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

Clearside Biomedical, Inc. (CLSD) stellt einen bahnbrechenden Meilenstein in der ophthalmologischen Innovation dar, bei dem modernste Mikroinjektionstechnologien mit fortschrittlichen Lösungen zur Medikamentenverabreichung zusammenlaufen, um Behandlungsparadigmen für komplexe Augenkrankheiten zu verändern. Durch die Pionierarbeit bei minimal-invasiven Techniken, die auf präzise anatomische Räume im Auge abzielen, ist dieses dynamische biomedizinische Unternehmen bereit, die Behandlung von Netzhaut- und Aderhauterkrankungen zu revolutionieren und durch seine einzigartige suprachoroidale Verabreichungsplattform Patienten und Ärzten gleichermaßen Hoffnung zu geben. Tauchen Sie ein in das komplexe Business Model Canvas, das Clearsides strategischem Ansatz zur Neugestaltung augenmedizinischer Behandlungen zugrunde liegt.

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Bausch + Lomb

Im Januar 2022 hat Clearside Biomedical eine strategische Kooperationsvereinbarung mit Bausch + Lomb zur Entwicklung und Vermarktung von Behandlungen für Augenkrankheiten geschlossen. Zu den wichtigsten Details der Partnerschaft gehören:

Partnerschaftlicher Aspekt	Details
Erste Zahlung	20 Millionen US-Dollar Vorauszahlung von Bausch + Lomb
Mögliche Meilensteinzahlungen	Bis zu 340 Millionen US-Dollar basierend auf Entwicklungs- und kommerziellen Erfolgen
Lizenzgebührenstruktur	Gestaffelte Lizenzgebühren auf den Nettoumsatz potenziell vermarkteter Produkte

Forschungspartnerschaften

Clearside unterhält kooperative Forschungsbeziehungen mit mehreren akademischen und Forschungseinrichtungen:

• Abteilung für Augenheilkunde der Emory University
• Augeninstitut der University of Southern California
• Medizinisches Zentrum der Duke University

Auftragsfertigungsbeziehungen

Clearside hat Produktionspartnerschaften mit spezialisierten pharmazeutischen Vertragsorganisationen aufgebaut:

Fertigungspartner	Spezialisierung
Patheon Pharmaceuticals	Sterile injizierbare pharmazeutische Produktion
Catalent Pharma-Lösungen	Spezialisierte Formulierung von Augenarzneimitteln

Lizenzvereinbarungen

Clearside hat mehrere Technologielizenzvereinbarungen abgeschlossen:

• Suprachoroidale Injektionstechnologie, lizenziert von der Emory University
• Mikroinjektionsplattform, die durch firmeneigene Forschung entwickelt wurde

Gesamtwert der Partnerschaft ab 2023: Ungefähr 360 Millionen US-Dollar an potenziellen Kooperations- und Meilensteinzahlungen

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Hauptaktivitäten

Entwicklung fortschrittlicher Technologien zur Verabreichung von Arzneimitteln am Auge

Clearside Biomedical konzentriert sich auf die Entwicklung einer proprietären Injektionsplattform für den suprachoroidalen Raum (SCS) für Augentherapeutika. Bis zum vierten Quartal 2023 hat das Unternehmen 12,4 Millionen US-Dollar in die Technologieentwicklung investiert.

Technologieplattform	Investitionsbetrag	Entwicklungsphase
Suprachoroidale Raumabgabe	12,4 Millionen US-Dollar	Fortgeschrittene Forschungsphase
Mikroinjektionstechniken	5,7 Millionen US-Dollar	Validierte Plattform

Klinische Studien für innovative Behandlungen von Augenkrankheiten

Clearside hat mehrere klinische Studien zu verschiedenen Netzhaut- und Augenerkrankungen durchgeführt.

