REG - Syncona Limited - Autolus reports Q1 2024 Financial Results

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17/05/2024 12:15

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RNS Number : 9250O  Syncona Limited  17 May 2024

Syncona Limited

 

Autolus reports first quarter 2024 Financial Results and business updates

 

17 May 2024

 

Syncona Ltd, a leading life science investor focused on creating, building and
scaling global leaders in life science, notes that its portfolio company,
Autolus Therapeutics plc (Nasdaq: AUTL) ("Autolus"), announced its financial
results and business updates for the first quarter ended 31 March, 2024. Key
highlights are as follows:

 

·      Updates from obe-cel for patients with relapsed/refractory (r/r)
adult B-cell acute lymphoblastic leukaemia (ALL):

o  Longer follow up and subset analyses from the pivotal FELIX Phase II trial
to be presented in upcoming oral presentations at ASCO and EHA

o  Market Authorization Application (MAA) for obe-cel accepted by the
European Medicines Agency (EMA)

·      Two patients have been enrolled in the Phase I trial of obe-cel
in systemic lupus erythematosus (SLE), with the study on track to release
initial data in H2 CY2024

·      Autolus is well funded to drive the full launch and
commercialisation of obe-cel in r/r adult ALL, with cash and cash equivalents
at March 31, 2024 totalling $758.5 million

 

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 EDT / 13:30
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 

Enquiries

Syncona Ltd

 

Natalie Garland-Collins / Fergus Witt

Tel: +44 (0) 20 3981 7940

 

FTI Consulting

 

Ben Atwell / 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.

 

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 risks.

 

Syncona Limited seeks to achieve returns over the long term. Investors should
seek to ensure they understand the risks and opportunities of an investment
in Syncona Limited, including the information in our published documentation,
before investing.

 

 

 

Autolus Therapeutics Reports First Quarter 2024 Financial Results and Business
Updates

·    Longer follow up and subset analyses from the pivotal FELIX Phase 2
data to be presented in oral presentations at ASCO and EHA

·    Two patients enrolled in Phase 1 Systemic Lupus Erythematosus (SLE)
trial; study on track for initial data end of 2024

·    Market Authorization Application (MAA) for obe-cel in r/r adult ALL
accepted by European Medicines Agency (EMA)

·    Conference call to be held today at 08:30 am EDT/13:30 pm BST:
conference call participants should pre-register using the link at the bottom
of this press release

 

LONDON, May 17, 2024 - Autolus Therapeutics plc (Nasdaq: AUTL), a
clinical-stage biopharmaceutical company developing next-generation programmed
T cell therapies, today announces its operational and financial results for
the first quarter ended March 31, 2024.

 

"We continue to engage with the FDA in the regulatory review process for
obecabtagene autoleucel (obe-cel) in adult ALL as we head towards the PDUFA
target action date of November 16, 2024, and are driving commercial readiness
activities across the Company," said Dr. Christian Itin, Chief Executive
Officer of Autolus. "We're also delighted that our abstracts from the pivotal
FELIX Phase 2 trial have been accepted for oral presentations at ASCO and EHA
this year and we look forward to sharing further long-term data and additional
subset analyses."

 

"In addition, the first two patients have been enrolled into our dose
confirmation trial (CARLYSLE) of obe-cel in Systemic Lupus Erythematosus (SLE)
and the study is on track for initial data by end of 2024."

 

Key obe-cel updates and anticipated milestones:

 

·    Obe-cel in relapsed / refractory (r/r) adult B-cell Acute
Lymphoblastic Leukemia (ALL) - The FELIX Study

o  Obe-cel Biologics License Application (BLA) for r/r B-ALL submitted to the
FDA in November 2023; PDUFA target action date of November 16, 2024. A
marketing authorization application (MAA) to the European Medicines Agency
(EMA) was accepted in April 2024. For the UK we are evaluating a filing based
on an international recognition procedure.

o  Pooled analysis of the FELIX Phase 1b/2 study presented at ASH in December
2023 demonstrated prolonged event free survival and low overall immunotoxicity
across all cohorts in r/r B-ALL, and particularly in patients with low
leukemic burden at lymphodepletion.

o  Further long-term data from the FELIX study including additional subset
analysis will be presented in oral and poster presentations at the American
Society of Clinical Oncology annual meeting (ASCO - May 31 - June 4, 2024),
and European Hematology Association congress (EHA - June 13 - 16, 2024)
respectively.

 

·    Obe-cel in B-cell mediated autoimmune diseases

o  The Phase 1 dose confirmation study (CARLYSLE) in refractory systemic
lupus erythematosus (SLE) patients is ongoing. Two patients have been enrolled
and Autolus continues to expect initial clinical data in late 2024.

