TIDMCIZ
RNS Number : 4568N
Cizzle Biotechnology Holdings PLC
30 September 2021
30 September 2021
Cizzle Biotechnology Holdings Plc
("Cizzle", the "Company" or the "Group")
Interim results for the six months ended 30 June 2021
Cizzle Biotechnology Holdings PLC (LSE: CIZ), the UK based
diagnostics developer, is pleased to announce its results for the
six months ended 30 June 2021.
Highlights
-- Completed the acquisition of Cizzle Biotechnology Limited
("CBL") on 14 May 2021 and admission to trading on the London Stock
Exchange by way of a Standard Listing, raising gross proceeds of
GBP2,200,000 before expenses from the issue of new shares.
-- Change of the company name from Bould Opportunities plc to Cizzle Biotechnology Holdings plc.
Post Period Highlights
-- Significant progress has been made to establish the
foundations of the Group in its ambition to commercialise and
realise the potential of its proprietary CIZ1B biomarker technology
that has been developed by Professor Dawn Coverley and her team at
the University of York for the early detection of lung cancer.
-- A collaboration agreement was signed with FairJourney
Biologics to develop proprietary antibodies for early lung cancer
detection tests. This important step will not only enable the
Company to develop its early ELISA hospital laboratory test, but
also provide reagents that can be produced and licensed to
commercial partners and facilitate adoption with key clinical
opinion leaders worldwide.
-- A Memorandum of Understanding ("MOU") was completed with St
George Street Capital ("SGSC"), to collaborate together to develop
a companion diagnostic platform for certain therapeutic assets
licensed to SGSC from one of the world's largest pharmaceutical
companies, Astra Zeneca. This seeks to address unmet clinical needs
in a wide variety of autoimmune diseases which will significantly
broaden the Company's product pipeline and for which SGSC will pay
up to GBP1 million in development fees.
-- A full commercial royalty sharing agreement announced with
SGSC grants the Company potential future royalty payments of up to
GBP5 million from the commercialisation of SGSC's therapeutic
asset, AZD1656 for the treatment of COVID 19 in vulnerable diabetic
patients. Under the terms of the agreement the Company will pay to
SGSC GBP135,000 in addition to GBP65,000 it paid on signing the
MOU.
-- A new research agreement was signed with the University of
York, a member of the Russell Group of research-intensive
universities and one of the world's premier institutions for
inspirational and life-changing research, for the development and
validation of molecular tests with potential applications in cancer
diagnosis and therapy.
Commenting Allan Syms, Chairman of Cizzle Biotechnology, said
:
"The Group's focus on providing pivotal and diagnostic products
for the early detection of cancer and other life-threatening
illnesses took a major step forward following the acquisition of
CBL, which is developing a product for the early detection of lung
cancer that has the potential to decisively help front line
physicians detect lung cancer in the clinic. For too long, their
diagnostic choices have had to rely on increasing invasive
procedures that in many cases are unnecessary. Given the rapid
advances in biologics and endoscopy, there is an urgent need now
for earlier stages of lung cancer to be reliably found where
survival is meaningfully improved for the patient. The Group
believes that is has the potential to be part of that step wise
change through the development of a product for the early detection
of lung cancer. This is proceeding well and in accordance with our
business plan.
"The collaboration with FairJourney Biologics represents a
significant step and in addition to providing the key antibodies
for our hospital test, provides the opportunity to licence these
proprietary key reagents to other global manufacturers to ensure
that we help facilitate early cancer detection everywhere and help
improve patient prognosis as widely as we can.
"Our next steps will be to consider how we can broaden the use
of our technology for widescale screening in doctor's office
testing. We also are keen to broaden the scope of our tests beyond
lung cancer so we can address the challenge of early diagnosis in
other cancers with unmet needs. Our continuing commitment to
research at the University of York will play an important part in
that potential being realised.
