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, 2019.
“We are excited about the opportunity to share
data updates at ASH on AUTO1 in ALL in three oral presentations, as
well as an oral presentation on AUTO3 in DLBCL. We are also looking
forward to presenting data on our other hematological clinical
programs at ASH, and non-clinical data on our lead solid tumor
program AUTO6NG at SITC,” stated Dr. Christian Itin, chairman and
chief executive officer of Autolus. “This quarter we have
made significant operational progress, delivering cell products
from our new manufacturing operations at the Cell and Gene Therapy
Catapult and further strengthening our management team.
Supported by a strong balance sheet, our key focus is on moving
AUTO1 into our first pivotal clinical program in adult patients
with ALL.”
Pipeline Updates:
- On November 5, the United States
Food and Drug Administration granted orphan drug designation for
AUTO1 for the treatment of acute lymphoblastic leukemia
(ALL).
- SITC Meeting PresentationSolid
tumors (AUTO6NG) - AUTO6NG: Next generation GD2-targeting CAR
T-cell therapy with improved persistence and insensitivity to TGFb
and checkpoint inhibition for relapsed/refractory neuroblastoma
(Saturday November 9, poster presentation)
- ASH Meeting PresentationsAdult ALL
(AUTO1) - AUTO1, a novel fast off CD19 CAR delivers durable
remissions and prolonged CAR T cell persistence with low CRS or
neurotoxicity in adult ALL (Saturday December 7, oral
presentation)Pediatric ALL (AUTO1) - Therapy of pediatric B-ALL
with a lower affinity CD19 CAR leads to enhanced expansion and
prolonged CAR T cell persistence in patients with low bone marrow
tumor burden, and is associated with a favorable toxicity profile
(Saturday December 7, oral presentation)Integration Site Analysis
(AUTO1) - Clonal dynamics of early responder and long-term
persisting CAR-T cells in humans (Saturday December 7, oral
presentation)DLBCL (AUTO3) - Phase 1/2 study of AUTO3 the first
bicistronic chimeric antigen receptor (CAR) targeting CD19 and CD22
followed by an anti-PD1 in patients with relapsed/refractory (r/r)
Diffuse Large B Cell Lymphoma (DLBCL): Results of Cohort 1 and 2 of
the ALEXANDER study (Saturday December 7, oral
presentation)Multiple Myeloma (AUTO2) - Phase 1 First-in-Human
study of AUTO2, the first chimeric antigen receptor (CAR) T cell
targeting APRIL for patients with relapsed/refractory Multiple
Myeloma (RRMM) (Sunday December 8, poster presentation)Pediatric
ALL (AUTO3) - Phase 1 Study of AUTO3, a Bicistronic Chimeric
Antigen Receptor (CAR) T-cell Therapy Targeting of CD19 and CD22,
in Pediatric Patients with Relapsed/Refractory B-cell Acute
Lymphoblastic Leukemia (r/r B-ALL): AMELIA Study (Sunday December
8, poster presentation)
Operational and Corporate
Highlights:
- Manufacturing updateThe Cell and
Gene Therapy Catapult site is fully operational and is delivering
clinical products for patients in both Europe and the US
- Significant change in shareholder
baseIn September, PPF Group announced that they had acquired,
mainly from Woodford Investment Management, an approximate 19%
holding of Autolus. Control of all the remaining shares of Autolus
held by Woodford Investment Management are in the process of being
transferred to Schroder UK Public Private Trust plc.
- Nature Medicine publication of
AUTO1 CARPALL study in pediatric ALLIn September, Autolus announced
that the journal Nature Medicine has published both pre-clinical
results and clinical data from the ongoing Phase 1 CARPALL trial of
AUTO1, demonstrating the potential of the company’s novel CAR T
therapy targeting CD19 in development for the treatment of
pediatric acute lymphoblastic leukemia (ALL).
- Executive Leadership Team
ChangesDavid Brochu has been named Senior Vice President, Head of
Product Delivery to lead the transition of the company’s
manufacturing organization to deliver products for late-stage
clinical studies and commercial sale. In addition, Vishal Mehta has
been named Vice President, Head of Clinical Operations.
