REG - Syncona Limited - Autolus reports Q3 2024 Financial Results

SynconaAnnouncement

12/11/2024 13:30

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20241112:nRSL9432La&default-theme=true

RNS Number : 9432L  Syncona Limited  12 November 2024

12 November 2024

 

Syncona Limited

 

Autolus reports third quarter 2024 Financial Results and business updates

 

Syncona Ltd, (the "Company"), a leading life science investor 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 financial results and business updates for the
third quarter ended 30 September 2024. Key highlights are as follows:

 

·     The U.S. Food and Drug Administration (FDA) granted marketing
approval for AUCATZYL(®) (obe-cel) for the treatment of adult patients with
relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r
B-ALL)

·     US commercial launch of AUCATZYL(®) initiated

·     Biologics License Application (BLA) approval triggers $30m
milestone payment to Autolus from Blackstone

·     Obe-cel is under regulatory review in both the EU and the UK, with
marketing authorisation submissions accepted by the European Medicines Agency
(EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA)

·     Matthias Will M.D. appointed as Chief Development Officer, effective
September 30, 2024

·     Cash and cash equivalents of $657.1 million as at 30 September, 2024

 

 

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 8:30am EST / 13:30pm
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/)

 

 

Enquiries

 

Syncona Ltd

 

Natalie Garland-Collins / Fergus Witt

Tel: +44 (0) 20 3981 7912

 

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.

 

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 Third Quarter 2024 Financial Results and
Business Updates

 

·      AUCATZYL(®) (obecabtagene autoleucel) approved by US FDA on
November 8, ahead of target PDUFA date of November 16; US commercial launch
initiated

·      BLA approval triggers $30m milestone payment to Autolus from
Blackstone

·      Marketing authorizations for obe-cel under review with both the
MHRA EMA

·      Matthias Will M.D. appointed as Chief Development Officer,
effective September 30, 2024

·      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, Nov. 12, 2024 - Autolus Therapeutics plc (Nasdaq: AUTL), an early
commercial-stage biopharmaceutical company developing next-generation
programmed T cell therapies, today announces its financial results for the
third quarter ended September 30, 2024, and provides additional operational
and clinical updates.

"With the U.S. Food and Drug Administration (FDA) having approved
AUCATZYL(®) (obe-cel) for the treatment of adult B-cell Acute Lymphoblastic
Leukemia (B-ALL) patients, we are all systems go with our commercial efforts
in the US across the Company," said Dr. Christian Itin, Chief Executive
Officer of Autolus. "This first FDA approval is just the beginning for
Autolus; we have great belief in our pipeline and our manufacturing
capabilities and are excited for the future."

Key updates and anticipated milestones:

·      AUCATZYL(®) was approved by the FDA for the treatment of adult
patients with relapsed and refractory B-cell acute lymphoblastic leukemia on
November 8, 2024.

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

o  Obe-cel is under regulatory review in both the EU and the UK, with
marketing authorization submissions accepted by the European Medicines Agency
in April 2024, and the UK Medicines and Healthcare products Regulatory Agency
in August 2024.

o  Post period, Autolus submitted obe-cel for appraisal by the U.K. National
Institute for Health and Care Excellence (NICE) and Autolus looks forward to
working with NICE and NHS England to make obe-cel available to patients in
England and Wales, if approved.

o  Autolus presented updated data from the pivotal Phase 1b/2 FELIX study at
the Society of Hematologic Oncology (SOHO) meeting in August 2024 which
demonstrated the rationale for tumor burden (TB)-guided dosing by analyzing
the impact of bone marrow (BM) blast percentage in patients treated with
obe-cel. The data demonstrated the importance of administering a split dose
and highlighted the differentiation of obe-cel based on its unique biding
properties and tumor burden-guided approach.

o  Post period, Autolus presented data at the 2024 Lymphoma, Leukemia &
Myeloma Congress on October 16-19. The poster presentation suggested that
adult patients with r/r B-ALL achieve comparable outcomes irrespective of the
timing of stem cell transplant (SCT) pre or post obe-cel, suggesting no
further benefit of consolidative transplant based on this post-hoc analysis.
Additionally, obe-cel given as a sole treatment to patients with lower Tumor
Burden (TB) at Lymphodepletion (LD) was associated with better outcomes.

