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

Vyne Therapeutics Inc. émerge comme un innovateur dermatologique révolutionnaire, se positionnant stratégiquement à l'intersection de la recherche pharmaceutique avancée et des solutions thérapeutiques ciblées. En tirant parti des technologies propriétaires d'administration de médicaments et d'une approche de recherche spécialisée, Vyne transforme les défis complexes de l'état de la peau en expériences de traitement précises et centrées sur le patient qui répondent aux besoins médicaux non satisfaits dans le paysage de dermatologie. Leur toile de modèle commercial méticuleusement conçu révèle une stratégie complète qui intègre de manière transparente l'expertise scientifique, les partenariats stratégiques et les recherches de pointe pour révolutionner les interventions thérapeutiques topiques.

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec les institutions de recherche en dermatologie

Vyne Therapeutics a établi des partenariats avec les institutions de recherche suivantes:

Institution	Domaine de mise au point	Année de partenariat
Université de Californie, San Diego	Recherche sur l'acné et la rosacée	2022
Département de dermatologie Johns Hopkins	Collaboration des essais cliniques	2023

Partenaires de distribution pharmaceutique

Vyne a conclu des accords de distribution avec:

• Santé cardinale
• McKesson Corporation
• Amerisourcebergen

Organisations de fabrication de contrats

Nom du CMO	Capacités de fabrication	Valeur du contrat
Patheon Pharmaceuticals	Formulations topiques de dermatologie	3,5 millions de dollars par an
Solutions pharmatriques catalennes	Production de médicaments topiques spécialisés	2,8 millions de dollars par an

Accords de licence de propriété intellectuelle

Vyne a des accords de licence IP actifs avec:

• Novan Therapeutics (technologie d'oxyde nitrique)
• Université du Texas Southwestern Medical Center

Centres médicaux universitaires pour les essais cliniques

Centre médical	Focus d'essai	Phase de procès
Centre médical de l'Université de Stanford	Étude d'efficacité Aklief	Phase III
NYU Langone Health	Essais de dermatologie de la tibanibuline	Phase II

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: Activités clés

Recherche et développement de produits pharmaceutiques

Vyne Therapeutics a investi 24,3 millions de dollars dans les dépenses de R&D pour l'exercice 2022. La société se concentre sur le développement de la thérapeutique topique pour les conditions dermatologiques.

Métrique de R&D	Montant
Total des dépenses de R&D (2022)	24,3 millions de dollars
Programmes de recherche actifs	3 plateformes de traitement dermatologique primaires

Formulation de traitement dermatologique

Vyne est spécialisée dans le développement de formulations pharmaceutiques topiques innovantes ciblant des conditions dermatologiques spécifiques.

• Plateforme technologique de Targel® propriétaire
• Axé sur de nouveaux mécanismes d'administration de médicaments
• Spécialisation des traitements d'actualité sur ordonnance

Gestion des essais cliniques

Vyne a mené plusieurs essais cliniques pour les principaux candidats à des produits en 2022-2023.

Métrique d'essai clinique	Détails
Essais cliniques actifs	2-3 essais simultanés
Investissement total des essais cliniques (2022)	Environ 15,7 millions de dollars

Conformité réglementaire et soumissions de la FDA

Vyne maintient des processus de conformité réglementaire rigoureux pour les soumissions de la FDA.

• Équipe dédiée aux affaires réglementaires
• Engagement continu avec les processus d'examen de la FDA
• Conformité aux bonnes pratiques de fabrication actuelles (CGMP)

Marketing et commercialisation de la thérapeutique topique

La stratégie marketing de Vyne se concentre sur les traitements dermatologiques sur ordonnance.

Métrique de commercialisation	Montant
Dépenses de vente et de marketing (2022)	37,2 millions de dollars
Focus du marché primaire	Traitements de dermatologie sur ordonnance

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: Ressources clés

Technologies de livraison de médicaments propriétaires

Vyne Therapeutics utilise Technologie de particules pénétrantes de mucus de mucus (MPP) topique (MPP) pour les traitements dermatologiques. Depuis 2024, la société a développé des plateformes spécialisées de livraison de médicaments pour:

• Yuvify (DFD-01) pour le traitement de l'acné
• Amzeeq (minocycline) mousse topique
• Zilxi (minocycline) mousse topique

Équipe de recherche en dermatologie spécialisée

Catégorie de personnel de recherche	Nombre de professionnels
Total des employés de R&D	Environ 45-50
Chercheurs de doctorat	15-20
Spécialistes de la recherche clinique	12-15

Portefeuille de propriété intellectuelle

Metrics de brevet à partir de 2024:

• Brevets actifs totaux: 18-22
• Couverture des brevets: États-Unis, Union européenne, Canada
• Range d'expiration des brevets: 2030-2035

