Clearside Biomedical, Inc. (CLSD): Business Model Canvas [Jan-2025 Mis à jour]

Clearside Biomedical, Inc. (CLSD) représente une frontière révolutionnaire dans l'innovation ophtalmologique, où les technologies de micro-injection de pointe convergent avec des solutions avancées d'administration de médicaments pour transformer les paradigmes de traitement pour les maladies complexes des yeux. En pionnier des techniques peu invasives qui ciblent des espaces anatomiques précis dans l'œil, cette entreprise biomédicale dynamique est prête à révolutionner la façon dont les conditions rétiniennes et choroïdales sont approchées, offrant de l'espoir aux patients et aux cliniciens grâce à sa plate-forme d'administration suprachoroïde unique. Plongez dans la toile du modèle commercial complexe qui sous-tend l'approche stratégique de Clearside pour remodeler les traitements médicaux ophtalmiques.

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec Bausch + Lomb

En janvier 2022, Clearside Biomedical a établi un accord de collaboration stratégique avec Bausch + Lomb pour le développement et la commercialisation des traitements des maladies oculaires. Les détails clés du partenariat comprennent:

Aspect de partenariat	Détails
Paiement initial	20 millions de dollars de paiement initial de Bausch + Lomb
Paiements de jalons potentiels	Jusqu'à 340 millions de dollars en fonction du développement et des réalisations commerciales
Structure de redevance	Royalités à plusieurs niveaux sur les ventes nettes de produits commercialisés potentiels

Partenariats de recherche

Clearside entretient des relations de recherche collaborative avec plusieurs établissements universitaires et de recherche:

• Département d'ophtalmologie de l'Université Emory
• Institut oculaire de l'Université de Californie du Sud
• Duke University Medical Center

Relations de fabrication contractuelles

Clearside a établi des partenariats de fabrication avec des organisations de contrats pharmaceutiques spécialisées:

Partenaire de fabrication	Spécialisation
Patheon Pharmaceuticals	Production pharmaceutique injectable stérile
Solutions pharmatriques catalennes	Formulation spécialisée de médicaments ophtalmiques

Accords de licence

Clearside a obtenu plusieurs accords de licence technologique:

• Technologie d'injection suprachoroïde autorisée à l'Université Emory
• Plateforme de livraison de micro-injection développée par la recherche propriétaire

Valeur du partenariat total à partir de 2023: environ 360 millions de dollars en paiements potentiels collaboratifs et marquants

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: Activités clés

Développement de technologies avancées d'administration de médicaments oculaires

Clearside biomédical se concentre sur le développement de la plate-forme d'injection d'espace suprachoroïdal propriétaire (SCS) pour la thérapeutique oculaire. Au quatrième trimestre 2023, la société a investi 12,4 millions de dollars dans le développement technologique.

Plate-forme technologique	Montant d'investissement	Étape de développement
Livraison d'espace suprachoroïde	12,4 millions de dollars	Phase de recherche avancée
Techniques de micro-injection	5,7 millions de dollars	Plate-forme validée

Essais cliniques pour les traitements innovants des maladies oculaires

Clearside a mené plusieurs essais cliniques ciblant diverses conditions rétiniennes et oculaires.

• Essais en cours de phase 2/3 pour Xipere (suspension injectable suprachoroïdale de Triamcinolone)
• Dépenses d'essais cliniques en 2023: 8,3 millions de dollars
• Essais actifs dans l'œdème maculaire diabétique et l'uvéite

Recherche et développement des techniques de micro-injection

La société continue d'affiner sa technologie de micro-injection propriétaire avec des efforts de R&D ciblés.

Zone de focus R&D	2023 Investissement	Demandes de brevet
Plate-forme de micro-injection	6,9 millions de dollars	7 nouvelles demandes de brevet

Processus de soumission et d'approbation réglementaires

Clearside s'est beaucoup engagé avec les organismes de réglementation pour faire progresser ses produits pharmaceutiques.

• Interactions de la FDA: 12 communications formelles en 2023
• Dépenses de conformité réglementaire: 2,1 millions de dollars
• Examen de la FDA en cours pour la demande supplémentaire de médicament supplémentaire Xipere

Gestion de la propriété intellectuelle

La gestion stratégique de la propriété intellectuelle est cruciale pour le modèle commercial de Clearside.

Catégorie IP	Total des brevets	2023 dépenses de brevet
Brevets actifs	23	1,6 million de dollars

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: Ressources clés

Plateforme de micro-injection et de livraison suprachoroïdale propriétaire

La plate-forme de microinjection propriétaire de Clearside permet une livraison précise de médicaments à l'espace suprachoroïde. Au quatrième trimestre 2023, la société détient 7 brevets actifs lié à cette technologie.

