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 March 31, 2021.
“We have had a productive first quarter and are
on track for multiple clinical read outs during the remainder of
this year and into 2022,” said Dr. Christian Itin, chief
executive officer of Autolus. “We are excited by the unique
characteristics of AUTO1 and encouraged by what we believe is the
significant clinical benefit AUTO1 can offer for patients with
relapsed/refractory (r/r) Acute Lymphoblastic Leukemia (ALL). AUTO1
is being evaluated in the P1b/2 FELIX study in adult ALL patients
with data expected in 2022. In addition, AUTO1 is being explored in
patients with B-NHL and in primary CNS lymphoma, and we are also
evaluating AUTO1/22 in pediatric ALL patients. Finally, several
programs are expected to enter the clinic in 2021, including our
next generation program AUTO6NG in Neuroblastoma, setting up
clinical news flow for 2022 and beyond.”
Key Pipeline Updates:
- AUTO1 in relapsed / refractory
(r/r) adult B-Acute Lymphocytic Leukemia (ALL).
- The International Nonproprietary Name (INN) name (obecabtagene
autoleucel, or obe-cel) was published.
- Autolus received PRIority MEdicines (PRIME) designation from
the European Medicines Agency (EMA) for AUTO1 being investigated in
the ongoing FELIX Phase 1b/2 clinical trial in ALL. This
designation is designed to accelerate the review of a
promising therapy targeting unmet medical need. Data from this
potentially pivotal program is expected in 2022, which, if
positive, could enable us to file for accelerated
approval.
- AUTO1 in indolent B cell
Non-Hodgkin Lymphoma (NHL) (cohort 1), high grade B-NHL (cohort 2)
and chronic lymphocytic leukemia (CLL) (cohort 3).
- The trial is progressing well and Autolus will present updated
data at the European Hematology Association (EHA) Congress in June
2021.
- AUTO4 in Peripheral T Cell Lymphoma
(PTCL).
- Autolus received innovative licensing and access pathway (ILAP)
designation from the UK Medicines and Healthcare products
Regulatory Agency (MHRA) for AUTO4, which is currently being
studied in a Phase 1 clinical trial in PTCL. As with the AUTO1
PRIME designation, this is intended to accelerate the review of a
promising therapy targeting unmet medical need. Autolus expects to
provide a next data update in the second half of
2021.
- Partnerable Coronavirus Disease (COVID-19) Project. Autolus’
research team has developed a potentially universal SARS-CoV2 decoy
receptor with virus neutralizing activity against SARS-CoV2 and its
variants and also active against SARS-CoV1.
Operational Highlights:
- In the first quarter of 2021,
Autolus sold an aggregate of 1,718,506 ADSs in offerings under its
Open Market Sales AgreementSM with Jefferies LLC, for net proceeds
of approximately $15.3 million.
- Successful closing of a follow-on
public offering raising net proceeds to Autolus, after underwriting
discounts and offering expenses, of $106.9 million in February
2021, taking total net cash raised in Q1 2021 to approximately
$122.2 million.
- As announced in Autolus’ business
update in January 2021, Autolus has realigned its research and
development resources to prioritize the AUTO1 program and plans to
partner the AUTO3 program before progressing it into the next phase
of development.
- Also announced in Autolus’ business
update in January 2021, the company adjusted its workforce and
infrastructure footprint, including an overall reduction in
headcount of approximately 20%. Autolus expects to realize cash
savings, on an annualized basis, of approximately $15 million with
the operational changes fully implemented.
- In March 2021, Autolus announced it
was establishing global commercial launch manufacturing capacity in
the UK, enabling the company to leverage the expertise and skill
base of its U.K. employees. As a result, future commercial supply
will be provided by a combination of the existing clinical trial
manufacturing facility at The Cell and Gene Therapy Catapult (CGTC)
facility and a new Autolus facility. This revised strategy aims to
deliver a less capital-intensive commercial manufacturing
infrastructure at a lower cost base. In conjunction, Autolus
announced the termination of its lease for the manufacturing and
office facility in, Rockville, MD, resulting in a cash payment to
Autolus of $2.0 million.
