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RNS Number : 2318F
Syncona Limited
03 November 2022
Syncona Limited
Autolus Reports Q3 2022 Financial Results and Operational
Progress
3 November 2022
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 third quarter ended September 30, 2022.
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations/news/ and the full text
of the announcement from Autolus is contained below. Autolus
management will host a conference call today, at 8:30 am ET/ 12:30
pm GMT, to discuss the company's financial results and provide a
general business update. To listen to the webcast and view the
accompanying slide presentation, please go to:
https://www.autolus.com/investor-relations/events/
[S]
Copies of this press release and other corporate information can
be found on the company website at: www.synconaltd.com
Forward-looking statements - this announcement contains certain
forward-looking statements with respect to the portfolio of
investments of Syncona Limited. These statements and forecasts
involve risk and uncertainty because they relate to events and
depend upon circumstances that may or may not occur in the future.
There are a number of factors that could cause actual results or
developments to differ materially from those expressed or implied
by these forward-looking statements. In particular, many companies
in the Syncona Limited portfolio are conducting scientific research
and clinical trials where the outcome is inherently uncertain and
there is significant risk of negative results or adverse events
arising. In addition, many companies in the Syncona Limited
portfolio have yet to commercialise a product and their ability to
do so may be affected by operational, commercial and other risk
Enquiries
Syncona Ltd
Annabel Clark / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Julia Bradshaw / Tim
Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona's purpose is to invest to extend and enhance human life.
We do this by founding and building companies to deliver
transformational treatments to patients in areas of high unmet
need.
Our strategy is to found, build and fund companies around
exceptional science to create a diversified portfolio of 15-20
globally leading healthcare businesses for the benefit of all our
stakeholders. We focus on developing treatments for patients by
working in close partnership with world-class academic founders and
management teams. Our balance sheet underpins our strategy enabling
us to take a long-term view as we look to improve the lives of
patients with no or poor treatment options, build sustainable life
science companies and deliver strong risk-adjusted returns to
shareholders.
Autolus Therapeutics Reports Third Quarter 2022 Financial
Results and Operational Progress
- Pivotal FELIX Phase 2 clinical trial of obe-cel in
relapsed/refractory (r/r) Acute Lymphoblastic Leukemia (ALL) on
track for Q4 2022 update
- Commercial manufacturing site build on schedule for handover
of first clean rooms to Autolus in Q4 2022
- Post-period end announcements: Bristol Myers Squibb licensed
Autolus' proprietary safety switch and Moderna exercised its option
for Autolus' proprietary binders
- Pipeline updates expected at American Society of Hematology
(ASH) Annual Meeting in December 2022 - abstracts online November
3, 2022 at 09:00 am ET/1:00 pm GMT
- Conference call to be held on November 3, 2022 at 8:30 am ET/12:30 pm GMT
LONDON , November 3, 2022 - 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, 2022.
"Autolus has continued to deliver further strategic and
operational progress during the third quarter of 2022, with our
pivotal FELIX trial on track for a Q4 2022 update, the commercial
manufacturing facility build on schedule for the handover of the
first clean rooms to Autolus, and the announcement post-period end
of an agreement for our proprietary technology with Bristol Myers
Squibb and an option exercise by Moderna," said Dr. Christian Itin,
CEO of Autolus "Alongside this, we have continued progressing our
pipeline candidates through Phase 1 clinical trials through our
long-standing collaboration with UCL, laying the foundations for
our clinical pipeline beyond obe-cel. We are looking forward to
updating the market with our progress over the coming months as we
remain fully focused on bringing obe-cel to market."
Key Pipeline Programs:
-- Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL - The FELIX Trial
o The pivotal FELIX Phase 2 clinical trial is on track to report
initial results in Q4 2022. Autolus plans to present FELIX Phase 2
data at a medical conference in mid-2023. Assuming a positive
outcome from the FELIX trial, the Company expects the data to form
the basis of a Biologics License Application (BLA) submission for
obe-cel to the FDA at the end of 2023.
-- Obe-cel in r/r adult ALL patients - ALLCAR19 Trial
o In collaboration with University College London (UCL), Autolus
expects to present long term follow-up data from the Phase 1
ALLCAR19 trial in Q4 2022 at the 2022 ASH meeting, to be held
December 10-13, 2022. Abstracts will be online November 3, 2022 at
09:00 am ET/1:00 pm GMT.
