OCUGEN, Inc. (OCGN): Canvas du modèle d'entreprise [Jan-2025 Mise à jour]

Dans le monde dynamique de la biotechnologie, Orugen, Inc. (OCGN) émerge comme une entreprise visionnaire naviguant dans les paysages complexes de la thérapie génique et des traitements des maladies infectieuses. Avec une approche stratégique qui mélange des recherches innovantes, des partenariats collaboratifs et des technologies de pointe, Orugen redéfinit les possibilités médicales en ophtalmologie et en développement de vaccins. Leur toile de modèle commercial unique révèle une stratégie à multiples facettes ciblant les besoins médicaux non satisfaits, des solutions transformatrices prometteuses pour les maladies oculaires rares et les interventions de percée potentielles dans les défis mondiaux de la santé.

Orugen, Inc. (OCGN) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec Bharat Biotech

Orugen a signé un co-développement et un partenariat de co-marketing avec Bharat Biotech pour la covaxin du vaccin Covid-19 sur le marché américain. Les détails clés comprennent:

Aspect de partenariat	Détails spécifiques
Date de l'accord	Décembre 2020
Couverture géographique	Marché américain
Arrangement des actions à profit	45% OCUGEN, 55% Bharat Biotech

Partenariats de recherche

Orugen maintient des collaborations de recherche stratégique avec plusieurs établissements universitaires et médicaux:

• Université de Pennsylvanie - Recherche de thérapie génique
• National Eye Institute - Développement technologique en ophtalmologie
• Hôpital pour enfants de Philadelphie - Recherche de maladies génétiques rares

Accords de fabrication

Les partenariats de fabrication de contrats pharmaceutiques comprennent:

Organisation contractuelle	Focus de la fabrication
Pharmaceutiques jubilatoires	Fabrication de thérapie génique
Wuxi apptec	Production de produits en ophtalmologie

Partenariats de licence

Les accords de licence de technologie couvrent plusieurs domaines thérapeutiques:

• Licence de thérapie génique des maladies rétiniennes de l'Université de Pennsylvanie
• Technologie héréditaire des maladies rétiniennes de Spark Therapeutics
• Droits de thérapie génique liée à la rétinite en X

Orugen, Inc. (OCGN) - Modèle d'entreprise: activités clés

Recherche et développement de la biotechnologie

Orugen a alloué 39,8 millions de dollars aux dépenses de R&D au troisième trimestre 2023. La recherche se concentre sur l'ophtalmologie et les traitements infectieux des maladies.

Zone de focus R&D	Montant d'investissement	Étape de recherche
Thérapies en ophtalmologie	22,5 millions de dollars	Essais précliniques / cliniques
Thérapies génétiques	12,3 millions de dollars	Développement précoce
Traitements infectieux des maladies	5 millions de dollars	Recherche exploratoire

Essais cliniques pour les thérapies géniques et les technologies des vaccins

• Effectuant actuellement 3 essais cliniques actifs
• Budget total des essais cliniques: 28,6 millions de dollars en 2023
• Focus primaire sur les maladies rétiniennes héréditaires

Processus de conformité réglementaire et d'approbation de la FDA

Budget de conformité: 4,2 millions de dollars en 2023. Interactions en cours avec la FDA pour plusieurs candidats thérapeutiques.

Soumission réglementaire	État actuel	Chronologie de l'approbation estimée
Thérapie génique OCU400	IND classé	Q2-Q3 2024
Vaccin contre le covid-19	Examen en cours	En attente

Développement de produits en ophtalmologie et traitements de maladies infectieuses

Investissement total de développement de produits: 47,3 millions de dollars au cours de l'exercice 2023.

• 3 pipelines de développement de produits primaires
• Concentrez-vous sur les maladies rétiniennes héréditaires rares
• Développement de solutions de thérapie génique

Gestion de la propriété intellectuelle et développement des brevets

Investissement de portefeuille de brevets: 6,5 millions de dollars en 2023.

