Iovance Biotherapeutics, Inc. (IOVA): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de l'immunothérapie contre le cancer en évolution, Iovance Biotherapeutics (IOVA) émerge comme un innovateur révolutionnaire, des traitements transformateurs à base de cellules pionnières qui pourraient révolutionner la façon dont nous abordons la gestion des tumeurs solides. En exploitant le pouvoir des thérapies lymphocytes (TIL) infiltrant les tumeurs, cette entreprise de biotechnologie de pointe repousse les limites du traitement du cancer personnalisé, offrant de l'espoir aux patients confrontés aux tumeurs malignes difficiles et difficiles à traiter. Leur modèle commercial unique mélange l'innovation scientifique, les partenariats stratégiques et un engagement axé sur le laser à développer des immunothérapies de précision qui pourraient potentiellement changer le paradigme du traitement du cancer.

Iovance Biotherapeutics, Inc. (IOVA) - Modèle commercial: partenariats clés

Collaborations stratégiques avec les institutions de recherche sur le cancer

Iovance a établi des partenariats clés avec les institutions de recherche suivantes:

Institution	Domaine de mise au point	Détails du partenariat
MD Anderson Cancer Center	Recherche thérapeutique des lymphocytes infiltrant des tumeurs (TIL)	Collaboration en cours cliniques
National Cancer Institute (NCI)	Recherche d'immunothérapie	Contrat de recherche collaboratif pour les thérapies

Partenariat avec les sociétés pharmaceutiques pour les essais cliniques

IOVANCE a développé des partenariats stratégiques pour l'avancement des essais cliniques:

• Miserrer & CO.: Collaboration pour les essais de thérapie combinée
• Bristol Myers Squibb: Recherche conjointe en immuno-oncologie

Accords de licence pour les technologies innovantes de thérapie cellulaire

Les partenariats sur les licences technologiques comprennent:

Partenaire technologique	Focus technologique	Statut de licence
Université de Pennsylvanie	Techniques d'ingénierie cellulaire	Contrat de licence exclusif
Memorial Sloan Kettering Cancer Center	Plate-forme d'immunothérapie	Accès technologique non exclusif

Alliances de recherche avec des centres médicaux académiques

Les alliances de recherche actives englobent:

• École de médecine de l'Université de Stanford
• Dana-Farber Cancer Institute
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Accords de co-développement potentiels avec des entreprises de biotechnologie

Partenariats de co-développement actuels:

Entreprise de biotechnologie	Focus de la collaboration	Investissement / financement
Thérapeutique adaptable	Développement de la thérapie des cellules T	15 millions de dollars d'investissement en recherche collaborative
TCR2 Thérapeutique	Plateformes de thérapie cellulaire avancés	Contrat de partage de technologie de 10 millions de dollars

Iovance Biotherapeutics, Inc. (IOVA) - Modèle d'entreprise: Activités clés

Développer des thérapies cellulaires autologues et allogéniques

Au quatrième trimestre 2023, Iovance a investi 298,7 millions de dollars dans la recherche et le développement. L'entreprise se concentre sur le développement de thérapies lymphocytes (TIL) infiltrant les tumeurs avec LifileUcel en tant que candidat principal à un produit de stade clinique.

Type de thérapie	Étape de développement	Investissement
Thérapie TIL autologue	Essais cliniques de phase 3	185,4 millions de dollars
Thérapie cellulaire allogénique	Recherche préclinique	113,3 millions de dollars

Effectuer des essais cliniques pour les thérapies TIL

Iovance a des essais cliniques actifs à travers plusieurs indications de cancer:

• Mélanome métastatique
• Cancer du col de l'utérus avancé
• Cancer du poumon non à petites cellules

Type de cancer	Phase d'essai clinique	Inscription des patients
Mélanome métastatique	Phase 3	168 patients
Cancer du col de l'utérus avancé	Phase 2	93 patients

Processus avancés d'ingénierie et de fabrication des cellules

Les capacités de fabrication comprennent une installation de 36 000 pieds carrés à Philadelphie avec Bonne pratique de fabrication actuelle (CGMP) Normes.

