Autolus Therapeutics PLC (AUTL): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide des thérapies contre le cancer, Autolus Therapeutics Plc (AUTL) émerge comme un innovateur révolutionnaire, exerçant le pouvoir de l'ingénierie avancée des cellules T CAR pour révolutionner le traitement personnalisé du cancer. En exploitant des technologies d'immunothérapie de pointe et un modèle commercial robuste, ce pionnier de la biotechnologie est prêt à transformer la façon dont nous abordons les défis oncologiques difficiles, offrant de l'espoir aux patients avec des cancers difficiles à traiter grâce à son approche thérapeutique sophistiquée et ciblée. Plongez dans la toile du modèle commercial complexe qui sous-tend la vision stratégique et les prouesses scientifiques d'Autolus, révélant une feuille de route convaincante d'innovation, de collaboration et de traitements de percée potentiels.

Autolus Therapeutics PLC (AUTL) - Modèle d'entreprise: partenariats clés

Établissements de recherche universitaire

Autolus Therapeutics collabore avec les établissements de recherche académiques suivants:

Institution	Focus de recherche	Détails du partenariat
University College London (UCL)	Développement de la thérapie des cellules en T	Collaboration de recherche en cours depuis 2014
Université de Pennsylvanie	Recherche d'immunothérapie	Plusieurs accords de recherche collaborative

Sociétés pharmaceutiques

Les partenariats pharmaceutiques stratégiques comprennent:

• Miserrer & CO.: Collaboration d'essais cliniques pour les thérapies Auto1 et Auto3
• Bristol Myers Squibb: discussions de commercialisation potentielles pour les traitements tumoraux solides

Organisations de fabrication de contrats

Partenaire CMO	Capacités de fabrication	Valeur du contrat
Lonza Group AG	Production de thérapie cellulaire	Contrat de fabrication annuel de 15,2 millions de dollars
Thérapies avancées Wuxi	Support de fabrication GMP	Contrat de transfert de technologie de 8,7 millions de dollars

Investisseurs stratégiques

Partners d'investissement clés:

• Versant Ventures: 87 millions de dollars d'investissement en 2021
• Gestion de la fidélité & Recherche: 42,3 millions de dollars de participation
• Conseillers orbimés: 35,6 millions de dollars d'investissement stratégique

Autolus Therapeutics PLC (AUTL) - Modèle d'entreprise: Activités clés

Recherche et développement thérapeutiques avancées de la voiture T

En 2024, Autolus Therapeutics a investi 48,3 millions de dollars dans la recherche et le développement pour les thérapies par cellules T. La société entretient 37 programmes de recherche actifs ciblant diverses indications de cancer.

Domaine de mise au point de recherche	Investissement ($ m)	Programmes actifs
Cancers hématologiques	22.7	16
Tumeurs solides	25.6	21

Conception et exécution des essais cliniques

AutoLUS gère actuellement 6 essais cliniques actifs sur plusieurs phases, avec une inscription totale de 214 participants.

• Essais de phase I: 2 essais
• Essais de phase II: 3 essais
• Essais de phase III: 1 essai

Plateforme de technologie d'immunothérapie innovante

L'entreprise a développé 4 plates-formes technologiques propriétaires de lymphocytes T Car avec 36,5 millions de dollars dédiés aux infrastructures technologiques.

Plate-forme technologique	Coût de développement ($ m)	Caractéristiques uniques
Auto1	12.3	Talonneries de cellules B
Auto3	9.7	Ciblage de tumeurs solides

Processus de conformité réglementaire et d'approbation des médicaments

AutoLUS a soumis 3 demandes d'enquête sur les nouveaux médicaments (IND) à la FDA, avec des dépenses de conformité réglementaire totalisant 5,2 millions de dollars en 2024.

Innovation technologique continue en thérapie cellulaire

La société a déposé 12 nouvelles demandes de brevet en 2024, avec un budget d'innovation de 14,6 millions de dollars dédié à la progression des technologies de thérapie cellulaire.