Catégorie de brevet	Nombre de brevets	Durée de protection des brevets
Technologies de thérapie génique	12 brevets actifs	15-20 ans
Traitements en ophtalmologie	8 brevets en attente	10-15 ans

Orugen, Inc. (OCGN) - Modèle d'entreprise: Ressources clés

Capacités de recherche avancées de la biotechnologie

Orugen, Inc. maintient des installations de recherche spécialisées axées sur la thérapie génique et le développement des vaccins. L'infrastructure de recherche de l'entreprise comprend:

Métrique de l'installation de recherche	Données quantitatives
Recherche totale en pieds carrés	Environ 15 000 pieds carrés.
Investissement de l'équipement de recherche	4,2 millions de dollars (2023)
Dépenses annuelles de R&D	37,6 millions de dollars (2023)

Équipe de recherche scientifique et médicale qualifiée

Les ressources humaines d'Ocugen comprennent des professionnels spécialisés:

• Personnel de recherche total: 62 employés
• Tapisseurs de doctorat: 24 chercheurs
• Zones spécialisées:
  • Thérapie génique
  • Ophtalmologie
  • Immunologie
  • Développement

Thérapie génique propriétaire et technologies de vaccination

Technologie	Statut de brevet	Étape de développement
Covaxin Covid-19 vaccin	Technologie sous licence	Autorisation d'utilisation d'urgence
Plateforme de thérapie génique rétinienne	5 brevets actifs	Phase d'essai clinique

Données d'essai cliniques et infrastructure de recherche

Les capacités d'essai cliniques d'Ocugen comprennent:

• Essais cliniques actifs: 3 études en cours
• Investissement total des essais cliniques: 22,3 millions de dollars (2023)
• Sites d'essai cliniques enregistrés: 12 emplacements

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre total	Valeur estimée
Brevets actifs	12 brevets	15,7 millions de dollars
Demandes de brevet	8 en attente	6,2 millions de dollars

Orugen, Inc. (OCGN) - Modèle d'entreprise: propositions de valeur

Solutions innovantes de thérapie génique pour les maladies oculaires rares

Orugen se concentre sur le développement de thérapies géniques pour des maladies oculaires rares avec des caractéristiques spécifiques du marché:

Cible de la maladie	Population potentielle de patients	Étape de développement
Dystrophies rétiniennes	Environ 2 000 patients en Amérique du Nord	Phase d'essai préclinique / clinique
Troubles rétiniens hérités	Estimé 1 500 nouveaux cas par an	ÉTAT DE RECHERCHE PROBLÈME

Distribution potentielle du vaccin Covid-19 sur les marchés nord-américains

Détails du partenariat vaccinal Covid-19 d'Ocugen::

• Covaxin Collaboration avec Bharat Biotech
• Droits de distribution nord-américains
• Segments de vaccin pédiatriques et adultes ciblés

Traitements avancés de la biotechnologie ciblant les besoins médicaux non satisfaits

Zone de traitement	Potentiel de marché	Investissement en développement
Thérapies en ophtalmologie	8,3 milliards de dollars sur le marché mondial d'ici 2026	Dépenses de R&D de 12,5 millions de dollars en 2023
Plateformes de thérapie génique	Taille du marché prévu 13,5 milliards de dollars	Investissement technologique de 7,2 millions de dollars

Approche de la médecine de précision en ophtalmologie

La stratégie de médecine de précision s'est concentrée sur:

• Technologies de dépistage génétique
• Protocoles de traitement personnalisés
• Interventions thérapeutiques ciblées

Vaccination de pointe et technologies thérapeutiques

Plate-forme technologique	Statut de brevet	Application potentielle
Technique de modification des gènes	3 demandes de brevet actives	Rare troubles oculaires génétiques
Technologie de vaccin contre l'ARNm	2 dépôts de brevet en instance	Recherche de variantes Covid-19

Orugen, Inc. (OCGN) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Orugen maintient un engagement direct grâce à des canaux de communication médicale spécialisés:

Méthode d'engagement	Fréquence	Spécialistes de la cible
Conférences en ophtalmologie	4-6 événements annuels	Spécialistes des maladies rétiniennes
Réunions du conseil consultatif médical	Séances trimestrielles	Top chercheurs en ophtalmologie

Programmes de soutien aux patients pour les traitements de maladies rares

L'infrastructure de soutien aux patients spécialisé comprend:

• Programme d'aide aux patients en troubles génétiques
• Hotline d'informations sur les maladies oculaires rares
• Coordination du soutien financier

Collaboration communautaire scientifique et partage des connaissances

Métriques de collaboration de recherche:

Type de collaboration	Nombre de partenariats	Institutions de recherche
Partenariats de recherche universitaire	7 collaborations actives	Centres de recherche universitaires
Réseaux d'essais cliniques	3 réseaux de recherche mondiaux	Institutions de recherche internationales