Capacité de fabrication	Production annuelle	Coût par traitement
Installation de 36 000 pieds carrés	Jusqu'à 500 traitements de patients / an	Estimé 250 000 $ par traitement

Conformité réglementaire et développement de produits

Depuis 2023, Iovance a:

• Désignation de thérapie révolutionnaire de la FDA pour LifileUcel
• Examen prioritaire du traitement du mélanome métastatique
• Interactions en cours avec les organismes de réglementation

Recherche translationnelle en immuno-oncologie

Investissement en recherche en 2023: 115,6 millions de dollars dédiés à la recherche et au développement immuno-oncologiques.

Focus de recherche	Budget de recherche	Personnel de recherche
Immuno-oncologie	115,6 millions de dollars	87 chercheurs

Iovance Biotherapeutics, Inc. (IOVA) - Modèle commercial: Ressources clés

Plateformes de technologie de thérapie cellulaire propriétaire

Iovance Biotherapeutics se concentre sur TIL (lymphocyte infiltrant tumoral) Plateforme technologique avec les capacités spécifiques suivantes:

• Plateforme de thérapie cellulaire autologue LN-145
• Technologie de thérapie cellulaire LN-244
• Processus de fabrication de thérapie cellulaire personnalisée

Installations de recherche et développement avancées

Emplacement de l'installation	Focus de recherche	En pieds carrés
San Carlos, Californie	Thérapie cellulaire R&D	45 000 pieds carrés
Philadelphie, Pennsylvanie	Développement clinique	25 000 pieds carrés

Équipes de recherche scientifique et médicale qualifiées

Composition de la main-d'œuvre en 2023:

• Total des employés: 389
• Chercheurs de doctorat: 42%
• Chercheurs MD: 18%
• Spécialistes de la recherche clinique: 25%

Portefeuille de propriété intellectuelle

Catégorie de brevet	Nombre de brevets	Plage d'expiration
Technologies de thérapie cellulaire	37 brevets accordés	2030-2041
Processus de fabrication	22 applications en attente	2035-2045

Données d'essai cliniques et capacités de recherche

Statistiques des essais cliniques:

• Essais cliniques actifs: 8
• Inscription totale des patients: 412
• Budget de recherche: 127,4 millions de dollars en 2023
• Phases des essais cliniques: I, II, III

Iovance Biotherapeutics, Inc. (IOVA) - Modèle d'entreprise: propositions de valeur

Immunothérapies innovantes à base de cellules pour le traitement du cancer

Iovance Biotherapeutics se concentre sur le développement Thérapies lymphocytes (TIL) infiltrant les tumeurs autologues (TIL) pour les cancers avancés.

Type de thérapie	Cancer Focus	Étape clinique
LN-145 (thérapie TIL)	Mélanome métastatique	FDA Biologics Licence Application (BLA) Soumis au quatrième trimestre 2023
LN-145 (thérapie TIL)	Cancer du col de l'utérus avancé	Phase 3 essai clinique en cours

Approches de traitement personnalisés utilisant les propres cellules immunitaires du patient

Iovance développe des immunothérapies personnalisées avec les caractéristiques clés suivantes:

• Traitement cellulaire spécifique au patient
• Technologie d'extension autologue
• Ciblage de cellules cancéreuses individualisées

Percée potentielle dans le traitement des tumeurs solides

Type de tumeur	Taux de réponse	Source de données clinique
Mélanome métastatique	Taux de réponse objectif de 34%	Essai de phase 2 de la société Masterkey-232
Cancer du col de l'utérus avancé	Taux de réponse objective de 24,5%	Données d'essai de phase 2 de l'entreprise

Solutions thérapeutiques avancées pour les cancers difficiles à traiter

Iovance cible les types de cancer avec des options de traitement limitées, notamment:

• Mélanome avancé
• Cancer du col de l'utérus métastatique
• Cancer du poumon non à petites cellules
• Carcinome épidermoïde de la tête et du cou

Médecine de précision ciblant des types de cancer spécifiques

Les investissements financiers et de recherche clés démontrent un engagement envers l'oncologie de précision:

Métrique	Valeur 2023
Dépenses de R&D	385,4 millions de dollars
Espèce et investissements	626,1 millions de dollars (au 30 septembre 2023)

Iovance Biotherapeutics, Inc. (IOVA) - Modèle d'entreprise: relations clients

Engagement direct avec les fournisseurs de soins de santé en oncologie

Iovance Biotherapeutics maintient un engagement direct grâce à des interactions spécialisées de l'équipe de vente en oncologie. Au quatrième trimestre 2023, la société a:

