Protagonist Therapeutics, Inc. (PTGX): Business Model Canvas [Dec-2025 Updated]

You're looking at a biotech that's definitely made the pivot from the lab bench to the finish line. As someone who's spent two decades mapping these shifts, I see Protagonist Therapeutics, Inc. (PTGX) right at that crucial inflection point: moving from pure R&D to a late-stage, partnership-driven commercial machine, anchored by rusfertide's impending U.S. NDA filing. They've smartly de-risked the pipeline by locking in giants like Takeda and JNJ for co-commercialization and development, which changes the whole risk/reward profile. It's a classic, high-stakes biotech model shift in action. Dive into the full Business Model Canvas below to see exactly how they plan to capture value from their oral peptide platform.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Key Partnerships

You're looking at the core alliances that fuel Protagonist Therapeutics, Inc.'s (PTGX) late-stage pipeline, which is a critical area for any investor tracking near-term value inflection points. These partnerships de-risk development and commercialization by bringing in established giants. Here's the quick math on what these arrangements look like as of late 2025.

Takeda Pharmaceuticals for rusfertide co-commercialization

The agreement with Takeda Pharmaceuticals for rusfertide, the hepcidin mimetic for polycythemia vera (PV), provides a significant, non-dilutive cash infusion and leverages Takeda's rare hematology commercial expertise. Protagonist Therapeutics remains primarily responsible for development through the U.S. New Drug Application (NDA) filing, which is expected in the fourth quarter of 2025. This structure allows PTGX to focus its resources on hitting that regulatory milestone, a defintely key event for the stock.

The financial structure is concrete:

Protagonist Therapeutics is eligible for additional worldwide development, regulatory, and commercial milestone payments, plus tiered royalties on ex-U.S. net sales. The durability of rusfertide's response was reinforced by 52-week results from the pivotal Phase 3 VERIFY study, which were presented orally at the 67th American Society of Hematology (ASH) Annual Meeting on December 6-9, 2025.

Johnson & Johnson (JNJ) for icotrokinra development and global commercialization

The collaboration with Johnson & Johnson (JNJ), via Janssen Biotech, Inc., covers icotrokinra, the oral IL-23 receptor antagonist. This partnership is structured such that J&J assumed responsibility for development starting in Phase 2 and holds exclusive worldwide commercialization rights. Protagonist Therapeutics was primarily responsible for development through Phase 1. The agreement was amended to increase milestone payments, showing the mutual commitment to the asset.

Key financial and regulatory data points include:

• Peak global sales estimate by Leerink Partners: $9.5 billion
• U.S. NDA submission to the FDA: July 2025
• EMA submission announced: September 11th, 2025
• Protagonist Therapeutics cash position as of September 30, 2025: $678.8 million

Icotrokinra is being developed across several immunology diseases, with Phase 3 trials in plaque psoriasis and ongoing development in ulcerative colitis and Crohn's disease.

Contract Research Organizations (CROs) for managing global Phase 3 clinical trials

Managing global Phase 3 trials for both rusfertide (VERIFY) and icotrokinra (ICONIC series) necessitates extensive use of Contract Research Organizations (CROs). While specific CRO contracts and their associated financial outlays are not public line items, the scale of these global efforts dictates substantial, multi-year service agreements. For icotrokinra, all Phase 3 trials are conducted by J&J, meaning J&J manages the associated CRO spend, though Protagonist Therapeutics bears the development risk/reward per their agreement.

The scope of work managed via these external partners includes:

• Rusfertide Phase 3 VERIFY study completion and 52-week data analysis.
• Icotrokinra Phase 3 ICONIC-TOTAL study in plaque psoriasis.
• Icotrokinra Phase 3 trial in psoriatic arthritis.

Academic and clinical Key Opinion Leaders (KOLs) for trial design and data presentation

The credibility and design rigor of late-stage trials depend heavily on KOL engagement. Protagonist Therapeutics and its partners actively present data at major medical congresses, validating the science to the clinical community.

