REG - Syncona Limited - Autolus Reports Q1 2022 Financial Results
05/05/2022 12:15
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RNS Number : 4805K Syncona Limited 05 May 2022
Syncona Limited
Autolus Reports Q1 2022 Financial Results
05 May 2022
Syncona Ltd, a leading healthcare company focused on founding, building and
funding 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 first quarter ended
March 31, 2022.
Key highlights include two updates from the FELIX Phase II study in obe-cel in
relapsed / refractory (r/r) adult acute lymphoblastic leukaemia (ALL):
· The study passed its futility analysis following a review by an
independent response review committee. Initial data from the study remains on
track to be released in H2 CY2022 with full data set to follow in H1 CY2023.
· The company plans to evaluate a separate cohort of up to 50 patients
with Minimal Residual Disease (MRD). This will further enable Autolus to
establish the profile of obe-cel in patients across all levels of disease
burden in adult ALL.
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations
(https://www.autolus.com/investor-relations) and the full text of the
announcement from Autolus is contained below. Autolus management will host a
conference call today, at 8:30 am ET/ 1:30 pm BST, to discuss the company's
financial results and provide a general business update. To listen to the
webcast and view the accompanying slide presentation, please go to:
https://www.autolus.com/investor-relations/news-and-events/events
(https://www.autolus.com/investor-relations/news-and-events/events) .
ENDS
Enquiries
Syncona Ltd
Natalie Garland-Collins / Fergus Witt
Tel: +44 (0) 7714 916615
FTI Consulting
Ben Atwell / Julia Bradshaw / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona's purpose is to invest to extend and enhance human life. We do this by
founding and building a portfolio of global leaders in life science to deliver
transformational treatments to patients in areas of high unmet need.
Our strategy is to found, build and fund companies around exceptional science
to create a diversified portfolio of 15-20 globally leading healthcare
businesses for the benefit of all our stakeholders. We focus on developing
treatments for patients by working in close partnership with world-class
academic founders and management teams. Our balance sheet underpins our
strategy enabling us to take a long-term view as we look to improve the lives
of patients with no or poor treatment options, build sustainable life science
companies and deliver strong risk-adjusted returns to shareholders.
Autolus Therapeutics Reports First Quarter 2022 Financial Results and
Operational Progress
- Conference call to be held on May 5, 2022 at 8:30 am ET/1:30 pm BST -
LONDON, May 5, 2022 - Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the quarter ended March 31, 2022.
"The momentum at Autolus has continued during the first quarter. We are delighted to note that the FELIX clinical trial of obe-cel in patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) passed its futility analysis during the period and we continue to enroll patients as planned, with initial data expected in the second half of 2022, with the full data in the first half of 2023," said Dr. Christian Itin, Chief Executive Officer of Autolus. "obe-cel recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), supporting our drive to bring this innovative therapy to patients as quickly as possible."
"We also have updates at the European Hematology Association (EHA) Congress in early June from four Phase 1 clinical trials. Two trials are evaluating obe-cel in B-Cell Non-Hodgkin's Lymphoma (B-NHL) and primary CNS lymphoma (PCNSL). In addition, two oral presentations will cover the first clinical data for AUTO4 in TRBC1+ Peripheral T cell lymphoma (PTCL) and data for the dual targeting AUTO1/22 in pediatric ALL patients."
Key Pipeline Updates:
· Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r)
adult ALL
o During the quarter, the FELIX study passed its pre-specified futility
analysis based on the results assessed by an independent response review
committee. As previously guided, the morphological cohort is expected to
complete enrollment in 2022 with initial data from the FELIX study expected to
be reported in H2 2022 and full data in H1 2023. Assuming a positive outcome
from the FELIX study, this data is expected to form the basis of a planned
Biologics License Application (BLA) submission by the Company.
o Autolus plans to evaluate a separate cohort of up to 50 additional patients
with Minimal Residual Disease (MRD). The additional data aims to establish the
profile of obe-cel in patients across all levels of disease burden in adult
ALL.
o In March 2022 obe-cel was granted Orphan Medical Product Designation by the
European Medicines Agency (EMA) for the treatment of ALL, having previously
received Orphan Drug Designation by the U.S. Food & Drug Administration
(FDA) for B-ALL.
· Obe-cel in r/r B-NHL - ALLCAR19 Extension Trial
o Subjects continue to be enrolled into the Phase 1 ALLCAR19 extension trial.