Métrique de l'engagement	Quantité
Représentants des ventes d'oncologie dédiés	48
Centres de traitement ciblés en oncologie	127
Points de contact annuels du fournisseur de soins de santé	3,672

Programmes de soutien aux patients et d'éducation

Iovance met en œuvre des stratégies complètes de soutien aux patients:

• Programme de navigation pour les patients personnalisés
• Conseil d'aide financière
• Webinaires d'information sur le traitement
• Services de consultation de patients en tête-à-tête

Partenariats de recherche clinique collaborative

Catégorie de partenariat	Nombre de partenariats actifs
Établissements de recherche universitaire	22
Réseaux de collaboration pharmaceutique	8
Centres de coordination des essais cliniques	37

Communication transparente sur les développements du traitement

Les canaux de communication comprennent:

• Appels de bénéfice des investisseurs trimestriels
• Présentations annuelles de la conférence scientifique
• Publications de revues médicales évaluées par des pairs
• Plateformes d'information numérique

Engagement communautaire médical en cours

Activité d'engagement	Fréquence annuelle
Présentations du symposium médical	14
Ateliers de formation des médecins	28
Réunions du conseil consultatif scientifique	6

Iovance Biotherapeutics, Inc. (IOVA) - Modèle d'entreprise: canaux

Force de vente directe ciblant les spécialistes de l'oncologie

Au quatrième trimestre 2023, Iovance Biotherapeutics maintient une équipe de vente en oncologie spécialisée de 87 représentants des ventes directes. L'équipe se concentre sur l'engagement des spécialistes de l'oncologie dans 412 centres de traitement clés aux États-Unis.

Métrique de l'équipe de vente	Données quantitatives
Représentants totaux des ventes directes	87
Centres de traitement cibles	412
Couverture géographique	États-Unis

Conférences médicales et symposiums scientifiques

Iovance participe à 23 conférences d'oncologie majeures chaque année, avec une présentation moyenne et un budget de présence de stands de 1,2 million de dollars.

• Réunion annuelle de l'American Society of Clinical Oncology (ASCO)
• Congrès de la Société européenne pour l'oncologie médicale (ESMO)
• Réunion annuelle de la Society for Immunotherapy of Cancer (SITC)

Plateformes de communication numérique

La société utilise plusieurs canaux numériques avec un budget de marketing numérique de 3,7 millions de dollars en 2023.

Plate-forme numérique	Métriques d'engagement
Liendin	42 500 abonnés
Gazouillement	18 700 abonnés
Site Web de l'entreprise	187 000 visiteurs mensuels uniques

Canaux de soumission réglementaires

Iovance s'engage avec la FDA et l'EMA grâce à des processus complets de soumission réglementaire, avec une équipe des affaires réglementaires de 15 professionnels et des dépenses de conformité annuelles de 2,9 millions de dollars.

Partenariats avec les institutions de soins de santé

En 2024, Iovance maintient des recherches actives et des partenariats cliniques avec 37 principaux institutions de traitement du cancer et de recherche.

Type de partenariat	Nombre d'institutions
Collaborations de recherche	22
Sites d'essais cliniques	15

Iovance Biotherapeutics, Inc. (IOVA) - Modèle d'entreprise: segments de clientèle

Fournisseurs de soins de santé en oncologie

Au quatrième trimestre 2023, IOVANCE cible environ 1 500 centres de traitement en oncologie spécialisés aux États-Unis. Les segments cibles clés comprennent:

• Hôpitaux du National Cancer Center Network
• Centres médicaux académiques
• Installations complètes de traitement du cancer

Type de fournisseur	Marché total adressable	Taux d'adoption potentiel
Centres médicaux académiques	285 centres	62%
Centres de cancer complets	71 centres désignés par le NCI	48%
Pratiques d'oncologie communautaire	1 200 centres	35%

Patients atteints de cancer avancé

Cible la population de patients pour la thérapie TIL d'Iovance:

• Patients atteints de mélanome métastatique: 99 780 diagnostiqués chaque année
• Patients de cancer du col de l'utérus avancés: 14 480 nouveaux cas par an
• Patients atteints de cancer du poumon non à petites cellules métastatiques: 228 150 nouveaux cas par an

Institutions de recherche

Iovance collabore avec 87 institutions de recherche dans le monde, en se concentrant sur la recherche sur l'immuno-oncologie.

