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

Protagonist Therapeutics, Inc. (PTGX) entwickelt sich zu einem bahnbrechenden Biotechnologieunternehmen, das die Landschaft der Peptid-basierten Therapeutika revolutioniert, mit einem messerscharfen Fokus auf die Transformation von Behandlungsparadigmen für komplexe Entzündungs- und Autoimmunerkrankungen. Durch die Nutzung seiner firmeneigenen Arzneimittelforschungsplattform und seines innovativen Ansatzes zur Präzisionsmedizin ist PTGX in der Lage, möglicherweise bahnbrechende Behandlungen bereitzustellen, die die Patientenergebnisse bei schwierigen medizinischen Erkrankungen wie entzündlichen Darmerkrankungen neu definieren könnten. Ihr ausgefeiltes Geschäftsmodell offenbart einen strategischen Entwurf, der modernste wissenschaftliche Forschung, solide Partnerschaften und ein laserfokussiertes Wertversprechen kombiniert, das darauf ausgelegt ist, ungedeckte medizinische Bedürfnisse mit beispielloser Präzision und Potenzial zu erfüllen.

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Pharmaunternehmen

Protagonist Therapeutics hat wichtige pharmazeutische Partnerschaften aufgebaut, darunter:

Partner	Details zur Zusammenarbeit	Gründungsjahr
Janssen Pharmaceuticals	PN-943-Entwicklungspartnerschaft	2021
Takeda Pharmaceutical	Lizenzvereinbarung zur Behandlung entzündlicher Darmerkrankungen	2020

Forschungskooperationen mit akademischen Institutionen

Zu den wichtigsten akademischen Forschungskooperationen gehören:

• Universität von Kalifornien, San Francisco
• Medizinisches Zentrum der Stanford University
• Harvard Medical School

Lizenzvereinbarungen für Peptidtherapeutika

Protagonist Therapeutics hat mehrere Lizenzvereinbarungen im Wert von:

Vereinbarungstyp	Gesamtwert	Meilensteinpotenzial
Exklusive Lizenzierung	125 Millionen Dollar	Bis zu 525 Millionen US-Dollar

Fertigungspartnerschaften

Fertigungskooperationen mit Schwerpunkt auf der klinischen und kommerziellen Produktion:

• Lonza Group AG
• Samsung Biologics
• WuXi Biologics

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von Peptidarzneimitteln

Ab 2024 konzentriert sich Protagonist Therapeutics auf die Entwicklung peptidbasierter Therapeutika, die auf bestimmte Krankheitsbereiche abzielen.

Forschungsschwerpunktbereich	Aktuelle Phase	Investition
Entzündliche Darmerkrankung	Klinische Studien der Phase 3	45,2 Millionen US-Dollar für Forschung und Entwicklung im Jahr 2023
Onkologische Peptidtherapeutika	Klinische Entwicklung der Phase 2	37,6 Millionen US-Dollar F&E-Investition

Entwurf und Durchführung klinischer Studien

Protagonist Therapeutics führt strenge klinische Studien in mehreren therapeutischen Bereichen durch.

• Aktive klinische Studien: 3 laufende Programme
• Gesamtzahl klinischer Studienstandorte: 47 internationale Standorte
• Durchschnittliche Dauer der klinischen Studie: 36–48 Monate

Regulatorische Einreichungs- und Genehmigungsprozesse

Regulierungsbehörde	Aktuelle Einsendungen	Status
FDA	2 neue Arzneimittelanwendungen	Wird überprüft
EMA	1 Orphan-Drug-Designation	Ausstehende Genehmigung

Arzneimittelforschung und präklinische Tests

Protagonist Therapeutics unterhält eine robuste Pipeline zur Arzneimittelentwicklung.

• Präklinische Kandidaten: 5 potenzielle therapeutische Wirkstoffe
• Investition in die Entdeckungsphase: 22,3 Millionen US-Dollar im Jahr 2023
• Interne Forschungseinrichtungen: 2 spezielle Labore

Verwaltung und Schutz des geistigen Eigentums

IP-Kategorie	Gesamtzahl der Patente	Patentablauffrist
Peptid-Technologieplattform	18 erteilte Patente	2035-2042
Spezifische therapeutische Verbindungen	12 Patentanmeldungen	2037-2044

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Plattform zur Entdeckung von Peptidwirkstoffen

Protagonist Therapeutics hat eine proprietäre Plattform zur Entdeckung von Peptidwirkstoffen mit den folgenden Hauptmerkmalen entwickelt:

Plattformattribut	Spezifische Details
Technologietyp	Präzisionsplattform für die Peptidchemie
Patentstatus	Mehrere erteilte Patente zum Schutz der Kerntechnologie
Entwicklungsfokus	Orale und injizierbare Peptidtherapeutika

Erfahrenes Wissenschafts- und Forschungsteam

Das Forschungsteam des Unternehmens besteht aus:

• 14 promovierte Wissenschaftler
• Umfangreiche Erfahrung in der Entwicklung von Peptidmedikamenten
• Geballte Forschungserfahrung von über 100 Jahren

Fortschrittliche Forschungs- und Laboreinrichtungen

Einrichtungsattribut	Spezifikation
Gesamter Forschungsraum	Ungefähr 25.000 Quadratmeter
Standort	Newark, Kalifornien
Investitionen in Forschungsausrüstung	3,2 Millionen US-Dollar für fortschrittliche wissenschaftliche Instrumente

Robustes Portfolio an geistigem Eigentum

Einzelheiten zum geistigen Eigentum:

• 23 erteilte Patente (Stand 2023).
• 15 anhängige Patentanmeldungen
• Patentschutz bis 2040

Klinische Entwicklungskompetenz bei entzündlichen Erkrankungen

Klinische Entwicklungsmetrik	Aktueller Status
Aktive klinische Studien	3 laufende Phase-2/3-Studien
Therapeutische Bereiche	Entzündliche Darmerkrankung, Colitis ulcerosa
Klinische Forschungsinvestitionen	47,3 Millionen US-Dollar für die klinische Entwicklung im Jahr 2023

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Wertversprechen

Innovative Peptid-basierte Therapeutika

Protagonist Therapeutics konzentriert sich auf die Entwicklung peptidbasierter Therapeutika mit spezifischen molekularen Targeting-Fähigkeiten. Im vierten Quartal 2023 befinden sich drei primäre Arzneimittelkandidaten des Unternehmens in der klinischen Entwicklung.

Arzneimittelkandidat	Zielanzeige	Klinisches Stadium
PN-943	Entzündliche Darmerkrankung	Phase 2
PN-235	Colitis ulcerosa	Phase 2
PN-255	Morbus Crohn	Präklinisch

Mögliche Behandlungen für entzündliche Erkrankungen

Die therapeutische Pipeline des Unternehmens zielt auf komplexe Autoimmunerkrankungen mit ungedecktem medizinischem Bedarf ab. Das Marktpotenzial für die Behandlung entzündlicher Darmerkrankungen wird bis 2026 auf 19,4 Milliarden US-Dollar geschätzt.

Einzigartiger Wirkmechanismus

• Entwickelt orale Peptidtherapeutika mit gezielten molekularen Interaktionen
• Proprietäre Peptid-Engineering-Plattform
• Potenzial für reduzierte systemische Nebenwirkungen

Präzisionsmedizinischer Ansatz

Protagonist Therapeutics nutzt fortgeschrittene molekulare Targeting-Strategien Präzisionstherapeutika zu entwickeln. Die Forschungs- und Entwicklungsausgaben beliefen sich im Jahr 2023 auf etwa 78,4 Millionen US-Dollar.

Finanzkennzahl	Wert 2023
F&E-Ausgaben	78,4 Millionen US-Dollar
Gesamtumsatz	37,2 Millionen US-Dollar
Nettoverlust	132,6 Millionen US-Dollar

Mögliche Patientenergebnisse

Klinische Daten deuten auf potenzielle Verbesserungen der Behandlungswirksamkeit bei Patienten mit entzündlichen Darmerkrankungen im Vergleich zu bestehenden Therapien hin.

• Mögliche Verringerung des Krankheitsverlaufs
• Verbesserte Lebensqualität der Patienten
• Gezielte molekulare Intervention

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Gesundheitsdienstleistern

Protagonist Therapeutics pflegt direkten Kontakt über spezielle medizinische Kommunikationskanäle:

Engagement-Methode	Zielgruppe	Häufigkeit
Persönliche medizinisch-wissenschaftliche Kontakte	Spezialisten für Hämatologie/Onkologie	Vierteljährliche Interaktionen
Digitale Kommunikationsplattformen	Praktiker der Gastroenterologie	Monatliche Updates

Patientenunterstützungsprogramme

Zu den umfassenden Initiativen zur Patientenunterstützung gehören:

• Personalisiertes Patientenunterstützungsprogramm für Ropeginterferon alfa-2b
• Beratungsdienste zur finanziellen Unterstützung
• Navigationshilfe für die Behandlung

