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

Dans le monde de pointe de la biotechnologie, la thérapeutique souple (PLRX) émerge comme une force transformatrice, pionnier des solutions thérapeutiques innovantes pour les maladies fibrotiques complexes. En tirant parti des plateformes de ciblage moléculaire avancées et des collaborations stratégiques, cette entreprise révolutionnaire redéfinit des traitements potentiels pour des conditions médicales difficiles comme la fibrose pulmonaire idiopathique (IPF) et la stéatohépatite non alcoolique (NASH). Leur modèle commercial méticuleusement conçu représente une approche sophistiquée pour répondre aux besoins médicaux non satisfaits, mélangeant l'expertise scientifique avec le développement de partenariat stratégique et les méthodologies de recherche révolutionnaire.

Pliant Therapeutics, Inc. (PLRX) - Modèle commercial: partenariats clés

Collaboration stratégique avec Novartis

En mars 2022, Pliant Therapeutics a établi une collaboration stratégique avec Novartis axée sur le développement de candidats thérapeutiques à la fibrose pulmonaire idiopathique (IPF) et à la stéatohépatite non alcoolique (NASH). Les détails clés du partenariat comprennent:

Composant de partenariat	Conditions financières
Paiement initial	50 millions de dollars
Paiements de jalons potentiels	Jusqu'à 615 millions de dollars
Potentiel de redevance	Redevances à plusieurs niveaux sur les ventes nettes

Partenariats de recherche

La thérapeutique souple entretient des relations de recherche collaborative avec plusieurs établissements universitaires et de recherche:

• Université de Californie, San Francisco
• Université de Stanford
• Duke University Medical Center

Collaborations d'essais cliniques

La société s'engage avec plusieurs organisations de recherche sous contrat (CRO) pour le développement clinique:

Partenaire CRO	Focus des essais cliniques
Icône plc	Essais IPF de phase 2
Parexel International	Études cliniques de Nash
Iqvia	Développement de diagnostic d'accompagnement

Accords potentiels de licence pharmaceutique

Discussions en cours pour les licences potentielles des candidats PLN-1474 et PLN-2240 avec des partenaires pharmaceutiques potentiels intéressés par les thérapies par intégrine.

Pliant Therapeutics, Inc. (PLRX) - Modèle d'entreprise: Activités clés

Recherche et développement de nouvelles thérapies ciblant les maladies fibrotiques

La thérapeutique souple se concentre sur le développement de la thérapeutique innovante pour les maladies fibrotiques. Au quatrième trimestre 2023, la société a investi 48,2 millions de dollars en dépenses de R&D.

Zones de mise au point R&D	Étape actuelle	Investissement
Fibrose pulmonaire idiopathique (IPF)	Essais cliniques de phase 2	22,7 millions de dollars
Fibrose hépatique	Essais cliniques de phase 1B	15,5 millions de dollars
Sclérose systémique	Développement préclinique	10 millions de dollars

Gestion des essais précliniques et cliniques

La société gère plusieurs essais cliniques dans différentes zones thérapeutiques.

• Essais cliniques actifs: 3 programmes en cours
• Inscription totale des patients: 287 patients dans tous les essais
• Durée moyenne de l'essai: 18-24 mois

Biologie moléculaire et recherche pharmacologique

La thérapeutique souple maintient une infrastructure de recherche robuste avec des capacités de biologie moléculaire spécialisées.

Capacité de recherche	Capacité	Budget annuel
Chercheur	42 employés à temps plein	12,3 millions de dollars
Installations de recherche	2 centres de recherche dédiés	5,6 millions de dollars

Développement de la propriété intellectuelle

En décembre 2023, Pliant Therapeutics a assuré la protection de la propriété intellectuelle pour ses principaux candidats thérapeutiques.

• Demandes totales de brevets: 17
• Brevets accordés: 9
• Demandes de brevet en instance: 8

Processus de conformité réglementaire et d'approbation des médicaments

La Société maintient des stratégies de conformité réglementaire rigoureuses à travers son pipeline de développement de médicaments.

Interaction réglementaire	Fréquence	Budget de conformité
Interactions de la FDA	Réunions trimestrielles	3,2 millions de dollars
Soumissions de réglementation des essais cliniques	6-8 soumissions par an	2,7 millions de dollars

Pliant Therapeutics, Inc. (PLRX) - Modèle d'entreprise: Ressources clés

Expertise scientifique avancée dans la recherche en fibrose

Depuis le quatrième trimestre 2023, Pliant Therapeutics compte 35 membres de la recherche spécialisés axés sur la recherche sur les maladies fibrotiques. La société a développé une expertise dans le ciblage des voies de signalisation de l'intégrine et du TGF-β.