- Dr Muhammad Al-Hajj, Senior Vice
President, Translational Sciences, left the Company in April 2021.
The company would like to thank Dr. Al-Hajj for his contributions
and wishes him well in the future.
- Post the period end, Dr Martin
Murphy was appointed non-executive chairman of Autolus.
Key Upcoming Clinical
Milestones:
- AUTO1 updates in 2021 on ALLCAR19
in patients with r/r B-NHL and longer term follow up of the fully
enrolled r/r aALL cohort.
- AUTO1 - Currently enrolling a
potentially pivotal Phase 1b/2 clinical trial (FELIX) in r/r adult
ALL patients with data expected in 2022.
- Updates on Phase 1 programs
AUTO1/22 in pediatric ALL, as well as AUTO4 in TRBC1+ Peripheral
TCL, in 2021.
- Phase 1 trials are expected to be
initiated in 2021 with AUTO1 in Primary CNS Lymphoma, AUTO5 in
TRBC2+ Peripheral TCL, AUTO6NG in Neuroblastoma, and AUTO8 in
Multiple Myeloma.
- First exploratory allogeneic
program expected to enter the clinic in 2021.
Financial Results for the Quarter Ended March 31,
2021
Cash at March 31,
2021 totaled $239.0 million, as compared to $153.3
million at December 31, 2020. In January
2021, the company sold 1.7 million ADSs under its Open
Market Sales AgreementSM with Jefferies LLC as sales agent,
resulting in net proceeds of $15.3 million and in February
2021, the company sold 16.4 million ADSs representing 16.4 million
ordinary shares in a follow-on, public offering, including the
exercise in full by the underwriters of their option to purchase an
additional 2.1 million ADSs, at a public offering price of $7.00
per ADS, yielding net proceeds of $106.9 million.
Net total operating expenses for the three
months ended March 31, 2021 were $39.9 million, net of
grant income of $0.3 million, as compared to net operating
expenses of $38.6 million, net of grant income of $0.3
million, for the same period in 2020.
Research and development expenses decreased to
$30.7 million for the three months ended March 31, 2021 from $31.3
million for the three months ended March 31, 2020. Cash costs,
which exclude depreciation and amortization as well as share-based
compensation, increased to $30.7 million from $25.6 million. The
increase in research and development cash costs of
$5.1 million consisted primarily of (i) an increase in
compensation and employment related costs, net of lower travel
costs (as a result of restricted travel due to the ongoing COVID-19
pandemic), of $3.5 million due to a combination of an increase
in employee headcount to support the advancement of our product
candidates in clinical development and severance payments related
to the reduction in workforce that began to take place during the
quarter, (ii) an increase of $2.2 million in facilities costs
related to the continued scaling of manufacturing operations, and
(iii) an increase of $0.4 million related to cell logistics,
which is offset by decreases in purchased materials in the amount
of $0.6 million and project expenses of $0.4 million.
Non-cash R&D costs decreased to $36,000 for
the three months ended March 31, 2021 from $5.7 million for the
three months ended March 31, 2020. The decrease is primarily
related to share-based compensation expense included in research
and development expenses, which decreased by $6.2 million as a
result of forfeitures of incentive share options related to
employees affected by the reduction in workforce. This was offset
by an increase in depreciation of $0.5 million.
General and administrative expenses increased to
$8.7 million for the three months ended March 31, 2021 from $7.6
million for the three months ended March 31, 2020. Cash costs,
which exclude depreciation expense as well as share-based expense
compensation increased to $7.6 million from $5.9 million. The
increase in general and administrative cash costs of $1.7 million
related to an increase of (i) $0.4 million in facilities cost, (ii)
an increase of $0.6 million in legal fees and audit fees, (iii) an
increase of $0.3 million of expenses related to preparations for
becoming a commercial stage company, and (iv) an increase of
$0.4 million in compensation and employment related costs due to an
increase in headcount, and severance payments related to the
reduction in workforce that began to take place during the
quarter.