Type d'institution	Nombre de partenariats
Institut national du cancer	12 collaborations de recherche active
Centres de recherche universitaires	45 partenariats en cours
Institutions de recherche privées	30 accords de collaboration

Sociétés pharmaceutiques

Paysage de collaboration pharmaceutique actuelle:

• 5 Accords de partenariat pharmaceutique actif
• Valeur de recherche collaborative totale: 78,5 millions de dollars
• Partenariats potentiels de co-développement en immuno-oncologie

Participants à l'essai clinique

Essai clinique en cours démographie des participants:

Phase de procès	Total des participants	Démographie du patient
Phase I / II	387 participants	Tranche d'âge: 35 à 75 ans
Phase III	245 participants	Divers types de cancer
Accès élargi	126 participants	Patients de stade avancé

Iovance Biotherapeutics, Inc. (IOVA) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Iovance Biotherapeutics a déclaré des dépenses de R&D de 351,5 millions de dollars.

Année	Dépenses de R&D	Pourcentage du total des revenus
2022	328,7 millions de dollars	86.4%
2023	351,5 millions de dollars	89.2%

Coûts de gestion des essais cliniques

Les dépenses d'essais cliniques pour l'IOVANCE en 2023 ont totalisé environ 215,6 millions de dollars.

• Essais cliniques du mélanome métastatique du LN-145: 87,3 millions de dollars
• Essais avancés du cancer du col de l'utérus: 62,4 millions de dollars
• Autres programmes d'essai en oncologie: 65,9 millions de dollars

Investissements de fabrication et de production

Les dépenses en capital pour les infrastructures manufacturières en 2023 étaient de 42,3 millions de dollars.

Usine de fabrication	Montant d'investissement	Emplacement
Installation de production de thérapie cellulaire	28,6 millions de dollars	San Carlos, Californie
Centre de fabrication avancée	13,7 millions de dollars	Newark, Delaware

Dépenses de conformité réglementaire

Les frais de réglementation et de conformité pour 2023 étaient de 24,7 millions de dollars.

• Préparation de la soumission de la FDA: 9,2 millions de dollars
• Systèmes d'assurance qualité: 8,5 millions de dollars
• Documentation réglementaire: 7,0 millions de dollars

Acquisition et rétention de talents

Le total des dépenses liées au personnel en 2023 a atteint 186,4 millions de dollars.

Catégorie de dépenses	Montant
Salaires et salaires	142,3 millions de dollars
Compensation en stock	34,6 millions de dollars
Avantages sociaux	9,5 millions de dollars

Iovance Biotherapeutics, Inc. (IOVA) - Modèle d'entreprise: Strots de revenus

Ventes de produits futurs potentiels

Au quatrième trimestre 2023, Iovance a déclaré des revenus potentiels de ses candidats principaux:

Produit candidat	Marché potentiel	Revenus potentiels estimés
LifileUcel (mélanome avancé)	Traitement du mélanome métastatique	250 à 500 millions de dollars potentiel annuel
LN-145 (cancer du col de l'utérus)	Cancer cervical récurrent / métastatique	150 à 300 millions de dollars potentiel annuel

Accords de licence

Revenus de licences actuelles à partir de 2023 rapports financiers:

• Revenu total des licences: 3,2 millions de dollars
• Accords de licence collaborative avec plusieurs partenaires de biotechnologie

Subventions de recherche

Sources de financement de subventions de recherche:

Source d'octroi	Montant d'octroi	Année
National Institutes of Health (NIH)	2,5 millions de dollars	2023
Ministère de la Défense	1,8 million de dollars	2023

Financement de recherche collaborative

PARTENATS DE RECHERCHE COLLABORATIFS:

• Financement total de recherche collaborative: 12,5 millions de dollars en 2023
• Partenariats avec les établissements universitaires et les sociétés pharmaceutiques

Paiements de jalons potentiels

Structure potentielle de paiement des étapes:

Partenariat	Paiements de jalons potentiels	Conditions
Partenariat pharmaceutique a	Jusqu'à 50 millions de dollars	Progression des essais cliniques
Partenariat pharmaceutique b	Jusqu'à 75 millions de dollars	Jalons d'approbation réglementaire

Iovance Biotherapeutics, Inc. (IOVA) - Canvas Business Model: Value Propositions

Personalized, one-time cell therapy for refractory solid tumors.