The latest data readout from this extension study of obe-cel in patients with
r/r B-Cell Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic Leukemia
(CLL) were presented at ASH in December 2021. Updated data from the trial will
be presented as a poster at the EHA Congress in June.
· Obe-cel in PCNSL - CAROUSEL Trial
o Subjects continue to be enrolled into the Phase 1 CAROUSEL trial. Data from
the trial will be presented as a poster at the EHA Congress in June.
· AUTO1/22 in pediatric ALL - CARPALL Trial
o Autolus continues to enroll patients into the AUTO1/22 Phase 1 CARPALL
trial. Initial clinical data from the trial will be presented as an oral
presentation at the EHA Congress in June.
· AUTO4 in Peripheral T Cell Lymphoma - LibrA T1 Trial
o Autolus continues to enroll patients into the AUTO4 Phase 1 clinical trial,
which is progressing through its dose escalation phase. Interim Phase 1 data
will be presented as an oral presentation at the EHA Congress in June.
· AUTO6NG in Neuroblastoma
o Autolus plans to initiate a Phase 1 clinical trial of AUTO6NG in patients
with neuroblastoma in H2 2022.
· AUTO8 in Multiple Myeloma - MCARTY Trial
o During the period, Autolus initiated a Phase 1 clinical trial of AUTO8, the
Company's next-generation product candidate for multiple myeloma. AUTO8
comprises two independent CARs targeting BCMA and CD19 designed to induce deep
and durable responses and extend the durability of effect.
Key Operational Updates during Q1 2022
· Effective March 31, 2022, Dr. Lucinda Crabtree was appointed as Chief
Financial Officer succeeding Andrew J. Oakley upon his retirement. Dr.
Crabtree served as SVP Finance prior to her promotion.
· Good progress is being made in the build phase of the Company's new
70,000 square foot commercial manufacturing facility in Stevenage, UK. This
facility is expected to be ready for GMP operations by H2 2023 and is designed
for a capacity of 2,000 batches a year with the option to expand.
Post Period Updates:
· On 25 April, the FDA granted Regenerative Medicine Advanced Therapy
(RMAT) designation to obe-cel, in recognition of the therapy's potential to
address significant unmet medical needs in patients with serious or
life-threatening conditions. RMAT designation provides important benefits in
the drug development process, designed to facilitate and expedite development
and regulatory review. Obe-cel also received PRIME designation from EMA and
ILAP from MHRA.
· On 2 May, Autolus announced the online publication of three abstracts
submitted to the American Society of Gene & Cell Therapy (ASGCT) to be
held May 16-19, 2022. The three abstracts focus on Autolus' modular approach
to CAR T product development, using innovative technology to improve our
pipeline of precise, controlled and highly active products. The three
abstracts cover: 1) enhancing CAR T therapy using constitutively active
cytokine receptors, 2) engineering CAR T cells to express a Fas-CD40 to
increase its persistence and tumor cytotoxicity and 3) developing a
minocycline mediated protein-protein displacement platform to make cell
therapies tunable, dose dependent and reversible.
Key Anticipated Clinical Milestones:
· Initial clinical data from the FELIX Phase 2 trial in H2 2022 and
full data in H1 2023.
· Updated Phase 1 data from the ALLCAR19 extension trial in patients
with r/r B-NHL and CLL presented as a poster at the EHA Congress in June 2022.
· Updates on the obe-cel Phase 1 CAROUSEL trial in Primary CNS Lymphoma
presented as a poster at the EHA Congress in June 2022.
· Initial clinical data from the AUTO1/22 CARPALL extension trial in
pediatric ALL presented as an oral presentation at the EHA Congress in June
2022, with longer follow up in H2 2022.
· Initial clinical data from AUTO4 LibraT1 Phase 1 trial in TRBC1+
Peripheral TCL presented as an oral presentation at the EHA Congress in June
2022.
· AUTO6NG Phase 1 clinical trial in neuroblastoma expected to start H2
2022. Expect first data in H2 2023.
· AUTO8 Phase 1 clinical trial in patients with multiple myeloma has
started, expect first data in H2 2023.
Financial Results for the Quarter Ended March 31, 2022
Cash at March 31, 2022, totaled $268.6 million, as compared to $310.3 million
at December 31, 2021.