Non-cash general and administrative costs
decreased to $1.1 million for the three months ended March 31, 2021
from $1.7 million for the three months ended March 31, 2020. The
decrease is attributed to share-based compensation expense as a
result of the lower fair value of stock options recognized during
the period. Loss on disposal of leasehold improvements of $0.7
million related to the leasehold improvements no longer being
utilized in the facility in White City, London.
Interest income decreased by $0.5 million for
three months ended March 31, 2021 due to lower interest rates for
cash held on deposit. Other income decreased by $3.7 million for
the three months ended March 31, 2021 from other income of $4.5
million for the three months ended March 31, 2020 to $0.8 million.
There was a decrease of $5.6 million primarily due to the weakening
of the U.S. dollar exchange rate relative to the pound sterling
during the three months ended March 31, 2021 as compared to the
three months ended March 31, 2020, offset by gains on lease
terminations of $2.0 million, net of the related expenses.
Income tax benefit increased to $5.7 million for
the three months ended March 31, 2021 from $3.7 million for the
three months ended March 31, 2020 due to increased research and
development credits. As research and development credits grew at a
faster rate than our net loss before income tax, this led to a
higher 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 $33.3 million for the three months ended March
31, 2021, compared to $29.9 million for the same period
in 2020. The basic and diluted net loss per ordinary share for the
three months ended March 31,
2021 totaled $(0.53) compared to a basic and diluted
net loss per ordinary share of $(0.60) for the three
months ended March 31, 2020.
Autolus estimates that its current cash on
hand will provide the Company with a cash runway into the first
half of 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 7756178.
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 7756178.
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 AUTO1 AUTO1 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, AUTO1 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,
AUTO1 is currently being evaluated in a Phase 1 clinical trial in
adult ALL and B-NHL. The company has also progressed AUTO1 to the
FELIX study, a potential pivotal study.
About AUTO1 FELIX
study The FELIX Phase 1b/2 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 AUTO3AUTO3 is a
programmed T cell investigational therapy containing two
independent chimeric antigen receptors targeting CD19 and CD22 that
have each been independently optimized for single target activity.
AUTO3 is designed to combine a favorable safety profile with a
reduced risk of relapse due to single antigen loss. AUTO3 is has
been tested in diffuse large B cell lymphoma in the ALEXANDER
clinical trial demonstrating a high level of clinical activity with
a favorable safety profile. The ALEXANDER study included a
20-patient out-patient cohort and demonstrated feasibility of AUTO3
delivery in an outpatient setting.
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 Autolus’ realigned
business strategy, including specifically on the development of the
AUTO1 program; the future clinical development, efficacy, safety
and therapeutic potential of its product candidates, 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; the efficacy, safety and therapeutic
potential of AUTO3 and ability for Autolus to obtain a partner for
next stages of clinical development; Autolus’ needs for additional
funding and ability to raise additional capital; Autolus’ ability
to attract and retain qualified employees and key personnel; the
restructuring program and Autolus’ expected cash savings as a
result of the restructuring program and operational changes; and
