TIDMSCLP
RNS Number : 7483N
Scancell Holdings Plc
25 January 2023
25 January 2023
Scancell Holdings plc
("Scancell" or the "Company")
Interim Results for the 6 months ended 31 October 2022
Strong clinical progress with ongoing ModiFY and SCOPE trials;
further safety, immune and clinical response data expected in
2023
Signed licensing agreement with Genmab to develop and
commercialise an anti-glycan mAb providing strong commercial
validation of the Company's scientific approach and strategy
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
today announces its interim results for the 6 months ended 31
October 2022 and provides a business update on progress achieved to
date.
Highlights (including post period):
Vaccines:
-- Fourteen patients enrolled and dosed in the expansion phase
of the monotherapy arms in the multicentre Phase 1/2 Modi-1
clinical trial (ModiFY). First patient dosed in Cohort 3 of ModiFY
in combination with a checkpoint inhibitor (CPI). There have been
no safety issues to date.
-- Expansion of SCIB1 Phase 2 combination trial (SCOPE) protocol
to include SCIB1 in combination with checkpoint doublet therapy
leading to significantly increased recruitment rate.
-- In-licensed the SNAPvax(TM) technology from Vaccitech plc to
formulate and manufacture Modi-2, with the aim of initiating a
Phase 1 clinical study in cancer patients during H1 2024.
-- Recruitment completed in COVIDITY Phase 1 clinical trial in
South Africa, with safety and immunogenicity data expected in Q1
2023, providing read across to our second-generation ImmunoBody(R)
platform.
Antibodies:
-- Plans to take two GlyMab(R) monoclonal antibodies (mAbs), a
redirecting T-cell bispecific (TCB) antibody and a T cell
costimulatory mAb into the clinic, with initiation of TCB
manufacturing in H1 2023 prior to clinical evaluation in 2024.
-- Signed licensing agreement with Genmab to develop and
commercialise an anti-glycan mAb, with the Company being eligible
to receive milestone payments of up to $208 million for each
product developed and commercialised, up to a maximum of $624
million if Genmab develops and commercialises products across all
defined modalities.
-- AvidiMab(R) technology continues to be applied to the
Company's internal programmes whilst evaluating how AvidiMab(R)
could be used to enhance the efficacy of third-party
antibodies.
-- Preclinical data on GlyMab(R) and AvidiMab(R) antibody
platforms presented at PEGS Europe and EuroMAbNet Annual Meeting in
H2 2022.
Corporate:
-- John Chiplin has announced he will resign as Executive
Chairman for personal reasons but is staying on for an interim
period until a new Chair is appointed.
-- Dr Richard Goodfellow, stepped down a Board Director at the
2022 Annual General Meeting (AGM).
-- Susan Clement Davies, an independent Non-Executive Director
and Chair of the Audit Committee, appointed as Deputy Chair.
Financial:
-- Reported loss for the 6-month period to 31 October 2022 of
GBP3.2 million (31 October 2021 profit of GBP3.2 million).
-- Received licence fee of GBP5.3 million relating to the
up-front payment receivable from Genmab following the signing of
the licence agreement in October 2022.
-- Group cash balance at 31 October 2022 was GBP24.0 million
(April 2022: GBP28.7 million) with a cash runway until Q1 2024.
Prof Lindy Durrant, Chief Executive Officer, Scancell ,
commented:
"We are pleased to report another period of progress for
Scancell, including strong clinical and commercial developments. We
have continued to advance our ModiFY Phase 1/2 trial for Modi-1 and
the SCOPE Phase 2 trial for SCIB1 and expect to generate safety,
immune and clinical response results during 2023. During the
period, we also continued to progress our earlier stage pipeline
having signed an in-licensing agreement with Vaccitech.
"It has been a defining period for our proprietary antibody
platform as we have signed a licensing agreement for one of our
anti-glycan mAbs with Genmab, providing strong validation of the
platform and the Company's scientific approach. We remain one of
only a few companies worldwide that has the capability to produce
high affinity, humanised anti-glycan antibodies and continue to
evaluate options and potential agreements for the Company's
GlyMab(R) antibodies in order to provide further third-party
validation, develop the business and generate revenues. We would
like to thank our shareholders for their continued support over the
past 6 months and look forward to updating the market on our future
clinical and operational progress during 2023."
