Autolus Therapeutics : Presentation - (260409 autl corporate presentation april 2026)
AUTL
Published on 04/13/2026 at 09:00 am EDT
Developing Next Generation Programmed T Cell Therapies
April 2026
For Investor communication only. Not for use in product promotion.
Autolus.com
Autolus is positioned for value creation
Obe-cel product franchise supports multiple growth opportunities
Initial Indication: Adult r/r B-ALL
Strong Execution in First Year of Launch
Pipeline expansion opportunities
grow future commercial potential in new indications
$74.3 million
Achieved CAR T market leadership in r/r B-ALL
Significant opportunity to grow overall CAR T market in adult r/r B-ALL
Physician interest to pursue investigator sponsored trials in 1stline ALL
Opportunity to establish a pipeline in a product with recent data presentations supporting potentially pivotal Phase 2 clinical trials with obe-cel in
lupus nephritis and pediatric ALL
Commercial and pipeline opportunities supported by proven manufacturing and product delivery capabilities and established authorized treatment centers
Autolus is a leader in CAR T manufacturing & product delivery
Executing on manufacturing and product delivery in the first year of launch:
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Manufacturing Life Cycle Strategy: Opportunities for Innovation to Improve Margins
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Optimizing the current manufacturing process and operating model
Enhancing automation opportunities on our existing process
Developing next-generation manufacturing platform with a step change in the cost and capacity profile
AUTOLUS' FIRST APPROVED PRODUCT
AUCATZYL®
A potentially best-in-class, standalone CD19 CAR T cell therapy
AUCATZYL® now approved in US, UK and EU
AUCATZYL indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL)
Highly active, fast off-rate CD19 CAR T therapy with a well managed safety profile1- approved in US, UK, EU
First and currently only approved CAR T therapy with customized, tumor-burden guided dosing - no FDA REMS obligation
Established infrastructure for manufacturing and commercialization
Commercial presence in more than 70 US centers
NICE determined AUCATZYL to be cost effective, UK* launched in January 2026
Approval in EU† in 2025; pricing and reimbursement evaluation ongoing on a country-by-country basis
1Roddie C, et al "Obecabtagene autoleucel in B-cell acute lymphoblastic leukemia" N Engl J Med 2024; DOI: 10.1056/NEJMoa2406526; *Conditional marketing authorization, † European Commission (EC) 6
conditional approval
Strong first year of U.S. AUCATZYL® launch
2026 Expectations
AUCATZYL Net Product Revenue
$120-$135 million
Shift to positive gross margin in 2026 based on increasing volumes and improved manufacturing plant operation
Treatment center activation (67 as of 12/31/25)
Positive physician and patient experience
Reliable manufacture and delivery of product
AUCATZYL geographic growth opportunities in ALL
UK Launch Q1 2026
Expansion
Conditional marketing authorization in the UK received April 2025
Successful NICE pricing and reimbursement process Nov 2025
AUCATZYL available in routine commissioning in NHS Dec 2025
EU market access -pending
European Commission (EC) conditional approval received July 2025
Ongoing country-by-country evaluation of pricing and reimbursement decisions to assess feasibility of market entry; no anticipated EU sales in 2026
Exploration of alternate market access mechanisms in 2026
We believe AUCATZYL® has a unique mechanism of action
Clinical data show increased activity and reduced toxicity
Fast off-rate
CAT19 fast off-rate binder²
CD8-derived hinge region/ transmembrane domain2
4-1BB co-stimulatory domain1,4 Shown to enhance CAR T-cell expansion and reduce exhaustion compared with CD28 CARs in preclinical studies
107
106
105
104
FMC63
HD37
B4
4G7
Other CD19 Binders
Obe-cel Binder
CAT
On-Rate: Ka[M-1S-1]
10-4 10-3 10-2 10-1
Potential for improved potency, reduced toxicity
Off Rate: Kd[S-1]
Shorter half-life of interaction compared to binders used in other approved products
AUCATZYL® = 9.8 seconds
Kymriah® = 21 minutes
CD3Ɀ activation domain¹
Avoided over-activation
of CAR T cells
→ Reduced toxicities
Increased CAR T peak expansion → Improved peak activity and
persistence
Avoided exhaustion
of CAR T-cells
→ Improved engraftment Improved persistence
References:1. AUCATZYL. Prescribing Information. Autolus, Inc. 2024. 2. Ghorashian S, Kramer AM, Onuoha S, et al. Enhanced CAR T cell expansion and prolonged persistence in pediatric patients with ALL treated with a low-affinity CD19 CAR. Nat Med. 2019;25:1408-
AUCATZYL was approved based on results from the FELIX trial
FELIX Phase 1b/2
Cohort IA
≥5% BM blast
Cohort IB
<5% BM blast MRD+
Cohort IIA
≥5% BM blast
Open-label, multinational, single-arm Phase 1b/2 trial in adult patients with R/R B-ALL1-2; largest CAR T cell therapy trial in R/R B-ALL to date (N=153 enrolled)
Conducted during COVID-19 pandemic with highly immune compromised patients
Cohort IIB
<5% BM blast MRD+
Cohort IIC Isolated EMD at screening
High ORR, encouraging EFS/OS and favorable tolerability with low levels of high-grade CRS and ICANS
Patients (N)
Ph1b/2 pooled1
Enrolled
