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REG - Syncona Limited - Autolus reports Q1 2023 Financial Results

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RNS Number : 4442Y  Syncona Limited  04 May 2023

Syncona Limited

 

Autolus reports first quarter 2023 Financial Results and Operational Progress

 

4 May 2023

Syncona Ltd, a leading healthcare company focused on creating, building and
scaling 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 quarter ended March
31, 2023.

Key highlights included:

·     Lead obe-cel therapy for relapsed/refractory (r/r) B-cell Acute
Lymphoblastic Leukemia (ALL) on track for data updates at the American Society
of Clinical Oncology (ASCO) and European Hematology Association (EHA)
conferences in June 2023, with a Biologics License Application submission to
the US Food and Drug Administration (FDA) planned by the end of the year

·   Post period end announced US commercial distribution partnership with
Cardinal Health, enabling distribution capabilities required to commercialise
a CAR T-cell therapy in the US

·    Purpose-built commercial manufacturing facility on track for the
commencement of Good Manufacturing Practice (GMP) operations in H2 2023, with
an initial capacity of up to 2,000 batches per year

·    Autolus estimates that its current cash and cash equivalents on hand
and anticipated future milestone payments from Blackstone will extend the
Company's runway into 2025

The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations/news/
(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/ 1:30 pm
BST, 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/
(https://www.autolus.com/investor-relations/events/)

 

 

 ENDS 

 

Copies of this press release and other corporate information can be found on
the company website at: www.synconaltd.com (http://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
creating and building companies to deliver transformational treatments to
patients in areas of high unmet need.

 

Our strategy is to create, build and scale companies around exceptional
science to create a diversified portfolio of 20-25 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 First Quarter 2023 Financial Results and
Operational Progress

 

-     Obe-cel, a potentially transformational treatment for
relapsed/refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL), on track
for next data update at ASCO and EHA, with a Biologics License Application
(BLA) submission to the US FDA planned by end of the year

-     Establishing core distribution capabilities required to
commercialize a CAR T-cell therapy in the US by selecting Cardinal Health as
commercial distribution partner

-     Purpose-built commercial manufacturing facility on track to commence
Good Manufacturing Practice (GMP) operations in H2 2023

-     Conference call to be held today at 8:30 am EDT/1:30 pm BST

 

LONDON, May 04, 2023 - 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 quarter ended March 31, 2023.

 

"It has been a busy quarter as we continue to execute on delivering on our
obe-cel strategy in order to bring this innovative and potentially
transformative treatment to an underserved adult Acute Lymphoblastic Leukemia
(ALL) patient population," said Dr. Christian Itin, Chief Executive Officer of
Autolus. "We look forward to presenting data from all patients treated in the
FELIX study in an oral presentation at the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting, as well as data at the European Hematology
Association (EHA) 2023 Congress, both in June, with longer term follow up data
expected at the American Society of Hematology (ASH) meeting at the end of the
year."

 

"Meanwhile, we continue to advance plans for the submission of a BLA for
obe-cel at the end of the year and working towards commercial launch in 2024,
subject to required regulatory approval. Post period end we selected Cardinal
Health as the US commercial distribution partner for obe-cel and we continue
to build out our own commercial infrastructure as we look to on-board centers
over the course of this year. Our purpose-built commercial manufacturing
facility is on track for the commencement of Good Manufacturing Practice (GMP)
operations in H2 2023 with an initial capacity of up to 2,000 batches per
year, which we predict will be sufficient to serve global demand in adult
ALL."

 

Key obe-cel Updates:

 

·    Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r)
adult ALL - The FELIX Study

o Oral presentations of the FELIX pivotal study to be presented at ASCO and
EHA. The Company expects data from the FELIX study to form the basis of a BLA
submission for obe-cel to the FDA at the end of 2023 and plans to present
longer term follow up data and subgroup analysis data at the American Society
of Hematology (ASH) meeting in late 2023, as well as at medical conferences in
H1 2024.

 

Obe-cel trials in collaboration with University College London

 

·    Obe-cel in r/r adult B-ALL patients - Phase 1 ALLCAR19 Study

o Long term follow-up data were presented at the Tandem Meetings:
Transplantation & Cellular Therapy Meetings of the American Society for
Transplantation and Cellular Therapy (ASTCT) and the Center for International
Blood & Marrow Transplant Research (CIBMTR). The data demonstrated that
35% of adult B-ALL patients remained in complete remission at a median follow
up of 36 months without the need for additional anti-leukemia therapy.

