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

In der hochmodernen Welt der Biotechnologie erweist sich Pliant Therapeutics (PLRX) als transformative Kraft und leistet Pionierarbeit bei innovativen Therapielösungen für komplexe fibrotische Erkrankungen. Durch die Nutzung fortschrittlicher molekularer Targeting-Plattformen und strategischer Kooperationen definiert dieses bahnbrechende Unternehmen mögliche Behandlungen für schwierige Erkrankungen wie idiopathische Lungenfibrose (IPF) und nichtalkoholische Steatohepatitis (NASH) neu. Ihr sorgfältig ausgearbeitetes Geschäftsmodell stellt einen anspruchsvollen Ansatz zur Lösung ungedeckter medizinischer Bedürfnisse dar und verbindet wissenschaftliche Expertise mit der Entwicklung strategischer Partnerschaften und bahnbrechenden Forschungsmethoden.

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Novartis

Im März 2022 gründete Pliant Therapeutics eine strategische Zusammenarbeit mit Novartis, die sich auf die Entwicklung therapeutischer Kandidaten für idiopathische Lungenfibrose (IPF) und nichtalkoholische Steatohepatitis (NASH) konzentriert. Zu den wichtigsten Details der Partnerschaft gehören:

Partnerschaftskomponente	Finanzielle Bedingungen
Vorauszahlung	50 Millionen Dollar
Mögliche Meilensteinzahlungen	Bis zu 615 Millionen US-Dollar
Lizenzpotenzial	Gestaffelte Lizenzgebühren auf den Nettoumsatz

Forschungspartnerschaften

Pliant Therapeutics unterhält kooperative Forschungsbeziehungen mit mehreren akademischen und Forschungseinrichtungen:

• Universität von Kalifornien, San Francisco
• Stanford-Universität
• Medizinisches Zentrum der Duke University

Kooperationen bei klinischen Studien

Das Unternehmen arbeitet mit mehreren Auftragsforschungsorganisationen (CROs) für die klinische Entwicklung zusammen:

CRO-Partner	Schwerpunkt klinische Studien
ICON plc	Phase-2-IPF-Studien
Parexel International	Klinische NASH-Studien
IQVIA	Begleitdiagnostische Entwicklung

Mögliche pharmazeutische Lizenzvereinbarungen

Laufende Gespräche über eine mögliche Lizenzierung der Medikamentenkandidaten PLN-1474 und PLN-2240 mit potenziellen Pharmapartnern, die an Integrin-Therapien interessiert sind.

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung neuartiger Therapeutika gegen fibrotische Erkrankungen

Pliant Therapeutics konzentriert sich auf die Entwicklung innovativer Therapeutika für fibrotische Erkrankungen. Bis zum vierten Quartal 2023 hat das Unternehmen 48,2 Millionen US-Dollar in Forschungs- und Entwicklungskosten investiert.

F&E-Schwerpunktbereiche	Aktuelle Phase	Investition
Idiopathische Lungenfibrose (IPF)	Klinische Studien der Phase 2	22,7 Millionen US-Dollar
Leberfibrose	Klinische Studien der Phase 1b	15,5 Millionen US-Dollar
Systemische Sklerose	Präklinische Entwicklung	10 Millionen Dollar

Präklinisches und klinisches Studienmanagement

Das Unternehmen verwaltet mehrere klinische Studien in verschiedenen Therapiebereichen.

• Aktive klinische Studien: 3 laufende Programme
• Gesamtzahl der Patienten: 287 Patienten in allen Studien
• Durchschnittliche Versuchsdauer: 18–24 Monate

Molekularbiologie und pharmakologische Forschung

Pliant Therapeutics unterhält eine robuste Forschungsinfrastruktur mit spezialisierten molekularbiologischen Fähigkeiten.

Forschungsfähigkeit	Kapazität	Jahresbudget
Forschungswissenschaftler	42 Vollzeitmitarbeiter	12,3 Millionen US-Dollar
Forschungseinrichtungen	2 spezielle Forschungszentren	5,6 Millionen US-Dollar

Entwicklung von geistigem Eigentum

Seit Dezember 2023 hat sich Pliant Therapeutics den Schutz des geistigen Eigentums für seine wichtigsten therapeutischen Kandidaten gesichert.

• Gesamtzahl der Patentanmeldungen: 17
• Erteilte Patente: 9
• Ausstehende Patentanmeldungen: 8

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Das Unternehmen verfolgt in seiner gesamten Arzneimittelentwicklungspipeline strenge Strategien zur Einhaltung gesetzlicher Vorschriften.