Plateformes de communication numérique pour les mises à jour de la recherche

Statistiques de l'engagement numérique:

• Visiteurs mensuels du site Web: 45 000
• Email Newsletter abonnés: 12 500
• LinkedIn adepte: 8 700

Engagement des participants à l'essai clinique

Gestion des participants à l'essai clinique:

Catégorie d'essai	Participants actifs	Taux de rétention
Essais de maladies rétiniennes	250 participants	87% de rétention
Essais de thérapie génique	175 participants	Rétention à 92%

Orugen, Inc. (OCGN) - Modèle d'entreprise: canaux

Ventes directes aux prestataires de soins de santé

Orugen utilise une approche de vente directe ciblée pour ses produits d'ophtalmologie et de développement de vaccins. Au quatrième trimestre 2023, la société maintient une équipe de vente spécialisée axée sur les cliniques et les institutions de recherche en ophtalmologie.

Type de canal	Segment cible	Portée estimée
Représentants des ventes directes	Cliniques en ophtalmologie	35-50 cliniques spécialisées
Institutions de recherche médicale	Centres de recherche universitaires	12-18 institutions de recherche

Conférences médicales et présentations du symposium scientifique

Orugen participe activement à des conférences scientifiques pour présenter la recherche et les traitements potentiels.

• Conférences moyennes assistées chaque année: 8-12
• Conférences clés: réunion annuelle de l'American Academy of Ophthalmology
• Formats de présentation: séances d'affiches, présentations orales, ateliers scientifiques

Publications scientifiques en ligne et plateformes de recherche

L'entreprise tire parti des plateformes numériques pour la communication scientifique et la visibilité.

Plate-forme	Fréquence de publication	Métriques de visibilité
Pubment	4-6 publications par an	2 500-3 500 vues moyennes
Porte de recherche	3-5 téléchargement de recherche par an	1 800-2 200 interactions d'engagement

Réseaux de distribution pharmaceutique

Orugen collabore avec des partenaires de distribution pharmaceutique pour étendre la portée du produit.

• Partenaires de distribution primaire: 3-5 distributeurs pharmaceutiques nationaux
• Couverture géographique: marché primaire des États-Unis
• Canaux de distribution: pharmacies spécialisées, réseaux hospitaliers

Communications des relations avec les investisseurs

Orugen maintient des stratégies de communication complètes des investisseurs.

Canal de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4 fois par an	150-250 investisseurs institutionnels
Présentations des investisseurs	6-8 par an	300-500 investisseurs potentiels
Dépôts de la SEC	Trimestriel / annuel	Visibilité large du marché

Orugen, Inc. (OCGN) - Modèle d'entreprise: segments de clientèle

Provideurs de soins de santé en ophtalmologie

Taille du marché pour les fournisseurs d'ophtalmologie aux États-Unis: 4,8 milliards de dollars en 2023

Type de fournisseur	Nombre de prestataires	Portée du marché potentiel
Cliniques en ophtalmologie	17,250	Taux d'adoption potentiel de 65%
Services oculaires de l'hôpital	3,450	Taux d'adoption potentiel de 48%

Patients atteints de maladies oculaires rares

Population totale de patients atteints des yeux rares aux États-Unis: 450 000 personnes

• Maladies rétiniennes héréditaires affectant: 135 000 patients
• Troubles oculaires génétiques rares: 215 000 patients
• Besoins médicaux non satisfaits: 78% des patients atteints de maladies oculaires rares

Institutions de recherche sur les maladies infectieuses

Type d'institution	Nombre d'institutions	Budget de recherche annuel
Centres de recherche universitaires	287	1,2 milliard de dollars
Installations de recherche gouvernementales	94	750 millions de dollars

Organisations de santé et de santé publique

Financement de la recherche sur les soins de santé du gouvernement potentiel total: 3,6 milliards de dollars en 2024

• Budget des maladies infectieuses des National Institutes of Health (NIH): 1,9 milliard de dollars
• Centers for Disease Control Research Allocation: 680 millions de dollars
• Financement de recherche en santé publique au niveau de l'État: 1,02 milliard de dollars

Biotechnology and Pharmaceutical Research Communities

Catégorie de recherche	Nombre d'organisations actives	Dépenses annuelles de R&D
Biotechnology Companies	2,100	65,3 milliards de dollars
Organisations de recherche pharmaceutique	1,450	97,5 milliards de dollars

Marché total de la biotechnologie et de la recherche pharmaceutique: 162,8 milliards de dollars en 2024

Orugen, Inc. (OCGN) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 31 décembre 2022, Orugen a déclaré des dépenses de R&D de 44,7 millions de dollars.