Key Upcoming Clinical
Milestones:
- Initiation of the pivotal program
of AUTO1 in adult ALL on track – dosing of first patients in the
first half of 2020
- Go/no go decision on Phase 2
initiation of AUTO3 in DLBCL expected in mid-2020
- Interim Phase 1 data in T cell
lymphoma with AUTO4 in the second half of 2020
Financial results for third quarter
2019
Cash and equivalents at September 30, 2019
totaled $229.4 million, compared with $247.1 million at September
30, 2018.
Net total operating expenses for the three
months ended September 30, 2019 were $35.6 million, net of grant
income of $0.3 million, as compared to net operating expenses of
$17.1 million, net of grant income of $0.3 million, for the same
period in 2018. The increase was due, in general, to the increase
in development activity, increased headcount primarily in our
development and manufacturing functions, and the cost of being a
public company.
Research and development expenses increased to
$27.3 million for the three months ended September 30, 2019 from
$10.1 million for the three months ended September 30, 2018. Cash
costs, which exclude depreciation as well as share-based
compensation, increased to $21.6 million from $9.0 million. The
increase in research and development cash costs of
$12.6 million consisted primarily of an increase of
compensation-related costs of $5.2 million primarily due to an
increase in employee headcount to support the advancement of our
product candidates in clinical development, an increase of $3.6
million in research and development program expenses related to the
activities necessary to prepare, activate, and monitor clinical
trial programs, including the manufacturing technical transfer
activities required for AUTO1 to enable the commencement at the end
of 2019 of a registration study in Adult Acute Lymphoblastic
Leukemia, an increase of $2.6 million in facilities costs
supporting the expansion of our research and translational science
capability and investment in manufacturing facilities and
equipment, an increase of $0.7 million in telecom and software
costs, and an increase of $0.5 million in other costs.
General and administrative expenses increased to
$8.6 million for the three months ended September 30, 2019
from $7.3 million for the three months ended September 30,
2018. Cash costs, which exclude depreciation expense as well as
share-based expense compensation decreased to $5.6 million from
$5.7 million. Compensation related expenses decreased by $0.6
million and IT, telecommunication, and general office expense costs
decreased by $0.7 million which were offset by an increase in legal
and professional fees of $0.9 million and an increase of $0.3
million in commercial costs.
Net loss attributable to ordinary shareholders
was $27.2 million for the three months ended September 30, 2019,
compared to $12.9 million for the same period in 2018.
The basic and diluted net loss per ordinary
share for the three months ended September 30, 2019 totaled $(0.61)
compared to a basic and diluted net loss per ordinary share of
$(0.33) for the three months ended September 30, 2018.
Autolus anticipates that cash on hand provides a
runway into the second half of 2021.
Conference Call and Presentation
Information
Autolus management will host a conference call
today, November 7, at 8:30 a.m. EST/ 1:30pm GMT, to discuss the
company’s financial results and operational update.
To listen to the webcast and view the
accompanying slide presentation, please go to:
https://www.autolus.com/investor-relations/news-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 5075598. 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
5075598.
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,
as well as statements regarding the anticipated development of
Autolus’ product candidates, including its intentions regarding the
timing for providing further updates on the development of its
product candidates, and the sufficiency of its cash resources. 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
on November 23, 2018 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.