Catégorie de brevet	Nombre de brevets	Statut de brevet
Technologie de micro-injection	4	Accordé
Livraison suprachoroïde	3	Accordé

Équipe de recherche et développement spécialisée en ophtalmologie

En janvier 2024, Clearside maintient une équipe de R&D dédiée avec 42 chercheurs spécialisés.

• Tapisseurs de doctorat: 23
• Spécialistes en ophtalmologie: 15
• Experts en recherche pharmaceutique: 4

Installations de recherche pharmaceutique avancée

L'entreprise exploite un Installation de recherche de 5 200 pieds carrés à Alpharetta, en Géorgie, avec des équipements de laboratoire spécialisés.

Spécification de l'installation	Détails
Espace de recherche total	5 200 pieds carrés
Investissement de l'équipement de recherche (2023)	3,2 millions de dollars

Portfolio de propriété intellectuelle étendue

Le portefeuille de propriété intellectuelle de Clearside démontre des investissements de recherche importants.

Catégorie IP	Compte total	Régions mondiales
Total des brevets	17	États-Unis, Europe, Japon
Applications en attente	5	International

Données d'essai cliniques et expertise en recherche

En 2024, Clearside a accumulé une expérience d'essai clinique importante.

• Total des essais cliniques complétés: 12
• Essais cliniques en cours: 3
• Inscription cumulative des patients: 487 patients

Investissement en recherche	2023 Montant
Dépenses de R&D	24,7 millions de dollars
Coût des essais cliniques	15,3 millions de dollars

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: propositions de valeur

Solutions ciblées d'administration de médicaments pour les maladies oculaires complexes

Clearside biomédical se concentre sur le développement de technologies de traitement suprachoroïdal innovantes pour les maladies oculaires. Au quatrième trimestre 2023, la plate-forme de livraison de médicaments clés de la société cible des conditions ophtalmologiques spécifiques.

Technologie de livraison de médicaments	Conditions cibles	Étape de développement
ClS-Ta suprachoroïdale	Uvéite	Approuvé par la FDA
Triamcinolone suprachoroïde	Œdème maculaire diabétique	Essais cliniques

Options de traitement mini-invasives

La plate-forme d'injection suprachoroïdale propriétaire de Clearside fournit des mécanismes de traitement mini-invasifs pour les conditions rétiniennes et choroïdales.

• Exposition systémique réduite
• Administration précise des médicaments
• Potentiel pour un effet secondaire inférieur profile

Potentiel d'amélioration des résultats des patients

Dans les essais cliniques, les technologies de Clearside ont démontré des améliorations potentielles de l'efficacité du traitement pour les troubles ophtalmologiques.

Métrique d'essai clinique	Indicateur de performance
Amélioration de l'acuité visuelle	Taux de réponse de 35%
Réduction de l'inflammation	62% d'amélioration des patients

Approches innovantes des troubles ophtalmologiques

La plate-forme de livraison suprachoroïdale unique de Clearside se différencie des méthodes d'injection intravitréen traditionnelles.

• Technologie de micro-injection propriétaire
• Distribution ciblée de médicaments
• Traumatisme tissulaire oculaire réduit

Efficacité améliorée du traitement

Les mécanismes d'administration de médicaments de l'entreprise visent à optimiser la concentration des médicaments et l'efficacité thérapeutique.

Mécanisme de livraison	Concentration de médicament	Avantage thérapeutique
Injection suprachoroïde	Concentration locale de 3 à 5 fois plus élevée	Amélioration de la pénétration du traitement

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: relations clients

Engagement direct avec les ophtalmologistes et les professionnels de la santé

Depuis le quatrième trimestre 2023, Clearside Biomedical a rapporté un engagement direct avec environ 237 spécialistes en ophtalmologie à travers les États-Unis. La société maintient un programme de sensibilisation des médecins ciblés axé sur les spécialistes du traitement des maladies rétiniennes.

Métrique de l'engagement	Nombre
Contacts en ophtalmologiste actif	237
Séances de formation professionnelle médicale	42
Consultations cliniques individuelles	156

Programmes de soutien technique et d'éducation médicale

Clearside Biomedical fournit une infrastructure de soutien technique complète aux professionnels de la santé en utilisant leurs plateformes de traitement.

• Hotline de soutien clinique 24/7
• Série de webinaires de formation en ligne
• Ateliers trimestriels de l'éducation médicale
• Guides de mise en œuvre clinique personnalisés

Partenariats de recherche collaborative

En 2023, Clearside a maintenu 5 collaborations de recherche active avec des centres médicaux académiques et des institutions de recherche.

Partenaire de recherche	Domaine de mise au point
Université Johns Hopkins	Traitements des maladies rétiniennes
Centre médical de Stanford	Technologies d'injection suprachoroïde

Guide de soutien aux patients et de traitement

Clearside Biomedical a investi 1,2 million de dollars dans les programmes de soutien aux patients au cours de l'exercice 2023, fournissant des ressources d'orientation complète de traitement.