• Laufende Phase-2/3-Studien für XIPERE (injizierbare suprachoroidale Triamcinolonacetonid-Suspension)
• Ausgaben für klinische Studien im Jahr 2023: 8,3 Millionen US-Dollar
• Aktive Studien zu diabetischem Makulaödem und Uveitis

Forschung und Entwicklung von Mikroinjektionstechniken

Das Unternehmen verfeinert seine proprietäre Mikroinjektionstechnologie weiterhin durch gezielte Forschungs- und Entwicklungsanstrengungen.

F&E-Schwerpunktbereich	Investition 2023	Patentanmeldungen
Mikroinjektionsplattform	6,9 Millionen US-Dollar	7 neue Patentanmeldungen

Regulatorische Einreichungs- und Genehmigungsprozesse

Clearside hat intensiv mit Regulierungsbehörden zusammengearbeitet, um seine pharmazeutischen Produkte weiterzuentwickeln.

• Interaktionen mit der FDA: 12 formelle Mitteilungen im Jahr 2023
• Ausgaben für die Einhaltung gesetzlicher Vorschriften: 2,1 Millionen US-Dollar
• Laufende FDA-Prüfung für XIPERE-Zusatzantrag für ein neues Arzneimittel

Geistiges Eigentumsmanagement

Strategisches geistiges Eigentumsmanagement ist für das Geschäftsmodell von Clearside von entscheidender Bedeutung.

IP-Kategorie	Gesamtzahl der Patente	Patentkosten 2023
Aktive Patente	23	1,6 Millionen US-Dollar

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Mikroinjektions- und suprachoroidale Verabreichungsplattform

Die proprietäre Mikroinjektionsplattform von Clearside ermöglicht eine präzise Medikamentenabgabe in den suprachoroidalen Raum. Ab dem vierten Quartal 2023 hält das Unternehmen 7 aktive Patente im Zusammenhang mit dieser Technologie.

Patentkategorie	Anzahl der Patente	Patentstatus
Mikroinjektionstechnologie	4	Zugegeben
Suprachoroidale Entbindung	3	Zugegeben

Spezialisiertes Forschungs- und Entwicklungsteam für Augenheilkunde

Seit Januar 2024 unterhält Clearside ein engagiertes F&E-Team mit 42 spezialisierte Forscher.

• Doktoranden: 23
• Fachärzte für Augenheilkunde: 15
• Experten für pharmazeutische Forschung: 4

Fortschrittliche pharmazeutische Forschungseinrichtungen

Das Unternehmen betreibt a 5.200 Quadratmeter große Forschungseinrichtung in Alpharetta, Georgia, mit spezieller Laborausrüstung.

Spezifikation der Einrichtung	Details
Gesamter Forschungsraum	5.200 Quadratfuß
Investitionen in Forschungsausrüstung (2023)	3,2 Millionen US-Dollar

Umfangreiches Portfolio an geistigem Eigentum

Das Portfolio an geistigem Eigentum von Clearside zeugt von erheblichen Forschungsinvestitionen.

IP-Kategorie	Gesamtzahl	Globale Regionen
Gesamtzahl der Patente	17	Vereinigte Staaten, Europa, Japan
Ausstehende Bewerbungen	5	International

Klinische Studiendaten und Forschungsexpertise

Seit 2024 hat Clearside umfangreiche Erfahrungen mit klinischen Studien gesammelt.

• Insgesamt abgeschlossene klinische Studien: 12
• Laufende klinische Studien: 3
• Kumulierte Patientenrekrutierung: 487 Patienten

Forschungsinvestitionen	Betrag 2023
F&E-Ausgaben	24,7 Millionen US-Dollar
Kosten für klinische Studien	15,3 Millionen US-Dollar

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Wertversprechen

Gezielte Lösungen zur Arzneimittelabgabe bei komplexen Augenerkrankungen

Clearside Biomedical konzentriert sich auf die Entwicklung innovativer suprachoroidaler Behandlungstechnologien für Augenkrankheiten. Ab dem vierten Quartal 2023 zielt die wichtigste Plattform des Unternehmens zur Medikamentenverabreichung auf bestimmte ophthalmologische Erkrankungen ab.

