30 January 2024
Scancell
Holdings plc
("Scancell" or the "Company")
Interim
Results for the six months ended 31 October 2023
Strong
clinical progress in the SCOPE trial with 85% ORR
reported from
the first 13 patients with unresectable melanoma
Post-period end capital raise of £11.9m to support important
clinical milestones in 2024
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
six months ended 31 October 2023 and provides a business update on
progress achieved to date.
Highlights (including post
period):
SCIB1 (SCOPE trial)
· SCIB1,
an oncology vaccine, reported positive data from the first stage of
its Phase 2 SCOPE trial for advanced melanoma.
· SCIB1
in combination with checkpoint inhibitors (CPIs) showed an 85%
objective response rate (ORR)
to treatment in 13 patients,
exceeding the target of 70% ORR and accompanied by meaningful
tumour
volume reduction. One patient
achieved a complete response following treatment.
· In the
real word setting in patients receiving doublet standard of care
CPI therapy alone, the ORR is 50% with a progression free survival
of 11.5 months.
· Recruitment in the second stage is expected to be complete in
Q1 2024 with highly anticipated data available in Q3
2024.
· The
addition of iSCIB1+ to the SCOPE trial has been approved by the
MHRA. Recruitment in this third cohort is expected to start in Q1
2024 with early data available in Q3 2024. iSCIB1+ includes additional melanoma-specific epitopes so it
has the potential to be even more effective in a broader patient
population.
· A
clear development pathway for registration and approval of SCIB1/
iSCIB1+ in the medium term for advanced melanoma has been mapped
out.
· This
represents a potential $1.5 billion per annum market and we
anticipate significant interest from potential partners.
Modi-1 (ModiFY trial)
· In
July 2023, the ModiFY trial moved into the expansion cohorts,
following approval by the safety review committee.
· Early
data from patients receiving Modi-1 as a monotherapy showed good T
cell responses, safety and tolerability, with no dose limiting
toxicities observed in dose escalation cohorts. Similar to SCIB1
monotherapy in metastatic disease, one patient achieved a partial
response and 60% of patients showed stable disease in response to
Modi-1 monotherapy.
· Modi-1
to be assessed in renal cell carcinoma in combination with double
CPI therapy in the ModiFY study pending protocol amendment by the
MHRA.
· Early
clinical data from patients treated with Modi-1 plus CPIs is
anticipated in 2024.
Antibodies:
· Development of SC129, out licensed to Genmab, continues on
track towards potential clinical development.
· GlyMab® and AvidiMab® platforms provide
potential out licensing opportunities with active discussions
ongoing with pharmaceutical and biotech companies.
Corporate
· Sath
Nirmalananthan appointed as Chief Financial Officer
· Dr
Mandeep Sehmi appointed as Head of Business Development
Financial:
· In
December 2023, the Company raised gross proceeds of £11.9 million
in aggregate (before expenses) through the capital raise with
significant participation from both existing and new healthcare
specialist investors.
· Group
cash balance at 31 October 2023 was £13.1 million (April 2023:
£19.9 million) with cash funding through to important clinical
milestones on clinical assets.
Prof Lindy Durrant, Chief Executive Officer,
Scancell, commented: "The Scancell team continues
to produce highly-significant data across its pipeline of cancer
vaccines and we have made strong progress in all parts of the
business in the first six months of the year. Most notably, we were
pleased to announce exceptional data from the first stage of the
SCOPE trial with SCIB1 showing an 85% ORR to treatment in 13
patients, exceeding 70% ORR expectations. With important clinical
milestones expected this year, including further data from both the
SCOPE and ModiFY trials, and with the recently secured funding in
place, the company's prospects in 2024 are exciting."
Professor Lindy Durrant, Chief
Executive Officer, and Sath Nirmalananthan, Chief Financial
Officer, will also host a live webcast and Q&A session for
analysts and investors today at 14:00 GMT. If you would like to
join the webcast, please follow this link:
https://www.lsegissuerservices.com/spark/ScancellHoldings/events/f581274b-146c-4a89-af15-05bcae874775
A replay of the webcast will be made
available shortly afterwards.
