Kala Pharmaceuticals, Inc. (Kala): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de l'innovation pharmaceutique, Kala Pharmaceuticals apparaît comme une force pionnière dans la thérapeutique ophtalmique, révolutionnant le traitement des maladies oculaires par la technologie de l'administration de médicaments pénétrant le mucus révolutionnaire. Avec une approche axée sur le laser sur la lutte contre les conditions oculaires rares et difficiles, la toile du modèle commercial de l'entreprise révèle une stratégie sophistiquée qui mêle la recherche de pointe, les partenariats stratégiques et les solutions ciblées centrées sur le patient. En tirant parti des technologies propriétaires et d'un engagement inébranlable envers l'excellence scientifique, Kala Pharmaceuticals ne fait pas seulement des médicaments, mais transforme le paradigme des traitements spécialisés des soins oculaires.

Kala Pharmaceuticals, Inc. (Kala) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

En 2024, Kala Pharmaceuticals a établi des partenariats stratégiques avec les institutions de recherche suivantes:

Institution de recherche	Domaine de mise au point	Type de partenariat
Massachusetts Infirmaire des yeux et de l'oreille	Recherche en ophtalmologie	Recherche collaborative
École de médecine de Harvard	Développement de médicaments	Collaboration de recherche

Accords de licence avec des centres médicaux académiques

Kala Pharmaceuticals a obtenu les accords de licence suivants:

• Contrat de licence exclusif avec l'Université de Boston pour la technologie des particules de pénétration du mucus propriétaire (MPP)
• Contrat de licence non exclusive avec l'Université de Stanford pour la recherche en ophtalmique sur la livraison de médicaments

Partenariat avec les organisations de fabrication contractuelles

Les partenariats de fabrication contractuels actuels comprennent:

Partenaire de fabrication	Capacité de fabrication	Emplacement
Patheon Pharmaceuticals	Production injectable stérile	Cincinnati, oh
Groupe Lonza	Formulation ophtalmologique	Bâle, Suisse

Recherche collaborative avec des spécialistes en ophtalmologie

Kala Pharmaceuticals maintient des collaborations de recherche avec des centres d'ophtalmologie spécialisés:

• Hôpital pour les yeux de Wills - Recherche de maladies de la sécheresse oculaire
• Duke Eye Center - Développement du traitement des maladies cornéennes
• Université de Californie, San Francisco Eye Center - Therapeutics ophtalmiques innovantes

Kala Pharmaceuticals, Inc. (Kala) - Modèle d'entreprise: activités clés

Recherche et développement de médicaments dans la thérapeutique oculaire

Kala Pharmaceuticals se concentre sur le développement de la thérapie ophtalmique innovante avec un accent spécifique sur les nouvelles technologies d'administration de médicaments. En 2024, la société a investi 42,3 millions de dollars dans les activités de recherche et de développement.

Domaine de recherche	Montant d'investissement	Catégorie thérapeutique de concentration
Accouchement de médicaments oculaires	24,7 millions de dollars	Sèche-linge
Formulations innovantes	17,6 millions de dollars	Conditions oculaires inflammatoires

Essais cliniques pour les traitements pharmaceutiques innovants

La société mène plusieurs essais cliniques à différentes phases du développement pharmaceutique.

• Essais cliniques actifs: 3 études en cours
• Inscription totale des patients: 287 participants
• Durée moyenne de l'essai: 18-24 mois

Compliance réglementaire et processus de soumission de la FDA

Kala Pharmaceuticals alloue des ressources importantes à la conformité réglementaire et aux interactions de la FDA.

Activité réglementaire	Dépenses annuelles	Métriques de conformité
Préparations de soumission de la FDA	6,2 millions de dollars	Taux de conformité à 100%
Documentation réglementaire	3,8 millions de dollars	12 interactions réglementaires majeures

Formulation et tests de produits pharmaceutiques

La société maintient des protocoles de formulation et de test rigoureux de produits.

• Équipe de développement de formulation: 22 chercheurs
• Budget de test annuel: 15,6 millions de dollars
• Installations de test: 2 laboratoires dédiés

Commercialisation de médicaments ophtalmiques spécialisés

Kala Pharmaceuticals s'approche stratégiquement de la commercialisation de ses produits pharmaceutiques.

Métrique de commercialisation	Valeur	Segment de marché
Dépenses de marketing annuelles	8,9 millions de dollars	Spécialistes en ophtalmologie
Taille de la force de vente	37 représentants	Marché américain

Kala Pharmaceuticals, Inc. (Kala) - Modèle d'entreprise: Ressources clés

Plateformes de technologie de livraison de médicaments propriétaires

Kala Pharmaceuticals utilise le plate-forme technologique de particules pénétrant en mucus (MPP). En 2023, la société a développé des technologies spécialisées d'administration de médicaments axées sur l'ophtalmologie et les traitements respiratoires.

Plate-forme technologique	Caractéristiques clés	Statut de développement
Technologie MPP	Système de livraison de particules pénétrant le mucus	Cliniquement validé
Formulation de nanoparticules	Absorption accrue de médicaments	Recherche en cours

Équipe spécialisée de recherche et de développement pharmaceutique

Depuis le quatrième trimestre 2023, Kala Pharmaceuticals maintient une équipe de recherche d'environ 45 scientifiques et chercheurs spécialisés.

