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RNS Number : 6762S
Syncona Limited
07 November 2019
Syncona Limited
Autolus reports Q3 2019 Financial Results
7 November 2019
Syncona Ltd, a leading healthcare company focused on founding,
building and funding global leaders in life science, notes the
announcement that its portfolio company, Autolus Therapeutics Plc
(NASDAQ: AUTL) (Autolus), reports its third quarter 2019 financial
results and operational progress today, 7 November 2019.
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations and full text of the
announcement from Autolus is contained below. Autolus management
will host a conference call today, November 7, at 8:30 a.m. EDT/
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.
[S]
Enquiries
Syncona Ltd
Siobhan Weaver / Annabel Clay
Tel: +44 (0) 20 3981 7940
FTI Consulting
Brett Pollard / Ben Atwell / Natalie Garland-Collins
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona is a leading FTSE250 healthcare company focused on
founding, building and funding global leaders in life science. Our
vision is to deliver transformational treatments to patients in
truly innovative areas of healthcare while generating superior
returns for shareholders.
We seek to partner with the best, brightest and most ambitious
minds in science to build globally competitive businesses.
We take a long-term view, underpinned by a deep pool of capital,
and are established leaders in gene and cell therapy. We focus on
delivering dramatic efficacy for patients in areas of high unmet
need.
Autolus Therapeutics Reports Third Quarter 2019 Financial
Results
and Operational Progress
- Conference call to be held on November 7, 2019 at 8:30 am
EDT/1:30 pm GMT -
LONDON, November 7, 2019 -- 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 Presentation
Solid 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 Presentations
Adult 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 update
The 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 base
In 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 ALL
In 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 Changes
David 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. EDT/ 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 Taylor
Vice President, Corporate Affairs and Communications
Autolus
+1-240-801-3850
s.taylor@autolus.com
UK:
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Autolus Therapeutics PLC
Condensed Consolidated Statements of Operations and
Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended Nine Months Ended
September 30, September 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 PLC
Condensed Consolidated Balance Sheets
September December
30, 31,
2019 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, GBP0.00001 par value; 34,425 shares
authorized, issued and outstanding at September
30, 2019 and December 31, 2018 - -
Deferred B shares, GBP0.00099 par value; 88,893,548
shares authorized, issued and outstanding at September
30, 2019 and December 31, 2018 118 118
Deferred C shares, GBP0.000001 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
======= =======
(In thousands, except share and per share amounts)
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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