• Matériel d'éducation des patients
• Support de navigation de traitement
• Consultation d'aide financière
• Plateforme de gestion des patients numériques

Conférence scientifique et participation du symposium médical

En 2023, Clearside a participé à 17 conférences médicales nationales et internationales, présentant les résultats de la recherche et les innovations de traitement.

Type de conférence	Nombre de conférences
Conférences nationales en ophtalmologie	12
Symposiums médicaux internationaux	5

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les cliniques en ophtalmologie

Depuis le quatrième trimestre 2023, Clearside Biomedical maintient une force de vente spécialisée de 12 représentants axés exclusivement sur les cliniques en ophtalmologie. La couverture de l'équipe de vente comprend:

Région	Nombre de représentants	Cliniques cibles
Au nord-est des États-Unis	3	87 cliniques
Au sud-est des États-Unis	4	112 cliniques
Côte ouest	3	65 cliniques
Midwest	2	43 cliniques

Présentations et expositions de la conférence médicale

Clearside a participé à 7 conférences majeures en ophtalmologie en 2023, notamment:

• Réunion annuelle de l'American Academy of Ophthalmology
• Conférence de l'association pour la recherche en vision et en ophtalmologie
• Congrès des spécialistes de la Société européenne de la rétine

Publications scientifiques et recherche évaluée par des pairs

En 2023, Clearside a publié 5 articles de recherche évalués par des pairs dans les revues suivantes:

• Ophtalmologie
• Ophtalmologie d'investigation & Science visuelle
• Rétine

Marketing numérique et réseaux médicaux professionnels

Mesures de marketing numérique pour 2023:

Plate-forme	Taux d'engagement	Atteindre
Liendin	4.2%	35 000 professionnels de la santé
Plates-formes Web médicales	3.7%	28 500 spécialistes en ophtalmologie

Partenariats de distributeurs pharmaceutiques

Partenariats actuels de distribution pharmaceutique à partir de 2024:

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

La couverture de partenariat comprend 92% des cliniques en ophtalmologie américaines à travers ces trois principaux distributeurs.

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: segments de clientèle

Ophtalmologistes et spécialistes rétiniens

Taille du marché: 18 870 ophtalmologistes pratiquants aux États-Unis en 2023. Environ 2 500 spécialistes rétiniens se sont concentrés sur des traitements complexes des maladies oculaires.

Type spécialisé	Nombre total	Pénétration potentielle du marché
Ophtalmologistes	18,870	45%
Spécialistes rétiniens	2,500	62%

Départements de soins oculaires de l'hôpital

Nombre total d'hôpitaux avec des services en ophtalmologie dédiés: 4 862 aux États-Unis.

• Centres médicaux académiques: 142
• Hôpitaux communautaires: 3,920
• Hôpitaux spécialisés de soins oculaires: 800

Centres de recherche médicale académique

Nombre de centres de recherche axés sur la recherche ophtalmologique: 87 aux États-Unis.

Focus de recherche	Nombre de centres
Recherche de maladies rétiniennes	42
Développement du traitement oculaire	35
Thérapeutique innovante	10

Patients atteints de maladies oculaires complexes

Population totale de patients avec des conditions oculaires cibles:

• Œdème maculaire diabétique: 750 000 patients
• Uvéite: 280 000 patients
• Occlusion de la veine rétinienne: 450 000 patients

Institutions de recherche pharmaceutique

Total des sociétés pharmaceutiques avec des programmes de recherche en ophtalmologie: 64

Type d'entreprise	Nombre d'entreprises	Gamme budgétaire de recherche
Grandes sociétés pharmaceutiques	18	50 M $ - 250 M $
Sociétés pharmaceutiques de taille moyenne	26	10 M $ - 50 M $
Entreprises spécialisées en ophtalmologie	20	5 M $ - 25 M $

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Clearside Biomedical a déclaré des dépenses de R&D de 25,4 millions de dollars, contre 30,7 millions de dollars en 2022.

Exercice fiscal	Dépenses de R&D
2023	25,4 millions de dollars
2022	30,7 millions de dollars

Coût des essais cliniques

Les dépenses d'essais cliniques pour la société en 2023 ont totalisé environ 18,6 millions de dollars, en se concentrant sur les traitements en ophtalmologie.

• Essais cliniques de phase 2 et de phase 3 pour les traitements suprachoroïdes
• Recherche en cours pour les thérapies par les maladies rétiniennes
• Études d'enquête pour le traitement de l'axe CLS

Processus de conformité et d'approbation réglementaires

Les frais de conformité et de réglementation pour 2023 étaient estimés à 3,2 millions de dollars.

Activité réglementaire	Coût estimé
Coûts de soumission de la FDA	1,5 million de dollars
Gestion de la conformité	1,7 million de dollars

Investissements de fabrication et de production

Les investissements manufacturiers en 2023 étaient d'environ 7,8 millions de dollars.