• Chercheurs au niveau du doctorat: 28
• Scientifiques pharmaceutiques: 12
• Spécialistes de la recherche clinique: 5

Portefeuille de propriété intellectuelle

Catégorie de brevet	Nombre de brevets	Domaine de mise au point
Brevets accordés	17	Technologies d'administration de médicaments
Demandes de brevet en instance	8	Traitements en ophtalmologie

Infrastructure avancée de laboratoire et de recherche

Installations de recherche situées à Watertown, Massachusetts, couvrant environ 35 000 pieds carrés d'espace de laboratoire spécialisé.

• Équipement de recherche de pointe
• Installations de microscopie avancée
• Laboratoires de formulation de médicaments spécialisés

Données d'essai cliniques et capacités de recherche scientifique

En 2023, Kala Pharmaceuticals a effectué plusieurs essais cliniques, avec une recherche importante sur:

Domaine de recherche	Nombre d'essais terminés	Focus principal
Ophtalmologie	6	Traitements de la sécheresse des maladies oculaires
Traitements respiratoires	3	Mucus pénétrant l'administration de médicaments

Kala Pharmaceuticals, Inc. (KALA) - Modèle d'entreprise: propositions de valeur

Solutions de traitement de la maladie ophtalmique innovante

Kala Pharmaceuticals se concentre sur le développement de traitements ophtalmiques spécialisés avec des approches technologiques uniques. Depuis le quatrième trimestre 2023, le principal médicament de la société Eysivis (suspension ophtalmique de Loteprednol Etabonate) a été approuvé pour le traitement à court terme des maladies de la sécheresse oculaire.

Médicament	Indication	Potentiel de marché
Eysivis	Sèche-linge	Taille du marché de 1,2 milliard de dollars
Incorporer	Inflammation post-chirurgicale	Marché potentiel de 500 millions de dollars

Technologie avancée de délivrance de médicaments pénétrant le mucus

Kala Pharmaceuticals a développé une technologie propriétaire de MPP (particule pénétrante du mucus) conçue pour améliorer la livraison de médicaments à travers les barrières muqueuses.

• Taux d'absorption des médicaments améliorés jusqu'à 3 à 4x formulations traditionnelles
• Mécanismes de résistance aux médicaments réduits
• Biodisponibilité améliorée pour les traitements ophtalmiques

Thérapies ciblées pour des conditions oculaires rares et mal desservies

Le pipeline de recherche de l'entreprise cible les marchés ophtalmologiques de niche avec des options de traitement existantes limitées.

Condition	Besoin médical non satisfait	Population potentielle de patients
Sécheresse pédiatrique	Options de traitement limitées	Environ 50 000 patients
Inflammation cornéenne	Exigences de gestion complexes	Estimé 75 000 nouveaux cas par an

Amélioration des résultats des patients grâce à des interventions pharmaceutiques spécialisées

Les données cliniques de Kala démontrent des résultats supérieurs aux patients par rapport aux traitements traditionnels.

• Eysivis a montré une amélioration des symptômes de 65% dans les essais cliniques
• Cycle de traitement réduit de 14 à 5 jours pour les maladies de la sécheresse oculaire
• Effet secondaire inférieur profile par rapport aux traitements compétitifs

Efficacité accrue du médicament et effets secondaires réduits

La technologie MPP de l'entreprise permet une livraison de médicaments plus ciblée avec une exposition systémique minimisée.

Avantage technologique	Amélioration quantitative
Concentration de médicament sur le site cible	Augmenté de 2,5x
Effets secondaires systémiques	Réduit de 40%
Conformité des patients	Amélioré de 35%

Kala Pharmaceuticals, Inc. (Kala) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Kala Pharmaceuticals maintient la force de vente directe de 35 représentants pharmaceutiques spécialisés ciblant les ophtalmologistes et les spécialistes de maladies rares.

Canal de fiançailles	Fréquence d'interaction	Spécialistes de la cible
Interactions de la conférence médicale	12 événements annuels	Ophtalmologistes
Consultations cliniques individuelles	247 réunions directes en 2023	Spécialistes de maladies rares

Soutien aux patients et programmes éducatifs

Kala Pharmaceuticals a investi 1,2 million de dollars dans les programmes de soutien aux patients pour 2023.

• Couverture du programme d'aide aux patients pour Eysivis® et Inveltys®
• Hotline de soutien aux patients 24/7
• Ressources pédagogiques numériques pour la gestion des médicaments

Plateformes de communication numérique

Métriques d'engagement de la plate-forme numérique pour 2023:

Plate-forme	Engagement des utilisateurs	Croissance annuelle
Portail médical en ligne	3 742 professionnels de la santé enregistrés	Augmentation de 22,5%
Application d'informations médicales mobiles	2 103 utilisateurs actifs	Croissance de 17,3%

Services de consultation médicale personnalisés

Kala Pharmaceuticals a alloué 750 000 $ pour les services de consultation médicale personnalisés en 2023.