Amtagvi offers an objective response rate (ORR) of 48.8% in commercial use among 41 evaluable patients treated at four authorized treatment centers in a real-world retrospective study.

Provides a treatment option for advanced melanoma after anti-PD-1 failure, being the first treatment option approved by the U.S. FDA for patients with advanced (unresectable or metastatic) melanoma following anti-PD-1 and targeted therapy.

Proleukin supply for the Amtagvi treatment regimen is essential, as aldesleukin (Proleukin) is a key component of the Amtagvi treatment protocol.

Here's the quick math on recent commercial performance and operational metrics as of late 2025:

Metric	Value	Period/Context
Amtagvi Wholesale Acquisition Cost	$515,000	Per dose
Total Product Revenue	~$68 million	Third Quarter 2025
U.S. Amtagvi Revenue	~$58 million	Third Quarter 2025
Global Proleukin Revenue	~$10 million	Third Quarter 2025
Commercial Patients Treated	102	Second Quarter 2025
Manufacturing Turnaround Time	32 days	Current average from inbound to return shipment to ATCs
Activated U.S. Authorized Treatment Centers (ATCs)	More than 80	As of Third Quarter 2025
Health Canada Approval Date	August 2025	For previously treated advanced melanoma

You can see the growth trajectory through these operational points:

• Full Year 2025 Total Product Revenue Guidance reaffirmed at $250 to $300 million.
• Gross Margin reached 43% in the third quarter of 2025.
• Cash, cash equivalents, investments, and restricted cash totaled ~$307 million as of September 30, 2025.
• Expected cash runway extends into the second quarter of 2027.
• Anticipated ex-U.S. approvals include the United Kingdom and Australia in the first half of 2026, and Switzerland in 2027.

Finance: draft 13-week cash view by Friday.

Iovance Biotherapeutics, Inc. (IOVA) - Canvas Business Model: Customer Relationships

You're building a commercial-stage cell therapy business, and for Iovance Biotherapeutics, Inc., the customer relationship model is intensely focused on the specialized centers that can actually administer Amtagvi (lifileucel). This isn't a product you ship to a standard pharmacy; it requires a highly coordinated, high-touch approach with the treatment sites and the patients themselves.

High-touch, specialized support for Authorized Treatment Centers (ATCs)

Iovance Biotherapeutics, Inc. relies on a specialized direct sales model centered on its network of Authorized Treatment Centers (ATCs) to deliver its complex TIL therapy. This relationship is critical for managing the logistics from tumor resection to infusion. The company has been aggressively expanding this network to ensure patient access.

Here's a look at the growth and reach of the U.S. ATC network as of late 2025:

Metric	Early 2025 Status	May 2025 Status	Q3 2025 Status (as of Nov 6, 2025)
Total U.S. ATCs Activated	Approximately 70	Over 80	More than 80
States with ATCs	32 states	35 states	Nearly 40 states
Addressable Patient Coverage (within two-hour drive)	Not explicitly stated	Approximately 95%	Approximately 95%

The level of engagement with these centers is deep. For instance, as of May 2025, of the ATCs onboarded, 56 had completed tumor resections, 48 had infused one or more patients, and 11 had already infused more than 10 patients. This shows a clear progression from activation to active utilization, which is key to hitting the reaffirmed full-year 2025 total product revenue guidance of $250 to $300 million. The company's Q3 2025 U.S. Amtagvi revenue reached ~$58 million of the total ~$68 million in product revenue, demonstrating the ATC network's growing contribution.

Dedicated patient support programs (IovanceCares™)

The complexity of cell therapy means patient support extends far beyond the prescription. IovanceCares™ is the dedicated hub for this, providing comprehensive support to patients, caregivers, and healthcare providers throughout the entire treatment journey. This is a necessary layer of service when dealing with a novel, high-acuity treatment.

The support structure includes:

• Case Managers available Monday-Friday from 8:00 am-9:00 pm ET.
• A dedicated contact line: 1 (833) 400-IOVA or 1 (833) 400-4682.
• Support covering reimbursement, logistics, and manufacturing tracking.
• Referrals to independent nationwide programs for non-drug related needs like transportation and housing.

