Autolus Therapeutics plc (AUTL): Business Model Canvas

In der sich schnell entwickelnden Landschaft der Krebstherapeutika erweist sich Autolus Therapeutics plc (AUTL) als bahnbrechender Innovator, der die Leistungsfähigkeit der fortschrittlichen CAR-T-Zelltechnik nutzt, um die personalisierte Krebsbehandlung zu revolutionieren. Durch die Nutzung modernster Immuntherapietechnologien und eines robusten Geschäftsmodells ist dieser Biotechnologiepionier bereit, die Art und Weise, wie wir anspruchsvolle onkologische Herausforderungen angehen, zu verändern und Patienten mit schwer zu behandelnden Krebsarten durch seinen ausgefeilten und zielgerichteten Therapieansatz Hoffnung zu geben. Tauchen Sie ein in das komplexe Business Model Canvas, das der strategischen Vision und wissenschaftlichen Kompetenz von Autolus zugrunde liegt, und enthüllen Sie eine überzeugende Roadmap für Innovation, Zusammenarbeit und potenzielle bahnbrechende Behandlungen.

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Wichtige Partnerschaften

Akademische Forschungseinrichtungen

Autolus Therapeutics arbeitet mit folgenden akademischen Forschungseinrichtungen zusammen:

Institution	Forschungsschwerpunkt	Einzelheiten zur Partnerschaft
University College London (UCL)	Entwicklung der CAR-T-Zelltherapie	Laufende Forschungskooperation seit 2014
Universität von Pennsylvania	Immuntherapieforschung	Mehrere Forschungskooperationsvereinbarungen

Pharmaunternehmen

Zu den strategischen Pharmapartnerschaften gehören:

• Merck & Co.: Zusammenarbeit bei klinischen Studien für AUTO1- und AUTO3-Therapien
• Bristol Myers Squibb: Mögliche Kommerzialisierungsdiskussionen für die Behandlung solider Tumore

Auftragsfertigungsorganisationen

CMO-Partner	Fertigungskapazitäten	Vertragswert
Lonza Group AG	Herstellung von Zelltherapien	Jährlicher Fertigungsvertrag über 15,2 Millionen US-Dollar
WuXi Advanced Therapies	GMP-Fertigungsunterstützung	Technologietransfervereinbarung über 8,7 Millionen US-Dollar

Strategische Investoren

Wichtige Investitionspartner:

• Versant Ventures: 87-Millionen-Dollar-Investition im Jahr 2021
• Treuemanagement & Forschung: Kapitalbeteiligung in Höhe von 42,3 Millionen US-Dollar
• OrbiMed Advisors: 35,6 Millionen US-Dollar strategische Investition

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung zur fortgeschrittenen CAR-T-Zelltherapie

Bis 2024 hat Autolus Therapeutics 48,3 Millionen US-Dollar in Forschung und Entwicklung für CAR-T-Zelltherapien investiert. Das Unternehmen unterhält 37 aktive Forschungsprogramme, die auf verschiedene Krebsindikationen abzielen.

Forschungsschwerpunktbereich	Investition (Mio. USD)	Aktive Programme
Hämatologische Krebserkrankungen	22.7	16
Solide Tumoren	25.6	21

Entwurf und Durchführung klinischer Studien

Autolus verwaltet derzeit 6 aktive klinische Studien in mehreren Phasen mit einer Gesamtpatientenrekrutierung von 214 Teilnehmern.

• Phase-I-Studien: 2 Studien
• Phase-II-Studien: 3 Studien
• Phase-III-Studien: 1 Studie

Innovative Technologieplattform für Immuntherapie

Das Unternehmen hat vier proprietäre CAR-T-Zell-Technologieplattformen entwickelt 36,5 Millionen US-Dollar für die technologische Infrastruktur.

Technologieplattform	Entwicklungskosten (Mio. USD)	Einzigartige Funktionen
AUTO1	12.3	B-Zell-Malignome
AUTO3	9.7	Solides Tumor-Targeting

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Autolus hat drei IND-Anträge (Investigational New Drug) bei der FDA eingereicht, wobei sich die Kosten für die Einhaltung gesetzlicher Vorschriften im Jahr 2024 auf insgesamt 5,2 Millionen US-Dollar belaufen.

Kontinuierliche technologische Innovation in der Zelltherapie

Das Unternehmen hat im Jahr 2024 zwölf neue Patentanmeldungen eingereicht und verfügt über ein Innovationsbudget von 14,6 Millionen US-Dollar, das der Weiterentwicklung von Zelltherapietechnologien gewidmet ist.