"Clearly early diagnosis is a vital tool in enabling early
clinical intervention and improving patient outcomes for a wide
range of diseases, notably lung cancer. In addition, diagnostic
products can be used to identify which patients may prove most
likely to respond to new drugs with the least side effect burden to
patients. Such companion diagnostics are a key part of treatments
for cancer, and other serious illnesses. Our new partnership with
SGSC opens doors for the Group to apply its expertise and products
in this regard, initially focussed on tests involved in autoimmune
disease. That the Group can now benefit from attractive potential
royalty streams from new therapeutics, as well as associated
companion diagnostics, and is expected to benefit from near term
revenues from development fees, is important to the Group's
long-term ambitions."
Executive Chairman's statement
Operational and strategic overview
The major event during the period was the completion of the
acquisition of CBL on 14 May 2021 and admission to trading on the
London Stock Exchange by way of a Standard Listing. As part of the
listing process the Company raised gross proceeds of GBP2,200,000,
before expenses, from the issue of new shares. Following the
acquisition, the Group's principal activity is now focussed on
realising and commercialising, through systematic development,
CBL's technology for the early detection of cancer.
CBL, a spin-out from the University of York, founded in 2006 by
Professor Coverley, is developing a blood test for the early
detection of lung cancer. CBL's technology is based on the ability
to detect the CIZ1B variant of the C1Z1 protein, which is a
naturally occurring cell nuclear protein involved in DNA
replication. The targeted C1Z1B variant is a stable plasma
biomarker that is highly correlated with early-stage lung cancer.
CBL's proof-of-concept prototype test is based on the ability to
detect CIZ1B in patient's blood. Peer-reviewed published research
led by Professor Coverley has demonstrated that CIZ1B can be
measured via a simple ELISA test, which should allow for its
incorporation into established hospital high-throughput testing
platforms. We believe that this development overcomes an important
barrier to further clinical development of this blood test, and
should allow for the detection of lung cancer at a stage when the
disease still bears a good prognosis.
Cizzle Biotechnology's goal is to help front line clinicians in
their diagnostic decision making by providing a test that can
quickly and accurately give another perspective on whether a
patient should be sent forward for more invasive testing. For the
majority of patients fortunate enough to have presented with benign
radiological findings, such a test would avoid the need for
intrusive follow up testing, which can include repeated CT scanning
and/or tissue biopsies, which are both costly to the NHS, health
providers and medical insurers and stressful to patients.
The Board intends for the Company's initial product to be a
diagnostic immunoassay that can be readily performed by hospitals
and reference laboratories, but a potential follow-on product could
be a point of care test provided by a primary health care provider
e.g. for doctor's office testing. The Board is currently focussed
on the development of the C1Z1B biomarker test through to CE
marking and/or FDA 510(k) clearance and will additionally consider
broadening its product range into screening tests and tests for
other forms of cancer. Significant progress has been made since the
acquisition to establish the foundations of the Group in its
ambitions as a developer and supplier of innovative clinical
diagnostic tests, and to commercialise the CIZ1B biomarker
technology.
The collaboration agreement with FairJourney Biologics to
develop proprietary antibodies is a key milestone in achieving our
goals and will provide important tools that can be used to build
not only our own range of hospital and doctor's office tests, but
also provide proprietary licensing opportunities with commercial
and clinical partners worldwide. Our new research agreement with
the University of York for the development and validation of these
molecular tests will strengthen those ambitions.
Post period end, in June 2021, a Memorandum of Understanding
("MOU") was completed with SGSC, to collaborate on the development
of a companion diagnostic, which is a clinical test used to support
the safe and effective use of a corresponding drug in appropriate
patient populations. This relates to certain therapeutic assets
(AZD16560) licensed to SGSC by Astra Zeneca which has been shown to
affect the immune system at sites of damaging inflammation which
can be typical in autoimmune disease and hence seeks to address
unmet clinical needs in autoimmune disease.
SGSC is a biomedical research charity founded to fast-track
clinical trials to get new treatments as quickly as possible to the
people who need them. The charity brings together a powerful mix of
expertise, from investors and business managers to academics and
clinicians, and has formed a long-term strategic relationship with
Cizzle where we can each benefit from strategically aligned skill
sets, building a complimentary portfolio of diagnostic and
therapeutic products.