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:
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Scancell Holdings plc
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+44 (0) 20 3709 5700
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Professor Lindy Durrant,
CEO
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Dr Jean-Michel Cosséry,
Non-Executive Chairman
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Stifel Nicolaus Europe Limited (Nominated Adviser and Joint Broker)
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+44 (0) 20 7710 7600
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Nicholas Moore/Samira Essebiyea/William Palmer-Brown (Healthcare Investment Banking)
Nick Adams/Nick Harland (Corporate
Broking)
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WG
Partners LLP (Joint Broker)
David Wilson/Claes Spang/Sathesh
Nadarajah/Erland Sternby
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+44 (0) 20 3705 9330
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Panmure Gordon (UK) Limited (Joint Broker)
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+44 (0) 20 7886 2500
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Freddy Crossley/Emma Earl (Corporate
Finance)
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Rupert Dearden (Corporate
Broking)
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ICR
Consilium
Mary-Jane Elliott/Matthew Neal/
Chris Welsh
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+44 (0) 20 3709 5700
scancell@consilium-comms.com
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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®
and ImmunoBody®
for vaccines and GlyMab® and
AvidiMab® 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® and ImmunoBody®) this includes citrullination and homocitrullination of
proteins, whereas its mAb portfolio targets glycans or sugars that
are added onto proteins and / or lipids (GlyMab®) or
enhances the potency of antibodies and their ability to directly
kill tumour cells
(AvidiMab®).
For further information about
Scancell, please visit: https://www.scancell.co.uk/
CHIEF EXECUTIVE OFFICER'S STATEMENT
I am pleased to report the Group's
interim results for the six-month period ended 31 October 2023.
During the period, Scancell achieved important clinical milestones
in the SCOPE trial with highly encouraging results giving us strong
confidence in the SCIB1/iSICB1+ vaccines for advanced melanoma. We
are now well positioned to conclude the SCOPE trial and progress
towards the registration Phase 2/3 study. In addition, we intend to
investigate Modi-1 in renal cancer in combination with
ipilimumab (Yervoy®) plus nivolumab
(Opdivo®) checkpoint inhibitors
as a new cohort in the ModiFY study. The recent capital raise of
£11.9m in gross proceeds with significant participation from
existing and new healthcare investors helps maintain our momentum
and progress towards these value creating clinical
milestones.
Set out below is a summary of
progress that has been made across our innovative and proprietary
vaccine and antibody platforms.
VACCINES
ImmunoBody® platform
Scancell's ImmunoBody®
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, 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 checkpoint inhibitors (CPIs) and
other agents. This platform has the potential to enhance tumour
destruction, prevent disease recurrence and extend
survival.
SCIB1
SCIB1 is the lead product from
Scancell's ImmunoBody® immunotherapy platform. It is
currently being evaluated in the SCOPE trial, a Phase 2 open-label,
multi-cohort, multicentre trial in the UK, in combination with CPIs
for the treatment of advanced melanoma. The trial includes a cohort
of advanced melanoma patients who will receive SCIB1 plus doublet
therapy consisting of ipilimumab (Yervoy®) plus
nivolumab (Opdivo®) in addition to the cohort who will
receive SCIB1 with pembrolizumab (Keytruda®). This
reflects the current treatment landscape for unresectable
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 patient outcomes for patients
with metastatic disease. The primary objectives of the trial are
tumour response rate, progression-free survival and overall
survival in patients with advanced melanoma. The SCIB1 vaccine is
delivered via a PharmaJet® needle-free injection, which
provides enhanced patient acceptance versus
electroporation.
In
September and subsequently
in November
2023, the SCOPE trial reported exceptional results
to date with 11 out of 13 patients showing at least a partial
response which is an objective response rate (ORR) of 85%, which is
better than 70% ORR that the trial was configured to show. This
compares to an ORR of 50% reported in patients just receiving this
doublet CPI therapy in the real world setting with a progression
free survival time of 11.5 months. These responses have been
verified in nine patients with a second scan at 19 weeks.
Significantly, one of the patients has achieved a complete response
following treatment.
The SCOPE trial has now successfully
transitioned into the second stage, which will recruit a further 27
patients (for a total of 43). The aim is to achieve at least 18
further responses (i.e., 27 responses in total) which would
statistically demonstrate that SCIB1, in combination with doublet
therapy, exceeds currently achievable ORRs. The second stage of
recruitment is expected to be complete by Q1 2024 with highly
anticipated data available in Q3 2024.
iSCIB1+
iSCIB1+ is a modified version of
SCIB1 developed using Scancell's AvidiMab® platform to
enhance its potency compared to SCIB1 and gives 15 years of
extended patent protection. iSCIB1+ also includes additional
melanoma-specific epitopes so it has the potential to be effective
in a broader patient population beyond the 40% of patients with the
tissue type treatable with SCIB1, where treatment is HLA
dependent.
In January 2024, the Company
received MHRA approval to add a third cohort to the SCOPE trial
using iSCIB1+. This cohort will recruit 43 advanced unresectable
melanoma patients who will receive iSCIB1+ with doublet therapy,
consisting of ipilimumab plus nivolumab. Recruitment is expected to start in Q1 2024 with early data
available in Q3 2024.