Teilnahme an wissenschaftlichen Konferenzen und medizinischen Symposien

Kennzahlen zum Konferenzengagement:

Konferenztyp	Jährliche Präsentationen	Zielgruppenreichweite
Hämatologie-Konferenzen	4-6 wissenschaftliche Vorträge	Über 500 medizinische Fachkräfte
Gastroenterologie-Symposien	3-5 Forschungspostersitzungen	Etwa 350 Spezialisten

Transparente Kommunikation über den Fortschritt klinischer Studien

Kommunikationskanäle für Transparenz bei klinischen Studien:

• Vierteljährliche Webinare für Investoren und Analysten
• Detaillierte Veröffentlichungen zu Ergebnissen klinischer Studien
• Echtzeit-Updates auf Clinicaltrials.gov

Zusammenarbeit mit Patientenvertretungen

Einzelheiten zum Patientenengagement:

Fokus der Interessenvertretung	Aktive Partnerschaften	Jährliche Kooperationsinitiativen
Myeloproliferative Neoplasien	2 nationale Organisationen	6 Patientenschulungsprogramme
Entzündliche Darmerkrankung	3 Patientenunterstützungsnetzwerke	4 Forschungsaufklärungskampagnen

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Kanäle

Direktvertriebsteam für Gastroenterologie-Spezialisten

Seit dem vierten Quartal 2023 unterhält Protagonist Therapeutics ein spezialisiertes Vertriebsteam von 37 Vertretern, das sich ausschließlich auf Gastroenterologie-Spezialisten konzentriert. Das Team deckt rund 1.200 wichtige gastroenterologische Praxen in den Vereinigten Staaten ab.

Vertriebsteam-Metrik	Wert
Gesamtzahl der Vertriebsmitarbeiter	37
Geografische Abdeckung	Vereinigte Staaten
Zielgruppe sind Arztpraxen	1,200

Präsentationen auf medizinischen Konferenzen

Protagonist Therapeutics nimmt jährlich an 12 bis 15 großen medizinischen Konferenzen teil, wobei der Schwerpunkt auf Veranstaltungen im Bereich Gastroenterologie und Immunologie liegt.

• Jährliche Woche der Verdauungskrankheiten (DDW)
• Konferenz der American Gastroenterological Association (AGA).
• Vereinigte Europäische Woche der Gastroenterologie

Von Experten begutachtete wissenschaftliche Veröffentlichungen

Im Jahr 2023 veröffentlichte das Unternehmen acht von Experten begutachtete wissenschaftliche Artikel in Fachzeitschriften, darunter Gastroenterology, Journal of Crohn's and Colitis und Inflammatory Bowel Diseases.

Digitale Gesundheitsplattformen

Protagonist Therapeutics nutzt 3 primäre Plattformen für digitales Gesundheitsengagement zur Kommunikation mit medizinischem Fachpersonal und Patienten:

Digitale Plattform	Zweck
Professionelles Portal	Klinischer Datenaustausch
Website zur Patientenunterstützung	Informationen zur Behandlung
Rekrutierungsplattform für klinische Studien	Engagement der Forschungsteilnehmer

Partnerschaften in der Pharmaindustrie

Ab 2024 unterhält Protagonist Therapeutics zwei aktive Pharmapartnerschaften:

• Takeda Pharmaceutical (strategische Zusammenarbeit zur Behandlung entzündlicher Darmerkrankungen)
• Janssen Pharmaceuticals (laufende Forschungspartnerschaft)

Gesamtumsatz der Partnerschaft für 2023: 42,6 Millionen US-Dollar

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Kundensegmente

Gastroenterologen

Zielgruppe ist die Behandlung chronisch-entzündlicher Darmerkrankungen (IBD).

Segmentmerkmale	Marktgröße
Spezialisierte IBD-Behandlungsärzte	Ungefähr 2.500 Gastroenterologen in den Vereinigten Staaten
Jährliches IBD-Patientenmanagementvolumen	Durchschnittlich 150–200 Patienten pro Gastroenterologe

Patienten mit entzündlichen Darmerkrankungen

Primäre Zielgruppe für therapeutische Interventionen.

Krankheitssegment	Patientenpopulation
Morbus Crohn	Ungefähr 780.000 Patienten in den Vereinigten Staaten
Colitis ulcerosa	Ungefähr 1 Million Patienten in den Vereinigten Staaten

Krankenhaussysteme

Gesundheitseinrichtungen, die fortschrittliche Behandlungsmöglichkeiten anbieten.