In September this year, SGSC reported encouraging results from
its ARCADIA clinical trial. The trial was initiated from an
existing collaboration between SGSC and AstraZeneca and funded by
international investment through Excalibur Medicines Ltd and an HM
Government grant through the UKRI/Innovate UK programme. Cizzle has
secured royalty sharing rights for AZD1656 for treating COVID 19
and additional disease indications,.
During September 2021 a royalty sharing agreement was announced
with SGSC to grant the Company potential future royalty payments
from the commercialisation of AZD1656, of up to GBP5 million. Under
the terms of the agreement the Company has paid GBP135,000 to SGSC
in addition to the GBP65,000 it paid on signing the MOU. The
Company intends, in due course to execute our collaboration
agreement, whereby SGSC will, in addition, pay the Group fees of up
to GBP1m for the development of a companion diagnostic.
Financial overview
During the six months ended 30 June 2021, the Company
transformed itself from a cash shell into an operating group that
is a focussed healthcare diagnostics developer. The Group consists
of Cizzle Biotechnology Holdings PLC as the parent company with
wholly owned subsidiaries, Cizzle Biotechnology Ltd ("CBL") and
Cizzle Biotech Ltd (formerly Enfis Ltd).
The financial results for the six months to 30 June 2021 are
summarised as follows:
-- Corporate expenses, before exceptional items, H1: GBP119,000 (H1 2020, CBL: GBP8,000).
-- Exceptional corporate expenses relating to the acquisition of
CBL, H1: GBP3,219,000 (H1 2020, CBL: GBPNil) which include
transaction costs of GBP304,000 and a non-cash share-based expense
of GBP2,815,000. The share-based expense of GBP2,815,000 arises as
these interim financial statements have been prepared using the
reverse acquisition methodology of consolidation. Rather than
recognising goodwill this expense represents the equity value given
up by CBL's shareholders and the share of the fair value of net
liabilities gained by CBL's shareholders. This is recognised as a
share-based payment on reverse acquisition and represents in
substance the cost of acquiring a London Stock Exchange
listing.
-- Total comprehensive loss in H1 2021: GBP3,238,000 (H1 2020, CBL loss of GBP8k).
-- Loss per share in H1 2021: (3.79)p, (H1 2020, CBL: loss of (0.004)p).
-- Cash balances as at 30 June 2021: GBP1,425,000 (30 June 2020 CBL: GBP10,000).
Responsibility Statement
We confirm that to the best of our knowledge:
-- the interim financial statements have been prepared in
accordance with International Accounting Standards 34, Interim
Financial Reporting;
-- give a true and fair view of the assets, liabilities,
financial position and loss of the Company;
-- the Interim report includes a fair review of the information
required by DTR 4.2.7R of the Disclosure and Transparency Rules,
being an indication of important events that have occurred during
the first six months of the financial year and their impact on the
set of interim financial statements; and a description of the
principal risks and uncertainties for the remaining six months of
the year; and
-- The Interim report includes a fair review of the information
required by DTR 4.2.8R of the Disclosure and Transparency Rules,
being the information required on related party transactions.
The interim report was approved by the Board of Directors and
the above responsibility statement was signed on its behalf by
Allan Syms on 29 September 2021.
Enquiries:
Cizzle Biotechnology Holdings Via IFC Advisory
plc
Allan Syms (Executive Chairman)
Allenby Capital Limited +44(0) 20 33285656
John Depasquale
Alex Brearley
Novum Securities Limited +44(0) 20 7399 9400
Colin Rowbury
Jon Bellis
IFC Advisory Limited +44(0) 20 3934 6630
Tim Metcalfe
Florence Chandler
About Cizzle Biotechnology
Cizzle Biotechnology is developing a blood test for the early
detection of lung cancer. Cizzle Biotechnology is a spin- out from
the University of York, founded in 2006 around the work of
Professor Coverley and colleagues . Its proof-of-concept prototype
test is based on the ability to detect a stable plasma biomarker, a
variant of CIZ1 known as CIZ1B. CIZ1 is a naturally occurring cell
nuclear protein involved in DNA replication, and the targeted CIZ1B
variant is highly correlated with early-stage lung cancer.