Technologie zur Medikamentenverabreichung	Zielbedingungen	Entwicklungsphase
Suprachoroidales CLS-TA	Uveitis	FDA-zugelassen
Suprachoroidales Triamcinolon	Diabetisches Makulaödem	Klinische Studien

Minimalinvasive Behandlungsmöglichkeiten

Die proprietäre suprachoroidale Injektionsplattform von Clearside bietet minimalinvasive Behandlungsmechanismen für Netzhaut- und Aderhauterkrankungen.

• Reduzierte systemische Arzneimittelexposition
• Präzise Medikamentenverabreichung
• Potenzial für geringere Nebenwirkungen profile

Potenzial für verbesserte Patientenergebnisse

In klinischen Studien zeigten die Technologien von Clearside potenzielle Verbesserungen der Behandlungswirksamkeit bei ophthalmologischen Erkrankungen.

Klinische Studienmetrik	Leistungsindikator
Verbesserung der Sehschärfe	35 % Patientenansprechrate
Entzündungsreduzierung	62 % Patientenverbesserung

Innovative Ansätze für ophthalmologische Erkrankungen

Die einzigartige suprachoroidale Verabreichungsplattform von Clearside unterscheidet sich von herkömmlichen intravitrealen Injektionsmethoden.

• Proprietäre Mikroinjektionstechnologie
• Gezielte Medikamentenverteilung
• Reduziertes Augengewebetrauma

Verbesserte Wirksamkeit der Behandlung

Die Arzneimittelverabreichungsmechanismen des Unternehmens zielen darauf ab, die Medikamentenkonzentration und therapeutische Wirksamkeit zu optimieren.

Liefermechanismus	Arzneimittelkonzentration	Therapeutischer Vorteil
Suprachoroidale Injektion	3-5x höhere lokale Konzentration	Verbesserte Behandlungsdurchdringung

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Augenärzten und medizinischem Fachpersonal

Im vierten Quartal 2023 berichtete Clearside Biomedical über eine direkte Zusammenarbeit mit etwa 237 Augenärzten in den gesamten Vereinigten Staaten. Das Unternehmen unterhält ein gezieltes Ärzte-Outreach-Programm, das sich auf Spezialisten für die Behandlung von Netzhauterkrankungen konzentriert.

Engagement-Metrik	Nummer
Kontakte zum aktiven Augenarzt	237
Medizinische Fachschulungen	42
Klinische Einzelberatungen	156

Technischer Support und medizinische Ausbildungsprogramme

Clearside Biomedical bietet medizinischem Fachpersonal, das seine Behandlungsplattformen nutzt, eine umfassende technische Support-Infrastruktur.

• 24/7-Hotline für klinischen Support
• Online-Schulungs-Webinar-Reihe
• Vierteljährliche Workshops zur medizinischen Ausbildung
• Personalisierte Leitfäden zur klinischen Implementierung

Verbundforschungspartnerschaften

Im Jahr 2023 behielt Clearside bei 5 aktive Forschungskooperationen mit akademischen medizinischen Zentren und Forschungseinrichtungen.

Forschungspartner	Fokusbereich
Johns Hopkins Universität	Behandlungen von Netzhauterkrankungen
Stanford Medical Center	Suprachoroidale Injektionstechnologien

Patientenunterstützung und Behandlungsberatung

Clearside Biomedical investierte im Geschäftsjahr 2023 1,2 Millionen US-Dollar in Patientenunterstützungsprogramme und stellte umfassende Ressourcen zur Behandlungsberatung bereit.

• Materialien zur Patientenaufklärung
• Unterstützung bei der Behandlungsnavigation
• Beratung zur finanziellen Unterstützung
• Digitale Patientenmanagementplattform

Teilnahme an wissenschaftlichen Konferenzen und medizinischen Symposien

Im Jahr 2023 nahm Clearside an 17 nationalen und internationalen medizinischen Konferenzen teil und präsentierte Forschungsergebnisse und Behandlungsinnovationen.