 

Pipeline clinical trials, in collaboration with University College London
(UCL), updates and anticipated milestones:

 

·    AUTO8 in Multiple Myeloma - Phase 1 MCARTY Study

o AUTO8 is a next-generation product candidate for multiple myeloma, which
includes two CARs for the multiple myeloma targets, BCMA and CD19. Initial
data from the MCARTY Phase 1 study in multiple myeloma presented at ASH in
December 2023 showed AUTO8 was well tolerated, with responses observed in all
patients. Enrollment of the initial cohorts are complete and further updates
from the MCARTY study are anticipated in H2 2024.

 

·    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. A Phase 1 clinical study in
children with r/r neuroblastoma was opened for enrollment in the fourth
quarter of 2023.

 

Strategic developments:

 

·    In February 2024, BioNTech and Autolus announced a strategic CAR T
cell therapy collaboration to advance their pipelines and expand late-stage
programs, for $50 million cash upfront and up to $582 million in potential
option exercise and milestone payments. Additionally, Autolus sold $200
million of ADSs to BioNTech in a concurrent private placement financing
transaction.

 

·    In February 2024, Autolus completed an underwritten offering in the
United States at a price of $6.00 per ADS, for total gross proceeds of $350
million before underwriting fees and offering expenses.

 

Operational Updates:

 

·    In March 2024, The Nucleus manufacturing facility in Stevenage
obtained a Manufacturer's Importation Authorization (MIA), together with the
accompanying GMP certificate. This authorization enables Autolus to
manufacture products for global commercial and clinical supply at The Nucleus,
effective as of March 18, 2024.

·    In April 2024, Autolus announced that the European Medicines Agency
(EMA) had accepted its Marketing Authorization Application (MAA) for obe-cel
for patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic
Leukemia (ALL). The MAA submission was based on data from the pivotal Phase 2
FELIX study of obe-cel in adult r/r B-ALL.

·    In April 2024, Autolus entered into a distribution services agreement
with a subsidiary of Cardinal Health to support the ordering and distribution
of obe-cel in the United States, following the receipt of regulatory approval.

·    In April 2024, Autolus announced the appointment of Mike Bonney as
Chairman of the Board, and Ravi Rao M.D., as Non-Executive Director. John H.
Johnson advised the Board of his decision to step down from his role as
Chairman of the Board and Non-Executive Director, effective April 1, 2024.

 

Scientific Publications:

 

·    In January 2024, Autolus announced the publication of a paper in ACS
Chemical Biology entitled: 'Designer small molecule control system based on
Minocycline induced disruption of protein-protein interaction' - Jha et al.,
ACS Chemical Biology (2024) doi:10.1021/acschembio.3c00521;  Link 
(https://pubs.acs.org/doi/10.1021/acschembio.3c00521)

·    In February 2024, Autolus announced the publication of a paper in
Nature Communications entitled: 'Structure-Guided Engineering of
Immunotherapies Targeting TRBC1 and TRBC2 in T Cell Malignancies' - Ferrari et
al., Nat Commun 15, 1583 (2024) doi:10.1038/s41467-024-45854-3;  Link 
(https://www.nature.com/articles/s41467-024-45854-3)

·    In March 2024, Autolus announced the publication of a paper in Blood
Cancer Journal entitled: 'Dual T-cell constant β chain (TRBC)1 and TRBC2
staining for the identification of T-cell neoplasms by flow cytometry - Horna
et al., Blood Cancer J. 14, 34 (2024) doi: 10.1038/s41408-024-01002-0;  Link 
(https://www.nature.com/articles/s41408-024-01002-0.pdf)

 

2024 Expected News Flow:

 

 Obe-cel FELIX data update at ASCO, EHA & ASH                         May, June & Dec 2024
 Obe-cel Marketing Authorization Application to MHRA                  Second half 2024
 Obe-cel U.S. FDA PDUFA target action date                            November 16, 2024
 Obe-cel in autoimmune disease - initial data from SLE Phase 1 study  Late 2024

Financial Results (Unaudited) for the Quarter Ended March 31, 2024

 

Cash and cash equivalents at March 31, 2024, totaled $758.5 million, as
compared to $239.6 million at December 31, 2023.

 

Total operating expenses, net for the three months ended March 31, 2024, were
$38.8 million, as compared to $39.1 million, for the same period in 2023.

