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Report is filed, to the extent not superseded by documents or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.