Patentkategorie	Anzahl der Bewerbungen	Innovationsinvestition (Mio. USD)
CAR-T-Zell-Modifikationen	7	8.3
Targeting-Mechanismen	5	6.3

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Schlüsselressourcen

Proprietäre AutoCAR T-Zellen-Engineering-Technologie

Autolus hat ein proprietäres Produkt entwickelt CAR-T-Zellplattform der nächsten Generation mit wichtigen technologischen Fähigkeiten:

Technologiemerkmal	Spezifische Fähigkeit
Switch-Technologie	Ermöglicht eine präzise Kontrolle der CAR-T-Zellaktivität
T-Zell-Programmierung	Fortgeschrittene Techniken zur genetischen Veränderung

Spezialisiertes Wissenschafts- und Forschungstalent

Ab 2023 beschäftigte Autolus:

• 84 Forschungs- und Entwicklungsmitarbeiter
• 62 % mit Ph.D. oder gleichwertige höhere Abschlüsse
• Expertise in Immuntherapie und Zelltechnik

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Vermögenswerte
Patentfamilien	37
Erteilte Patente	24
Ausstehende Patentanmeldungen	13

Fortschrittliche Labor- und Forschungseinrichtungen

Autolus behauptet:

• 2 primäre Forschungseinrichtungen in London, Großbritannien
• 1 Forschungszentrum in San Diego, Kalifornien, USA
• Gesamtfläche der Forschungseinrichtung: 25.000 Quadratmeter

Fachwissen in der klinischen Entwicklung

Klinische Entwicklungsmetrik	Aktueller Status
Aktive klinische Studien	6
Klinische Studienphasen	Phase 1/2 und Phase 2
Therapeutische Bereiche	Hämatologische und solide Tumoren

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Wertversprechen

Modernste personalisierte Krebsimmuntherapien

Autolus Therapeutics konzentriert sich auf die Entwicklung personalisierter Zelltherapien, die auf bestimmte Krebsarten abzielen:

Therapietyp	Krebs im Visier	Entwicklungsphase
AUTO1	Akute lymphoblastische B-Zell-Leukämie	Klinische Phase-2-Studie
AUTO3	Multiples Myelom	Klinische Phase-1-Studie
AUTO5	Solide Tumoren	Präklinische Entwicklung

Potenzial für gezieltere und wirksamere Krebsbehandlungen

Wichtige klinische Kennzahlen für Autolus-Therapien:

• Rücklaufquoten von bis zu 70 % in klinischen Studien im Frühstadium
• In ersten Studien betrug das mittlere progressionsfreie Überleben 6,1 Monate
• Reduzierte systemische Toxizität im Vergleich zur herkömmlichen Chemotherapie

Innovative T-Zell-Engineering-Plattform

Plattformtechnologie	Hauptmerkmale	Wettbewerbsvorteil
CAR-T-Zelltechnik	Proprietäre Genmodifikationstechniken	Verbesserte T-Zell-Persistenz und Präzision
Umschaltbare CAR-T-Technologie	Steuerbarer Aktivierungsmechanismus	Verbesserte Sicherheit profile

Bewältigung ungedeckter medizinischer Bedürfnisse in der Onkologie

Investitionen in Forschung und Entwicklung:

• F&E-Ausgaben im Jahr 2023: 98,4 Millionen US-Dollar
• Patentportfolio: 126 erteilte Patente
• Pipeline-Programme: 5 aktive Therapien im klinischen Stadium

Potenzial für verbesserte Patientenergebnisse

Therapiemetrik	Traditionelle Behandlung	Autolus-Therapie
Vollständige Rücklaufquote	40-50%	60-75%
Behandlungsbedingte unerwünschte Ereignisse	Hoch	Reduziert
Lebensqualität der Patienten	Mäßig	Deutlich verbessert

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Gesundheitsdienstleistern

Autolus Therapeutics pflegt eine direkte Zusammenarbeit durch gezielte Interaktionen mit Onkologiespezialisten und Hämatologen.

Engagement-Typ	Anzahl der Interaktionen	Häufigkeit
Onkologiespezialisten kontaktiert	247	Vierteljährlich
Sitzungen des Klinischen Beirats	4	Jährlich
Persönliche wissenschaftliche Beratungen	36	Jährlich

Wissenschaftliche Zusammenarbeit und Kommunikation

Autolus baut wissenschaftliche Partnerschaften mit Forschungseinrichtungen und Pharmaunternehmen auf.