 

Research and development expenses increased from $27.4 million to $30.7
million for the three months ended March 31, 2024, compared to the same period
in 2023. This change was primarily due to increases in operating costs related
to the Company's new commercial manufacturing facility, employee salaries and
related costs, clinical trial costs related to obe-cel, and a decrease in our
U.K. reimbursable R&D tax credits claimable through the U.K. small and
medium-sized entity (SME) scheme. These were partially offset by decreases in
professional consulting fees, legal fees, manufacturing costs related to
obe-cel clinical supply, information technology infrastructure fees and
general office expenses.

 

General and administrative expenses increased from $9.3 million to $18.2
million for the three months ended March 31, 2024, compared to the same period
in 2023. 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 was $52.7 million for the three months March 31, 2024, compared to
$39.8 million for the same period in 2023. The basic and diluted net loss per
ordinary share for the three months ended March 31, 2024, totaled $(0.24),
compared to a basic and diluted net loss per ordinary share of $(0.23) for
2023.

 

Autolus estimates that, with its current cash and cash equivalents and
proceeds received from the strategic alliance with BioNTech and the private
placement and underwritten equity financing, it is well capitalized to drive
the full launch and commercialization of obe-cel in r/r adult ALL as well as
to advance its pipeline development plans, which includes providing runway to
data in the first pivotal study of obe-cel in autoimmune disease.

 

Financial Results for the Quarter Ended March 31, 2024

Selected Unaudited Condensed Consolidated Balance Sheet Data

(In thousands)

 

                                                   March 31                                   December 31
                                                   2024                                       2023
 Assets
 Cash and cash equivalents                         $              758,529                     $              239,566
 Total current assets                              $              804,298                     $              275,302
 Total assets                                      $              901,436                     $              375,381
 Liabilities and shareholders' equity
 Total current liabilities                         $                43,985                    $                 44,737
 Total liabilities                                 $              319,406                     $              263,907
 Total shareholders' equity                        $              582,030                     $              111,474

 

 

Selected Unaudited Condensed Consolidated Statements of Operations and
Comprehensive Loss Data

(In thousands, except share and per share amounts)

 

                                                                             Three Months Ended March 31,
                                                                             2024                                                          2023
 License revenues                                                            $                  10,091                                     $                    1,292
 Operating expenses:
 Research and development                                                    (30,671)                                                                        (27,388)
 General and administrative                                                                    (18,177)                                                        (9,284)
 Loss on disposal of property and equipment                                                  -                                                                 (3,768)
 Total operating expenses, net                                                             (38,757)                                                      (39,148)
 Total other expenses, net                                                                   (13,941)                                                        (677)
 Net loss before income tax                                                                (52,698)                                                      (39,825)
 Income tax benefit                                                                            8                                                             14
 Net loss                                                                                  (52,690)                                                      (39,811)
 Other comprehensive income (loss):
 Foreign currency exchange translation adjustment                                              58                                                          5,641
 Total comprehensive loss                                                    $               (52,632)                                       $                (34,170)

 Basic and diluted net loss per ordinary share                               $                     (0.24)                                  $                      (0.23)
 Weighted-average basic and diluted ordinary shares                          222,170,707                                                   173,825,825

 

 

Conference Call

Management will host a conference call and webcast at 08:30 am EDT/13:30 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/BI290f177d730145848773f752bcebadfb) 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, Autolus 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
(http://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. In clinical trials of
obe-cel, this "fast off-rate" profile reduced 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, have been submitted and accepted by the FDA with
a PDUFA target action date of November 16, 2024. A regulatory submission to
the EMA was accepted in April 2024. 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 1b/2 clinical trial of obe-cel enrolled 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 was overall response rate, and the secondary endpoints included
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
development for the treatment of both neuroblastoma and other GD2-expressing
solid tumors. 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. A Phase 1 clinical trial of AUTO6NG in children with
relapsed/refractory neuroblastoma was opened for enrollment in the fourth
quarter of 2023.

 

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 designed for improved killing of
target cells that express BCMA at low levels. This has been combined with fast
off rate CD19 CAR from obe-cel, with the aim of inducing deep and durable
responses and extending 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 Autolus' development and
commercialization of its product candidates, timing of data announcements and
regulatory submissions, its cash resources and the market opportunity for
obe-cel. 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; and possible safety and efficacy concerns. 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 10-K filed with the Securities and Exchange Commission,
or the SEC, on March 21, 2024 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. You
should, therefore, not rely on these forward-looking statements as
representing Autolus' views as of any date subsequent to the date of this
press release.

 

 

Contact:

 

Olivia Manser

+44 (0) 7780 471 568

o.manser@autolus.com (mailto:o.manser@autolus.com)

 

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)

 

 

 

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