Autolus Therapeutics plc (AUTL): Business Model Canvas [Dec-2025 Updated]

You're looking at Autolus Therapeutics plc right at the pivot point-that tricky transition from a pure R&D shop to actually selling a complex cell therapy. Honestly, mapping out their Business Model Canvas shows a company betting big on its proprietary T cell programming tech and its in-house Nucleus manufacturing facility to deliver AUCATZYL® for relapsed/refractory B-ALL. For context, by Q3 2025, they booked $21.1 million in net product revenue, which is the start of their revenue stream, while still holding a healthy war chest of $367.4 million in cash and equivalents. This canvas breaks down exactly how they plan to manage the high fixed costs of autologous CAR T-cell manufacturing while supporting their growing network of Authorized Treatment Centers. Dive in below to see the precise partnerships and channels driving this near-term commercial push.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Key Partnerships

You're looking at the critical external relationships Autolus Therapeutics plc (AUTL) relies on to bring its programmed T cell therapies to market and scale operations. These aren't just vendor agreements; they are foundational to the commercial viability of AUCATZYL (obecabtagene autoleucel) and the pipeline.

AGC Biologics for commercial viral vector supply

Autolus Therapeutics plc (AUTL) has an agreement with AGC Biologics for the late-stage clinical and commercial supply of viral vector. This external supply arrangement is governed by manufacturing agreements that also provide access to necessary services. These services include quality management systems, qualified persons for product release, frozen storage, and warehousing services. Autolus Therapeutics plc (AUTL) also maintains some internal capability to produce vector for early and late-stage trials, alongside manufacturing agreements with King's College London for early phase vector manufacturing.

Miltenyi Biotec GmbH for CliniMACS Prodigy instruments and disposables

The operational backbone for cell processing relies on external providers for critical equipment. While specific contract values aren't public, the reliance on platforms like the Miltenyi Biotec GmbH CliniMACS Prodigy instruments and disposables is a key operational dependency for Autolus Therapeutics plc (AUTL) manufacturing.

BioNTech strategic collaboration for technology platform licensing and potential royalties

The strategic collaboration with BioNTech SE is a major financial and operational pillar. This deal, announced in early 2024, provided significant capital infusion to support the AUCATZYL launch and pipeline development. The financial structure of this partnership is detailed below:

Component	Amount/Term
Upfront Cash Payment from BioNTech	$50 million
Investment in Autolus Therapeutics plc (AUTL) ADSs (Private Placement)	$200 million
Total Upfront/Investment from BioNTech	$250 million
Concurrent Stock Offering Proceeds (Gross)	$350 million
Total Capital Raised (BioNTech + Offering)	$600 million
Potential Milestone Payments (Overall Agreement)	Up to $582 million
Royalty on obe-cel Net Sales	Up to mid-single digit royalty
2024 License Revenue Recognized (from BioNTech Agreement)	$10.1 million
BioNTech ADS Purchase Price (Feb 2024)	$6.00 per ADS

This collaboration also grants BioNTech options to co-commercialize AUTO1/22 and AUTO6NG, with Autolus Therapeutics plc (AUTL) eligible for option exercise fees, milestone payments, and co-funding of development expenses if options are exercised. Furthermore, BioNTech gains access to Autolus Therapeutics plc (AUTL)'s manufacturing and commercial supply infrastructure to advance its BNT211 program. The Cost of Sales for Autolus Therapeutics plc (AUTL) in the second quarter of 2025 totaled $24.4 million, which includes 3rd party royalties for certain technology licenses.

Authorized Treatment Centers (ATCs) for product administration and patient care

The commercial success of AUCATZYL hinges on the rapid expansion of the treatment center network. As of the third quarter of 2025, Autolus Therapeutics plc (AUTL) had achieved broad US market access with 60 authorized treatment centers. This represents significant growth from the 24 centers authorized as of January 10, 2025. The target for year-end 2025 was to surpass 60 centers, having secured coverage for greater than 90% of total U.S. medical lives by the second quarter of 2025. The UK launch is anticipated in the second half of 2025, following conditional marketing authorization granted in April 2025.