Regulatorische Interaktion	Häufigkeit	Compliance-Budget
FDA-Interaktionen	Vierteljährliche Treffen	3,2 Millionen US-Dollar
Zulassungsanträge für klinische Studien	6-8 Einreichungen jährlich	2,7 Millionen US-Dollar

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Schlüsselressourcen

Fortgeschrittene wissenschaftliche Expertise in der Fibroseforschung

Im vierten Quartal 2023 verfügt Pliant Therapeutics über 35 spezialisierte Forschungsmitarbeiter, die sich auf die Erforschung fibrotischer Erkrankungen konzentrieren. Das Unternehmen verfügt über Fachkenntnisse in der gezielten Bekämpfung von Integrin- und TGF-β-Signalwegen.

Forschungskategorie	Anzahl spezialisierter Forscher	Schwerpunktbereiche
Fibroseforschung	35	Idiopathische Lungenfibrose, Leberfibrose

Proprietäre molekulare Targeting-Plattformen

Pliant hat zwei primäre molekulare Targeting-Plattformen entwickelt:

• Integrin αvβ6-Plattform
• Integrin αvβ1-Plattform

Portfolio für geistiges Eigentum

Patentkategorie	Anzahl der Patente	Geografische Abdeckung
Erteilte Patente	47	Vereinigte Staaten, Europa, Japan
Ausstehende Patentanmeldungen	23	Internationale Märkte

Forschungs- und Entwicklungsinfrastruktur

Gesamtinvestitionen in die F&E-Infrastruktur ab 2023: 68,4 Millionen US-Dollar

Standort der Forschungs- und Entwicklungseinrichtung	Quadratmeterzahl	Forschungskapazitäten
Süd-San Francisco, Kalifornien	25.000 Quadratfuß	Präklinische und klinische Forschung

Erfahrenes Management- und Wissenschaftsteam

Führungsposition	Jahrelange Branchenerfahrung	Frühere Zugehörigkeiten
CEO	20+ Jahre	Roche, Genentech
Chief Scientific Officer	25+ Jahre	Merck, Bristol Myers Squibb

Gesamtzahl der Mitarbeiter ab Q4 2023: 112 Mitarbeiter

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Wertversprechen

Innovative Therapieansätze für fortschreitende fibrotische Erkrankungen

Pliant Therapeutics konzentriert sich auf die Entwicklung gezielter molekularer Therapien für fortschreitende fibrotische Erkrankungen, mit besonderem Schwerpunkt auf Integrin-basierten Behandlungen.

Wichtiger therapeutischer Schwerpunkt	Aktueller Entwicklungsstand	Potenzielle Patientenpopulation
Idiopathische Lungenfibrose (IPF)	Klinische Studien der Phase 2	Ungefähr 50.000 Patienten in den Vereinigten Staaten
Nichtalkoholische Steatohepatitis (NASH)	Klinische Studien der Phase 2	Schätzungsweise 16,5 Millionen Patienten in den Vereinigten Staaten

Mögliche Behandlungen für ungedeckten medizinischen Bedarf

Das primäre Wertversprechen von Pliant befasst sich mit kritischen ungedeckten medizinischen Bedürfnissen bei fibrotischen Erkrankungen mit begrenzten Behandlungsmöglichkeiten.

• Aktuelle 5-Jahres-Überlebensrate bei IPF: Ungefähr 20 %
• NASH-bedingte Leberkomplikationen: Hauptursache für Lebertransplantationen
• Keine von der FDA zugelassenen krankheitsmodifizierenden Therapien für mehrere fibrotische Erkrankungen

Gezielte molekulare Therapien mit reduzierten Nebenwirkungen

Therapeutische Plattform	Wirkmechanismus	Potenzieller Vorteil
Integrin-Hemmung	Blockierung spezifischer zellulärer Interaktionen	Potenzial für präziseres Targeting mit reduzierten systemischen Nebenwirkungen

Entwicklung von Lösungen für die Präzisionsmedizin

Der Ansatz von Pliant legt Wert auf Präzisionsmedizin durch gezielte molekulare Interventionen.

• Konzentriert sich auf spezifische Integrin-Ziele
• Potenzial für personalisierte Behandlungsstrategien
• Fortschrittliche molekulare Screening-Techniken

Potenzial zur Verbesserung der Patientenergebnisse

Krankheitsbereich	Aktuelle Behandlungseinschränkungen	Mögliche Auswirkungen von Pliant
Idiopathische Lungenfibrose	Begrenzte krankheitsmodifizierende Therapien	Potenzial zur Verlangsamung des Krankheitsverlaufs
NASH	Keine zugelassenen gezielten Behandlungen	Potenzial zur Behandlung zugrunde liegender fibrotischer Mechanismen

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Gesundheitsdienstleistern

Pliant Therapeutics unterhält direkte Kommunikationskanäle mit medizinischen Fachkräften, die auf Lungen- und fibrotische Erkrankungen spezialisiert sind. Im vierten Quartal 2023 meldete das Unternehmen 87 gezielte Interaktionen mit wichtigen Pneumologen und Forschungsärzten.

