REG - Syncona Limited - Autolus reports Q3 2023 Financial Results
02/11/2023 11:45
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RNS Number : 2145S Syncona Limited 02 November 2023
Syncona Limited
Autolus reports Q3 2023 financial results
2 November 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
September 30, 2023. A copy of the announcement is set out below, with key
highlights as follows:
· Lead obe-cel therapy, a potentially transformational treatment
for r/r adult B-Cell acute lymphoblastic leukaemia (B-ALL), on track for a
Biologics License Application (BLA) submission to the US Food & Drug
Administration (FDA) by end of CY2023 and commercial launch in CY2024,
dependent on the necessary regulatory approvals
· Clinical data updates expected at the American Society of
Hematology (ASH) meeting in December 2023, including long-term follow-up and
sub-group analysis from the pivotal FELIX trial of obe-cel and initial data
from a study of AUTO8 in multiple myeloma
· Continued progress with Autolus' commercial manufacturing
facility, The Nucleus, with process performance qualification production phase
complete and data package on track to support obe-cel's BLA filing.
Anticipated capacity of approximately 2,000 batches per annum sufficient to
meet US and EU adult ALL demand.
· Obe-cel's Phase I study in refractory systemic lupus
erythematosus (SLE) to start in H1 CY2024, with initial clinical data expected
in H2 CY2024
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 9:00 am EDT / 1:00 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/
(https://www.autolus.com/investor-relations/events/)
ENDS
Enquiries
Syncona Ltd
Annabel Clark / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / 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, across development stage and therapeutic areas, 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 2023 Financial Results and Business
Updates
· Obe-cel, a potentially transformational treatment for
relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), on
track for a Biologics License Application (BLA) submission to the US Food
& Drug Administration (FDA) by end of 2023
· Updated clinical data at the American Society of Hematology (ASH)
meeting in December 2023: Long-term follow-up and sub-group analysis from the
FELIX trial of obe-cel and initial data from a study of AUTO8 in multiple
myeloma
· Continued progress with commercial manufacturing facility, The
Nucleus, with process performance qualification production phase complete and
data package on track to support BLA submission
· Obe-cel Phase 1 study in refractory systemic lupus erythematosus
(SLE) expected to initiate in early 2024
· Conference call to be held today at 09:00 am EDT/1:00 pm GMT:
Conference call participants should pre-register using the link at the bottom
of this press release
LONDON, November 02, 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 September 30, 2023.
"The coming months will be an exciting and instrumental time for Autolus as we
plan for our first BLA submission for obe-cel with the US FDA by year end and
we continue with our preparatory activities for a planned commercial launch in
2024, pending the necessary regulatory approvals," said Dr. Christian Itin,
Chief Executive Officer of Autolus. "The data we have observed to date in the
FELIX study highlights the potential of obe-cel to deliver a high complete
remission rate combined with low levels of immunotoxicity and excellent CAR T
expansion and persistence in adult patients with relapsed/refractory ALL. We
look forward to building on the positive data when we present longer term
follow up and additional subgroup analysis data at ASH in December."
"Alongside this, our commercial manufacturing facility, The Nucleus, completed
process performance qualification activities in Q4 to support the BLA
submission, and we believe we are in a strong position operationally to
deliver product and meet the global demand for adult ALL treatment."
"Obe-cel's excellent risk/benefit profile combined with its ability to make
deep cuts into the CD19+ cell compartment, as illustrated by MRD-negative
complete remissions in adult and pediatric ALL patients, is a strong
foundation for the development of obe-cel in autoimmune disease. The clinical
profile together with our commercial product delivery base, attractive cost of
goods, and commercial infrastructure should help to drive an accelerated and
differentiated expansion of the obe-cel opportunity. We are excited at the
growing body of evidence that CAR T can address a significant unmet need in
autoimmune disease, and we look forward to starting a Phase I study of obe-cel
in refractory systemic lupus erythematosus (SLE) patients in early 2024."
Key obecabtagene autoleucel (obe-cel) updates and anticipated milestones:
· Obe-cel in relapsed / refractory (r/r) adult ALL - The FELIX Study
o Longer term follow-up data and subgroup analysis data will be presented at
ASH in December 2023, as well as at medical conferences in H1 2024.
o BLA submission is on track to the FDA by the end of 2023 and a submission of
a marketing authorization application to the European Medicines Agency (EMA)
in the first half of 2024.
· Obe-cel in B-cell mediated autoimmune diseases
o Phase 1 study in refractory SLE patients is on track to start in early 2024,
with initial clinical data expected in late 2024.
Pipeline clinical trials, in collaboration with University College London
(UCL), updates and anticipated milestones
· AUTO1/22 in pediatric B-ALL patients - Phase 1 CARPALL Study
o The data presented at European Society for Blood and Marrow
Transplantation (EBMT) in April 2023 on the AUTO1/22 Phase 1 CARPALL study was
published in Blood, in August 2023, entitled 'CD19/CD22 targeting with
co-transduced CAR T-cells to prevent antigen negative relapse after CAR T-cell
therapy of B-ALL'.