Catégorie de recherche	Nombre de chercheurs spécialisés	Domaines de concentration
Recherche de fibrose	35	Fibrose pulmonaire idiopathique, fibrose hépatique

Plates-formes de ciblage moléculaire propriétaires

Pliant a développé deux plates-formes de ciblage moléculaire primaires:

• Plate-forme d'intégrine αvβ6
• Plate-forme d'intégrine αvβ1

Portefeuille de propriété intellectuelle

Catégorie de brevet	Nombre de brevets	Couverture géographique
Brevets délivrés	47	États-Unis, Europe, Japon
Demandes de brevet en instance	23	Marchés internationaux

Infrastructure de recherche et de développement

Investissement total d'infrastructure de R&D en 2023: 68,4 millions de dollars

Emplacement de l'installation de R&D	En pieds carrés	Capacités de recherche
South San Francisco, CA	25 000 pieds carrés	Recherche préclinique et clinique

Équipe de gestion expérimentée et scientifique

Poste de direction	Années d'expérience dans l'industrie	Affiliations antérieures
PDG	20 ans et plus	Roche, Genentech
Chef scientifique	25 ans et plus	Merck, Bristol Myers Squibb

Le total des employés comptez au quatrième trimestre 2023: 112 employés

Pliant Therapeutics, Inc. (PLRX) - Modèle d'entreprise: propositions de valeur

Approches thérapeutiques innovantes pour les maladies fibrotiques progressives

La thérapeutique souple se concentre sur le développement de thérapies moléculaires ciblées pour les maladies fibrotiques progressives, avec un accent spécifique sur les traitements basés sur l'intégrine.

Focus thérapeutique clé	Étape de développement actuelle	Population potentielle de patients
Fibrose pulmonaire idiopathique (IPF)	Essais cliniques de phase 2	Aux États-Unis, environ 50 000 patients
Stéatohépatite non alcoolique (NASH)	Essais cliniques de phase 2	Estimé 16,5 millions de patients aux États-Unis

Traitements potentiels pour les besoins médicaux non satisfaits

La proposition de valeur primaire de Pliant répond aux besoins médicaux critiques non satisfaits dans les maladies fibrotiques avec des options de traitement limitées.

• Taux de survie à 5 ans actuels IPF: environ 20%
• Complications hépatiques liées à la NASH: principale cause de transplantation hépatique
• Aucune thérapie modifiant la maladie approuvée par la FDA pour plusieurs conditions fibrotiques

Thérapies moléculaires ciblées avec des effets secondaires réduits

Plate-forme thérapeutique	Mécanisme d'action	Avantage potentiel
Inhibition de l'intégrine	Bloquer des interactions cellulaires spécifiques	Potentiel de ciblage plus précis avec des effets secondaires systémiques réduits

Développement de solutions de médecine de précision

L'approche de Pliant met l'accent sur la médecine de précision par des interventions moléculaires ciblées.

• Axé sur des cibles d'intégrine spécifiques
• Potentiel de stratégies de traitement personnalisées
• Techniques de dépistage moléculaire avancées

Potentiel pour améliorer les résultats des patients

Zone de maladie	Limites de traitement actuelles	Impact potentiel de Pliant
Fibrose pulmonaire idiopathique	Thérapies modificatrices limitées	Potentiel à ralentir la progression de la maladie
Nash	Pas de traitements ciblés approuvés	Potentiel pour aborder les mécanismes fibrotiques sous-jacents

Pliant Therapeutics, Inc. (PLRX) - Modèle d'entreprise: relations clients

Engagement direct avec les prestataires de soins de santé

La thérapeutique souple maintient les canaux de communication directs avec des professionnels de la santé spécialisés dans les maladies pulmonaires et fibrotiques. Au quatrième trimestre 2023, la société a signalé 87 interactions ciblées avec les clés de pulmonologues et les médecins de recherche.

Type d'engagement	Nombre d'interactions	Fréquence
Réunions de conseil clinique	24	Trimestriel
Collaborations de recherche	36	Semestriel
Présentations de la conférence scientifique	27	Annuel

Programmes de soutien aux patients et d'éducation

La société a développé des initiatives complètes de soutien aux patients axées sur la fibrose pulmonaire idiopathique (IPF) et les communautés de patients sclérosantes primaires (PSC).

