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RNS Number : 8712E
Syncona Limited
03 March 2020
Syncona Limited
Autolus reports Q4 2019 Financial Results
3 March 2020
Syncona Ltd, a leading healthcare company focused on founding,
building and funding a portfolio of global leaders in life science,
notes that its portfolio company, Autolus Therapeutics Plc (NASDAQ:
AUTL) (Autolus), announced its operational and financial results
for the fourth quarter and full year ended December 31, 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, at 8:30 am EST/1:30 pm 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
Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona is a leading FTSE250 healthcare company focused on
founding, building and funding a portfolio of global leaders in
life science. Our vision is to build a sustainable, diverse
portfolio of 15 - 20 companies focused on delivering
transformational treatments to patients in truly innovative areas
of healthcare, through which we are seeking to deliver strong
risk-adjusted 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 strategic capital base which
provides us with control and flexibility over the management of our
portfolio. We focus on delivering dramatic efficacy for patients in
areas of high unmet need.
Autolus Therapeutics Reports Fourth Quarter and Full Year 2019
Financial Results
and Operational Progress
- Conference call to be held on March 3, 2020 at 8:30 am
EST/1:30 pm GMT -
LONDON , March 3, 2020 -- 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 fourth quarter and full
year ended December 31, 2019.
"It has been an exciting year of progress for Autolus concluding
with the presentation of encouraging AUTO 1 and AUTO 3 clinical
data at the ASH conference in December 2019. AUTO1 is poised for a
pivotal Phase 2 clinical trial starting in the first half of 2020,
and AUTO3 is progressing to a Phase 2 decision point in mid-2020,"
said Dr. Christian Itin, chairman and chief executive officer of
Autolus. "Supported by a strong balance sheet and alongside the two
lead programs, we also continue to advance our next generation
programs towards key near-term value inflection points."
Key Pipeline Updates:
-- AUTO1 in adult lymphocytic leukemia (ALL). Data presented at
the American Society of Hematology (ASH) demonstrated that AUTO1, a
novel fast off CD19 CAR, was well-tolerated with a high level of
clinical activity. As of the most recent cut-off date of November
25, 2019, of the 15 patients evaluable for efficacy, 13 patients
(87%) achieved minimal residual disease, or MRD, negative complete
responses at one month and all patients had ongoing CAR T cell
persistence at last follow-up. 10 of the 15 evaluable patients
(67%) remain disease-free at a median follow up of 11 months (range
of 0.5 month - 21 months). Of the 16 patients dosed, ten patients
were dosed with AUTO1 manufactured using our semi-automated, fully
enclosed system for manufacturing. In this cohort, nine patients
were evaluable and achieved MRD negative complete responses of
100%. The median follow-up in this cohort was 6.7 months (range of
1.1 month-14.5 months). The event free survival or EFS and overall
survival or OS data are preliminary considering the small number of
patients.
In October 2019 the U.S. Food and Drug Administration, or FDA,
granted orphan drug designation for AUTO1 for the treatment of
ALL.
-- AUTO3 in Diffuse large B-cell lymphoma (DLBCL). Data were
presented at ASH with an update provided in a keynote lecture at
EHA-EBMT 2nd European CAR T Cell Meeting. These data support the
encouraging early indications of durability and high level of
activity previously reported and show the potential for a
differentiated product profile. As of the data cut-off date of
January 21, 2020 (data availability as of January 28, 2020), 18
patients in the ALEXANDER Phase 1/2 clinical trial of AUTO3 were
evaluable for safety and efficacy with minimum 28-day follow-up. In
the cohorts dosed at 450 x 10(6) AUTO3 cells plus pembrolizumab,
five out of seven patients (ORR=71%) achieved a response (complete
response + partial response) and four out of seven patients
(CRR=57%) achieved a complete response. Across all dose levels,
seven out of eight complete responders (87%) had ongoing complete
responses at a median follow up of six months (range of one month -
18 months). All seven out of seven complete responders (100%)
treated with AUTO3 and pembrolizumab have ongoing complete
responses as of January 21, 2020 at a median follow up of three
months (range of one month - 18 months). AUTO3 was generally well
tolerated, with no patients experiencing dose limiting toxicity,
and there were no treatment-related deaths. Notably, none of the
patients treated in the higher dose cohorts experienced any high
grade CRS or any neurotoxic events of any grade, which may provide
AUTO3 with a safety profile suitable for the outpatient setting,
and allow for a significant expansion of the market opportunity
compared to CAR T therapies currently approved for DLBCL.