A full copy of the announcement can be found on the Scancell
website: www.scancell.co.uk
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please contact:
Scancell Holdings plc +44 (0) 20 3727 1000
Dr John Chiplin, Executive Chairman
Professor Lindy Durrant, CEO
Stifel Nicolaus Europe Limited (Nominated
Adviser and Joint Broker) +44 (0) 20 7710 7600
Nicholas Moore/ Samira Essebiyea/William Palmer-Brown
(Healthcare Investment Banking)
Nick Adams/Nick Harland (Corporate Broking)
Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
FTI Consulting +44 (0) 20 3727 1000
Simon Conway/Rob Winder/Alex Davis
About Scancell
Scancell is a clinical stage biopharmaceutical company that is
leveraging its proprietary research, built up over many years of
studying the human adaptive immune system, to generate novel
medicines to treat significant unmet needs in cancer and infectious
disease. The Company is building a pipeline of innovative products
by utilising its four technology platforms: Moditope (R) and
ImmunoBody (R) for vaccines and GlyMab(R) and AvidiMab (R) for
antibodies.
Adaptive immune responses include antibodies and T cells (CD4
and CD8), both of which can recognise damaged or infected cells. In
order to destroy such cancerous or infected cells, Scancell uses
either vaccines to induce immune responses or monoclonal antibodies
(mAbs) to redirect immune cells or drugs. The Company's unique
approach is that its innovative products target modifications of
proteins and lipids. For the vaccines (Moditope (R) and ImmunoBody
(R) ) this includes citrullination and homocitrullination of
proteins, whereas its mAb portfolio targets glycans or sugars that
are added onto proteins and / or lipids (GlyMab(R) ) or enhances
the potency of antibodies and their ability to directly kill tumour
cells (AvidiMab (R) ).
For further information about Scancell, please visit:
https://www.scancell.co.uk/
CHAIRMAN'S STATEMENT
I am pleased to report the Group's interim results for the
6-month period ended 31 October 2022. During the period, Scancell
has continued to make good clinical trial progress with recruitment
accelerating in the ongoing ModiFY and SCOPE trials, and the
completion of dosing in the COVIDITY Phase 1 study. In addition, we
have signed two encouraging deals, with Genmab which has
accelerated one of our antibodies into development, and post-period
with Vaccitech plc to streamline the future manufacture of Modi-2.
In our early stage pipeline, it is exciting to see Scancell's T
cell bispecific (TCB) redirecting programme advancing towards
identification of the lead product for our in-house clinical
development. We are indebted to our staff in all aspects of the
Company for their hard work, creative ideas and thoughtful approach
to working with their fellow employees to help achieve this strong
progress.
Set out below is a summary of progress that has been made across
our innovative and proprietary vaccine and antibody platforms.
VACCINES
Moditope(R) platform
Moditope(R) is a versatile proprietary cancer vaccine platform
that targets stress-induced post-translational modifications
(siPTMs) of proteins. This discovery has allowed us to develop a
completely new class of potent and selective therapeutic vaccines.
Examples of such modifications include citrullination, an
enzyme-based conversion of arginine to citrulline, and
homocitrullination, in which lysine residues are converted to
homocitrulline. Vaccination with peptides containing these
modifications have been demonstrated to induce potent CD4 cytotoxic
T cells that induce anti-tumour activity without any associated
toxicity in preclinical models.
Modi-1
Modi-1, which targets citrullinated cancer antigens, is the
first therapeutic vaccine candidate to emerge from Scancell's
Moditope(R) platform. The ModiFY study is a multicentre Phase 1/2
first-in-human clinical trial, with Modi-1 being administered alone
or in combination with checkpoint inhibitors (CPIs) in patients
with head and neck, triple negative breast and renal tumours, as a
monotherapy in patients with ovarian cancer where there are no
approved CPI therapies and in patients with the other tumour types
where CPIs are not indicated. This open label study will recruit up
to 138 patients in up to 20 clinical trial sites across the UK.
Nine sites are actively recruiting with another three being set up
and expected to initiate screening during 2023. To date, 21
patients have been immunised in the ModiFY study and a further 16
have been recruited.
