Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced its financial and operational
results for the second quarter ended June 30, 2020.
“We have had a busy second quarter with data
updates across our portfolio at key medical and scientific
conferences,” said Dr Christian Itin, chairman and chief executive
officer of Autolus. “Both our later stage programs,
AUTO1 and AUTO3, continue to show encouraging clinical activity
with tolerable safety in adult patients with ALL and DLBCL,
respectively, and we are excited by the potential for these product
candidates to have differentiated profiles addressing indications
with high unmet needs. We look forward to providing further
updates in H2 2020, starting with AUTO3 ALEXANDER data at a mini
oral session at ESMO in September.”
“At AACR we presented data across a number of
next generation programs,” said Dr Martin Pule, chief scientific
officer of Autolus. “These data demonstrate the strength of our
binder discovery capabilities with highly selective targeting in
AUTO5 for T Cell lymphoma, as well as the ability of our cell
programming modules to address the hostile solid tumor
microenvironment as shown for AUTO6NG and AUTO7 for small cell lung
cancer and prostate cancer, respectively. We are excited to be
progressing these next generation programs into Phase 1 in
2021.”
Pipeline Updates:
- AUTO1 in acute lymphocytic leukemia
(ALL). Positive data were presented at the European Hematology
Association (EHA) meeting in June 2020. These data showed an
encouraging durability of response without subsequent stem cell
transplant and confirmed the safety profile. Autolus has now
started enrolment of adult patients with relapsed / refractory ALL
in its pivotal Phase 1b/2 AUTO1 program and is targeting to have
full data by the end of 2021.
- AUTO3 in diffuse large B-cell
lymphoma (DLBCL). Positive data were presented at the American
Society of Clinical Oncology (ASCO) meeting in June 2020. These
data showed a high level of complete remissions and a safety
profile supportive of evaluation of outpatient use. Based on these
data, Autolus selected its recommended Phase 2 dose range of 150 -
450 x 106 cells, with a single dose of pembrolizumab during
preconditioning. In addition, the company has also commenced an
outpatient cohort as an extension to its ongoing Phase 1/2
ALEXANDER study, with results expected in the second half of 2020.
The data from this outpatient cohort will provide important
insights that will be used to refine the design of the potential
pivotal Phase 2 part of the ALEXANDER study. Autolus expects to
present next updated data from the study at ESMO in September
2020.
- AUTO5 in T cell lymphoma. Positive
preclinical data were presented at the American Association for
Cancer Research II (AACR) Meeting in June 2020. The data highlight
the specificity and selectivity of the company’s T-cell lymphoma
product candidate, AUTO5.
- AUTO6NG in small cell lung cancer
(SCLC). Positive preclinical data were presented at the AACR
Meeting in June 2020. Autolus has designed enhancing modules to
specifically overcome tumor microenvironment (TME) defenses in
solid tumor settings. The new data suggest that AUTO6NG can
overcome the immune suppressive mechanisms in the TME.
- AUTO7 in prostate cancer. Positive
preclinical data were presented at an oral presentation at the AACR
Meeting in June 2020. The program builds on a novel and optimized
CAR to PSMA designed to be highly active, even in an acidic
environment, and combines modules introduced in AUTO6NG with a
novel low level secretion of IL-12 to change the prostate tumor
from an immunologically cold to an immunologically supportive
environment.
Operational Highlights:
- Appointment of Dr Jay T Backstrom
to Autolus’ Board of Directors, effective August 1, 2020. Dr
Backstrom currently serves as EVP, Head of Research &
Development at Acceleron Pharma Inc. and prior to that served as
CMO and Head of Regulatory Affairs at Celgene
Corporation.
- Dr Nushmia Khokhar promoted to
Senior Vice President, Clinical Development. Dr Khokhar will take
over the clinical leadership role at Autolus. She is a
board-certified oncologist with extensive early and late stage
clinical development experience, having led several successful
registration trials within the industry in both solid tumors and
hematologic malignancies, including the global daratumumab program
at Janssen Oncology. Dr Vijay Peddareddigari, Senior Vice
President, Chief Medical Officer will be leaving the Company to
return to the United States.
- Expanded manufacturing capacity at
the Cell and Gene Therapy Catapult to secure initial commercial
launch capability.
Key Upcoming Clinical
Milestones:
- Further update for AUTO3 at ESMO in Q3 2020.
- Further data updates for both AUTO1 and AUTO3 in Q4
2020.
- First data from outpatient cohort in the AUTO3 ALEXANDER study
in H2 2020.
- Interim Phase 1 data for AUTO4 in T cell lymphoma in H1
2021.
- Initiation of Phase 1 study for AUTO1NG in pediatric ALL in H2
2020.