Investor and media contact: Silvia TaylorVice
President, Corporate Affairs and Communications
Autolus+1-240-801-3850s.taylor@autolus.com
UK:Julia Wilson+44 (0) 7818
430877 j.wilson@autolus.com
Autolus Therapeutics
PLCCondensed Consolidated Statements of Operations
and Comprehensive Loss (Unaudited)(In thousands,
except share and per share amounts)
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
Grant income |
$ |
297 |
|
$ |
307 |
|
$ |
2,599 |
|
$ |
1,176 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
(27,310) |
|
(10,096) |
|
(76,050) |
|
(30,586) |
|
General and administrative |
(8,605) |
|
(7,273) |
|
(29,531) |
|
(19,706) |
|
Total operating expenses, net |
(35,618) |
|
(17,062) |
|
(102,982) |
|
(49,116) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
509 |
|
796 |
|
2,124 |
|
1,351 |
|
Other income |
3,263 |
|
1,206 |
|
6,659 |
|
4,655 |
|
Total other income, net |
3,772 |
|
2,002 |
|
8,783 |
|
6,006 |
|
Net loss before income tax |
(31,846) |
|
(15,060) |
|
(94,199) |
|
(43,110) |
|
Income tax benefit |
4,598 |
|
2,200 |
|
11,294 |
|
5,883 |
|
Net loss attributable to ordinary
shareholders |
(27,248) |
|
(12,860) |
|
(82,905) |
|
(37,227) |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
Foreign currency exchange translation adjustment |
(9,044) |
|
(973) |
|
(12,865) |
|
(7,215) |
|
Total comprehensive loss |
$ |
(36,292) |
|
$ |
(13,833) |
|
$ |
(95,770) |
|
$ |
(44,442) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per ordinary share |
$ |
(0.61) |
|
$ |
(0.33) |
|
$ |
(1.95) |
|
$ |
(1.14) |
|
Weighted-average basic and diluted ordinary shares |
44,505,383 |
|
39,214,334 |
|
42,547,755 |
|
32,516,001 |
|
Autolus Therapeutics
PLCCondensed Consolidated Balance
Sheets(In thousands, except share and per share
amounts)
|
September 30, 2019 |
|
December 31, 2018 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
229,366 |
|
|
$ |
217,450 |
|
Restricted cash |
681 |
|
|
105 |
|
Prepaid expenses and other current assets |
30,136 |
|
|
15,411 |
|
Total current assets |
260,183 |
|
|
232,966 |
|
Non-current assets: |
|
|
|
Property and equipment, net |
28,413 |
|
|
19,968 |
|
Right of use asset, net |
24,133 |
|
|
— |
|
Long-term deposits |
1,912 |
|
|
1,276 |
|
Total assets |
$ |
314,641 |
|
|
$ |
254,210 |
|
Liabilities and shareholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
2,733 |
|
|
2,022 |
|
Accrued expenses and other liabilities |
15,548 |
|
|
19,054 |
|
Lease liability |
2,282 |
|
|
— |
|
Total current liabilities |
20,563 |
|
|
21,076 |
|
Non-current liabilities: |
|
|
|
Lease liability |
24,407 |
|
|
— |
|
Long-term lease incentive obligation |
— |
|
|
207 |
|
Other long-term payables |
30 |
|
|
285 |
|
Total liabilities |
45,000 |
|
|
21,568 |
|
|
|
|
|
Shareholders' equity: |
|
|
|
Ordinary shares, $0.000042 par value; 200,000,000 shares authorized
as of September 30, 2019 and December 31, 2018; 44,982,378 and
40,145,617, shares issued and outstanding at September 30, 2019 and
December 31, 2018, respectively |
2 |
|
|
2 |
|
Deferred shares, £0.00001 par value; 34,425 shares authorized,
issued and outstanding at September 30, 2019 and December 31,
2018 |
— |
|
|
— |
|
Deferred B shares, £0.00099 par value; 88,893,548 shares
authorized, issued and outstanding at September 30, 2019 and
December 31, 2018 |
118 |
|
|
118 |
|
Deferred C shares, £0.000001 par value; 1 share authorized, issued
and outstanding at September 30, 2019 and December 31, 2018 |
— |
|
|
— |
|
Additional paid-in capital |
494,080 |
|
|
361,311 |
|
Accumulated other comprehensive loss |
(28,353 |
) |
|
(15,488 |
) |
Accumulated deficit |
(196,206 |
) |
|
(113,301 |
) |
Total shareholders' equity |
269,641 |
|
|
232,642 |
|
Total liabilities and shareholders' equity |
$ |
314,641 |
|
|
$ |
254,210 |
|
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