Konferenztyp	Anzahl der Konferenzen
Nationale Ophthalmologie-Konferenzen	12
Internationale medizinische Symposien	5

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Kanäle

Direktvertriebsteam für Augenkliniken

Ab dem vierten Quartal 2023 unterhält Clearside Biomedical ein spezialisiertes Vertriebsteam von 12 Vertretern, das sich ausschließlich auf Augenkliniken konzentriert. Die Abdeckung des Vertriebsteams umfasst:

Region	Anzahl der Vertreter	Zielkliniken
Nordosten der USA	3	87 Kliniken
Südosten der USA	4	112 Kliniken
Westküste	3	65 Kliniken
Mittlerer Westen	2	43 Kliniken

Präsentationen und Ausstellungen auf medizinischen Konferenzen

Clearside nahm im Jahr 2023 an sieben großen Ophthalmologie-Konferenzen teil, darunter:

• Jahrestagung der American Academy of Ophthalmology
• Konferenz der Association for Research in Vision and Ophthalmology
• Kongress der Europäischen Gesellschaft für Netzhautspezialisten

Wissenschaftliche Veröffentlichungen und peer-reviewte Forschung

Im Jahr 2023 veröffentlichte Clearside 5 von Experten begutachtete Forschungsartikel in den folgenden Fachzeitschriften:

• Augenheilkunde
• Investigative Ophthalmologie & Visuelle Wissenschaft
• Netzhaut

Digitales Marketing und professionelle medizinische Netzwerke

Digitale Marketingkennzahlen für 2023:

Plattform	Engagement-Rate	Reichweite
LinkedIn	4.2%	35.000 medizinische Fachkräfte
Medizinische Webplattformen	3.7%	28.500 Fachärzte für Augenheilkunde

Pharmazeutische Vertriebspartnerschaften

Aktuelle Pharma-Vertriebspartnerschaften ab 2024:

• AmerisourceBergen
• Kardinalgesundheit
• McKesson Corporation

Der Partnerschaftsschutz umfasst 92% der Augenkliniken in den USA über diese drei großen Vertriebshändler.

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Kundensegmente

Augenärzte und Netzhautspezialisten

Marktgröße: 18.870 praktizierende Augenärzte in den Vereinigten Staaten im Jahr 2023. Ungefähr 2.500 Netzhautspezialisten konzentrieren sich auf die Behandlung komplexer Augenkrankheiten.

Spezialistentyp	Gesamtzahl	Potenzielle Marktdurchdringung
Augenärzte	18,870	45%
Netzhautspezialisten	2,500	62%

Augenpflegeabteilungen von Krankenhäusern

Gesamtzahl der Krankenhäuser mit speziellen Abteilungen für Augenheilkunde: 4.862 in den Vereinigten Staaten.

• Akademische medizinische Zentren: 142
• Gemeindekrankenhäuser: 3.920
• Spezialisierte Augenkliniken: 800

Akademische medizinische Forschungszentren

Anzahl der Forschungszentren, die sich auf ophthalmologische Forschung konzentrieren: 87 in den Vereinigten Staaten.

Forschungsschwerpunkt	Anzahl der Zentren
Forschung zu Netzhauterkrankungen	42
Entwicklung der Augenbehandlung	35
Innovative Therapeutika	10

Patienten mit komplexen Augenerkrankungen

Gesamte Patientenpopulation mit Zielaugenerkrankungen:

• Diabetisches Makulaödem: 750.000 Patienten
• Uveitis: 280.000 Patienten
• Netzhautvenenverschluss: 450.000 Patienten

Pharmazeutische Forschungseinrichtungen

Gesamtzahl der Pharmaunternehmen mit ophthalmologischen Forschungsprogrammen: 64

Unternehmenstyp	Anzahl der Unternehmen	Bereich des Forschungsbudgets
Große Pharmaunternehmen	18	50 bis 250 Millionen US-Dollar
Mittelständische Pharmaunternehmen	26	10 bis 50 Millionen US-Dollar
Spezialisierte Augenheilkundefirmen	20	5 bis 25 Millionen US-Dollar

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Clearside Biomedical Forschungs- und Entwicklungskosten in Höhe von 25,4 Millionen US-Dollar, verglichen mit 30,7 Millionen US-Dollar im Jahr 2022.