For more information please see
https://cizzlebiotechnology.com
You can also follow the Company through its twitter account
@CizzlePlc and on LinkedIn.
Consolidated Statement of Comprehensive Income
For the six months ended 30 June 2021
CBL CBL
Group Six months Year ended
Six months ended 30 31 December
ended June
2021 2020 2020
Unaudited Unaudited Unaudited
Notes GBP'000 GBP'000 GBP'000
Revenue - - -
Cost of Sales - - -
Gross Profit - - -
Administrative Expenses
(119) (8) (14)
* On-going administrative costs (304) - -
3 (2,815) - -
* Transaction costs
* Reverse acquisition expenses
--------------------- ----------------------- ------------------------
Total administrative expenses
including exceptional items (3,238) (8) (14)
--------------------- ----------------------- ------------------------
Operating (Loss) and (loss)
before income tax (3,238) (8) (14)
Taxation 4 - - -
--------------------- ----------------------- ------------------------
(Loss) and total comprehensive
income for the period attributable
to the equity shareholders of
the parent (3,238) (8) (14)
--------------------- ----------------------- ------------------------
Earnings per share (Loss)- basic
and diluted - pence 5 (3.79)p (0.004)p (0.007)p
Consolidated Statement of Financial Position
as at 30 June 2021
Group CBL CBL
30 June 30 June 31 December
2021 2020 2020
Notes Unaudited Unaudited Unaudited
GBP'000 GBP'000 GBP'000
Non-Current Assets
Property, Plant & Equipment - - -
Intangible Assets - - -
Total Non-Current Assets - - -
------------ ---------- ---------------------------
Current Assets
Trade & Other Receivables 99 1 3
Cash & Cash Equivalents 1,425 10 7
------------ ---------- ---------------------------
Total Current Assets 1,524 11 10
------------ ---------- ---------------------------
Total Assets 1,524 11 10
------------ ---------- ---------------------------
Equity
Ordinary Share Capital 3,493 3 3
Share premium 31,521 1,585 1,585
Share capital reduction reserve 10,081 - -
Share option reserve 13 - -
Reverse acquisition reserve 3 (38,953) - -
Retained losses (4,833) (1,589) (1,596)
Equity 1,322 (1) (8)
------------ ---------- ---------------------------
Liabilities
Current Liabilities
Trade & Other Payables 202 12 8
Borrowings - - 10
Total Current Liabilities 202 12 18
------------ ---------- ---------------------------
Non-Current Liabilities
Deferred Tax Liabilities - - -
Total Liabilities - - -
------------ ---------- ---------------------------
Total Equity and Liabilities 1,524 11 10
------------ ---------- ---------------------------
Consolidated Statement of Cash Flows
For the six months ended 30 June 2021
Group CBL CBL
6 Months 6 Months Year
Ended Ended Ended
30 June 30 June 31 December
2021 2020 2020
Unaudited Unaudited Unaudited
GBP'000 GBP'000 GBP'000
Cash flow from operating activities Notes
Operating (loss) before tax (3,238) (8) (14)
Adjustment for:
Reverse acquisition share based
expense 3 2,815 - -
Operating cash flow before working
capital movements (423) (8) (14)
(Increase) / decrease in trade and
other receivable (49) 3 1
(Decrease) / increase in trade and
other payables (116) 2 (3)
------------------------- ------------ --------------
Net cash (outflow) from operating
activities (588) (3) (16)
------------------------- ------------ --------------
Cash flow from investing activities
Cash acquired in acquisition of
subsidiary 46 - -
Proceeds from the issue of capital
net of issue costs 1,970 - -
------------------------- ------------ --------------
Net cash inflow from investing activities 2,016 - -
------------------------- ------------ --------------
Cash flow from financing activities
Borrowings received - - 10
Borrowings repaid (10) - -
------------------------- ------------ --------------
Net cash (outflow) / inflow from
financing activities (10) - 10
------------------------- ------------ --------------
Net increase/ (decrease) in cash
and cash equivalents 1,418 (3) (6)
Cash and cash equivalents at the
start of the period 7 13 13
------------------------- ------------ --------------
Cash and cash equivalents at the
end of the period 1,425 10 7
------------------------- ------------ --------------
Consolidated Statement of Changes in Equity
For the six months ended 30 June 2021 (unaudited)
Ordinary Capital Share Reverse
Share Share Redemption Option Acquisition Retained