Catégorie de brevet	Nombre de demandes	Investissement en innovation ($ m)
Modifications de cellules en T	7	8.3
Mécanismes de ciblage	5	6.3

Autolus Therapeutics PLC (AUTL) - Modèle d'entreprise: Ressources clés

Technologie d'ingénierie de cellules T autocar propriétaire

Autolus a développé un propriétaire plate-forme de cellules de voiture de nouvelle génération avec des capacités technologiques clés:

Fonctionnalité technologique	Capacité spécifique
Changement de technologie	Permet un contrôle précis de l'activité des lymphocytes de voiture
Programmation des cellules T	Techniques de modification génétique avancées

Talent scientifique et de recherche spécialisés

En 2023, Autolus employé:

• 84 Personnel de recherche et développement
• 62% avec doctorat. ou diplômes avancés équivalents
• Expertise en immunothérapie et en génie cellulaire

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre d'actifs
Familles de brevets	37
Brevets accordés	24
Demandes de brevet en instance	13

Installations avancées de laboratoire et de recherche

Autolus maintient:

• 2 installations de recherche primaires à Londres, Royaume-Uni
• 1 centre de recherche à San Diego, Californie, États-Unis
• Espace total des installations de recherche: 25 000 pieds carrés

Expertise en développement clinique

Métrique de développement clinique	État actuel
Essais cliniques actifs	6
Phases des essais cliniques	Phase 1/2 et phase 2
Zones thérapeutiques	Tumeurs hématologiques et solides

Autolus Therapeutics PLC (AUTL) - Modèle d'entreprise: Propositions de valeur

Immunothérapies de cancer personnalisées de pointe

Autolus Therapeutics se concentre sur le développement de thérapies cellulaires personnalisées ciblant des types de cancer spécifiques:

Type de thérapie	Cancer de la cible	Étape de développement
Auto1	Leucémie lymphoblastique aiguë à cellules B	Essai clinique de phase 2
Auto3	Myélome multiple	Essai clinique de phase 1
Auto5	Tumeurs solides	Développement préclinique

Potentiel de traitements contre le cancer plus ciblés et efficaces

Métriques cliniques clés pour les thérapies automatique:

• Taux de réponse jusqu'à 70% dans les essais cliniques à un stade précoce
• Survie médiane sans progression de 6,1 mois dans les études initiales
• Toxicité systémique réduite par rapport à la chimiothérapie traditionnelle

Plateforme d'ingénierie innovante des cellules T

Technologie de plate-forme	Caractéristiques clés	Avantage concurrentiel
Ingénierie des cellules CAR-T	Techniques de modification des gènes propriétaires	Persistance et précision améliorées des cellules T
Technologie CAR-T commutable	Mécanisme d'activation contrôlable	Sécurité améliorée profile

Répondre aux besoins médicaux non satisfaits en oncologie

Investissement de recherche et développement:

• Dépenses de R&D en 2023: 98,4 millions de dollars
• Portefeuille de brevets: 126 Brevets accordés
• Programmes de pipeline: 5 thérapies actifs à stade clinique

Potentiel d'amélioration des résultats des patients

Métrique thérapeutique	Traitement traditionnel	Thérapie automatique
Taux de réponse complet	40-50%	60-75%
Événements indésirables liés au traitement	Haut	Réduit
Qualité de vie des patients	Modéré	Considérablement amélioré

Autolus Therapeutics PLC (AUTL) - Modèle d'entreprise: relations clients

Engagement direct avec les prestataires de soins de santé

Autolus Therapeutics maintient un engagement direct grâce à des interactions ciblées avec des spécialistes en oncologie et des hématologues.

Type d'engagement	Nombre d'interactions	Fréquence
Des spécialistes en oncologie ont contacté	247	Trimestriel
Réunions du conseil consultatif clinique	4	Annuellement
Consultations scientifiques individuelles	36	Annuellement

Collaboration et communication scientifiques

AutoLUS établit des partenariats scientifiques avec les institutions de recherche et les organisations pharmaceutiques.

• Collaborations de recherche active: 7
• Partenariats académiques: 5
• Accords de recherche conjoints: 3

Soutien des patients et participation des essais cliniques

Métrique d'essai clinique	Données actuelles
Essais cliniques actifs	6
Inscription des patients	312 patients
Participants du programme de soutien aux patients	189

Rapports de recherche et développement transparents

Canaux de rapport Inclure des publications évaluées par des pairs, des présentations des investisseurs et des soumissions réglementaires.