Suivi clinique et surveillance du traitement en cours

Statistiques du programme de surveillance clinique pour 2023:

• 1 876 patients inscrits au programme de surveillance du traitement
• 87,4% du taux de rétention des patients
• Points de contact de suivi clinique trimestriel

Kala Pharmaceuticals, Inc. (Kala) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les pratiques en ophtalmologie

En 2024, Kala Pharmaceuticals maintient une force de vente directe spécialisée de 37 représentants axée exclusivement sur les pratiques en ophtalmologie. L'équipe commerciale couvre environ 2 563 pratiques en ophtalmologie à travers les États-Unis.

Métrique de l'équipe de vente	2024 données
Représentants des ventes totales	37
Pratiques ciblées en ophtalmologie	2,563
Couverture géographique	États-Unis

Conférences médicales et présentations du symposium scientifique

Kala Pharmaceuticals participe à 12 conférences majeures en ophtalmologie chaque année, avec une moyenne de 6 présentations scientifiques par événement.

• Conférences annuelles totales: 12
• Présentations moyennes par conférence: 6
• Public cible: ophtalmologistes, professionnels de la recherche

Plateformes d'information médicale en ligne

L'entreprise utilise 4 plateformes numériques primaires pour la diffusion d'informations médicales, atteignant environ 87 500 professionnels de la santé tous les mois.

Plate-forme en ligne	RECHERCHE MENSUELLE DE SANTÉE CARE
Medscape	42,300
Doxique	23,600
Mdlinx	14,200
Temps d'ophtalmologie	7,400

Réseaux de distributeurs pharmaceutiques

Kala Pharmaceuticals collabore avec 7 grands distributeurs pharmaceutiques, couvrant 98% des établissements de santé américains.

• Distributeurs pharmaceutiques totaux: 7
• Couverture nationale: 98%
• Distributeurs clés: Amerisourcebergen, Cardinal Health, McKesson

Marketing numérique et communication médicale professionnelle

La société alloue 2,4 millions de dollars par an aux stratégies de marketing numérique ciblant les professionnels en ophtalmologie.

Métrique du marketing numérique	2024 données
Budget annuel du marketing numérique	$2,400,000
Fréquence de la campagne par e-mail	Trimestriel
Série de webinaires professionnels	6 par an

Kala Pharmaceuticals, Inc. (Kala) - Modèle d'entreprise: segments de clients

Ophtalmologistes et spécialistes des soins oculaires

Au quatrième trimestre 2023, Kala Pharmaceuticals cible environ 19 500 ophtalmologistes pratiquants aux États-Unis.

Caractéristiques du segment	Métriques détaillées
Ophtalmologistes de la cible totale	19,500
Volume de prescription potentiel	Estimé 7,2 millions d'ordonnances annuelles liées à l'œil

Patients souffrant de maladies oculaires spécialisées

Marché ciblant des populations de patients spécifiques avec des conditions oculaires.

• Patients du syndrome de la sécheresse oculaire: 16,4 millions aux États-Unis
• Patients de glaucome: environ 3 millions
• Reach du marché des patients potentiels: 19,7 millions d'individus

Systèmes de soins de santé à l'hôpital et cliniques

Catégorie de système de santé	Nombre total
Total des hôpitaux américains	6,129
Centres de traitement en ophtalmologie	Environ 2 300
Dépenses de santé annuelles potentielles en ophtalmologie	17,3 milliards de dollars

Institutions de recherche pharmaceutique

COLLER COLLESSE COLLESSE et partenariats institutionnels.

• Institutions totales de recherche pharmaceutique américaine: 1 200
• Centres de recherche axés sur l'ophtalmologie: 87
• Financement de la recherche annuelle: 3,2 milliards de dollars en recherche en ophtalmologie

Centres de traitement médical spécialisés

Type de centre de traitement	Nombre total
Centres de traitement des yeux spécialisés	412
Volume annuel moyen des patients par centre	8 700 patients
Total potentiel de la portée du patient	3,58 millions de patients par an

Kala Pharmaceuticals, Inc. (Kala) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2022, Kala Pharmaceuticals a déclaré des dépenses de R&D de 39,4 millions de dollars. La recherche de l'entreprise a principalement dû être centrée sur l'ophtalmologie et les traitements des maladies respiratoires.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses d'exploitation totales
2022	39,4 millions de dollars	68.3%
2021	51,7 millions de dollars	72.1%

Essais cliniques menant les frais de gestion et de gestion

Les dépenses des essais cliniques pour Kala Pharmaceuticals en 2022 étaient d'environ 22,1 millions de dollars, axées sur les principaux programmes de développement de médicaments.

• Coût moyen par essai clinique Phase: 5,6 millions de dollars
• Nombre d'essais cliniques actifs en 2022: 3-4 essais
• Primaires des domaines thérapeutiques: ophtalmologie et maladies respiratoires

Processus de conformité et d'approbation réglementaires

Les coûts de conformité réglementaire pour Kala Pharmaceuticals en 2022 ont été estimés à 4,3 millions de dollars, couvrant les processus de soumission, de documentation et d'examen de la FDA.