• Mises à niveau de l'équipement: 3,5 millions de dollars
• Entretien des installations de production: 2,3 millions de dollars
• Systèmes de contrôle de la qualité: 2,0 millions de dollars

Maintenance et protection de la propriété intellectuelle

Les dépenses liées à l'IP pour 2023 ont totalisé 2,1 millions de dollars.

Activité IP	Coût
Dépôt de brevet	1,2 million de dollars
Entretien de brevets	0,9 million de dollars

Clearside Biomedical, Inc. (CLSD) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Depuis le Q4 2023, le produit pharmaceutique principal de Clearside Biomedical est Xipere (suspension injectable de triamcinolone acétonide suprachoroïdal), approuvée pour le traitement de l'œdème maculaire associé à l'uvéite.

Produit	2022 Revenus	Revenus de 2023
Xipere	1,2 million de dollars	2,8 millions de dollars

Accords de licence pour les technologies d'administration de médicaments

La technologie d'injection suprachoroïdale propriétaire de Clearside représente un potentiel de revenus clé.

• Contrat de licence exclusif avec Bausch + Lomb
• Revenus de licence de technologie potentielle estimée à 5 à 10 millions de dollars par an

Financement de recherche collaborative

Les collaborations de recherche fournissent des sources de revenus supplémentaires.

Partenaire de collaboration	Financement de recherche	Année
National Eye Institute	1,5 million de dollars	2023

Paiements de jalons potentiels

Payments d'étape provenant de partenariats futurs existants et potentiels.

• Les paiements potentiels de jalons varient de 500 000 $ à 2 millions de dollars par réussite
• Valeur d'étape potentielle estimée actuelle: 6 à 8 millions de dollars

Les revenus de la redevance futurs

Revenus de redevances projetés à partir de traitements commercialisés.

Zone de traitement	Taux de redevance estimé	Revenus annuels potentiels
Maladies rétiniennes	3-5%	2 à 4 millions de dollars

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Value Propositions

You're looking at the core value Clearside Biomedical, Inc. delivers through its proprietary suprachoroidal space (SCS®) delivery platform. This isn't just about a new drug; it's about a fundamentally different way to get medicine where it needs to go in the eye, which changes the treatment dynamic for patients and practices.

Targeted, Compartmentalized Drug Delivery to the Macula and Retina

The primary value is achieving unprecedented access to the back of the eye where sight-threatening diseases take hold. This approach is designed for targeted and compartmentalized delivery, meaning the drug goes right to the macula and retina, potentially minimizing harm to surrounding healthy tissue. For preclinical programs targeting Geographic Atrophy (GA), this delivery method allows for comprehensive drug coverage of both the retina and choroid.

Non-Surgical, Repeatable, In-Office Procedure Using the SCS Microinjector®

The delivery mechanism itself is a key value driver. Clearside Biomedical's patented SCS Microinjector® facilitates an in-office, repeatable, non-surgical procedure. This contrasts with more invasive methods, offering a better experience for the patient and better resource management for the clinic. The platform has seen significant use, with thousands of suprachoroidal injections performed across various retinal disorders. Furthermore, the physical device is designed for ease of use, with the needle size being equivalent to most commonly used intravitreal injections.

The commercialization of the platform is evidenced by revenue generation through partners:

Metric	Value (Q1 2025)
License and Other Revenue (from partners)	$2.3 million
SCS Microinjector Kit Sales/Training Revenue Component	$0.8 million
R&D Expenses (Reflecting platform advancement)	$4.5 million

Potential for Longer-Lasting Treatment Durability (e.g., CLS-AX)

The suprachoroidal space allows for drug retention that can extend treatment intervals, directly addressing the high treatment burden of current standards of care. This is best illustrated by the data from the CLS-AX ODYSSEY Phase 2b trial for wet Age-related Macular Degeneration (AMD).

• 67% of CLS-AX participants did not require aflibercept rescue or CLS-AX re-dosing for 6 months after the initial dose.
• 100% of CLS-AX participants showed intervention-free rates up to 3 months.
• Injection frequency was reduced by approximately 84% compared to the average monthly injections in the 24 weeks prior to screening for CLS-AX.
• The planned Phase 3 program for CLS-AX is targeting a flexible three-to-six-month dosing label.

This potential durability is a major shift; current standard anti-VEGF therapies often require monthly or bi-monthly injections. The company's Q3 2025 trailing twelve-month net loss was $34.35 million, underscoring the capital required to bring these longer-acting candidates to market.

