Protagonist Therapeutics, Inc. (PTGX): Business Model Canvas [Jan-2025 Mis à jour]

Protagonist Therapeutics, Inc. (PTGX) émerge comme une entreprise de biotechnologie révolutionnaire révolutionnant le paysage des thérapies à base de peptides, avec un accent accéléré de rasoir sur la transformation des paradigmes de traitement pour les maladies inflammatoires et auto-immunes complexes. En tirant parti de sa plate-forme de découverte de médicaments propriétaires et de son approche innovante de la médecine de précision, le PTGX est prêt à offrir des traitements potentiellement révolutionnaires qui pourraient redéfinir les résultats des patients dans des conditions médicales difficiles comme les maladies inflammatoires de l'intestin. Leur toile de modèle commercial sophistiqué révèle un plan stratégique qui combine des recherches scientifiques de pointe, des partenariats robustes et une proposition de valeur axée sur le laser conçue pour répondre aux besoins médicaux non satisfaits avec une précision et un potentiel sans précédent.

Protagonist Therapeutics, Inc. (PTGX) - Modèle commercial: partenariats clés

Collaboration stratégique avec les sociétés pharmaceutiques

Protagonist Therapeutics a établi des partenariats pharmaceutiques critiques, notamment:

Partenaire	Détails de collaboration	Année établie
Janssen Pharmaceuticals	Partenariat de développement PN-943	2021
Takeda Pharmaceutique	Contrat de licence pour le traitement inflammatoire de l'intestin	2020

Partenariats de recherche avec les établissements universitaires

Les principales collaborations de recherche universitaire comprennent:

• Université de Californie, San Francisco
• Centre médical de l'Université de Stanford
• École de médecine de Harvard

Accords de licence pour les thérapies peptidiques

Protagonist Therapeutics a obtenu plusieurs accords de licence évalués à:

Type d'accord	Valeur totale	Potentiel d'étape
Licence exclusive	125 millions de dollars	Jusqu'à 525 millions de dollars

Partenariats de fabrication

Collaborations de fabrication axées sur la production clinique et commerciale:

• Lonza Group AG
• Samsung Biologics
• Biologiques wuxi

Protagonist Therapeutics, Inc. (PTGX) - Modèle d'entreprise: Activités clés

Recherche et développement des médicaments peptidiques

En 2024, la thérapeutique protagoniste se concentre sur le développement de thérapies basées sur les peptides ciblant les zones de maladie spécifiques.

Domaine de mise au point de recherche	Étape actuelle	Investissement
Maladie inflammatoire de l'intestin	Essais cliniques de phase 3	45,2 millions de dollars de R&D en 2023
Thérapeutique peptidique en oncologie	Phase 2 Développement clinique	Investissement de R&D de 37,6 millions de dollars

Conception et exécution des essais cliniques

La thérapeutique protagoniste effectue des essais cliniques rigoureux dans plusieurs domaines thérapeutiques.

• Essais cliniques actifs: 3 programmes en cours
• Sites totaux d'essais cliniques: 47 emplacements internationaux
• Durée moyenne des essais cliniques: 36-48 mois

Processus de soumission et d'approbation réglementaires

Agence de réglementation	Soumissions actuelles	Statut
FDA	2 nouvelles applications de médicament	En cours d'examen
Ema	1 désignation de médicament orphelin	Approbation en attente

Découverte de médicaments et tests précliniques

La thérapeutique protagoniste maintient un robuste pipeline de découverte de médicaments.

• Candidats précliniques: 5 composés thérapeutiques potentiels
• Investissement en phase de découverte: 22,3 millions de dollars en 2023
• Installations de recherche interne: 2 laboratoires dédiés

Gestion et protection de la propriété intellectuelle

Catégorie IP	Total des brevets	Plage d'expiration des brevets
Plate-forme technologique peptidique	18 brevets accordés	2035-2042
Composés thérapeutiques spécifiques	12 demandes de brevet	2037-2044

Protagonist Therapeutics, Inc. (PTGX) - Modèle commercial: Ressources clés

Plateforme de découverte de médicaments peptidiques propriétaires

Protagonist Therapeutics a développé une plate-forme de découverte de médicaments peptidiques propriétaires avec les caractéristiques clés suivantes:

Attribut de plate-forme	Détails spécifiques
Type de technologie	Plateforme de chimie peptidique de précision
Statut de brevet	Plusieurs brevets émis protégeant la technologie de base
Focus de développement	Thérapeutique peptidique orale et injectable

Équipe scientifique et de recherche expérimentée

L'équipe de recherche de l'entreprise comprend:

• 14 scientifiques de niveau doctoral
• Expérience approfondie du développement de médicaments peptidiques
• Expérience de recherche cumulée de plus de 100 ans

Recherche avancée et installations de laboratoire

Attribut de l'installation	Spécification
Espace de recherche total	Environ 25 000 pieds carrés
Emplacement	Newark, Californie
Investissement de l'équipement de recherche	3,2 millions de dollars en instrumentation scientifique avancée

Portfolio de propriété intellectuelle robuste

Détails de la propriété intellectuelle:

• 23 brevets délivrés en 2023
• 15 demandes de brevet en instance
• Protection des brevets s'étendant jusqu'en 2040

Expertise en développement clinique dans les maladies inflammatoires

Métrique de développement clinique	État actuel
Essais cliniques actifs	3 essais de phase 2/3 en cours
Zones thérapeutiques	Maladie inflammatoire de l'intestin, colite ulcéreuse
Investissement de recherche clinique	47,3 millions de dollars en 2023 Développement clinique

Protagonist Therapeutics, Inc. (PTGX) - Modèle d'entreprise: propositions de valeur

Thérapeutique innovante à base de peptides

La thérapie protagoniste se concentre sur le développement de thérapies à base de peptides avec des capacités de ciblage moléculaire spécifiques. Au quatrième trimestre 2023, l'entreprise compte 3 principaux candidats médicamenteux en développement clinique.

Drogue	Indication cible	Étape clinique
PN-943	Maladie inflammatoire de l'intestin	Phase 2
PN-235	Rectocolite hémorragique	Phase 2
PN-255	La maladie de Crohn	Préclinique

Traitements potentiels pour les conditions inflammatoires

Le pipeline thérapeutique de l'entreprise cible des conditions auto-immunes complexes avec des besoins médicaux non satisfaits. Le potentiel de marché des traitements inflammatoires de l'intestin est estimé à 19,4 milliards de dollars d'ici 2026.

Mécanisme d'action unique

• Développe des thérapies peptidiques orales avec des interactions moléculaires ciblées
• Plate-forme d'ingénierie peptidique propriétaire
• Potentiel de réduction des effets secondaires systémiques

Approche de la médecine de précision

La thérapeutique protagoniste utilise Stratégies de ciblage moléculaire avancées pour développer des thérapies de précision. Les dépenses de recherche et de développement en 2023 étaient d'environ 78,4 millions de dollars.

Métrique financière	Valeur 2023
Dépenses de R&D	78,4 millions de dollars
Revenus totaux	37,2 millions de dollars
Perte nette	132,6 millions de dollars

Résultats potentiels des patients

Les données cliniques suggèrent des améliorations potentielles de l'efficacité du traitement pour les patients atteints de maladies inflammatoires de l'intestin par rapport aux thérapies existantes.

• Réduction potentielle de la progression de la maladie
• Amélioration de la qualité de vie des patients
• Intervention moléculaire ciblée

Protagonist Therapeutics, Inc. (PTGX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les prestataires de soins de santé

La thérapeutique protagoniste maintient un engagement direct grâce à des canaux de communication médicale spécialisés:

Méthode d'engagement	Public cible	Fréquence
Liaisons scientifiques médicales individuelles	Spécialistes de l'hématologie / oncologie	Interactions trimestrielles
Plateformes de communication numérique	Praticiens de gastroentérologie	Mises à jour mensuelles

Programmes de soutien aux patients

Les initiatives complètes de soutien aux patients comprennent:

• Programme d'aide aux patients personnalisé pour RopegorFerferon Alfa-2b
• Services de counseling de soutien financier
• Assistance à la navigation au traitement

Conférence scientifique et participation du symposium médical

Métriques d'engagement de la conférence:

Type de conférence	Présentations annuelles	Poutenir
Conférences d'hématologie	4-6 présentations scientifiques	Plus de 500 professionnels de la santé
Symposiums gastroentérologiques	3-5 Sessions d'affiches de recherche	Environ 350 spécialistes

Communication transparente sur les progrès des essais cliniques

Canaux de communication pour la transparence des essais cliniques:

• Investisseur trimestriel et webinaires d'analystes
• Publications détaillées des résultats des essais cliniques
• Mises à jour en temps réel sur ClinicalTrials.gov

Collaboration avec des groupes de défense des patients

Détails de l'engagement du plaidoyer des patients:

Focus du groupe de plaidoyer	Partenariats actifs	Initiatives collaboratives annuelles
Néoplasmes myéloprolifératifs	2 organisations nationales	6 programmes d'éducation des patients
Maladie inflammatoire de l'intestin	3 réseaux de soutien aux patients	4 campagnes de sensibilisation à la recherche

Protagonist Therapeutics, Inc. (PTGX) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les spécialistes de la gastroentérologie

Depuis le quatrième trimestre 2023, la thérapeutique protagoniste maintient une force de vente spécialisée de 37 représentants axés exclusivement sur les spécialistes de la gastroentérologie. L'équipe couvre environ 1 200 pratiques clés de la gastro-entérologie à travers les États-Unis.

Métrique de l'équipe de vente	Valeur
Représentants des ventes totales	37
Couverture géographique	États-Unis
Pratiques médicales cibles	1,200

Présentations de la conférence médicale

Protagonist Therapeutics participe à 12 à 15 conférences médicales majeures chaque année, en mettant l'accent sur les événements de gastro-entérologie et d'immunologie.

• Semaine annuelle des maladies digestives (DDW)
• Conférence de l'American Gastroenterological Association (AGA)
• Semaine de la gastroentérologie européenne unie

Publications scientifiques évaluées par des pairs

En 2023, la société a publié 8 articles scientifiques évalués par des pairs dans des revues telles que la gastroentérologie, le Journal of Crohn et la colite et les maladies inflammatoires de l'intestin.

Plateformes de santé numérique

La thérapeutique protagoniste utilise 3 plates-formes d'engagement de santé numérique primaires Pour communiquer avec les professionnels de la santé et les patients:

Plate-forme numérique	But
Portail professionnel	Partage de données cliniques
Site Web d'assistance des patients	Informations sur le traitement
Plateforme de recrutement d'essais cliniques	Engagement des participants à la recherche

Partenariats de l'industrie pharmaceutique

Depuis 2024, Protagonist Therapeutics maintient 2 partenariats pharmaceutiques actifs:

• Takeda Pharmaceutical (collaboration stratégique pour les traitements inflammatoires des maladies de l'intestin)
• Janssen Pharmaceuticals (partenariat de recherche en cours)

Revenus de partenariat total pour 2023: 42,6 millions de dollars

Protagonist Therapeutics, Inc. (PTGX) - Modèle d'entreprise: segments de clientèle

Gastro-entérologues

Groupe de clients cible spécialisé dans le traitement des maladies inflammatoires de l'intestin (MII).

Caractéristiques du segment	Taille du marché
Médecins de traitement des MII spécialisés	Aux États-Unis, environ 2 500 gastro-entérologues aux États-Unis
Volume annuel de gestion des patients IBD	Moyenne de 150 à 200 patients par gastro-entérologue

Patients atteints de maladies inflammatoires de l'intestin

Population cible primaire pour les interventions thérapeutiques.

Segment des maladies	Population de patients
La maladie de Crohn	Aux États-Unis, environ 780 000 patients
Rectocolite hémorragique	Aux États-Unis, environ 1 million de patients

Systèmes hospitaliers

Les établissements de santé offrant des options de traitement avancées.

• Top 50 des centres médicaux universitaires aux États-Unis
• Centres de traitement gastro-entérologie spécialisés
• Réseaux de soins IBD complets

Institutions de recherche

Les centres universitaires et de recherche se sont concentrés sur la thérapeutique innovante.

Type d'institution	Nombre de collaborateurs potentiels
Centres de recherche financés par les NIH	Environ 60 institutions de recherche majeures
Centres de recherche gastro-entérologie	Plus de 120 installations de recherche spécialisées

Sociétés pharmaceutiques

Partenaires potentiels intéressés par de nouvelles approches thérapeutiques.