• VERIFY 52-week data presented at the 67th ASH Annual Meeting (December 6-9, 2025).
• Dr. Andrew T. Kuykendall, M.D., served as the VERIFY Lead Investigator.
• ICONIC-LEAD and ICONIC-TOTAL data presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting.
• Pediatric data for icotrokinra presented at the 2025 World Congress of Pediatric Dermatology (WCPD).

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Key Activities

You're looking at the core engine driving Protagonist Therapeutics, Inc. (PTGX) right now-the day-to-day execution that turns pipeline assets into potential revenue. It's all about hitting those critical regulatory and clinical deadlines, especially with two late-stage partnered assets.

Advancing rusfertide (PV) through U.S. NDA filing by year-end 2025.

This is a major focus, given the asset is co-developed with Takeda Pharmaceuticals. Protagonist Therapeutics remains primarily responsible for development through the New Drug Application (NDA) filing. The company achieved a significant regulatory win when rusfertide was granted FDA Breakthrough Therapy designation in August 2025. The final data package supporting the filing is being solidified by long-term results; the 52-week VERIFY data from the Phase 3 trial is scheduled for presentation at the ASH meeting in December 2025. The U.S. NDA filing itself is targeted for Q4 2025, or by year-end 2025.

Managing global regulatory review for icotrokinra (psoriasis) NDA/MAA submissions.

Icotrokinra, licensed to Johnson & Johnson (JNJ), has seen rapid regulatory movement. The New Drug Application (NDA) to the U.S. FDA was submitted in July 2025. Following that, the European Medicines Agency (EMA) application was submitted in September 2025. The success of these submissions directly impacts Protagonist Therapeutics' milestone revenue potential, such as the $25M on NDA acceptance and $50M upon receipt of any marketing approval.

Discovery and preclinical development of new oral peptide candidates like PN-477.

The company is actively feeding the pipeline, validating its proprietary peptide technology platform. A key recent milestone was the nomination of PN-477, a GLP-1R, GIPR, and GCGR triple agonist, as a development candidate in June 2025, with both oral (PN-477o) and subcutaneous (PN-477sc) versions planned. The key activity here is progressing the IND-enabling studies, with the goal of initiating Phase I clinical studies in the second quarter of 2026. Furthermore, an oral hepcidin candidate nomination is expected by year-end 2025.

Here's a snapshot of the pipeline advancement activities:

• First subject dosed in Phase 1 for oral IL-17 antagonist PN-881.
• PN-477o and PN-477sc progressing through IND-enabling studies.
• Oral hepcidin candidate nomination targeted for year-end 2025.
• JNJ expanding the icotrokinra program into psoriatic arthritis, ulcerative colitis, and Crohn's disease.

Strategic alliance management with Takeda and JNJ to ensure milestone achievement.

Managing these relationships is crucial, as they provide the bulk of the near-term non-dilutive funding. Protagonist Therapeutics' financial health is directly tied to these partners hitting their targets. As of September 30, 2025, the company held $678.8M in cash, which is expected to fund operations through at least the end of 2028. The Q3 2025 license and collaboration revenue was $4.712M, primarily from Takeda development services, though the overall revenue base is highly dependent on milestone recognition.

The structure of these alliances dictates key activity triggers:

You need to track every development service provided under the Takeda agreement, which was $4.712M in Q3 2025.

Manufacturing and supply chain preparation for potential commercial launches in 2026.

With both lead assets targeting potential 2026 approvals and launches, significant operational activity is required to prepare the supply chain. While specific capital expenditure figures for manufacturing scale-up aren't itemized in the latest updates, the overall R&D expense, which rose to $40.0M in Q3 2025, reflects the ramp-up in preclinical work and the necessary groundwork for future commercialization readiness for both rusfertide and icotrokinra.

The financial reality of this activity is reflected in the P&L:

• Q3 2025 Net Loss: $39.3M (up from $33.2M in Q3 2024).
• Q3 2025 R&D Expense: $40.0M (up 11% Year-over-Year).

Finance: draft 13-week cash view by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Key Resources

The Key Resources for Protagonist Therapeutics, Inc. center on its foundational technology, significant financial backing, and critical clinical validation of its lead assets.