• Webinaires de l'éducation des patients: 12 séances en 2023
• Ressources de support en ligne: 3 plateformes numériques dédiées
• Inscription du programme d'assistance aux patients: 156 patients

Communication et collaboration communautaires scientifiques

La thérapeutique souple s'engage activement avec des chercheurs scientifiques à travers de multiples canaux de communication.

Type de collaboration	Partenariats totaux	Institutions de recherche
Partenariats de recherche universitaire	14	8 universités
Réseaux de recherche clinique	7	5 réseaux internationaux

Rapports d'essais cliniques transparents

La Société maintient une transparence rigoureuse dans la divulgation des données des essais cliniques.

• Essais cliniques enregistrés: 5 essais actifs
• Plateformes de divulgation publique: 3 registres internationaux
• Rapports de transparence des données: publications trimestrielles

Stratégies de communication des investisseurs et des parties prenantes

La thérapeutique souple met en œuvre des stratégies complètes de relations avec les investisseurs.

Canal de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4 fois par an	320 investisseurs institutionnels
Présentations des investisseurs	6 conférences	450 analystes financiers
Réunion des actionnaires annuelle	1 fois par an	Environ 200 participants

Pliant Therapeutics, Inc. (PLRX) - Modèle d'entreprise: canaux

Force de vente directe pour la commercialisation potentielle des médicaments futurs

Depuis le quatrième trimestre 2023, Pliant Therapeutics n'a pas encore établi une force commerciale complète, en se concentrant principalement sur le développement de médicaments à un stade clinique.

Présentations de la conférence médicale

Conférence	Année	Présentations
Société thoracique américaine (ATS)	2023	3 présentations scientifiques
Société respiratoire européenne (ERS)	2023	2 présentations scientifiques

Réseaux de publication scientifique

Métriques de publication:

• Publications totales à comité de lecture: 12 en 2023
• Journaux clés: Nature, Cell, Journal of Clinical Investigation
• Indice de citation: environ 85 citations au total

Plateformes de santé numérique

Les canaux de fiançailles numériques comprennent:

• Site Web de l'entreprise: www.pliantx.com
• Page d'entreprise LinkedIn: 2 500 abonnés
• Compte Twitter: @PliantTx, 1 200 abonnés

Réseaux de partenariat pharmaceutique

Partenaire	Année	Focus de la collaboration
Novartis	2022	Recherche idiopathique de la fibrose pulmonaire
Sciences de Gilead	2021	Collaboration de scène préclinique

Pliant Therapeutics, Inc. (PLRX) - Modèle d'entreprise: segments de clientèle

Patients atteints de fibrose pulmonaire idiopathique (IPF)

Population de patients IPF mondiale estimée à 132 000 aux États-Unis en 2024.

Groupe d'âge	Prévalence IPF	Taux de diagnostic annuel
50-75 ans	85% du total des patients	30 000 à 40 000 nouveaux cas par an

Patients atteints de stéatohépatite non alcoolique (NASH)

Population de patients Nash aux États-Unis: environ 17,4 millions de patients en 2024.

Gravité de la Nash	Distribution des patients
Étape précoce	12,6 millions de patients
Fibrose avancée	4,8 millions de patients

Hépatologie et médecins spécialistes de la pulmonologie

• Hépatologues totaux aux États-Unis: 3 200
• Total de pulmonologues aux États-Unis: 4 500
• Spécialistes cibles potentiels pour les thérapies souples: 7 700

Institutions de soins de santé

Type d'institution	Total des institutions	Cible potentielle
Centres de fibrose spécialisés	87	62 centres
Principaux centres médicaux académiques	141	98 centres

Organisations de recherche

Organisations de recherche intéressées par les approches thérapeutiques de la thérapeutique souple.

Type d'organisation de recherche	Total des organisations
Établissements de recherche universitaire	276
Fondations de recherche privée	43

Pliant Therapeutics, Inc. (PLRX) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pliant Therapeutics a déclaré des frais de recherche et de développement de 106,7 millions de dollars pour l'exercice 2022.

Année	Dépenses de R&D	Pourcentage des dépenses totales
2022	106,7 millions de dollars	78.4%
2021	85,3 millions de dollars	75.2%

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour les thérapies souples en 2022 étaient d'environ 62,4 millions de dollars.

• Essais cliniques de phase 2 pour le traitement de la fibrose pulmonaire idiopathique (IPF)
• Développement clinique en cours pour GLPG4716
• Études habilitantes à nouveau médicament (IND)

Frais de protection de la propriété intellectuelle

Les coûts de protection des brevets et de la propriété intellectuelle pour 2022 ont été estimés à 3,2 millions de dollars.

