Protagonist Therapeutics (PTGX -0.07%), a clinical-stage biotechnology company developing peptide-based therapies for blood and immune diseases, released second quarter results on August 6, 2025. The most significant news from the release was the company’s continued advancement of its late-stage clinical pipeline, even as GAAP revenue fell short of consensus estimates. GAAP earnings per share showed a narrower loss of $0.55, outperforming the anticipated loss of $0.58. GAAP revenue was $5.5 million, falling well below the estimate of $7.51 million. The period underscored important regulatory and clinical progress, but also reinforced ongoing reliance on milestone-related payments and a lack of recurring revenues.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.55) | $(0.58) | $(0.50) | -10.0% |
| Revenue (GAAP) | $5.5 million | $7.51 million | $4.2 million | 31.0% |
| Research and Development Expense | $37.0 million | $33.5 million | 10.4% | |
| General and Administrative Expense | N/A | $9.4 million | N/A | |
| Cash, Cash Equivalents and Marketable Securities (as of period end) | $673.0 million | $559.2 million† | 20.3% |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Recent Strategic Focus
Protagonist Therapeutics develops peptide-based drugs targeting hematological (blood) and inflammatory diseases. Its main programs focus on polycythemia vera (a rare blood disorder) and plaque psoriasis. The business relies heavily on clinical milestones and strategic partnerships to fund operations as it moves therapies through late-stage development.
The company’s recent focus has been on advancing its lead drug candidates, rusfertide for polycythemia vera and icotrokinra for psoriasis and ulcerative colitis, through late-stage clinical trials and towards regulatory approvals. Partnerships with Takeda Pharmaceuticals and Johnson & Johnson have generated upfront and milestone-related revenues, as reflected in license and collaboration revenue recognized under GAAP. Timely regulatory submissions are key success factors.
Quarterly Highlights and Operational Progress
The quarter featured several major developments in the company’s drug pipeline. For rusfertide, a peptide therapy being developed for polycythemia vera, the company presented positive phase 3 data at the American Society of Clinical Oncology annual meeting in June, confirming that treatment met its primary and secondary efficacy goals. Takeda Pharmaceuticals is expected to file a New Drug Application for this drug later in the year, which could unlock future milestone payments and eventual royalties.
Meanwhile, icotrokinra, an oral peptide targeting the IL-23 receptor for moderate to severe plaque psoriasis, achieved a significant milestone with submission of its first U.S. drug application in July 2025. The submission included data from four phase 3 studies from the ICONIC program, as part of the NDA filing for icotrokinra announced on July 21, 2025. Early data from the ANTHEM study in ulcerative colitis, another form of inflammatory bowel disease, demonstrated positive results, with a full presentation of results scheduled for October 2025.
Preclinical assets also made headway. PN-881, an oral therapy targeting IL-17 for use in autoimmune diseases, showed potent biological activity and favorable drug properties in research presented at a dermatology meeting in May. PN-477, a triple agonist targeting metabolic hormone receptors for obesity, progressed to candidate selection, highlighting the company’s expansion into metabolic disease research.
Financial results for the period reflected the company's transition away from large upfront payments and toward a future dependent on product launches. License and collaboration revenue continues to account for all operating income, with $5.5 million (GAAP)—down from much larger amounts in previous periods following a $25 million Takeda milestone recognized earlier in the year. Rising research and development expenses (GAAP), which increased by 10.5% year over year, were mainly driven by new pre-clinical programs, offset by lower costs for rusfertide as trials conclude. General and administrative expenses also climbed, reflecting increased compensation and supporting activities as the company nears potential commercialization, as reported on a GAAP basis. No dividend changes were reported.
Looking Ahead: Guidance and Investor Considerations
Management did not provide explicit financial guidance for 2025. It noted that the company’s cash, cash equivalents, and marketable securities totaled $673.0 million (GAAP) as of Q2 2025, which are expected to fund operations at least through the end of 2028. Leadership emphasized upcoming catalysts: regulatory filings for rusfertide and ongoing readouts for the broader pipeline.
Looking forward, investors should monitor progress toward key regulatory decisions and milestone events. If approved, the lead drug candidates would generate new royalty and product revenue streams. Continued increases in operating expenses, as new programs move forward, and any future adjustments in cash runway or development timelines should also be watched.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