Group Capital Premium Reserve Reserve Reserve Losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 2021 - - - - - (1,595) (1,595)
Recognition of plc
equity
at acquisition date 3,470 8,852 10,081 - (38,953) - (16,550)
Issue of shares for
acquisition of
subsidiary 21 20,610 - - - - 20,631
Issue of shares for
cash 2 2,198 - - - - 2,200
Issue of shares in
settlement
of fees - 32 32
Issue of warrants - (13) - 13 - - -
Cost of share issue - (158) - - - - (158)
Comprehensive Loss for
the Period - - - - - (3,238) (3,238)
At 30 June 2021 3,493 31,521 10,081 13 (38,953) (4,833) 1,322
-------- -------- ------------ -------- ---------------------- --------- -------------
For the six months ended 30 June 2020 (unaudited)
Ordinary
Share Share Retained
CBL Capital Premium Losses Total
GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 2020 3 1,585 (1,582) 6
Comprehensive loss for
the period - - (7) (7)
At 30 June 2020 3 1,585 (1,589) (1)
----------- ---------- ----------- ---------
For the year ended 31 December 2020 (unaudited)
Ordinary
Share Share
Capital Premium Retained
CBL Losses Total
GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 2020 3 1,585 (1,582) 6
Comprehensive loss for
the period - - (14) (14)
At 31 December 2020 3 1,585 (1,596) (8)
----------- ---------- ----------- ---------
Notes to the financial statements
For the six months ended 30 June 2021 (unaudited)
1. Basis of preparation
These interim financial statements have been prepared in
accordance with IAS 34 - Interim Financial Reporting using the
recognition and measurement principles of International Accounting
Standards, International Financial Reporting Standards and
Interpretations adopted for use in the European Union (collectively
"Adopted IFRS").
The principal accounting policies used in preparing these
interim financial statements are those expected to apply to the
Group's Consolidated Financial Statements for the year ending 31
December 2021.
The results for the six-months ended 30 June 2021 are the Group
results following the acquisition of Cizzle Biotechnology Limited
("CBL") on 14 May 2021. The results for the period to 30 June 2020
and 31 December 2020 are the results of CBL prior to the creation
of the new Group.
The financial information for the six months ended 30 June 2021,
30 June 2020 and 31 December 2020 is unaudited and does not
constitute statutory financial statements for those periods.
2. Continuing and discontinued operations
The Group is considered to have one class of business which is
focused on the early detection of lung cancer via the development
of an immunoassay test for the CIZ1B biomarker.
3. Reverse acquisition
On 14 May 2021 the Company acquired through a share for share
exchange the entire share capital of CBL whose principal activity
is the early detection of lung cancer through the development of
tests to detect CIZ1 variant protein.
Although the transaction resulted in CBL becoming a wholly owned
subsidiary of the Company, the transaction constitutes a reverse
acquisition as the previous shareholders of CBL own a substantial
majority of the shares of the Company.
In substance the shareholders of CBL acquired a controlling
interest in the Company and the transaction has therefore been
accounted for as a reverse acquisition. As the Company's activities
prior to the acquisition were purely the maintenance of the AIM
listing, acquiring CBL and raising equity finance to provide the
required funding for the operations of the acquisition it did not
meet the definition of a business combination in accordance with
IFRS 3.
Accordingly, this reverse acquisition does not constitute a
business combination and was accounted for in accordance with IFRS
2 "Share-based Payments" and associated IFRIC guidance. Although
the reverse acquisition is not a business combination, the Company
has become a legal parent and is required to apply IFRS 10 and
prepare consolidated financial statements. The directors have
prepared these financial statements using the reverse acquisition
methodology, but rather than recognise goodwill, the difference
between the equity value given up by the CBL shareholders is
charged to the statement of comprehensive income as a share-based
payment on reverse acquisition, and represents in substance the
cost of acquiring a quoted company.
