REG - Scancell Hlds - Interim Results
30/01/2024 07:00
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RNS Number : 2802B Scancell Holdings Plc 30 January 2024
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
(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 (http://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 3709 5700
Professor Lindy Durrant, CEO
Dr Jean-Michel Cosséry, Non-Executive Chairman
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)
WG Partners LLP (Joint Broker) +44 (0) 20 3705 9330
David Wilson/Claes Spang/Sathesh Nadarajah/Erland Sternby
Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
ICR Consilium +44 (0) 20 3709 5700
Mary-Jane Elliott/Matthew Neal/ Chris Welsh scancell@consilium-comms.com (mailto:scancell@consilium-comms.com)
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/ (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
(https://www.scancell.co.uk/scancell-announces-positive-data-from-the-first-stage-in-its-phase-2-scope-trial-with-scib1-cancer-vaccine-delivered-by-needle-free-injection-for-advanced-melanoma)
and subsequently in November
(https://www.scancell.co.uk/update-on-scope-trial-) 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 30/04/2023
Restated 1
£'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 (#_ftn2) 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 30/04/2023
Restated1
£'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 30/04/2023
Restated1
£'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
(http://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
1 Please refer to note 5 for further details on the prior period restatement
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