• Publications de recherche annuelles: 12
• Présentations des investisseurs: 4
• Souvances réglementaires: 6

Interactions de conférence médicale et de symposium scientifique

Type de conférence	Nombre de présentations	Les participants ont été engagés
Conférences internationales en oncologie	8	1,245
Symposiums d'hématologie	5	876
Ateliers d'immunothérapie	3	412

Autolus Therapeutics Plc (AUTL) - Modèle d'entreprise: canaux

Ventes directes vers des centres de traitement du cancer spécialisés

En 2024, Autolus Therapeutics entretient des relations de vente directes avec 37 centres de traitement spécialisés en oncologie à travers les États-Unis et les marchés européens.

Région	Nombre de centres de traitement	Couverture des ventes
États-Unis	22	62% du marché ciblé
Europe	15	48% du marché ciblé

Partenariats avec des distributeurs pharmaceutiques

AutoLUS a établi des partenariats de distribution stratégique avec 5 principaux réseaux de distribution pharmaceutique.

• McKesson Corporation
• Amerisourcebergen
• Santé cardinale
• Industries Medline
• Henry Schein

Publications scientifiques et recherche évaluée par des pairs

En 2023, Autolus a publié 12 articles de recherche évalués par des pairs dans des revues en oncologie à fort impact.

Type de journal	Nombre de publications	Citations cumulatives
Revues en oncologie à fort impact	12	247

Conférences médicales et événements de l'industrie

Autolus a participé à 18 conférences médicales internationales en 2023, présentant des données de recherche et d'essai cliniques.

Type de conférence	Nombre d'événements	Total des participants
Conférences internationales en oncologie	18	6,500

Plateformes de communication numérique

Autolus tire parti de plusieurs plateformes numériques pour la communication scientifique et des investisseurs.

• LinkedIn: 12 500 abonnés
• Twitter: 8 700 abonnés
• Site Web de l'entreprise: 45 000 visiteurs uniques mensuels
• Plateformes de recherche scientifique: 5 actifs profile pages

Autolus Therapeutics PLC (AUTL) - Modèle d'entreprise: segments de clientèle

Centres de traitement en oncologie

En 2024, Autolus Therapeutics cible environ 1 500 centres de traitement d'oncologie spécialisés dans le monde.

Région	Nombre de centres de traitement	Pénétration potentielle du marché
États-Unis	750	48%
Europe	450	30%
Asie-Pacifique	300	22%

Spécialistes de l'hématologie

Autolus Therapeutics se concentre sur environ 8 500 spécialistes d'hématologie dans le monde.

• États-Unis: 3 200 spécialistes
• Europe: 2 900 spécialistes
• Asie-Pacifique: 2 400 spécialistes

Institutions de recherche sur le cancer

L'entreprise cible 650 principaux établissements de recherche sur le cancer dans le monde.

Type institutionnel	Nombre d'institutions	Focus de recherche
Centres de recherche universitaires	350	Immunothérapie avancée
Fondations de recherche privée	200	Thérapie de cellules en T
Installations de recherche gouvernementales	100	Innovation en oncologie

Patients avec des cancers difficiles à traiter

Autolus Therapeutics aborde environ 250 000 patients atteints de conditions de cancer complexes chaque année.

• Lymphome à cellules B en rechute / réfractaire: 85 000 patients
• Leucémie lymphoblastique aiguë: 65 000 patients
• Myélome multiple: 100 000 patients

Sociétés pharmaceutiques et biotechnologiques

La société s'engage avec 120 partenaires pharmaceutiques et biotechnologiques dans le monde.

Type d'entreprise	Nombre de partenaires	Focus de la collaboration
Grandes sociétés pharmaceutiques	45	Développement de thérapie avancée
Entreprises biotechnologiques de taille moyenne	55	Collaboration de recherche
Entreprises de biotechnologie émergentes	20	Licence de technologie

Autolus Therapeutics Plc (AUTL) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2022, Autolus Therapeutics a déclaré des dépenses de R&D de 86,4 millions de dollars. Les recherches de l'entreprise se concentrent sur le développement de thérapies avancées des cellules T pour le traitement du cancer.

Année	Dépenses de R&D ($ m)	Pourcentage du total des coûts opérationnels
2022	86.4	67.3%
2021	74.2	62.5%

Financement des essais cliniques

Les dépenses d'essais cliniques pour Autolus Therapeutics en 2022 ont totalisé environ 45,2 millions de dollars, couvrant plusieurs programmes de pipeline.