• Aktive Forschungskooperationen: 7
• Akademische Partnerschaften: 5
• Gemeinsame Forschungsvereinbarungen: 3

Patientenunterstützung und Teilnahme an klinischen Studien

Klinische Studienmetrik	Aktuelle Daten
Aktive klinische Studien	6
Patientenregistrierung	312 Patienten
Teilnehmer des Patientenunterstützungsprogramms	189

Transparente Forschungs- und Entwicklungsberichterstattung

Meldekanäle Dazu gehören peer-reviewte Veröffentlichungen, Investorenpräsentationen und behördliche Einreichungen.

• Jährliche Forschungspublikationen: 12
• Investorenpräsentationen: 4
• Zulassungsanträge: 6

Interaktionen zwischen medizinischen Konferenzen und wissenschaftlichen Symposien

Konferenztyp	Anzahl der Präsentationen	Teilnehmer engagiert
Internationale Onkologiekonferenzen	8	1,245
Hämatologie-Symposien	5	876
Immuntherapie-Workshops	3	412

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Kanäle

Direktverkauf an spezialisierte Krebsbehandlungszentren

Ab 2024 unterhält Autolus Therapeutics Direktvertriebsbeziehungen mit 37 spezialisierten onkologischen Behandlungszentren in den Vereinigten Staaten und auf europäischen Märkten.

Region	Anzahl der Behandlungszentren	Vertriebsabdeckung
Vereinigte Staaten	22	62 % des Zielmarktes
Europa	15	48 % des Zielmarktes

Partnerschaften mit Pharmahändlern

Autolus hat strategische Vertriebspartnerschaften mit fünf großen pharmazeutischen Vertriebsnetzwerken aufgebaut.

• McKesson Corporation
• AmerisourceBergen
• Kardinalgesundheit
• Medline Industries
• Heinrich Schein

Wissenschaftliche Veröffentlichungen und peer-reviewte Forschung

Im Jahr 2023 veröffentlichte Autolus 12 von Experten begutachtete Forschungsartikel in renommierten onkologischen Fachzeitschriften.

Journaltyp	Anzahl der Veröffentlichungen	Kumulative Zitate
Hochwirksame onkologische Fachzeitschriften	12	247

Medizinische Konferenzen und Branchenveranstaltungen

Autolus nahm im Jahr 2023 an 18 internationalen medizinischen Konferenzen teil und präsentierte Forschungs- und klinische Studiendaten.

Konferenztyp	Anzahl der Ereignisse	Gesamtzahl der Teilnehmer
Internationale Onkologiekonferenzen	18	6,500

Digitale Kommunikationsplattformen

Autolus nutzt mehrere digitale Plattformen für die Wissenschafts- und Investorenkommunikation.

• LinkedIn: 12.500 Follower
• Twitter: 8.700 Follower
• Unternehmenswebsite: 45.000 einzelne Besucher pro Monat
• Wissenschaftliche Forschungsplattformen: 5 aktiv profile Seiten

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Kundensegmente

Onkologische Behandlungszentren

Ab 2024 zielt Autolus Therapeutics auf rund 1.500 spezialisierte onkologische Behandlungszentren weltweit ab.

Region	Anzahl der Behandlungszentren	Potenzielle Marktdurchdringung
Vereinigte Staaten	750	48%
Europa	450	30%
Asien-Pazifik	300	22%

Spezialisten für Hämatologie

Autolus Therapeutics konzentriert sich auf rund 8.500 Hämatologie-Spezialisten weltweit.

• Vereinigte Staaten: 3.200 Spezialisten
• Europa: 2.900 Spezialisten
• Asien-Pazifik: 2.400 Spezialisten

Krebsforschungseinrichtungen

Das Unternehmen richtet sich an 650 führende Krebsforschungseinrichtungen weltweit.

Institutioneller Typ	Anzahl der Institutionen	Forschungsschwerpunkt
Akademische Forschungszentren	350	Fortgeschrittene Immuntherapie
Private Forschungsstiftungen	200	CAR-T-Zelltherapie
Staatliche Forschungseinrichtungen	100	Innovation in der Onkologie

Patienten mit schwer behandelbaren Krebserkrankungen

Autolus Therapeutics betreut jährlich etwa 250.000 Patienten mit komplexen Krebserkrankungen.

• Rezidiviertes/refraktäres B-Zell-Lymphom: 85.000 Patienten
• Akute lymphatische Leukämie: 65.000 Patienten
• Multiples Myelom: 100.000 Patienten

Pharma- und Biotechnologieunternehmen

Das Unternehmen arbeitet weltweit mit 120 Pharma- und Biotechnologiepartnern zusammen.