153
Infused
127
Timely and reliable clinical product supply and logistics despite COVID-19 pandemic restrictions
Across all Phase 1b/2 cohorts, 40% of responders in ongoing remission without subsequent stem cell transplant/other therapy1
Survival outcomes suggesting potential of long-term plateau1
FELIX trial published in New England Journal of Medicine1
Favourable response rate and tolerability, despite challenging patient population
High overall response rate with deep molecular responses
Durable responses, particularly in patients with a low-to-intermediate bone marrow burden
Excellent tolerability profile
Very low rates of high-grade immunotoxicities
No high-grade events in low disease burden patients
Response by disease status at lymphodepletion
Overall Remission Rate (CR/CRi)
All patients (n=127)
77%
Morphological disease (n=91)
75%
Measurable residual disease (n=29)
96%
Isolated extramedullary disease (n=7)
71%
Safety by disease burden at lymphodepletion
Grade ≥3 CRS
Grade ≥3 ICANS
All patients (n=127)
2%
7%
>75% Blasts (n=40)
2%
12%
5-75% Blasts (n=51)
4%
8%
<5% Blasts (n=36)
0%
0%
Data continue to show long term remissions in r/r adult B-ALL
At 24 months, overall survival probability was 46.0%
Duration of response: median 42.6 months at last data cut
More than half of patients still in remission at 24 months
Expanding the
obe-cel opportunity
Deep value program with potentially broad applicability
Pipeline supports growth with multiple development opportunities
Product
Indication
Target
Preclinical
Phase 1
Phase 2/Pivotal
Approved
Status
AUCATZYL®
(obe-cel)
Adult ALL
CD19
FDA, MHRA^& EC
approved†
obe-cel
Pediatric ALL
CD19
Currently enrolling
obe-cel
Lupus Nephritis
CD19
Currently enrolling
obe-cel
Progressive Multiple Sclerosis CD19
Currently enrolling
Product
Indication
Target
Preclinical
Phase 1
Status
AUTO8*
Multiple Myeloma
CD19 & BCMA
Currently enrolling
AUTO8*
Light Chain Amyloidosis
CD19 & BCMA
Currently enrolling
AUTO1/22*
Pediatric ALL
CD19 & CD22
Currently enrolling
15
^Conditional marketing authorization; † European Commission (EC) conditional approval; *UCL Collaboration Oncology Autoimmune / B-cell mediated
Growing the obe-cel franchise commercial opportunity
Robust clinical database and demonstrated commercial capabilities position Autolus for efficient path in new indications
Significant Market Opportunity
Graphic is illustrative, not to scale
Adult r/r B-ALL
Approved
Pediatric r/r B-ALL
Phase 2
Refractory Lupus Nephritis
Phase 2
Progressive MS
Phase 1
Hem Oncology Autoimmune
1. Based on National Cancer Institue SEER estimates and internal analysis; 2. Clarivate/DRG Epidemiology, Arthritis Rheumatol. 2023 Apr;75(4):567-573, Arthritis & Rheumatology. 2017;69(10):2006-2017; 3. GlobalData MS Market Forecast 2020-2030 April 2023; 16
Pediatric r/r B-ALL development strategy
CATULUS trial is currently enrolling; data expected at end of 2027
Regenerative Medicine Advanced Therapy (RMAT) designation supports development pathway
Development Rationale: High Unmet Medical Need
Obe-cel aims to include all
patients post-frontline therapy, including first line high-risk relapsed patients
Kymriah approved for
refractory and 2ndrelapse patients - excluding first line high-risk relapsed patients
Data reported at ASH
2025 annual meeting
ORR of 95%, CRR of 91%
Low rates of high-grade
CRS and ICANS
Collaboration with
Children's Oncology Group (COG)
Ages 0 - 18 and a minimum weight of 6 kg
Single weight-based infusion of 1 million cells per kg
International study (US,
UK, SP)
30 patients, SAT
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CATULUS Phase 2
CATULUS Phase 1
Complete
CATULUS Phase 1 data support progressing into Phase 2
Safety profile of obe-cel in pediatric patients consistent with that previously reported in adults
*One patient experienced both Grade 3 CRS and Grade 3 ICANS.
‡Time to onset (days) = [(Date of start of Any grade/Grade≥3 CRS/ICANS − Date of first obe-cel infusion) +1].
B-ALL, B-cell acute lymphoblastic leukemia; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; IVIG, intravenous immunoglobulin
Ghorashian et. al. ASH 2025 Annual Meeting
CATULUS data demonstrate promising initial efficacy in pediatric patients
At median follow-up of 8.8 months in pediatric r/r B-ALL patients: ORR was 95.5%; CR was achieved in 90.9%
Swimmer plot showing disease assessments in the B-ALL cohort
MOA and commercial capabilities are key differentiators in AID
Obe-cel is the only CD19 CAR approved in other indications that is now being tested for autoimmune disease
Autolus Potential Advantage
Favorable tolerability to drive acceptability in non-oncology indications
Supports differentiated approach and potential for obe-cel in autoimmune disease areas
Deep cut into the CD19+ B cells and plasma blasts
Robust, economical and scalable manufacturing and established commercial infrastructure
Potential for accelerated clinical program
FDA-approved CAR-T therapy, with existing safety database, now in development for autoimmune indications
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Disclaimer
Autolus Therapeutics plc published this content on April 13, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 13, 2026 at 12:59 UTC.