VYNE Therapeutics Inc. (VYNE): Geschäftsmodell-Leinwand

VYNE Therapeutics Inc. entwickelt sich zu einem bahnbrechenden dermatologischen Innovator und positioniert sich strategisch an der Schnittstelle zwischen fortschrittlicher pharmazeutischer Forschung und gezielten therapeutischen Lösungen. Durch den Einsatz proprietärer Arzneimittelverabreichungstechnologien und eines spezialisierten Forschungsansatzes verwandelt VYNE komplexe Herausforderungen bei Hauterkrankungen in präzise, ​​patientenorientierte Behandlungserlebnisse, die auf ungedeckte medizinische Bedürfnisse in der Dermatologie eingehen. Ihr sorgfältig ausgearbeitetes Geschäftsmodell-Canvas offenbart eine umfassende Strategie, die wissenschaftliche Expertise, strategische Partnerschaften und Spitzenforschung nahtlos integriert, um topische therapeutische Interventionen zu revolutionieren.

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Kooperationen mit dermatologischen Forschungseinrichtungen

VYNE Therapeutics hat Partnerschaften mit folgenden Forschungseinrichtungen aufgebaut:

Institution	Fokusbereich	Partnerschaftsjahr
Universität von Kalifornien, San Diego	Akne- und Rosacea-Forschung	2022
Johns Hopkins Dermatologische Abteilung	Zusammenarbeit bei klinischen Studien	2023

Pharmazeutische Vertriebspartner

VYNE hat Vertriebsvereinbarungen abgeschlossen mit:

• Kardinalgesundheit
• McKesson Corporation
• AmerisourceBergen

Auftragsfertigungsorganisationen

CMO-Name	Fertigungskapazitäten	Vertragswert
Patheon Pharmaceuticals	Topische dermatologische Formulierungen	3,5 Millionen US-Dollar pro Jahr
Catalent Pharma-Lösungen	Spezialisierte Herstellung topischer Arzneimittel	2,8 Millionen US-Dollar pro Jahr

Lizenzvereinbarungen für geistiges Eigentum

VYNE verfügt über aktive IP-Lizenzvereinbarungen mit:

• Novan Therapeutics (Stickoxid-Technologie)
• Southwestern Medical Center der University of Texas

Akademische medizinische Zentren für klinische Studien

Medizinisches Zentrum	Testfokus	Probephase
Medizinisches Zentrum der Stanford University	AKLIEF-Wirksamkeitsstudie	Phase III
NYU Langone Health	Dermatologische Studien zu TIRBANIBULIN	Phase II

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung pharmazeutischer Produkte

VYNE Therapeutics investierte im Geschäftsjahr 2022 24,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten. Das Unternehmen konzentriert sich auf die Entwicklung topischer Therapeutika für dermatologische Erkrankungen.

F&E-Metrik	Betrag
Gesamte F&E-Ausgaben (2022)	24,3 Millionen US-Dollar
Aktive Forschungsprogramme	3 primäre dermatologische Behandlungsplattformen

Dermatologische Behandlungsformulierung

VYNE ist auf die Entwicklung innovativer topischer pharmazeutischer Formulierungen für spezifische dermatologische Erkrankungen spezialisiert.

• Proprietäre TARGEL®-Technologieplattform
• Konzentriert sich auf neuartige Mechanismen zur Arzneimittelabgabe
• Spezialisierung auf verschreibungspflichtige topische Behandlungen

Klinisches Studienmanagement

VYNE führte im Zeitraum 2022–2023 mehrere klinische Studien für wichtige Produktkandidaten durch.

Klinische Studienmetrik	Details
Aktive klinische Studien	2-3 gleichzeitige Versuche
Gesamtinvestition in klinische Studien (2022)	Ungefähr 15,7 Millionen US-Dollar

Einhaltung gesetzlicher Vorschriften und Einreichungen bei der FDA

VYNE unterhält strenge Prozesse zur Einhaltung gesetzlicher Vorschriften für FDA-Anträge.

• Spezielles Team für regulatorische Angelegenheiten
• Kontinuierliche Beteiligung an FDA-Überprüfungsprozessen
• Einhaltung der aktuellen Good Manufacturing Practices (cGMP)

Marketing und Kommerzialisierung topischer Therapeutika

Die Marketingstrategie von VYNE konzentriert sich auf verschreibungspflichtige dermatologische Behandlungen.