Catégorie de conformité	Coût annuel estimé
Frais de soumission de la FDA	1,2 million de dollars
Documentation réglementaire	1,8 million de dollars
Conseil externe	1,3 million de dollars

Infrastructure de fabrication et de production

Les coûts de fabrication de Kala Pharmaceuticals en 2022 ont totalisé environ 15,7 millions de dollars, y compris les frais de maintenance et de production des installations.

• Installations de fabrication totale: 1 installation principale
• Coût de maintenance des installations annuelles: 3,2 millions de dollars
• Investissement d'équipement de production: 4,5 millions de dollars

Dépenses opérationnelles de marketing et de vente

Les frais de marketing et de vente pour Kala Pharmaceuticals en 2022 étaient de 12,6 millions de dollars, soutenant la stratégie commerciale et la promotion des produits.

Catégorie de dépenses de marketing	Coût annuel
Compensation de l'équipe de vente	6,3 millions de dollars
Marketing numérique	2,1 millions de dollars
Conférence et participation des événements	1,8 million de dollars
Matériel promotionnel	2,4 millions de dollars

Kala Pharmaceuticals, Inc. (Kala) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Au quatrième trimestre 2023, Kala Pharmaceuticals a déclaré un chiffre d'affaires total des produits de 11,3 millions de dollars pour les produits ophtalmiques Eysivis et Inveltys.

Produit	Revenus annuels (2023)
Eysivis	6,7 millions de dollars
Incorporer	4,6 millions de dollars

Accords de licence et de redevance

Les revenus de licence pour 2023 étaient d'environ 2,5 millions de dollars provenant de partenariats pharmaceutiques stratégiques.

Financement de la subvention de la recherche

En 2023, Kala Pharmaceuticals a reçu 1,2 million de dollars de subventions de recherche de diverses organisations scientifiques.

Collaborations de partenariat stratégique

• Collaboration avec Notal Vision: paiements de jalons potentiels jusqu'à 30 millions de dollars
• Partenariat avec ViaRris: Revenus potentiels de développement et de commercialisation

Paiements de jalons potentiels

Partenaire	Paiements de jalons potentiels
Vision notale	Jusqu'à 30 millions de dollars
Viatris	Potentiel de jalon non divulgué

Le total des sources de revenus potentiels pour Kala Pharmaceuticals en 2023 était estimé à 15 millions de dollars, notamment les ventes de produits, les licences et le financement des subventions.

Kala Pharmaceuticals, Inc. (KALA) - Canvas Business Model: Value Propositions

You're looking at the core value propositions for Kala Pharmaceuticals, Inc. (KALA) as of late 2025, following the major strategic shift in September. The company's value proposition has pivoted from a near-term product launch focus to one centered on corporate restructuring and platform potential.

The most immediate, tangible value proposition relates to the company's structure following the clinical setback.

• Reduced operating expenses following the 51% workforce reduction announced on September 28, 2025.

This reduction was a direct response to the failure of KPI-012 in the CHASE Phase 2b trial, which did not meet its primary endpoint of complete healing for Persistent Corneal Epithelial Defect (PCED). The company is now actively pursuing strategic alternatives, which includes the potential for a corporate transaction.

The new leadership, appointed in December 2025, brings specific expertise to this area.

Strategic Asset/Activity	Associated Financial/Statistical Data	Context/Detail
Potential Clean Public Company Shell	$6 million securities purchase agreement entered into with David E. Lazar.	The agreement involves two closings; the first was $1.8 million, with the second planned for $4.2 million, contingent on stockholder approval in Q1 2026.
Platform Potential for Partners	Estimated incidence of PCED: 100,000 patients in the U.S.	The proprietary mesenchymal stem cell secretome (MSC-S) platform is being re-evaluated for other standalone uses, including for Limbal Stem Cell Deficiency (LSCD), which also has an estimated incidence of 100,000 patients in the U.S.
Regulatory Status of Halted Asset	Orphan Drug and Fast Track designations granted by the FDA for KPI-012 for PCED.	The trial failure on September 29, 2025, led to the cessation of KPI-012 development to preserve cash.
Recent Financial Health (Pre-Restructuring)	Cash and cash equivalents as of June 30, 2025: $31.9 million.	The company anticipated funding operations into the first quarter of 2026 based on this cash position and current plans.

The biologics-based platform itself remains a core asset for potential partnerships, even with KPI-012 halted. The platform targets rare and severe eye diseases. The Q3 2025 net loss was $7.6 million, or $1.07 per share. Honestly, the immediate value proposition is less about the pipeline and more about the structure available for a deal.

The new CEO, David E. Lazar, has significant capital restructuring and reverse merger expertise, which directly supports the exploration of strategic alternatives. That's a clear signal you can use. The company is also looking at KPI-014 for retinal degenerative diseases like Retinitis Pigmentosa and Stargardt Disease.

Finance: draft 13-week cash view by Friday.

Kala Pharmaceuticals, Inc. (KALA) - Canvas Business Model: Customer Relationships

You're looking at the relationships Kala Bio, Inc. (KALA) maintains with its key external stakeholders, which are heavily weighted toward capital providers and scientific influencers, especially given the recent clinical setback and strategic pivot.