·      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 and Autolus expects to complete
enrolment and patient dosing, as well as present initial data in Q1 2025. The
Company anticipates that full data with adequate follow-up will be targeted
for 2H 2025 at a medical conference.

·      Pipeline programs in collaboration with University College London

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

Operational Updates:

·      The FDA approval for AUCATZYL triggers a $30 million milestone
payment to Autolus from Blackstone in accordance with the terms of the
collaboration agreement between the parties. In addition, Autolus will make a
£10 million regulatory milestone payment to UCL Business Ltd. in accordance
with the license agreement between the parties.

·      In September 2024, Autolus announced the appointment of Matthias
Will M.D. as Chief Development Officer, effective September 30, 2024. Dr. Will
joins Autolus from Dren Bio, Inc., a privately held biotech company, where he
served as Chief Medical Officer. During his tenure, Matthias led the expansion
of the clinical team and oversaw the submission of two INDs for candidates to
potentially treat hematologic cancers. Prior to that he served as Vice
President of Clinical Development for CRISPR Therapeutics where he led the
development of the company's allogeneic CAR T programs targeting CD70 in
T-cell lymphomas and renal cell carcinoma and the early stage CD70-NK cell
program in collaboration with NKarta Inc.

 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  Q1 2025
 Initial data from PY01 trial of obe-cel in pediatric ALL             H2 2025
 SLE Phase 1 trial presentation at medical conference                 H2 2025

2024/2025 Expected News Flow:

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

Cash and cash equivalents at September 30, 2024 totaled $657.1 million, as
compared to $239.6 million at December 31, 2023.

Total operating expenses, net for the three months ended September 30, 2024
were $67.9 million, as compared to $42.9 million for the same period in 2023.

Research and development expenses increased from $32.3 million to $40.3
million for the three months ended September 30, 2024, compared to the same
period in 2023. This change was primarily due to increases in employee
salaries and related costs, and clinical trial and manufacturing costs related
to obe-cel, partially offset by a decrease in professional fees and an
increase in our U.K. R&D tax credits that reduce R&D expense.

General and administrative expenses increased from $10.6 million to $27.3
million for the three months ended September 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 $82.1 million for the three months ended September 30, 2024,
compared to $45.8 million for the same period in 2023. Basic and diluted net
loss per ordinary share for the three months ended September 30, 2024, totaled
$(0.31), 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 September 30, 2024

Selected Unaudited Condensed Consolidated Balance Sheet Data

(In thousands)

                                         September 30,       December 31,

2024
2023
 Assets
 Cash and cash equivalents               $        657,067    $        239,566
 Total current assets                    $        718,114    $        275,302
 Total assets                            $        827,490    $        375,381
 Liabilities and shareholders' equity
 Total current liabilities               $        52,474     $        44,737
 Total liabilities                       $        350,525    $        263,907
 Total shareholders' equity              $        476,965    $        111,474

 

 Selected Unaudited Condensed Consolidated Statements of Operations and
 Comprehensive Loss Data

(In thousands, except share and per share amounts)

                                                                               Three Months Ended                                   Nine Months Ended

September 30,
September 30,
                                                                                    2024                        2023                    2024                             2023
 License revenue                                                               $    -                      $    406                 $   10,091                   $       1,698
 Operating expenses:
 Research and development                                                           (40,323      )              (32,318      )          (107,606     )                   (92,938      )
 General and administrative                                                         (27,330      )              (10,611      )          (67,410      )                   (31,017      )
 Loss on disposal of property and equipment                                         (223         )              -                       (223         )                   (3,791       )
 Impairment of operating lease right-of-use assets and related property and         -                           (382         )          (414         )                   (382         )
 equipment
 Total operating expenses, net                                                      (67,876      )              (42,905      )          (165,562     )                   (126,430     )
 Total other expenses, net                                                          (14,196      )              (2,965       )          (27,428      )                   (4,777       )
 Net loss before income tax                                                         (82,072      )              (45,870      )          (192,990     )                   (131,207     )
 Income tax (expense) benefit                                                       (22          )              21                      (66          )                   (5           )
 Net loss                                                                           (82,094      )              (45,849      )          (193,056     )                   (131,212     )
 Other comprehensive income (loss):
 Foreign currency exchange translation adjustment                                   27,010                      (5,837       )          28,094                           5,104
 Total comprehensive loss                                                      $    (55,084      )         $    (51,686      )      $   (164,962     )           $       (126,108     )