-- Obe-cel in r/r B-NHL patients - ALLCAR19 Extension Trial
o In collaboration with UCL, patients continue to be enrolled
into the Phase 1 ALLCAR19 extension trial. Data were presented at
the European Hematology Congress (EHA) in June 2022, and
longer-term follow up will be presented at the 2022 ASH meeting in
December. Abstracts will be online November 3, 2022 at 09:00 am
ET/1:00 pm GMT.
-- Obe-cel in Primary CNS Lymphoma patients - CAROUSEL Trial
o In collaboration with UCL, patients continue to be enrolled
into the Phase 1 CAROUSEL trial. Data were presented at EHA in June
2022 - and longer-term follow up data is planned in 2023.
-- AUTO1/22 in pediatric ALL patients - CARPALL Trial
o In collaboration with UCL, patients continue to be enrolled
into the AUTO1/22 Phase 1 CARPALL trial. Data were presented at EHA
in June 2022, and longer-term follow up data will be presented at
the 2022 ASH Meeting in December. Abstracts will be online November
3, 2022 at 09:00 am ET/1:00 pm GMT.
-- AUTO4 in T Cell Lymphoma patients - LibrA T1 Trial
o Autolus has optimized the manufacturing process for AUTO4, and
is currently enrolling additional patients into the trial to test
this manufacturing change. Data were presented at EHA in June 2022,
and longer-term follow up data will be presented at the 2022 ASH
Meeting in December. Abstracts will be online November 3, 2022 at
09:00 am ET/1:00 pm GMT.
-- AUTO8 in Multiple Myeloma - MCARTY Trial
o In collaboration with UCL, patients continue to be enrolled
into the AUTO8 Phase 1 clinical trial, with first data expected in
H2 2023.
-- AUTO6NG in Neuroblastoma - MCARGD2 Trial
o In collaboration with UCL, the first patient is expected to be
dosed in the Phase 1 MCARGD2 clinical trial in H1 2023, with
initial data expected towards the end of 2023.
Key Operational Updates during Q3 2022
-- The build phase of the Company's new 70,000 square foot
commercial manufacturing facility in Stevenage, UK has continued to
progress on track with the planned schedule during Q3 2022, with
Phase 1 of the buildout scheduled to complete in Q4 2022. This
first phase includes the first of three cell product commercial
manufacturing clean rooms in Stevenage. Final equipment
installations and qualification by Autolus are on track for the
commencement of Good Manufacturing Practice (GMP) operations in H2
2023. This facility has been designed for a capacity of 2,000
batches per year with the option to expand capacity as needed.
-- Autolus is on schedule to complete the development work and
report generation for the Chemistry Manufacturing and Controls
(CMC) package planned to be submitted to the FDA. All work
including process qualification activities in the new Stevenage
facility are on track for submission of a BLA by the end of
2023.
Post Period End:
-- In October 2022, Autolus announced a new collaboration with
Bristol Myers Squibb, and the exercise of an option by Moderna
under an existing license and option agreement announced in August
2021. These two technology deals underscore the scientific
capabilities and expertise at Autolus.
o Bristol Myers Squibb entered into a licensing agreement with
Autolus for access to the Company's proprietary RQR8
rituximab-induced safety switch for incorporation into a set of
selected cell therapy programs, in return for an upfront payment,
with potential for near term option exercise fees and development
milestone payments plus royalties.
o Moderna exercised an option on one of the proprietary binders
being developed against an undisclosed immuno-oncology target for
the delivery of pioneering messenger RNA (mRNA) therapeutics, in
return for an upfront payment, development and commercial milestone
payments for each product successfully commercialized, as well as
royalties on net sales of all products commercialized under the
agreement.
This license option stems from a deal announced on August 2,
2021, granting Moderna an exclusive option to license Autolus'
proprietary binders for incorporation in certain mRNA
therapeutics.
Financial Results for the Quarter Ended September 30, 2022
Cash at September 30, 2022, totaled $163.1 million, as compared
to cash of $310.3 million at December 31, 2021. Post period end the
company received $19.1m in relation to its 2021 U.K research and
development tax credit claim.