Catégorie IP	Coût annuel estimé
Dépôt de brevet	1,5 million de dollars
Entretien de brevets	1,7 million de dollars

Surfaçon administratives et opérationnelles

Les dépenses administratives totales pour les thérapies souples en 2022 étaient de 24,5 millions de dollars.

• Frais de personnel administratif général
• Frais d'infrastructure de bureau
• Technologie et investissements logiciels

Dépenses de marketing et de communication

Les dépenses de marketing et de communication pour 2022 étaient d'environ 5,6 millions de dollars.

Canal de marketing	Budget alloué
Participation de la conférence scientifique	2,1 millions de dollars
Marketing numérique	1,5 million de dollars
Relations avec les investisseurs	2,0 millions de dollars

Pliant Therapeutics, Inc. (PLRX) - Modèle commercial: Strots de revenus

Paiements de jalons potentiels provenant de partenariats pharmaceutiques

Depuis le quatrième trimestre 2023, Pliant Therapeutics a établi des partenariats pharmaceutiques clés avec des paiements de jalons potentiels:

Partenaire	Paiement de jalon potentiel	Programme
Novartis	Jusqu'à 1,3 milliard de dollars	Programmes IPF et NASH
Bristol Myers Squibb	Jusqu'à 1,2 milliard de dollars	Collaboration des maladies fibrotiques

Revenus de commercialisation des médicaments futurs

Revenus commerciaux potentiels des candidats en médicaments principaux:

• PLN-74809 (traitement IPF): taille du marché potentiel estimé de 3,4 milliards de dollars par an
• PLN-1474 (traitement NASH): valeur marchande potentielle de 2,8 milliards de dollars

Accords de licence

Détails de l'accord de licence actuel:

Partenaire de licence	Valeur de l'accord	Domaine de mise au point
Novartis	80 millions de dollars de paiement initial	Programme d'inhibiteur de l'intégrine αvβ6

Subventions de recherche et financement gouvernemental

Sources de financement de la recherche pour 2023-2024:

• Subventions NIH: 2,5 millions de dollars
• Subventions SBIR / STTR: 1,2 million de dollars

Revenus de redevances potentielles des développements de médicaments

Gamme de redevances projetées:

Drogue	Range potentielle de redevances	Étape de commercialisation
PLN-74809	8 à 12% des ventes nettes	Essais cliniques de phase 2
PLN-1474	10-15% des ventes nettes	Essais cliniques de phase 1B

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Value Propositions

You're looking at the core value Pliant Therapeutics, Inc. (PLRX) offers across its pipeline, which is heavily focused on integrin-based therapeutics for high-need areas. The value is grounded in novel mechanisms and clinical signals, supported by a financial structure positioned for execution.

Novel oral, small molecule therapy (PLN-101095) for ICI-refractory solid tumors.

PLN-101095, an oral, small molecule, dual selective inhibitor of $\alpha v\beta 8$ and $\alpha v\beta 1$ integrins, is showing anti-tumor activity in patients who have not responded to immune checkpoint inhibitors (ICIs). As of November 30th, 2025, interim data from the Phase 1 trial showed:

• One confirmed Complete Response (CR) and three Partial Responses (PR) across the three highest dose cohorts out of 10 secondary ICI refractory patients evaluated.
• 60% of these secondary refractory patients demonstrated stable disease or tumor reduction.
• Responding patients exhibited large increases, specifically 4- to 13-fold versus baseline, in plasma interferon gamma (IFN-γ) after a 14-day monotherapy run-in.
• The median time on treatment for these responders was 15 months.

This positions PLN-101095 as a potential option where current standards fail, with plans to accelerate development via a Phase 1b indication expansion trial starting in 2026.

Potential to stabilize or improve liver fibrosis markers in Primary Sclerosing Cholangitis (PSC).

While development for Idiopathic Pulmonary Fibrosis (IPF) was discontinued, Pliant Therapeutics, Inc. (PLRX) is assessing potential next steps for bexotegrast, which could include new indications such as liver diseases. The underlying science for this class of drug has been validated:

Study/Data Point	Target/Measure	Patient Cohort Size	Key Finding
Phase 2a PET Imaging Trial (Bexotegrast)	Collagen deposition in lungs	10 patients with IPF	Positive results using PET and magnetic resonance imaging to evaluate antifibrotic mechanism.

Addressing high unmet medical needs in rare fibrotic diseases and advanced cancers.