 Basic and diluted net loss per ordinary share                                 $    (0.31        )         $    (0.26        )      $   (0.77        )           $       (0.75        )
 Weighted-average basic and diluted ordinary shares                                 266,084,589                 173,984,101             251,480,521                      173,890,666

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://www.globenewswire.com/Tracker?data=JdGYhA1DZFugo1hq9_GjdfTaFSI_AatAcAwyA8qYp6Su1_Y4lm4kBmlOBGefd1WtiRoMEPV-d_uYMtUlrx4sDu9Ll8d_AITMsxy0trBbX_e9sBUVlo2xaJjvyIhuS_WXvyzwsNuHPdqIjwYdpCLdvg==)
 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.globenewswire.com/Tracker?data=rDWoM32ismb-6NZZROMoOzuVR4jenzH1TdiCZADkx5XHhOIahwJqe4SzFyxSTRe1fG7annHZvKb4XUHSLwgKA0upYXH91dUjXtduQgD14Vu9gFQ5jfaZoJe_-_zDJgBTXskS6fjIU0sttn-eRVEPYA==)
 of Autolus' website.

About Autolus Therapeutics plc

Autolus is a 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 recognize target cells, break down their
defense mechanisms and eliminate these cells. Autolus has an FDA approved
product, AUCATZYL(®), and 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
(https://www.globenewswire.com/Tracker?data=yLO27t_jMHwbbwnCpWjmdgXahY36AuCuHZnmTToYhQt_4DZcVYUuop6wcKNRE5Y48ONRVph6hoE3QBHq4CAnQg==)
 

About Aucatzyl(®) (obecabtagene autoleucel, AUTO1)

AUCATZYL(®) is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor
(CAR) T cell therapy approved by the FDA for the treatment of
relapsed/refractory (r/r) Adult B-cell Acute Lymphoblastic Leukemia (B-ALL).
Please see full Prescribing Information
(https://www.globenewswire.com/Tracker?data=1Mv__O7FH-cBMHA7oalx1YYAp9LgvOO362Vxyyxg7PylenU9K-SCNmEi-uZ0e5okWqVHgim6yS3WcmawvPuPbXIxdMYkdITTJT8694_y__U3DaRGNj0C_Haa6RUrPKwe)
, including BOXED WARNING and Medication Guide. Obe-cel is designed with a
fast target binding off-rate to minimize excessive activation of the
programmed T cells. 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 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://www.globenewswire.com/Tracker?data=XmNk7JvLp0UZTyYhqPwArp-Mg2s8fp8TmzvkVU4O1vnkQ-GucYNitItcQ7fMrDDu1wBwIuBJbO_m56DjD0UG6E5lGeGOgwRDzHeJtge2lOTmvzQAIQ8h0IcRfFirFRiP)
]

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 the market opportunity
for AUCATZYL(®), Autolus' development and commercialization of its product
candidates, and the timing of data announcements and regulatory submissions.
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:

Amanda Cray

+1 617-967-0207
a.cray@autolus.com
(https://www.globenewswire.com/Tracker?data=Crpdfk1bto2PwKae8mqgLm5RL2TD2c8H0_CoIacggzQiK2WnIddXPImO2sqPdaFRC82pZCy9IOwGIuk8CKBDYHus-_X7smhd_RN1yPuXYyo=)

Olivia Manser

+44 (0) 7780 471 568
o.manser@autolus.com
(https://www.globenewswire.com/Tracker?data=agD0r1DN-IoZIp4YrimDoniLaIcJ_xs2m6H-QhnvcCSNZxmhI9gAVpAaCD5Hr2RzxKYtsXRCXzxHnn5I6KasiGykyHEOodf8DLF2d-S4EOg=)

Susan A. Noonan

S.A. Noonan Communications

+1-917-513-5303
susan@sanoonan.com
(https://www.globenewswire.com/Tracker?data=Y4sDbe7cuSTUjScZd4aFVK0iQ6mwHqnpPKbc3AB6YmAxqk8jLCZ4lME1vGrWJr0ncrVIFlo_SXuob7z2pCWtEGTdbOvjQ179RitT3y0XwB8=)

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  PFUBXBDBUBBDGSD