 

·    Obe-cel in r/r B-NHL and CLL patients - Phase 1 ALLCAR19 Extension
Study

o Data presented at the ASH meeting in December 2022 demonstrated the
potentially best-in-class profile of obe-cel supported by the data observed in
B-cell non-Hodgkin lymphoma (NHL), with continued high levels of clinical
activity paired with an encouraging tolerability profile across diffuse large
B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL)
and chronic lymphocytic leukemia (CLL). Patients continue to be enrolled into
the study and the Company expects to publish the full results in a
peer-reviewed journal.

 

·    Obe-cel in Primary CNS Lymphoma patients - Phase 1 CAROUSEL Study

o Data presented at the EHA meeting in June 2022 demonstrated first activity
in primary CNS lymphoma. The study is fully enrolled, and the Company expects
to publish the full results in a peer-reviewed journal.

 

·    AUTO1/22 in pediatric B-ALL patients - Phase 1 CARPALL Study

o Data presented at the European Society for Blood and Marrow Transplantation
(EBMT) Annual Meeting in April 2023 by the Company's UCL collaborators, showed
favorable safety profile and good efficacy in a heavily pre-treated cohort of
patients. Importantly, there were no observed antigen negative relapses
observed as of the data cut-off date, indicating that the combining of our
optimized CD22 CAR design with the CD19 CAR used in obe-cel may be effective
in preventing antigen-loss driven relapse in pediatric B-ALL. The preclinical
data supporting this program was published in Molecular Therapy in March 2023.

 

Early-stage pipeline - leveraging academic collaborations to generate
opportunity for non-dilutive funding

 

·    AUTO4 in T Cell Lymphoma patients - Phase 1/2 LibrA T1 Study

o Autolus has optimized the manufacturing process for AUTO4 and is enrolling
additional patients into the trial to evaluate this manufacturing change. The
next update is planned as an oral presentation at the International Conference
on Malignant Lymphoma in June 2023.

 

·    AUTO8 in Multiple Myeloma - Phase 1 MCARTY Study

o AUTO8 is a next-generation product candidate for multiple myeloma, which
comprises two independent CARs for the multiple myeloma targets, BCMA and
CD19. In collaboration with UCL, the Company initiated a study in Q1 2022.
Patients continue to be enrolled and initial data is expected in 2023.

 

·    AUTO6NG in Neuroblastoma

o AUTO6NG contains a CAR that targets GD2 alongside additional programming
modules to enhance the activity and persistence. In collaboration with UCL,
the Company is planning on initiating a clinical trial of AUTO6NG in 2023.

 

Key Operational Updates during Q1 2023

 

·    The Company's new 70,000 square foot commercial manufacturing
facility in Stevenage, UK has continued to progress on track. Key equipment
installation and validation were completed by Autolus in Q1 2023 enabling
operational qualifications commencing in Q2 2023. Activities are on track for
the commencement of GMP operations in H2 2023. The 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 is on track for submission of a BLA
by the end of 2023.

 

·    Announced a collaboration with Cabaletta Bio in January 2023. Autolus
received an upfront payment for non-exclusive access to the RQR8 safety switch
for use in Cabaletta's CD19-CAR T cell therapy program for the treatment of
autoimmune disease, with the potential for near term option exercise fees and
development and regulatory milestone payments. In addition, Autolus is
entitled to receive royalties on net sales of all Cabaletta cell therapy
products that incorporate the RQR8 safety switch.

 

·    Announced two changes to the Board of Directors. The Company's
non-executive Chairman, John H. Johnson, who has held the role since September
2021, will not stand for re-election at Autolus' upcoming annual shareholder
meeting. Additionally, Dr. Jay T. Backstrom, who has served on Autolus' Board
of Directors since August 2020, stepped down from Autolus' Board of Directors
at the end of February 2023.

 

·    Dr. Lucinda Crabtree will step down as CFO in August 2023. A search
for a successor is under way.

 

Post Period End:

 

·    Autolus selected Cardinal Health to provide core distribution
capabilities required for U.S. commercialization of CAR T-cell therapies.
Under the proposed agreement, Cardinal Health 3PL Services will establish
essential capabilities for Autolus to commercialize a CAR T-cell therapy in
the US, including a depot model that allows Autolus to maintain custody and
physically position product closer to treatment sites during finalization of
product release, with the goal of shortening vein-to-delivery times. In
addition, Cardinal Health will help provide seamless order-to-cash
capabilities.

 

·    Autolus hosted a Virtual Capital Markets Day on Thursday, April 27,
2023, where members of the Executive Management Team and Key Opinion Leaders
presented on the obe-cel commercial opportunity and positioning. A replay
(https://edge.media-server.com/mmc/p/eqkenav8) of the event is available on
the Autolus website.