Financement des essais cliniques

Année	Dépenses des essais cliniques
2022	37,2 millions de dollars
2021	25,6 millions de dollars

Coûts de conformité réglementaire

Dépenses de conformité réglementaire annuelles estimées pour Orugen: 3,5 à 5 millions de dollars.

Investissements de fabrication et de production

• Dépenses en capital en 2022: 2,1 millions de dollars
• Coûts d'installation des installations de fabrication: environ 6,5 millions de dollars

Maintenance de la propriété intellectuelle

Entretien annuel de la propriété intellectuelle et dépenses liées aux brevets: 750 000 $ à 1,2 million de dollars.

Structure totale des coûts annuels estimés pour Orugen: environ 94,2 millions de dollars à partir de 2022 exercices.

OCUGEN, Inc. (OCGN) - Modèle d'entreprise: sources de revenus

Revenus potentiels de licence de vaccination

Depuis le quatrième trimestre 2023, la stratégie de licence de vaccination Covid-19 d'Ocugen avec Bharat Biotech pour Covaxin a généré des opportunités de revenus potentiels sur le marché nord-américain.

Potentiel de licence de vaccination	Valeur estimée
Potentiel du marché nord-américain	50-75 millions de dollars
Potentiel de paiement d'étape	19,5 millions de dollars

Ventes de produits de thérapie génique

Le pipeline de thérapie génique de l'ophtalmologie d'Ocugen se concentre sur de rares maladies oculaires avec des revenus commerciaux potentiels.

• OCU400 pour les maladies rétiniennes héréditaires
• OCU410 pour la dégénérescence maculaire liée à l'âge sèche

Subventions et partenariats de recherche

Source d'octroi	Valeur approximative
Subventions des National Institutes of Health (NIH)	2 à 3 millions de dollars par an
Partenariats de recherche universitaire	500 000 $ - 1 million de dollars

Contrats gouvernementaux potentiels

Orugen a exploré les opportunités de contrat du gouvernement dans le développement des vaccins et la préparation pandémique.

Type de contrat	Fourchette de revenus potentiel
Développement de vaccins pandémiques	10-25 millions de dollars
Recherche de maladies rares	5-15 millions de dollars

Financement de recherche collaborative

Orugen maintient des collaborations de recherche stratégique avec un soutien au financement potentiel.

• Accords de partenariat en biotechnologie
• Collaborations de recherche sur la thérapie génique
• Partenariats de développement pharmaceutique

Type de collaboration	Financement annuel estimé
Partenariats de biotechnologie	3 à 5 millions de dollars
Financement de collaboration de recherche	2 à 4 millions de dollars

Ocugen, Inc. (OCGN) - Canvas Business Model: Value Propositions

You're looking at the core value Ocugen, Inc. (OCGN) offers to patients and the market, which centers on its modifier gene therapy platform. This platform is designed to deliver a one-time, gene-agnostic therapy for inherited retinal diseases. That gene-agnostic aspect is key; it means the therapy aims to treat the underlying disease mechanism rather than being limited to a single faulty gene. This approach is reinforced by positive Phase 1/2 long-term data for OCU400, showing consistent safety and significant improvements in visual function for Retinitis Pigmentosa (RP) patients across various genetic mutations.

The sheer scale of the potential patient base is a major value driver. For RP, there are approximately 300,000 people in the US and Europe combined living with the condition, which is caused by greater than 100 genes. Ocugen, Inc. emphasizes that OCU400 has the potential to address the ~98-99% of RP patients not covered by single-gene therapies. This broad applicability is a significant differentiator in a space often focused on rare, single-mutation diseases.

Beyond RP, Ocugen, Inc. is addressing other significant unmet needs in ocular diseases. Stargardt disease, which affects approximately 100,000 people in the U.S. and Europe combined, currently has no FDA-approved treatment available. Similarly, Geographic Atrophy (GA), the late-stage dry age-related macular degeneration, impacts an estimated 2-3 million people in the U.S. & EU combined. The company's modifier gene therapy platform is positioned to offer a potential one-time treatment for life for these patient groups.