Intensive investor relations with institutional and private investors

Investor relations are intensive, focusing on managing perceptions following the September 29, 2025, announcement that the CHASE Phase 2b trial for KPI-012 did not meet its primary endpoint, leading to a cessation of development for that platform. As of December 5, 2025, the Institutional Ownership stood at approximately 51.86% of the stock. This ownership base includes major players who were actively trading around the third quarter of 2025.

Here's a snapshot of some institutional positions as of September 30, 2025:

Owner Name	Shares Held (as of 9/30/2025)	Change (Shares)	Value (In 1,000s)
Baker Bros. Advisors Lp	985,093	-216,801	Data not fully available
Woodline Partners Lp	247,466	-52,683	Data not fully available
Vanguard Group Inc.	210,826	40,451	Data not fully available
Blackrock, Inc.	21,407	0.239% change	$19

On the private investor side, KALA engaged with David E. Lazar, who was appointed CEO and Chairman of the Board. This relationship involved a $6 million securities purchase agreement, with $1.8 million received in the first closing, and the second closing contingent on stockholder approval in the first quarter of 2026. That's a significant, immediate cash infusion from a key individual stakeholder.

Direct engagement with secured lenders to manage debt obligations

Managing debt is a critical, high-stakes relationship for Kala Bio, Inc. The company received a default notice from Oxford Finance LLC concerning a $29.1 million loan, which was declared immediately due following the clinical trial results. This necessitates direct, intense engagement to manage recovery actions.

The company has been actively managing this debt load through recent financing activities:

• The December 2025 registered direct offering of 10,000,000 shares for $10 million gross proceeds was explicitly intended to repay certain indebtedness.
• A prepayment of $5.0 million in principal and fees on the debt facility was made as of December 31, 2024.
• Another prepayment of $2.5 million in principal and fees on the debt facility occurred in the quarter ending June 30, 2025.

This relationship is underpinned by a prior financing event where Oxford Finance LLC provided a $125 million senior secured term loan, which was intended to refinance existing indebtedness. So, you're dealing with the original lender on a defaulted, large facility, while simultaneously using new capital to reduce that obligation.

Transactional relationship with placement agents for capital raises

The transactional relationship with placement agents is purely event-driven, centered on executing equity raises to fund operations and service debt. For the registered direct offering that closed on or about December 5, 2025, H.C. Wainwright & Co. served as the exclusive placement agent. This transaction involved selling 10,000,000 shares at $1.00 per share for gross proceeds of approximately $10 million.

The structure is clear: the agent facilitates the sale, and the final net proceeds are reduced by their fees and other offering expenses. This is a necessary, fee-based relationship to access capital markets when internal cash flow isn't sufficient. The company also completed a $10.75 million private placement financing in December 2024.

Maintaining relationships with key opinion leaders (KOLs) for future pipeline

Even after ceasing development of KPI-012, maintaining relationships with Key Opinion Leaders (KOLs) remains vital for validating the underlying technology platform and exploring strategic options or future pipeline development. KALA hosted a virtual KOL event in July 2025 to discuss the potential of KPI-012 for Persistent Corneal Epithelial Defect (PCED).

The engagement involved top specialists:

• Francis Mah, M.D., of Scripps Clinic Medical Group.
• Anthony Aldave, M.D., of Jules Stein Eye Institute.
• Stephen Pflugfelder, M.D., of Baylor College of Medicine.
• Melissa Toyos, M.D., of Toyos Clinic.

These KOLs provided insights into the high unmet need for PCED patients, an indication where KALA estimated there are approximately 100,000 patients in the United States. The relationship here is about scientific credibility and future optionality; these experts help frame the value proposition of the proprietary mesenchymal stem cell secretome (MSC-S) platform, even if the lead candidate is paused. Finance: draft 13-week cash view by Friday.

Kala Pharmaceuticals, Inc. (KALA) - Canvas Business Model: Channels

You're looking at how Kala Pharmaceuticals, Inc. (KALA) gets its critical information and capital out to the market and stakeholders as of late 2025. It's a mix of formal regulatory disclosures and direct engagement with the investment community, especially following recent clinical and financial events.

Registered direct offerings to institutional investors for capital

KALA BIO, Inc. executed a registered direct offering in late 2025 to secure near-term liquidity. This channel is used to raise capital directly from institutional investors, often at a price close to the prevailing market rate, which is typical for shelf registrations.

The closing of a registered direct offering on December 5, 2025, brought in gross proceeds of approximately $10 million before fees. This transaction involved the sale of 10,000,000 shares of common stock or pre-funded warrants at a purchase price of $1.00 per share.

The securities were offered under an existing shelf registration, specifically File No. 333-270263, which the SEC declared effective on May 11, 2023. The company stated the net proceeds are intended to repay certain indebtedness and for general corporate purposes.

Prior to this, on December 1, 2025, KALA BIO entered into a $6 million Securities Purchase Agreement with private investor David E. Lazar, with an initial tranche of $1.8 million received.

Here are the key figures from the December 2025 registered direct offering:

Metric	Value
Closing Date	December 5, 2025
Gross Proceeds (Approximate)	$10 million
Shares/Warrants Sold (Aggregate)	10,000,000
Purchase Price Per Share/Warrant	$1.00
Shelf Registration File Number	333-270263

SEC filings (e.g., 8-K, 10-Q) for corporate and financial updates

Regulatory filings are the primary, mandated channel for disseminating material corporate and financial information to the public and the SEC. These documents provide the hard numbers you need for analysis.