The results from these SCIB1 and
iSCIB1+ cohorts, administered in combination with doublet therapy,
will enable the Company to make a data-led decision regarding
initiation of a randomised Phase 2/3 adapted registration programme
in patients with unresectable melanoma, which represents a
potential $1.5 billion per annum market. The Phase 2 part of the
adapted trial is anticipated to take 18 months, with the potential
to generate attractive licensing opportunities.
Moditope® platform
Moditope® is a versatile
proprietary cancer vaccine platform that targets stress-induced
post-translational modifications (siPTMs) of proteins. This
discovery has allowed Scancell 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. Expression of peptides
containing these modifications have been demonstrated to induce
potent CD4 cytotoxic T cells that induce anti-tumour activity
without any associated toxicity.
Modi-1
Modi-1, which targets citrullinated
cancer antigens, is the first therapeutic vaccine candidate to
emerge from Scancell's Moditope® platform. Modi-1
consists of three citrullinated tumour-associated peptides
exploiting the normal immune response to stressed cells, which is
largely mediated by cytotoxic CD4 T cells.
The ModiFY study is an open-label,
multi-cohort, multicentre, adaptive Phase 1/2 trial with Modi-1
being administered alone or in combination with CPIs in patients
with head and neck, triple negative breast and renal tumours and 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.
The ModiFY trial has completed its
dose escalation and safety cohorts. Data from patients receiving
the Modi-1 cancer vaccine as a monotherapy showed that it was safe
and well tolerated and demonstrated encouraging early efficacy in a
head and neck cancer patient and in other hard-to-treat cancers
such as high grade serous ovarian carcinoma and triple negative
breast cancer. All patients had failed on previous treatments and
their disease was actively progressing when they entered the study.
Following treatment with Modi-1 60% of patients achieved stable
disease for at least eight weeks, with some patients experiencing a
longer duration of disease stability for four months or more. The
number of patients who have experienced long periods of stable
disease following monotherapy with Modi-1 is encouraging and
similar to the response rate with SCIB1 monotherapy in advanced
disease.
The Company believes that
combination therapy with checkpoint inhibitors, could further
improve outcomes for this patient group. With this intention we will investigate Modi-1 in renal cancer
in combination with ipilimumab
(Yervoy®) plus nivolumab (Opdivo®)
checkpoint inhibitors. This is partly due to a
change of standard of care within the treating community and partly
because the SCOPE study results suggest that the double checkpoints
are ideal in synergising with vaccines.
Early clinical data from patients
treated data with Modi-1 plus CPIs is anticipated in
2024.
Modi-2
Modi-2, which targets
homocitrullinated cancer antigens, is the second therapeutic
vaccine candidate from the Company's Moditope® platform
and has the potential to address different cancer indications to
Modi-1, including tumours with a particularly immunosuppressive
environment.
In November 2022, Scancell
in-licensed the SNAPvax™ technology from Vaccitech plc, a
clinical-stage biopharmaceutical company engaged in the discovery
and development of novel immunotherapies and vaccines. The
agreement allows Scancell to formulate and manufacture
Modi-2.
Scancell expects that the
combination of Modi-2 with this highly effective platform for
inducing T cells will lead to a potentially superior therapeutic
vaccine candidate.
ANTIBODIES
The GlyMab® and
AvidiMab® platforms provide potential out licensing
opportunities with active discussions ongoing with Pharmaceutical
and Biotech companies.
GlyMab®
The GlyMab® platform
provides a powerful and versatile approach to generating novel
antibody drug candidates for our own clinical pipeline but also to
create upfront, milestone and revenue generating partnerships with
other companies in areas such as drug targeting to capitalise on
other groups expertise. The GlyMab® antibodies bind to
sugar motifs, rather than peptide epitopes, found on the surface of
glycosylated proteins and lipids expressed by cancer cells. The
Company currently has a pipeline of five anti-glycan monoclonal
antibodies (mAbs): SC129, SC134, SC2811, SC88 and SC27 that target
solid tumours including pancreatic, small cell lung, colorectal and
gastric cancers. All of these drug candidates have now been
successfully humanised and are ready for the next stage of
development.
In October 2022, Scancell signed its
first commercial license agreement with Genmab. Genmab were granted
a worldwide license to an anti-glycan monoclonal antibody generated
via Scancell's proprietary GlyMab® platform, for the
development and commercialisation of novel therapeutic products.