- Initiation of Phase 1 study for AUTO8 in multiple myeloma in H2
2020.
- Progression of additional next generation programs from
preclinical stages to Phase 1 throughout 2021.
- Expansion of the company’s suite of
cell programming technologies to include additional modules
designed for allogeneic applications, with the first novel
allogeneic program expected to enter the clinic in Q4 2020.
Financial Results for the Quarter Ended
June 30, 2020
Cash and equivalents at June 30,
2020 totaled $212.0 million, compared with $243.3
million at March 31, 2020.
Net total operating expenses for the three
months ended June 30, 2020 were $39.5 million, net
of grant income of $0.3 million, as compared to net operating
expenses of $37.2 million, net of grant income of $0.3
million, for the same period in 2019.
Research and development expenses increased to
$31.3 million for the three months ended June 30, 2020 from $26.2
million for the three months ended June 30, 2019. Cash costs, which
exclude depreciation and amortization as well as share-based
compensation, increased to $26.5 million from $20.2 million. The
increase in research and development cash costs of
$6.3 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 $1.8 million due
to an increase in employee headcount to support the advancement of
our product candidates in clinical development, (ii) an increase of
$3.0 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 $1.3 million in facilities costs related to the
commencement of a lease for an additional manufacturing suite and
the continued scaling of operations in the manufacturing facility,
and (iv) an increase in IT and telecoms, general office expense,
and professional fees of $0.6 million, which is offset by a
decrease in materials purchases of $0.4 million.
Non-cash costs decreased to $4.8 million for the
three months ended June 30, 2020 from $6.0 million for the three
months ended June 30, 2019. The decrease is primarily related to
share-based compensation expense included in research and
development expenses, which decreased by $1.3 million as a result
of a lower fair value of stock options recognized in the period,
offset by a small increase in depreciation.
General and administrative expenses decreased to
$8.5 million for the three months ended June 30, 2020 from $11.4
million for the three months ended June 30, 2019. Cash costs, which
exclude depreciation expense as well as share-based expense
compensation decreased to $6.7 million from $7.3 million.
Compensation related expenses decreased by $0.1 million aided by
lower travel costs as described above. Further there was a decrease
of $0.7 million in commercial activities. These decreases were
offset by an increase of $0.1 million in legal and professional
fees.
Non-cash costs decreased to $1.8 million for the
three months ended June 30, 2020 from $3.9 million for the three
months ended June 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 $1.1 million for
three months ended June 30, 2020 due to lower interest
rates.
Other income decreased to $0.5 million for the
three months ended June 30, 2020 from other income of $4.4 million
for the three months ended June 30, 2019 primarily due to a
decrease of the U.S. dollar exchange rate relative to the pound
sterling during the three months ending June 30, 2020 as compared
to the three months ended June 30, 2019.
Income tax benefit increased to $7.0 million for
the three months ended June 30, 2020 from $3.3 million for the
three months ended June 30, 2019 due to increased R&D expenses,
which 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 $32.0 million for the three
months ended June 30, 2020, compared to $28.5
million for the same period in 2019.The basic and diluted net
loss per ordinary share for the three months ended June 30,
2020 totaled $(0.62) compared to a basic and diluted
net loss per ordinary share of $(0.65) for the three
months ended June 30, 2019.
The Company anticipates that cash on hand is
sufficient to fund operations into 2022.
Conference Call and Presentation
Information
Autolus management will host a conference call
today, August 6, at 8:30 a.m. EDT/ 1:30pm BST, to discuss the
company’s financial results and operational update.
To access the live and subsequent replay, as
well as dial in information of this webcast and view the
accompanying slide presentation, please register here.
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 Autolus’ financial condition and results of operations,
including its expected cash runway; the development of Autolus’
product candidates, including statements regarding the timing of
initiation, completion and the outcome of preclinical studies or
clinical trials and related preparatory work, and the periods
during which the results of the studies and trials will become
available; Autolus’ plans to research, develop, manufacture and
commercialize its product candidates; the potential for Autolus’
product candidates to be alternatives in the therapeutic areas
investigated; and Autolus’ manufacturing capabilities and strategy.