· AUTO8 in Multiple Myeloma - Phase 1 MCARTY Study
o AUTO8 is a next-generation product candidate for multiple myeloma, which
comprises two CARs for the multiple myeloma targets, BCMA and CD19. In
collaboration with UCL, the Company initiated a study in 2022. Patients
continue to be enrolled and initial data will be presented at ASH in December
2023.
· AUTO6NG in Neuroblastoma - Phase 1 MAGNETO Study
o AUTO6NG contains a CAR that targets GD2 alongside additional programming
modules to enhance the activity and persistence. UCL has received MHRA
approval for the conduct of a Phase 1 clinical study in children with r/r
neuroblastoma. The study is on track to be initiated in Q4 2023.
Key Operational Updates during Q3 2023
· The Company's new 70,000 square foot commercial manufacturing
facility, The Nucleus, in Stevenage, UK has completed process performance
qualification and is on track to support the BLA submission for obe-cel. The
Company estimates capacity of approximately 2,000 batches per annum, which is
anticipated to be sufficient to meet US and EU adult ALL demand.
· Previously announced leadership appointments of Rob Dolski as Chief
Financial Officer, effective August 7, 2023, as well as Dr. Veronica
Hersberger as Senior Vice President, Medical Affairs and Miranda Neville as
Senior Vice President Program Management.
Scientific Publications:
· Publication of a paper in Nature Medicine titled: 'Transcriptional
hallmarks of persisting CD19 CAR T-cells in children with leukemia' -
Ghorashian, S. et al, Nature Medicine; 2023. doi: 10.1038/s41591-023-02415-3
(https://www.nature.com/articles/s41591-023-02415-3) . Link to paper
(https://www.nature.com/articles/s41591-023-02415-3) .
· Publication of a paper in Blood titled: 'CD19/CD22 targeting with
co-transduced CAR T-cells to prevent antigen negative relapse after CAR T-cell
therapy of B-ALL' - Ghorashian et al, Blood; doi.org/10.1182/blood.2023020621
(https://www.globenewswire.com/Tracker?data=FneTpwv9IkhLOstQ7Sg3PLNNkTKR1k8VsA0aLWH38id0AJHGKhuAkVwMXqu3fGdlZLsFf_RWNoK5l6E_2OCxT-Bmm2_CZjtrj9nHP8gFH3eO6rWrmz9ql4nqB9F5OHz8)
. Link to paper
(https://ashpublications.org/blood/article-abstract/doi/10.1182/blood.2023020621/497728/CD19-CD22-targeting-with-co-transduced-CAR-T-cells?redirectedFrom=fulltext)
.
Expected News Flow
Obe-cel BLA submission to FDA By end 2023
Obe-cel FELIX data at ASH December 2023
AUTO8 update (MCARTY) at ASH December 2023
AUTO6NG Phase 1 study start (MAGNETO) By end 2023
Obe-cel in autoimmune disease - refractory SLE Phase 1 study start Early 2024
Obe-cel filing for a Marketing Authorization Application to EMA First half 2024
Financial Results for the Third Quarter Ended September 30, 2023
Cash and cash equivalents at September 30, 2023, totaled $256.4 million, as
compared to $382.4 million at December 31, 2022.
Total operating expenses, net for the three months ended September 30, 2023,
were $47.8 million, as compared to $43.5 million, for the same period in 2022.
Research and development expenses decreased by $0.4 million to $37.2 million
for the three months ended September 30, 2023 compared to the same period in
2022. This change was primarily due to decreases in clinical and manufacturing
costs related to the Company's obe-cel clinical program partially offset by
increases in operating costs related to the Company's new commercial
manufacturing facility and in salaries and related costs driven by increased
headcount.
General and administrative expenses increased by $2.4 million to $10.6 million
for the three months ended September 30, 2023 compared to the same period in
2022. This increase was primarily due to salaries and other employment-related
costs driven by an increase in general and administrative headcount supporting
the overall growth of the business, primarily relating to
pre-commercialization activities.
Net loss attributable to ordinary shareholders was $45.8 million for the three
months ended September 30, 2023, compared to $42.8 million for the same period
in 2022. The basic and diluted net loss per ordinary share for the three
months ended September 30, 2023, totaled $(0.26) compared to a basic and
diluted net loss per ordinary share of $(0.47) for the three months ended
September 30, 2022.
Autolus estimates that its current cash and cash equivalents on hand and
anticipated future milestone payment from Blackstone will extend the Company's
cash runway into 2025.
