REG - Syncona Limited - Autolus reports Q2 2024 Financial Results

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08/08/2024 12:15

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RNS Number : 7494Z  Syncona Limited  08 August 2024

8 August 2024

 

Syncona Limited

 

Autolus reports second quarter 2024 Financial Results and business updates

 

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 second quarter ended 30 June 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  Autolus is on track for the potential US commercial launch of obe-cel,
with the FDA's target action date for reviewing its biologics license
application (BLA) set for 16 November 2024

o  Longer follow up and subset analyses from the pivotal FELIX Phase II trial
presented at ASCO and EHA, with the majority of responders showing durable
responses and 40% of patients being in ongoing remission without subsequent
stem cell transplant (SCT) or other intervention; a further data update is
expected at ASH in December 2024

o  Market Authorisation Application (MAA) submitted to the Medicine and
Healthcare products Regulatory Authority (MHRA) in the UK at the end of July
2024, as the MAA review process continues with the European Medicines Agency
(EMA)

·    A Phase I trial of obe-cel in systemic lupus erythematosus (SLE) is
ongoing, 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 30 June 2024
totalling $705.9 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, building and scaling companies to deliver transformational
treatments to patients in areas of high unmet need.

 

We aim to build and maintain a diversified portfolio of 20-25 globally leading
life science businesses, across development stage, modality and therapeutic
area, for the benefit of all our stakeholders. We focus on developing
treatments that deliver patient impact by working in close partnership with
world-class academic founders and experienced 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/)

 

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 Second Quarter 2024 Financial Results

and Business Updates

·    On track for potential US commercial launch of obe-cel; PDUFA date
November 16, 2024

·    Longer follow up and subset analyses from pivotal FELIX Phase 2 data
presented at ASCO and EHA; majority of responders showed durable responses;
40% of patients in ongoing remission without subsequent stem cell transplant
(SCT) or other intervention

·    A Market Authorization Application (MAA) for obe-cel in
relapsed/refractory r/r adult B-cell Acute Lymphoblastic Leukemia (B-ALL) was
submitted to the Medicine and Healthcare products Regulatory Authority (MHRA)
in the UK at the end of July 2024. The MAA review process continues with the
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, August 8, 2024 - Autolus Therapeutics plc (Nasdaq: AUTL), a
clinical-stage biopharmaceutical company developing next-generation programmed
T cell therapies, today announces its financial results for the second quarter
ended June 30, 2024, and provides additional operation and clinical updates.

 

"We are focused on driving commercial readiness activities across Autolus to
bring our lead product obecabtagene autoleucel (obe-cel) to adult B-ALL
patients. Applications for marketing authorizations are under review by
regulatory agencies in the US, Europe and UK, and we are working towards a US
Food and Drug Administration (FDA) PDUFA target date of November 16, 2024,"
said Dr. Christian Itin, Chief Executive Officer of Autolus. "Data from the
FELIX Phase 1b/2 study with a median follow up of 21 months presented at ASCO
and EHA indicate a long-term plateau forming in event-free and overall
survival rates. Stem cell transplant post obe-cel did not appear to improve
patient outcomes, and patients with long-term persisting obe-cel appear to
have improved event free survival. The data support the potential for obe-cel
as a stand-alone therapy in a portion of r/r adult ALL patients."

 

Key obe-cel updates and anticipated milestones:

 

·    Obe-cel in r/r adult B-ALL - The FELIX Study

o In the UK, an MAA was submitted to the MHRA at the end of July 2024. The
Biologics License Application (BLA) is on track with the FDA, working towards
a Prescription Drug User Fee Act (PDUFA) target action date of November 16,
2024. An MAA submitted to EMA was accepted in April 2024.

o Pooled analysis of the FELIX Phase 1b/2 study were presented at the American
Society of Oncology (ASCO) and European Hematology Association (EHA) annual
meetings in June 2024, with a median follow-up of 21 months. Data showed
stabilization of event-free survival and overall survival following treatment
with obe-cel, with 40% of patients in ongoing remission. Of the 99 responders
following treatment with obe-cel, 18 received a subsequent stem cell
transplant (SCT) while in minimal residual disease (MRD)-negative response but
did not show improved survival compared to patients who did not have a
subsequent SCT. Patients with prolonged obe-cel persistence experienced
improved event-free survival and data indicate that bridging of high tumor
burden patients with inotuzumab could be effective at reducing tumor burden,
cytokine release syndrome (CRS) and immune effector cell-associated
neurotoxicity syndrome (ICANS) without increasing liver toxicity.

·    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. Autolus continues to expect initial
clinical data in late 2024.

·    Pipeline programs in collaboration with University College London

o Clinical programs AUTO8, AUTO6NG and AUTO1/22 are progressing well and we
are planning data updates for all programs in 2025.

 

Operational Updates:

 

·    During the quarter, Autolus promoted the following individuals to
Senior Vice President: Andrea Braun, Regulatory Affairs; Markus Gruell,
Corporate Quality; Claudia Mercedes Mayer, Manufacturing Strategy and
Technology; Chris Gray, Technical Operations and Facilities and Dilip Patel,
Market Access and Pricing Strategy. These individuals bring significant
leadership experience and continue to drive Autolus' regulatory activities and
preparation for the potential commercialization and launch of obe-cel.