It's important to note the scope: IovanceCares™ is specifically for commercially insured patients; it is not available for those enrolled in Medicare, Medicaid, TRICARE, or VA programs. The program's function is to cover the out-of-pocket expenses for Iovance products only.

Direct engagement with specialized oncologists and surgical teams

Securing buy-in from the treating physicians is paramount. Iovance Biotherapeutics, Inc. focuses its engagement efforts on ensuring its therapy is considered and adopted by the right specialists. A major factor driving this adoption is the therapy's positioning in clinical guidelines.

Key elements of this engagement include:

• Driving adoption through favorable positioning in the National Comprehensive Cancer Network® (NCCN) guidelines for cutaneous melanoma.
• Prioritizing commercial efforts in 2025 to increase patient referrals and broader utilization.
• Integrating community treatment centers to drive earlier treatment.

The company's financial health, with cash and equivalents totaling ~$307 million as of September 30, 2025, is being managed to support these commercial activities while advancing pipeline programs. The gross margin improved to 43% in Q3 2025, reflecting better execution, which supports the high-touch service model.

Iovance Biotherapeutics, Inc. (IOVA) - Canvas Business Model: Channels

You're looking at how Iovance Biotherapeutics, Inc. gets its therapy, Amtagvi, from the manufacturing center to the patient. This is a complex, high-touch process for a personalized cell therapy, so the channels have to be tightly controlled.

The primary U.S. channel relies on a growing network of specialized facilities. As of the third quarter of 2025, Iovance Biotherapeutics, Inc. had activated more than 80 U.S. authorized treatment centers (ATCs) across nearly 40 states. This extensive footprint is designed to ensure broad patient access; these centers cover approximately 95% of addressable patients within a two-hour drive. The company is actively adding more ATCs, including large community practices, to further expand this reach.

Direct sales and distribution are managed through this ATC network, which handles the complex logistics of receiving the patient's tumor tissue, coordinating with the Iovance Cell Therapy Center (iCTC) for manufacturing, and receiving the final Amtagvi product for infusion. The efficiency of this chain is critical; the current average manufacturing turnaround time is reported at 32 days from inbound tissue receipt to return shipment to the ATCs as of late 2025. The U.S. Amtagvi revenue from this channel for the third quarter of 2025 was reported at ~$58 million.

To supplement the direct ATC channel, Iovance Biotherapeutics, Inc. has established a specialty pharmacy pathway. In September 2025, the company announced the selection of InspiroGene by McKesson as the specialty pharmacy partner for Amtagvi. This move opens a new distribution route, leveraging Biologics by McKesson's oncology expertise to help reduce administrative burdens for providers and expand access flexibility for ATCs.

The global channel strategy is kicking off with regulatory success outside the U.S. Iovance Biotherapeutics, Inc. achieved a significant milestone when Health Canada granted conditional marketing authorization for AMTAGVI in August 2025 for adult patients with unresectable or metastatic melanoma who have progressed after prior systemic therapy. This marks the first marketing authorization for Iovance Biotherapeutics, Inc. outside the United States. Further international expansion is planned, with potential approvals anticipated in the United Kingdom and Australia in the first half of 2026.

Here are the key operational metrics tied to the distribution and access channels:

Channel Metric	Value as of Late 2025	Reference Point/Date
Activated U.S. ATCs	More than 80	Q3 2025
U.S. States with ATCs	Nearly 40	Q3 2025
Specialty Pharmacy Partner	InspiroGene by McKesson	September 2025
Health Canada Approval Date	August 2025	Advanced Melanoma
Average Manufacturing Turnaround Time	32 days	Q3 2025

The company is also working to improve patient flow through the system, which is a key part of the channel effectiveness. You can see the focus on optimizing the patient journey through these access points:

• Patient Support: InspiroGene by McKesson will provide tailored services including order management and reimbursement navigation.
• Geographic Reach: The U.S. network aims for 95% patient coverage within a two-hour drive of an ATC.
• International Focus: Post-Canada, the strategy targets the UK and Australia for potential approvals in the first half of 2026.
• Referral Trends: Increased awareness from real-world evidence is driving earlier Amtagvi adoption and improved referral trends among medical oncologists.