Pliant Therapeutics, Inc. (PLRX) targets patient populations with limited or no effective options. For advanced cancers, the value is in overcoming resistance to immune checkpoint inhibitors. For fibrotic diseases, the company is looking to pivot following the discontinuation of the IPF program, aiming at other fibrotic conditions like liver diseases. The company's financial position supports this focus:

• Cash, cash equivalents, and short-term investments were $243.3 million as of September 30, 2025.
• This strong cash position is noted to support planned operations through 2028.
• The Q3 2025 net loss was $26.3 million, a reduction from $57.8 million in the prior year period, reflecting cost management.

Demonstrated antifibrotic mechanism of action through PET imaging data.

The mechanism of action for the discontinued bexotegrast was scientifically validated. Results from a Phase 2a positron emission tomography (PET) imaging trial were published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). This publication reviewed positive results showing the drug's effect on collagen deposition in the lungs of 10 IPF patients.

Potential for a first-in-class treatment for muscular dystrophies (PLN-101325).

PLN-101325 is being developed as a monoclonal antibody agonist of integrin $\alpha 7\beta 1$ for muscular dystrophies. This program has advanced to a point where Pliant Therapeutics, Inc. (PLRX) has received regulatory clearance for a Phase 1 study, with a Clinical Trial Approval (CTA) open in Australia.

Finance: review Q4 2025 cash burn projections by next Tuesday.

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Customer Relationships

For Pliant Therapeutics, Inc. (PLRX), customer relationships are segmented across three primary groups: the scientific/clinical community (KOLs and investigators), the investment community, and patient advocacy organizations relevant to their pipeline candidates.

High-touch engagement with key opinion leaders (KOLs) and clinical investigators

Engagement with the clinical community centers on validating the integrin platform and managing the transition following the BEACON-IPF trial. While the development of bexotegrast in idiopathic pulmonary fibrosis (IPF) was discontinued in Q2 2025 due to an unfavorable risk-benefit profile, the commitment to scientific transparency remains. Full results from the global, multinational BEACON-IPF Phase 2b/3 clinical trial are slated for future publication, and close-out activities were expected to be completed in the fourth quarter of 2025. This commitment to sharing data, even from a discontinued program, serves to maintain credibility with investigators. Furthermore, the ongoing Phase 1 trial for PLN-101095 in solid tumors, which completed enrollment across all five dose cohorts by the third quarter of 2025, requires close collaboration with oncology investigators. The company presented research at ATS in May 2025, including an Oral Presentation on 'Characterizing the antifibrotic activity of bexotegrast on distinct fibroblast populations in PCLS from multiple ILD subtypes,' demonstrating continued scientific dialogue with the pulmonology community.

Investor relations and public communications to manage shareholder expectations post-IPF setback

Investor communication has been focused on navigating the significant shift following the August 7, 2025, announcement of the bexotegrast IPF discontinuation. Management, led by CEO Bernard Coulie, M.D., Ph.D., immediately pivoted to emphasizing the advancement of the oncology program and the maintenance of core capabilities. Following a strategic realignment in May 2025 that included an approximately 45% reduction in workforce, the company provided regular updates to manage the cash runway, which stood at $264.4 million in cash, cash equivalents, and short-term investments as of June 30, 2025, decreasing to $243.3 million by September 30, 2025. The commitment to shareholders was explicitly stated: 'We remain committed to delivering shareholder value and look forward to providing updates in the future,' following the Q2 2025 results. The focus for the remainder of 2025 was on delivering data from the PLN-101095 trial by year-end.

Direct communication with patient advocacy groups for rare diseases

Pliant Therapeutics, Inc. is developing PLN-101325, a monoclonal antibody agonist of integrin $\alpha_7\beta_1$, specifically targeting muscular dystrophies, which falls under the rare disease category. While specific partnership metrics for Pliant Therapeutics, Inc. are not public, the operational necessity for such engagement is clear, as patient advocacy groups (PAGs) are increasingly vital partners. For PAGs serving diseases without an approved therapy, 51% reported no clinical trials in progress at the time of a recent industry survey, highlighting the need for industry collaboration to initiate trials. Furthermore, 79% of surveyed PAGs reported research engagement in some capacity, including registries and clinical trials, underscoring that active participation from these groups is essential for trial success and enrollment. For Pliant Therapeutics, Inc., engaging these groups is critical to support the Phase 1 study of PLN-101325.

