Protagonist Therapeutics(PTGX) - 2025 Q2 - Quarterly Results

Corporate Update and Q2 2025 Highlights Corporate Update and Q2 2025 Highlights Protagonist Therapeutics reported significant progress in Q2 2025, highlighted by an NDA submission for icotrokinra and a strong cash position of $673.0 million - Submitted a New Drug Application (NDA) to the U.S. FDA for icotrokinra for the treatment of moderate to severe plaque psoriasis in adults and adolescents[1] - The U.S. NDA filing for rusfertide in polycythemia vera (PV) is on track for the fourth quarter of 2025[1][3] - Announced a new oral and injectable triple agonist anti-obesity peptide development candidate in June[2] Cash Position and Runway | Metric | Value | | :--- | :--- | | Cash, cash equivalents and marketable securities (as of June 30, 2025) | $673.0 million | | Anticipated cash runway | Through at least end of 2028 | Pipeline Developments Rusfertide (Hepcidin Mimetic for PV) Positive Phase 3 VERIFY trial data for rusfertide was presented at ASCO, with a U.S. NDA filing on track for the fourth quarter of 2025 by partner Takeda - The complete data from the positive Phase 3 VERIFY trial was presented during the plenary session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting[3] - The U.S. NDA filing for rusfertide for the treatment of patients with PV is expected in Q4 2025, to be submitted by partner Takeda Pharmaceuticals[6] Icotrokinra (Oral IL-23 Receptor Antagonist) An NDA for icotrokinra in psoriasis was submitted based on four Phase 3 studies, and positive Phase 2b data in ulcerative colitis will be presented in October - The first icotrokinra NDA was filed in July for treating adults and adolescents with moderate to severe plaque psoriasis (PsO), based on data from four pivotal Phase 3 studies (ICONIC program)[6] - Positive top-line results from the Phase 2b ANTHEM trial in moderately to severely active ulcerative colitis (UC) were announced, with a full data presentation scheduled for UEGW on October 7[1][6] Early-Stage Development Pipeline (PN-881 & PN-477) The company advanced its early-stage pipeline by selecting PN-477 for obesity and presenting positive preclinical data for the oral IL-17 antagonist PN-881 - Selected PN-477, a GLP-1, GIP, GCG receptor triple agonist peptide, as a development candidate for obesity treatment, with potential for both oral and subcutaneous administration[5][6] - Preclinical data on the oral IL-17 peptide antagonist PN-881 showed it potently and selectively binds IL-17A and -17F, with in vitro potency comparable to bimekizumab[6][11] - PN-881 demonstrated metabolic stability for oral delivery and dose-dependent efficacy in a rat IL-23 induced skin inflammation model[11] Second Quarter 2025 Financial Results Financial Summary The company reported a Q2 2025 net loss of $34.8 million, wider than Q2 2024, and a six-month net loss of $46.4 million compared to a significant net income in H1 2024 Q2 & H1 2025 Financial Performance (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | License and collaboration revenue | $5,546 | $4,167 | $33,867 | $259,120 | | Research and development expense | $37,036 | $33,520 | $72,929 | $67,254 | | General and administrative expense | $10,551 | $9,440 | $22,289 | $24,350 | | Net (Loss) Income | $(34,771) | $(30,616) | $(46,426) | $176,724 | | Diluted (Loss) Earnings Per Share | $(0.55) | $(0.50) | $(0.73) | $2.77 | - The significant decrease in net income for the six-month period year-over-year was primarily due to the recognition of $259.1 million in revenue in H1 2024 related to the upfront payment from the Takeda collaboration[10][13] Revenue Analysis Q2 2025 revenue rose to $5.5 million from development services, while H1 2025 revenue of $33.9 million included a $25 million milestone from Takeda - Q2 2025 revenue of $5.5 million was comprised of development services provided under the Takeda collaboration agreement, an increase from $4.2 million in Q2 2024[9] - Revenue for the six months ended June 30, 2025, was $33.9 million, which included proportional recognition of a $25 million milestone from Takeda earned in Q1 2025[10] Expense Analysis Operating expenses increased in Q2 2025, driven by higher R&D costs for new candidates and increased G&A expenses from stock-based compensation - The increase in R&D expenses was primarily due to costs related to new product candidates, IL-17 oral peptide antagonist PN-881 and obesity triple agonist peptide PN-477[12] - The increase in G&A expense for Q2 2025 was mainly due to higher stock-based compensation and other personnel-related expenses[12] Stock-based Compensation Expense (in thousands) | Category | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,291 | $5,097 | $14,282 | $10,385 | | General and administrative | $4,621 | $3,847 | $10,432 | $7,911 | | Total | $10,912 | $8,944 | $24,714 | $18,296 | Financial Position The company ended Q2 2025 with a robust cash position of $673.0 million and total stockholders' equity of $668.0 million Selected Balance Sheet Data (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $672,958 | $559,165 | | Working capital | $567,019 | $544,243 | | Total assets | $718,006 | $744,725 | | Total stockholders' equity | $668,018 | $675,295 | Corporate Information About Protagonist Therapeutics Protagonist is a late-stage biopharmaceutical company with a proprietary peptide platform and an advanced pipeline including two assets with pending NDAs - A discovery through late-stage development biopharmaceutical company with a proprietary peptide discovery platform[14] - Key assets include icotrokinra (licensed to J&J, NDA submitted) and rusfertide (co-developed with Takeda, NDA expected by end of 2025)[14] - Maintains pre-clinical programs including IL-17 oral peptide antagonist PN-881 and obesity triple agonist peptide PN-477[14] Cautionary Note on Forward-Looking Statements This release contains forward-looking statements subject to risks and uncertainties, and readers are directed to SEC filings for a full discussion of risk factors - The press release contains forward-looking statements regarding the potential benefits and timing of clinical trials and regulatory submissions for icotrokinra and rusfertide[16] - These statements are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated[16] - Investors are advised to review the 'Risk Factors' section in the company's most recent Form 10-K and 10-Q filings with the SEC for more information[16]