The success of the channel is directly reflected in the reported U.S. Amtagvi revenue of ~$58 million in the third quarter of 2025. Finance: draft 13-week cash view by Friday.

Iovance Biotherapeutics, Inc. (IOVA) - Canvas Business Model: Customer Segments

You're looking at the core patient populations Iovance Biotherapeutics, Inc. (IOVA) targets right now and where they plan to expand their focus. This is all about who gets the cell therapy, Amtagvi (lifileucel), and who prescribes it.

Advanced (unresectable or metastatic) melanoma patients post-anti-PD-1 therapy

This is the current commercial segment for Amtagvi, which is the first FDA-approved T cell therapy for solid tumors in this specific setting. The addressable market here is substantial, though adoption rates are what drive the near-term financials.

Here's a snapshot of the commercial execution as of late 2025:

Metric	Value as of Late 2025 Data
Total Patients Treated (First 12 Months U.S. Launch)	More than 275
U.S. Amtagvi Revenue (Q1 2025)	$43.6 million
U.S. Amtagvi Revenue (Q2 2025)	$54.1 million
U.S. Amtagvi Sales (Q3 2025)	About $57.5 million
Full Year 2025 Total Product Revenue Guidance	$250 to $300 million
Estimated Annual U.S. Addressable Patient Population	More than 30,000 (U.S. and initial global markets)

The reimbursement process is moving, with an average financial clearance time of about three weeks. Also, approximately 75% of Amtagvi patients are covered by private payers, and payers covering more than 250 million lives have added Amtagvi to policies since launch. Still, the company is focused on optimizing manufacturing turnaround time, which was aligning with launch expectations of approximately 34 days from inbound to return shipment to ATCs.

Specialized oncologists and hematologists at major cancer centers

These are the prescribers and the gatekeepers for the therapy, operating out of the Authorized Treatment Centers (ATCs). The strategy involves building out this network to ensure patient access, moving beyond just the top academic institutions.

The current treatment infrastructure supporting these specialists includes:

• Total U.S. Authorized Treatment Centers (ATCs): More than 80 across 35 states.
• Initial Wave of ATCs: 70 centers.
• ATCs that completed tumor resections: 56.
• ATCs that infused one or more patients: 48.
• ATCs that infused more than 10 patients: 11.
• Patient Proximity: 95% of addressable patients live within 200 miles of an ATC.

The focus is on accelerating community referral activities to drive earlier treatment with Amtagvi, which means the customer segment is broadening from just the specialized oncologists at the initial academic centers to those in large community practices.

Future: Non-small cell lung cancer (NSCLC) and endometrial cancer patients

These represent the next wave of potential patients if clinical trials yield positive, approvable data. The company is actively enrolling patients in trials for these indications.

Key pipeline milestones relevant to these future segments include:

• NSCLC (IOV-LUN-202 trial): Data update anticipated in the second half of 2025 to support a potential U.S. accelerated approval by 2027.
• Endometrial Cancer (IOV-END-201 trial): Initial results from this Phase 2 trial are on track for early 2026 (with data expected in the second half of 2025).

The IOV-END-201 trial is investigating lifileucel after platinum-based chemotherapy and anti-PD-1 therapy. The NSCLC trial is evaluating lifileucel monotherapy in patients who progressed after anti-PD-1 therapy. The company also has the PD-1 inactivated TIL cell therapy candidate, IOV-4001, enrolling in advanced melanoma and NSCLC.

Iovance Biotherapeutics, Inc. (IOVA) - Canvas Business Model: Cost Structure

You're looking at the core expenses that drive Iovance Biotherapeutics, Inc.'s operations as they scale their first commercial product. For a cell therapy company, the cost structure is heavily weighted toward research, manufacturing, and the necessary infrastructure to support both.

The most significant recurring cost is tied to the science itself. High R&D expenses are necessary to support ongoing clinical trials and pipeline development. For instance, Research & Development expenses in the second quarter of 2025 reached $79.4 million. This increase, up 28% year-over-year for Q2 2025, reflected higher headcount and the costs associated with continued enrollment in existing trials.