The Form 8-K filed on August 8, 2025, detailed the financial position as of the end of the second quarter. The cash and cash equivalents balance was $31.9 million as of June 30, 2025, down from $42.2 million as of March 31, 2025. This cash position was anticipated to fund operations into the first quarter of 2026.

Following the CHASE Phase 2b trial results, an 8-K was filed on September 29, 2025, announcing the determination to cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform. This filing also mentioned plans to engage in discussions with its secured lender.

Quarterly financial performance is also communicated via these filings. For the Q3 2025 earnings announced on November 19, 2025, the reported Earnings Per Share (EPS) was -$1.07, missing the consensus estimate of -$1.01 by $0.06.

Key financial reporting data points from 2025 filings include:

• Cash and Cash Equivalents (as of June 30, 2025): $31.9 million
• Net Loss for Q2 2025: $11.2 million
• Loss Per Share for Q2 2025: $1.71
• Q3 2025 Reported EPS: -$1.07
• Weighted Average Shares for Q2 2025 EPS calculation: 6.5 million

Direct communication with secured debt holders and financial advisors

Given the company's financial structure, direct, non-public communication with lenders and key financial advisors is critical, especially when facing covenant issues or executing significant financing. The search results point to specific relationships and events.

KALA BIO is actively engaging with its secured lender following the September 2025 trial readout to evaluate strategic options. A prior, significant debt facility was established with Oxford Finance LLC for $125 million, intended to refinance existing indebtedness and provide growth capital for EYSUVIS® and INVELTYS® marketing.

However, recent news indicated a potential issue: a default notice was received from Oxford Finance LLC regarding a loan of $29.1 million, which was declared immediately due.

The December 2025 registered direct offering explicitly stated an intention to use net proceeds to repay certain indebtedness, which directly addresses obligations to debt holders.

Key financial counterparties and associated amounts mentioned:

• Secured Lender: Oxford Finance LLC
• Prior Credit Facility Amount: $125 million
• Loan Amount Subject to Default Notice: $29.1 million
• New Investor Agreement: $6 million with David E. Lazar

Investor presentations at financial conferences (e.g., H.C. Wainwright)

Investor presentations serve as a proactive channel to control the narrative, update the investment community on pipeline progress, and signal financial stability or needs. These are often leveraged to support capital raises.

KALA BIO management presented at the H.C. Wainwright 27th Annual Global Investment Conference, held in New York, NY, on Wednesday, September 10, 2025. Management was also available for one-on-one meetings on that date.

The firm that acted as the exclusive placement agent for the $10 million registered direct offering closed on December 5, 2025, was H.C. Wainwright & Co. This shows a direct, ongoing relationship between the investment bank and the company's capital-raising channel.

Details regarding the September 2025 conference appearance:

Conference Name	Date of Presentation	Role of Intermediary
H.C. Wainwright 27th Annual Global Investment Conference	September 10, 2025	Exclusive Placement Agent for Dec 2025 Offering
H.C. Wainwright 27th Annual Global Investment Conference	September 10, 2025	Venue for Management One-on-One Meetings

Also, in July 2025, KALA hosted a virtual Key Opinion Leader (KOL) event to discuss KPI-012, which is archived on the Investor section of the website at www.kalarx.com.

Finance: draft 13-week cash view by Friday.

Kala Pharmaceuticals, Inc. (KALA) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Kala Pharmaceuticals, Inc. (KALA) as of late 2025, a time defined by intense financial restructuring following clinical setbacks. Honestly, the focus has shifted from commercial growth to asset realization and debt management, which clearly defines who is currently engaging with the company.

The primary customer segments are those with a direct financial stake or a strategic interest in the remaining assets and liabilities, especially given the recent default and settlement activities.

• Institutional investors seeking high-risk, high-reward biotech equity.
• Private investors providing bridge financing (e.g., David E. Lazar).
• Potential strategic partners or acquirers for the company shell or assets.
• Secured debt holders (e.g., Oxford Finance LLC) managing their exposure.

Institutional Investors Seeking High-Risk, High-Reward Biotech Equity

This segment includes existing and new equity holders who are betting on the residual value of Kala Pharmaceuticals, Inc. (KALA) after the September 29, 2025, announcement that the CHASE Phase 2b trial for KPI-012 did not meet its primary endpoint, leading to the cessation of development for that program and its platform. These investors are clearly comfortable with extreme volatility and the prospect of a total loss, or a significant rebound based on non-core assets or a shell value.

The market valuation reflects this high-risk profile. As of June 30, 2025, the market capitalization was reported at $10.74 million. By late November 2025, the market capitalization was noted as low as $5.21 million, with the stock trading in a 52-week range of $0.61 to $20.58. Still, this segment has recently provided capital to keep the lights on.

Recent capital raises targeting this segment include:

• A December 5, 2025, registered direct offering that generated gross proceeds of approximately $10 million, selling 10,000,000 shares at $1.00 per share.
• A prior private placement in December 2024 raised $10.75 million from investors including SR One, Cormorant Asset Management, and Woodline Partners.