Scientific publications to validate the integrin platform and drug mechanism

Validation of the core integrin platform is driven by peer-reviewed publications and conference presentations. The company has published results from a Phase 2a positron emission tomography (PET) imaging trial in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The platform itself is supported by a proprietary library of over 15,000 integrin binding molecules. The oncology program's interim data, released in December 2025, further validates the mechanism, showing that responders in the PLN-101095 trial had 4- to 13-fold increases in plasma IFN-$\gamma$ after a 14-day monotherapy run-in. The platform's broad applicability is also highlighted by its use in developing PLN-101095 (dual selective inhibitor of $\alpha_v\beta_8$ and $\alpha_v\beta_1$) and PLN-101325 (agonist of integrin $\alpha_7\beta_1$).

Here is a summary of key quantitative data points relevant to these relationships:

Relationship Metric Area	Data Point	Context/Date
Platform Validation Asset Size	15,000+	Proprietary integrin binding molecules in the screening library.
Investor Relations Context	45%	Workforce reduction announced in May 2025 to extend cash runway.
Investor Relations Financials	$243.3 million	Cash, cash equivalents, and short-term investments as of September 30, 2025.
Scientific Validation (Oncology)	4	Responders (1 CR, 3 PR) out of 10 secondary ICI-refractory patients in highest PLN-101095 dose cohorts (Interim data as of Nov 30, 2025).
Scientific Validation (Oncology)	60%	Secondary refractory patients showing stable disease or tumor reduction with PLN-101095 (Interim data as of Nov 30, 2025).
Scientific Validation (Oncology)	15 months	Median time on treatment for PLN-101095 responders as of November 30, 2025.
Patient Advocacy Context	79%	Patient advocacy groups reporting research engagement in some capacity (General Rare Disease Data).

You'll want Finance to track the burn rate closely against the $243.3 million cash position at the end of Q3 2025, especially given the shift in R&D focus post-IPF. Operations: confirm the final BEACON-IPF close-out is complete by the end of Q4 2025 as planned.

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Channels

You're looking at how Pliant Therapeutics, Inc. gets its science and potential products to the relevant stakeholders-from clinical sites to potential partners and, eventually, patients. The channels are heavily weighted toward research and external partnerships right now, which makes sense given the late-stage clinical focus.

Global clinical trial networks for patient enrollment and drug testing

Pliant Therapeutics, Inc. relies on established clinical trial infrastructure to test its integrin-based candidates. While the BEACON-IPF Phase 2b/3 trial, which evaluated bexotegrast, was a global effort, it involved approximately 360 patients across 262 international sites before its discontinuation. Currently, the channel focus is on the oncology program, specifically the Phase 1 dose-escalation trial for PLN-101095 in solid tumors resistant to immune checkpoint inhibitors. This trial has completed enrollment of all five planned dose cohorts. In the earlier stages of this trial, 16 patients with nine different tumour types were enrolled across five dosing groups to test various regimens, such as 1,000 mg BID (twice daily) for six subjects and 2,000 mg BID for three patients. The company is positioned to execute advanced trials, maintaining a deeply experienced late-stage clinical and regulatory development organization.

Here's a snapshot of the recent clinical trial channel activity:

Trial/Program	Status as of Late 2025	Key Metric/Scope
BEACON-IPF (Bexotegrast)	Close out activities expected in Q4 2025	Approx. 360 patients across 262 international sites
PLN-101095 Phase 1 Oncology	Enrollment of five dose cohorts completed	16 patients enrolled across five groups in initial cohorts
PLN-101325 (Muscular Dystrophies)	Received regulatory clearance for Phase 1 study	Early-stage platform asset

Scientific and medical conferences (e.g., AASLD) to present clinical data

Presenting data at key scientific venues is a primary channel for validating science and engaging the medical community. Pliant Therapeutics, Inc. presented at the American Thoracic Society (ATS) 2025 International Conference in May 2025. This included a featured oral presentation and three scientific posters covering bexotegrast and biomarker analysis in Interstitial Lung Disease (ILD) subtypes. The company makes these presentations available on its website under the Publications section.

• ATS 2025 Conference attendance: May 16-21, 2025.
• Number of scientific posters presented at ATS 2025: Three.
• Data presented included evaluation of bexotegrast in human precision-cut lung slices (PCLS).

Licensing and collaboration agreements (e.g., Novartis) for non-core assets or territories

External partnerships serve as a crucial channel for advancing non-core assets or leveraging global reach for specific indications. The strategic collaboration and license agreement with Novartis for PLN-1474 (for NASH-related liver fibrosis) and up to three additional integrin targets, originally signed in October 2019, is a prime example. Pliant completed the Phase 1 development for PLN-1474, after which Novartis assumed all future development, manufacturing, and commercialization.