-- AUTO6NG in neuroblastoma. Pre-clinical data presented at the
Society for Immunotherapy of Cancer (SITC) from the Company's next
generation GD2-targeting CAR T cell therapy, demonstrates the
utility of three modules added to the clinically active and
validated AUTO6 GD-2 targeting CAR that not only improve CAR T
persistence but also combat the immunosuppressive tumor
microenvironment.
Operational and Corporate Highlights:
-- Completed public offerings in April 2019 and January 2020
raising net proceeds of approx. $184 million.
-- Presented clinical data on our lead programs AUTO1 and AUTO3
in four oral presentations at Annual American Society of Hematology
(ASH) conference in December 2019.
-- Presented non-clinical data for our most advanced next
generation solid tumor program AUTO6NG at the annual meeting of the
Society for Immunotherapy Conference (SITC) in November 2019,
highlighting a suite of activity enhancing programming modules
built into the clinically active AUTO6 program.
-- Licensed the PRIME (proliferation-inducing and
migration-enhancing) technology from Noile-Immune Biotech, Inc. in
November 2019, which can provide our next-generation solid tumor
CAR T programs the ability to activate the patient's immune system
against the cancer cells.
-- Initiated manufacturing at the Cell and Gene Therapy Catapult
site in Stevenage, UK, in March 2019, and delivering clinical
products for patients in both Europe and the US.
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.
-- Report data from multiple clinical and pre-clinical programs
at key medical conferences throughout the year and progress
additional next generation programs through pre-clinical into
clinical development.
-- Expansion of the Company's suite of cell programming
technologies to include programming modules designed for allogeneic
applications, with the first novel allogeneic program expected to
enter the clinic in the fourth quarter of 2020.
Financial Results for the Quarter and Year Ended December 31,
2019
Cash and equivalents at December 31, 2019 totaled $210.6
million, before adjusting for the public offering in January 2020
of approximately $75 million net. This compared to $217.5 million
at December 31, 2018.
Net total operating expenses for the twelve months ended
December 31, 2019 were $146.1 million, net of grant income of $2.9
million, as compared to net operating expenses of $74.1 million,
net of grant income of $1.5 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 $105.4 million
for the year ended December 31, 2019 from $48.3 million for the
year ended December 31, 2018. Cash costs, which exclude
depreciation as well as share-based compensation, increased to
$83.4 million from $41.5 million. The increase in research and
development cash costs of $41.9 million consisted of an increase in
compensation-related costs of $20.0 million, primarily due to an
increase in headcount to support the advancement of our product
candidates in clinical development and investment in manufacturing
facilities and equipment, an increase of $4.1 million in research
and manufacturing consumables, in part due to the migration and
expansion of our research and process development laboratories from
Forest House to our new location in the Media Works facility,
preparations in advance of any potential disruption to supply
arrangements that may occur due to Brexit, as well as validation
and training costs as part of the start-up at the Catapult
facility, an increase of $10.2 million in facility costs primarily
related to the addition of Media Works and Catapult, an increase of
$3.8 million in project expenses related to the activities
necessary to prepare, activate, and monitor clinical trial
programs, an increase of $1.5 million in consulting, contracting
and license fees that includes a decrease in milestone payments of
$0.5 million consisting of a milestone payable to UCL Business plc
in 2018 and a milestone payable to Noile-Immune Biotech Inc. in
2019, and an increase in IT and general office expenses of $2.3
million.