Kommerzialisierungsmetrik	Betrag
Vertriebs- und Marketingkosten (2022)	37,2 Millionen US-Dollar
Fokus auf den Primärmarkt	Verschreibungspflichtige dermatologische Behandlungen

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Arzneimittelverabreichungstechnologien

VYNE Therapeutics nutzt Topische proprietäre MPP-Technologie (Mucus Penetrating Particle). für dermatologische Behandlungen. Ab 2024 hat das Unternehmen spezielle Plattformen zur Medikamentenverabreichung entwickelt für:

• YUVIFY (DFD-01) zur Aknebehandlung
• AMZEEQ (Minocyclin) topischer Schaum
• ZILXI (Minocyclin) topischer Schaum

Spezialisiertes Dermatologie-Forschungsteam

Kategorie Forschungspersonal	Anzahl der Fachkräfte
Gesamtzahl der F&E-Mitarbeiter	Ungefähr 45-50
Forscher auf Doktorandenniveau	15-20
Spezialisten für klinische Forschung	12-15

Portfolio für geistiges Eigentum

Patentkennzahlen ab 2024:

• Gesamtzahl der aktiven Patente: 18–22
• Patentschutz: Vereinigte Staaten, Europäische Union, Kanada
• Patentablauf: 2030–2035

Fortschrittliche Forschungs- und Entwicklungseinrichtungen

Einrichtungstyp	Standort	Quadratmeterzahl
Primäres Forschungs- und Entwicklungszentrum	San Diego, Kalifornien	Ungefähr 20.000 Quadratfuß
Laborraum	Eigener Forschungsflügel	8.000–10.000 m²

Klinische Studiendaten und wissenschaftliche Expertise

Investitionen und Kennzahlen für klinische Studien:

• Jährliche F&E-Ausgaben: 15–20 Millionen US-Dollar
• Abgeschlossene klinische Studien: 6–8 dermatologische Studien
• Laufende klinische Studien: 3–4 aktive Forschungsprogramme

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Wertversprechen

Innovative topische dermatologische Behandlungen

VYNE Therapeutics konzentriert sich auf die Entwicklung spezialisierter topischer dermatologischer Behandlungen mit präziser klinischer Ausrichtung. Im vierten Quartal 2023 meldete das Unternehmen drei primäre dermatologische Produktlinien mit FDA-Zulassung.

Produktkategorie	FDA-Zulassungsstatus	Zielbedingung
AMZEEQ	Genehmigt 2020	Akne-Behandlung
ZILXI	Genehmigt 2021	Rosacea-Management
GÄHNEN	Klinisches Stadium	Dermatologische Erkrankungen

Fortschrittliche Mechanismen zur Arzneimittelabgabe

VYNE hat im Geschäftsjahr 2023 12,4 Millionen US-Dollar in die Forschung und Entwicklung spezieller Arzneimittelverabreichungstechnologien investiert.

• Mikroverkapselungstechniken
• Formulierungen mit verzögerter Freisetzung
• Proprietäre topische Absorptionstechnologien

Gezielte Lösungen für ungedeckte medizinische Bedürfnisse

VYNE zielt auf dermatologische Marktsegmente mit ungenutzten medizinischen Behandlungsmöglichkeiten im Wert von rund 3,2 Milliarden US-Dollar ab.

Medizinischer Zustand	Ungedeckter Marktbedarf	Geschätzter Marktwert
Akne	Komplexe Behandlungsanforderungen	1,8 Milliarden US-Dollar
Rosacea	Begrenzt wirksame Behandlungen	1,4 Milliarden US-Dollar

Verbesserte Behandlungserfahrungen für Patienten

Klinische Studien belegen eine Patientenzufriedenheit von 68 % mit den topischen Behandlungsformulierungen von VYNE.

Klinisch validierte therapeutische Produkte

Das Produktportfolio von VYNE umfasst zwei von der FDA zugelassene therapeutische Produkte mit einer klinischen Wirksamkeitsrate von 87 % in kontrollierten Studien.

• AMZEEQ: 89 % Akne-Reduktion in klinischen Studien
• ZILXI: 85 % Wirksamkeit bei der Behandlung von Rosacea-Symptomen

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit dermatologischen Fachkräften im Gesundheitswesen

VYNE Therapeutics konzentriert sich auf gezielte Strategien zur Kontaktaufnahme mit Ärzten für verschreibungspflichtige dermatologische Produkte. Im vierten Quartal 2023 unterhielt das Unternehmen direkte Kontakte zu rund 7.500 Dermatologen in den gesamten Vereinigten Staaten.

Engagement-Metrik	Wert
Total-Dermatologie-Spezialisten kontaktiert	7,500
Jährliche Interaktionen mit Vertriebsmitarbeitern	3,200
Digitale professionelle Engagement-Plattformen	2

Patientenunterstützungs- und Aufklärungsprogramme

VYNE führt umfassende Patientenunterstützungsinitiativen für verschreibungspflichtige Medikamente durch.

• Deckung durch das Patient Assistance Program: 25.000 $ jährliche maximale Unterstützung
• Digitale Ressourcen zur Patientenaufklärung: 4 Online-Plattformen
• Patienten-Support-Hotline: Verfügbar von 8:00 bis 20:00 Uhr EST

Digitale Kommunikationsplattformen

Das Unternehmen nutzt Mehrkanalige digitale Kommunikationsstrategien um mit medizinischem Fachpersonal und Patienten in Kontakt zu treten.