The Company received £5.3 million in up front payment as well as
potential 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. The Company will also receive low single digit
royalties from Genmab on net sales of all commercialised products.
Development of this antibody remains on track as it progresses
towards potential clinical development.
AvidiMab®
AvidiMab® is a versatile
proprietary platform technology that can enhance the avidity and
thereby the potency of any antibody. To date, the Scancell has used
AvidiMab® 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® 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.
The AvidiMab® platform
has been successfully applied to internal programmes, including
iSCIB1+ and COVIDITY, and holds potential to enhance the efficacy
of third-party antibodies.
FINANCIAL
REVIEW
Profit or Loss and Other Comprehensive Income
Statement
The Group made an operating loss for
the six-month period to 31 October 2023 of £8.12 million (six-month
period to 31 October 2022: loss of £1.97 million).
Development expenditure has
increased to £5.69 million (2022: £4.35 million) as a result of
increased costs on the SCOPE and ModiFY clinical trials.
There was a small increase in
administrative expenditure to £2.43 million (2022: £2.37
million).
Interest payable of £0.49 million
(2022: £0.57 million) largely relates to the interest on the
Convertible Loan Notes (CLNs).
The finance gain on revaluation of
£4.86 million (2022: expense: £3.48 million) relates to the
derivative liability and is the fair value adjustment of the
derivative liability at the respective period ends. The finance
gain is not a cash item and has no impact on the Company's
cashflow.
The loss before taxation for the
period amounted to £3.59 million (2022: £5.9 million). The R&D
tax credit increased slightly to £1.04 million (2022: £0.98
million) in spite of an increase in development expenditure. This
is because the Government has reduced the amount of tax credits
payable to companies.
Overall, the loss post tax for the
six-month period was £2.55 million (2022: £4.96
million).
Statement of Financial Position
At 31 October 2023, the net
liabilities of the Group amounted to £8.4 million (30 April 2023:
£6.2 million) including cash at bank of £13.1 million (30 April
2023: £19.9 million). Post period in December 2023, the Company
announced it raised gross proceeds of £11.9 million in aggregate
(before expenses) through a capital raise with significant
participation from both existing and new healthcare specialist
investors.
Current assets include tax
receivable due at the end of the period of £3.9 million (April
2023: £4.7 million) and relate to the R&D tax credit for the
year ended 30 April 2023 amounting to £2.4 million plus an estimate
of the amount recoverable at 31 October 2023.
Within liabilities are CLNs and
Derivative Liabilities. The total amount of the CLNs which remain
outstanding is £19.65 million which are due to be redeemed in
August 2025 (£1.75 million) and November 2025 (£17.9
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 reduced to £1.7 million (April 2023: £3.0 million). All
balances owing to suppliers at the end of the six-month period were
paid in accordance with their terms and conditions.
Consolidated Cash Flow Statement
As at 31 October 2023, Company bank
balances amounted to £13.1 million (April 2023: £19.9 million). The
reduction in bank balances during the six-month period is primarily
due to net cash used in operating activities of £8.5 million (30
April 2023: £9.4 million). This expenditure has been offset by the
R&D tax credit received of £1.7 million (30 April 2023: £1.2
million).
OUTLOOK
Given the significant clinical and
commercial milestones achieved in the period, positive early
efficacy data, and with sufficient resources to fund our current
strategy, the Company is confident it will achieve its near-term
clinical milestones. Key near-term milestones include:
· Second
stage of SCOPE study in advanced melanoma with SCIB1 anticipated to
complete recruitment in Q1 2024 with data available in Q3
2024
· iSCIB1+ cohort of the SCOPE study to start recruitment in Q1
2024 with clinical data expected in Q3 2024
· Phase
2/3 randomised adaptive registration trial readiness with trial to
begin H2 2024
· ModiFY
trial data, including renal cell carcinoma with double checkpoint
inhibitors expected in 2024
· Continue to progress out-licensing opportunities for the
GlyMab® and AvidiMab® platforms providing a
source of non-dilutive cash to drive the Company's other assets
forward in development.
The Board is pleased with the
progress that the Company has achieved over the period and would
like to thank our investors and staff for their continued
support.