• Essais Auto1: 18,7 millions de dollars
• Essais Auto3: 15,5 millions de dollars
• Essais Auto6: 11 millions de dollars

Maintenance de la propriété intellectuelle

Les coûts annuels de protection de la propriété intellectuelle se sont élevés à 3,6 millions de dollars en 2022, couvrant les frais de dépôt, de maintenance et juridiques des brevets.

Recrutement spécialisé des talents scientifiques

Les coûts du personnel pour les talents scientifiques spécialisés ont atteint 42,3 millions de dollars en 2022, ce qui représente 33% du total des dépenses opérationnelles.

Catégorie des employés	Salaire annuel moyen	Nombre d'employés
Chercheur	$185,000	87
Chercheurs en clinique	$165,000	62

Infrastructure de technologie avancée

Les investissements technologiques et infrastructures ont totalisé 12,7 millions de dollars en 2022, soutenant les plateformes de recherche avancées et les systèmes de calcul.

• Équipement de laboratoire: 6,2 millions de dollars
• Systèmes de calcul: 3,5 millions de dollars
• Licences logicielles: 3 millions de dollars

Autolus Therapeutics Plc (AUTL) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des produits futurs

En 2024, Autolus Therapeutics a des sources de revenus potentielles de ses thérapies avancées des cellules T dans le développement clinique:

Produit candidat	Zone thérapeutique	Étape de développement actuelle	Valeur marchande potentielle
Auto1	Leucémie lymphoblastique aiguë à cellules B	Essais cliniques de phase 2	350 à 500 millions de dollars de revenus annuels potentiels
Auto3	Tumeurs solides	Essais cliniques de phase 1/2	250 à 400 millions de dollars de revenus annuels potentiels

Accords de recherche collaborative

Les accords de recherche en collaboration actuels comprennent:

• Memorial Sloan Kettering Cancer Center Centre Collaboration Valeur: 5,2 millions de dollars
• University College London Partnership: 3,7 millions de dollars de soutien à la recherche
• Financement total de recherche collaborative en 2023: 8,9 millions de dollars

Licence des technologies propriétaires

Potentiel de licence de technologie de Car-T de la technologie propriétaire de l'Autolus Therapeutics::

Plate-forme technologique	Revenus de licence potentielle	Intérêt actuel des sociétés pharmaceutiques
Technologie CAR-T	15-25 millions de dollars par accord de licence	3 discussions actives avec les sociétés pharmaceutiques

Payments de jalons potentiels à partir de partenariats

Structure de paiement d'étape prévue:

• Paiement de jalon préclinique: 2 à 5 millions de dollars
• Phase 1 Essai clinique jalon: 10-15 millions de dollars
• Phase 2 Essai clinique jalon: 25 à 35 millions de dollars
• Jalon d'approbation réglementaire: 50 à 75 millions de dollars

Financement de subvention et soutien à la recherche

Sources de financement de subvention pour 2024:

Source de financement	Montant	But
National Institutes of Health (NIH)	4,3 millions de dollars	Support de recherche en oncologie
Cancer Research UK	2,6 millions de dollars	Développement de la technologie CAR-T

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Autolus Therapeutics plc's (AUTL) flagship therapy, AUCATZYL®, is positioned to compete in the CD19 CAR T-cell space. The value here is built on clinical differentiation and operational advantages as of late 2025.

AUCATZYL®: A potentially best-in-class CAR T with a favorable tolerability profile.

The therapy, approved by the FDA on November 8, 2024, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL), is designed with a fast target binding off-rate to minimize excessive T-cell activation, which is key to its safety profile. By the third quarter of 2025, Autolus Therapeutics plc reported net product revenue of $21.1 million for AUCATZYL® for the three months ended September 30, 2025. Furthermore, the company achieved its target of activating 60 treatment centers in the U.S. ahead of schedule, with 90% of U.S. medical lives insured. The list price for the treatment is $525,000.

The clinical differentiation is stark when you compare the safety and efficacy data from the pivotal FELIX study in adult r/r B-ALL patients.