 

·    In April 2023 Autolus announced data from the AUTO1/22 in a clinical
trial of pediatric ALL patients at the EBMT Annual Meeting. This followed the
publication of the preclinical work supporting this program in March in
Molecular Therapy, 'Dual targeting of CD19 and CD22 against B-ALL using a
novel high sensitivity aCD22 CAR.'

 

·    In April 2023 Autolus announced the publication of a paper in
Molecular Therapy Nucleic Acids, 'Novel Fas-TNFR chimeras that prevent Fas
ligand-mediated kill and signal synergistically to enhance CAR T-cell
efficacy. The paper outlined how Fas-CD40 chimera can render T cell therapies
resistant to FasL-mediated cell death and improve their effectiveness against
solid tumors.

 

·    In April 2023, Autolus moved funds to additional highly rated liquid
money market funds. The limit to any one counterparty is less than 25% of the
Company's total cash and cash equivalents balance.

 

Financial Results for the First Quarter Ended March 31, 2023

Cash and cash equivalents and restricted cash at March 31, 2023, totaled
$343.4 million, as compared to cash of $382.8 million at December 31, 2022.

 

Net total operating expenses for the three months ended March 31, 2023, were
$43.1 million, which included license revenue income of $1.3 million, as
compared to net total operating expenses of $41.8 million, which included
grant income of $0.2 million, for the same period in 2022.

 

Research and development expenses decreased by $2.7 million to $31.3 million
for the three months ended March 31, 2023 from $34.0 million for the three
months ended March 31, 2022 primarily due to:

·    a decrease of $5.5 million in clinical trial and manufacturing costs
which is offset by an increase of $0.8 million in manufacturing material costs
due to increased validation activities undertaken, primarily relating to our
obe-cel clinical product candidate,

·    a decrease of $0.2 million in depreciation and amortization related
to property, plant and equipment and intangible assets due to the reduction in
our depreciable asset base,

·    a decrease of $0.1 million in legal fees and professional consulting
fees in relation to our research and development activities,

·    an increase of $1.4 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 $0.7 million related to information technology
infrastructure and support for information systems related to the conduct of
clinical trials and manufacturing operations, and

·    an increase of $0.2 million in facilities costs related to our new
manufacturing facility, the "Nucleus", in Stevenage, United Kingdom as well
increase in costs related to maintaining our current leased properties.

 

General and administrative expenses increased by $1.3 million to $9.3 million
for the three months ended March 31, 2023 from $8.0 million for the three
months ended March 31, 2022 primarily due to:

·    an increase of $0.7 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 $0.7 million in commercial readiness costs due to
increased commercial readiness activities being undertaken,

·    an increase of $0.1 in general office supplies and expenses
facilities costs due to the increase in space utilized for general and
administrative activities,

·    a decrease of $0.2 million primarily related to a reduction in
directors' and officers' liability insurance premiums, legal and professional
fees.

For the three months ended March 31, 2023, we recognized a loss on disposal
of property and equipment of $3.8 million related to fixed assets no longer
being utilized in the manufacturing facility exited in Stevenage, United
Kingdom. There were no such disposals for the three months ended March 31,
2022.

 

Other income, net decreased to $0.8 million from $0.9 million for the three
months ended March 31, 2023 and 2022, respectively. The decrease of $0.1
million is primarily due to the recognition of a lease termination loss
arising from the termination and exit of one of our manufacturing suites in
Stevenage, United Kingdom.

 

Interest income increased to $3.4 million for the three months ended March 31,
2023, as compared to $28,000 for the three months ended March 31, 2022. The
increase in interest income of $3.4 million primarily relates to the increase
in interest rates on our interest-bearing bank accounts and short-term
investments during the three months ended March 31, 2023 as compared to the
three months ended March 31, 2022.

 

Interest expense increased to $4.9 million for the three months ended March
31, 2023 as compared to $1.8 million for the three months ended March 31,
2022. Interest expense is primarily related to the liability for future
royalties and sales milestones, net associated with our strategic
collaboration agreement with Blackstone.

 

Net loss attributable to ordinary shareholders was $39.8 million for the three
months ended March 31, 2023, compared to $37.1 million for the same period in
2022. The basic and diluted net loss per ordinary share for the three months
ended March 31, 2023, totaled $(0.23) compared to a basic and diluted net loss
per ordinary share of $(0.41) for the three months ended March 31, 2022.

 

Autolus estimates that its current cash and cash equivalents on hand and
anticipated future milestone payment from Blackstone will extend the Company's
runway into 2025.