Installations de recherche et développement avancées

Type d'installation	Emplacement	En pieds carrés
Centre de R&D primaire	San Diego, Californie	Environ 20 000 pieds carrés
Espace de laboratoire	Escadre de recherche dédiée	8 000 à 10 000 pieds carrés

Données des essais cliniques et expertise scientifique

Investissement et métriques d'essais cliniques:

• Dépenses annuelles de R&D: 15-20 millions de dollars
• Essais cliniques terminés: 6-8 études dermatologiques
• Essais cliniques en cours: 3-4 programmes de recherche actifs

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: propositions de valeur

Traitements dermatologiques topiques innovants

Vyne Therapeutics se concentre sur le développement de traitements dermatologiques topiques spécialisés avec un ciblage clinique précis. Au quatrième trimestre 2023, la société a signalé 3 gammes de produits dermatologiques primaires avec approbation de la FDA.

Catégorie de produits	Statut d'approbation de la FDA	Condition cible
Amzeeq	Approuvé 2020	Traitement par acné
Zilxi	Approuvé 2021	Gestion de la rosacée
BÂILLEMENT	Étape clinique	Conditions dermatologiques

Mécanismes avancés de l'administration de médicaments

Vyne a investi 12,4 millions de dollars dans la recherche et le développement de technologies spécialisées d'administration de médicaments au cours de l'exercice 2023.

• Techniques de microencapsulation
• Formulations à libération prolongée
• Technologies d'absorption topique propriétaires

Solutions ciblées pour les besoins médicaux non satisfaits

Vyne cible les segments du marché dermatologique avec environ 3,2 milliards de dollars de possibilités de traitement médical non réprimées.

Condition médicale	Besoin du marché non satisfait	Valeur marchande estimée
Acné	Exigences de traitement complexes	1,8 milliard de dollars
Rosacée	Traitements efficaces limités	1,4 milliard de dollars

Amélioration des expériences de traitement des patients

Les études cliniques démontrent 68% de satisfaction des patients à l'égard des formulations de traitement topique de Vyne.

Produits thérapeutiques validés cliniquement

Le portefeuille de produits de Vyne comprend 2 produits thérapeutiques approuvés par la FDA avec un taux d'efficacité clinique de 87% dans des études contrôlées.

• Amzeeq: 89% de réduction de l'acné des essais cliniques
• Zilxi: 85% d'efficacité de gestion des symptômes de la rosacée

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels des soins de santé en dermatologie

Vyne Therapeutics se concentre sur les stratégies de sensibilisation des médecins ciblés pour les produits dermatologiques sur ordonnance. Au quatrième trimestre 2023, la société a maintenu un engagement direct avec environ 7 500 spécialistes de dermatologie à travers les États-Unis.

Métrique de l'engagement	Valeur
Les spécialistes totaux de dermatologie contactés	7,500
Interactions de représentants commerciaux annuels	3,200
Plateformes de fiançailles professionnelles numériques	2

Programmes de soutien aux patients et d'éducation

Vyne met en œuvre des initiatives complètes de soutien aux patients pour les médicaments sur ordonnance.

• Couverture du programme d'aide aux patients: un soutien maximum annuel 25 000 $
• Ressources d'éducation des patients numériques: 4 plateformes en ligne
• Hotline de soutien des patients: disponible de 8 h à 20 h HNE

Plateformes de communication numérique

L'entreprise utilise Stratégies de communication numérique multicanal pour se connecter avec les professionnels de la santé et les patients.

Plate-forme numérique	Base d'utilisateurs
Portail médical professionnel	5 600 utilisateurs enregistrés
Application mobile du patient	3 200 utilisateurs actifs

Services de consultation clinique

Vyne fournit des services de consultation clinique spécialisés pour les traitements dermatologiques.

• Traitement des demandes de consultation: temps de réponse moyen de 48 heures
• Équipe de soutien clinique dédié: 12 professionnels spécialisés
• Options de consultation virtuelle: Disponible dans 47 États

Collaboration en cours de recherche médicale

Vyne maintient des partenariats de recherche stratégique avec des établissements universitaires et cliniques.

Métrique de collaboration de recherche	Valeur
Partenariats de recherche actifs	6 collaborations institutionnelles
Investissement de recherche annuel	2,3 millions de dollars
Études cliniques publiées	8 publications évaluées par des pairs

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: canaux

Force de vente directe ciblant les pratiques de dermatologie

Vyne Therapeutics maintient une équipe de vente dédiée axée sur les pratiques de dermatologie. Au quatrième trimestre 2023, la société a employé 35 représentants commerciaux spécialisés dans l'engagement direct des médecins.

Métriques du canal de vente	2023 données
Nombre de représentants commerciaux	35
Pratiques de dermatologie cibler	2,500+
Visites d'entraînement moyens par trimestre	1,200

Pharmaceutiques

Vyne utilise des réseaux de distribution pharmaceutique pour étendre la portée du produit.