Total operating expenses, net of grant income of $0.2 million, for the three
months ended March 31, 2022, were $41.8 million, as compared to total
operating expenses, net of grant income of $0.3 million, of $39.9 million for
the same period in 2021.
Grant income decreased by $0.1 million to $0.2 million for the three months
ended March 31, 2022, as compared to $0.3 million for the same period in the
prior year. The decrease is due to a corresponding decrease in reimbursable
expenditures.
Research and development expenses increased to $34.0 million for the three
months ended March 31, 2022, as compared to $30.7 million for the three months
ended March 31, 2021. Cash costs decreased to $30.6 million from $30.7
million. The decrease in research and development cash costs of $0.1 million
consisted primarily of (i) $2.8 million decrease in compensation and
employment related costs which was due to a combination of lower retention,
severance payments and timing and salary mix of new employee hires, (ii) $0.9
million decrease in facilities costs related to the termination and exit of
the Company's US manufacturing facility in 2021 and shift in its manufacturing
strategy, and (iii) $0.2 million in research and development costs related to
cell logistics.
This was offset by an increase of (i) $2.9 million in clinical costs and
manufacturing costs primarily relating to the Company's obe-cel clinical
product candidate, (ii) $0.8 million increase in legal fees and professional
consulting fees in relation to our research and development activities, and
(iii) $0.1 million increase related to information technology infrastructure
and support for information systems related to the conduct of clinical trials
and manufacturing operations.
Non-cash costs increased to $3.4 million for the three months ended March 31,
2022 from $36,000 for the three months ended March 31, 2021. The increase is
primarily attributable to an increase of $3.1 million in share-based
compensation expense included in research and development expenses as a result
of retention of employees post the reduction of workforce that was implemented
during the three months ended March 31, 2021. In addition, depreciation and
amortization expense increased by $0.3 million.
General and administrative expenses decreased by $0.7 million to $8.0 million
for the three months ended March 31, 2022, from $8.7 million for the three
months ended March 31, 2021. Cash costs, which exclude depreciation and
amortization as wells as share-based compensation decreased to $7.0 million
from $7.6 million. The decrease in general and administrative cash costs of
$0.6 million related to decreases of (i) $0.5 million in facilities costs
related to the termination and exit of the Company's lease agreements in the
prior year, (ii) $0.4 million of commercial preparation costs due to the
timing of related activities and (iii) $0.3 million associated with
compensation expense due to fewer contracted staff. These decreases were
offset by increases of $0.5 million primarily related to higher directors' and
officers' liability insurance premiums and professional fees in relation to
business development opportunities and $0.1 million in costs related to
information technology infrastructure and support for information systems.
Non-cash costs decreased by $0.1 million to $1.0 million for the three months
ended March 31, 2022 from $1.1 million for the three months ended March 31,
2021. The decrease of $0.1 million primarily related to a decrease in
depreciation and amortization expense.
There were no disposals of leasehold improvements for the three month period
ended March 31, 2022. For the three months ended March 31, 2021, the Company
incurred a loss on disposal of leasehold improvements of $0.7 million related
to the leasehold improvements no longer being utilized in its facility in
White City, London.
Other income, net for the three months ended March 31, 2022, was consistent
with the three months ended March 31, 2021. During the three months ended
March 31, 2022 there was a strengthening of the U.S. dollar exchange rate
relative to the pound sterling resulting in a foreign exchange gain of $0.8
million. This compares to the three months ended March 31, 2021 where there
was a gain on lease terminations of $2.0 million offset by other expenses of
$1.2 million related to a foreign exchange loss.
Interest expense increased to $1.8 million for the three months ended March
31, 2022 and relates to the liability related to sales of future royalties and
sales milestones which arose upon entering into the Blackstone Strategic
Collaboration and Financing Agreement with BXLS V - Autobahn L.P., in November
2021. There was no interest expense during the comparable period in 2021.
Income tax benefit decreased by $0.1 million to $5.6 million for the three
months ended March 31, 2022 from $5.7 million for the three months ended March
31, 2021 due to a decrease in the research and development expenditures which
were qualifying for the quarter. As research and development credits fell at
a faster rate than the Company's net loss before income tax, this led to a
lower effective tax rate.