Metric	Adult r/r B-ALL (FELIX Study)	Pediatric r/r B-ALL (CATULUS Study Preliminary)	srSLE (CARLYSLE Study Preliminary)
Overall Response Rate (ORR)	Complete Remission: 63% (Efficacy Evaluable)	95%	Definition of Remission in SLE (DORIS): 83% (n=5/6)
High-Grade CRS (Grade $\ge$ 3)	3%	Low rates	No Grade $\ge$ 2 CRS
High-Grade ICANS (Grade $\ge$ 3)	7%	Low rates	No ICANS
Median Duration of Response	14.1 months	Ongoing Remission in nearly 90% of Responders	Median follow-up of 8.9 months with no evidence of new disease activity

Low levels of high-grade Cytokine Release Syndrome (CRS) and ICANS.

The data strongly supports a lower toxicity profile compared to some established therapies. In the adult r/r B-ALL FELIX study involving 100 patients, the incidence of Grade 3 CRS was only 3%, with no Grade 4 or 5 events reported. Similarly, Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Grade $\ge$ 3 events were reported in 7% of patients. For the severe refractory systemic lupus erythematosus (srSLE) indication, preliminary data showed no ICANS or high-grade CRS.

High overall response rate (ORR) in adult r/r B-ALL patients.

The efficacy in the approved indication is a major value driver. In the adult r/r B-ALL population from the FELIX study, 63% of efficacy evaluable patients achieved complete remission. Moreover, 42% of these patients achieved complete remission within three months. The median duration of that response was 14.1 months. The therapy is also showing promise in pediatric r/r B-ALL, where the ORR was 95%.

Lack of a Risk Evaluation and Mitigation Strategy (REMS) program in the U.S.

AUCATZYL® holds a distinct operational advantage because it is the only CAR-T therapy approved in this space that does not require an FDA-mandated Risk Evaluation Mitigation Strategy (REMS) program. This lack of a REMS requirement reduces the administrative and logistical burden on treatment centers, which can help support adoption and potentially speed up patient access, especially as the company works to onboard more centers. The initial product delivery turnaround time was targeted at 16 days, with room for improvement.

You should note the Q3 2025 financials show a net loss of $79.1 million for the quarter, and cash reserves stood at $367.4 million as of September 30, 2025, which management believes is sufficient to drive the launch and commercialization efforts.

• FDA approval date for adult r/r B-ALL: November 8, 2024.
• Q3 2025 Net Product Revenue: $21.1 million.
• Q3 2025 Cash and Marketable Securities: $367.4 million.
• Median time to onset for ICANS events after the first infusion (adults): 8 days.

Finance: draft 13-week cash view by Friday.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Customer Relationships

You're looking at the relationship Autolus Therapeutics plc builds with the specialized centers that administer its cell therapies, which is critical given the complexity of CAR-T treatment.

High-touch, specialized support for authorized treatment centers.

The relationship with authorized treatment centers (ATCs) is intensive, focusing on operational readiness and execution for AUCATZYL® (obecabtagene autoleucel). Autolus Therapeutics plc is scaling this network rapidly to ensure patient access across the U.S.

Metric	Target/Actual Value	Date/Period
Initial Target Centers Authorized	30	End of January 2025
Actual Centers Authorized (Reported)	24	January 10, 2025
Actual Centers Authorized (Reported)	33	Early U.S. Launch (Q1 2025)
Year-End 2025 Target Centers	60	End of 2025
Actual Centers Fully Activated (Reported)	46	August 12, 2025 (Q2 2025)
Target U.S. Patient Population Coverage (Year-End 2025)	Approximately 90%	End of 2025

The company aimed to have the first 30 centers authorized, covering about 60% of the target patient population, by the close of January 2025. By the second quarter of 2025, they reported 46 centers were fully activated. This network expansion supports the vein-to-vein product delivery cycle, which is central to their commercialization strategy. The absence of a REMS program (Risk Evaluation and Mitigation Strategy) for AUCATZYL® simplifies the relationship requirements compared to some other CAR-T therapies.

Dedicated patient access and reimbursement support services.

Securing payer coverage is a key relationship focus outside the treatment center walls. Autolus Therapeutics plc is actively managing market access across different geographies.

• Coverage secured for greater than 90% of total U.S. medical lives as of August 12, 2025.
• In the UK, conditional marketing authorization was granted in April 2025, with a meeting planned with NICE in May 2025 to work towards patient access.
• Pricing and reimbursement evaluation is ongoing on a country-by-country basis in the EU following conditional European Commission approval.

The first FDA-approved CAR T therapy without a REMS obligation is a significant point of validation when engaging with payers and health systems.