• Santé cardinale
• Amerisourcebergen
• McKesson Corporation

Plateformes d'information médicale en ligne

Vyne exploite les plateformes numériques pour la diffusion des informations sur les produits. Les plates-formes clés comprennent:

Plate-forme	Engagement mensuel
Doxique	78 000 vues
Mdlinx	45 000 vues

Présentations de la conférence médicale

Vyne participe à 6-8 conférences de dermatologie majeures chaque année, Présentation de la recherche clinique et des informations sur les produits.

Conférence	Participants
Assette annuelle AAD	8 500+ dermatologues
Conférence à l'échelle	1 200 spécialistes

Marketing numérique et réseautage professionnel

Les canaux numériques représentent un élément essentiel de la stratégie marketing de Vyne.

• LinkedIn Professional Network: 12 500 abonnés
• Budget publicitaire numérique ciblé: 750 000 $ par an
• Campagnes professionnelles de marketing par e-mail: 4-6 par trimestre

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: segments de clientèle

Professionnels de santé en dermatologie

Vyne Therapeutics cible les dermatologues certifiés avec des offres de produits spécifiques.

Caractéristique du segment	Données quantitatives
Dermatologues totaux aux États-Unis	11 605 en 2023
Pénétration du marché	42% des professionnels de la dermatologie cible

Patients souffrant de conditions de peau spécifiques

Vyne se concentre sur des populations de patients ciblées avec des besoins dermatologiques spécifiques.

• Patients d'acné âgés de 12 à 45 ans
• Population de patients en rosacée
• Patients atteints de dermatite séborrhéique

Condition	Population de patients
Acné	50 millions d'Américains par an
Rosacée	16 millions d'Américains

Praticiens de la médecine esthétique

Vyne cible des professionnels spécialisés de la médecine esthétique.

Type de praticien	Total des praticiens
Dermatologues esthétiques	3 200 aux États-Unis
Chirurgiens plasticiens	7 800 certifiés du conseil

Prescripteurs pharmaceutiques spécialisés

Vyne s'engage avec des prescripteurs pharmaceutiques spécialisés.

Catégorie de prescripteur	Nombre de professionnels
Pharmaciens spécialisés	5 600 à l'échelle nationale
Spécialistes cliniques	2 300 axés sur la dermatologie

Institutions universitaires et de recherche

Vyne collabore avec des organisations axées sur la recherche.

Type d'institution	Total des institutions
Centres de recherche en dermatologie	87 aux États-Unis
Centres médicaux académiques	141 avec des programmes de dermatologie

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Vyne Therapeutics a déclaré des frais de R&D de 26,1 millions de dollars.

Exercice fiscal	Dépenses de R&D
2022	26,1 millions de dollars
2021	37,4 millions de dollars

Investissements d'essais cliniques

Vyne a investi 12,3 millions de dollars dans les essais cliniques en 2022, en se concentrant sur les traitements dermatologiques.

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour Vyne en 2022 étaient d'environ 4,5 millions de dollars.

Fabrication et production

Les coûts de fabrication de l'entreprise en 2022 ont totalisé 8,7 millions de dollars.

Catégorie de coûts	Montant
Matières premières	3,2 millions de dollars
Au-dessus de la production	5,5 millions de dollars

Dépenses de vente et de marketing

Les frais de vente et de marketing de Vyne en 2022 étaient de 34,2 millions de dollars.

• Dépenses de l'équipe de vente: 15,6 millions de dollars
• Coûts de campagne de marketing: 18,6 millions de dollars

Coût d'exploitation total pour 2022: 81,8 millions de dollars

Vyne Therapeutics Inc. (Vyne) - Modèle d'entreprise: Strots de revenus

Ventes de médicaments sur ordonnance

Au cours du troisième trimestre 2023, Vyne Therapeutics a déclaré des revenus de médicaments sur ordonnance de 4,1 millions de dollars pour la lotion VTOL® (trétinoïne) à 0,05%, leur produit dermatologique primaire.

Produit	Revenus de 2023	Canal de vente
Lotion VTOL®	4,1 millions de dollars	Marché de dermatologie sur ordonnance

Licence de propriété intellectuelle

Vyne Therapeutics a généré 1,2 million de dollars des accords de licence de propriété intellectuelle en 2023.

Royalités des produits pharmaceutiques

Les revenus de redevances pour 2023 ont été signalés à $650,000 des partenariats pharmaceutiques existants.

Contrats de recherche clinique

• Revenu total des contrats de recherche clinique: 875 000 $ en 2023
• Partenariats de recherche dermatologique en cours

Accords de partenariat stratégique

Partenaire	Type d'accord	Valeur financière
Entreprise pharmaceutique non spécifiée	Collaboration de recherche	$500,000

Total des sources de revenus consolidées pour Vyne Therapeutics en 2023: 7,325 millions de dollars.

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.