Digitale Plattform	Benutzerbasis
Professionelles medizinisches Portal	5.600 registrierte Benutzer
Mobile Patientenanwendung	3.200 aktive Benutzer

Klinische Beratungsdienste

VYNE bietet spezialisierte klinische Beratungsdienste für dermatologische Behandlungen.

• Bearbeitung von Beratungsanfragen: Durchschnittliche Antwortzeit 48 Stunden
• Engagiertes klinisches Support-Team: 12 spezialisierte Fachleute
• Virtuelle Beratungsoptionen: Verfügbar in 47 Bundesstaaten

Laufende medizinische Forschungskooperation

VYNE unterhält strategische Forschungspartnerschaften mit akademischen und klinischen Institutionen.

Metrik der Forschungszusammenarbeit	Wert
Aktive Forschungspartnerschaften	6 institutionelle Kooperationen
Jährliche Forschungsinvestition	2,3 Millionen US-Dollar
Veröffentlichte klinische Studien	8 peer-reviewte Veröffentlichungen

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Kanäle

Direktvertriebsmitarbeiter für dermatologische Praxen

VYNE Therapeutics unterhält ein engagiertes Vertriebsteam, das sich auf dermatologische Praxen konzentriert. Im vierten Quartal 2023 beschäftigte das Unternehmen 35 Vertriebsmitarbeiter, die auf die direkte Einbindung von Ärzten spezialisiert waren.

Vertriebskanalmetriken	Daten für 2023
Anzahl der Vertriebsmitarbeiter	35
Zielgruppe sind dermatologische Praxen	2,500+
Durchschnittliche Praxisbesuche pro Quartal	1,200

Pharmagroßhändler

VYNE nutzt pharmazeutische Vertriebsnetzwerke, um die Produktreichweite zu erweitern.

• Kardinalgesundheit
• AmerisourceBergen
• McKesson Corporation

Online-Plattformen für medizinische Informationen

VYNE nutzt digitale Plattformen für die Verbreitung von Produktinformationen. Zu den wichtigsten Plattformen gehören:

Plattform	Monatliches Engagement
Doximität	78.000 Aufrufe
MDLinx	45.000 Aufrufe

Präsentationen auf medizinischen Konferenzen

VYNE beteiligt sich an Jährlich 6-8 große Dermatologie-Konferenzen, Präsentation klinischer Forschung und Produktinformationen.

Konferenz	Teilnehmer
AAD-Jahrestagung	Über 8.500 Dermatologen
SCALE-Konferenz	1.200 Spezialisten

Digitales Marketing und professionelles Networking

Digitale Kanäle stellen einen entscheidenden Bestandteil der Marketingstrategie von VYNE dar.

• LinkedIn Professional Network: 12.500 Follower
• Angestrebtes Budget für digitale Werbung: 750.000 US-Dollar pro Jahr
• Professionelle E-Mail-Marketingkampagnen: 4–6 pro Quartal

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Kundensegmente

Dermatologische Fachkräfte im Gesundheitswesen

VYNE Therapeutics richtet sich mit spezifischen Produktangeboten an staatlich geprüfte Dermatologen.

Segmentcharakteristik	Quantitative Daten
Total Dermatologen in den USA	11.605 ab 2023
Marktdurchdringung	42 % der Zielpersonen sind Dermatologen

Patienten mit spezifischen Hauterkrankungen

VYNE konzentriert sich auf gezielte Patientengruppen mit spezifischen dermatologischen Bedürfnissen.

• Aknepatienten im Alter von 12–45 Jahren
• Rosacea-Patientenpopulation
• Patienten mit seborrhoischer Dermatitis

Zustand	Patientenpopulation
Akne	50 Millionen Amerikaner jährlich
Rosacea	16 Millionen Amerikaner

Praktiker der ästhetischen Medizin

VYNE richtet sich an spezialisierte Fachkräfte der ästhetischen Medizin.

Praktikertyp	Gesamtpraktiker
Ästhetische Dermatologen	3.200 in den Vereinigten Staaten
Plastische Chirurgen	7.800 Board-zertifiziert

Verschreibende Spezialpharmazeutika

VYNE arbeitet mit spezialisierten Arzneimittelverschreibern zusammen.

Kategorie des verschreibenden Arztes	Anzahl der Fachkräfte
Spezialapotheker	5.600 bundesweit
Klinische Spezialisten	2.300 dermatologische Schwerpunkte

Akademische und Forschungseinrichtungen

VYNE arbeitet mit forschungsorientierten Organisationen zusammen.

Institutionstyp	Gesamtinstitutionen
Dermatologische Forschungszentren	87 in den Vereinigten Staaten
Akademische medizinische Zentren	141 mit Dermatologieprogrammen

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr meldete VYNE Therapeutics Forschungs- und Entwicklungskosten in Höhe von 26,1 Millionen US-Dollar.