Proprietary Peptide 2.0 platform for oral peptide drug discovery.

Protagonist Therapeutics, Inc. possesses a proprietary technology platform focused on discovering and developing peptide-based new chemical entities (NCEs). This platform is engineered to create desired degrees of potency, specificity, solubility, metabolic stability, and manufacturability through specific peptidomimetic and chemical modifications. The technology encompasses multiple tools and methods, including molecular design tools and large virtual libraries of conformationally constrained scaffolds, known as Vectrix™. The platform has been applied to develop agonists and antagonists against diverse targets such as cytokines, cytokine receptors, integrin, transmembrane solute transporters, GPCRs, and ion channels. The ultimate proof of this platform is the internal discovery of lead candidates like rusfertide and icotrokinra. The focus is on creating therapeutics that can offer the significant advantage of oral administration, potentially transforming treatment paradigms often dominated by injectable biologics.

Cash, cash equivalents, and securities of $678.8 million as of Q3 2025.

The balance sheet strength provides a substantial operational runway. As of September 30, 2025, Protagonist Therapeutics, Inc. reported $678.8 million in cash, cash equivalents, and marketable securities. Management has reiterated that this level of liquidity is expected to fund operations through at least the end of 2028. This financial position offers strategic flexibility amid increased discovery spend.

The following table summarizes key financial and clinical resource milestones as of late 2025:

Intellectual property and patents protecting rusfertide and icotrokinra.

The intellectual property portfolio is anchored by the proprietary platform that generated the lead candidates. This IP protects the novel peptide structures and their specific modifications, which confer the desired pharmacological properties for rusfertide and icotrokinra. The success of the platform is evidenced by the advanced clinical development of these two compounds. The company also has a pipeline of preclinical programs, including an oral IL-17 receptor antagonist (PN-881) and an oral obesity program (PN-477sc and PN-477o), which are also protected by the platform's IP estate.

Late-stage clinical data, including positive Phase 3 VERIFY results for rusfertide.

Clinical data represents a tangible asset, especially for late-stage assets. Protagonist Therapeutics, Inc. and Takeda announced positive topline results for the Phase 3 VERIFY study of rusfertide in patients with Polycythemia Vera on March 3, 2025. The study met its primary endpoint and all four key secondary endpoints. Further data durability is a key resource, with 52-week results from the VERIFY study scheduled for presentation at the American Society of Hematology (ASH) meeting in December 2025. For icotrokinra, the New Drug Application (NDA) was submitted to the U.S. FDA in July 2025, and the Marketing Authorisation Application (MAA) was submitted to the EMA in September 2025. The first subject was dosed in the Phase 1 trial for PN-881.

The company's R&D expense for the three months ended September 30, 2025, was $40.0 million, reflecting the investment into these pipeline assets.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Value Propositions

You're looking at the core value Protagonist Therapeutics, Inc. (PTGX) is delivering to its target patient populations and partners as of late 2025. It's all about novel peptides hitting high unmet needs, often with a superior delivery method.

Rusfertide: First-in-class erythrocytosis-specific agent for Polycythemia Vera (PV).

Rusfertide, the subcutaneous injectable hepcidin mimetic, is positioned to potentially become the new standard of care for Polycythemia Vera (PV) because its data show it effectively controls erythrocytosis and substantially reduces the frequency of therapeutic phlebotomy compared to existing treatments. The company is on track to file the New Drug Application (NDA) for rusfertide by the end of 2025. This is critical in a market that was valued at approximately USD 1,900 million in 2024 in the 7MM and is projected to grow to USD 2,087 million in 2025. The strength of the Phase 3 VERIFY trial data, which was presented at the prestigious ASCO plenary session, supported the FDA granting rusfertide Breakthrough Therapy Designation in August 2025.

Icotrokinra: Oral peptide with biologic-like efficacy for moderate-to-severe psoriasis.