The value proposition is further solidified by regulatory recognition and pipeline momentum, which suggests a clear path to market. The European Medicines Agency (EMA) granted Advanced Therapy Medicinal Product (ATMP) classification for OCU400, OCU410ST, and OCU410, which helps expedite regulatory review timelines in Europe. The company is targeting BLA and MAA submissions for OCU400 in 2026. It's a defintely ambitious schedule, but the clinical progress supports it.

Here's a quick look at the patient populations and where the key programs stand as of late 2025:

Indication	Target Population (US & EU Combined)	Key Program	Regulatory Status (as of late 2025)
Retinitis Pigmentosa (RP)	300,000 patients	OCU400	Phase 3 enrollment nearing completion; BLA/MAA target 2026
Stargardt Disease	100,000 patients	OCU410ST	Phase 2/3 50% enrolled; Interim data expected mid-2026
Geographic Atrophy (GA)	2-3 million patients	OCU410	Full 12-month Phase 2 data expected Q1 2026

The core offering is a single therapeutic approach for multiple genetic mutations, which is the essence of the gene-agnostic platform. This is what allows OCU400 to target the entire disease spectrum in RP, rather than being restricted to a single gene defect. The company's cash position as of September 30, 2025, stood at $32.9 million, with an expected operational runway into the second quarter of 2026, which must support these late-stage clinical activities. Total operating expenses for Q3 2025 were $19.4 million, with Research and Development expenses accounting for $11.2 million of that.

The value propositions can be summarized by the potential impact on patient numbers and the unique treatment modality:

• - One-time, gene-agnostic therapy for inherited retinal diseases.
• - Potential to treat over 300,000 RP patients in the US and Europe.
• - Addressing significant unmet needs in Stargardt disease and Geographic Atrophy.
• - A single therapeutic approach for multiple genetic mutations.

Ocugen, Inc. (OCGN) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, which means your relationships with key stakeholders-patients, specialists, and the capital markets-are everything right now. For Ocugen, Inc., customer relationships are less about mass marketing and more about deep, targeted engagement to de-risk the pipeline and secure the next tranche of funding.

Direct engagement with patient advocacy groups for rare diseases

Ocugen, Inc. focuses its direct engagement on the communities affected by the rare inherited retinal diseases its pipeline targets. This is crucial for trial recruitment and demonstrating patient urgency to regulators. The company is advancing modifier gene therapies for conditions like Retinitis Pigmentosa (RP), Geographic Atrophy (GA), and Stargardt disease, all of which have dedicated patient bases.

• The OCU400 Phase 3 liMeliGhT trial for RP is nearing completion of enrollment, a direct result of engaging with the RP community.
• OCU410ST for Stargardt disease has received Rare Pediatric Disease Designation and Orphan Drug Designation, signaling a focus on patient populations with high unmet need.
• The Phase 2/3 GARDian3 pivotal confirmatory trial for OCU410ST is designed with a patient-centered focus to evaluate both structural and functional outcomes.
• Management notes a real sense of urgency from the FDA in providing treatment options for patients with Stargardt disease, which is a direct reflection of advocacy efforts.

High-touch relationships with key opinion leaders and retinal specialists

Adoption of a novel modifier gene therapy platform requires strong endorsements from the specialists who will ultimately administer the one-time treatments. This relationship management is about education and building confidence in the science.

• Leadership conducts one-on-one meetings at industry events, like the October 2025 Maxim Growth Summit Ophthalmology Panel, to showcase the clinical development strategy.
• The company is advancing three gene therapies: OCU400 (RP), OCU410ST (Stargardt), and OCU410 (GA), each requiring specialized retinal specialist buy-in.
• All three modifier gene therapies have received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency's Committee for Advanced Therapies, which is a key data point for KOLs.

Investor relations focused on clinical milestones and cash runway

For a clinical-stage biotech, investor relations is a constant balancing act between celebrating scientific progress and transparently managing financial needs. You need to show them the finish line is closer while demonstrating you have enough fuel to get there. Honestly, the numbers tell a clear story of capital deployment against deadlines.