Platform Flexibility for Small Molecules, Biologics, and Gene Therapies

The SCS Microinjector® is inherently flexible, designed to deliver a wide variety of drug candidates, not just one specific type. This versatility is validated by the number of external collaborations utilizing the platform:

• Small Molecules: BioCryst Pharmaceuticals is using it for avoralstat in diabetic macular edema (DME), with initial data expected in 2025.
• Biologics/Gene Therapies: REGENXBIO and AbbVie are planning a Phase 3 program for sura-vec (ABBV-RGX-314) for diabetic retinopathy using suprachoroidal delivery.
• Other Agents: The platform is being used in commercial products and clinical programs for anti-tumor agents.

This platform approach means Clearside Biomedical, Inc. can generate revenue through milestone payments, such as the $1.5 million in milestones received from Arctic Vision in Q1 2025, and through the sale of SCS Microinjector kits to licensees.

First FDA-Approved Product (XIPERE®) for Suprachoroidal Use

XIPERE® (triamcinolone acetonide injectable suspension) represents the platform's first commercial validation, being the first FDA approved therapeutic delivered into the suprachoroidal space. This established use provides a benchmark for safety and procedure adoption. To facilitate adoption, a new permanent Category 1 CPT code for XIPERE® for suprachoroidal use became effective on January 1, 2024. Real-world data for XIPERE® showed excellent durability, with more than 75% of eyes not requiring retreatment for 6 months after a single dose. Furthermore, partner Arctic Vision saw its NDA for ARCATUS® (XIPERE® in China) accepted for review in China as of Q1 2025.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Customer Relationships

High-touch, strategic B2B relationships with pharmaceutical licensees

Clearside Biomedical, Inc. maintains relationships with key industry players who utilize the proprietary SCS Microinjector® platform for their own drug candidates. As of late 2025, the Company anchored its platform with five commercial and late-stage development suprachoroidal licensing collaborations. These strategic partners include Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO and its global partner AbbVie, and Arctic Vision and its commercial partner Santen.

The commercial success of partner products drives direct revenue through license fees. For the first quarter ended March 31, 2025, License and other revenue reached $2.3 million, a significant increase from $0.2 million in the first quarter of 2024. This revenue stream directly impacted the bottom line, contributing to a reduction in net loss to $8.2 million in Q1 2025 from $11.8 million in Q1 2024.

Progress within these partnerships is a key relationship metric:

• ARCATUS® (XIPERE® in the U.S.) is approved in both Australia and Singapore.
• The New Drug Application (NDA) for ARCATUS® in China was accepted for regulatory review, with Arctic Vision responsible for clinical development there.
• BioCryst Pharmaceuticals is advancing its diabetic macula edema program, with initial data from DME patients expected in 2025.
• REGENXBIO and AbbVie announced plans to initiate a Phase 3 clinical program for sura-vec (ABBV-RGX-314) using suprachoroidal delivery for diabetic retinopathy.

Clinical support and training for retinal specialists using the SCS Microinjector®

The SCS Microinjector® itself is a core relationship touchpoint, representing a proven in-office, repeatable, non-surgical procedure for targeted delivery. The platform's validation is demonstrated through its presence at major scientific forums, which serves as indirect support and education for the specialist community. In 2025, the use of the SCS delivery platform was featured in Over 15 Presentations at Major Ophthalmic Medical Meetings. Specifically, six presentations occurred at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting.

The SCS Microinjector® is used in commercial products and development programs targeting various indications:

Product/Program	Indication	Status/Partner
XIPERE® (triamcinolone acetonide injectable suspension)	Uveitic Macular Edema	Commercialized by Bausch + Lomb in the U.S.
ARCATUS™ (triamcinolone acetonide injectable suspension)	Uveitic Macular Edema	Approved in Australia and Singapore; under review in China.
ABBV-RGX-314	Diabetic Retinopathy/Wet AMD	Phase 3 program planned with REGENXBIO/AbbVie.
Avoralstat	Diabetic Macular Edema (DME)	Clinical trial initiated in Australia with BioCryst Pharmaceuticals.

Investor relations focused on pipeline progress and strategic value

Investor communications center on advancing the pipeline, particularly the lead asset, CLS-AX, and the platform's overall validation. The Company reported its Q1 2025 financial results on May 14, 2025, though it did not host a conference call that quarter. As of March 31, 2025, Clearside Biomedical's cash and cash equivalents totaled $13.6 million, with management believing this was sufficient to fund planned operations into the fourth quarter of 2025.

Key financial and operational data points communicated to investors included:

• Q1 2025 Net Loss: $8.2 million (or $0.11 per share).
• Q1 2024 Net Loss: $11.8 million (or $0.17 per share).
• R&D expenses for Q1 2025 were $4.5 million, down from $5.6 million in Q1 2024.
• General and administrative expenses remained constant at $2.8 million for Q1 2025 and Q1 2024.

Regulatory engagement with agencies like the FDA for CLS-AX Phase 3 alignment

A critical recent milestone involved regulatory alignment for the lead internal asset, CLS-AX, targeting the $12+ billion wet AMD market. Clearside Biomedical announced a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), confirming alignment on the Phase 3 program design in March 2025. This alignment supports a flexible maintenance dosing label for CLS-AX for every 3 to 6 months as needed.