Professor Lindy Durrant
Chief Executive Officer
29 January 2024
Scancell Holdings plc
Consolidated Profit or Loss and Other Comprehensive Income
Statement
for
the 6-month period to 31 October 2023
|
|
Unaudited
|
Unaudited
|
Audited
|
|
|
6 months
|
6 months
|
Year to
|
|
|
31/10/2023
|
31/10/2022
Restated[1]
|
30/04/2023
|
|
|
£'000
|
£'000
|
£'000
|
Continuing operations
|
|
|
|
|
Revenue
|
|
-
|
5,271
|
5,271
|
Cost of Sales
|
|
-
|
(525)
|
(525)
|
Gross Profit
|
|
-
|
4,746
|
4,746
|
Development expenses
|
|
(5,693)
|
(4,347)
|
(11,645)
|
Administrative expenses
|
|
(2,427)
|
(2,373)
|
(5,021)
|
|
|
|
|
|
OPERATING LOSS
|
|
(8,120)
|
(1,974)
|
(11,920)
|
|
|
|
|
|
Interest receivable and similar
income
|
|
161
|
81
|
284
|
Interest payable
|
|
(493)
|
(567)
|
(1,215)
|
Finance gain/ (expense) relating to
revaluation of derivative liability
|
|
4,864
|
(3,476)
|
(1,453)
|
Gain on substantial modification of
convertible loan notes
|
|
-
|
-
|
-
|
|
|
|
|
|
(LOSS)/PROFIT BEFORE
TAXATION
|
|
(3,588)
|
(5,936)
|
(14,304)
|
|
|
|
|
|
Tax on loss on ordinary
activities
|
|
1,040
|
980
|
2,368
|
|
|
|
|
|
|
|
|
|
|
(LOSS) FOR THE PERIOD
|
|
(2,548)
|
(4,956)
|
(11,936)
|
|
|
|
|
|
|
|
|
|
EARNINGS PER ORDINARY SHARE (PENCE)
Note 2
|
|
|
|
|
|
|
|
|
Basic
|
|
(0.31)p
|
(0.61)pp
|
(1.46)p
|
|
|
|
|
|
Scancell Holdings plc
Consolidated Statement of Changes in Equity
for
the 6-month period to 31 October 2023
|
|
Share
|
Share
|
|
|
Share
|
premium
|
option
|
Retained
|
Total
|
capital
|
account
|
reserve
|
earnings
|
Equity
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
|
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
At 1 May 2023
|
819
|
65,181
|
2,123
|
(74,356)
|
(6,233)
|
Share issue
|
1
|
34
|
-
|
-
|
35
|
(Loss) for the period
|
-
|
-
|
-
|
(2,548)
|
(2,548)
|
Share option costs
|
-
|
-
|
383
|
-
|
383
|
At 31 October 2023
|
820
|
65,215
|
2,506
|
(76,904)
|
(8,363)
|
|
|
|
|
|
|
|
|
|
|
|
|
At 1 May 2022
|
815
|
65,019
|
1,395
|
(49,119)
|
18,110
|
Prior Period Restatement
|
-
|
-
|
-
|
(13,301)
|
(13,301)
|
At 1 May 2022 (Restated)1
|
815
|
65,019
|
1,395
|
(62,420)
|
4,809
|
Loss for the period
|
-
|
-
|
-
|
(4,956)
|
(4,956)
|
Share option costs
|
-
|
-
|
481
|
-
|
481
|
At 31 October 2022
|
815
|
65,019
|
1,876
|
(67,376)
|
334
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Audited
|
Audited
|
Audited
|
Audited
|
Audited
|
At 1 May 2022
|
815
|
65,019
|
1,395
|
(62,420)
|
4,809
|
Share Issue
|
4
|
162
|
-
|
-
|
166
|
(Loss) for the year
|
-
|
-
|
-
|
(11,936)
|
(11,936)
|
Share option costs
|
-
|
-
|
728
|
-
|
728
|
At 30 April 2023
|
819
|
65,181
|
2,123
|
(74,356)
|
(6,233)
|
Scancell Holdings plc
Consolidated Statement of Financial Position
as
at 31 October 2023
|
|
Unaudited
|
Unaudited
|
Audited
|
|
|
31/10/2023
|
31/10/2022
Restated1
|
30/04/2023
|
|
|
£'000
|
£'000
|
£'000
|
ASSETS
|
|
|
|
|
Non-current assets
|
|
|
|
|
Tangible fixed assets
|
|
983
|
1,467
|
1,246
|
Right of use assets
|
|
845
|
1,124
|
1,003
|
Goodwill
|
|
3,415
|
3,415
|
3,415
|
|
|
5,243
|
6,006
|
5,664
|
|
|
|
|
|
Current assets
|
|
|
|
|
Trade and other
receivables
|
|
476
|
5,612
|
538
|
Income tax assets
|
|
3,454
|
2,760
|
4,148
|
Cash and cash equivalents