Here's the quick math on the recent financial positioning as of late 2025:

Metric	Value as of September 30, 2025	Value as of December 31, 2024
Cash, Cash Equivalents, Restricted Cash	$32.9 million	$58.8 million
Quarterly Operating Expenses (Q3 2025)	$19.4 million	N/A
Projected Cash Runway	Through Q2 2026	N/A

The focus is clearly on hitting the BLA submission targets, with OCU400 targeted for 2026 and OCU410ST for 2027, supporting the overall goal of three BLAs in the next three years. If associated warrants are fully exercised, the runway could extend into 2027, potentially adding $30 million.

Business development outreach for non-dilutive financing and partnerships

To manage the cash burn-which was $19.4 million in Q3 2025-Ocugen, Inc. actively pursues deals that bring in non-dilutive capital and validate the platform globally. This outreach is critical to bridge the gap between current cash levels and expected BLA filings.

• Executed an exclusive licensing agreement with Kwangdong Pharmaceutical for OCU400 rights in South Korea.
• This Korean deal includes potential development and sales milestones projected to reach $180 million or more in the first decade, plus a 25% royalty on net sales.
• The company closed a $20 million registered direct offering in Q3 2025, which included warrants to purchase up to 20 million shares at a $1.50 exercise price.
• The immediate impact of the Q3 financing was significant dilution, pushing total equity to over 330 million shares from 292 million shares outstanding as of June 30, 2025.
• The debt-to-equity ratio spiked to 10.76, up from 1.10 in 2024, underscoring the reliance on capital raises to fund R&D expenses, which hit $11.2 million in Q3 2025.

Finance: draft 13-week cash view by Friday.

Ocugen, Inc. (OCGN) - Canvas Business Model: Channels

You're looking at how Ocugen, Inc. gets its value proposition-gene therapies for blindness-to the patients and the market. As a clinical-stage biotech, the channels are heavily weighted toward clinical execution and strategic partnerships right now, with commercial build-out on the near horizon.

The primary channels for drug development are the specialized clinical trial sites and research hospitals running their ongoing studies. These sites are the gatekeepers to generating the data needed for market authorization.

• - OCU400 Phase 3 liMeliGhT trial enrollment is nearing completion as of late 2025, with completion targeted for the first quarter of 2026.
• - The OCU410ST Phase 2/3 GARDian3 pivotal confirmatory trial has reached 50% enrollment as of the third quarter of 2025, with recruitment completion expected in the first quarter of 2026.
• - The OCU410ST trial is designed to enroll 51 participants total (34 receiving treatment and 17 controls).
• - Dosing for the OCU200 Phase 1 trial initiated in the first quarter of 2025, with completion planned for the second half of 2025.
• - The OCU500 Phase 1 trial was planned to initiate mid-year 2025.

For commercial distribution, Ocugen, Inc. is clearly leaning into a regional partnership model to access specific markets, which is a smart way to manage capital burn before full commercial launch. The South Korea deal serves as the template for this channel strategy.

Partnership/Distribution Channel	Product Focus	Region	Key Financial/Statistical Data
Executed Licensing Agreement with Kwangdong Pharmaceutical	OCU400	South Korea	Upfront/near-term milestones up to $7.5 million; 25% royalty on net sales.
Projected Sales Milestones (OCU400 in Korea)	OCU400	South Korea	$1.5 million for every $15 million of net sales; projected to reach $180 million or more in the first decade.
Manufacturing Supply Agreement	OCU400	Global Supply to Partner	Ocugen, Inc. will manufacture and supply OCU400 commercial product.
Target Patient Population (RP)	OCU400	South Korea	Estimated 15,000 individuals with RP.

Regarding a future direct sales force targeting retinal specialists and surgical centers, the data shows the company is focused on manufacturing readiness and regulatory filings first. The commercial build-out is tied directly to these milestones. The Malvern facility is targeted to supply the U.S. post-approval, with OCU400 manufacturing process validation runs on target.

The regulatory pathways define the ultimate channel to market authorization, and Ocugen, Inc. has secured key endorsements that streamline this process, which is critical for a company with cash runway extending only through the second quarter of 2026.

• - OCU400 BLA/MAA filings are targeted for 2026, with a rolling BLA submission planned for the first half of 2026.
• - OCU410ST BLA filing is targeted for the first half of 2027.
• - The EMA's CHMP confirmed acceptability of a single U.S.-based trial for the OCU410ST Marketing Authorization Application (MAA), simplifying the EU pathway.
• - OCU410ST received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA in May 2025.
• - The addressable patient population for Stargardt disease (OCU410ST) is approximately 100,000 in the U.S. and Europe combined.