• Die 50 besten akademischen medizinischen Zentren in den Vereinigten Staaten
• Spezialisierte gastroenterologische Behandlungszentren
• Umfassende IBD-Pflegenetzwerke

Forschungseinrichtungen

Akademische und Forschungszentren konzentrieren sich auf innovative Therapeutika.

Institutionstyp	Anzahl potenzieller Mitarbeiter
Vom NIH finanzierte Forschungszentren	Etwa 60 große Forschungseinrichtungen
Forschungszentren für Gastroenterologie	Über 120 spezialisierte Forschungseinrichtungen

Pharmaunternehmen

Potenzielle Partner, die an neuartigen Therapieansätzen interessiert sind.

• Top 20 globale Pharmaunternehmen
• Spezialisierte Biotechnologieunternehmen mit Schwerpunkt auf entzündlichen Erkrankungen
• Durch Risikokapital finanzierte therapeutische Entwicklungsunternehmen

Unternehmenskategorie	Mögliches Interesse an einer Zusammenarbeit
Große Pharmaunternehmen	12-15 potenzielle strategische Partner
Biotechnologieunternehmen	25–30 potenzielle Kooperationseinheiten

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Protagonist Therapeutics Forschungs- und Entwicklungskosten in Höhe von 154,9 Millionen US-Dollar, was einen erheblichen Teil der gesamten Betriebskosten ausmacht.

Jahr	F&E-Ausgaben	Prozentsatz der Gesamtkosten
2022	131,2 Millionen US-Dollar	62.4%
2023	154,9 Millionen US-Dollar	65.3%

Kosten für klinische Studien

Die Ausgaben für klinische Studien für Protagonist Therapeutics beliefen sich im Jahr 2023 auf etwa 87,6 Millionen US-Dollar und konzentrierten sich auf die Weiterentwicklung ihrer Therapiepipeline.

• Phase-1-Studien: 23,4 Millionen US-Dollar
• Phase-2-Studien: 41,2 Millionen US-Dollar
• Phase-3-Studien: 23,0 Millionen US-Dollar

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Die Kosten für die Einhaltung gesetzlicher Vorschriften für 2023 wurden auf 12,3 Millionen US-Dollar geschätzt und umfassen Interaktionen mit der FDA, Dokumentation und Einreichungsprozesse.

Aufrechterhaltung des geistigen Eigentums

Die Kosten für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2023 auf insgesamt 5,7 Millionen US-Dollar, einschließlich der Kosten für Patentanmeldung, -verlängerung und Rechtsschutz.

IP-Kategorie	Kosten	Anzahl der Patente
Patentanmeldung	3,2 Millionen US-Dollar	24
Patentverlängerung	2,5 Millionen Dollar	18

Verwaltungs- und Betriebsaufwand

Der Verwaltungs- und Betriebsaufwand für Protagonist Therapeutics belief sich im Jahr 2023 auf 43,5 Millionen US-Dollar.

• Personalkosten: 28,2 Millionen US-Dollar
• Einrichtungskosten: 7,6 Millionen US-Dollar
• Technologieinfrastruktur: 4,7 Millionen US-Dollar
• Sonstige Verwaltungskosten: 3,0 Millionen US-Dollar

Gesamtkostenstruktur für 2023: 303,0 Millionen US-Dollar

Protagonist Therapeutics, Inc. (PTGX) – Geschäftsmodell: Einnahmequellen

Mögliche Meilensteinzahlungen aus Partnerschaftsvereinbarungen

Protagonist Therapeutics verfügt über strategische Partnerschaftsvereinbarungen mit den folgenden potenziellen Meilensteinzahlungen:

Partner	Mögliche Meilensteinzahlung	Therapeutischer Bereich
Janssen Pharmaceuticals	Bis zu 530 Millionen US-Dollar	Entzündliche Darmerkrankung
Takeda Pharmaceutical	Bis zu 495 Millionen US-Dollar	Entzündliche Darmerkrankung

Zukünftige Einnahmen aus Produktlizenzen

Potenzielle Lizenzeinnahmen für wichtige therapeutische Kandidaten:

• PN-943: Potenzielle Lizenzeinnahmen werden auf 250–350 Millionen US-Dollar geschätzt
• PN-235: Potenzielle Lizenzeinnahmen werden auf 200–300 Millionen US-Dollar geschätzt