Net total operating expenses for the three months ended
September 30, 2022, were $43.5 million, which included license
revenue income of $2.4 million, as compared to net operating
expenses of $40.4 million, which included grant income of $0.2
million, for the same period in 2021.
Research and development expenses increased by $5.3 million to
$37.6 million for the three months ended September 30, 2022 from
$32.3 million for the three months ended September 30, 2021
primarily due to:
-- an increase of $3.6 million in clinical costs and
manufacturing costs primarily relating to the Company's obe-cel
clinical product candidate,
-- an increase of $2.0 million in salaries and other employment
related costs including share-based compensation expense, which was
mainly driven by an increase in the number of employees engaged in
research and development activities,
-- an increase of $0.8 million in legal fees and professional
consulting fees in relation to the Company's research and
development activities,
-- an increase of $0.2 million related to information technology
infrastructure and support for information systems related to the
conduct of clinical trials and manufacturing operations.
-- a decrease of $0.7 million in facilities costs related to the
termination and closure of the Company's US manufacturing facility
in 2021 and a shift in the Company's overall manufacturing
strategy, and
-- a decrease of $0.6 million in depreciation and amortization
related to property, plant and equipment and intangible assets.
General and administrative expenses decreased by $0.1 million to
$8.2 million for the three months ended September 30, 2022 from
$8.3 million for the three months ended September 30, 2021
primarily due to:
-- an increase of $1.0 million in salaries and other employment
related costs including share-based compensation expenses, which
was mainly driven by an increase in the number of employees engaged
in general and administrative activities,
-- an increase of $0.1 million in facilities costs due to the
increased space utilized for general and administrative
activities,
-- a decrease of $1.1 million primarily related to a reduction
in directors' and officers' liability insurance premiums, as well
as reduced professional fees and information technology costs,
and
-- a decrease of $0.1 million in depreciation and amortization
related to property, plant and equipment and intangible assets.
Other (expense) / income net, decreased to an expense of $3.7
million from an income of $1.0 million for the three months ended
September 30, 2022 and 2021, respectively. The decrease of $4.7
million is primarily due to the weakening of the pound sterling
relative to the U.S. dollar exchange rate during the three month
period.
Interest expense increased to $1.9 million for the three months
ended September 30, 2022 and relates primarily to the liability
related to sale of future royalties and sales milestones which
arose upon the Company's entry into the strategic collaboration and
financing agreement with Blackstone, in November 2021. There was no
interest expense during the comparable period in 2021.
Income tax benefit increased by $0.8 million to $6.2 million for
the three months ended September 30, 2022 from $5.4 million for the
three months ended September 30, 2021 due to an increase in
qualifying research and development expenditures for the
quarter.
Net loss attributable to ordinary shareholders was $42.8 million
for the three months ended September 30, 2022, compared to $34.0
million for the same period in 2021. The basic and diluted net loss
per ordinary share for the three months ended September 30, 2022,
totaled $(0.47) compared to a basic and diluted net loss per
ordinary share of $(0.47) for the three months ended September 30,
2021.
Autolus estimates that its current cash on hand and anticipated
milestone payments in the relevant period from Blackstone extends
the Company's runway into 2024.