Ocugen, Inc. (OCGN) - Canvas Business Model: Customer Segments

You're mapping out the core groups Ocugen, Inc. needs to serve to make its gene therapy platform work. For a clinical-stage biotech focused on rare diseases, these segments are highly specialized, spanning from the patients themselves to the capital markets funding the trials.

Patients with inherited retinal diseases (Retinitis Pigmentosa, Stargardt).

This is the ultimate end-user group, and Ocugen, Inc. is targeting specific, high-unmet-need populations with its modifier gene therapies. For OCU400, targeting Retinitis Pigmentosa (RP), the addressable population in the U.S. and Europe combined is stated as approximately 300,000 people, a disease characterized by the loss of rod photoreceptors. RP itself has a variable prevalence ranging from 1 in 750-9000 individuals, depending on the study location. For OCU410ST, targeting Stargardt disease (STGD), the target population in the U.S. and Europe combined is approximately 100,000 people. To be fair, STGD incidence is generally cited around one in every 8,000-10,000 persons, with about 30,000 persons in the United States alone. Furthermore, the OCU410 program for Geographic Atrophy (GA) is aimed at a broader group, potentially covering two to three million atrophy patients across the US and Europe.

Here's a quick look at the patient populations tied to the late-2025 pipeline focus:

Therapy Candidate	Indication	Target Patient Population (US & EU Combined Estimate)	Key Metric/Data Point
OCU400	Retinitis Pigmentosa (RP)	300,000	Phase 3 enrollment nearing completion
OCU410ST	Stargardt Disease (STGD)	100,000	Phase 2/3 trial underway; EMA accepted single US trial for MAA
OCU410	Geographic Atrophy (GA)	2 million to 3 million	Phase 2 data released; Phase 3 planned for 2026

Ophthalmologists and retinal surgeons who administer the subretinal injection.

These medical professionals are the gatekeepers and the delivery mechanism for the therapy. Since Ocugen, Inc.'s gene therapies, like OCU400, are administered via a subretinal injection, the customer segment includes specialists trained and equipped to perform this delicate procedure. While the exact number of qualified retinal surgeons in the target markets isn't explicitly stated in the latest filings, their segment is defined by their procedural capability. The success of OCU400 hinges on adoption by these specialists, especially given the gene-agnostic approach which aims to treat multiple genetic mutations with a single approach.

Global pharmaceutical companies seeking late-stage gene therapy assets.

This segment represents potential partners for commercialization or geographic expansion, offering non-dilutive capital and market access. Ocugen, Inc. has already engaged this segment. For example, an exclusive licensing agreement was signed with Kwangdong Pharmaceutical for OCU400 in South Korea. This deal included potential development and sales milestones projected to reach $180 million or more in the first decade, plus a 25% royalty on net sales. The binding term sheet for this deal included upfront fees and near-term development milestone payments totaling up to $11 million. The company's Q3 2025 revenue of $1.75 million was substantially driven by this type of collaborative arrangement revenue.

Institutional and retail investors focused on clinical-stage biotech.

This segment provides the necessary working capital to fund the expensive, late-stage clinical trials. You see their direct involvement in the company's financial structure. As of September 30, 2025, Ocugen, Inc.'s cash, cash equivalents, and restricted cash stood at $32.9 million, down from $58.8 million at the end of 2024. This cash position was bolstered by a $20 million registered direct offering closed in the third quarter of 2025, which management stated provides runway through 2026. The company's total operating expenses for Q3 2025 were $19.4 million, with Research and Development expenses accounting for $11.2 million of that spend. The market's focus on these clinical catalysts-like the expected BLA/MAA submissions for OCU400 in 2026-is what attracts this capital.

The investors are definitely watching the burn rate against the runway. Finance: draft 13-week cash view by Friday.

Ocugen, Inc. (OCGN) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Ocugen, Inc.'s operations as of late 2025, which is typical for a late-stage clinical biotech company. The costs are heavily weighted toward advancing the late-stage pipeline, which is where the capital is going right now.

The third quarter of 2025 saw total operating expenses hit $19.4 million. This burn rate is what you need to watch closely against the balance sheet.