General and administrative expenses increased to $39.5 million
for the year ended December 31, 2019 from $27.3 million for the
year ended December 31, 2018. Cash costs, which exclude
depreciation as well as share-based compensation increased to $26.6
million from $21.4 million. The increase of $5.2 million consisted
primarily of an increase in compensation-related costs of $2.6
million due to an overall increase in headcount, an increase of
$1.9 million in commercial costs, an increase in public company
compliance costs of $1.0 million, an increase of $0.7 million in
facility costs related to lease and maintenance costs, offset by
decrease of $1.0 million in IT charges, project expenses, and other
office expenses.
Net loss attributable to ordinary shareholders was $123.8
million for the twelve months ended December 31, 2019, compared to
$57.9 million for the same period in 2018.
The basic and diluted net loss per ordinary share for the twelve
months ended December 31, 2019 totaled $(2.88) compared to a basic
and diluted net loss per ordinary share of $(1.48) for the twelve
months ended December 31, 2018.
Autolus anticipates that cash on hand provides a runway into
2022.
Conference Call and Presentation Information
Autolus management will host a conference call today, March 3,
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 1090568. 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
1090568.
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 pre-clinical 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
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, PhD
Vice President, Investor Relations and Corporate
Communications
+44 (0) 7587 372 619
l.crabtree@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-212-966-3650
susan@sanoonan.com
# # #
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
December 31,
(unaudited)
2019 2018
---------------------------------------------- -------------------------------------
Grant income $ 2,908 $ 1,472
Gain on disposal
Operating expenses:
Research and development (105,418) (48,299)
General and
administrative (39,452) (27,299)
Loss on impairment of
leasehold
improvements (4,102) -
---------------------------------------------- -------------------------------------
Total operating expenses,
net (146,064) (74,126)
Other income (expense):
Interest income 2,542 2,011
Other Income / (expense) 4,514 5,752
---------------------------------------------- -------------------------------------
Total other income
(expense),
net 7,056 7,763
---------------------------------------------- -------------------------------------
Net loss before income tax (139,008) (66,363)
Income tax benefit 15,159 8,488
---------------------------------------------- -------------------------------------
Net loss attributable to
ordinary
shareholders $ (123,849) $ (57,875)
Basic and diluted net
loss per
ordinary share $ (2.88) $ (1.48)
Weighted-average basic
and diluted
ordinary shares 43,065,542 39,163,413
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
December 31,
2019 2018
--------- -----------
Assets
Current assets:
Cash $210,643 $217,450
Restricted cash 787 105
Prepaid expenses and other current assets 37,826 15,411
-------- --------
Total current assets 249,256 232,966
Non-current assets:
Property and equipment, net 28,164 19,968
Right of use asset, net 23,409 -
Long-term deposits 2,040 1,276
Deferred tax asset 410 -
Intangible assets, net 254 -
--------
Total assets $303,533 $254,210
======= =======
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 1,075 2,022
Accrued expenses and other liabilities 21,398 19,054
Lease liability 2,511 -
--------
Total current liabilities 24,984 21,076
Non-current liabilities:
Lease liability 23,710 -
Long-term lease incentive obligation - 207
Other long-term payables - 285
-------- --------
Total liabilities 48,694 21,568
Shareholders' equity:
Ordinary shares, $0.000042 par value; 200,000,000
shares authorized at December 31, 2019 and 2018,
44,983,006 and 40,145,617 shares issued and outstanding
at December 31, 2019 and 2018 2 2
Deferred shares, GBP0.00001 par value; 34,425 shares
authorized, issued and outstanding at December 31,
2019 and 2018 - -
Deferred B shares, GBP0.00099 par value; 88,893,548
shares authorized, issued and outstanding at December
31, 2019 and 2018 118 118
Deferred C shares, GBP0.000008 par value; 1 share
authorized, issued and outstanding at December 31,
2019 and 2018 - -
Additional paid-in capital 500,560 361,311
Accumulated other comprehensive loss (8,691) (15,488)
Accumulated deficit (237,150) (113,301)
-------- --------
Total shareholders' equity 254,839 232,642
-------- --------
Total liabilities and shareholders' equity $303,533 $254,210
======= =======
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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