Icotrokinra, the first-in-class targeted oral peptide blocking the IL-23 receptor, is showing efficacy comparable to injectables for moderate-to-severe plaque psoriasis. The company submitted the NDA to the U.S. FDA in July 2025, followed by the European Medicines Agency (EMA) application in September 2025. In the Phase 3 ICONIC-LEAD study, the results were compelling: 64.7% of patients achieved an Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) at Week 16, which improved to 74.1% at Week 24. Furthermore, in the ICONIC-TOTAL study, which looked at difficult-to-treat areas, 72% of patients with scalp psoriasis and 85% with genital psoriasis achieved site-specific clear or almost clear skin by Week 52.

You can see the key metrics for these two late-stage assets side-by-side here:

Convenience of oral administration for chronic inflammatory diseases.

A major differentiator for Icotrokinra is its delivery mechanism. It is a first-in-class oral peptide. For chronic inflammatory diseases, offering a once-daily pill is a significant convenience factor over injectable treatments, potentially shifting the treatment paradigm. This oral convenience is a core part of the value proposition being presented to prescribers and patients alike.

Pipeline of novel, targeted peptide therapies for unmet medical needs.

Protagonist Therapeutics, Inc. is backing up its late-stage assets with a deep, wholly-owned pipeline of novel peptides, which gives you confidence in their long-term platform. The company reported cash reserves of $678.8 million as of September 30, 2025, which is anticipated to provide cash runway through at least the end of 2028, supporting these earlier-stage efforts.

The pipeline value propositions include:

• Advancing PN-881, a first-in-class oral IL-17 peptide antagonist, with the first patient dosed in the Phase 1 trial.
• Progressing PN-477, a triple agonist anti-obesity peptide candidate.
• Advancing the oral hepcidin program, with a development candidate expected to be nominated by year-end 2025.

The company is definitely building value beyond its two lead candidates.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Customer Relationships

You're managing relationships with some of the biggest names in pharma and the specialized medical community, which is key to getting your pipeline products to market. The quality of these interactions directly impacts your financial runway and future revenue potential. Here's the breakdown of how Protagonist Therapeutics, Inc. (PTGX) handles its critical external relationships as of late 2025.

High-touch, strategic management of Big Pharma collaboration agreements

The relationship management here is centered on co-development and co-commercialization, which means shared risk and shared reward with major partners. For rusfertide, the hepcidin mimetic for Polycythemia Vera (PV), the agreement with Takeda Pharmaceuticals is structured around significant upfront and milestone payments. Protagonist Therapeutics received a $300 million upfront payment from Takeda for rusfertide. For the nine months ended September 30, 2025, Protagonist Therapeutics recognized $38.6 million in license and collaboration revenue, which included proportional recognition of a $25 million milestone earned from Takeda in Q1 2025. The total potential future milestones available from Takeda for rusfertide stand at $630 million.

With Johnson & Johnson (JNJ) for icotrokinra, the relationship involves JNJ assuming development responsibility from Phase 2 onward, though Protagonist remains primarily responsible for development through NDA filing. This partnership structure is critical, as evidenced by the significant regulatory progress made in 2025.

The financial stability derived from these relationships is substantial; Protagonist Therapeutics reported cash, cash equivalents and marketable securities of $678.8 million as of September 30, 2025, which is anticipated to provide cash runway through at least the end of 2028.

Here are the key financial and structural elements of these major collaborations:

Direct engagement with hematologists and dermatologists through medical affairs

Engagement with specialists is driven by presenting compelling, late-stage clinical data at major medical society meetings. For rusfertide, targeting hematologists for PV, Protagonist Therapeutics had four presentations at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, December 6-9, 2025.

For icotrokinra, targeting dermatologists for plaque psoriasis (PsO), data was presented at the 2025 Society for Investigative Dermatology Annual Meeting in May 2025 and the 2025 World Congress of Pediatric Dermatology (WCPD) in April 2025.

The company also engages Key Opinion Leaders (KOLs) directly; an investor event on February 6, 2025, featured KOL insights from Dr. Andrew Kuykendall (Moffitt Cancer Center) and Dr. Joseph Michael Scandura (Weill Cornell Medicine) on the PV treatment landscape.

