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 third quarter ended September 30, 2020.
“We have made steady progress in the third
quarter and continued to enroll in our AUTO3 ALEXANDER outpatient
cohort, as well as our AUTO1 program as planned. For the fourth
quarter and into the winter months we will continue to monitor the
COVID-19 situation and adjust our trial conduct accordingly,” said
Dr. Christian Itin, chairman and chief executive officer of
Autolus. “At ESMO we presented data from our recommended Phase 2
dose cohort from the ALEXANDER trial of AUTO3, showing a high level
of complete remissions and a well tolerated safety profile. We look
forward to presenting an update from the study at the ASH meeting
in December, along with data from our AUTO1 ALLCAR study in adult
ALL.”
Pipeline Updates:
- Data presented at the European Society for Medical Oncology
(ESMO) Virtual Congress 2020 from our recommended Phase 2 dose
cohort from the ALEXANDER trial of AUTO3, a CD19 and CD22 dual
targeting CAR T product candidate in relapsed/refractory
diffuse large B cell lymphoma (DLBCL).
- Data on both AUTO1 and AUTO3 will be presented in oral
presentations at the American Society of Hematology (ASH) in
December 2020° AUTO1 in adult Acute Lymphoblastic Leukemia
(ALL) - longer term follow up° AUTO3 in DLBCL - updated
data and longer term follow up from ALEXANDER study.
- Plans to progress the solid tumor programs, AUTO6NG in GD2
positive tumors and AUTO7 in prostate cancer, into the clinic in
2021.
Key Upcoming Clinical
Milestones:
- Clinical updates for AUTO1 in
adult ALL (ALLCAR study) at ASH in December 2020.
- Clinical update for AUTO3 in DLBCL
(ALEXANDER study) at ASH.
- Initiation of Phase 1 study for
AUTO1/22 in pediatric ALL in Q4 2020.
- Phase 1 interim data for AUTO4 in T
cell lymphoma in 2021.
- Initiation of Phase 1 studies for
AUTO6NG and AUTO7 in solid tumors in 2021.
- First exploratory allogeneic
program expected to enter the clinic in Q1 2021.
Financial results for third quarter
2020
Cash and equivalents at September 30,
2020 totaled $177.7 million, compared with $212.0
million at June 30, 2020.
Net total operating expenses for the three
months ended September 30, 2020 were $42.7 million,
net of grant income of $0.4 million and license revenue of
$0.2 million, as compared to net operating expenses of $35.6
million, net of grant income of $0.3 million, for the same
period in 2019.
Research and development expenses increased to
$33.5 million for the three months ended September 30, 2020 from
$27.3 million for the three months ended September 30, 2019. Cash
costs, which exclude depreciation and amortization as well as
share-based compensation, increased to $30.0 million from $21.6
million. The increase in research and development cash costs of
$8.4 million consisted primarily of (i) an increase in
compensation and employment related costs, net of lower travel
costs as a result of the ongoing pandemic, of $1.5 million due
to an increase in employee headcount to support the advancement of
our product candidates in clinical development, (ii) an increase of
$3.6 million in project expenses as a consequence of the
advancement of our clinical portfolio which includes research and
process development and manufacturing activities necessary to
prepare, activate, and monitor clinical trial programs, (iii) an
increase of $2.1 million in facilities costs related to the
commencement of a lease for a manufacturing facility and the
continued scaling of manufacturing operations, (iv) an increase of
$1.4 million in IT infrastructure and support for information
systems related to the conduct of clinical trials, (v) an increase
of $0.8 million related to cell logistics and (vi) an increase of
$0.4 million in legal and professional fees, which is offset by
decreases in materials purchases of $1.3 million.
Non-cash costs decreased to $3.5 million for the
three months ended September 30, 2020 from $5.7 million for the
three months ended September 30, 2019. The decrease is primarily
related to share-based compensation expense included in research
and development expenses, which decreased by $2.5 million as a
result of a lower fair value of stock options recognized in the
period, offset by a $0.3 million increase in depreciation.
General and administrative expenses increased to
$9.8 million for the three months ended September 30, 2020 from
$8.6 million for the three months ended September 30, 2019. Cash
costs, which exclude depreciation expense as well as share-based
expense compensation, increased to $7.7 million from $5.6 million.
There was an increase of (i) $1.0 million in commercial activities,
(ii) an increase of $0.7 million in patent legal fees, audit fees,
and costs incurred as a result of being a public company, and (iii)
an increase of $0.3 million in compensation and employment related
costs due to an increase in headcount, net of lower travel
costs.
Non-cash costs decreased to $2.1 million for the
three months ended September 30, 2020 from $3.0 million for the
three months ended September 30, 2019. The decrease is attributed
to share-based compensation expense as a result of the lower fair
value of stock options recognized during the period.
Interest income decreased by $0.5 million for
three months ended September 30, 2020 due to lower interest rates
for cash held on deposit.
Other (expense)/ income decreased by $5.8
million for the three months ended September 30, 2020 from other
income of $3.3 million for the three months ended September 30,
2019 to other expense of $2.5 million primarily due to a decrease
of $7.1 million with regard to weakening of the U.S. dollar
exchange rate relative to the pound sterling during the three
months ended September 30, 2020, as compared to the three months
ended September 30, 2019, offset by lease termination gains of $1.3
million.
Income tax benefit increased to $7.9 million for
the three months ended September 30, 2020 from $4.6 million for the
three months ended September 30, 2019 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 $37.3 million for the three months
ended September 30, 2020, compared to $27.2
million for the same period in 2019. The basic and diluted net
loss per ordinary share for the three months ended September
30, 2020 totaled $(0.72), compared to a basic and diluted
net loss per ordinary share of $(0.61) for the three
months ended September 30, 2019.
