Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced its operational and financial
results for the quarter ended June 30, 2021.
“We are very encouraged by the obe-cel data in
adult acute lymphoblastic leukemia (ALL) and in B-cell non-Hodgkins
Lymphoma (B-NHL) presented at the European Hematology Association
(EHA) Virtual Congress in June. In adult patients with ALL,
event-free survival stabilized at 50% with 12 months follow up and
was sustained at 24 months. These data indicate that obe-cel may be
the first stand-alone therapy in adult ALL with curative potential
in a last line setting. The FELIX trial is progressing well, and we
expect pivotal data during 2022,” said Dr. Christian Itin, chief
executive officer of Autolus. “Additional data were presented at
EHA for obe-cel in indolent B-NHL indicating a high level of
clinical activity combined with a well manageable safety profile.
Further data in patients with aggressive B-NHL and chronic
lymphocytic leukemia (CLL) are expected by the end of the
year.”
Key Pipeline Updates:
- Obe-cel in relapsed / refractory
(r/r) adult B-Acute Lymphocytic Leukemia (ALL).
- Data presented at EHA in June 2021
from the ALLCAR19 trial in r/r adult ALL patients demonstrated that
obe-cel was generally well tolerated, with no patients experiencing
Grade 3 or higher cytokine release syndrome (CRS). Three patients
(15%), all of whom had high leukemia burden (>50% blasts),
experienced Grade 3 immune effector cell-associated neurotoxicity
syndrome (ICANS) that resolved swiftly with steroids. Of the 20
patients treated with obe-cel, 17 (85%) achieved minimum residual
disease (MRD)-negative complete remission (CR) at one month. Most
notably, as of the data cutoff date of May 17, 2021, the durability
of remissions is encouraging. Across all treated patients, event
free survival (EFS) at twelve months and twenty-four months was
50.2% with median EFS not being reached.
- Obe-cel in other
relapsed/refractory B-NHL – ALLCAR19 extension (Cohort D)
- Data presented at EHA in June 2021
in r/r B-NHL (Follicular Lymphoma (FL) and Mantle Cell Lymphoma
(MCL)) patients demonstrated that, as of the data cut-off date
of May 17, 2021, 9 r/r B-NHL patients (7 FL, 2 MCL) infused
with obe-cel achieved a complete metabolic remission and, apart
from one, all evaluable patients remained in CR. Obe-cel has a
tolerable safety profile in adult patients with r/r FL and MCL,
despite high disease burden. Grade 1 CRS was reported in 4 patients
and Grade 2 CRS in 1 patient. No ICANS of any grade was observed in
the trial.
- Obe-cel in high grade B-NHL and CLL
– ALLCAR19 extension (Cohorts B & C)
- The ALLCAR extension trial also
involves two cohorts of patients with high grade B-NHL (DLBCL) and
CLL. These cohorts are progressing well and Autolus plans to
present updated data at the 63rd American Society of Hematology
(ASH) Meeting in December 2021.
- Autolus received preferred
regulatory access for obe-cel from UK Medicines and Healthcare
products Regulatory Agency (MHRA) and European Medicines Agency
(EMA):
- Autolus received an innovative
licensing and access pathway (ILAP) designation from the MHRA for
obe-cel being investigated in the ongoing FELIX trial in ALL.
- Autolus received PRIority MEdicines
(PRIME) designation from the EMA.
- These designations are designed to
accelerate the review of a promising therapy targeting an unmet
medical need. Data from the FELIX trial is expected in 2022, which,
if positive, could enable Autolus to file for accelerated
approval.
- AUTO4 in Peripheral T Cell Lymphoma
(PTCL).
- Autolus received ILAP designation
from the MHRA for AUTO4 being investigated in PTCL.
- AUTO4 Phase 1 clinical trial is
progressing through dose escalation and Autolus expects to provide
a next data update in the first half of 2022.