The financial structure of this channel included:

• Initial payment from Novartis: $80 million (upfront payment and equity investment commitments).
• Total potential milestone payments: Up to $416 million.
• Royalty structure: Tiered royalties on product sales ranging from the mid-single digits to low double digits.

This structure allowed Pliant Therapeutics, Inc. to fund R&D activities related to the deal while transferring late-stage risk and commercialization responsibility externally.

Future specialty pharmacy and direct-to-physician sales channels post-approval

For Pliant Therapeutics, Inc.'s current pipeline assets, particularly PLN-101095 in oncology, the commercial channel strategy is still in the planning phase, contingent on successful later-stage data. The company is accelerating development of PLN-101095 with the initiation of a Phase 1b indication expansion trial planned for 2026. The company's current financial position, with cash, cash equivalents, and short-term investments reported at $243.3 million as of September 30, 2025, supports planned operations through 2028. This runway is intended to support execution of clinical trials, including any late-stage trials, following a workforce realignment that reduced personnel by approximately 45% in May 2025. The actual structure for specialty pharmacy or direct-to-physician sales for an approved oncology product would be determined after positive data from the planned 2026 expansion trial and subsequent Phase 3 studies.

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Customer Segments

Oncology patients with advanced solid tumors resistant to immune checkpoint inhibitors.

This segment is targeted by the investigational drug PLN-101095, which is being evaluated in combination with pembrolizumab for patients refractory to immune checkpoint inhibitors (ICI). Interim data from the Phase 1 dose escalation trial showed antitumor activity in this heavily pretreated population. Across the three highest dose cohorts, there were four responders out of the 10 secondary ICI refractory patients. Specifically, 60% of secondary refractory patients demonstrated stable disease or tumor reduction. The median time on treatment in these patients was 15 months, as of November 30th, 2025. Clinical responses were observed in patients with cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer (NSCLC). Final data from this trial, including the two highest dose cohorts, is expected by the end of 2025.

Patients diagnosed with Primary Sclerosing Cholangitis (PSC).

PSC is a rare, progressive liver disease. The estimated patient population is over 100,000 patients worldwide and more than 30,000 patients in the United States. Currently, there are no FDA or EMA-approved therapies for patients with PSC. Pliant Therapeutics evaluated bexotegrast in the INTEGRIS-PSC Phase 2a trial. The 320 mg dose cohort enrolled 27 patients in the active arm and 9 patients in the placebo arm. Pliant Therapeutics had a cash position of $243.3 million as of September 30, 2025, to support ongoing pipeline advancement.

Patients with muscular dystrophies (future segment for PLN-101325).

PLN-101325 targets $\alpha7\beta1$ integrin, a receptor upregulated in Duchenne muscular dystrophy (DMD) and other forms of muscular dystrophy. This therapy is Phase 1 ready with a Clinical Trial Approval (CTA) open in Australia. Preclinical data in mouse models showed improved diaphragm strength and function, addressing a leading cause of death in muscular dystrophy patients. Pliant Therapeutics reported a net loss of $26.3 million in Q3 2025, with a strategic restructuring involving a ~45% workforce reduction to extend cash runway for future clinical execution.

Specialist physicians: oncologists, hepatologists, and rare disease experts.

The specialist physician segment is defined by their practice focus on the target indications:

• Oncologists treating advanced solid tumors.
• Hepatologists managing Primary Sclerosing Cholangitis.
• Rare disease experts focused on muscular dystrophies.

The company's cash, cash equivalents and short-term investments were $264.4 million as of June 30, 2025, supporting the clinical development necessary to engage these specialists.

Indication/Program	Target Population Metric	Value/Status (Late 2025)
Oncology (PLN-101095)	Confirmed Partial Responses (3rd Cohort)	3 out of 6 patients
Oncology (PLN-101095)	Secondary Refractory Patients with Stable Disease/Reduction	60%
PSC (Bexotegrast)	US Patient Estimate	More than 30,000
PSC (Bexotegrast)	FDA/EMA Approved Therapies	None
Muscular Dystrophy (PLN-101325)	Development Status	Phase 1 ready (CTA open in Australia)
Corporate Cash Position (Q3 2025)	Cash, Cash Equivalents, and Short-Term Investments	$243.3 million (as of September 30, 2025)

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Cost Structure

You're looking at the cost side of Pliant Therapeutics, Inc. (PLRX) operations as of late 2025. The structure is heavily weighted toward R&D, which is typical for a clinical-stage biopharma, but the recent strategic moves have clearly tightened the burn rate.