• US Authorized Treatment Centers (Q2 2025): 46
• US Authorized Treatment Centers (Q3 2025): 60
• Target US Centers by Year-End 2025: Over 60
• US Medical Lives Covered (as of Q2 2025): Greater than 90%
• Manufacturing Success Rate (as of Q3 2025): Above 90%

The net product sales for the three months ending June 30, 2025, were $20.9 million. The first six months of the AUCATZYL launch generated $29.9 million in product sales.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Key Activities

You're looking at the operational engine driving Autolus Therapeutics plc's transition from R&D to commercial entity, which is all about scaling the delivery of AUCATZYL® while pushing the pipeline forward. Here's the breakdown of the core activities based on late 2025 data.

Manufacturing and delivering the autologous CAR T-cell therapy (AUCATZYL®)

Manufacturing is centered at The Nucleus site in Stevenage, UK, which is dedicated to commercial supply of AUCATZYL®. The company also maintains separate manufacturing capabilities for clinical-stage programs, like those for autoimmune conditions, at the Cell and Gene Therapy Catapult in Stevenage.

The commercial delivery process saw significant scaling in 2025:

• The security interest with Blackstone terminated in January 2025 upon the first commercial sale of AUCATZYL® in the US.
• The median dose of AUCATZYL® administered in the pivotal FELIX study was 410 × 10⁶ CD19 CAR-positive viable T cells.

The financial impact of manufacturing and delivery is captured in the Cost of Sales:

Period Ended September 30, 2025	Amount (USD)
Cost of Sales (Q3 2025)	$28.6 million
Cost of Sales (Q2 2025)	$24.4 million
Cost of Sales (Q1 2025)	$18.0 million

Commercial launch and market share expansion in relapsed/refractory B-ALL

The commercial launch of AUCATZYL® began in the US in January 2025, following FDA approval in November 2024. The focus has been on rapidly building out the treatment center network and securing reimbursement.

Key commercial milestones and revenue figures for the U.S. launch through Q3 2025:

Metric	Value / Date
FDA Approval Date	November 8, 2024
US Commercial Launch	January 2025
UK Conditional Marketing Authorization	April 2025
US Activated Centers (as of Aug 12, 2025)	46 centers
US Target Centers Expected by YE 2025	60 centers
US Medical Lives Covered (as of Aug 12, 2025)	Greater than 90%
Net Product Revenue (Q1 2025)	$9.0 million
Net Product Revenue (Q2 2025)	$20.9 million
Net Product Revenue (Q3 2025)	$21.1 million
Total Net Product Sales (9 Months Ended Sep 30, 2025)	$51.0 million
Deferred Revenue (as of Sep 30, 2025)	$7.6 million

Durability data from the FELIX study continues to support market penetration:

• At a median follow-up of 33 months, 38% of responders were in ongoing remission without subsequent therapy.
• At $\ge$3 years of follow-up, 40% of responders remained in ongoing remission without subsequent stem cell therapy.
• The 24-month probability of Overall Survival was 46.0%.

Ongoing clinical development for obe-cel in pediatric ALL and autoimmune diseases

Autolus Therapeutics plc is actively broadening the utility of obe-cel beyond the approved adult indication. The company stated its next phase of growth includes conducting potential pivotal studies in pediatric ALL and in severe lupus nephritis.

Clinical progress by indication:

• Pediatric R/R B-ALL (CATULUS study): Overall Response Rate (ORR) was 95%; nearly 90% of responders had ongoing remission at data cut-off.
• The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel for pediatric r/r B-ALL in October 2025.
• Systemic Lupus Erythematosus (SLE - CARLYSLE study): Initial data showed achievement of definition of remission in SLE (DORIS) in 83% (n=5/6) of patients and complete renal response (CRR) in 50% (n=3/6) of patients.
• A pivotal Phase 2 trial in lupus nephritis was planned to start by year-end 2025.
• A Phase 1 clinical trial in Multiple Sclerosis was planned by the end of 2025.