Unaudited Financial Results for the Third Quarter Ended September 30, 2023
Selected Condensed Consolidated Balance Sheet Data
(In thousands)
September 30, December 31,
2023 2022
Assets
Cash and cash equivalents $ 256,415 $ 382,436
Total current assets $ 308,382 $ 425,771
Total assets $ 406,098 $ 490,274
Liabilities and shareholders' equity
Total current liabilities $ 37,540 $ 46,366
Total liabilities $ 225,580 $ 191,600
Total shareholders' equity $ 180,518 $ 298,674
Total liabilities and shareholders' equity $ 406,098 $ 490,274
Selected Condensed Consolidated Statements of Operations and Comprehensive
Loss Data
(In thousands, except share and per share amounts)
Three Months Ended September 30, Nine Months Ended September 30,
2023 2022 2023 2022
Grant income - - - $ 166
License revenues $ 406 $ 2,369 $ 1,698 $ 2,369
Operating expenses:
Research and development (37,237) (37,632) (105,323) (109,806)
General and administrative (10,611) (8,231) (31,017) (24,487)
Loss on disposal of property and equipment - - (3,791) -
Impairment of operating lease right-of-use assets and related property and (382) - (382) -
equipment
Total operating expenses, net (47,824) (43,494) (138,815) (131,758)
Total other expense, net (2,965) (5,425) (4,777) (9,380)
Net loss before income tax (50,789) (48,919) (143,592) (141,138)
Income tax benefit 4,940 6,152 12,380 19,250
Net loss attributable to ordinary shareholders (45,849) (42,767) (131,212) (121,888)
Other comprehensive (loss) income
Foreign currency exchange translation adjustment (5,837) (14,054) 5,104 (38,994)
Total comprehensive loss $ (51,686) $ (56,821) $ (126,108) $ (160,882)
Basic and diluted net loss per ordinary share $ (0.26) $ (0.47) $ (0.75) $ (1.34)
Weighted-average basic and diluted ordinary shares 173,984,101 91,240,801 173,890,666 91,028,562
Conference Call
Management will host a conference call and webcast at 9:00 am EDT/1:00 pm GMT
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/BIb593d01795494b57af1256c7198f1a18) 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 and
autoimmune disease. 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 target 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, solid tumors and autoimmune
diseases. 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. Obe-cel is designed with a fast target binding off-rate to
minimize excessive activation of the programmed T cells. Clinical trials of
obe-cel have demonstrated that this "fast off-rate" profile reduces toxicity
and T cell exhaustion, resulting in improved persistence and leading to high
levels of durable remissions in r/r Adult ALL patients. The results of the
FELIX trial, a pivotal trial for adult ALL, are being prepared for regulatory
submissions with the FDA and EMA. In collaboration with Autolus' academic
partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical
trials for B-NHL.
About obe-cel FELIX clinical trial
Autolus' Phase Ib/II clinical trial of obe-cel enrolled adult patients with
relapsed / refractory B-precursor ALL. The trial had a Phase Ib component
prior to proceeding to the single arm, Phase II 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 enrolled over
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 I clinical trial for patients with r/r
pediatric ALL. [NCT02443831 (https://clinicaltrials.gov/ct2/show/NCT02443831)
]
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 a 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. This
product candidate is currently in a Phase I clinical trial for patients with
r/r multiple myeloma. NCT04795882
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
obe-cel and Autolus' other product candidates, including statements regarding
the initiation, timing, progress and the results of clinical studies or trials
and related preparatory work, the period during which the results of the
trials will become available and research and development activities; the
timing of availability or disclosure of data from those clinical trials and
the timing of planned regulatory submissions; the potential for obe-cel or
Autolus' other product candidates to receive regulatory approval from the FDA
or equivalent foreign regulatory agencies, and whether, if approved, obe-cel
or Autolus' other product candidates will be successfully distributed,
marketed and commercialized; the size and growth potential of the markets for
obe-cel or Autolus' other product candidates, if approved, and the rate and
degree of market acceptance of obe-cel or Autolus' other product candidates,
including reimbursement that may be received from payors; potential
therapeutic effects of obe-cel and Autolus' other product candidates;
anticipated clinical data presentations; Autolus' commercialization, marketing
and manufacturing capabilities and strategy; the commercial potential of
obe-cel; the progress and estimated completion of the Company's commercial
manufacturing facility including anticipated capacity; the Company's ability
to achieve milestones and receive associated milestone payments pursuant to
the terms of its collaboration agreements, including pursuant to the
Blackstone collaboration and the Company's expected 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; any of Autolus' or its partners' product
candidates may fail in development, may not receive required regulatory
approvals, or may be delayed to a point where they are not commercially
viable; Autolus may not achieve milestones or receive additional payments
under its collaborations; regulatory agencies may impose additional
requirements or delay the initiation of clinical trials; the impact of new or
changing laws and regulations; market conditions; and the impact of the global
health crises or geopolitical conditions on Autolus' business, research and
clinical development plans and timelines and results of operations, including
impact on its clinical trial sites, collaborators, and contractors who act for
or on Autolus' behalf; Autolus' assumptions and estimates regarding its
financial condition, future financial performance and estimated cash runway
may be incorrect; and inability to maintain or enter into new partnerships or
strategic collaborations. 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)
Lauren Williams
Investase
+44 23 9438 7760
lauren@investase.com
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