The most dominant expense category is Research and Development (R&D). For the third quarter of 2025, R&D expenses were reported at $17.9 million. This figure reflects a significant step-down from the prior-year quarter's $47.8 million, largely because the company is winding down the BEACON-IPF trial for bexotegrast. Still, this R&D spend supports the ongoing advancement of other pipeline assets.

General and Administrative (G&A) costs followed R&D as the next largest component. In Q3 2025, G&A totaled $10.3 million, down from $14.3 million in the prior-year quarter. This reduction signals the direct impact of the May 2025 strategic realignment.

Here's a quick look at those key operating expenses for the quarter:

Cost Component	Q3 2025 Amount (USD Millions)	Context
Research and Development (R&D)	17.9	Driven down by BEACON-IPF discontinuation
General and Administrative (G&A)	10.3	Reflects post-restructuring personnel cost savings
Total Operating Expenses (Implied)	28.2 (approx.)	Excludes other minor costs not explicitly detailed

Personnel costs saw a major adjustment following the May 2025 strategic realignment. That restructuring involved a reduction of approximately 45% of Pliant Therapeutics, Inc.'s current workforce. This action was specifically designed to minimize costs and preserve cash reserves, which stood at $243.3 million as of September 30, 2025, extending the cash runway.

Beyond the direct personnel and trial costs, the cost structure necessarily includes ongoing operational expenditures essential for maintaining the company's platform and future optionality. These include:

• Intellectual property maintenance fees for core patents.
• Legal fees associated with ongoing corporate and clinical matters.
• Manufacturing costs for clinical trial materials for active programs like PLN-101095.
• Site costs and vendor management for the ongoing Phase 1 trial in solid tumors.

The costs for clinical trial execution and manufacturing of drug candidates remain significant, even with the BEACON-IPF wind-down. The focus has shifted to executing the Phase 1 trial of PLN-101095, which completed enrollment, meaning future costs will be tied to data analysis and potential subsequent trial planning, rather than large-scale patient enrollment and drug supply for the discontinued IPF program.

To be fair, the October prepayment of outstanding amounts under the Oxford Finance loan agreement also impacts the balance sheet and future cash flow, reducing debt-related obligations, which is a form of future cost management.

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Pliant Therapeutics, Inc. (PLRX) as of late 2025. Honestly, for a clinical-stage company, the revenue streams are almost entirely non-product related right now, which is typical.

Zero product revenue is the reality, as Pliant Therapeutics, Inc. is still deep in clinical development and has not achieved regulatory approval for any therapeutic candidate. Reported revenue was zero for Q3 2025, consistent with analyst expectations.

The current, tangible income comes from the balance sheet. You see interest and other income generated from their cash reserves. For the third quarter of 2025, this totaled approximately $2.8 million.

This cash position, as of September 30, 2025, stood at $243.3 million in cash, cash equivalents, and short-term investments. That cash is what generates the interest income you see.

The next layer of revenue is tied up in the success of their partnerships, specifically the one with Novartis. These are milestone payments from existing strategic collaborations. The agreement for PLN-1474, which has already transitioned to Novartis after Phase 1 completion, allows Pliant Therapeutics, Inc. to earn milestone payments up to $416 million upon the achievement of specified development, regulatory, and commercial milestones. Also, under the 2019 collaboration, Pliant Therapeutics, Inc. received a $4 million milestone payment for advancing another integrin target into development.

Here's a quick look at the structure of that key Novartis deal:

Payment Type	PLN-1474 Potential Amount	Status/Notes
Upfront Fee	$50 million	Received for worldwide exclusive license
Equity Investment	$30 million	Commitments from Novartis
Development/Regulatory/Commercial Milestones	Up to $416 million	Contingent on achievement

Also, you have to factor in the future potential royalties from licensed candidates like PLN-1474. Upon commercialization, Pliant Therapeutics, Inc. is eligible for tiered royalties ranging from the mid-single digit to low double-digit percentages on product sales.

Finally, the big, long-term, high-risk stream is future product sales revenue. This is entirely contingent on successful regulatory approval and market launch for their pipeline assets, such as PLN-101095 in solid tumors or PLN-101325 for muscular dystrophies.

The current revenue-generating activities can be summarized:

• Zero product sales revenue as clinical-stage.
• Interest income from cash reserves, totaling $2.8 million in Q3 2025.
• Potential milestone payments from the Novartis collaboration.
• Future tiered royalties on licensed assets.
• Contingent future revenue from pipeline product sales.

Finance: draft 13-week cash view by Friday.