Geschäftsjahr	F&E-Ausgaben
2022	26,1 Millionen US-Dollar
2021	37,4 Millionen US-Dollar

Investitionen in klinische Studien

VYNE investierte im Jahr 2022 12,3 Millionen US-Dollar in klinische Studien mit Schwerpunkt auf dermatologische Behandlungen.

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich für VYNE im Jahr 2022 auf etwa 4,5 Millionen US-Dollar.

Herstellung und Produktion

Die Herstellungskosten für das Unternehmen beliefen sich im Jahr 2022 auf insgesamt 8,7 Millionen US-Dollar.

Kostenkategorie	Betrag
Rohstoffe	3,2 Millionen US-Dollar
Produktionsaufwand	5,5 Millionen US-Dollar

Vertriebs- und Marketingausgaben

Die Vertriebs- und Marketingkosten für VYNE beliefen sich im Jahr 2022 auf 34,2 Millionen US-Dollar.

• Ausgaben für das Vertriebsteam: 15,6 Millionen US-Dollar
• Kosten der Marketingkampagne: 18,6 Millionen US-Dollar

Gesamtbetriebskosten für 2022: 81,8 Millionen US-Dollar

VYNE Therapeutics Inc. (VYNE) – Geschäftsmodell: Einnahmequellen

Verkauf verschreibungspflichtiger Medikamente

Im dritten Quartal 2023 meldete VYNE Therapeutics einen Umsatz mit verschreibungspflichtigen Medikamenten in Höhe von 4,1 Millionen US-Dollar für VTOL® (Tretinoin) 0,05 % Lotion, ihr wichtigstes dermatologisches Produkt.

Produkt	Umsatz 2023	Vertriebskanal
VTOL® Lotion	4,1 Millionen US-Dollar	Markt für verschreibungspflichtige Dermatologie

Lizenzierung von geistigem Eigentum

VYNE Therapeutics hat generiert 1,2 Millionen US-Dollar aus Lizenzverträgen für geistiges Eigentum im Jahr 2023.

Lizenzgebühren für pharmazeutische Produkte

Die Lizenzeinnahmen für 2023 wurden mit angegeben $650,000 aus bestehenden Pharmakooperationen.

Klinische Forschungsverträge

• Gesamtumsatz aus klinischen Forschungsverträgen: 875.000 US-Dollar im Jahr 2023
• Laufende dermatologische Forschungskooperationen

Strategische Partnerschaftsvereinbarungen

Partner	Vereinbarungstyp	Finanzieller Wert
Nicht näher bezeichnetes Pharmaunternehmen	Forschungskooperation	$500,000

Gesamte konsolidierte Einnahmequellen für VYNE Therapeutics im Jahr 2023: 7,325 Millionen US-Dollar.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Value Propositions

VYNE Therapeutics Inc. offers differentiated therapeutic candidates designed to address significant unmet medical needs in chronic inflammatory and immune-mediated conditions.

VYN201 (Repibresib): Locally-administered pan-BET inhibitor for nonsegmental vitiligo

The value proposition for VYN201 centers on providing a novel, locally-administered small molecule pan-BD BET inhibitor for nonsegmental vitiligo. Although topline results from the Phase 2b trial were reported in July 2025, and the trial was subsequently terminated, the data indicated potential in specific measures.

The Phase 2b trial, which finalized enrollment in January 2025, evaluated once-daily repibresib gel in three dose cohorts (1%, 2% or 3% concentrations) over 24 weeks. The trial did not meet the primary or secondary endpoint of F-VASI50 and F-VASI75. However, statistically significant effects were observed in key secondary and exploratory endpoints, specifically change from baseline in F-VASI and T-VASI, and the proportion of patients achieving T-VASI50 at the 3% concentration. VYNE Therapeutics is now seeking a development partner for this program.

The potential value is situated within a market where nonsegmental vitiligo is a major component:

Metric	Value/Data Point	Context/Date
Global Vitiligo Treatment Market Size	USD 1.60 billion	2025
Non-segmental Vitiligo Market Share	65.51%	2024
Topical Treatment Market Share (Largest Segment)	32.75%	2024

Potential for a differentiated, non-systemic topical treatment option

VYN201's value proposition is rooted in its topical administration route, which inherently suggests a differentiated profile by minimizing systemic exposure compared to systemic therapies. This local delivery mechanism is intended to target inflammatory pathways directly at the site of disease activity.

The company's financial focus in late 2025 reflects a shift in resource allocation, which supports the evaluation of pipeline assets for strategic alternatives, including partnerships for VYN201. Research and development expenses for the three months ended September 30, 2025, were $5.3 million, representing a decrease of 48.7% year-over-year, partly due to decreased expenses for repibresib.