The Company anticipates that cash on hand is
sufficient to fund operations into 2022.
Conference Call and Presentation
Information
Management will host a conference call and
webcast at 8:30 am ET/1:30 pm GMT 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: https://www.autolus.com/investor-relations/news-and-events/events.
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 5562455.
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 5562455.
About Autolus Therapeutics
plc
Autolus 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.
Forward-Looking Statements
This 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 efficacy, safety and therapeutic potential of AUTO3
and the future clinical development of AUTO3 including progress,
expectations as to the reporting of data, conduct and timing. 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 3, 2020, as amended, 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 the company 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, Investor Relations and Corporate
Communications+44 (0) 7587 372
619 l.crabtree@autolus.comJulia Wilson+44 (0) 7818
430877j.wilson@autolus.comSusan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
Autolus Therapeutics PLC
Condensed Consolidated Statements of
Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share
amounts)
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Grant income |
$ |
438 |
|
|
$ |
297 |
|
|
$ |
1,069 |
|
|
$ |
2,599 |
|
License revenue |
242 |
|
|
— |
|
|
242 |
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
(33,545 |
) |
|
(27,310 |
) |
|
(96,160 |
) |
|
(76,050 |
) |
General and administrative |
(9,843 |
) |
|
(8,605 |
) |
|
(25,966 |
) |
|
(29,531 |
) |
Total operating expenses, net |
(42,708 |
) |
|
(35,618 |
) |
|
(120,815 |
) |
|
(102,982 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
37 |
|
|
509 |
|
|
500 |
|
|
2,124 |
|
Other (expense) income |
(2,509 |
) |
|
3,263 |
|
|
2,500 |
|
|
6,659 |
|
Total other (expense) income, net |
(2,472 |
) |
|
3,772 |
|
|
3,000 |
|
|
8,783 |
|
Net loss before income tax |
(45,180 |
) |
|
(31,846 |
) |
|
(117,815 |
) |
|
(94,199 |
) |
Income tax benefit |
7,865 |
|
|
4,598 |
|
|
18,582 |
|
|
11,294 |
|
Net loss attributable to ordinary
shareholders |
(37,315 |
) |
|
(27,248 |
) |
|
(99,233 |
) |
|
(82,905 |
) |
Other comprehensive (loss) income: |
|
|
|
|
|
|
|
Foreign currency exchange translation adjustment |
10,915 |
|
|
(9,044 |
) |
|
(8,605 |
) |
|
(12,865 |
) |
Total comprehensive loss |
$ |
(26,400 |
) |
|
$ |
(36,292 |
) |
|
$ |
(107,838 |
) |
|
(95,770 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per ordinary share |
$ |
(0.72 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.93 |
) |
|
$ |
(1.95 |
) |
Weighted-average basic and diluted ordinary shares |
52,093,826 |
|
|
44,505,383 |
|
|
51,339,662 |
|
|
42,547,755 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share and per share
amounts)
|
September 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
177,695 |
|
|
$ |
210,643 |
|
Restricted cash |
786 |
|
|
787 |
|
Prepaid expenses and other assets, current |
50,388 |
|
|
37,826 |
|
Total current assets |
228,869 |
|
|
249,256 |
|
Non-current assets: |
|
|
|
Property and equipment, net |
32,755 |
|
|
28,164 |
|
Right of use assets, net |
49,535 |
|
|
23,409 |
|
Long-term deposits |
2,446 |
|
|
2,040 |
|
Prepaid expenses and other assets, non-current |
2,890 |
|
|
— |
|
Deferred tax asset |
410 |
|
|
410 |
|
Intangible assets, net |
172 |
|
|
254 |
|
Total assets |
$ |
317,077 |
|
|
$ |
303,533 |
|
Liabilities and shareholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
1,997 |
|
|
1,075 |
|
Accrued expenses and other liabilities |
25,400 |
|
|
21,398 |
|
Lease liabilities |
3,413 |
|
|
2,511 |
|
Total current liabilities |
30,810 |
|
|
24,984 |
|
Non-current liabilities: |
|
|
|
Lease liabilities |
49,456 |
|
|
23,710 |
|
Total liabilities |
80,266 |
|
|
48,694 |
|
|
|
|
|
Shareholders' equity: |
|
|
|
Ordinary shares, $0.000042 par value; 200,000,000 shares authorized
as of September 30, 2020 and December 31, 2019; 52,298,876 and
44,983,006, shares issued and outstanding at September 30, 2020 and
December 31, 2019, respectively |
3 |
|
|
2 |
|
Deferred shares, £0.00001 par value; 34,425 shares authorized,
issued and outstanding at September 30, 2020 and December 31,
2019 |
— |
|
|
— |
|
Deferred B shares, £0.00099 par value; 88,893,548 shares
authorized, issued and outstanding at September 30, 2020 and
December 31, 2019 |
118 |
|
|
118 |
|
Deferred C shares, £0.000008 par value; 1 share authorized, issued
and outstanding at September 30, 2020 and December 31, 2019 |
— |
|
|
— |
|
Additional paid-in capital |
590,369 |
|
|
500,560 |
|
Accumulated other comprehensive loss |
(17,296 |
) |
|
(8,691 |
) |
Accumulated deficit |
(336,383 |
) |
|
(237,150 |
) |
Total shareholders' equity |
236,811 |
|
|
254,839 |
|
Total liabilities and shareholders' equity |
$ |
317,077 |
|
|
$ |
303,533 |
|
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