older, marking a significant step in its commercialization process in the country [1][4]. Group 1: Drug Development and Approval - Icotrokinra, an oral peptide drug developed by Johnson & Johnson with an investment of nearly $1 billion from Protagonist, is the first IL-23R antagonist to seek market approval globally [2]. - The drug has already been submitted for approval in the United States and Europe earlier this year, with expectations of peak annual sales exceeding $5 billion [2]. - The Chinese submission has been prioritized for review by the CDE, based on its demonstrated efficacy and safety in multiple international clinical trials [4]. Group 2: Clinical Trial Results - The ICONIC-ADVANCE1 and 2 trials, which are randomized controlled Phase III studies, evaluated the efficacy and safety of Icotrokinra compared to placebo and the first approved TYK-2 inhibitor, deucravacitinib, in moderate to severe plaque psoriasis patients [3]. - Icotrokinra achieved significant primary endpoints at week 16, showing superior skin clearance rates compared to both placebo and deucravacitinib, with a similar incidence of adverse events [3]. - Long-term data from the ICONIC-LEAD study indicated sustained skin clearance and good safety profiles for Icotrokinra at week 52 [4]. Group 3: Future Research and Comparisons - Johnson & Johnson has initiated the Phase III ICONIC-ASCEND study, which aims to demonstrate the superiority of Icotrokinra over the injectable biologic drug ustekinumab in a head-to-head comparison [4].

Core Insights - Protagonist Therapeutics reported a quarterly loss of $0.62 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.59, and compared to a loss of $0.54 per share a year ago, indicating a negative earnings surprise of -5.08% [1] - The company generated revenues of $4.71 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 52.88%, and showing a slight increase from $4.68 million in the same quarter last year [2] - Protagonist Therapeutics shares have increased approximately 101.8% year-to-date, significantly outperforming the S&P 500's gain of 15.6% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.53 on revenues of $10.35 million, and for the current fiscal year, it is -$1.84 on revenues of $50.25 million [7] - The estimate revisions trend for Protagonist Therapeutics was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Protagonist Therapeutics belongs, is currently ranked in the top 41% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Another company in the same industry, ADC Therapeutics SA, is expected to report a quarterly loss of $0.40 per share, with revenues projected at $16.1 million, down 12.8% from the previous year [9][10]