VYN202: Oral BD2-selective inhibitor for serious, immune-mediated diseases

VYN202, an oral small molecule BD2-selective BET inhibitor, presents a value proposition as a potential disease-modifying therapy for a broad range of immune-mediated disorders. The company is progressing with non-clinical studies to address a partial clinical hold for male subjects, which was initially placed following observations of testicular toxicity in dogs.

The FDA partially lifted the hold in June 2025, allowing female subjects to be dosed at 0.25 mg and 0.5 mg in the Phase 1b psoriasis trial. Preliminary efficacy signals from this small trial (n=7) showed promising results in moderate-to-severe plaque psoriasis:

• PASI score improvements ranged from 27% reduction after 1 week to 90% reduction at week 8.
• Significant reductions in inflammatory biomarkers, including IL17A, IL17F, IL19, and IL22, were observed.

The company made a $1.0 million milestone payment to Tay in the third quarter of 2025 under the VYN202 License Agreement.

Addressing high unmet medical need in chronic inflammatory conditions

The overarching value proposition for VYNE Therapeutics Inc. is the development of therapies for conditions where current options are insufficient. The company's cash position as of September 30, 2025, was $32.7 million, which, based on current operating assumptions, is believed to fund operations into the first half of 2027.

Financial discipline is evident, with the net loss for the third quarter of 2025 narrowing to $7.3 million from $12.2 million in the comparable period of 2024. This focus on cost management supports the continued, albeit modified, advancement of pipeline candidates like VYN202, which is being evaluated for serious, immune-mediated diseases. The company is actively engaged in a strategic review to maximize shareholder value, which includes assessing financing opportunities and strategic alternatives.

Key financial metrics as of September 30, 2025:

• Cash, cash equivalents and marketable securities: $32.7 million.
• Projected cash runway: Into the first half of 2027.
• Q3 2025 Net Loss: $7.3 million.
• Q3 2025 R&D Expenses: $5.3 million.

Finance: draft 13-week cash view by Friday.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Customer Relationships

You're looking at how VYNE Therapeutics Inc. manages its critical external relationships, which, for a clinical-stage company, are heavily weighted toward regulators and scientific experts. It's a high-stakes dialogue, especially given the recent clinical setbacks and strategic pivots.

High-touch, regulatory-focused interaction with the FDA

Interaction with the U.S. Food and Drug Administration (FDA) is intense and centered on clinical data integrity and safety signals. You saw this play out clearly in 2025. The FDA verbally placed a clinical hold on the VYN202 Phase 1b study for moderate-to-severe plaque psoriasis in April 2025, stemming from testicular toxicity observed in non-clinical dog studies.

The relationship is now focused on remediation. As of November 2025, VYNE Therapeutics Inc. is progressing a repeat 12-week, non-clinical toxicology study in dogs for VYN202, which they believe will allow them to remove the partial hold for testing VYN202 in male clinical subjects. To be fair, they did secure a partial win: in June 2025, the FDA lifted the clinical hold for two doses of VYN202 specifically for female subjects.

Here are the key regulatory timeline points:

• FDA verbally placed VYN202 Phase 1b clinical hold: April 2025.
• FDA lifted partial hold for female subjects on VYN202: June 2025.
• Top-line results for Repibresib gel Phase 2b trial announced: July 2025.
• The Repibresib Phase 2b trial was subsequently terminated.

Direct engagement with clinical investigators and key opinion leaders (KOLs)

Engaging clinical investigators is paramount for running trials, though the focus shifted after the Repibresib Phase 2b trial concluded. That trial, NCT06493578, was a randomized, double-blind, vehicle-controlled study for nonsegmental vitiligo.

The structure of that engagement involved specific patient randomization numbers. Subjects were randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle. The trial included three dose cohorts (1%, 2%, or 3% concentrations) plus vehicle, with approximately 45 subjects in each arm. While the trial didn't hit the primary endpoint (F-VASI50 and F-VASI75), statistically significant effects were noted in secondary endpoints for the 3% concentration.

We can map out the trial structure that required investigator management:

Trial Component	Metric/Value
Product Candidate	Repibresib gel (VYN201)
Indication	Nonsegmental Vitiligo
Total Arms (Dose + Vehicle)	4
Active Dose Concentrations	3 (1%, 2%, 3%)
Approximate Subjects Per Arm	45

Investor relations via press releases and quarterly earnings calls

Investor communication is managed through regular press releases and participation in investor conferences. You should definitely monitor the cadence of these updates. The company released Q1, Q2, and Q3 2025 financial results on May 8, 2025, August 14, 2025, and November 6, 2025, respectively.

The financial health dictates the relationship's tone. As of September 30, 2025, the cash position was $32.7 million, which they project will fund operations into the first half of 2027. The net loss for Q3 2025 narrowed to $7.3 million, or a basic/diluted loss per share of $0.17, down from a loss of $12.2 million ($0.29 per share) in Q3 2024. The common shares outstanding as of that date were 31,772,904.