In accordance with the reverse acquisition principles, these
consolidated financial statements represent a continuation of the
consolidated statements of Cizzle Biotechnology Holdings Plc and
its subsidiaries and include:
- The assets and liabilities of CBL at their pre-acquisition
carrying value amounts and the results for all periods reported;
and
- The assets and liabilities of the Company as at 14 May 2021
and its results from the date of reverse acquisition (14 May 2021)
to 30 June 2021.
On 14 January 2021 the Company issued 206,310,903 ordinary
shares to acquire the 313,932 ordinary shares of CBL Limited. At 14
January 2021 the valuation of the investment in CBL was
GBP21,600,000.
Because the legal subsidiary, CBL, was treated on consolidation
as the accounting acquirer and the legal parent company, Cizzle
Biotechnology Holdings Plc, was treated as an accounting
subsidiary, the fair value of the shares deemed to be issued by CBL
was calculated at GBP2,598,000 based on an assessment of the
purchase consideration for a 100% holding of Cizzle Biotechnology
Holdings plc.
The fair value of the net liabilities of Cizzle Biotechnology
Holdings Plc at acquisition was as follows:
GBP'000
Cash and cash equivalents 46
Other assets 47
Liabilities (310)
--------
Net (Liabilities) (217)
--------
The difference between the deemed cost of GBP2,598,000 and the
fair value of the net liabilities noted above of GBP(217,000)
resulted in GBP2,815,000 being expensed as "reverse acquisition
expenses" in accordance with IFRS2, Share- based Payments,
reflecting the economic cost to CBL shareholders of acquiring a
quoted entity.
The reverse acquisition reserve which arose from the reverse
takeover is made up as follows:
GBP'000
Pre-acquisition equity(1) (21,563)
CBL share capital at acquisition(2) 1,588
Investment in CBL(3) (21,703)
Reverse acquisition expense(4) 2,815
---------
(38,993)
---------
1. Recognition of pre-acquisition equity of Cizzle Biotechnology Holdings PLC at 14 May 2021.
2. CBL had issued share capital and share premium of
GBP1,588,000. As these financial statements represent the capital
structure of the legal parent entity, the equity of CBL is
eliminated.
3. The value of the shares issued by the Company in exchange for
the entire share capital of CBL plus stamp duty expenses. The above
entry is required to eliminate the balance sheet impact of this
transaction.
4. The reverse acquisition expense represents the difference
between the value of the equity issued by the Company, and the
deemed consideration given by CBL to the Group.
4. Income Tax
There was no income tax for the new Group for the six months
ended 30 June 2021. CBL also has no income tax for the six months
ended 30 June 2020 and year ended 31 December 2020.
5. Earnings per share
Group CBL CBL
6 months 6 months Year
ended ended ended
31 December
30 June 2021 30 June 2020 2020
Basic loss per share:
Total comprehensive (loss)
- GBP'000 GBP(3,238) GBP(8) GBP(14)
Weighted number of Ordinary
Shares - '000 85,448 206,625 206,625
(Loss) per share - operations
- pence (3.79p) (0.004p) (0.007p)
The weighted number of shares of CBL for the six months ended 30
June 2020 and year ended 31 December 2020 include 314,000 ordinary
shares of CBL plus 206,311,000 consideration shares issued by the
Company to acquire CBL.
Diluted earnings per share is calculated by dividing the profit
attributable to ordinary shareholders by the weighted average
number of ordinary shares outstanding after adjusting these amounts
for the effects of dilutive potential ordinary shares.
As the Group result for the six months ended 30 June 2020 is a
loss, any exercise of share options or warrants would have an
anti-dilutive effect on earnings per share. Consequently earnings
per share and diluted earnings per share are the same, as
potentially dilutive share options have been excluded from the
calculation.
6. Copies of Interim Report
Copies of this interim report are available upon request to
members of the public from the Company Secretary, SGH Company
Secretaries Limited, 6(th) Floor, 60 Gracechurch Street, London,
EC3V 0HR. This interim report can also be viewed on the Group's
website: https://cizzlebiotechnology.com .
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IR VKLFLFKLFBBQ
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