Autolus Therapeutics Plc · NASDAQ:AUTL
Autolus Therapeutics — Corporate Update (November 2024)
14 slides from Autolus Therapeutics's corporate update, Nov 12, 2024
Slide 1: FDA Approval Conference Call AUCATZYL (obecabtagene autoleucel)
Autolus.com FDA Approval Conference Call AUCATZYL® (obecabtagene autoleucel) For Investor communication only. Not for use in product promotion. Not for further distribution. EX-99.2
Slide 2: Disclaimer
Disclaimer These slides contain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,”
Slide 3: AUCATZYL now FDA approved
AUCATZYL® now FDA approved 3 ✓ AUCATZYL indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) ✓ First chimeric antigen receptor T-cell (CAR T) therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigat
Slide 4: Important Safety Information
Important Safety Information 4 • The safety of AUCATZYL includes a boxed warning for CRS, neurologic toxicities, and secondary hematological malignancies. ICANS, including fatal or life-threatening reactions, occurred in patients receiving AUCATZYL. T-cell malignancies have occurred following treatm
Slide 5: AUCATZYL was approved based on results from the FELIX trial
AUCATZYL was approved based on results from the FELIX trial 5 FELIX Phase 1b/2 Cohort IA ≥5% BM blast 1 FELIX Ph1b/2 pooled data presented at ASH 2023 (data cut off Sept. 13, 2023; median follow up 16.6 months) and ASCO & EHA 2024 (data cut off Feb. 7, 2024; median follow up 21.5 months) 2 FELIX Ph2
Slide 6: FELIX trial was conducted during pandemic, in real-world setting
FELIX trial was conducted during pandemic, in real-world setting 6 FDA efficacy excludes 22 patients with <5% bone marrow blasts prior to lymphodepletion as a result of bridging therapy Enrolled1 N=112 Cohort IIA ≥5% BM blast at enrolment Infused N=94 Discontinued 18 • Death 11 • Supply related 5 •
Slide 7: FDA evaluable patients/analysis
FDA evaluable patients/analysis 7 FDA efficacy-evaluable patients n = 65 OCR (CR+CRi)# 63% CR within 3 months 42% CR “At Anytime” 51% CRi “At Anytime” 12% DoR# of OCR (mos) 14.1 FDA safety-evaluable patients n = 100 CRS ≥3 3% ICANS ≥3 7% Neurotox* ≥3 12% * Not reported at time of event/analysis #OCR
Slide 8: ASH 2023 FELIX Phase 1b/2 pooled data: leukemic burden at screening
Illustrative purposes - ASH 2023 FELIX Phase 1b/2 pooled data 8 Leukemic burden at screening is not predictive of leukemic burden prior to lymphodepletion *Bridging therapy per physician’s choice, including inotuzumab ozogamicin; BM, bone marrow; Roddie et al., ASH 2023 16% 28% 53% 40% 31% 31% BM bl
Slide 9: Lower leukemic burden prior to lymphodepletion is associated with better outcomes
Illustrative purposes - ASH 2023 FELIX Phase 1b/2 pooled data 9 Lower leukemic burden prior to lymphodepletion* is associated with better outcomes *Censoring new non-protocol anti-cancer therapies including SCT with disease assessment by IRRC (data cut-off date: September 13, 2023); BM, bone marrow;
Slide 10: Pillars to drive launch success
Pillars to drive launch success 10 30 key centers primed for activation covering ~ 60% of r/r B-ALL target population with ~30 additional centers to follow by end 2025 Prioritizing activation of centers Post-approval Pricing reflects clinical evidence, differentiated safety profile, economic value $
Slide 11: Dedicated point of contact and comprehensive set of services
Dedicated-point of contact and comprehensive set of services for treatment centers, patients and caregivers 11 *For eligible patients; not an exhaustive list of services. Eligibility may vary. More information can be found at www.autolusassist.com AutolusAssist Services Treatment Centers, Patients &
Slide 12: Origins of obe-cel/AUCATZYL
Origins of obe-cel/AUCATZYL® 12 Close collaboration with University College London (UCL) and Great Ormond Street Hospital (GOSH) in London, UK Martin Pule Autolus/UCL Claire Roddie UCL Sara Ghorashian GOSH Persis Amrolia GOSH Karl Peggs UCL Leila Mekkaoui Anne Kramer Gordon Cheung Autolus/UCL
Slide 13: Thank You
13For Investor communication only. Not for use in product promotion. Not for further distribution. THANK YOU We are truly grateful for all those who have helped us bring AUCATZYL to patients and supported our mission of developing life changing therapies for cancer and autoimmune disease
Slide 14: Q&A
Autolus.com Q&A Dr. Christian Itin, Chief Executive Officer Chris Vann, Chief Operating Officer Rob Dolski, Chief Financial Officer
Autolus Therapeutics — Corporate Update (November 2024) on 6ix