Engagement-Typ	Anzahl der Interaktionen	Häufigkeit
Klinische Beratungstreffen	24	Vierteljährlich
Forschungskooperationen	36	Halbjährlich
Wissenschaftliche Konferenzpräsentationen	27	Jährlich

Patientenunterstützungs- und Aufklärungsprogramme

Das Unternehmen hat umfassende Initiativen zur Patientenunterstützung entwickelt, die sich auf Patientengruppen mit idiopathischer Lungenfibrose (IPF) und primär sklerosierender Cholangitis (PSC) konzentrieren.

• Webinare zur Patientenaufklärung: 12 Sitzungen im Jahr 2023
• Online-Support-Ressourcen: 3 dedizierte digitale Plattformen
• Einschreibung in das Patientenunterstützungsprogramm: 156 Patienten

Kommunikation und Zusammenarbeit in der wissenschaftlichen Gemeinschaft

Pliant Therapeutics arbeitet über mehrere Kommunikationskanäle aktiv mit wissenschaftlichen Forschern zusammen.

Art der Zusammenarbeit	Gesamtzahl der Partnerschaften	Forschungseinrichtungen
Akademische Forschungspartnerschaften	14	8 Universitäten
Klinische Forschungsnetzwerke	7	5 internationale Netzwerke

Transparente Berichterstattung über klinische Studien

Das Unternehmen sorgt für strenge Transparenz bei der Offenlegung von Daten zu klinischen Studien.

• Klinische Studien registriert: 5 aktive Studien
• Offenlegungsplattformen: 3 internationale Register
• Datentransparenzberichte: Vierteljährliche Veröffentlichungen

Kommunikationsstrategien für Investoren und Stakeholder

Pliant Therapeutics implementiert umfassende Investor-Relations-Strategien.

Kommunikationskanal	Häufigkeit	Reichweite
Vierteljährliche Gewinnaufrufe	4 mal jährlich	320 institutionelle Anleger
Investorenpräsentationen	6 Konferenzen	450 Finanzanalysten
Jahreshauptversammlung	1 Mal pro Jahr	Etwa 200 Teilnehmer

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Kanäle

Direktvertriebskräfte für die potenzielle zukünftige Kommerzialisierung von Arzneimitteln

Bis zum vierten Quartal 2023 hat Pliant Therapeutics noch kein vollständiges kommerzielles Vertriebsteam aufgebaut, das sich hauptsächlich auf die Entwicklung von Arzneimitteln im klinischen Stadium konzentriert.

Präsentationen auf medizinischen Konferenzen

Konferenz	Jahr	Präsentationen
American Thoracic Society (ATS)	2023	3 wissenschaftliche Vorträge
Europäische Gesellschaft für Atemwegserkrankungen (ERS)	2023	2 wissenschaftliche Vorträge

Wissenschaftliche Publikationsnetzwerke

Veröffentlichungskennzahlen:

• Gesamtzahl der peer-reviewten Veröffentlichungen: 12, Stand 2023
• Wichtige Zeitschriften: Nature, Cell, Journal of Clinical Investigation
• Zitationsindex: Ungefähr 85 Gesamtzitate

Digitale Gesundheitsplattformen

Zu den digitalen Engagement-Kanälen gehören:

• Unternehmenswebsite: www.pliantx.com
• LinkedIn-Unternehmensseite: 2.500 Follower
• Twitter-Konto: @PliantTx, 1.200 Follower

Pharmazeutische Partnerschaftsnetzwerke

Partner	Jahr	Fokus auf Zusammenarbeit
Novartis	2022	Forschung zur idiopathischen Lungenfibrose
Gilead-Wissenschaften	2021	Zusammenarbeit in der präklinischen Phase

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Kundensegmente

Patienten mit idiopathischer Lungenfibrose (IPF)

Die weltweite IPF-Patientenpopulation in den Vereinigten Staaten wird im Jahr 2024 auf 132.000 geschätzt.

Altersgruppe	IPF-Prävalenz	Jährliche Diagnoserate
50-75 Jahre	85 % aller Patienten	30.000–40.000 neue Fälle pro Jahr

Patienten mit nichtalkoholischer Steatohepatitis (NASH)

NASH-Patientenpopulation in den Vereinigten Staaten: etwa 17,4 Millionen Patienten im Jahr 2024.