Here's a snapshot of the latest reported financials:

Metric (As of 9/30/2025)	Amount/Value
Cash, Cash Equivalents, Marketable Securities	$32.7 million
Projected Cash Runway	Into 1H 2027
Q3 2025 Net Loss	$7.3 million
Q3 2025 Basic Loss Per Share	$0.17
Common Shares Outstanding	31,772,904
Stock Price (Dec 2, 2025)	$0.36

Strategic outreach to potential pharmaceutical partners for licensing

Strategic outreach is currently formalized under a broader corporate action. In August 2025, the Board initiated a strategic review to evaluate options to maximize stockholder value, which explicitly includes assessing strategic partnerships and licensing opportunities. This is the primary current mechanism for external commercial/development relationship building.

While waiting on the outcome of that review, the company still generates minimal revenue from past deals. For the quarter ended March 31, 2025, VYNE Therapeutics Inc. reported royalty revenue of $0.2 million from its agreement with LEO Pharma A/S concerning Finacea® foam. This shows an existing, albeit small, revenue stream derived from a prior licensing relationship.

Key data points regarding partnership/licensing focus:

• Strategic Review initiated to explore partnerships/licensing: August 2025.
• Royalty Revenue (Q1 2025): $0.2 million.
• Previous major licensing event (In4Derm BET platform): August 2021.

Finance: draft 13-week cash view by Friday.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Channels

You're looking at how VYNE Therapeutics Inc. gets its products, data, and corporate messages to the right people. For a clinical-stage company, the channels are heavily weighted toward clinical execution and regulatory interaction, plus the necessary investor outreach.

Clinical trial sites and contract research organizations (CROs)

The execution of clinical studies is a primary channel for data generation and regulatory interaction. For the Repibresib gel Phase 2b trial in nonsegmental vitiligo, the company utilized 45 sites in North America to enroll subjects. This trial involved a randomized, double-blind, vehicle-controlled design with subjects equally randomized (1:1:1:1 ratio) across three active dose cohorts (1%, 2%, or 3% concentrations) and the vehicle group, with approximately 45 subjects in each arm.

For the VYN202 program, the Phase 1b trial in moderate-to-severe plaque psoriasis faced a clinical hold in April 2025. However, by June 2025, the FDA lifted this hold for two doses of VYN202 for female subjects. The company is currently running a 12-week, non-clinical toxicology study in dogs to address the partial hold for male clinical subjects. Research and development expenses related to these activities for the three months ended September 30, 2025, were $5.3 million, a 48.7% decrease from the prior year's $10.2 million.

Key operational metrics related to clinical channels include:

• Phase 2b Repibresib trial sites: 45
• VYN202 clinical hold lifted for: two doses
• VYN202 toxicology study duration: 12-week
• R&D expense for Q3 2025: $5.3 million

Regulatory submissions and direct communication with the FDA

Direct engagement with the U.S. Food and Drug Administration (FDA) is critical for advancing pipeline assets. The most significant recent regulatory channel events involved the VYN202 program and the Repibresib trial results.

The FDA verbally placed a clinical hold on the VYN202 Phase 1b trial in April 2025. The company announced topline results from the Repibresib Phase 2b trial on July 30, 2025. Following these results, VYNE Therapeutics Inc. stated its intent to seek an outside partner for Repibresib's continued development.

The table below summarizes key regulatory timeline touchpoints in 2025:

Product/Trial	Regulatory Event/Communication	Date	Status/Action
VYN202 Phase 1b	Verbal Clinical Hold Issued by FDA	April 2025	Suspended screening, enrollment, and dosing
VYN202 Phase 1b	FDA Lifted Hold for Female Subjects	June 2025	Allowed continuation for female subjects on two doses
Repibresib Phase 2b	Announcement of Topline Results	July 30, 2025	Company to seek external partner for continued development

Investor conferences and corporate website for public disclosure

VYNE Therapeutics Inc. uses investor conferences and its corporate website as primary channels for communicating with the investment community, often to comply with Regulation FD disclosure rules. Management participated in two key conferences in March 2025.

The company's investor relations strategy included:

• Participation in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, which included a fireside chat and one-on-one meetings.
• Participation in the Leerink Partners Global Healthcare Conference on March 11, 2025, featuring one-on-one meetings.
• Webcast replays for the Leerink conference were made available on the VYNE website for 90 days.

Financially, the company reported its Q3 2025 results on November 6, 2025. As of September 30, 2025, the company had $32.7 million in cash, cash equivalents, and marketable securities, projecting a cash runway into the first half of 2027. The Annual Meeting for stockholders of record as of November 6, 2025, is scheduled for December 12, 2025.