Unaudited Financial Results for the Quarter Ended September 30,
2022
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
September December
30, 2022 31,
2021
------------------------------ ------------------------------
Assets
Current assets:
Cash $ 163,053 $ 310,338
Restricted cash 315 338
Prepaid expenses and other assets, current 48,943 36,276
------------------------------ ------------------------------
Total current assets 212,311 346,952
Non-current assets:
Property and equipment, net 32,474 33,541
Prepaid expenses and other non-current assets 1,718 2,362
Operating lease right-of-use assets 13,235 18,775
Long-term deposits 1,688 2,039
Deferred tax asset 2,396 1,826
Intangible assets, net 8 65
------------------------------ ------------------------------
Total assets $ 263,830 $ 405,560
============================== ==============================
Liabilities and shareholders' equity
Current liabilities:
Accounts payable $ 334 $ 431
Accrued expenses and other liabilities 34,669 23,667
Operating lease liabilities 3,815 4,453
------------------------------ ------------------------------
Total current liabilities 38,818 28,551
Non-current liabilities:
Operating lease liabilities, net of current portion 11,310 16,545
Liability related to sale of future royalties and
sales milestones, net 52,443 47,016
Other long-term payables 105 128
------------------------------ ------------------------------
Total liabilities 102,676 92,240
Commitments and contingencies (Note 12)
Shareholders' equity:
Ordinary shares, $0.000042 par value;
290,909,783
and 200,000,000 shares authorized as of
September
30, 2022 and December 31, 2021,
respectively; 91,132,356
and 90,907,830, shares issued and
outstanding at
September 30, 2022 and December 31, 2021,
respectively 4 4
Deferred shares, GBP0.00001 par value; 34,425
shares
authorized, issued and outstanding at
September 30,
2022 and December 31, 2021 - -
Deferred B shares, GBP0.00099 par value;
88,893,548
shares authorized, issued and outstanding at
September
30, 2022 and December 31, 2021 118 118
Deferred C shares, GBP0.000008 par value; 1
share
authorized, issued and outstanding at
September 30,
2022 and December 31, 2021 - -
Additional paid-in capital 851,824 843,108
Accumulated other comprehensive loss (47,564) (8,570)
Accumulated deficit (643,228) (521,340)
------------------------------ ------------------------------
Total shareholders' equity 161,154 313,320
------------------------------ ------------------------------
Total liabilities and shareholders' equity $ 263,830 $ 405,560
============================== ==============================
Condensed Consolidated Statements of Operations and
Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
2022 2021 2022 2021
------------------- ----------------------- ---------------------- -----------------------
Grant income $ - $ 236 $ 166 $ 643
License revenue 2,369 - 2,369 1,507
Operating
expenses:
Research and
development (37,632) (32,292) (109,806) (95,154)
General and
administrative (8,231) (8,299) (24,487) (24,274)
Loss on disposal of
leasehold
improvements - - - (672)
------------------- ----------------------- ---------------------- -----------------------
Total operating
expenses,
net (43,494) (40,355) (131,758) (117,950)
Other (expense)
income:
Other (expense)
income, net (3,740) 951 (4,214) (59)
Interest income 165 28 282 113
Interest expense (1,850) - (5,448) -
------------------- ----------------------- ---------------------- -----------------------
Total other
(expense) income,
net (5,425) 979 (9,380) 54
------------------- ----------------------- ---------------------- -----------------------
Net loss before
income tax (48,919) (39,376) (141,138) (117,896)
Income tax benefit 6,152 5,385 19,250 17,466
------------------- ----------------------- ---------------------- -----------------------
Net loss
attributable to
ordinary
shareholders (42,767) (33,991) (121,888) (100,430)
Other
comprehensive
loss:
Foreign currency
exchange
translation
adjustment (14,054) (6,463) (38,994) (3,648)
------------------- ----------------------- ---------------------- -----------------------
Total comprehensive
loss $ (56,821) $ (40,454) $ (160,882) $ (104,078)
=================== ======================= ====================== =======================
Basic and diluted
net loss
per ordinary share $ (0.47) $ (0.47) $ (1.34) $ (1.46)
=================== ======================= ====================== =======================
Weighted-average
basic and
diluted ordinary
shares 91,240,801 72,896,362 91,028,562 68,770,962
=================== ======================= ====================== =======================
Conference Call
Management will host a conference call and webcast at 8:30 am
ET/12:30 pm GMT to discuss the Company's financial results and
provide a general business update. Conference call participants
should pre-register using this link to receive the dial-in numbers
and a personal PIN, which are required to access the conference
call. The webcast can be accessed at this link .
A simultaneous audio webcast and replay will be accessible on
the events section of Autolus' website.
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.
About obe-cel (AUTO1)
Obe-cel is a CD19 CAR T cell investigational therapy designed to
overcome the limitations in clinical activity and safety compared
to current CD19 CAR T cell therapies. Designed to have a fast
target binding off-rate to minimize excessive activation of the
programmed T cells, obe-cel may reduce toxicity and be less prone
to T cell exhaustion, which could enhance persistence and improve
the ability of the programmed T cells to engage in serial killing
of target cancer cells. In collaboration with Autolus' academic
partner, UCL, obe-cel is currently being evaluated in a Phase 1
clinical trials for B-NHL. Autolus has progressed obe-cel to the
FELIX trial, a pivotal trial for adult ALL.