Net loss attributable to ordinary shareholders was $37.1 million for the three
months ended March 31, 2022, compared to $33.3 million for the same period in
2021. The basic and diluted net loss per ordinary share for the three months
ended March 31, 2022, totaled $(0.41) compared to a basic and diluted net loss
per ordinary share of $(0.53) for the three months ended March 31, 2021.
Autolus estimates that its current cash on hand and anticipated milestone
payments from Blackstone extends the Company's runway into 2024.
Unaudited Financial Results for the Quarter Ended March 31, 2022
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
March 31, 2022 December 31, 2021
Assets
Current assets:
Cash $ 268,558 $ 310,338
Restricted cash 334 338
Prepaid expenses and other assets, current 40,571 36,276
Total current assets 309,463 346,952
Property and equipment, net 31,017 33,541
Prepaid expenses and other non-current assets 2,119 2,362
Operating lease right-of-use assets 17,366 18,775
Long-term deposits 1,983 2,039
Deferred tax asset 2,000 1,826
Intangible assets, net 46 65
Total assets $ 363,994 $ 405,560
Liabilities and shareholders' equity
Current liabilities:
Accounts payable $ 153 $ 431
Accrued expenses and other liabilities 24,513 23,667
Operating lease liabilities 4,174 4,453
Total current liabilities 28,840 28,551
Operating lease liabilities, net of current portion 15,081 16,545
Liability related to sale of future royalty and sales milestones, net 48,806 47,016
Other long-term payables 124 128
Total liabilities 92,851 92,240
Commitments and contingencies (Note 11)
Shareholders' equity:
Ordinary shares, $0.000042 par value; 200,000,000 shares authorized as of 4 4
March 31, 2022 and December 31, 2021; 90,907,941 and 90,907,830, shares issued
and outstanding at March 31, 2022 and December 31, 2021, respectively
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and - -
outstanding at March 31, 2022 and December 31, 2021
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued 118 118
and outstanding at March 31, 2022 and December 31, 2021
Deferred C shares, £0.000008 par value; 1 share authorized, issued and - -
outstanding at March 31, 2022 and December 31, 2021
Additional paid-in capital 845,448 843,108
Accumulated other comprehensive loss (16,025) (8,570)
Accumulated deficit (558,402) (521,340)
Total shareholders' equity 271,143 313,320
Total liabilities and shareholders' equity $ 363,994 $ 405,560
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended March 31,
2022 2021
Grant income $ 166 $ 269
Operating expenses:
Research and development (33,963) (30,731)
General and administrative (7,987) (8,738)
Loss on disposal of leasehold improvements - (672)
Total operating expenses, net (41,784) (39,872)
Other income (expense):
Interest income 28 44
Other income, net 860 838
Interest expense (1,790) -
Total other (expense) income, net (902) 882
Net loss before income tax (42,686) (38,990)
Income tax benefit 5,624 5,724
Net loss attributable to ordinary shareholders (37,062) (33,266)
Other comprehensive (loss) income:
Foreign currency exchange translation adjustment (7,455) 1,273
Total comprehensive loss $ (44,517) $ (31,993)
Basic and diluted net loss per ordinary share $ (0.41) $ (0.53)
Weighted-average basic and diluted ordinary shares 90,914,175 62,447,606
Conference Call
Management will host a conference call and webcast today at 8:30 am ET/1:30
pm BST to discuss the Company's financial results and provide a general
business update. To listen to the webcast and view the accompanying slide
presentation, please go to the events section
(https://www.autolus.com/investor-relations/news-and-events/events) of
Autolus' website.
The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada
callers or (409) 217-8320 for international callers. Please reference
conference ID: 3245616. After the conference call, a replay will be available
for one week. To access the replay, please dial (855) 859-2056 for U.S. and
Canada callers or (404) 537-3406 for international callers. Please reference
conference ID: 3245616.
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing
next-generation, programmed T cell therapies for the treatment of cancer.
Using a broad suite of proprietary and modular T cell programming
technologies, the Company is engineering precisely targeted, controlled and
highly active T cell therapies that are designed to better recognize cancer
cells, break down their defense mechanisms and eliminate these cells. Autolus
has a pipeline of product candidates in development for the treatment of
hematological malignancies and solid tumors. For more information, please
visit www.autolus.com.