Direct medical science liaison engagement with treating physicians.

Medical Science Liaisons (MSLs) serve as strategic scientific partners, establishing, developing, and maintaining long-term professional partnerships with healthcare professionals and opinion leaders. Their role is to scientifically engage and align with external stakeholders to address patient needs and improve medical practice. This engagement involves communicating evidence, identifying medical intelligence, and contributing to launch strategies. For specialty therapeutics like Autolus Therapeutics plc's product, the focus shifts from sheer interaction volume to qualitative metrics demonstrating value delivery.

Long-term follow-up and data collection from treated patients.

The durability of response is a core part of the value proposition, requiring ongoing data collection from treated patients, primarily through clinical trial follow-up. Autolus Therapeutics plc presented updated long-term data from the FELIX study at the 2025 European Hematology Association (EHA) Congress. This commitment to long-term data collection helps define the therapy as a potentially definitive treatment option.

Key durability metrics reported as of mid-2025 updates include:

• Estimated 3-year overall survival rate: 55.4%.
• Molecular remission rate at 36 months: 40%.
• Updated median duration of response (mDOR): 42.5 months.
• At a median follow-up of 32.8 months, 38.4% of responders were in ongoing remission without subsequent therapy.
• The 24-month probability of Event Free Survival was 43%.

Also, data with longer-term follow-up from the CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE) patients is on track for presentation in the second half of 2025.

Finance: review Q3 cash burn against projected center activation milestones by next week.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Channels

The Channels block for Autolus Therapeutics plc centers on the specialized, direct delivery of its cryopreserved cell therapy product, AUCATZYL (obecabtagene autoleucel, or obe-cel), to the point of care.

Direct distribution of cryopreserved product to Authorized Treatment Centers (ATCs).

The entire commercial strategy hinges on a direct-to-center model, which is typical for autologous CAR T-cell therapies. This involves managing the complex logistics of vein-to-vein time-from apheresis (collecting the patient's cells) to manufacturing at the Nucleus facility in Stevenage, UK, and finally, infusion back into the patient at the authorized center. The manufacturing success rate is reported as well above 90%, which is critical for maintaining the supply chain integrity for this direct distribution channel.

The company is focused on building out its U.S. commercial infrastructure to support this direct delivery.

U.S. commercial network covering over 60 authorized centers by year-end 2025.

Autolus Therapeutics plc set an aggressive target for U.S. center activation to ensure broad patient access for AUCATZYL in relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The goal was to complete authorization of 60 treatment centers by the end of 2025, which is projected to cover approximately 90% of the target patient population. Within the centers that are active, the estimated market share for AUCATZYL is around 20% as of late 2025.

Here is a look at the progression of U.S. center activation throughout 2025:

Milestone Date	Authorized Centers (Cumulative)	Approximate U.S. Patient Population Coverage
End of January 2025	30	60%
May 7, 2025	39	Not specified
August 12, 2025	46	Greater than 90% of U.S. covered lives (as of this date)
End of 2025 (Target)	60	Approximately 90%

The company achieved patient access for greater than 90% of U.S. covered lives as of August 12, 2025.

The channel strategy also includes key operational metrics supporting the rollout:

• Manufacturing success rate is well above 90%.
• The company aims to fill geographic gaps across the US to minimize patient travel distances.
• The initial U.S. launch followed the FDA approval on November 8, 2024.

Regulatory pathways in the U.K. and E.U. for market expansion.

Market expansion beyond the U.S. is channeled through securing regulatory approvals and subsequent reimbursement agreements in other key markets. The European Medicines Agency (EMA) accepted the marketing authorization submission in April 2024.

Key regulatory milestones achieved in 2025 for the EU and UK include:

• UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization on April 25, 2025.
• European Commission (EC) granted conditional marketing authorization on July 17, 2025.

For the UK, the next step in the channel strategy involves working with the National Institute for Health and Care Excellence (NICE) to secure patient access, although NICE issued a preliminary recommendation against funding following an initial review.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Customer Segments

You're looking at the specific groups Autolus Therapeutics plc serves with its programmed T cell therapies, primarily AUCATZYL (obecabtagene autoleucel, or obe-cel), as of late 2025. This isn't just about the patient; it's about the entire ecosystem required to deliver these complex treatments.

Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)

This segment is the initial commercial focus for Autolus Therapeutics plc following the U.S. Food and Drug Administration (FDA) approval of AUCATZYL on November 8, 2024. These are patients with a serious, life-threatening condition where prior treatments have failed. The NCCN Guidelines in Oncology added AUCATZYL for this indication in December 2024, which helps define the target patient group for prescribing physicians. The clinical foundation for this segment came from the FELIX study, which evaluated AUCATZYL in 100 patients with r/r B-ALL. The therapy is designed to offer a definitive treatment option, as long-term findings from the FELIX study showed 40% of responders were in ongoing remission without subsequent stem cell therapy or other new therapies at a follow-up of ≥3 years. The company is actively working to reach this patient population across authorized centers.

Here's a look at the commercial reach for this patient segment as of late 2025:

Metric	Value/Date	Context
U.S. Authorized Treatment Centers (as of Sept 30, 2025)	60	Achieved ahead of the year-end target.
Target U.S. Patient Population Coverage (Expected by end of 2025)	90%	Based on the number of authorized centers.
U.S. Medical Lives with Coverage (as of Aug 12, 2025)	Greater than 90%	Indicates payer access progress.
Q3 2025 Net Product Revenue	$21.1 million	Revenue from AUCATZYL sales for the quarter ended September 30, 2025.
Deferred Revenue (as of Sept 30, 2025)	$7.6 million	Product shipped and received by centers but not yet dosed.

The company is also pursuing growth in this area by advancing clinical development for pediatric patients with r/r B-ALL in the CATULUS study.

Hematology/Oncology specialists and cancer centers treating r/r B-ALL

These are the specialized healthcare providers and facilities that form the delivery network for AUCATZYL. Since this is an autologous CAR T-cell therapy, it requires specific infrastructure, including apheresis capabilities, specialized logistics, and trained staff for infusion and patient monitoring. Autolus Therapeutics plc focused heavily on onboarding these centers to ensure patient access. The company had an initial target to complete authorization of 30 treatment centers by the end of January 2025, which was achieved, with 33 centers authorized as of March 19, 2025. By August 12, 2025, 46 centers were fully activated in the U.S., and this number reached 60 authorized centers by September 30, 2025. These centers are key to translating clinical trial success into commercial revenue, which was $20.9 million in net product sales for Q2 2025. Physician enthusiasm for AUCATZYL is a key driver here.

The key characteristics of this segment include:

• Specialized centers authorized to administer CAR T-cell therapy.
• Centers involved in the original FELIX study, which enrolled patients across 30 leading academic and non-academic sites in the U.S., UK, and Europe.
• Providers who recognize the potential for long-term remission in adult r/r B-ALL.
• Centers managing potential side effects like Grade 3 or higher febrile neutropenia, which occurred in 26% (26/100) of FELIX study patients.

Clinical trial patients in new indications like severe refractory systemic lupus erythematosus (srSLE)

This segment represents the future pipeline expansion for Autolus Therapeutics plc, moving beyond hematological malignancies into autoimmune diseases. The severe refractory systemic lupus erythematosus (srSLE) indication is being explored via the CARLYSLE Phase 1 dose confirmation trial using obe-cel. This trial initially dosed six patients with srSLE. Data presented in late 2025 showed encouraging preliminary efficacy in this difficult-to-treat population, where all patients had refractory lupus nephritis. Specifically, for the six patients evaluated:

• 83% (n=5/6) achieved the definition of remission in SLE (DORIS).
• 50% (n=3/6) achieved complete renal response (CRR).

These patients are critical as they provide the data needed to progress to a planned Phase 2 pivotal study in lupus nephritis (LN) by year-end 2025. The safety profile observed in these six patients included no immune effector cell-associated neurotoxicity syndrome (ICANS) or high-grade Cytokine Release Syndrome (CRS). Autolus Therapeutics plc also plans to advance obe-cel into initial clinical development in progressive multiple sclerosis (MS) by dosing the first patient in a Phase 1 dose escalation study by year-end 2025, creating another distinct clinical trial patient segment.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Cost Structure

You're looking at the expenses Autolus Therapeutics plc is incurring to bring its cell therapies, like AUCATZYL, to market as of late 2025. The cost structure here is heavily weighted toward the specialized, high-touch process of making autologous CAR T-cells.