About obe-cel FELIX clinical trial
Autolus' Phase 1b/2 clinical trial of obe-cel is enrolling adult
patients with relapsed / refractory B-precursor ALL. The trial had
a Phase 1b component prior to proceeding to the single arm, Phase 2
clinical trial. The primary endpoint is overall response rate, and
the secondary endpoints include duration of response, MRD negative
CR rate and safety. The trial is designed to enroll approximately
100 patients across 30 of the leading academic and non-academic
centers in the United States, United Kingdom and Europe.
[NCT04404660]
About AUTO1/22
AUTO1/22 is a novel dual targeting CAR T cell based therapy
candidate based on obe-cel. It is designed to combine the enhanced
safety, robust expansion & persistence seen with the fast off
rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to
reduce antigen negative relapses. This product candidate is
currently in a Phase 1 clinical trial for patients with r/r
pediatric ALL. [ NCT02443831 ]
About AUTO4
AUTO4 is a programmed T cell product candidate in clinical
development for T cell lymphoma, a setting where there are
currently no approved programmed T cell therapies. AUTO4 is
specifically designed to target TRBC1 derived cancers, which
account for approximately 40% of T cell lymphomas, and is a
complement to the AUTO5 T cell product candidate, which is in
pre-clinical development.
About AUTO5
AUTO5 is a programmed T cell product candidate in pre-clinical
development for T cell lymphoma, a setting where there are
currently no approved programmed T cell therapies. AUTO5 is
specifically designed to target TRBC2 derived cancers, which
account for approximately 60% of T cell lymphomas, and is a
complement to the AUTO4 T cell product candidate currently in
clinical development.
About AUTO6NG
AUTO6NG is a next generation programmed T cell product candidate
in pre-clinical development. AUTO6NG builds on preliminary proof of
concept data from AUTO6, a CAR targeting GD2-expression cancer cell
currently in clinical development for the treatment of
neuroblastoma. AUTO6NG incorporates additional cell programming
modules to overcome immune suppressive defense mechanisms in the
tumor microenvironment, in addition to endowing the CAR T cells
with extended persistence capacity. AUTO6NG is currently in
pre-clinical development for the potential treatment of both
neuroblastoma and other GD2-expressing solid tumors.
About AUTO8
AUTO8 is our next-generation product candidate for multiple
myeloma which comprises two independent CARs for the multiple
myeloma targets, BCMA and CD19. We have developed an optimized BCMA
CAR which is designed for improved killing of target cell that
express BCMA at low levels. This has been combined with fast off
rate CD19 CAR from obe-cel. We believe that the design of AUTO8 has
the potential to induce deep and durable responses and extend the
durability of effect over other BCMA CARs currently in
development.
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
the development of Autolus' product candidate pipeline and
achievement of expected near- and long-term milestones; the
development of the obe-cel program including planned readouts after
the completed futility analysis and completion of patient
enrollment; the future clinical development, efficacy, safety and
therapeutic potential of its other product candidates such as
AUTO1/22, AUTO4. AUTO5, AUTO6NG, and AUTO8, including progress,
expectations as to the reporting of data, conduct and timing and
potential future clinical activity and milestones; expectations
regarding regulatory approval process for any product candidates;
Autolus' eligibility for potential milestone and royalty payments,
and the Company's anticipated cash runway. 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. These risks and
uncertainties include, but are not
limited to, the risks that Autolus' preclinical or clinical
programs do not advance or result in approved products on a timely
or cost effective basis or at all; the results of early clinical
trials are not always being predictive of future results; the cost,
timing and results of clinical trials; that many product candidates
do not become approved drugs on a timely or cost effective basis or
at all; the ability to enroll patients in clinical trials; possible
safety and efficacy concerns; and the impact of the ongoing
COVID-19 pandemic on Autolus' business. For a discussion of other
risks and uncertainties, and other important factors, any of which
could cause Autolus' 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 10, 2022, as well as
discussions of potential risks, uncertainties, and other important
factors in Autolus' subsequent filings with the Securities and
Exchange Commission. All information in this press release is as of
the date of the release, and Autolus 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:
Olivia Manser
+44 (0) 7780 471568
o.manser@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com
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