Operational Highlights:
- Post the period end, in July 2021,
Autolus announced an agreement with Moderna, Inc., a biotechnology
company pioneering messenger RNA (mRNA) therapeutics and vaccines,
granting Moderna an exclusive license to develop and commercialize
mRNA-based therapeutics incorporating Autolus’ proprietary binders
to up to four immuno-oncology targets. Under the terms of the
agreement, Autolus would be eligible to receive an upfront payment
for each target licensed by Moderna and development and commercial
milestone payments for each product successfully commercialized. In
addition, Autolus will be entitled to receive royalties on net
sales of all products commercialized under the agreement. The use
of the technology in Moderna’s mRNA platform underscores Autolus’
leadership in the development of innovative differentiated binder
and cell programming technologies.
- Post the period end, in July 2021,
Autolus announced the appointment of Edgar Braendle M.D., Ph.D., as
chief development officer. Dr Braendle is an experienced oncologist
who joined Autolus from Sumitomo Dainippon Pharma Oncology, where
he held the position of Chief Medical Officer and Global Head of
Development and was responsible for leading the global oncology
development programs of Sumitomo Dainippon. He is part of Autolus’
executive team and is leading the company's development
organization. In addition, Wolfram Brugger M.D., Ph.D. joined
Autolus as VP, Head of Clinical Development in June 2021. Wolfram
is a highly experienced hematologist, medical oncologist, and
internal medicine specialist with 21 years of academia and
hospital-based clinical physician experience in hematological
malignancies in Germany, including 15 years of leadership as Chief
Medical Director at the teaching hospital of Freiburg University.
Wolfram joined Autolus from MorphoSys, where he was Head of Global
Clinical Programs and oversaw the development of Monjuvi
(tafasitamab).
Key Upcoming Clinical
Milestones:
- Obe-cel updates from the ALLCAR19
extension trial in patients with r/r B-NHL and longer term follow
up of the fully enrolled r/r aALL cohort in H2 2021
- Obe-cel currently enrolling the
FELIX trial in r/r adult ALL patients with pivotal data expected in
2022
- Updates on the obe-cel Phase 1
trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022
- Updates on the AUTO1/22 CARPALL
extension trial in pediatric ALL in Q4 2021
- Updates on the AUTO4 Phase 1 trial
in TRBC1+ Peripheral TCL in H1 2022
- Phase 1 trials are expected to be
initiated in H2 2021 with AUTO8 in Multiple Myeloma
- Phase 1 trials are expected to be
initiated in H1 2022 with AUTO6NG in solid tumors and AUTO5 in
TRBC2+ Peripheral TCL
- First exploratory allogeneic
development candidate expected to enter the clinic in 2021
Financial Results for the Quarter Ended June 30,
2021
Cash at June 30,
2021, totaled $216.4 million, as compared to $239.0
million at March 31, 2020. During the three months ended
June 30, 2021, the company issued an aggregate of 2,069,466 ADSs
under its Sales Agreement with Jefferies for net proceeds, after
underwriting discounts and offering expenses, of $14.3 million.
Net total operating expenses for the three
months ended June 30, 2021 were $37.7 million, net of
grant income and license revenue of $1.6 million, as compared
to net operating expenses of $39.5 million, net of grant
income of $0.3 million, for the same period in 2020.
Research and development expenses increased to
$32.1 million for the three months ended June 30, 2021, from $31.3
million for the three months ended June 30, 2020. Cash costs, which
exclude depreciation and amortization as well as share-based
compensation, increased to $29.2 million from $26.5 million. The
increase in research and development cash costs of
$2.7 million consisted primarily of (i) an increase in
compensation and employment related costs of $0.7 million due to
severance payments related to the reduction in workforce that
started in the first quarter, and offset by a reduction in
employment costs due to a decrease in headcount, (ii) an increase
of $1.0 million in facilities costs related to the continued
scaling of manufacturing operations, (iii) an increase of $0.9
million related to purchased materials, (iv) an increase of $0.3
million related to cell logistics, and (v) an increase of $0.3
million related to IT infrastructure and support for information
systems related to the conduct of clinical trials and manufacturing
operations. This was offset by a decrease of $0.4 million in
clinical costs and $0.1 million of legal expenses.