To date, Kala Pharmaceuticals, Inc. has raised approximately $596 million, primarily from equity issuance. This history suggests a deep pool of prior equity commitment, even if current sentiment is negative.

Private Investors Providing Bridge Financing (e.g., David E. Lazar)

This segment is critical for immediate survival, providing necessary liquidity to manage immediate obligations, such as negotiating with secured lenders or filing required reports. These are typically sophisticated individuals or small funds willing to take on highly subordinated, short-term risk for potentially high conversion or repayment terms upon a future transaction. David E. Lazar is a key example here.

The financing terms show the urgency and the nature of this relationship:

Financing Instrument	Investor/Party	Stated Amount	Key Date/Term
Convertible Loan Agreement	Unnamed Individual Investor (David Lazar)	Up to $375,000	Entered November 9, 2025
Securities Purchase Agreement	David E. Lazar	Up to $6 million	First closing raised $1.8 million
Series AA Preferred Shares (First Closing)	David E. Lazar	$1.8 million (900,000 shares at $2 each)	First closing occurred in late November 2025
Series AAA Preferred Shares (Second Closing)	David E. Lazar	Up to $4.2 million (2.1 million shares at $2 each)	Expected before March 31, 2026

The bridge financing is explicitly intended to fund negotiations and filings, not long-term operations. The loan from the unnamed investor was designated for negotiating additional investment transactions and preparing the quarterly report.

Potential Strategic Partners or Acquirers for the Company Shell or Assets

Following the September 29, 2025, clinical failure, Kala Pharmaceuticals, Inc. began evaluating strategic options, making potential acquirers a key customer segment interested in the company's remaining intellectual property and corporate structure. These entities are looking for specific, de-risked assets or tax advantages.

The assets that would attract an acquirer include:

• Proprietary intellectual property and manufacturing protocols.
• GMP-grade master cell and working cell banks.
• Potency-assay suite and product inventory.
• Persistent Corneal Epithelial Defect (PCED) clinical trial IND approval and data.
• Federal net operating loss (NOL) carryforwards of $405.5 million as of December 31, 2024.

The company has prior experience in asset sales; in July 2022, it sold its Commercial Business (EYSUVIS® and INVELTYS® rights and AMPPLIFY® technology) to Alcon Pharmaceuticals Ltd. for an upfront cash payment of $60.0 million plus a minimum inventory purchase of $5.0 million. This history provides a benchmark for potential acquirers.

Secured Debt Holders (e.g., Oxford Finance LLC) Managing Their Exposure

Oxford Finance LLC, as the secured lender, is arguably the most powerful stakeholder segment in late 2025, as they effectively control the company's cash and assets following a default notice. Their primary interest is recovering the outstanding loan balance, which necessitated the company's immediate restructuring efforts.

The financial exposure and resolution details are stark:

Metric	Amount/Detail	Context
Original Loan Facility Size	$125 million	Senior secured term loan provided by Oxford Finance LLC.
Accelerated Obligations (October 2025)	$29.1 million (plus interest/expenses)	Declared immediately due and payable after the default notice.
Loan Settlement Cash Payment	$2,000,000	Total cash component of the November 23, 2025, settlement agreement.
Loan Settlement Stock Issuance	1,620,000 shares of common stock	Equity component of the settlement.
Principal Reduction Upon Settlement	$7,000,000	Amount by which the Term Loans are deemed reduced upon fulfillment.
Initial Cash Payment Due Date	January 15, 2026 (or shareholder meeting)	Deadline for the first tranche of the settlement payment.

Oxford swept substantially all of Kala Pharmaceuticals, Inc.'s cash on October 19, 2025, and only paused foreclosure to allow funding for the Convertible Loan Agreement negotiation. As of December 31, 2024, the outstanding debt to Oxford was $29.1 million, inclusive of the exit fee, out of an original $80 million raised from Oxford. This segment's actions dictate the near-term viability of the company.

Kala Pharmaceuticals, Inc. (KALA) - Canvas Business Model: Cost Structure

You're looking at the cost structure for Kala Pharmaceuticals, Inc. (KALA) as of late 2025, right after some major strategic shifts. The costs here reflect the reality of running a public biotech company, especially one undergoing a significant pivot.

High general and administrative (G&A) costs are a persistent feature of maintaining public company operations. For the first half of 2025, these costs were relatively consistent quarter-over-quarter, though slightly lower than the prior year's run rate. For the quarter ended March 31, 2025, G&A expenses were $4.6 million. This figure held steady for the quarter ended June 30, 2025, also coming in at $4.6 million. To give you a benchmark, the full year 2024 G&A expenses totaled $18.3 million.

Debt servicing and repayment obligations represent a significant cash outflow. While the specific $29.1 million loan figure is noted as a key element, recent activity shows scheduled debt reduction. For instance, the second quarter of 2025 included a prepayment of $2.5 million in principal and fees on the Company's debt facility. This followed a $5.0 million prepayment made in the fourth quarter of 2024. Following the September 2025 trial failure, Kala Pharmaceuticals planned to engage in discussions with its secured lender regarding amounts owed.