As previously reported, Cohort 1 of the study confirmed the
safety profile of a low dose of two citrullinated vimentin
peptides. The objective for Cohort 2 of the trial was to assess the
safety of the two citrullinated vimentin peptides plus an enolase
peptide at a higher dose. We are pleased to announce that all three
patients in Cohort 2 have now successfully received multiple doses
and the injections were well tolerated with no safety concerns. The
head and neck patient in Cohort 2 has now shown a confirmed partial
response with further regression of their tumour at week 16 whilst
one ovarian patient in Cohort 1 and one in Cohort 2 have stable
disease.
Based on the safety data analysed from Cohort 2, post-period the
ModiFY trial was expanded at this dose for Modi-1 monotherapy in
three tumour types. To date, 13 ovarian, two breast and three head
and neck patients, including one in Cohort 3 in combination with a
CPI, have been dosed with no safety issues. Modi-1 stimulates CD4 T
cells which may directly impact tumour growth. However, in some
patients these T cells may need to be protected by CPIs if the
tumour environment is highly immunosuppressive.
Modi-1 peptides are linked to AMPLIVANT(R) , a potent adjuvant
which enhanced the immune response 10-100-fold and resulted in
highly efficient tumour clearance, including protection against
tumour recurrence, in preclinical models. AMPLIVANT(R) is the
subject of a worldwide licensing and collaboration agreement with
ISA Pharmaceuticals for the manufacturing, development, and
commercialisation of Modi-1.
The Company expects further safety, immunogenicity and efficacy
data from the ModiFY study to be available during 2023.
Modi-2
Modi-2, which targets homocitrullinated cancer antigens, is the
second therapeutic vaccine candidate from the Company's Moditope(R)
platform and has the potential to address different cancer
indications to Modi-1, including tumours with a particularly
immunosuppressive environment. During the period, internal
preclinical research and formulation development work has continued
to progress Modi-2 towards the clinic.
Post period, we were pleased to announce that we had in-licensed
the SNAPvax(TM) technology from Vaccitech plc, a clinical-stage
biopharmaceutical company engaged in the discovery and development
of novel immunotherapies and vaccines.
The SNAPvax(TM) technology enables peptides to self-assemble
with TLR-7/8a, a powerful adjuvant, to promote strong T cell
responses and is proven to successfully overcome historic
formulation issues associated with immunogenic peptide antigens,
which are often highly hydrophobic and prone to manufacturing
challenges with conventional formulations. For Modi-2, the Company
plans to use SNAPvax(TM) to co-deliver homocitrullinated peptide
antigens and TLR-7/8a adjuvants in self-assembling nanoparticles
designed to prime tumour killing T cells. The Company expects that
the combination of Scancell's Modi-2 with a highly effective
platform for inducing T cells will lead to a potentially superior
therapeutic vaccine candidate.
Homocitrullination is a process that occurs by a different
mechanism compared to citrullination (Modi-1) and is therefore
applicable to a distinct set of highly immune suppressed tumours.
Scancell will leverage its deep understanding of T cell immunology
and cancer immunotherapy together with its strong development
capabilities to bring Modi-2 to clinical validation, adding value
to the entire Moditope (R) platform. The agreement with Vaccitech
plc, signed in November 2022, will allow Scancell to formulate and
manufacture Modi-2, with the aim of initiating a Phase 1 clinical
study in cancer patients in H1 2024.
ImmunoBody(R) platform
Scancell's ImmunoBody(R) immunotherapy platform uses the body's
immune system to identify, attack and destroy tumours. This is
achieved by delivering a DNA plasmid to enhance the uptake and
presentation of cancer antigens to harness high avidity T cell
responses. Each ImmunoBody(R) vaccine can be designed to target a
particular cancer in a highly specific manner, offering the
potential for enhanced efficacy and safety compared with more
conventional approaches. These vaccines have the potential to be
used as monotherapy or in combination with CPIs and other agents.
The Board believe that this platform has the potential to enhance
tumour destruction, prevent disease recurrence and extend survival
rates for patients.
Scancell's ImmunoBody(R) vaccine approach can also be exploited
to induce immune responses against infectious diseases. As research
data emerged at the beginning of the COVID-19 pandemic, it was
clear that the induction of potent and activated T cells could play
a critical role in the development of long-term immunity and
clearance of virus-infected cells. Scancell therefore used its
proven cancer vaccine concept to design a vaccine against
SARS-CoV-2, the virus that causes COVID-19.