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. For
a discussion of other risks and uncertainties, and other important
factors, any of which could cause our 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' future filings with the
Securities and Exchange Commission from time to time. 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
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
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Grant income |
$ |
293 |
|
|
|
$ |
338 |
|
|
|
$ |
631 |
|
|
|
$ |
2,302 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
(31,328 |
) |
|
|
(26,173 |
) |
|
|
(62,615 |
) |
|
|
(48,738 |
) |
General and
administrative |
(8,509 |
) |
|
|
(11,370 |
) |
|
|
(16,123 |
) |
|
|
(20,926 |
) |
Total operating
expenses, net |
(39,544 |
) |
|
|
(37,205 |
) |
|
|
(78,107 |
) |
|
|
(67,362 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest (expense) income |
(47 |
) |
|
|
1,073 |
|
|
|
463 |
|
|
|
1,615 |
|
Other income |
525 |
|
|
|
4,380 |
|
|
|
5,009 |
|
|
|
3,396 |
|
Total other income,
net |
478 |
|
|
|
5,453 |
|
|
|
5,472 |
|
|
|
5,011 |
|
Net loss before income
tax |
(39,066 |
) |
|
|
(31,752 |
) |
|
|
(72,635 |
) |
|
|
(62,351 |
) |
Income tax benefit |
7,021 |
|
|
|
3,274 |
|
|
|
10,717 |
|
|
|
6,696 |
|
Net loss attributable
to ordinary shareholders |
(32,045 |
) |
|
|
(28,478 |
) |
|
|
(61,918 |
) |
|
|
(55,655 |
) |
Other comprehensive
(loss) income: |
|
|
|
|
|
|
|
Foreign currency exchange
translation adjustment |
(1,819 |
) |
|
|
(8,872 |
) |
|
|
(19,520 |
) |
|
|
(3,821 |
) |
Total comprehensive
loss |
(33,864 |
) |
|
|
(37,350 |
) |
|
|
(81,438 |
) |
|
|
(59,476 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per
ordinary share |
$ |
(0.62 |
) |
|
|
$ |
(0.65 |
) |
|
|
$ |
(1.22 |
) |
|
|
$ |
(1.34 |
) |
Weighted-average basic and
diluted ordinary shares |
52,041,340 |
|
|
|
43,611,531 |
|
|
|
50,956,566 |
|
|
|
41,552,718 |
|
Condensed Consolidated Balance Sheets
(Unaudited)(In thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
June 30,2020 |
|
December 31,2019 |
Assets |
|
|
|
Current
assets: |
|
|
|
Cash |
$ |
212,044 |
|
|
|
$ |
210,643 |
|
Restricted cash |
786 |
|
|
|
787 |
|
Prepaid expenses and other assets, current |
35,901 |
|
|
|
37,826 |
|
Total current assets |
248,731 |
|
|
|
249,256 |
|
Non-current
assets: |
|
|
|
Property and equipment,
net |
30,954 |
|
|
|
28,164 |
|
Right of use assets, net |
25,100 |
|
|
|
23,409 |
|
Long-term deposits |
2,354 |
|
|
|
2,040 |
|
Prepaid expenses and other
assets, non-current |
2,813 |
|
|
|
— |
|
Deferred tax asset |
410 |
|
|
|
410 |
|
Intangible assets, net |
186 |
|
|
|
254 |
|
Total
assets |
$ |
310,548 |
|
|
|
$ |
303,533 |
|
Liabilities and
shareholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
626 |
|
|
|
1,075 |
|
Accrued expenses and other liabilities |
22,753 |
|
|
|
21,398 |
|
Lease liabilities |
3,888 |
|
|
|
2,511 |
|
Total current liabilities |
27,267 |
|
|
|
24,984 |
|
Non-current
liabilities: |
|
|
|
Lease liabilities |
24,329 |
|
|
|
23,710 |
|
Total
liabilities |
51,596 |
|
|
|
48,694 |
|
|
|
|
|
Shareholders'
equity: |
|
|
|
Ordinary shares, $0.000042 par value; 200,000,000 shares
authorized as of June 30, 2020 and December 31, 2019; 52,250,404
and 44,983,006, shares issued and outstanding at June 30, 2020 and
December 31, 2019, respectively |
3 |
|
|
|
2 |
|
Deferred shares, £0.00001 par
value; 34,425 shares authorized, issued and outstanding at June 30,
2020 and December 31, 2019 |
— |
|
|
|
— |
|
Deferred B shares, £0.00099
par value; 88,893,548 shares authorized, issued and outstanding at
June 30, 2020 and December 31, 2019 |
118 |
|
|
|
118 |
|
Deferred C shares, £0.000008
par value; 1 share authorized, issued and outstanding at June 30,
2020 and December 31, 2019 |
— |
|
|
|
— |
|
Additional paid-in
capital |
586,110 |
|
|
|
500,560 |
|
Accumulated other
comprehensive loss |
(28,211 |
) |
|
|
(8,691 |
) |
Accumulated deficit |
(299,068 |
) |
|
|
(237,150 |
) |
Total shareholders'
equity |
258,952 |
|
|
|
254,839 |
|
Total liabilities and
shareholders' equity |
$ |
310,548 |
|
|
|
$ |
303,533 |
|
|
|
|
|
|
|
|
|
|
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