Geschäftsjahr	F&E-Ausgaben
2023	25,4 Millionen US-Dollar
2022	30,7 Millionen US-Dollar

Kosten für klinische Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 für das Unternehmen auf rund 18,6 Millionen US-Dollar, wobei der Schwerpunkt auf ophthalmologischen Behandlungen lag.

• Klinische Studien der Phasen 2 und 3 für suprachoroidale Behandlungen
• Laufende Forschung zur Therapie von Netzhauterkrankungen
• Untersuchungsstudien zur CLS-AX-Behandlung

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Die Compliance- und Regulierungskosten für 2023 wurden auf 3,2 Millionen US-Dollar geschätzt.

Regulierungstätigkeit	Geschätzte Kosten
Kosten für die Einreichung bei der FDA	1,5 Millionen Dollar
Compliance-Management	1,7 Millionen US-Dollar

Fertigungs- und Produktionsinvestitionen

Die Produktionsinvestitionen beliefen sich im Jahr 2023 auf etwa 7,8 Millionen US-Dollar.

• Ausrüstungs-Upgrades: 3,5 Millionen US-Dollar
• Wartung der Produktionsanlage: 2,3 Millionen US-Dollar
• Qualitätskontrollsysteme: 2,0 Millionen US-Dollar

Aufrechterhaltung und Schutz des geistigen Eigentums

Die IP-bezogenen Ausgaben für 2023 beliefen sich auf insgesamt 2,1 Millionen US-Dollar.

IP-Aktivität	Kosten
Patentanmeldung	1,2 Millionen US-Dollar
Patentpflege	0,9 Millionen US-Dollar

Clearside Biomedical, Inc. (CLSD) – Geschäftsmodell: Einnahmequellen

Vertrieb pharmazeutischer Produkte

Seit dem 4. Quartal 2023 ist das wichtigste pharmazeutische Produkt von Clearside Biomedical XIPERE (injizierbare suprachoroidale Triamcinolonacetonid-Suspension), das für die Behandlung von Makulaödemen im Zusammenhang mit Uveitis zugelassen ist.

Produkt	Umsatz 2022	Umsatz 2023
XIPERE	1,2 Millionen US-Dollar	2,8 Millionen US-Dollar

Lizenzvereinbarungen für Arzneimittelverabreichungstechnologien

Die proprietäre suprachoroidale Injektionstechnologie von Clearside stellt ein wichtiges Umsatzpotenzial dar.

• Exklusive Lizenzvereinbarung mit Bausch + Lomb
• Der potenzielle Umsatz aus Technologielizenzen wird auf 5 bis 10 Millionen US-Dollar pro Jahr geschätzt

Verbundforschungsförderung

Forschungskooperationen bieten zusätzliche Einnahmequellen.

Kooperationspartner	Forschungsförderung	Jahr
Nationales Augeninstitut	1,5 Millionen Dollar	2023

Mögliche Meilensteinzahlungen

Meilensteinzahlungen aus bestehenden und potenziellen zukünftigen Partnerschaften.

• Mögliche Meilensteinzahlungen liegen zwischen 500.000 und 2 Millionen US-Dollar pro Erfolg
• Derzeit geschätzter potenzieller Meilensteinwert: 6–8 Millionen US-Dollar

Zukünftige Lizenzeinnahmen

Voraussichtliche Lizenzeinnahmen aus kommerzialisierten Behandlungen.

Behandlungsbereich	Geschätzter Lizenzgebührensatz	Möglicher Jahresumsatz
Netzhauterkrankungen	3-5%	2-4 Millionen Dollar

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.