SCIB1 and iSCIB1+
SCIB1 is the lead product from the Company's ImmunoBody(R)
immunotherapy platform, which uses the body's immune system to
identify, attack and destroy tumours and is currently being
evaluated in a Phase 2 clinical trial ('SCOPE') in the UK in
combination with a CPI for the treatment of metastatic
melanoma.
Following the approval of a protocol amendment by the UK's
Medicines and Healthcare products Regulatory Agency (MHRA), the
trial now includes a cohort of melanoma patients who will receive
SCIB1 plus doublet therapy consisting of ipilimumab (Yervoy(R) )
plus nivolumab (Opdivo(R) ), in addition to the cohort who will
receive SCIB1 with pembrolizumab (Keytruda(R) ). This protocol
amendment reflects changes in the current treatment landscape for
metastatic melanoma patients. The Phase 2 study is designed to
assess whether the addition of SCIB1 treatment to CPI standard of
care results in an improvement in outcomes for patients with
metastatic disease. The primary objectives of the SCOPE trial are
tumour response rate, progression-free survival and overall
survival in patients with advanced melanoma.
Under the updated protocol the Company is now also testing the
SCIB1 vaccine delivered via needle-free injection, using a
PharmaJet(R) device. Prior to the amendment, SCIB1 had been
delivered using electroporation to enhance the uptake and
presentation of the DNA vaccine to the immune system and, although
electroporation is a proven delivery method, the Company believes
that needle-free injection (such as the PharmaJet(R) device) could
provide enhanced patient acceptance and uptake. Eight sites are
currently recruiting with a further six in the set-up stage.
Although recruitment remains challenging, the recent protocol
changes have resulted in an uplift in enrolment rates in the SCOPE
study.
In addition, to further increase eligibility t he Company has
been developing iSCIB1+, an AvidiMab(R) modified version of SCIB1,
which is expected to increase both the potency of SCIB1 and extend
its patent life. This modification also includes multiple epitopes
so it can be used to treat all patients rather than being limited
to the 40% of patients who have the appropriate human leukocyte
antigen (HLA) type for treatment with SCIB1. Given the significant
potential improvements in potency, utility and patent life with
iSCIB1+, the Company plans to transition the SCOPE trial to the
iSCIB1+ product during 2023.
The current modifications to the SCOPE protocol have
significantly increased the recruitment rate into the ongoing Phase
2 trial at the existing UK sites and the transition to iSCIB1+
during 2023 is also expected to further increase patient enrolment
rates. As a result, the Company intends to withdraw the open
Investigational New Drug (IND) application in the US for the SCIB1
product and focus its resources on continuing to expand recruitment
in the UK for SCIB1 and transitioning the iSCIB1+ product into the
existing SCOPE study.
COVIDITY
The COVIDITY programme, focusing on the Company's novel COVID-19
vaccine candidates SCOV1 and SCOV2, recently completed dosing in
South Africa and we expect to report safety and immunogenicity data
in Q1 2023. As previously disclosed, given the large size of later
stage trials and the competitive landscape the Company does not
intend to do further trials and will focus its resources on the
oncology platforms. The Company has successfully used PharmaJet(R)
needle-free injection systems in this trial and is now using it in
the SCOPE trial of SCIB1.
ANTIBODIES
GlyMab (R)
The GlyMab(R) platform provides a powerful and versatile
approach to generating novel antibody drug candidates for our own
clinical pipeline, but also to partner with other companies in
areas such as drug targeting to combine our novel platform with
other groups' expertise. The GlyMab(R) antibodies bind to sugar
motifs, rather than peptide epitopes, found on the surface of
glycosylated proteins and lipids that are implicated as drug
targets in particular cancers and potentially other diseases. As
such, this novel proprietary platform expands on the Company's
innovative approach to developing ground-breaking therapies for
cancer and infectious disease.
The Company currently has a pipeline of five anti-glycan
monoclonal antibodies (mAbs): SC129, SC134, SC88 and SC27 that
target solid tumours including pancreatic, small cell lung,
colorectal and gastric cancers, and SC2811 that targets a
glycolipid present on T cells. A robust portfolio of patents and
applications, as well as know-how, surround the GlyMab(R) platform
and generated drug candidates. All five drug candidates have been
successfully humanised and are ready for the Company or a partner
to take them to next stage of development.