 

Unaudited Financial Results for the Quarter Ended March 31, 2023

Condensed Consolidated Balance Sheet

(In thousands, except share and per share amounts)

 

                                                                                 March 31                      December 31
                                                                                 2023                          2022
 Assets
 Current assets:
 Cash and cash equivalents                                                       $         343,027             $          382,436
 Restricted cash                                                                             328                                 325
 Prepaid expenses and other current assets                                       50,530                        43,010
 Total current assets                                                            393,885                       425,771
 Non-current assets:
 Property and equipment, net                                                     34,667                        35,209
 Prepaid expenses and other non-current assets                                   465                           2,176
 Operating lease right-of-use assets, net                                        26,861                        23,210
 Long-term deposits                                                              1,821                         1,832
 Deferred tax asset                                                              2,272                         2,076
 Total assets                                                                    459,971                       490,274
 Liabilities and shareholders' equity
 Current liabilities:
 Accounts payable                                                                353                           531
 Accrued expenses and other liabilities                                          34,463                        40,797
 Operating lease liabilities, current                                            4,821                         5,038
 Total current liabilities                                                       39,637                        46,366
 Non-current liabilities:
 Operating lease liabilities, non-current                                        22,495                        19,218
 Liability related to future royalties and sales milestones, net                 130,805                       125,900
 Other long-term payables                                                        114                           116
 Total liabilities                                                               193,051                       191,600

 Shareholders' equity:
 Ordinary shares, $0.000042 par value; 290,909,783 authorized as of March 31,    8                             8
 2023 and December 31, 2022; 173,074,510 shares issued and outstanding at
 March 31, 2023 and December 31, 2022
 Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and                   -                                    -
 outstanding at March 31, 2023 and December 31, 2022
 Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued     118                           118
 and outstanding at March 31, 2023 and December 31, 2022
 Deferred C shares, £0.000008 par value; 1 share authorized, issued and                      -                                    -
 outstanding at March 31, 2023 and December 31, 2022
 Additional paid-in capital                                                      1,010,041                     1,007,625
 Accumulated other comprehensive loss                                            (33,257)                      (38,898)
 Accumulated deficit                                                             (709,990)                     (670,179)
 Total shareholders' equity                                                      266,920                       298,674
 Total liabilities and shareholders' equity                                      $         459,971             $          490,274

 

Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)

(In thousands, except share and per share amounts)

 

                                                         Three Months Ended March 31,
                                                         2023                                                        2022
 Grant income                                            $                        -                                  $                     166
 License revenue                                         1,292                                                                                -
 Operating expenses:
 Research and development                                (31,344)                                                    (33,963)
 General and administrative                              (9,284)                                                     (7,987)
 Loss on disposal of property and equipment              (3,768)                                                     -
 Total operating expenses, net                           (43,104)                                                    (41,784)
 Other income, net                                       782                                                         860
 Interest income                                         3,446                                                       28
 Interest expense                                        (4,905)                                                     (1,790)
 Total other expense, net                                (677)                                                       (902)
 Net loss before income tax                              (43,781)                                                    (42,686)
 Income tax benefit                                      3,970                                                       5,624
 Net loss attributable to ordinary shareholders          (39,811)                                                    (37,062)
 Other comprehensive loss:
 Foreign currency exchange translation adjustment        5,641                                                       (7,455)
 Total comprehensive loss                                $         (34,170)                                          $         (44,517)

 Basic and diluted net loss per ordinary share           $(0.23)                                                     $(0.41)
 Weighted-average basic and diluted ordinary shares      173,825,825                                                 90,914,175

 

Conference Call

Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST
to discuss the company's financial results and provide a general business
update. Conference call participants should pre-register using this link
(https://register.vevent.com/register/BIcd0f890b70154161b63d1500d4338cee) to
receive the dial-in numbers and a personal PIN, which are required to access
the conference call.

 

A simultaneous audio webcast and replay will be accessible on the events
section (https://www.autolus.com/investor-relations/news-and-events/events) 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 and
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 (https://clinicaltrials.gov/ct2/show/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 continued
development of Autolus' AUTO1/22 program; the status of clinical trials
(including, without limitation, expectations regarding the data that is being
presented, the expected timing of data releases and development, as well as
completion of clinical trials) and development timelines for the Company's
product candidates. 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 7, 2023,
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:

 

Julia Wilson

+44 (0) 7818 430877

j.wilson@autolus.com (mailto:j.wilson@autolus.com)

 

Susan A. Noonan

S.A. Noonan Communications

+1-917-513-5303

susan@sanoonan.com (mailto:susan@sanoonan.com)

 

Alexandra Deschner

+32-490-58-35-23

a.deschner@autolus.com (mailto:a.deschner@autolus.com)

 

 

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