Overall, data from over 200 patients treated across different indications with obe-cel had been reported to date as of Q2 2025.

Protecting and expanding proprietary T cell programming technology and IP

This activity is reflected in the management of Research and Development (R&D) expenses and strategic agreements. The company is innovating on manufacturing technology as a foundation for further access expansion.

R&D spending shows a trend of cost discipline while maintaining investment:

R&D Expense Metric	Amount (USD)
R&D Expense (Q2 2025)	$27.4 million
R&D Expense (Q1 2025)	$26.7 million
YoY R&D Reduction (Q2 2025 vs Q2 2024)	25% reduction

The proprietary technology base is being leveraged across the pipeline, though some early collaborations have concluded:

• The product option for AUTO1/22 with BioNTech expired as of February 8, 2025.
• Selling, General, and Administrative (SG&A) expenses for Q3 2025 were $36.3 million, up from $27.3 million in Q3 2024, driven by headcount supporting commercialization.

Finance: draft 13-week cash view by Friday.

Autolus Therapeutics plc (AUTL) - Canvas Business Model: Key Resources

You're looking at the core assets Autolus Therapeutics plc (AUTL) relies on to operate and commercialize its cell therapy platform as of late 2025. These aren't just ideas; they are tangible and intellectual capital that drive the business.

Proprietary modular T cell programming technology is central. This suite of technology allows Autolus Therapeutics plc to engineer precisely targeted, controlled, and highly active T cell therapies. The pipeline built on this technology currently comprises five product candidates being developed across seven hematological and solid tumor indications, plus one autoimmune indication. Initial data from the CARLYSLE Phase 1 trial in refractory systemic lupus erythematosus (SLE) patients was reported on April 23, 2025.

The physical asset supporting commercialization is the in-house, purpose-built Nucleus manufacturing facility in Stevenage, UK. This facility spans 70,000 square feet and is designed to manufacture and test approximately 2,000 batches per year, with built-in expansion opportunities. The facility secured a Manufacturer's Importation Authorisation (MIA) and a GMP certificate in March 2024. The company aims for a greater than 95% manufacturing success rate with target V2C (time from leukapheresis to quality release) times of less than 15 days, building on prior clinical trial success where median V2C was 21 days.

Financially, a key resource is the liquidity position. As of September 30, 2025, Autolus Therapeutics plc held cash, cash equivalents, and marketable securities totaling $367.4 million. This compares to $588.0 million at the close of 2024.

Here's a quick look at the recent financial performance tied to the commercial asset:

Metric	Period Ending September 30, 2025	Comparison Data Point
Cash, Cash Equivalents, and Marketable Securities	$367.4 million	$588.0 million (as of December 31, 2024)
Net Product Revenue (Q3)	$21.1 million	$20.9 million (Q2 2025)
Net Product Sales (Year-to-Date)	$51 million	For the nine months ended September 30, 2025
Deferred Revenue Balance	$7.6 million	$2.1 million (Q2 2025)
Cost of Sales (Q3)	$28.6 million	Reported for the three months ended September 30, 2025

The final, and perhaps most critical, resource is the FDA-approved product, AUCATZYL® (obecabtagene autoleucel). This therapy received FDA approval for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) on November 8, 2024. The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization on April 25, 2025. The company reported strong U.S. launch momentum, aiming to complete authorization of 60 treatment centers covering approximately 90% of the identified target patient population by the end of 2025. Patient access to AUCATZYL® in the U.S. has secured coverage for greater than 90% of total U.S. medical lives.

You can see the operational achievements supporting this product:

• FDA approval date: November 8, 2024.
• UK MHRA conditional marketing authorization date: April 25, 2025.
• Targeted U.S. treatment centers authorized by end of 2025: 60.
• U.S. treatment centers fully activated as of August 12, 2025: 46.
• Manufacturing success rate for commercial product: greater than 90%.
• Pipeline expansion trials initiated: pediatric ALL Phase 2 and lupus nephritis pivotal study (CARLYSLE).

Finance: review the Q4 cash burn projection based on Q3 operating loss of $71.6 million.

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.