Key data points shared with specialists in late 2025 include:

• Rusfertide 52-week durability data presented at ASH December 6, 2025.
• In the rusfertide Phase 3 VERIFY study, 61.9% of continuously treated patients maintained absence of phlebotomy eligibility from baseline to Week 52.
• Icotrokinra achieved clear or almost clear skin (IGA 0/1) in 64.7% of patients at Week 16 in the ICONIC-LEAD study.
• Icotrokinra Phase 2b ANTHEM-UC trial showed 31.7% of patients achieved clinical remission by Week 28 for ulcerative colitis.

Patient advocacy and support programs for rare disease communities like PV

For the rare disease community of Polycythemia Vera (PV), Protagonist Therapeutics focuses on patient access and awareness. The company actively encourages participation in its clinical trials, specifically mentioning the call to 'Join Our Polycythemia Vera VERIFY Clinical Study.'

The clinical data itself speaks directly to patient needs, showing that in the Phase 2 REVIVE study, hematocrit levels were maintained below 45% and fully eliminated the need for phlebotomies. This focus on eliminating phlebotomies is a core element of patient support and education efforts. The company states that teams present the latest findings or walk 'side-by-side with patients to support rare disease awareness.'

Regulatory body interaction (FDA, EMA) for drug approval processes

Regulatory interaction has been highly productive, leading to key designations and submission milestones for both lead candidates in 2025. Rusfertide received a significant regulatory boost from the FDA.

The timeline for key regulatory interactions is as follows:

The FDA interaction for rusfertide included an End-of-Phase 2 meeting, providing supportive feedback for the pivotal clinical development plan. The company is definitely pushing hard to meet the expected NDA filing for rusfertide by the end of 2025.

Finance: draft 13-week cash view by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Channels

You're looking at how Protagonist Therapeutics, Inc. gets its value proposition-the potential of its pipeline drugs like Rusfertide and Icotrokinra-to the customer. Right now, in late 2025, the channels are heavily weighted toward strategic partners and the scientific community, which makes sense for a late-stage biotech.

Global Commercialization Network Provided by Partners Takeda and JNJ

Protagonist Therapeutics, Inc. is not building out a massive, proprietary global sales force yet; instead, it relies on established giants for commercial reach. This structure minimizes immediate operating expenses while maximizing market penetration potential upon approval.

For Rusfertide, a hepcidin mimetic for polycythemia vera (PV), the channel is a co-commercialization effort with Takeda Pharmaceuticals under a 2024 agreement. Protagonist Therapeutics remains primarily responsible for development through the New Drug Application (NDA) filing, which is expected in the fourth quarter of 2025.

For Icotrokinra (JNJ-2113), targeting immune diseases, the channel is entirely managed by J&J Innovative Medicines (JNJ), which holds exclusive global rights for its development and commercialization. To be fair, J&J already holds 4% of Protagonist Therapeutics' shares, showing a deep alignment in this channel strategy.

The financial implications of this partnership channel are significant for Protagonist Therapeutics:

• Eligible for up to $305.0 million in additional worldwide development, regulatory, and commercial milestone payments for Rusfertide.
• A milestone of $50.0 million is tied to the FDA approval of an NDA for Rusfertide in PV (or $75.0 million if Protagonist exercises its Full Opt-out Right).
• In the United States, Protagonist Therapeutics and Takeda share equally in profits and losses (50% to Protagonist and 50% to Takeda) if Rusfertide is approved.
• If Protagonist Therapeutics exercises its right to opt-out of the profit and loss sharing, it receives tiered royalties of 14% to 29% on annual worldwide net sales of the Licensed Products.

Clinical Trial Sites and Investigators for Drug Development and Data Generation

The clinical development channel is the engine generating the data needed for regulatory submissions and future commercial success. This involves a network of specialized clinical trial sites and key opinion leaders (KOLs).

The Phase 3 VERIFY study for Rusfertide, which evaluated the drug in patients with PV, was a global, randomized, placebo-controlled trial involving 293 patients over a 156-week period. The investigators running these trials are critical channels for patient access and high-quality data collection.

Key investigators and sites identified in connection with Protagonist Therapeutics' data generation include:

It's clear that KOL engagement is a primary channel for validating the science before the commercial launch phase even begins. These experts become advocates and educators.