|
|
13,079
|
24,035
|
19,920
|
|
|
17,009
|
32,407
|
24,606
|
|
|
|
|
|
TOTAL ASSETS
|
|
22,252
|
38,413
|
30,270
|
|
|
|
|
|
LIABILITIES
|
|
|
|
|
Non-current liabilities
|
|
|
|
|
Convertible Loan note
|
|
(18,947)
|
(18,396)
|
(18,481)
|
Derivative liability
|
|
(9,136)
|
(16,022)
|
(14,000)
|
Lease liabilities
|
|
(562)
|
(831)
|
(746)
|
|
|
(28,645)
|
(35,249)
|
(33,227)
|
Current liabilities
|
|
|
|
|
Trade and other payables
|
|
(1,664)
|
(2,511)
|
(2,970)
|
Lease liabilities
|
|
(306)
|
(319)
|
(306)
|
|
|
(1,970)
|
(2,830)
|
(3,276)
|
|
|
|
|
|
TOTAL LIABILITIES
|
|
(30,615)
|
(38,079)
|
(36,503)
|
|
|
|
|
|
NET
(LIABILITIES)/ASSETS
|
|
(8,363)
|
334
|
(6,233)
|
|
|
|
|
|
|
|
|
|
|
TOTAL EQUITY
|
|
|
|
|
Called up share capital
|
|
820
|
815
|
819
|
Share premium account
|
|
65,215
|
65,019
|
65,181
|
Share option reserve
|
|
2,506
|
1,876
|
2,123
|
Retained earnings
|
|
(76,904)
|
(67,376)
|
(74,356)
|
|
|
(8,363)
|
334
|
(6,233)
|
|
|
|
|
|
Scancell Holdings plc
Consolidated Cash Flow Statement
for
the 6-month period to 31 October 2023
|
Unaudited
|
Unaudited
|
Audited
|
|
6 months
|
6 months
|
Year to
|
|
31/10/2023
|
31/10/2022
Restated1
|
30/04/2023
|
|
£'000
|
£'000
|
£'000
|
Cash
flows from operating activities
|
|
|
|
(Loss) before tax for the
period
|
(3,588)
|
(5,936)
|
(14,304)
|
Adjustments for:
|
|
|
|
Finance income
|
(161)
|
(81)
|
(284)
|
Lease interest paid
|
24
|
28
|
54
|
Convertible Loan note
interest
|
468
|
539
|
1,161
|
Finance (gain)/expense relating to
derivative
|
(4,864)
|
3,476
|
1,453
|
Gain on substantial modification of
CLNs
|
-
|
-
|
-
|
Depreciation
|
276
|
261
|
536
|
Amortisation of right of use
asset
|
158
|
197
|
366
|
Share based payment charge
|
383
|
481
|
728
|
Cash
used in operations before changes in working
capital
|
(7,304)
|
(1,035)
|
(10,290)
|
|
|
|
|
Decrease/(increase) in trade and
other receivables
|
62
|
(4,965)
|
111
|
(Decrease)/increase in trade and
other payables
|
(1,306)
|
373
|
829
|
Cash
used in operations
|
(8,548)
|
(5,627)
|
(9,350)
|
Tax credits received
|
1,734
|
1,210
|
1,210
|
Net
cash used in operating activities
|
(6,814)
|
(4,417)
|
(8,140)
|
|
|
|
|
Cash
flows from investing activities
|
|
|
|
Purchase of tangible fixed
assets
|
(13)
|
(149)
|
(203)
|
Finance income
|
161
|
81
|
284
|
Net
cash (used in) investing activities
|
148
|
(68)
|
81
|
|
|
|
|
Financing activities
|
|
|
|
Proceeds from issue of share
capital
|
35
|
-
|
166
|
Convertible loan interest
paid
|
-
|
-
|
(537)
|
Lease payments
|
(210)
|
(205)
|
(375)
|
Net
cash generated from financing activities
|
(175)
|
(205)
|
(746)
|
|
|
|
|
Net
increase/(decrease) in cash and cash equivalents
|
(6,841)
|
(4,690)
|
(8,805)
|
|
|
|
|
Cash
and cash equivalents at beginning of the year
|
19,920
|
28,725
|
28,725
|
|
|
|
|
Cash
and cash equivalents at end of the period
|
13,079
|
24,035
|
19,920
|
Scancell Holdings plc
Notes to the Interim Financial Statements
for
the 6-month period to 31 October 2023
1 Basis of
preparation
This interim statement for the
6-month period to 31 October 2023 is unaudited and was approved by
the Directors on 29 January 2024. 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 2023.