Manufacturing the complex, personalized therapy is the other major cost driver, reflected in the Cost of Goods Sold (COGS). For the third quarter of 2025, the Cost of Sales was reported at $38.477 million. This figure, which aligns with the requested ~$39 million, is directly tied to the production of Amtagvi and Proleukin, and management has been focused on optimizing this area. The gross margin for Q3 2025 improved to 43%, up significantly from 5% in the previous quarter, showing initial benefits from operational excellence initiatives.

To manage these heavy operating costs, Iovance Biotherapeutics initiated a major strategic restructuring. This effort is designed to achieve over $100 million in annual cost savings, with these savings expected to begin taking effect starting in the fourth quarter of 2025. This restructuring included a workforce reduction of approximately 19% in the third quarter of 2025. The goal of these cost controls is to extend the company's cash runway into the fourth quarter of 2026 or later.

Despite the revenue growth from Amtagvi, the high operating expenses still result in substantial losses. The operating costs drove a net loss of $91.3 million for the third quarter of 2025. This loss from operations for Q3 2025 was specifically $94.901 million. The company also incurred $5.143 million in restructuring charges during that same quarter.

Here's a look at how the key operating expenses trended across Q2 and Q3 2025. You can see the immediate impact of the restructuring starting to show in the SG&A line item, even as R&D remains high to support the pipeline.

Cost Component (in thousands)	Q2 2025	Q3 2025
Cost of Sales (COGS)	$56,700	$38,477
Research & Development (R&D)	$79,400	$75,174
Selling, General & Administrative (SG&A)	$37,700	$34,555
Restructuring Charges	Not Separately Itemized	$5,143
Loss from Operations	N/A (Net Loss $111.7M)	($94,901)

The cost structure is characterized by several key areas of expenditure that you need to monitor:

• High fixed costs related to maintaining the specialized cell therapy manufacturing infrastructure.
• Variable costs tied directly to patient treatments, including raw materials and logistics.
• Significant investment in clinical development for non-melanoma indications.
• One-time costs associated with the Q3 2025 strategic restructuring efforts.
• SG&A expenses that are being actively managed downward, with a year-over-year decline noted in Q2 2025.

The company is actively working to shift the cost base by centralizing manufacturing at the Iovance Cell Therapy Center (iCTC) in early 2026, which is expected to further reduce external manufacturing expenses and lift gross margins. Finance: draft 13-week cash view by Friday.

Iovance Biotherapeutics, Inc. (IOVA) - Canvas Business Model: Revenue Streams

You're looking at how Iovance Biotherapeutics, Inc. brings in cash as they scale up the commercial launch of their first product. The revenue streams are tightly focused right now, centering on their newly approved cell therapy and the necessary companion product.

The primary financial expectation for the full fiscal year 2025 remains the same, even with the initial launch period behind them. Iovance Biotherapeutics, Inc. reaffirmed its total product revenue guidance for the full year 2025 to be within the range of $250 million to $300 million. This range covers the first full calendar year of Amtagvi sales. The company is on track to hit this target, citing strong demand and execution.

For the most recent reported period, the third quarter of 2025, the total product revenue reached approximately $68 million. This figure shows sequential growth, which management attributes to increasing Amtagvi demand as they integrate community treatment centers. Here's the quick math on that Q3 performance:

Revenue Component	Q3 2025 Amount
Total Product Revenue	$68 million
Product sales of Amtagvi (lifileucel) in the U.S.	Approximately $58 million
Sales of Proleukin (IL-2) for use in the Amtagvi regimen and other uses	Approximately $10 million

The revenue recognition for Amtagvi is tied directly to patient infusion, which is a key operational metric, though management has shifted focus to revenue as the primary indicator going forward. The sales of Proleukin (IL-2) are recognized globally and support the Amtagvi regimen, but also come from other commercial, clinical, manufacturing, and research applications. The gross margin for the third quarter also saw a significant improvement to 43%, reflecting better execution and initial benefits from cost optimization efforts.

You should also note the drivers supporting this revenue stream:

• More than 80 U.S. authorized treatment centers (ATCs) have been activated across nearly 40 states.
• This network provides a broad reach, with approximately 95% of Amtagvi patients located within a two-hour drive of an ATC.
• The manufacturing turnaround time improved to a current average of 32 days from inbound to return shipment to ATCs.
• The company is integrating new academic and community ATCs, with expected growth acceleration in future quarters.