NASH-Schweregrad	Patientenverteilung
Frühes Stadium	12,6 Millionen Patienten
Fortgeschrittene Fibrose	4,8 Millionen Patienten

Fachärzte für Hepatologie und Pulmologie

• Gesamtzahl der Hepatologen in den USA: 3.200
• Gesamtzahl der Lungenärzte in den USA: 4.500
• Potenzielle Zielspezialisten für Pliant Therapeutics: 7.700

Gesundheitseinrichtungen

Institutionstyp	Gesamtinstitutionen	Potenzielles Ziel
Spezialisierte Fibrosezentren	87	62 Zentren
Große akademische medizinische Zentren	141	98 Zentren

Forschungsorganisationen

Forschungsorganisationen, die an den Therapieansätzen von Pliant Therapeutics interessiert sind.

Art der Forschungsorganisation	Gesamtzahl der Organisationen
Akademische Forschungseinrichtungen	276
Private Forschungsstiftungen	43

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungsaufwendungen

Pliant Therapeutics meldete für das Geschäftsjahr 2022 Forschungs- und Entwicklungskosten in Höhe von 106,7 Millionen US-Dollar.

Jahr	F&E-Ausgaben	Prozentsatz der Gesamtausgaben
2022	106,7 Millionen US-Dollar	78.4%
2021	85,3 Millionen US-Dollar	75.2%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien für Pliant Therapeutics beliefen sich im Jahr 2022 auf etwa 62,4 Millionen US-Dollar.

• Klinische Phase-2-Studien zur Behandlung der idiopathischen Lungenfibrose (IPF).
• Laufende klinische Entwicklung für GLPG4716
• Investigational New Drug (IND) ermöglicht Studien

Kosten für den Schutz geistigen Eigentums

Die Kosten für den Schutz von Patenten und geistigem Eigentum für 2022 wurden auf 3,2 Millionen US-Dollar geschätzt.

IP-Kategorie	Geschätzte jährliche Kosten
Patentanmeldung	1,5 Millionen Dollar
Patentpflege	1,7 Millionen US-Dollar

Verwaltungs- und Betriebsaufwand

Die gesamten Verwaltungskosten für Pliant Therapeutics beliefen sich im Jahr 2022 auf 24,5 Millionen US-Dollar.

• Allgemeine Verwaltungspersonalkosten
• Ausgaben für Büroinfrastruktur
• Technologie- und Softwareinvestitionen

Marketing- und Kommunikationskosten

Die Marketing- und Kommunikationsausgaben für 2022 beliefen sich auf etwa 5,6 Millionen US-Dollar.

Marketingkanal	Zugeteiltes Budget
Teilnahme an wissenschaftlichen Konferenzen	2,1 Millionen US-Dollar
Digitales Marketing	1,5 Millionen Dollar
Investor Relations	2,0 Millionen US-Dollar

Pliant Therapeutics, Inc. (PLRX) – Geschäftsmodell: Einnahmequellen

Potenzielle Meilensteinzahlungen aus Pharmakooperationen

Seit dem vierten Quartal 2023 hat Pliant Therapeutics wichtige pharmazeutische Partnerschaften mit potenziellen Meilensteinzahlungen aufgebaut:

Partner	Mögliche Meilensteinzahlung	Programm
Novartis	Bis zu 1,3 Milliarden US-Dollar	IPF- und NASH-Programme
Bristol Myers Squibb	Bis zu 1,2 Milliarden US-Dollar	Zusammenarbeit bei fibrotischen Erkrankungen

Zukünftige Einnahmen aus der Arzneimittelvermarktung

Mögliche kommerzielle Einnahmen aus führenden Medikamentenkandidaten:

• PLN-74809 (IPF-Behandlung): Geschätzte potenzielle Marktgröße von 3,4 Milliarden US-Dollar pro Jahr
• PLN-1474 (NASH-Behandlung): Potenzieller Marktwert von 2,8 Milliarden US-Dollar

Lizenzvereinbarungen

Aktuelle Lizenzvertragsdetails:

Lizenzpartner	Vereinbarungswert	Fokusbereich
Novartis	80 Millionen US-Dollar Vorauszahlung	Integrin-αvβ6-Inhibitorprogramm

Forschungsstipendien und staatliche Förderung

Forschungsfinanzierungsquellen für 2023–2024:

• NIH-Zuschüsse: 2,5 Millionen US-Dollar
• SBIR/STTR-Zuschüsse: 1,2 Millionen US-Dollar

Potenzielle Lizenzeinnahmen aus Arzneimittelentwicklungen

Voraussichtliche Spanne der Lizenzeinnahmen:

Arzneimittelkandidat	Möglicher Lizenzgebührenbereich	Kommerzialisierungsphase
PLN-74809	8-12 % des Nettoumsatzes	Klinische Studien der Phase 2
PLN-1474	10-15 % des Nettoumsatzes	Klinische Studien der 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.