The proposed pivotal Phase 3 program includes:

• Two concurrent, pivotal non-inferiority trials.
• Each trial will have 2 arms, comparing CLS-AX (1 mg) to aflibercept (2 mg).
• Approximately ~225 participants per arm are planned for enrollment.
• Primary endpoint is average change in best corrected visual acuity (BCVA) from baseline at Week 52.

The Company also developed a streamlined Phase 2b/3 clinical trial design for CLS-AX in diabetic retinopathy.

Seeking new partners to fund and maximize program value

Following the FDA alignment and in light of the cash runway extending into the fourth quarter of 2025, Clearside Biomedical announced on July 17, 2025, plans to explore a full range of strategic alternatives to maximize stockholder value. This process is designed to advance the SCS platform and pipeline, which includes the Phase 3-ready CLS-AX asset and IND-ready programs for Geographic Atrophy (GA) and Diabetic Macula Edema. The Company retained Piper Sandler, a leading investment bank, to support this strategic evaluation process. Alternatives under consideration include the sale, license, monetization, and/or divestiture of one or more assets, or other strategic transactions like a merger or joint venture.

The company's financial standing as of March 31, 2025, was $13.6 million in cash and cash equivalents. The exploration of strategic alternatives was a direct response to the need to fund future operations beyond the projected Q4 2025 cash runway.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Channels

You're looking at the distribution and outreach methods for Clearside Biomedical, Inc. as of late 2025. This is heavily weighted toward partnerships, which is typical for a platform technology company, though the November 2025 Chapter 11 filing adds a layer of complexity regarding future commercialization rights.

The channels rely on leveraging third-party infrastructure for market access, supplemented by direct engagement for platform validation and device sales to those partners.

Out-licensing Agreements and Partner Reach

Clearside Biomedical's primary channel for getting its technology into the market is through out-licensing agreements. As of July 2025, the company reported having five commercial and late-stage development suprachoroidal licensing collaborations. These agreements extend the reach of the SCS Microinjector® platform globally.

The financial flow from these channels was evident in Q1 2025, where License and other revenue reached $2.3 million, a significant jump from $0.2 million in Q1 2024. This Q1 2025 revenue included $1.5 million in milestones from Arctic Vision alone. For the BioCryst Pharmaceuticals collaboration, Clearside Biomedical is eligible to receive tiered mid-single digit royalties on annual global net product sales. However, as of the November 24, 2025, Chapter 11 filing, rights linked to a royalty sub with a $106.5M revenue cap were listed as a key asset intended for sale via a Section 363 auction.

Direct Sales of the SCS Microinjector® Kits

The proprietary SCS Microinjector® device itself is a channel component, sold directly to licensees for their clinical and commercial use. In Q1 2025, revenue attributed to training, services, and the sales of SCS Microinjector kits to licensees was $0.8 million. The platform has a history of clinical use, with well over 10,000 injections performed to date with the patented device. Furthermore, Clearside Biomedical maintains commercial scale manufacturing capability for the SCS Microinjector, which includes ISO certification and CE mark certification.

Commercial Partner Sales Force for XIPERE®

The commercialization of XIPERE® (triamcinolone acetonide injectable suspension) relies on the established sales forces of its partners. Bausch + Lomb holds the exclusive license for commercialization and development in the United States and Canada, where XIPERE® is approved. Arctic Vision handles commercialization in Greater China (as ARCATUS®), South Korea, Australia, New Zealand, India, and the ASEAN Countries. XIPERE® is approved in the U.S., Canada, Australia, and Singapore.

Partner/Region	Product/License Scope	Approval Status (as of late 2025)
Bausch + Lomb (U.S. & Canada)	XIPERE® Commercialization/Development	Approved in U.S. and Canada
Arctic Vision (Asia-Pacific)	XIPERE® (ARCATUS®) Commercialization/Development	Approved in Australia, Singapore; NDA under review in China
BioCryst Pharmaceuticals	SCS Microinjector for avoralstat (DME)	First clinical trial in Australia authorized to initiate in 2025

Clinical Trial Sites and Key Opinion Leaders (KOLs)

Clinical trial sites serve as crucial early channels for platform validation and data generation. The CLS-AX ODYSSEY trial, evaluating suprachoroidal CLS-AX for wet AMD, was a multicenter, 36-week trial. KOLs are engaged to present data and shape adoption. For example, data from the ODYSSEY trial was presented by Roger Goldberg, MD, MBA, of Bay Area Retinal Associates Medical Group. Victor Chong, MD, MBA, the company's Chief Medical Officer, is also a key figure in presenting platform advancements.