In October 2022 we were pleased to have granted Genmab the
exclusive rights to develop and commercialise one of Scancell's
antibodies, in multiple novel potential therapeutic products for
any and all potential disease areas, excluding cell therapy
applications. Under the terms of the agreement, Scancell has
received an up-front payment of $6 million and will be eligible to
receive potential development and commercialisation milestone
payments, as well as royalties on products sold. The potential
milestone payments will be up to $208 million for each product
developed and commercialised, up to a maximum of $624 million if
Genmab develops and commercialises products across all defined
modalities. In addition, Scancell will also receive single digit
royalties from Genmab on net sales of all commercialised products.
This first license agreement with GlyMab(R) provides strong
validation for our proprietary platform and our ability to utilise
this technology to support the creation of novel, differentiated
antibody products in a range of disease areas.
In addition, Scancell plans to take two of these five mAbs a
redirecting TCB antibody and a T cell costimulatory mAb into the
clinic. It is anticipated that manufacturing will start in H1 2023
with a view to entering the clinic in 2024.The Board believes that
this could be a promising new therapeutic approach for treating
cancer. TCB antibodies have dual-binding specificity which
crosslinks tumour cells via their glycans with an activating
receptor CD3 on T cells. This results in activation of killer T
cells and tumour cell death. These antibodies are particularly
potent in tumours which have lost the T cell recognition molecule
major histocompatibility antigen or where there is limited T cell
infiltration as they by-pass normal T cell activation pathways and
redirect the host immune system to the tumour. Scancell will
combine its proprietary GlyMab(R) antibodies with in-licenced Fc
silencing technology from Oxford-based mAbsolve Limited. The
technology from mAbsolve Limited reduces the likelihood of toxicity
caused by cytokine storms, which can be associated with clinical
antibodies engaging the immune system.
AvidiMab (R)
AvidiMab(R) is a versatile platform technology that can enhance
the avidity and thereby the potency of any antibody. To date, the
Company has used AvidiMab(R) in its internal programmes to:
-- Engineer the anti-glycan mAbs to improve their ability to directly kill tumour cells.
-- Engineer other mAbs to enhance their potency and/or extend their patent lifetime.
-- Increase the breadth of response and potency of Scancell's ImmunoBody(R) cancer products.
-- Increase the potency of the T cell response in Scancell's
COVID-19 vaccine which in turn should lead to improvements in
long-term protection and immunological memory.
During the period, Scancell presented preclinical data on its
antibody platforms at 14(th) Annual PEGS (Protein & Antibody
Engineering Summit) Europe in Barcelona, Spain and 12(th)
EuroMAbNet Annual Meeting in Hamburg, Germany which demonstrated
the versatility and specificity of the Company's platforms in
generating novel antibody drug candidates using its GlyMab(R)
technology and enhancing their anti-cancer potential with
AvidiMab(R) . Looking forward, Scancell is planning to increase the
value of this rich pipeline of products through the generation of
further early-stage clinical data, either alone or in combination
with strategic partners.
CORPORATE
Directorate changes
As announced in October 2022, prior to the Company's Annual
General Meeting (AGM), I notified the Board of my intension to
resign as Executive Chairman and Non-Executive Director of the
Company for personal reasons. I remain confident in the future
prospects of Scancell and will be staying on for an interim period
until a new Chair is appointed. The Board has subsequently
initiated a formal search for a new Chair and a further
announcement regarding details and timings will be made when
appropriate. At the Company's AGM, Dr Richard Goodfellow who had
been a Director at Scancell since 1999 decided not to stand for
re-election and retire. In addition, we strengthened the leadership
of the Board and appointed Susan Clement Davies, an independent
Non-Executive Director and Chair of the Audit Committee, as Deputy
Chair.
Zakari Therapeutics Limited
The Board felt that there was no further need to retain the
Zakari Therapeutics subsidiary company. Therefore, application has
been made to the Registrar of Companies for Zakari Therapeutics
Limited, a non-trading subsidiary of Scancell Limited, to be
dissolved.
FINANCIAL REVIEW
Profit or Loss and Other Comprehensive Income Statement
The Group made an operating loss for the 6-month period to 31
October 2022 of GBP1.97 million (6-month period to 31 October 2021:
loss of GBP5.4 million).