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 2023, 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
2023 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 to
|
6 months to
|
Year ended
|
|
31/10/2023
|
31/10/20221
|
30/04/2023
|
|
£'000
|
£'000
|
£'000
|
|
|
|
|
(Loss) after taxation
|
(2,548)
|
(4,956)
|
(11,936)
|
|
|
|
|
|
Number
|
Number
|
Number
|
Weighted average number of shares
used in basic eps
|
819,024,113
|
815,218,831
|
816,051,311
|
|
|
|
|
Basic earnings per share
|
(0.31)p
|
(0.61)p
|
(1.46)p
|
Diluted loss per share
As the Group is reporting a loss
from continuing operations for all period then, consequentially,
the share options are not considered dilutive because the exercise
of the share options would have the effect of reducing the loss per
share.
At the 31 October 2023 the issued
share capital amounted to 819,663,461 ordinary
shares.
3 Taxation
Taxation for the 6 months ended 31
October 2023 is based on the effective rates of taxation which are
estimated to apply for the year ended 30 April 2024.
4 Interim results
These results were approved by the
Board of Directors on 29 January 2024. 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.
5 Prior Period
Restatement
The Company reviewed the valuation
and accounting for convertible loan notes and identified certain
corrections required to the prior periods' Group and company
results. This is fully described in note 24 to the consolidated
financial statements, included in the Annual Report and Accounts
for the year ended 30 April 2023.
This prior period restatement also
resulted in adjustments to the cashflow statements, in respect of
adjusting loss before tax, non-cash revaluation gains/losses and
non-cash interest payable. The restatement impact on the results to
31 October 2022 is shown in appendix 1.
There was no impact on cash itself
and the prior period restatement does not impact the convertible
loans' notional amounts or maturity dates disclosed. The
consolidated financial statements are available on the Company
website.
6 Subsequent Events
In December 2023, the Company
announced it raised gross proceeds of £11.9 million in aggregate
(before expenses) through a capital raise. This comprised of (i)
gross proceeds of £10.7 million in aggregate through the Placing
and the Subscription with significant participation from both
existing and new healthcare specialist investors and (ii) gross
proceeds of £1.2 million through the Open Offer reflecting renewed
support from existing shareholders. Following the capital raise,
the issued share capital of the company will be
927,819,977.
Appendix 1: Impact of Prior Period
Restatement
Consolidated Profit or Loss and Other Comprehensive Income
Statement for the 6-month period to 31
October 2022
|
|
Reported
|
Restatement
|
Restated
|
|
|
6 months
|
|
6 months
|
|
|
31/10/2022
|
|
31/10/2022
|
|
|
£'000
|
£'000
|
£'000
|
Continuing operations
|
|
|
|
|
Revenue
|
|
5,271
|
-
|
5,271
|
Cost of Sales
|
|
(525)
|
-
|
(525)
|
Gross Profit
|
|
4,746
|
-
|
4,746
|
Development expenses
|
|
(4,347)
|
-
|
(4,347)
|
Administrative expenses
|
|
(2,373)
|
-
|
(2,373)
|
|
|
|
|
|
OPERATING LOSS
|
|
(1,974)
|
-
|
(1,974)
|
|
|
|
|
|
Interest receivable and similar
income
|
|
81
|
-
|
81
|
Interest payable
|
|
(1,343)
|
776
|
(567)
|
Finance gain/ (expense) relating to
revaluation of derivative liability
|
|
(910)
|
(2,566)
|
(3,476)
|
Gain on substantial modification of
convertible loan notes
|
|
-
|
-
|
-
|
|
|
|
|
|
(LOSS)/PROFIT BEFORE
TAXATION
|
|
(4,146)
|
(1,790)
|
(5,936)
|
|
|
|
|
|
Tax on loss on ordinary