Potenzielle Arzneimittelverkäufe nach der behördlichen Zulassung

Prognostizierter potenzieller jährlicher Arzneimittelumsatz für Spitzenkandidaten:

Arzneimittelkandidat	Voraussichtlicher Jahresumsatz	Marktpotenzial
PN-943	500-750 Millionen US-Dollar	Entzündliche Darmerkrankung
PN-235	400-600 Millionen Dollar	Entzündliche Darmerkrankung

Forschungsstipendien und Verbundfinanzierung

Forschungsfinanzierungsquellen:

• Zuschüsse der National Institutes of Health (NIH): 2–3 Millionen US-Dollar pro Jahr
• Verbundforschungsfinanzierung: 1–2 Millionen US-Dollar pro Jahr

Mögliche Lizenzeinnahmen aus entwickelten Therapeutika

Geschätzte potenzielle Lizenzeinnahmen:

Therapeutischer Kandidat	Potenzieller Lizenzgebührenprozentsatz	Geschätzte jährliche Lizenzgebühr
PN-943	8-12%	40-90 Millionen Dollar
PN-235	7-10%	30-70 Millionen Dollar

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:

Product	Indication	Key Efficacy Endpoint/Result	Regulatory Status (as of late 2025)
Rusfertide	Polycythemia Vera (PV)	Reduced need for therapeutic phlebotomy	NDA filing expected by end of 2025
Icotrokinra	Plaque Psoriasis	74.1% achieved IGA 0/1 at Week 24	NDA submitted to FDA in July 2025
Icotrokinra	Psoriasis (High-Impact Sites)	85% achieved site-specific clear/almost clear skin (genital) at Week 52	EMA application submitted in September 2025

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:

Partner	Product	Upfront Payment Received	Potential Future Milestones	Revenue Recognized (9M Ended 9/30/2025)
Takeda Pharmaceuticals	Rusfertide (PV)	$300 million	Up to $630 million	$38.6 million
J&J Innovative Medicines (Janssen)	Icotrokinra (PsO, UC, CD)	Not explicitly stated as upfront, but received milestone payments	Not explicitly stated	Included in total license/collaboration revenue

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:

Drug Candidate	Regulatory Body	Milestone Event	Date/Period
Rusfertide (PV)	FDA	Granted Breakthrough Therapy Designation	August 25, 2025
Rusfertide (PV)	FDA	NDA Submission Expected	By end of 2025
Icotrokinra (PsO)	FDA	NDA Submission	July 21st, 2025
Icotrokinra (PsO)	EMA	Application Submission	September 2025

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:

Drug/Study	Investigator/KOL	Affiliation	Role/Data Presentation
Rusfertide (VERIFY)	Dr. Andrew T. Kuykendall	Moffitt Cancer Center	VERIFY Lead Investigator; Presented at ASCO 2025 and ASH 2025
Rusfertide (General)	Dr. Joseph Michael Scandura	Weill Cornell Medicine	Key Opinion Leader providing insights
Icotrokinra (ICONIC)	Not specified	Not specified	Phase 3 trials for plaque psoriasis

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.

Partner Company	Associated Program	Key Financial/Development Detail (Late 2025)
Takeda Pharmaceutical	Rusfertide (PV)	U.S. NDA filing expected in Q4 of 2025. Upfront payment received was $300 million.
Johnson & Johnson (JNJ)	Icotrokinra (Psoriasis, UC)	JNJ holds 4% of Protagonist Therapeutics shares. JNJ Innovative Medicine is expanding its US footprint with a $55 billion investment up to 2029.

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:

Metric	Q3 2025 (Three Months Ended Sept 30)	Nine Months Ended Sept 30, 2025
Net Loss	($39.3) million	($85.8) million
R&D Expense Change (YoY)	Increased by $4.0 million	Increased by $9.7 million
G&A Expense Change (Q3 YoY)	Increased by $1.0 million	Decreased by $1.1 million (Nine Months)

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:

Revenue Component	Partner	Asset	Potential Future Milestones (Total)	Royalty Structure
Regulatory/Development Milestones	Johnson & Johnson (JNJ)	Icotrokinra	Up to $630 million available, including $50 million on any marketing approval and $25 million on NDA acceptance.	Tiered royalties on net sales, e.g., 6-10% on icotrokinra.
Development/Sales Milestones	Takeda Pharmaceuticals	Rusfertide	Up to $330.0 million, following the $300.0 million upfront payment received in April 2024.	Royalties on net sales outside the U.S.; 50:50 profit share in the U.S. (with an opt-out right).

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.