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RNS Number : 4403I
Syncona Limited
08 August 2019
Syncona Limited
Autolus reports Q2 2019 Financial Results
08 August 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 second quarter 2019 financial
results and operational progress today, 8 August 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, August 8, at 8:30 a.m.
EDT/1:30pm BST, 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 Second Quarter 2019 Financial
Results and Operational Progress
- Conference call to be held on August 8, 2019 at 8:30 am
EDT/1:30 pm BST -
LONDON, August 8, 2019 -- 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, 2019.
Operational Highlights:
-- In April, Autolus announced the presentation of initial data
from the ongoing Phase 1/2 ALLCAR19 clinical trial of AUTO1 in
adult ALL at the American Association for Cancer Research (AACR)
Annual Meeting 2019 in Atlanta, Georgia. As of the data cutoff date
of May 18, 2019, 13 patients were leukapheresed, and products for
12 patients were manufactured, including 7 with Autolus'
semi-automated, fully enclosed manufacturing process. Using the Lee
criteria, there were no patients with severe cytokine release
syndrome (CRS) (>= Grade 3), and only 2 of 10 patients (20%)
with Grade 2 CRS. Tocilizumab was used in 2 of 10 patients (20%).
None of the patients were admitted to intensive care due to CRS.
One patient developed delayed Grade 3 neurotoxicity following high
levels of CAR T expansion, which resolved promptly following
administration of steroids. Four patients died while enrolled in
the trial, 2 due to progression of the disease and 2 due to sepsis,
a common complication in patients with advanced ALL. Nine patients
were evaluable for response at 1 month with 8 (88%) achieving a
molecular complete response. One patient died of sepsis before the
one-month evaluation point. At a median follow-up of 5 months
(range 0.62-10.6 months), 6 of 10 patients were alive and continue
to be in molecular remission with continued evidence of ongoing B
cell aplasia and CAR T persistence.
-- In April, Autolus completed an underwritten public offering
of 4,830,000 American Depositary Shares ("ADSs") representing
4,830,000 ordinary shares, at a public offering price of $24.00 per
ADS, which includes an additional 630,000 ADSs issued upon the
exercise in full of the underwriters' option to purchase additional
ADSs. Aggregate net proceeds to Autolus, after underwriting
discounts but before estimated offering expenses, were $108.8
million.
Pipeline Updates and Anticipated Milestones:
-- Initiation of a Phase 2 registration trial of AUTO1 in adult
ALL in the fourth quarter of 2019 (pending regulatory feedback).
Updated Phase 1 data from the ALLCAR19 clinical trial is expected
at ASH 2019.
-- Decision on Phase 2 initiation for the Alexander study of
AUTO3 in DLBCL is expected for mid-2020. Interim Phase 1 data is
expected at ASH 2019.
-- Development of AUTO1 in pediatric ALL as part of a pediatric
investigational program (PIP). Next data update from CARPALL
clinical trial is expected at ASH 2019. Development program
includes a next generation version of AUTO1 (AUTO1NG), which
incorporates the CD19 CAR of AUTO1 and a novel CD22 CAR. First
preclinical data on CD22 CAR expected to be presented at ASH
2019.
-- Additional presentations targeted for ASH 2019 are: data from
AMELIA clinical trial of AUTO3 in pediatric ALL and data from
clinical trial of AUTO2 in multiple myeloma.
-- Next generation (NG) programs for AUTO1, AUTO2, AUTO3 and
AUTO6 are expected to enter the clinic in 2020.
"This quarter we have focused on expanding operations at our
clinical manufacturing site at the Catapult Cell and Gene facility
in Stevenage, UK, enabling us to meet our expected clinical trial
demand, including a registration trial with AUTO1. In April, we
presented encouraging data on our ALLCAR19 clinical trial of AUTO1
in adult ALL. These data show that AUTO1 is well differentiated
from the standard of care in ALL and other CAR T products in
development, reaching a high level of clinical activity without
inducing severe cytokine release syndrome," stated Dr. Christian
Itin, chairman and chief executive officer of Autolus. "For the
remainder of 2019, our efforts are focused on moving AUTO1 into a
Phase 2 registration trial in adult ALL and advancing AUTO3 in
DLBCL toward a Phase 2 decision point in Q2 2020."
Financial results for second quarter 2019:
-- Cash and equivalents at June 30, 2019 totaled $266.2 million,
compared with $217.5 million at December 31, 2018.
-- Net total operating expenses for the three months ended June
30, 2019 were $37.2 million, net of grant income of $0.3 million,
as compared to net operating expenses of $16.5 million, net of
grant income of $0.4 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 $26.2 million
for the three months ended June 30, 2019 from $8.9 million for the
three months ended June 30, 2018. Cash costs, which exclude
depreciation as well as share-based compensation, increased to
$20.2 million from $7.1 million. The increase in research and
development cash costs of $13.1 million consisted primarily of an
increase of compensation-related costs of $5.6 million primarily
due to an increase in headcount to support the advancement of our
product candidates in clinical development, an increase of $2.3
million in facilities costs supporting the expansion of our
research and translational science capability and investment in
manufacturing facilities and equipment, an increase of $3.3 million
in research and development program expenses related to the
activities necessary to prepare, activate, and monitor clinical
trial programs, an increase of $0.8 million in professional fees,
an increase of $0.5 million in telecom and software costs, and
other additional costs in the amount of $0.4 million.