Future pharmaceutical licensing and commercialization partners

The company is actively using its strategic review, initiated in August 2025, to explore channels for external partnerships, including licensing opportunities. This is a direct channel to monetize pipeline assets that the company may not commercialize internally.

Current partnership-related financial data points include:

• Royalty revenue from the existing license with LEO Pharma A/S (for Finacea foam) for Q3 2025: $0.2 million.
• A $1.0 million milestone payment was made to Tay in Q3 2025 under the VYN202 License Agreement amendment.

The strategic review initiated in August 2025 explicitly evaluates alternatives such as strategic partnerships and licensing opportunities. Finance: draft 13-week cash view by Friday.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Customer Segments

You're looking at the customer segments for VYNE Therapeutics Inc. (VYNE) as of late 2025. This is a clinical-stage biotech, so the customer base is split between the people who need the medicine and the people who fund the science.

Patients with nonsegmental vitiligo and other chronic inflammatory diseases.

The primary patient segment is individuals suffering from nonsegmental vitiligo, an autoimmune depigmenting disorder where treatment options are severely limited; only 1 FDA-approved therapy exists as of early 2025. VYNE Therapeutics Inc. is focused on this high unmet need area with its lead candidate, repibresib gel (VYN201). The patient pool is substantial, with an estimated 70 million people globally affected by vitiligo, which is approximately 1% of the global population. Specifically within the 7MM (Major Markets), the 12-month prevalence of vitiligo was estimated at 8.2 million cases in 2023, with about 500K cases being treated. The US represents a significant portion, accounting for roughly 60% of those diagnosed cases in the 7MM. The Phase 2b trial for VYN201 involved approximately 180 participants across 45 sites in North America. Beyond vitiligo, VYNE Therapeutics Inc. is also developing VYN202, an oral BET inhibitor, for other serious, immune-mediated diseases, having previously evaluated it in a Phase 1b trial for moderate-to-severe plaque psoriasis.

Here's a quick look at the target patient population metrics:

Metric	Value	Context/Date
Global Vitiligo Prevalence	Approx. 70 million people	As of early 2025
Global Population Percentage	Approx. 1%	As of early 2025
7MM 12-Month Prevalence (Vitiligo)	8.2 million cases	2023 estimate
7MM Treated Cases	Approx. 500K cases	2023 estimate
US Share of 7MM Diagnosed Cases	Approx. 60%	As of early 2025
VYN201 Phase 2b Trial Enrollment	Approx. 180 subjects	Enrolled as of January 2025

Dermatologists and rheumatologists treating these conditions.

This segment consists of the specialists who prescribe and manage treatments for chronic inflammatory and dermatological conditions. While specific numbers for the treating population are not public, the focus is on specialists managing the 8.2 million prevalent cases in the 7MM. The Phase 2b trial for VYN201 utilized 45 clinical sites in North America, indicating the geographic breadth of the required physician network for potential commercialization or partnership efforts. The development of VYN202 suggests a future need to engage rheumatologists for systemic inflammatory diseases, broadening the required specialist base beyond just dermatologists.

• The Phase 2b trial for repibresib gel involved 45 clinical sites in North America.
• The patient population requires specialists familiar with autoimmune depigmenting disorders and broader immuno-inflammatory conditions.

Institutional investors and financial analysts tracking clinical-stage biotech.

These stakeholders are crucial for funding VYNE Therapeutics Inc.'s operations, especially given its clinical-stage status. As of November 2025, institutional ownership is a significant factor, with the holding percentage fluctuating; for instance, it stood at 26.8% in June 2025 before dropping to 15.54% in November 2025. Insiders held 5.94%, and Mutual Funds held 4.19% in November 2025. The company's cash position as of September 30, 2025, was $32.7 million, which is projected to fund operations into the first half of 2027. Analysts track key financial events, such as the Q3 2025 net loss of $7.3 million and R&D expenses of $5.3 million for that quarter, against the cash runway to assess viability. Major institutional holders have included Eventide Asset Management LLC and Adage Capital Partners GP L.L.C. in the past, with reported transaction volumes in the millions of dollars.

Here's a snapshot of the ownership structure and recent financial health metrics:

Metric	Value	As of Date
Cash, Cash Equivalents, Marketable Securities	$32.7 million	September 30, 2025
Projected Cash Runway	Into first half of 2027	Based on September 30, 2025 data
Net Loss (Q3 2025)	$7.3 million	Quarter ended September 30, 2025
R&D Expenses (Q3 2025)	$5.3 million	Three months ended September 30, 2025
Revenues (Q3 2025)	$0.2 million	Three months ended September 30, 2025
Institutional Investors Holding	15.54%	November 2025

Large pharmaceutical companies seeking pipeline assets (potential acquirers).