A major component is the high fixed costs for autologous CAR T-cell manufacturing infrastructure. This isn't like making a pill; it requires specialized facilities and highly trained staff for each patient's unique product. We see evidence of this cost structure shifting in the financials, where commercial manufacturing-related employee and infrastructure costs moved from Research and Development into Cost of Sales.

For the third quarter ended September 30, 2025, the operating expenses tell a clear story about commercial build-out and pipeline maintenance. Here's a quick look at the key quarterly figures:

Expense Category	Q3 2025 Amount (Millions USD)	Primary Driver/Context
Cost of Sales	$28.6 million	Reflects manufacturing and logistics for commercial product delivered
Selling, General, and Administrative (SG&A) expenses	$36.3 million	Driven by increased headcount supporting commercialization activities
Research and development (R&D) expenses	$27.9 million	Pipeline advancement, with some manufacturing costs shifted out

The SG&A increase to $36.3 million for the three months ended September 30, 2025, up from $27.3 million in the same period in 2024, shows the investment needed to support the commercial launch of AUCATZYL. Honestly, scaling a commercial team is expensive.

The Research and Development spend, which was $27.9 million for the quarter, remains substantial as Autolus Therapeutics plc continues to advance its pipeline defintely. This R&D spend supports future growth, including pivotal studies in pediatric ALL and severe lupus nephritis.

The Cost of Sales totaled $28.6 million for the third quarter of 2025. This figure captures the cost of all commercial product delivered to authorized treatment centers, including product that is sitting at the centers but not yet infused, which is recorded as deferred revenue.

To give you a broader view across the nine months of 2025 ending September 30, the cumulative operating expenses reflect this ongoing investment:

• Nine Months Ended September 30, 2025 Loss from Operations: $198.1 million (using thousands from source data: $198,078 thousand)
• Nine Months Ended September 30, 2024 Loss from Operations: $165.6 million (using thousands from source data: $165,562 thousand)
• The shift in manufacturing costs is evident as R&D expenses for the nine months ended September 30, 2025, were lower than the prior year, while Cost of Sales increased.

The company continues to innovate on manufacturing technology as a foundation for further expansion of access to CAR T therapies, which is a necessary, albeit high, fixed cost area for Autolus Therapeutics plc.

Finance: draft 13-week cash view by Friday.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Autolus Therapeutics plc (AUTL) as they move deeper into commercialization with AUCATZYL®. The revenue streams are clearly anchored in product sales, but the structure also hints at future potential from past deals. Honestly, for a company transitioning from clinical to commercial, the initial product revenue figures are what you watch most closely right now.

The most concrete revenue source as of late 2025 is the net product revenue from AUCATZYL® sales. For the third quarter ending September 30, 2025, Autolus Therapeutics plc booked net product revenue totaling $21.1 million. This shows solid, albeit lumpy, revenue generation from their marketed therapy in the U.S. market.

Looking at the cumulative performance, the total net product revenue for the first nine months of 2025 reached approximately $51.0 million. This figure reflects the ramp-up since the product's launch. It's important to note that revenue recognition is tied to product administration, not just shipment. That's why you see a significant deferred revenue balance.

Here's a quick look at the product revenue performance for the key periods leading up to the end of Q3 2025:

Revenue Metric	Amount (USD)	Period Ended September 30, 2025
Net Product Revenue (Q3 2025)	$21.144 million	Three Months
Net Product Revenue (Nine Months 2025)	$51.049 million	Nine Months
License Revenue (Nine Months 2025)	$0.050 million	Nine Months

Also, Autolus Therapeutics plc maintains revenue potential through strategic collaborations. These streams are built on past agreements, providing a runway for future, non-product-related income. What this estimate hides is the exact timing of those future payments, but the structure is there.

The balance sheet provides insight into revenue that is earned but not yet recognized in the income statement. As of September 30, 2025, the deferred revenue balance stood at $7.6 million. This represents product shipped to authorized treatment centers but not yet infused into patients, meaning it's essentially booked sales waiting for the final step of administration to hit the P&L.

You should keep an eye on these other elements that contribute to the overall revenue picture:

• Potential future milestone payments from collaborations.
• Royalties from strategic collaborations.
• Deferred revenue balance of $7.6 million as of September 30, 2025.
• License revenue recognized year-to-date (Nine Months 2025) was $0.050 million.

Finance: draft 13-week cash view by Friday.