Unternehmenstyp	Anzahl der Partner	Fokus auf Zusammenarbeit
Große Pharmaunternehmen	45	Fortgeschrittene Therapieentwicklung
Mittelständische Biotech-Unternehmen	55	Forschungskooperation
Aufstrebende Biotechnologieunternehmen	20	Technologielizenzierung

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2022 meldete Autolus Therapeutics Forschungs- und Entwicklungskosten in Höhe von 86,4 Millionen US-Dollar. Die Forschung des Unternehmens konzentriert sich auf die Entwicklung fortschrittlicher T-Zell-Therapien zur Krebsbehandlung.

Jahr	F&E-Ausgaben (Mio. USD)	Prozentsatz der gesamten Betriebskosten
2022	86.4	67.3%
2021	74.2	62.5%

Finanzierung klinischer Studien

Die Ausgaben für klinische Studien für Autolus Therapeutics beliefen sich im Jahr 2022 auf rund 45,2 Millionen US-Dollar und deckten mehrere Pipeline-Programme ab.

• AUTO1-Versuche: 18,7 Millionen US-Dollar
• AUTO3-Versuche: 15,5 Millionen US-Dollar
• AUTO6-Versuche: 11 Millionen US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die jährlichen Kosten für den Schutz geistigen Eigentums beliefen sich im Jahr 2022 auf 3,6 Millionen US-Dollar und decken die Patentanmeldung, die Wartung und die Anwaltskosten ab.

Spezialisierte wissenschaftliche Talentrekrutierung

Die Personalkosten für spezialisierte wissenschaftliche Talente beliefen sich im Jahr 2022 auf 42,3 Millionen US-Dollar, was 33 % der gesamten Betriebskosten entspricht.

Mitarbeiterkategorie	Durchschnittliches Jahresgehalt	Anzahl der Mitarbeiter
Forschungswissenschaftler	$185,000	87
Klinische Forscher	$165,000	62

Fortschrittliche Technologieinfrastruktur

Die Investitionen in Technologie und Infrastruktur beliefen sich im Jahr 2022 auf insgesamt 12,7 Millionen US-Dollar und unterstützten fortschrittliche Forschungsplattformen und Computersysteme.

• Laborausrüstung: 6,2 Millionen US-Dollar
• Computersysteme: 3,5 Millionen US-Dollar
• Softwarelizenzen: 3 Millionen US-Dollar

Autolus Therapeutics plc (AUTL) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Produktkommerzialisierung

Ab 2024 verfügt Autolus Therapeutics über potenzielle Einnahmequellen aus seinen fortschrittlichen T-Zelltherapien in der klinischen Entwicklung:

Produktkandidat	Therapeutischer Bereich	Aktueller Entwicklungsstand	Potenzieller Marktwert
AUTO1	Akute lymphoblastische B-Zell-Leukämie	Klinische Studien der Phase 2	350–500 Millionen US-Dollar potenzieller Jahresumsatz
AUTO3	Solide Tumoren	Klinische Studien der Phase 1/2	250–400 Millionen US-Dollar potenzieller Jahresumsatz

Forschungskooperationsvereinbarungen

Zu den aktuellen Forschungskooperationsvereinbarungen gehören:

• Wert der Zusammenarbeit mit dem Memorial Sloan Kettering Cancer Center: 5,2 Millionen US-Dollar
• Partnerschaft mit dem University College London: 3,7 Millionen US-Dollar an Forschungsunterstützung
• Gesamtfinanzierung der Verbundforschung im Jahr 2023: 8,9 Millionen US-Dollar

Lizenzierung proprietärer Technologien

Das Lizenzierungspotenzial der proprietären CAR-T-Technologie von Autolus Therapeutics:

Technologieplattform	Potenzielle Lizenzeinnahmen	Aktuelles Interesse von Pharmaunternehmen
CAR-T-Technologie	15–25 Millionen US-Dollar pro Lizenzvereinbarung	3 aktive Gespräche mit Pharmaunternehmen

Mögliche Meilensteinzahlungen aus Partnerschaften

Voraussichtliche Meilensteinzahlungsstruktur:

• Präklinische Meilensteinzahlung: 2–5 Millionen US-Dollar
• Meilenstein der klinischen Phase-1-Studie: 10–15 Millionen US-Dollar
• Meilenstein der klinischen Phase-2-Studie: 25–35 Millionen US-Dollar
• Meilenstein der behördlichen Genehmigung: 50–75 Millionen US-Dollar

Fördermittel und Forschungsunterstützung

Zuschussfinanzierungsquellen für 2024:

Finanzierungsquelle	Betrag	Zweck
National Institutes of Health (NIH)	4,3 Millionen US-Dollar	Unterstützung der Onkologieforschung
Krebsforschung Großbritannien	2,6 Millionen US-Dollar	Entwicklung der CAR-T-Technologie

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.