Non-cash costs decreased to $2.9 million for the
three months ended June 30, 2021, from $4.8 million for the three
months ended June 30, 2020. The decrease is primarily related to
share-based compensation expense included in research and
development expenses, which decreased by $2.8 million as a result
of the lower fair value of stock options recognized during the
period, combined with forfeitures of incentive share options and
unvested RSUs related to employees affected by the reduction in
workforce. This was offset by an increase in depreciation of $0.9
million.General and administrative expenses decreased to $7.2
million for the three months ended June 30, 2021, from $8.5 million
for the three months ended June 30, 2020. Cash costs, which exclude
depreciation expense as well as share-based expense compensation
decreased to $6.6 million from $6.7 million. The decrease in
general and administrative cash costs of $0.1 million related to
decreases of (i) $0.3 million related to the reduction in workforce
that began to take place in the first quarter, which reduced the
headcount, and (ii) $0.3 million of expenses related to
preparations for becoming a commercial stage company. These
decreases were offset by an increase of $0.5 million in legal fees
and directors & officers liability insurance premiums.
Non-cash costs decreased to $0.6 million for the
three months ended June 30, 2021, from $1.8 million for the three
months ended June 30, 2020. The decrease is mainly attributed to
share-based compensation expense as a result of the lower fair
value of stock options recognized during the period, combined with
forfeitures of incentive share options and unvested RSUs related to
employees affected by the reduction in workforce.
Other income/(expense) decreased by $2.3 million
for the three months ended June 30, 2021, from other income of $0.5
million for the three months ended June 30, 2020, to an other
expense of $1.8 million. The decrease was primarily due to the
weakening of the U.S. dollar exchange rate relative to the pound
sterling during the three months ended June 30, 2021 as compared to
the three months ended June 30, 2020.
Income tax benefit decreased to $6.4 million for
the three months ended June 30, 2021 from $7.0 million for the
three months ended June 30, 2020 due to a decrease in the research
and development expenditures which were qualifying for the quarter.
As research and development credits fell at a faster rate than our
net loss before income tax, this led to a lower effective tax rate.
Research and development credits are obtained at a maximum rate of
33.35% of our qualifying research and development expenses, and the
increase in the net credit was primarily attributable to an
increase in our eligible research and development expenses.
Net loss attributable to ordinary shareholders
was $33.2 million for the three months ended June
30, 2021, compared to $32.1 million for the same period
in 2020. The basic and diluted net loss per ordinary share for the
three months ended June 30, 2021 totaled $(0.47) compared
to a basic and diluted net loss per ordinary share
of $(0.62) for the three months ended June 30,
2020.
Autolus estimates that its current cash on
hand will provide the Company with a cash runway into H1 2023.
Conference Call
Management will host a conference call and
webcast today at 8:30 am ET/1:30 pm BST to discuss the
company’s financial results and provide a general business update.
To listen to the webcast and view the accompanying slide
presentation, please go to the events section of Autolus’
website.
The call may also be accessed by dialing (866)
679-5407 for U.S. and Canada callers or (409) 217-8320 for
international callers. Please reference conference ID 9757293.
After the conference call, a replay will be available for one week.
To access the replay, please dial (855) 859-2056 for U.S. and
Canada callers or (404) 537-3406 for international callers. Please
reference conference ID 9757293.
About Autolus Therapeutics
plcAutolus is a clinical-stage biopharmaceutical company
developing next-generation, programmed T cell therapies for the
treatment of cancer. Using a broad suite of proprietary and modular
T cell programming technologies, the company is engineering
precisely targeted, controlled and highly active T cell therapies
that are designed to better recognize cancer cells, break down
their defense mechanisms and eliminate these cells. Autolus has a
pipeline of product candidates in development for the treatment of
hematological malignancies and solid tumors. For more information,
please visit www.autolus.com.