• Top 20 des sociétés pharmaceutiques mondiales
• Des sociétés de biotechnologie spécialisées axées sur les maladies inflammatoires
• Sociétés de développement thérapeutique soutenues en capital-risque

Catégorie d'entreprise	Intérêt potentiel de collaboration
Grandes sociétés pharmaceutiques	12-15 partenaires stratégiques potentiels
Entreprises de biotechnologie	25-30 entités collaboratives potentielles

Protagonist Therapeutics, Inc. (PTGX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Protagonist Therapeutics a déclaré des dépenses de R&D de 154,9 millions de dollars, ce qui représente une partie importante de leurs coûts d'exploitation totaux.

Année	Dépenses de R&D	Pourcentage des coûts totaux
2022	131,2 millions de dollars	62.4%
2023	154,9 millions de dollars	65.3%

Coût des essais cliniques

Les dépenses des essais cliniques pour les thérapies protagonistes en 2023 étaient d'environ 87,6 millions de dollars, axées sur la progression de leur pipeline de thérapies.

• Essais de phase 1: 23,4 millions de dollars
• Essais de phase 2: 41,2 millions de dollars
• Essais de phase 3: 23,0 millions de dollars

Processus de conformité et d'approbation réglementaires

Les coûts de conformité réglementaire pour 2023 ont été estimés à 12,3 millions de dollars, couvrant les interactions, la documentation et les processus de soumission de la FDA.

Maintenance de la propriété intellectuelle

Les coûts de maintenance de la propriété intellectuelle en 2023 ont totalisé 5,7 millions de dollars, notamment les dépenses de dépôt de brevets, de renouvellement et de protection juridique.

Catégorie IP	Coût	Nombre de brevets
Dépôt de brevet	3,2 millions de dollars	24
Renouvellement des brevets	2,5 millions de dollars	18

Surfaçon administratives et opérationnelles

Les frais généraux administratifs et opérationnels pour la thérapeutique protagoniste en 2023 étaient de 43,5 millions de dollars.

• Coûts de personnel: 28,2 millions de dollars
• Frais de facilité: 7,6 millions de dollars
• Infrastructure technologique: 4,7 millions de dollars
• Autres frais administratifs: 3,0 millions de dollars

Structure totale des coûts pour 2023: 303,0 millions de dollars

Protagonist Therapeutics, Inc. (PTGX) - Modèle d'entreprise: Strots de revenus

Paiements de jalons potentiels à partir des accords de partenariat

Protagonist Therapeutics a des accords de partenariat stratégique avec les paiements potentiels suivants:

Partenaire	Paiement de jalon potentiel	Zone thérapeutique
Janssen Pharmaceuticals	Jusqu'à 530 millions de dollars	Maladie inflammatoire de l'intestin
Takeda Pharmaceutique	Jusqu'à 495 millions de dollars	Maladie inflammatoire de l'intestin

Revenus de licence de produits futurs

Revenus potentiels de licence pour les principaux candidats thérapeutiques:

• PN-943: Revenus de licence potentiels estimés à 250 à 350 millions de dollars
• PN-235: Revenus de licence potentiels estimés à 200 à 300 millions de dollars

Ventes potentielles de médicaments après approbation réglementaire

Ventes annuelles potentielles projetées pour les candidats principaux:

Drogue	Ventes annuelles projetées	Potentiel de marché
PN-943	500 à 750 millions de dollars	Maladie inflammatoire de l'intestin
PN-235	400 à 600 millions de dollars	Maladie inflammatoire de l'intestin

Subventions de recherche et financement collaboratif

Sources de financement de la recherche:

• Subventions des National Institutes of Health (NIH): 2 à 3 millions de dollars par an
• Financement de recherche collaborative: 1 à 2 millions de dollars par an

Revenus potentiels de redevances des thérapies développées

Revenus de redevance potentiels estimés:

Candidat thérapeutique	Pourcentage de redevances potentielles	Redevance annuelle estimée
PN-943	8-12%	40 à 90 millions de dollars
PN-235	7-10%	30 à 70 millions de dollars

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.