About obe-cel (AUTO1)
Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the
limitations in clinical activity and safety compared to current CD19 CAR T
cell therapies. Designed to have a fast target binding off-rate to minimize
excessive activation of the programmed T cells, obe-cel may reduce toxicity
and be less prone to T cell exhaustion, which could enhance persistence and
improve the ability of the programmed T cells to engage in serial killing of
target cancer cells. In collaboration with Autolus' academic partner, UCL,
obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.
Autolus has progressed obe-cel to the FELIX trial, a potential pivotal trial
for adult ALL.
About obe-cel FELIX clinical trial
Autolus' Phase 1b/2 clinical trial of obe-cel is enrolling adult patients with
relapsed / refractory B-precursor ALL. The trial had a Phase 1b component
prior to proceeding to the single arm, Phase 2 clinical trial. The primary
endpoint is overall response rate, and the secondary endpoints include
duration of response, MRD negative CR rate and safety. The trial is designed
to enroll approximately 100 patients across 30 of the leading academic and
non-academic centers in the United States, United Kingdom and Europe.
NCT04404660
About AUTO1/22
AUTO1/22 is a novel dual targeting CAR T cell based therapy candidate based on
obe-cel. It is designed to combine the enhanced safety, robust expansion &
persistence seen with the fast off rate CD19 CAR from obe-cel with a high
sensitivity CD22 CAR to reduce antigen negative relapses. This product
candidate is currently in a Phase 1 clinical trial for patients with r/r
pediatric ALL. [NCT02443831 (https://clinicaltrials.gov/ct2/show/NCT02443831)
]
About AUTO4
AUTO4 is a programmed T cell product candidate in clinical development for T
cell lymphoma, a setting where there are currently no approved programmed T
cell therapies. AUTO4 is specifically designed to target TRBC1 derived
cancers, which account for approximately 40% of T cell lymphomas, and is a
complement to the AUTO5 T cell product candidate, which is in pre-clinical
development.
About AUTO5
AUTO5 is a programmed T cell product candidate in pre-clinical development for
T cell lymphoma, a setting where there are currently no approved programmed T
cell therapies. AUTO5 is specifically designed to target TRBC2 derived
cancers, which account for approximately 60% of T cell lymphomas, and is a
complement to the AUTO4 T cell product candidate currently in clinical
development.
About AUTO6NG
AUTO6NG is a next generation programmed T cell product candidate in
pre-clinical development. AUTO6NG builds on preliminary proof of concept data
from AUTO6, a CAR targeting GD2-expression cancer cell currently in clinical
development for the treatment of neuroblastoma. AUTO6NG incorporates
additional cell programming modules to overcome immune suppressive defense
mechanisms in the tumor microenvironment, in addition to endowing the CAR T
cells with extended persistence capacity. AUTO6NG is currently in
pre-clinical development for the potential treatment of both neuroblastoma and
other GD2-expressing solid tumors.
About AUTO8
AUTO8 is our next-generation product candidate for multiple myeloma which
comprises two independent CARs for the multiple myeloma targets, BCMA and
CD19. We have developed an optimized BCMA CAR which is designed for improved
killing of target cell that express BCMA at low levels. This has been combined
with fast off rate CD19 CAR from obe-cel. We believe that the design of AUTO8
has the potential to induce deep and durable responses and extend the
durability of effect over other BCMA CARs currently in development.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements are statements that are not historical
facts, and in some cases can be identified by terms such as "may," "will,"
"could," "expects," "plans," "anticipates," and "believes." These statements
include, but are not limited to, statements regarding the development of
Autolus' product candidate pipeline and achievement of expected near- and
long-term milestones; the development of the obe-cel program including planned
readouts after the completed futility analysis and completion of patient
enrollment; the future clinical development, efficacy, safety and therapeutic
potential of its other product candidates such as AUTO1/22, AUTO4. AUTO5,
AUTO6NG, and AUTO8, including progress, expectations as to the reporting of
data, conduct and timing and potential future clinical activity and
milestones; expectations regarding regulatory approval process for any product
candidates; Autolus' eligibility for potential milestone and royalty payments,
and the Company's anticipated 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; and the impact of the ongoing COVID-19 pandemic on Autolus'
business. For a discussion of other risks and uncertainties, and other
important factors, any of which could cause Autolus' actual results to differ
from those contained in the forward-looking statements, see the section titled
"Risk Factors" in Autolus' Annual Report on Form 20-F filed with the
Securities and Exchange Commission on March 10, 2022, 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:
Olivia Manser
+44 (0) 7780 471568
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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