Autolus’ expected cash runway. 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:
Julia Wilson+44 (0) 7818
430877 j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
Financial Results for the three months ended March 31,
2021
Condensed Consolidated Statements of
Operations and Comprehensive Loss (Unaudited)(In
thousands, except share and per share amounts)
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
Grant income |
$ |
269 |
|
|
|
$ |
338 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
Research and development |
(30,731 |
) |
|
|
(31,287 |
) |
|
General and
administrative |
(8,738 |
) |
|
|
(7,614 |
) |
|
Loss on disposal of leasehold
improvements |
(672 |
) |
|
|
— |
|
|
Total operating
expenses, net |
(39,872 |
) |
|
|
(38,563 |
) |
|
Other income
(expense): |
|
|
|
Interest income |
44 |
|
|
|
510 |
|
|
Other income (expense) |
838 |
|
|
|
4,484 |
|
|
Total other income,
net |
882 |
|
|
|
4,994 |
|
|
Net loss before income
tax |
(38,990 |
) |
|
|
(33,569 |
) |
|
Income tax benefit |
5,724 |
|
|
|
3,696 |
|
|
Net loss attributable
to ordinary shareholders |
(33,266 |
) |
|
|
(29,873 |
) |
|
Other comprehensive
income (loss): |
|
|
|
Foreign currency exchange
translation adjustment |
1,273 |
|
|
|
(17,701 |
) |
|
Total comprehensive
loss |
$ |
(31,993 |
) |
|
|
$ |
(47,574 |
) |
|
|
|
|
|
Basic and diluted net loss per
ordinary share |
$ |
(0.53 |
) |
|
|
$ |
(0.60 |
) |
|
Weighted-average basic and
diluted ordinary shares |
62,447,606 |
|
|
|
49,859,739 |
|
|
Condensed Consolidated Balance Sheets
(Unaudited)(In thousands, except share and per share
amounts)
|
|
|
|
|
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash |
$ |
239,012 |
|
|
|
$ |
153,299 |
|
|
Restricted cash |
786 |
|
|
|
786 |
|
|
Prepaid expenses and other assets, current |
48,262 |
|
|
|
42,899 |
|
|
Total current assets |
288,060 |
|
|
|
196,984 |
|
|
Non-current
assets: |
|
|
|
Property and equipment,
net |
33,543 |
|
|
|
38,046 |
|
|
Right of use assets, net |
21,199 |
|
|
|
51,637 |
|
|
Long-term deposits |
1,836 |
|
|
|
2,625 |
|
|
Prepaid expenses and other
assets, non-current |
2,939 |
|
|
|
3,033 |
|
|
Deferred tax asset |
2,034 |
|
|
|
1,754 |
|
|
Intangible assets, net |
135 |
|
|
|
158 |
|
|
Total
assets |
$ |
349,746 |
|
|
|
$ |
294,237 |
|
|
Liabilities and
shareholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
2,259 |
|
|
|
2,263 |
|
|
Accrued expenses and other liabilities |
24,683 |
|
|
|
27,781 |
|
|
Lease liabilities |
3,657 |
|
|
|
3,590 |
|
|
Total current liabilities |
30,599 |
|
|
|
33,634 |
|
|
Non-current
liabilities: |
|
|
|
Lease liabilities |
19,580 |
|
|
|
50,571 |
|
|
Total
liabilities |
50,179 |
|
|
|
84,205 |
|
|
|
|
|
|
Shareholders'
equity: |
|
|
|
Ordinary shares, $0.000042 par value; 200,000,000 shares
authorized as of March 31, 2021 and December 31, 2020; 70,515,354
and 52,346,231, shares issued and outstanding at March 31, 2021 and
December 31, 2020, respectively |
3 |
|
|
|
3 |
|
|
Deferred shares, £0.00001 par
value; 34,425 shares authorized, issued and outstanding at March
31, 2021 and December 31, 2020 |
— |
|
|
|
— |
|
|
Deferred B shares, £0.00099
par value; 88,893,548 shares authorized, issued and outstanding at
March 31, 2021 and December 31, 2020 |
118 |
|
|
|
118 |
|
|
Deferred C shares, £0.000008
par value; 1 share authorized, issued and outstanding at March 31,
2021 and December 31, 2020 |
— |
|
|
|
— |
|
|
Additional paid-in
capital |
716,544 |
|
|
|
595,016 |
|
|
Accumulated other
comprehensive loss |
(4,588 |
) |
|
|
(5,861 |
) |
|
Accumulated deficit |
(412,510 |
) |
|
|
(379,244 |
) |
|
Total shareholders'
equity |
299,567 |
|
|
|
210,032 |
|
|
Total liabilities and
shareholders' equity |
$ |
349,746 |
|
|
|
$ |
294,237 |
|
|
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