The licence fee of GBP5.3 million (2021: GBPnil) relates to the
up-front payment receivable from Genmab following the signing of
the Licence Agreement in October 2022.
Development expenditure has increased to GBP4.9 million (2021;
GBP4.0 million) as a result of an increase in research staff
numbers together with increased costs on the Modi-1 clinical trial
and the GlyMab(R) and AvidiMab(R) platforms.
The increase in administrative expenditure to GBP2.4 million
(2021: GBP1.9 million) is due to the increased share option charge
in the period.
Interest payable of GBP1.3 million (2021: GBP1.7 million)
relates to the interest on the Convertible Loan Notes (CLNs). The
interest is lower as a result of the maturity date of the CLNs
being extended from 2022 to 2025 in October 2021.
The finance expense of GBP0.9 million (2021: credit GBP2.4
million) relates to the derivative liability and is the fair value
adjustment of the derivative liability at the respective period
ends. The finance expense is not a cash item and has no impact on
the Company's cashflow.
The loss before taxation for the period amounted to GBP4.1
million (2021: profit GBP2.5 million). The R&D tax credit
increased to GBP0.9 million (2021: GBP0.7 million) as a result of
an increased level of development expenditure claimable in the
6-month period .
Overall, the loss post tax for the 6-month period was GBP3.2
million (2021: profit GBP3.2 million ).
Statement of Financial Position
At 31 October 2022, the net assets of the Group amounted to
GBP15.4 million (30 April 2022: GBP18.1 million) including cash at
bank of GBP24.0 million (30 April 2022: GBP28.7 million).
Within trade and other receivables is an amount of GBP5.3
million (2021: GBPnil) in respect of the up-front licence fee which
was received in November 2022.
Current assets include tax receivable due at the end of the
period of GBP2.76 million (April 2022: GBP2.99 million) and relate
to the R&D tax credit for the year ended 30 April 2022
amounting to GBP1.70 million and an estimate of the amount
recoverable at 31 October 2022.
Within liabilities are CLNs and Derivative Liabilities. The
total amount of the CLNs which remain outstanding is GBP19.65
million which are due to be redeemed in August 2025 (GBP1.75
million) and November 2022 (GBP17.9 million).
The Derivative Liabilities represents the fair value of the
conversion feature of the CLN at the time of issue of the CLNs with
changes in value being shown in the Consolidated Profit or Loss and
Other Comprehensive Income Statement as a finance credit or
expense.
The current Trade and other payables have increased to GBP2.51
million (April 2022: GBP2.1 million). The increase reflects
additional accruals recognised at the month-end. All balances owing
to suppliers at the end of the 6-month period were paid in
accordance with their terms and conditions.
Consolidated Cash Flow Statement
As at 31 October 2022, Company bank balances amounted to GBP24.0
million (April 2022: GBP28.7 million). The reduction in bank
balances during the 6-month period is primarily due to net cash
used in operating activities of GBP4.4 million (30(t) April 2022:
GBP10.20 million). This expenditure has been offset by the R&D
tax credit received of GBP1.2 million (30(t) April 2022: GBP1.3
million).
OUTLOOK
The Company has made good progress during the period turning our
scientific expertise into world leading vaccines and antibodies
targeting post-translational modifications, and so continuing our
journey towards the goal of building a sustainable company which
delivers both patient outcomes and shareholder value.
Looking forward, it is anticipated that during 2023 we will
progress towards key clinical milestones by continuing to recruit
patients to our ongoing ModiFY and SCOPE clinical trials, and
generating safety, immune and clinical response results for our
current Moditope(R) and ImmunoBody(R) vaccine candidates. In our
earlier stage pipeline, with the recent in-licensing of the
SNAPvax(TM) technology from Vaccitech plc, we expect to accelerate
the development of Modi-2 and progress a redirecting TCB antibody
and a T cell costimulatory mAb to the clinic. In addition, the
Board continues to evaluate further potential deals to develop the
business, generate revenue and provide further third-party
validation of our platforms.
The Board is pleased with the progress that the Company has
achieved over the period and would like to thank our shareholders
once again for their continued support.