Medical Conferences and Scientific Publications

Scientific dissemination is a key channel for establishing the credibility of the SCS Microinjector® platform. In 2025, Clearside Biomedical highlighted its technology through numerous presentations. The company featured six presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting. Other prominent venues in 2025 included the Angiogenesis, Exudation, and Degeneration meeting, Retina Unplugged, and the Macula Society Annual Meeting. The platform's advancements were also set to be featured at the 25th EURETINA Congress in September 2025.

• Presentations at ARVO 2025: 6
• Total known 2025 medical meetings featuring data: 8 (ARVO + 7 others)
• EURETINA Congress 2025 dates: September 4 - 7

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Customer Segments

You're looking at the customer landscape for Clearside Biomedical, Inc. as of late 2025. Given the Chapter 11 filing in November 2025, the immediate focus shifts to asset monetization, but the underlying customer base for the platform technology remains the foundation.

Global pharmaceutical and biotech companies seeking novel ocular delivery

These partners license the SCS platform for their own therapeutic agents. As of July 2025, Clearside Biomedical had five commercial and late-stage development suprachoroidal licensing collaborations anchored to the SCS Microinjector platform. Specific partners utilizing the SCS Microinjector in commercial products or clinical development programs include Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO (with its global partner AbbVie), and Arctic Vision (with its commercial partner Santen). For instance, BioCryst Pharmaceuticals is advancing its diabetic macular edema program using the SCS Microinjector, with initial data expected in 2025. Revenue from these partners was a key component of the Q1 2025 results, with license fees contributing $1.5 million in milestones from Arctic Vision and other revenue streams totaling $0.8 million.

Retinal specialists and ophthalmologists performing in-office injections

This segment comprises the clinical users of the SCS Microinjector for repeatable, non-surgical delivery. The company's expertise in this area is evidenced by the fact that over 15,000 injections have been completed to date using the clinically validated suprachoroidal injection training program with the SCS Microinjector. The platform supports the delivery of Clearside's own pipeline, such as CLS-AX, which is designed for a flexible three-to-six month dosing label, aiming to fit seamlessly into physician practices. The approved product, XIPERE (triamcinolone acetonide injectable suspension), is available in the U.S. through a commercial partner for treating macular edema associated with uveitis.

Patients with sight-threatening back-of-the-eye diseases (e.g., wet AMD, uveitis)

These are the ultimate beneficiaries of the technology, suffering from conditions like neovascular age-related macular degeneration (wet AMD), uveitic macular edema (UME), and geographic atrophy (GA). Clearside's lead internal program, CLS-AX, targets wet AMD and is Phase 3-ready following alignment with the FDA on the pivotal trial program. The company is also evaluating small molecules for the potential long-acting treatment of geographic atrophy (GA). The commercial product, XIPERE, treats macular edema associated with uveitis, and its Asia-Pacific version, ARCATUS, is approved in Australia and Singapore.

Investors and potential acquirers interested in platform technology monetization

This segment became acutely relevant in late 2025. On November 24, 2025, Clearside Biomedical filed for voluntary Chapter 11 bankruptcy to pursue an auction and sale process of its assets. The company retained Piper Sandler to support the strategic evaluation process, which considers the sale, license, or divestiture of assets. Financially, the company reported a net loss of $19.36 million for Q2 2025, translating to a loss of $0.27 per share. The EBIT for the current year (2025) was reported at -16.69 M USD. Cash and cash equivalents stood at $13.6 million as of March 31, 2025, which was sufficient to fund operations into Q4 2025.

Academic and clinical researchers utilizing the SCS platform

The scientific community validates the platform through presentations and data sharing. Clearside Biomedical data was featured in six presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting. In total, the use of suprachoroidal drug delivery was featured in over 15 presentations at major ophthalmic medical meetings in 2025. The company's internal R&D expenses for Q2 2025 were $10.22 million, while Q1 2025 R&D expenses were $4.5 million.

Here's a quick look at key financial metrics leading up to the strategic review:

Metric	Q1 2025 Value	Q2 2025 Value
Total Revenue	$2.3 million	$320,000
Net Loss	$8.2 million	$19.36 million
EPS (Diluted)	-$0.11	-$0.27
Cash & Equivalents (End of Period)	$13.6 million (as of 3/31/2025)	Not specified

The company's operating expenses for Q2 2025 included $5.9 million in SG&A costs.

The platform's reach is quantified by the following:

• Number of SCS Microinjector injections completed to date: over 15,000.
• Number of licensing collaborations: five.
• Number of ARVO 2025 presentations featuring data: six.

Finance: review the cash burn rate implied by the Q2 2025 loss of $19.78 million operating loss against the Q1 cash balance by Monday.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Cost Structure

You're looking at the cost structure for Clearside Biomedical, Inc. (CLSD) right as the company entered a major restructuring phase in late 2025. The primary ongoing costs revolve around advancing the pipeline and maintaining the corporate structure, but the immediate, significant costs are tied to the Chapter 11 filing and the subsequent sale process.