-- General and administrative expenses increased to $11.4
million for the three months ended June 30, 2019 from $8.1 million
for the three months ended June 30, 2018. Cash costs, which exclude
depreciation as well as share-based compensation, increased to $7.3
million from $6.9 million. The increase of $0.4 million consisted
primarily of an increase in commercial costs of $1.2 million,
compensation-related expense of $0.5 million due to an overall
increase in headcount, offset by a decrease in legal and
professional fees of $1.3 million related to certain corporate
reorganization costs that were incurred in the three months ended
June 30, 2018.
-- Net loss attributable to ordinary shareholders was $28.5
million for the three months ended June 30, 2019, compared to $7.7
million for the same period in 2018.
-- The basic and diluted net loss per ordinary share for the
three months ended June 30, 2019 totaled $(0.65) compared to a
basic and diluted net loss per ordinary share of $(0.26) for the
three months ended June 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, August 8,
at 8:30 a.m. EDT/ 1:30pm BST, 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 2763978. 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
2763978.
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 Statement
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.
Autolus Therapeutics PLC
Condensed Consolidated Statements of Operations and
Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three months ended Six Months Ended
June 30, June 30,
2019 2018 2019 2018
------------- ------------- ------------- -------------
Grant income $ 338 $ 443 $ 2,302 $ 869
Operating expenses:
Research and development (26,173) (8,863) (48,738) (20,490)
General and administrative (11,370) (8,103) (20,926) (12,433)
------------ ------------ ------------ ------------
Total operating expenses, net (37,205) (16,523) (67,362) (32,054)
Other income (expense):
Interest income 1,074 266 1,615 555
Other income 4,380 6,390 3,396 3,449
------------ ------------ ------------ ------------
Total other income, net 5,454 6,656 5,011 4,004
------------ ------------ ------------ ------------
Net loss before income tax (31,751) (9,867) (62,351) (28,050)
Income tax benefit 3,274 2,217 6,696 3,683
------------ ------------ ------------ ------------
Net loss attributable to ordinary
shareholders (28,477) (7,650) (55,655) (24,367)
Other comprehensive income:
Foreign currency exchange translation
adjustment (8,872) (11,206) (3,821) (6,242)
Total comprehensive loss $ (37,349) $ (18,856) $ (59,476) $ (30,609)
======== ======== ======== ========
Basic and diluted net loss
per ordinary share $ (0.65) $ (0.26) $ (1.34) $ (0.84)
Weighted-average basic and
diluted ordinary shares 43,611,531 29,386,128 41,552,718 29,111,323
Autolus Therapeutics PLC
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
June 30, December
31,
2019 2018
--------- -----------
Assets
Current assets:
Cash $266,194 $217,450
Restricted cash 683 105
Prepaid expenses and other current assets 25,831 15,411
-------- --------
Total current assets 292,708 232,966
Non-current assets:
Property and equipment, net 25,967 19,968
Right of use asset, net 25,505 -
Long-term deposits 1,965 1,276
-------- --------
Total assets $346,145 $254,210
======= =======
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 3,143 2,022
Accrued expenses and other liabilities 17,237 19,054
Lease liability 1,925 -
-------- --------
Total current liabilities 22,305 21,076
Non-current liabilities:
Lease liability 25,497 -
Long-term lease incentive obligation - 207
Other long-term payables 121 285
-------- --------
Total liabilities 47,923 21,568
Shareholders' equity:
Ordinary shares, $0.000042 par value; 200,000,000
shares authorized as of June 30, 2019 and December
31, 2018; 44,981,860 and 40,145,617, shares issued
and outstanding at June 30, 2019 and December 31,
2018, respectively 2 2
Deferred shares, GBP0.00001 par value; 34,425 shares
authorized, issued and outstanding at June 30, 2019
and December 31, 2018 - -
Deferred B shares, GBP0.00099 par value; 88,893,548
shares authorized, issued and outstanding at June
30, 2019 and December 31, 2018 118 118
Deferred C shares, GBP0.000001 par value; 1 share
authorized, issued and outstanding at June 30, 2019
and December 31, 2018 - -
Additional paid-in capital 486,369 361,311
Accumulated other comprehensive loss (19,309) (15,488)
Accumulated deficit (168,958) (113,301)
-------- --------
Total shareholders' equity 298,222 232,642
Total liabilities and shareholders' equity $346,145 $254,210
======= =======
Investor contact:
Susan A. Noonan
S.A. Noonan Communications
+1-212-966-3650
susan@sanoonan.com
Media contact:
Silvia Taylor
Vice President, Corporate Affairs and Communications,
Autolus
+1-240-801-3850
s.taylor@autolus.com
Julia Wilson
JW Communications
+44 (0) 7818 430877
j.wilson@autolus.com
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
IR UGUAARUPBGGR
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