About
Obe-cel (AUTO1)Obe-cel is a CD19 CAR T cell
investigational therapy designed to overcome the limitations in
clinical activity and safety compared to current CD19 CAR T cell
therapies. Designed to have a fast target binding off-rate to
minimize excessive activation of the programmed T cells, obe-cel
may reduce toxicity and be less prone to T cell exhaustion, which
could enhance persistence and improve the ability of the programmed
T cells to engage in serial killing of target cancer cells. In
collaboration with our academic partner, UCL, obe-cel is currently
being evaluated in a Phase 1 clinical trial in adult ALL and B-NHL.
The company has also progressed obe-cel to the FELIX trial, a
potential pivotal trial.
About Obe-cel FELIX trialThe
FELIX clinical trial is enrolling adult patients with relapsed /
refractory ALL. The trial has a short Phase 1b component prior to
proceeding to a single arm Phase 2 clinical trial. The primary
endpoint is overall response rate, and the key secondary endpoints
include duration of response, MRD negative CR rate and safety. The
trial will enroll approximately 100 patients across 30 of the
leading academic and non-academic centers in the United
States, United Kingdom and Europe.
About AUTO4AUTO4 is a
programmed T cell product candidate in clinical development for T
cell lymphoma, a setting where there are currently no approved
programmed T cell therapies. AUTO4 is specifically designed to
target TRBC1 derived cancers, which account for approximately 40%
of T cell lymphomas, and is a complement to the AUTO5 T cell
product candidate, which is in pre-clinical development.
Forward-Looking StatementsThis
press release contains 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," "will," "could," "expects,"
"plans," "anticipates," and "believes." These statements include,
but are not limited to, statements regarding the future clinical
development, efficacy, safety, and therapeutic potential of
obe-cel, including progress, expectations as to the reporting of
data, conduct and timing and potential future clinical activity and
milestones, expectations regarding the initiation, design and
reporting of data from clinical trials. Any forward-looking
statements are based on management's current views and assumptions
and involve risks and uncertainties that could cause actual
results, performance, or events to differ materially from those
expressed or implied in such statements. These risks and
uncertainties include, but are not limited to, the risks that
Autolus’ preclinical or clinical programs do not advance or result
in approved products on a timely or cost effective basis or at all;
the results of early clinical trials are not always being
predictive of future results; the cost, timing and results of
clinical trials; that many product candidates do not become
approved drugs on a timely or cost effective basis or at all; the
ability to enroll patients in clinical trials; possible safety and
efficacy concerns; and the impact of the ongoing COVID-19 pandemic
on Autolus’ business. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause Autolus’ actual results to differ from those contained in the
forward-looking statements, see the section titled "Risk Factors"
in Autolus' Annual Report on Form 20-F filed with the Securities
and Exchange Commission on March 4, 2021, as well as discussions of
potential risks, uncertainties, and other important factors in
Autolus' subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and Autolus undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events, or otherwise, except as required by
law.
Contact:
Lucinda Crabtree, PhDVice President, Business
Strategy and Planning+44 (0) 7587 372
619l.crabtree@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
Financial Results for the three months
ended June 30, 2021
Condensed Consolidated Statements of