activities
|
|
980
|
-
|
980
|
|
|
|
|
|
|
|
|
|
|
(LOSS) FOR THE PERIOD
|
|
(3,166)
|
(1,790)
|
(4,956)
|
|
|
|
|
|
|
|
|
|
EARNINGS PER ORDINARY SHARE (PENCE)
Note 2
|
|
|
|
|
|
|
|
|
Basic
|
|
(0.39)p
|
(0.22)p
|
(0.61)p
|
Appendix 1: Impact of Prior Period Restatement
(Continued)
Consolidated Statement of Financial Position as at 31 October
2022
|
|
Reported
|
Restatement
|
Restated
|
|
|
31/10/2022
|
|
31/10/2022
|
|
|
£'000
|
£'000
|
£'000
|
ASSETS
|
|
|
|
|
Non-current assets
|
|
|
|
|
Tangible fixed assets
|
|
1,467
|
-
|
1,467
|
Right of use assets
|
|
1,124
|
-
|
1,124
|
Goodwill
|
|
3,415
|
-
|
3,415
|
|
|
6,006
|
-
|
6,006
|
|
|
|
|
|
Current assets
|
|
|
|
|
Trade and other
receivables
|
|
5,612
|
-
|
5,612
|
Income tax assets
|
|
2,760
|
-
|
2,760
|
Cash and cash equivalents
|
|
24,035
|
-
|
24,035
|
|
|
32,407
|
-
|
32,407
|
|
|
|
|
|
TOTAL ASSETS
|
|
38,413
|
-
|
38,413
|
|
|
|
|
|
LIABILITIES
|
|
|
|
|
Non-current liabilities
|
|
|
|
|
Convertible Loan note
|
|
(8,322)
|
(10,074)
|
(18,396)
|
Derivative liability
|
|
(11,005)
|
(5,017)
|
(16,022)
|
Lease liabilities
|
|
(831)
|
-
|
(831)
|
|
|
(20,158)
|
(15,091)
|
(35,249)
|
Current liabilities
|
|
|
|
|
Trade and other payables
|
|
(2,511)
|
-
|
(2,511)
|
Lease liabilities
|
|
(319)
|
-
|
(319)
|
|
|
(2,830)
|
-
|
(2,830)
|
|
|
|
|
|
TOTAL LIABILITIES
|
|
(22,988)
|
(15,091)
|
(38,079)
|
|
|
|
|
|
NET
(LIABILITIES)/ASSETS
|
|
15,425
|
(15,091)
|
334
|
|
|
|
|
|
|
|
|
|
|
TOTAL EQUITY
|
|
|
|
|
Called up share capital
|
|
815
|
-
|
815
|
Share premium account
|
|
65,019
|
-
|
65,019
|
Share option reserve
|
|
1,876
|
-
|
1,876
|
Retained earnings
|
|
(52,285)
|
(15,091)
|
(67,376)
|
|
|
15,425
|
(15,091)
|
334
|
|
|
|
|
|
Appendix 1: Impact of Prior Period Restatement
(Continued)
Consolidated Cash Flow Statement for the 6-month period to 31
October 2022
|
Reported
|
Restatement
|
Restated
|
|
6 months
|
6 months
|
Year to
|
|
31/10/2022
|
|
31/10/2022
|
|
£'000
|
£'000
|
£'000
|
Cash
flows from operating activities
|
|
|
|
(Loss) before tax for the
period
|
(4,146)
|
(1,790)
|
(5,936)
|
Adjustments for:
|
|
|
|
Finance income
|
(81)
|
-
|
(81)
|
Lease interest paid
|
28
|
-
|
28
|
Convertible Loan note
interest
|
1,315
|
(776)
|
539
|
Finance (gain)/expense relating to
derivative
|
910
|
2,566
|
3,476
|
Gain on substantial modification of
CLNs
|
-
|
-
|
-
|
Depreciation
|
261
|
-
|
261
|
Amortisation of right of use
asset
|
197
|
-
|
197
|
Share based payment charge
|
481
|
-
|
481
|
Cash
used in operations before changes in working
capital
|
(1,035)
|
-
|
(1,035)
|
|
|
|
|
Decrease/(increase) in trade and
other receivables
|
(4,965)
|
-
|
(4,965)
|
(Decrease)/increase in trade and
other payables
|
373
|
-
|
373
|
Cash
used in operations
|
(5,627)
|
-
|
(5,627)
|
Tax credits received
|
1,210
|
-
|
1,210
|
Net
cash used in operating activities
|
(4,417)
|
-
|
(4,417)
|
|
|
|
|
Cash
flows from investing activities
|
|
|
|
Purchase of tangible fixed
assets
|
(149)
|
-
|
(149)
|
Finance income
|
81
|
-
|
81
|
Net
cash (used in) investing activities
|
(68)
|
-
|
(68)
|
|
|
|
|
Financing activities
|
|
|
|
Proceeds from issue of share
capital
|
-
|
-
|
-
|
Convertible loan interest
paid
|
-
|
-
|
-
|
Lease payments
|
(205)
|
-
|
(205)
|
Net
cash generated from financing activities
|
(205)
|
-
|
(205)
|
|
|
|
|
Net
increase/(decrease) in cash and cash equivalents
|
(4,690)
|
-
|
(4,690)
|
|
|
|
|
Cash
and cash equivalents at beginning of the year
|
28,725
|
-
|
28,725
|
|
|
|
|
Cash
and cash equivalents at end of the period
|
24,035
|
-
|
24,035
|
|
|
|
|
|