·    In April 2024, Autolus announced that the EMA had accepted its MAA
for obe-cel for patients with r/r adult 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, if it receives 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 stepped down from his roles as Chairman of the Board and Non-Executive
Director, effective April 1, 2024.

 

2024 Expected News Flow:

 

 Obe-cel U.S. FDA PDUFA target action date                            November 16, 2024
 Obe-cel FELIX data at American Society of Hematology (ASH) meeting   December 2024
 Obe-cel in autoimmune disease - initial data from SLE Phase 1 study  Late 2024

 

 

Financial Results (Unaudited) for the Quarter Ended June 30, 2024

 

Cash and cash equivalents at June 30, 2024 totaled $705.9 million, as compared
to $239.6 million at December 31, 2023.

 

Total operating expenses, net for the three months ended June 30, 2024 were
$58.9 million, as compared to $44.4 million for the same period in 2023.

 

Research and development expenses increased from $33.2 million to $36.6
million for the three months ended June 30, 2024, compared to the same period
in 2023. This change was primarily due to increases in operating costs related
to our new manufacturing facility, employee salaries and related costs, and
clinical trial and manufacturing costs related to obe-cel, partially offset by
an increase in our U.K. reimbursable R&D tax credits that reduce R&D
expense.

 

General and administrative expenses increased from $11.1 million to $21.9
million for the three months ended June 30, 2024, compared to the same period
in 2023. This increase was primarily due to salaries and other
employment-related costs driven by increased headcount supporting
pre-commercialization activities.

 

Net loss was $58.3 million for the three months June 30, 2024, compared to
$45.6 million for the same period in 2023. Basic and diluted net loss per
ordinary share for the three months ended June 30, 2024, totaled $(0.22),
compared to basic and diluted net loss per ordinary share of $(0.26) for the
same period in 2023.

 

Autolus estimates that, with its current cash and cash equivalents, it is well
capitalized to drive the full launch and commercialization of obe-cel in r/r
adult B-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 June 30, 2024

Selected Unaudited Condensed Consolidated Balance Sheet Data

(In thousands)

 

                                                   June 30                                    December 31
                                                   2024                                       2023
 Assets
 Cash and cash equivalents                         $              705,939                     $              239,566
 Total current assets                              $              758,600                     $              275,302
 Total assets                                      $              853,620                     $              375,381
 Liabilities and shareholders' equity
 Total current liabilities                         $                40,904                    $                 44,737
 Total liabilities                                 $              325,776                     $              263,907
 Total shareholders' equity                        $              527,844                     $              111,474

 

 

Selected Unaudited Condensed Consolidated Statements of Operations and
Comprehensive Loss Data

(In thousands, except share and per share amounts)

 

                                                                                 Three Months Ended June 30,                                                                               Six Months Ended June 30,
                                                                                 2024                                                      2023                                            2024                                                     2023
 License revenue                                                                 $                    -                                    $                    -                          $            10,091                                      $              1,292
 Operating expenses:
 Research and development                                                                    (36,612)                                                  (33,232)                                        (67,283)                                                 (60,620)
 General and administrative                                                                  (21,903)                                                  (11,122)                                        (40,080)                                                 (20,406)
 Loss on disposal of property and equipment                                                            -                                                       (23)                                              -                                                (3,791)
 Impairment of operating lease right-of-use assets and related property and      (414)                                                                           -                                           (414)                                                        -
 equipment
 Total operating expenses, net                                                               (58,929)                                                  (44,377)                                        (97,686)                                                 (83,525)
 Total other income (expense), net                                               708                                                                     (1,135)                                       (13,233)                                                   (1,812)
 Net loss before income tax                                                                  (58,221)                                                  (45,512)                                      (110,919)                                                  (85,337)
 Income tax expense                                                                                  (51)                                                      (40)                                            (43)                                                     (26)
 Net loss                                                                                    (58,272)                                                  (45,552)                                      (110,962)                                                  (85,363)
 Other comprehensive income (loss):
 Foreign currency exchange translation adjustment                                                1,026                                                     5,300                                           1,084                                                  10,941
 Total comprehensive loss                                                        $          (57,246)                                       $          (40,252)                             $        (109,878)                                       $          (74,422)

 Basic and diluted net loss per ordinary share                                   $              (0.22)                                     $              (0.26)                           $              (0.43)                                    $              (0.49)
 Weighted-average basic and diluted ordinary shares                                  266,025,783                                               173,860,491                                     255,131,873                                              173,843,249

 

 

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/BI03841fb920b84c46a939ade0bac36e93) 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)

Obecabatagene autoleucel (obe-cel) is a B-lymphocyte antigen CD19 (CD19)
chimeric antigen receptor (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 relapsed/refractory (r/r) Adult B-cell Acute
Lymphoblastic Leukemia (B-ALL) patients. The results of the FELIX trial, a
pivotal trial for adult B-ALL, have been submitted and accepted by the FDA
with a PDUFA target action date of November 16, 2024. In the EU a regulatory
submission to the EMA was accepted in April 2024, while in the UK, an MAA was
submitted to MHRA in July 2024. In collaboration with Autolus' academic
partner, University College London, obe-cel is currently being evaluated in a
Phase 1 clinical trial for B-cell non-Hodgkin lymphoma (B-NHL).

 

About obe-cel FELIX clinical trial

Autolus' Phase 1b/2 clinical trial of obe-cel enrolled adult patients with r/r
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
complete remission 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 1 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, B-cell
maturation antigen (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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