Operations and Comprehensive Loss (Unaudited)(In
thousands, except share and per share amounts)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Grant income |
$ |
138 |
|
|
$ |
293 |
|
|
$ |
407 |
|
|
$ |
631 |
|
License revenue |
1,507 |
|
|
— |
|
|
1,507 |
|
|
— |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
(32,131 |
) |
|
(31,328 |
) |
|
(62,862 |
) |
|
(62,615 |
) |
General and
administrative |
(7,237 |
) |
|
(8,509 |
) |
|
(15,975 |
) |
|
(16,123 |
) |
Loss on disposal of leasehold
improvements |
— |
|
|
— |
|
|
(672 |
) |
|
— |
|
Total operating
expenses, net |
(37,723 |
) |
|
(39,544 |
) |
|
(77,595 |
) |
|
(78,107 |
) |
Other (expense)
income: |
|
|
|
|
|
|
|
Interest income (expense) |
42 |
|
|
(47 |
) |
|
85 |
|
|
463 |
|
Other (expense) income |
(1,849 |
) |
|
525 |
|
|
(1,011 |
) |
|
5,009 |
|
Total other (expense)
income, net |
(1,807 |
) |
|
478 |
|
|
(926 |
) |
|
5,472 |
|
Net loss before income
tax |
(39,530 |
) |
|
(39,066 |
) |
|
(78,521 |
) |
|
(72,635 |
) |
Income tax benefit |
6,357 |
|
|
7,021 |
|
|
12,081 |
|
|
10,717 |
|
Net loss attributable
to ordinary shareholders |
(33,173 |
) |
|
(32,045 |
) |
|
(66,440 |
) |
|
(61,918 |
) |
Other comprehensive
income (loss): |
|
|
|
|
|
|
|
Foreign currency exchange
translation adjustment |
1,542 |
|
|
(1,819 |
) |
|
2,815 |
|
|
(19,520 |
) |
Total comprehensive
loss |
(31,631 |
) |
|
(33,864 |
) |
|
(63,625 |
) |
|
(81,438 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per
ordinary share |
$ |
(0.47 |
) |
|
$ |
(0.62 |
) |
|
$ |
(1.00 |
) |
|
$ |
(1.22 |
) |
Weighted-average basic and
diluted ordinary shares |
70,832,077 |
|
|
52,041,340 |
|
|
66,663,003 |
|
|
50,956,566 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited)(In thousands, except share and per share
amounts)
|
June 30,2021 |
|
December 31,2020 |
Assets |
|
|
|
Current
assets: |
|
|
|
Cash |
$ |
216,352 |
|
|
$ |
153,299 |
|
Restricted cash |
210 |
|
|
786 |
|
Prepaid expenses and other assets, current |
52,944 |
|
|
42,899 |
|
Total current assets |
269,506 |
|
|
196,984 |
|
Non-current
assets: |
|
|
|
Property and equipment,
net |
34,190 |
|
|
38,046 |
|
Right of use assets, net |
20,598 |
|
|
51,637 |
|
Long-term deposits |
1,846 |
|
|
2,625 |
|
Prepaid expenses and other
assets, non-current |
2,760 |
|
|
3,033 |
|
Deferred tax asset |
1,643 |
|
|
1,754 |
|
Intangible assets, net |
112 |
|
|
158 |
|
Total
assets |
$ |
330,655 |
|
|
$ |
294,237 |
|
Liabilities and
shareholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
1,119 |
|
|
2,263 |
|
Accrued expenses and other liabilities |
23,173 |
|
|
27,781 |
|
Lease liabilities |
3,895 |
|
|
3,590 |
|
Total current liabilities |
28,187 |
|
|
33,634 |
|
Non-current
liabilities: |
|
|
|
Lease liabilities |
18,786 |
|
|
50,571 |
|
Total
liabilities |
46,973 |
|
|
84,205 |
|
Shareholders'
equity: |
|
|
|
Ordinary shares, $0.000042 par
value; 200,000,000 shares authorized as of June 30, 2021 and
December 31, 2020; 72,742,582 and 52,346,231, shares issued and
outstanding at June 30, 2021 and December 31, 2020,
respectively |
3 |
|
|
3 |
|
Deferred shares, £0.00001 par
value; 34,425 shares authorized, issued and outstanding at June 30,
2021 and December 31, 2020 |
— |
|
|
— |
|
Deferred B shares, £0.00099
par value; 88,893,548 shares authorized, issued and outstanding at
June 30, 2021 and December 31, 2020 |
118 |
|
|
118 |
|
Deferred C shares, £0.000008
par value; 1 share authorized, issued and outstanding at June 30,
2021 and December 31, 2020 |
— |
|
|
— |
|
Additional paid-in
capital |
732,290 |
|
|
595,016 |
|
Accumulated other
comprehensive loss |
(3,046 |
) |
|
(5,861 |
) |
Accumulated deficit |
(445,683 |
) |
|
(379,244 |
) |
Total shareholders'
equity |
283,682 |
|
|
210,032 |
|
Total liabilities and
shareholders' equity |
$ |
330,655 |
|
|
$ |
294,237 |
|
|
|
|
|
|
|
|
|
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