The core operational expenses leading up to the filing show a focus on Research and Development (R&D) to push the CLS-AX program forward, though R&D spending had actually decreased in the first quarter of 2025 compared to the prior year, reflecting lower clinical trial costs after the ODYSSEY Phase 2b trial completion. General and Administrative (G&A) costs remained steady, covering essential overhead like legal and patent maintenance for the suprachoroidal delivery platform.

Here's a quick look at the reported Q1 2025 operational expenses:

Cost Category	Q1 2025 Expense Amount	Comparison Point
Research and Development (R&D)	$4.5 million	Down from $5.6 million in Q1 2024
General and Administrative (G&A)	$2.8 million	Constant compared to Q1 2024

The most significant cost driver as of November 2025 is the Chapter 11 restructuring itself. When Clearside Biomedical filed for Chapter 11 bankruptcy protection on November 24, 2025, it immediately incurred substantial professional fees related to the process. These costs are necessary to manage the structured auction and sale of its business and assets, which is intended to maximize stakeholder value.

The costs associated with this strategic shift include fees for specialized advisors retained to navigate the bankruptcy court proceedings. You should track these carefully, as they are non-recurring but material expenses that impact the final recovery value. The company estimated its liabilities to be between $50 million and $100 million at the time of filing, against assets estimated between $1 million and $10 million.

The key professional services engaged for this process represent a major, albeit temporary, cost component:

• Legal counsel retained: Cooley LLP and Richards, Layton & Finger, P.A.
• Financial restructuring advisor retained: Berkeley Research Group LLC (BRG)
• The process involves pursuing a sale under Section 363 of the U.S. Bankruptcy Code.

To be fair, even before the bankruptcy filing, the company was managing costs while planning for a potential Phase 3 program for CLS-AX. The net loss for Q1 2025 was $8.2 million, an improvement from the $11.8 million net loss in Q1 2024, largely due to increased license fees offsetting these operational costs.

Finance: draft 13-week cash view by Friday.

Clearside Biomedical, Inc. (CLSD) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Clearside Biomedical, Inc. as of late 2025, which is heavily influenced by its strategic partnerships and, critically, its recent filing for Chapter 11 protection to facilitate an asset sale.

The primary ongoing revenue streams for Clearside Biomedical, Inc. flow from its intellectual property licensing agreements for the suprachoroidal space (SCS) delivery platform.

License fees and milestone payments from strategic partners form a key component of the top line. For the first quarter ended March 31, 2025, the total License and other revenue was reported as $2.3 million. This Q1 2025 figure significantly surpassed the analyst estimate of $0.17 million.

Specifically within that Q1 2025 revenue, milestone payments were a major driver. This included $1.5 million in milestones received from Arctic Vision.

Sales of the SCS Microinjector® kits to licensees also contribute to the revenue base. This was grouped into the 'other revenue' category for Q1 2025, which amounted to $0.8 million, alongside training and services.

Royalties on commercial sales of licensed products, such as XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, represent another expected stream. However, the rights to these Royalties, along with milestone payments under existing license agreements, were largely sold in a prior transaction. As of late 2025, the assets available for sale related to the Royalty Sub included the equity in Clearside Royalty LLC and the right to revenue from the Royalties only after reaching a revenue cap of $106.5 million purchased by HCR.

The late 2025 focus is dominated by potential one-time proceeds from the sale or divestiture of assets. On November 24, 2025, Clearside Biomedical, Inc. filed for Chapter 11 bankruptcy with the intention to pursue a structured auction and sale process under Section 363 of the U.S. Bankruptcy Code to maximize stakeholder value. The key assets slated for this sale include the commercial SCS Microinjector platform, the Phase 3-ready CLS-AX program, and the existing suprachoroidal licensing collaborations.

Here's a look at some key financial figures impacting the revenue and asset valuation context:

Financial Metric	Amount/Value	Period/Context
License and other revenue	$2.3 million	Q1 2025
Q1 2025 Arctic Vision Milestone	$1.5 million	Q1 2025
Q1 2025 Training, Services, Kit Sales	$0.8 million	Q1 2025
Royalty Revenue Cap	$106.5 million	Related to Royalty Sub sale
Cash and Cash Equivalents	$13.6 million	As of March 31, 2025

The assets intended for sale via the Section 363 auction include:

• The commercial SCS Microinjector platform and associated intellectual property.
• The CLS-AX program, which is Phase 3 ready for wet AMD.
• IND-ready programs for Geographic Atrophy (GA) and Diabetic Macular Edema (DME).
• Rights linked to the royalty sub with the $106.5M revenue cap.

The company noted that the assets are attractive based on its clinically proven SCS Microinjector® platform and multiple suprachoroidal licensing agreements. The Chapter 11 filing was intended to maximize stakeholder value through this structured process.

Finance: draft asset sale timeline based on Section 363 process by Monday.