Medical Conferences (ASH, ASCO) for Disseminating Pivotal Clinical Data

Medical conferences serve as the primary, high-impact channel for disseminating clinical evidence to the treating physician community, payers, and key decision-makers. Protagonist Therapeutics has successfully used these venues for its lead assets in 2025.

For Rusfertide, the data dissemination was high-profile:

• The VERIFY Phase 3 results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2025, in a Plenary Session at McCormick Place, Hall B1.
• The 67th American Society of Hematology (ASH) Annual Meeting in Orlando, FL, from December 6-9, 2025, featured four presentations on Rusfertide, including 52-week results from the VERIFY study.
• One oral presentation at ASH 2025 occurred on December 6, 2025, with Presentation ID 81.

For Icotrokinra, data was also presented at the EADV 2025 Congress. These presentations are crucial for establishing the clinical profile of the drugs, which directly impacts future formulary access and physician adoption.

Direct Sales Force Development for Wholly-Owned Assets Post-Approval (Future)

Currently, the commercial channels for the most advanced assets are partner-driven. However, Protagonist Therapeutics maintains a pipeline of preclinical programs, including the IL-17 oral peptide antagonist PN-881 and the obesity triple agonist peptide PN-477.

The development of a wholly-owned asset channel is a future consideration, likely contingent on the success and commercial strategy for Rusfertide and the progression of Icotrokinra. At the end of Q2 2025, the company was focused on NDA filings, not sales force build-out. The structure for a future direct sales force would need to be built to support assets where Protagonist Therapeutics retains US commercial rights or for wholly-owned pipeline candidates.

The current cash position as of June 30, 2025, with 62,211,318 shares of Common Stock outstanding, provides a runway, but establishing a full commercial sales force represents a significant future financial commitment, likely requiring a substantial increase in operating expenses beyond the current structure. Finance: draft a preliminary 2027 operating budget scenario assuming a US-only specialty sales force of 150 reps by Q1 2027 by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Customer Segments

Patients with rare hematological disorders, specifically Polycythemia Vera (PV).

Rusfertide, a hepcidin mimetic, is being developed for Polycythemia Vera (PV).

The rare chronic blood disorder PV affects about 150,000 patients in the U.S..

The global Polycythemia vera market size is projected to grow to $2.03 billion by 2032.

Data from the Phase 3 VERIFY trial showed that rusfertide-treated patients achieved clinical response at a rate of 77% compared to 33% for placebo during weeks 20-32 (p<0.0001).

Patients with chronic inflammatory diseases, starting with moderate-to-severe Plaque Psoriasis.

Icotrokinra, an oral IL-23 receptor antagonist, targets adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO).

In the ICONIC-LEAD Phase 3 study at week 16, 49.6% of patients on icotrokinra achieved PASI 90, against 4.4% on placebo.

Also at week 16 of the same study, nearly two-thirds, or 64.7%, of icotrokinra-treated patients reached IGA scores of 0/1 (clear or almost clear skin).

Global pharmaceutical companies (Takeda, JNJ) as licensing and development partners.

Protagonist Therapeutics, Inc. has two lead programs advanced through partnerships, providing non-dilutive funding and development support.

The Company reported cash, cash equivalents and marketable securities of $678.8 million as of September 30, 2025.

This cash position is anticipated to provide a cash runway through at least the end of 2028.

The net loss for the third quarter ended September 30, 2025, was $39.3 million.

Revenue for the third quarter was $4.71 million.

Finance: draft 13-week cash view by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Cost Structure

You're looking at the core spending that fuels Protagonist Therapeutics, Inc.'s (PTGX) engine-it's almost entirely focused on advancing its peptide pipeline. This is typical for a clinical-stage biopharma, but the numbers show the scale of the current investment phase.

The most immediate figure reflecting this cost base is the bottom line. For the third quarter ending September 30, 2025, Protagonist Therapeutics reported a net loss of ($39.3) million. This loss is wider than the ($33.2) million net loss reported for the same period in 2024. The nine-month period ending September 30, 2025, shows a cumulative net loss of ($85.8) million, a significant swing from the net income of $143.5 million reported for the first nine months of 2024. Honestly, this shift from income to loss highlights the transition from milestone-heavy revenue recognition to heavy operational spending.