John Chiplin
Chairman 24 January 2023
Scancell Holdings plc
Consolidated Profit or Loss and Other Comprehensive Income
Statement
for the 6-month period to 31 October 2022
Unaudited Unaudited Audited
6 months 6 months Year to
31/10/2022 31/10/2021 30/04/2022
GBP'000 GBP'000 GBP'000
Continuing operations
Licence fees 5,271 - -
Development expenses (4,872) (4,029) (9,477)
Administrative expenses (2,373) (1,916) (4,787)
Grant income - 550 965
OPERATING LOSS (1,974) (5,395) (13,299)
Interest receivable and similar
income 81 2 4
Interest payable (1,343) (1,728) (2,882)
Finance (expense)/ gain relating
to revaluation of derivative
liability (910) 2,443 5,243
Gain on substantial modification
of convertible loan notes - 7,166 7,166
(LOSS)/PROFIT BEFORE TAXATION (4,146) 2,488 (3,768)
Tax on loss on ordinary activities 980 719 1,703
(LOSS)/PROFIT FOR THE PERIOD (3,166) 3,207 (2,065)
EARNINGS PER ORDINARY SHARE (PENCE)
Note 2
Basic (0.39)p 0.39p (0.25)p
Diluted (0.39)p 0.38p (0.25)p
----------- ----------- -----------
Scancell Holdings plc
Consolidated Statement of Changes in Equity
for the 6-month period to 31 October 2022
Share Share
Share premium option Retained Total
capital account reserve earnings Equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Unaudited Unaudited Unaudited Unaudited Unaudited
At 1 May 2022 815 65,019 1,395 (49,119) 18,110
(Loss) for the period (3,166) (3,166)
Share option costs 481 481
---------- ---------- ---------- ---------- ----------
At 31 October 2022 815 65,019 1,876 (52,285) (15,425)
---------- ---------- ---------- ---------- ----------
At 1 May 2021 815 65,019 705 (47,054) 19,485
Profit for the period 3,207 3,207
Share option costs
---------- ---------- ---------- ---------- ----------
At 31 October 2021 815 65,019 705 (43,847) 22,692
---------- ---------- ---------- ---------- ----------
Audited Audited Audited Audited Audited
At 1 May 2021 815 65,019 705 (47,054) 19,485
(Loss) for the year (2,065) (2,065)
Share option costs 690 690
---------- ---------- ---------- ---------- ----------
At 30 April 2022 815 65,019 1,395 (49,119) 18,110
---------- ---------- ---------- ---------- ----------
Scancell Holdings plc
Consolidated Statement of Financial Position
as at 31 October 2022
Unaudited Unaudited Audited
31/10/2022 31/10/2021 30/04/2022
GBP'000 GBP'000 GBP'000
ASSETS
Non-current assets
Tangible fixed assets 1,467 1,324 1,579
Right of use assets 1,124 1,532 1,165
Goodwill 3,415 3,415 3,415
----------- ----------- -----------
6,006 6,271 6,159
----------- ----------- -----------
Current assets
Trade and other receivables 5,612 853 647
Income tax assets 2,760 2,007 2,990
Cash and cash equivalents 24,035 35,570 28,725
32,407 38,430 32,362
----------- ----------- -----------
TOTAL ASSETS 38,413 44,701 38,521
----------- ----------- -----------
LIABILITIES
Non-current liabilities
Convertible Loan note (8,322) (6,423) (7,008)
Derivative liability (11,005) (12,895) (10,095)
Lease liabilities (831) (1,093) (856)
----------- ----------- -----------
(20,158) (20,411) (17,959)
----------- ----------- -----------
Current liabilities
Trade and other payables (2,511) (1,148) (2,137)
Lease liabilities (319) (450) (315)
----------- ----------- -----------
(2,830) (1,598) (2,452)
----------- ----------- -----------
TOTAL LIABILITIES (22,988) (22,009) (20,411)
----------- ----------- -----------
NET ASSETS 15,425 22,692 18,110
----------- ----------- -----------
TOTAL EQUITY
Called up share capital 815 815 815
Share premium account 65,019 65,019 65,019
Share option reserve 1,876 705 1,395
Retained earnings (52,285) (43,847) (49,119)
15,425 22,692 18,110
----------- ----------- -----------
Scancell Holdings plc
Consolidated Cash Flow Statement
for the 6-month period to 31 October 2022
Unaudited Unaudited Audited
6 months 6 months Year to
31/10/2022 31/10/2021 30/04/2022
GBP'000 GBP'000 GBP'000
Cash flows from operating activities
(Loss)/Profit before tax for the
period (4,146) 2,488 (3,768)
Adjustments for:
Finance income (81) (2) (4)
Lease interest paid 28 48
Convertible Loan note interest 1,315 1,728 2,834
Finance expense/(gain) relating to
derivative 910 (2,443) (5,243)