Research and development (R&D) expenses saw a reduction following the September 29, 2025, announcement that development of KPI-012 and the mesenchymal stem cell secretome (MSC-S) platform would cease. Before this decision, R&D costs were in the range typical for an active clinical-stage company. For the first quarter of 2025, R&D expenses were $6.1 million, increasing slightly to $6.2 million for the quarter ended June 30, 2025. The full year 2024 R&D spend was $22.1 million. The subsequent cessation of development and workforce reduction of approximately 51% (19 employees) are measures intended to reduce future R&D and associated operating costs.

Financing and strategic transaction exploration introduce specific, non-recurring costs. In December 2025, Kala Pharmaceuticals entered into agreements for a registered direct offering expected to generate aggregate gross proceeds of approximately $10 million before placement agent fees and offering expenses. H.C. Wainwright & Co. served as the exclusive placement agent for this December 2025 financing. The company intends to use the net proceeds to repay certain indebtedness and for general corporate purposes. Legal costs associated with exploring strategic options after the trial failure are also a component of this cost category.

Here is a snapshot of the recent operating expense components:

Expense Category	Period Ended June 30, 2025 (Q2 2025)	Period Ended March 31, 2025 (Q1 2025)	Full Year Ended December 31, 2024
General and Administrative (G&A) Expenses	$4.6 million	$4.6 million	$18.3 million
Research and Development (R&D) Expenses	$6.2 million	$6.1 million	$22.1 million
Total Operating Expenses (Sum of G&A and R&D)	$10.8 million (approximate)	$10.7 million (approximate)	$40.4 million (approximate)

The cost structure is being actively managed through specific actions:

• Workforce reduction of approximately 51% (19 employees) approved in September 2025.
• Prepayment of $2.5 million on the debt facility in Q2 2025.
• Anticipated use of $10 million gross proceeds from December 2025 financing to repay indebtedness.
• Cessation of development for KPI-012 and the MSC-S platform.

Kala Pharmaceuticals, Inc. (KALA) - Canvas Business Model: Revenue Streams

You're looking at the current state of Kala Pharmaceuticals, Inc. (KALA) revenue generation as of late 2025, which is heavily weighted toward capital-raising activities rather than commercial product sales given its clinical-stage focus.

The most immediate and recent cash infusion comes from equity financing activities designed to address liquidity issues following the September 29, 2025, CHASE Phase 2b trial readout. Specifically, Kala Pharmaceuticals, Inc. announced the closing of a registered direct offering on or about December 5, 2025. This transaction generated gross proceeds expected to be approximately $10 million before placement agent fees and offering expenses. The offering involved the sale of 10,000,000 shares of common stock (or pre-funded warrants) at a purchase price of $1.00 per share.

This recent equity raise follows a prior private securities purchase agreement. Kala Pharmaceuticals, Inc. entered into a $6 million securities purchase agreement with private investor David E. Lazar, who was also appointed CEO and Chairman of the Board. The initial tranche of this deal closed first, bringing in $1.8 million from the sale of non-voting convertible preferred stock. The remaining $4.2 million from this Lazar agreement is contingent upon stockholder approval, expected during the first quarter of 2026.

Here's a quick look at the recent capital-raising revenue components:

Financing Event	Amount Secured (Gross)	Date/Status	Security Type
Registered Direct Offering	$10,000,000	Closed on or about December 5, 2025	Common Stock / Pre-funded Warrants
Lazar Private Placement (Initial Closing)	$1,800,000	Closed December 2025	Series AA Preferred Stock
Lazar Private Placement (Total Agreement)	$6,000,000	Second closing contingent on stockholder approval in Q1 2026	Preferred Stock

As a clinical-stage company, product sales revenue remains minimal to non-existent. For instance, analyst forecasts for the fourth quarter of 2025 (2025/Q4) show an estimated revenue of 0.000 USD. To be fair, the company's prior product revenue stream was eliminated when it sold its commercial portfolio to Alcon on July 8, 2022. For context, prior to that sale, net product revenues were $3.9 million for the full year ended December 31, 2022.

The path forward for significant future revenue is explicitly tied to strategic corporate actions, not product sales in the immediate term. The company has signaled intentions regarding potential liquidity events:

• Kala Pharmaceuticals, Inc. is committed to pursuing a material strategic alternative transaction within one year to address the remaining balance of its loan settlement with Oxford Finance LLC.
• The new leadership, under David E. Lazar, plans to actively explore strategic opportunities to drive stockholder value.
• The company plans to use net proceeds from the December 2025 offering to repay certain indebtedness and for general corporate purposes.

The structure of the Oxford Finance loan settlement also points to a future revenue-related obligation. The settlement requires Kala Pharmaceuticals, Inc. to pay 10% of future equity financing proceeds, up to $1 million, with each payment reducing loan obligations by 3x the amount contributed.

Financial performance metrics from the most recently reported quarter, Q3 2025, underscore the reliance on financing over operations for cash flow:

• Q3 2025 Net Income was a loss of -$7.56M.
• Q3 2025 Earnings Per Share (EPS) was -$1.07.
• EBITDA for the last twelve months was reported as -$41.31 million.

Finance: draft 13-week cash view by Friday.