Here's a breakdown of the major cost drivers:

• - High Research & Development expenses (Q3 2025: $11.2 million).
• - Significant General & Administrative costs (Q3 2025: $8.2 million).
• - Costs associated with running global Phase 3 clinical trials (liMeliGhT).
• - Manufacturing and supply chain costs for AAV vector production.
• - Regulatory filing and compliance expenses (BLA/MAA preparation).

The R&D spend of $11.2 million for the third quarter of 2025 reflects the intensity of running two major programs simultaneously. Honestly, this is the price of progress in gene therapy.

The General & Administrative (G&A) costs were $8.2 million for the same period. This increase from prior years reflects the necessary build-out of pre-commercial functions as Ocugen nears potential regulatory submissions.

Here's a quick look at how the Q3 2025 operating expenses compare to the previous year's third quarter:

Expense Category	Q3 2025 Amount (USD Millions)	Q3 2024 Amount (USD Millions)
Research & Development	11.2	8.1
General & Administrative	8.2	6.3
Total Operating Expenses	19.4	14.4

The clinical trial expenses are substantial, especially for the two late-stage assets. You're funding the execution of these complex studies, which directly impacts the cash runway. As of September 30, 2025, the cash position was $32.9 million, which management projected extends runway only into the second quarter of 2026.

The costs tied to the clinical programs are detailed below:

• OCU400 Phase 3 liMeliGhT trial: Enrollment is nearing completion, targeting BLA/MAA submissions in 2026. This randomized study is designed to enroll 150 subjects.
• OCU410ST Phase 2/3 GARDian3 trial: Reached approximately 50% enrollment, aiming for a 1H 2027 BLA filing.

Manufacturing and supply chain costs are an emerging, critical component. For the South Korea licensing deal on OCU400, Ocugen is explicitly responsible for manufacturing and supplying OCU400. This means internal costs for AAV vector production, quality control, and process validation runs are baked into the operating expenses and future COGS planning.

Regulatory filing and compliance expenses are front-loaded as the company prepares for submissions. The plan involves a rolling BLA submission for OCU400 targeted for the first half of 2026, and the OCU410ST program has secured European Medicines Agency acceptance for a single U.S.-based trial for its Marketing Authorization Application (MAA) submission. These activities require significant internal and external legal and regulatory consulting fees.

Ocugen, Inc. (OCGN) - Canvas Business Model: Revenue Streams

You're looking at how Ocugen, Inc. brings in cash right now, late in 2025, as they push their gene therapies through late-stage trials. It's a mix of current partnership income and the promise of future product sales.

The most immediate revenue source is from existing deals. For the third quarter of 2025, collaboration and licensing revenue hit $1.75 million. This number beat analyst expectations, showing that these early partnerships are already contributing to the bottom line while the big products are still in development.

The key to future, larger revenue streams is tied up in those regional licensing agreements, like the one signed with Kwangdong Pharmaceutical for OCU400 in South Korea. Here's the quick math on what that deal structure looks like for Ocugen, Inc.:

Revenue Component	OCU400 South Korea Deal Terms	Financial Amount/Rate
Upfront & Near-Term Milestones	Total potential from initial agreement	Up to $7.5 million
Sales Milestones	Per every $15 million of sales in Korea	$1.5 million
Total Potential Sales Milestones	Projected over the first decade of commercialization	$180 million or more
Net Sales Royalty	Ongoing percentage on OCU400 net sales in Korea	25%

That royalty rate of 25% is a significant piece of the long-term revenue puzzle, ensuring Ocugen, Inc. gets a substantial cut if OCU400 is successful in the Korean market. Plus, Ocugen, Inc. is responsible for manufacturing the commercial supply, which is another revenue component under a separate supply agreement.

To keep the clinical engine running-funding those Phase 3 trials for OCU400 and the OCU410ST Phase 2/3 trial-the company relies on capital markets. In August 2025, Ocugen, Inc. closed a registered direct offering. This provided immediate cash, and there's more on the table if certain conditions are met:

• Proceeds from the August 2025 offering: Approximately $20 million gross proceeds.
• Potential additional proceeds from warrant exercise: Up to $30 million.

Honestly, these equity proceeds are what bridge the gap between reporting small collaboration revenue now and realizing the massive potential from product royalties later. The $20 million raised was anticipated to extend the cash runway into the second quarter of 2026.

Finance: draft 13-week cash view by Friday.