This segment represents potential strategic partners or acquirers. In August 2025, the Board of Directors initiated a strategic review to evaluate options, including strategic partnerships, licensing, merger, or acquisition transactions. Following the July 2025 announcement that the Phase 2b trial did not meet its primary endpoints, VYNE Therapeutics Inc. explicitly stated it would seek an external partner for the continued development of repibresib. This signals a strong, active interest in engaging with larger pharmaceutical entities that have the resources to advance the asset through later-stage trials and commercialization. The company has a history of engaging with this segment, having previously licensed the rights to Finacea® foam to LEO Pharma A/S.

• Strategic review initiated in August 2025 to explore M&A or licensing.
• Actively seeking an external partner for continued development of repibresib post-July 2025 data.
• Previous licensing activity with LEO Pharma A/S demonstrates prior engagement with large pharma.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Cost Structure

The cost structure for VYNE Therapeutics Inc. is heavily weighted toward the discovery, development, and regulatory navigation of its clinical pipeline assets, VYN201 and VYN202.

Dominant Research and Development (R&D) expenses represent a significant cash outlay, reported at \$16.3 million for the nine months ended September 30, 2025.

General and Administrative (G&A) overhead followed, totaling \$8.7 million for the same nine-month period ending September 30, 2025.

The cost profile for the third quarter of 2025 showed R&D expenses of \$5.3 million and G&A expenses of \$2.7 million, resulting in an operating loss of \$7.792 million for that quarter alone. The net loss for the nine months ended September 30, 2025, was \$21.6 million.

Expense Category	Nine Months Ended Sep 30, 2025 (As Specified)	Three Months Ended Sep 30, 2025 (Actual)
Research and Development (R&D)	\$16.3 million	\$5.3 million
General and Administrative (G&A)	\$8.7 million	\$2.7 million
Total Operating Expenses (Approximate)	Not Directly Available	\$7.961 million

Clinical trial costs were a major component of R&D spending, though subject to timing and program status. The termination of the repibresib (VYN201) Phase 2b trial in nonsegmental vitiligo following topline results in July 2025 impacted the expected expense trajectory for that program. Concurrently, costs were incurred for the ongoing 12-week, non-clinical toxicology study of VYN202 in dogs, initiated to address the partial clinical hold in male subjects.

Licensing and milestone payments are transactional costs tied to specific development achievements. VYNE Therapeutics Inc. made a \$1.0 million milestone payment to Tay in the third quarter of 2025 under an amendment to the VYN202 License Agreement. This payment resolved a dispute regarding the VYN202 Phase 2 milestone.

Personnel costs form a core part of both R&D and G&A spending, reflecting the need for specialized scientific, clinical, and management teams. For the three months ended September 30, 2025, the decrease in G&A expenses, which fell to \$2.7 million, was primarily driven by a decrease in employee-related expenses of \$0.2 million compared to the prior year period.

Specific drivers influencing the R&D cost base include:

• Decreased expenses for repibresib due to the trial termination.
• Decreased clinical expenses for Phase 1 trials evaluating VYN202.
• The \$1.0 million milestone payment to Tay, which partially offset the VYN202 expense decrease in Q3 2025.
• Costs associated with the repeat 12-week, non-clinical toxicology study for VYN202.

Cost discipline was a focus, as evidenced by the overall reduction in operating expenses year-over-year, which helped extend the projected cash runway into the first half of 2027 based on September 30, 2025, cash balances of \$32.7 million.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Revenue Streams

VYNE Therapeutics Inc.'s current revenue streams are minimal and primarily derived from legacy licensing agreements, reflecting its status as a clinical-stage company focused on pipeline development.

Minimal Royalty revenues totaled $0.44 million for the nine months ended September 30, 2025. This figure is the sum of quarterly royalty receipts from the Finacea® foam license.

The primary source of this recurring revenue is Royalties from the licensed Finacea® foam product (LEO Pharma A/S). The quarterly breakdown for the first three quarters of 2025 shows the following royalty income:

Period Ended	Royalty Revenue (USD Thousands)
March 31, 2025 (Q1)	202
June 30, 2025 (Q2)	69
September 30, 2025 (Q3)	169

For the six months ended June 30, 2025, the royalty revenues from LEO Pharma in connection with Finacea sales were $0.3 million.

The business model anticipates Potential future upfront and milestone payments from strategic partnerships. As an example of such a payment, a $1.0 million milestone payment was made to Tay in the third quarter of 2025 under an amendment to the VYN202 License Agreement.

The long-term revenue potential hinges on Future product sales, contingent on regulatory approval. This is dependent on the successful advancement of pipeline assets, specifically:

• Resolving the partial clinical hold for VYN202 in male subjects following an ongoing 12-week, non-clinical toxicology study in dogs.
• Securing a development and commercialization partner for the repibresib gel program after the Phase 2b trial termination.

As of September 30, 2025, VYNE Therapeutics Inc. had $32.7 million of cash, cash equivalents and marketable securities, which management believes is sufficient to fund operations into the first half of 2027.