INCORPORATION BY REFERENCE
The information contained in this Report, including Exhibits 99.1 and 99.2 of this Report, shall be deemed to be incorporated by reference into the
registration statements on Form S-8 (File No. 333-226457), Form F-3 (File
No. 333-258556), Form F-3 (File No. 333-264304), and Form F-3 (File No. 333-264650) of Autolus Therapeutics plc (the “Company”) and any related prospectuses, as such registration statements and prospectuses may be amended from time to time, and to be a part thereof
from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently furnished.
INFORMATION
CONTAINED IN THIS REPORT ON FORM 6-K
Taxation Update
On December 8, 2022, the Company filed with the SEC a preliminary prospectus supplement as part of a registration statement on Form F-3 (File No. 333-258556) (the “Preliminary Prospectus Supplement”). The Preliminary Prospectus Supplement contains an updated disclosure regarding material tax
consequences to U.S. and U.K. shareholders in the section titled “Taxation,” which is attached hereto as Exhibit 99.1 and incorporated herein by reference. The Company is filing the updated taxation disclosure for the purpose of
supplementing and updating the description of material tax consequences to U.S. and U.K. shareholders and contained in the Company’s prior public filings with the SEC, including those discussed under the heading “Item 10.E. Taxation”
in the Company’s Annual Report on Form 20-F for the year ended December 31, 2021 filed with the SEC on March 10, 2022. The updated disclosures are filed herewith as Exhibit 99.1 and are
incorporated herein by reference.
Business Update
In the Preliminary Prospectus Supplement, the Company updated its business information as follows:
Obe-cel (AUTO1) Phase 2 Clinical Trial in Adult ALL (FELIX Trial)
As previously announced in 2021, we initiated the Phase 2 portion of our pivotal FELIX clinical trial, or the FELIX trial, of obecabtagene
autoleucel, or obe-cel, in relapsed/refractory, or r/r, adult Acute Lymphoblastic Leukemia, or ALL. On December 8, 2022, we announced the FELIX trial has met its primary endpoint, based on a pre-planned interim analysis of 50 patients with
morphological disease, as verified by an independent data monitoring committee. The primary endpoint for the FELIX trial is the overall remission rate, or ORR, defined as the proportion of patients achieving a complete remission, or CR, and a
complete remission with incomplete blood count recovery, or CRi, as assessed by an independent response review committee.
Based on the
interim analysis of 50 patients, the data we have observed thus far from the FELIX trial continues to support the profile of obe-cel observed in our prior ALLCAR19 trial, and demonstrated an ORR of 70%. In addition, obe-cel showed comparable
expansion and initial persistence (median follow-up 6.4 months) to our prior observations in the ALLCAR19 study. Now, with a larger data set of an aggregate of 92 patients treated with obe-cel and evaluable for safety to date, we believe we
have observed a differentiated safety profile of obe-cel, with low rates of Grade 3 or higher cytokine release syndrome, or CRS, and immune effector cell-associated neurotoxicity syndrome, or ICANS. In the interim analysis, we observed that only 3%
of patients experienced Grade 3 or higher CRS, while 8% experienced Grade 3 or higher ICANS, and 23% of patients experienced ICANS of any grade. The trial has completed screening patients for entry into the morphological cohort as the
pre-specified goal of approximately 90 patient enrollments has been reached, and Autolus plans to present the results from the FELIX trial at a medical conference in mid-2023, with longer follow up planned to be reported at the end of 2023.
Announcement of Two Milestone Payments from Blackstone
Our collaboration partner Blackstone Life Sciences, or Blackstone, has committed to make two pre-agreed
milestone payments of $35 million to us, totaling an aggregate of $70 million (each, a “Blackstone Milestone” and together, the “Blackstone Milestones”). The Blackstone Milestones are expected to be paid before
December 31, 2022. The first Blackstone Milestone of $35 million is being paid earlier than anticipated as a result of the joint steering committee’s review of our interim analysis of the FELIX trial discussed above. The second
Blackstone Milestone of $35 million is a manufacturing milestone as a result of our completion of planned activities demonstrating the performance and qualifications of our obe-cel manufacturing process.