The primary driver for these operating costs is Research and Development (R&D). Here's a quick look at how the expenses stacked up through the first three quarters of 2025:

The R&D spend is directly tied to pipeline progression, which you can see by breaking down where the money is going. The increases in R&D expense are primarily due to higher drug discovery and pre-clinical research costs. For instance, in Q2 2025, R&D expense was $37.0 million (GAAP), up 10.4% year-over-year.

You need to track these costs against the specific late-stage and early-stage assets:

• Late-Stage Assets (Rusfertide): Costs related to the Phase 3 VERIFY clinical trial for rusfertide tapered in Q2 2025 as the trial neared completion of key phases. The company remains primarily responsible for development through NDA filing for rusfertide.
• Late-Stage Assets (Icotrokinra): The focus shifted to regulatory filing costs, with the New Drug Application (NDA) for icotrokinra submitted to the U.S. FDA in July 2025 and the EMA application in September 2025.
• Early-Stage Programs (PN-881): R&D increases include costs related to the IL-17 oral peptide antagonist PN-881, for which the first patient was dosed in a Phase 1 trial.
• Other Discovery Programs: Costs also cover IND-enabling studies for triple agonists PN-477sc and PN-477o.

General and Administrative (G&A) costs are also creeping up, reflecting the move toward commercial readiness. The Q3 2025 increase of $1.0 million was mainly due to higher professional services. In Q2 2025, G&A expenses climbed, reflecting increased compensation and supporting activities as the company nears potential commercialization. Still, the cash position as of September 30, 2025, stood at $678.8 million, which management expects will fund operations through at least the end of 2028. Finance: draft 13-week cash view by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Protagonist Therapeutics, Inc. (PTGX), which is heavily weighted toward partnerships right now, as is common for a company in late-stage development. The numbers we have for late 2025 show a clear picture of where the money is coming from while they push their wholly-owned assets toward potential approval.

The most immediate, realized revenue stream is the License and collaboration revenue. For the third quarter ending September 30, 2025, this figure totaled $4.712 million. Honestly, this number is small compared to the big milestone payments recognized in 2024, but it reflects the ongoing development services revenue recognized from partners like Takeda. The company noted that the 2025 year-to-date revenue is sharply below 2024 because of the prior year recognition of the Takeda upfront payment and a Johnson & Johnson milestone.

The real upside in the revenue model comes from Non-dilutive milestone payments. These are cash injections tied to specific clinical, regulatory, or commercial achievements from their partners. Protagonist Therapeutics has two major collaboration structures driving this potential income.

Here's a quick look at the structure of those potential milestone payments and royalties:

You can see the structure is designed to reward success at every stage. For instance, on the icotrokinra side, Protagonist Therapeutics is eligible for $45 million upon receipt of a marketing approval in a second indication, which is a clear, tangible target. The cash position as of September 30, 2025, was strong at $678.8 million, which helps them fund their wholly-owned programs independently.

The third major revenue stream is the Future tiered royalties on net sales of partnered products. This is the long-term, sustainable income once these drugs are commercialized. The royalty rate for icotrokinra is specified as 6-10% on net sales, with the 10% tier kicking in once worldwide net sales reach $4 billion or more. This structure aligns Protagonist Therapeutics' long-term financial success directly with the ultimate market performance of their partners' products.

Finally, the fourth stream is the Potential product sales revenue from wholly-owned assets post-approval. This is where Protagonist Therapeutics transitions from a pure collaboration-based revenue model to a commercial entity for its own assets. The key asset here is rusfertide for polycythemia vera (PV).

Key points on the wholly-owned revenue potential include:

• Rusfertide received FDA Breakthrough Therapy Designation in August 2025.
• The U.S. New Drug Application (NDA) filing for rusfertide is expected by the end of 2025.
• The company plans to nominate a development candidate from its oral hepcidin program by year-end 2025.
• The company has a cash runway extending through at least the end of 2028, supporting the development of these internal assets.