Gain on substantial modification
of CLNs - (7,166) (7,166)
Depreciation 261 141 381
Amortisation of right of use asset 197 149 359
Share based payment charge 481 - 690
----------- ----------- -----------
Cash used in operations before changes
in working capital (1,035) (5,105) (11,869)
(Increase)/decrease in trade and
other receivables (4,965) 115 321
Increase/(decrease) in trade and
other payables 373 (939) 51
----------- ----------- -----------
Cash used in operations (5,627) (5,929) (11,497)
Tax credits received 1,210 1,301 1,304
Net cash used in operating activities (4,417) (4,628) (10,193)
----------- ----------- -----------
Cash flows from investing activities
Purchase of tangible fixed assets (149) (774) (1,268)
Finance income 81 2 4
Net cash (used in) investing activities (68) (772) (1,264)
----------- ----------- -----------
Financing activities
Convertible loan interest paid - - (537)
Lease payments (205) (140) (391)
----------- ----------- -----------
Net cash generated from financing
activities (205) (140) (928)
----------- ----------- -----------
Net increase/(decrease) in cash
and cash equivalents (4,690) (5,540) (12,385)
Cash and cash equivalents at beginning
of the year 28,725 41,110 41,110
Cash and cash equivalents at end
of the period 24,035 35,570 28,725
----------- ----------- -----------
Scancell Holdings plc
Notes to the Interim Financial Statements
for the 6-month period to 31 October 2022
1 Basis of preparation
This interim statement for the 6-month period to 31 October 2022
is unaudited and was approved by the Directors on 24 January 2023.
The financial information contained in the interim report has been
prepared in accordance with the accounting policies set out in the
annual report and accounts for the year ended 30 April 2022.
The financial information contained in the interim report does
not constitute statutory accounts as defined in section 434 of the
Companies Act 2006. The financial information for the full
preceding year is based on the statutory accounts for the year
ended 30 April 2022, upon which the auditors, BDO LLP, issued an
unqualified audit opinion which did not contain any statement under
section 498(2) or 498(3) of the Companies Act 2006. The audited
statutory accounts for the year ended 30 April 2022 have been
submitted to the Registrar of Companies.
As permitted, this interim report has been prepared in
accordance with AIM Rule 18 and not in accordance with IAS 34
"Interim Financial Reporting" therefore it is not fully in
compliance with IFRS as adopted by the European Union.
2 Earnings per share
Basic earnings per share, from continuing operations, is
calculated by dividing the earnings attributable to ordinary
shareholders by the weighted average number of ordinary shares
outstanding during the year.
The calculations of earnings per share are based on the
following losses and numbers of shares.
6 months 6 months Year ended
to to
31/10/2022 31/10/2021 30/04/2022
GBP'000 GBP'000 GBP'000
(Loss)/Profit after taxation (3,166) 3,207 (2,065)
-------------- -------------- --------------
Number Number Number
Weighted average number of shares used in basic eps 815,218,831 815,218,831 815,218,831
-------------- -------------- --------------
Weighted average number of shares used in diluted eps 815,218,831 853,247,713 815,218,831
-------------- -------------- --------------
Basic earnings per share (0.39)p 0.39p (0.25)p
Diluted earnings per share (0.39)p 0.38p (0.25)p
At 31 October 2022 the Company had 815,218,831 Ordinary Shares
of 0.1p in issue.
3 Taxation
Taxation for the 6 months ended 31 October 2022 is based on the
effective rates of taxation which are estimated to apply for the
year ended 30 April 2023.
4 Interim results
These results were approved by the Board of Directors on 24
January 2023. Copies of the interim report are available to the
public from the Group's registered office and the Group's website,
www.scancell.co.uk .
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END
IR PPUCCGUPWGRC
(END) Dow Jones Newswires
January 25, 2023 02:00 ET (07:00 GMT)
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