TIDMSCLP
RNS Number : 7844R
Scancell Holdings Plc
31 October 2023
31 October 2023
Scancell Holdings plc
("Scancell" or the "Company")
Results for the Year Ended 30 April 2023
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
today announces its final audited financial results for the year
ended 30 April 2023 as well as a business update on progress
achieved post-period.
Key highlights (including post-period) SCIB1 (SCOPE trial)
-- SCIB1 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 82% objective response rate (ORR) to treatment in 11 patients,
exceeding 70% ORR expectations and accompanied by meaningful tumour
volume reduction
-- In the real word setting in patients just receiving the
doublet CPI therapy, the ORR is 50% with a progression free
survival of 11.5 months
-- Recruitment in the second stage is expected to be complete by
the end of 2023 with data available in H1 2024 and a clear
potential development pathway
-- iSCIB1+ cohort could be added to SCOPE trial if the protocol
amendment is approved by the MHRA with early data with iSCIB1+
available in H1 2024
Modi-1 (ModiFY trial)
-- Modi-1 has completed dose escalation and safety cohorts of
the Phase 1/2 ModiFY trial and is now into expansion cohorts
-- Early data from patients receiving Modi-1 as a monotherapy
showed good safety and tolerability, with no dose limiting
toxicities observed in dose escalation cohorts
-- Modi-1 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 (HGSOC) and triple negative
breast cancer (TNBC)
-- Early clinical data with Modi-1 expected to be available in 2024
Antibodies
-- GlyMab (R) and AvidiMab (R) platforms provide potential out
licensing opportunities with active discussions ongoing with
Pharmaceutical and Biotech companies.
-- Data presented at AACR-CIMT in September illustrated the
potential of Scancell antibodies as chimeric antigen receptor T
cell (CART) therapies
Corporate
-- Jean-Michel Cosséry appointed as our Non-Executive Chairman,
bringing over 25 years of healthcare experience and a sustained
global track record of success
-- Sath Nirmalananthan appointed as Chief Financial Officer
-- Dr Mandeep Sehmi appointed as Head of Business Development
building our commercial capabilities
Financial Highlights
-- Operating loss for the 12-month period to 30 April 2023 of
GBP11.9 million (30 April 2022: operating loss of GBP13.3
million)
-- Group cash balance at 30 April 2023 was GBP19.9 million (30
April 2022: GBP28.7 million) with a cash runway through to early
2025 achieving the near-term clinical milestones for SCIB1 and
Modi-1
.
Prof Lindy Durrant, Chief Executive Officer, Scancell,
commented: "Throughout the year, we have continued to deliver
strong progress across the business and have achieved a number of
significant milestones. As previously communicated, our strategic
focus is to continue to progress our two lead assets, SCIB1 and
Modi-1, through clinical development. Both trials have made good
progress throughout the year and early data is encouraging. We were
particularly impressed by the recent positive data from the first
stage of our SCOPE trial with SCIB1 showing an 82% objective
response rates (ORR) better than 70% ORR that the trial was
configured to show. We are looking forward to progressing both the
SCOPE trial and the ModiFY trial and are funded to continue the
development of these high-potential assets to the next near-term
value inflection points.
Following our commercial license agreement with Genmab, we are
continuing to have active discussions with Pharmaceutical and
Biotech companies to maximize the value of our antibody platforms
through additional licensing opportunities and I look forward to
updating the market on those discussions in due course.
We were also pleased to welcome Jean-Michel Cosséry as
Non-Executive Chairman, Sath Nirmalananthan as Chief Financial
Officer and Dr Mandeep Sehmi as Head of Business Development. Now,
with a bolstered leadership team, sufficient cash in place to fund
our current strategy and with further key data from both the SCOPE
and ModiFY trial anticipated during 2024, I believe we are well
placed to achieve the potential of our treatments for patients
whilst also creating and delivering significant long-term value for
our shareholders."
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)
Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
Consilium Strategic Communications +44 (0) 20 3709 5700
Mary-Jane Elliott/Matthew Neal/Chris Welsh 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(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
It is with great pleasure that I to write to you for the first
time as Chairman of Scancell. Since joining in February 2023, I
have been impressed by the groundbreaking science from which we
have developed a pipeline of patent-protected innovative
immune-oncology products and I strongly believe this is a pivotal
time in the Company's evolution.
Our lead cancer vaccines, SCIB1 and Modi-1, have shown positive
early efficacy results and recruitment continues on track to meet
further near-term clinical milestones during 2024. These clinical
assets are supplemented by our proprietary antibody platforms,
GlyMab(R)and AvidiMab(R), which provide potential for further
out-licensing deals following our commercial license agreement with
Genmab in October 2022.
Scancell is funded to reach these near-term milestones with
sufficient funds through to early 2025 and is backed by specialist
biotech investors, including Redmile Group and Vulpes Life
Sciences. We have an experienced board and leadership team with a
track record of delivery, combined with a highly skilled scientific
team and a lean organisation, all focused on delivering value from
our platforms in efficient timelines.
I'd like to take this opportunity to highlight our recent
impressive results from the first stage of the Phase 2 SCOPE trial.
The Phase 2 SCOPE trial is investigating SCIB1 delivered
needle-free and in combination with checkpoint inhibitors (CPIs) in
advanced melanoma. Remarkable initial data from 11 patients showed
an 82% objective response rate (ORR) to treatment with no increase
in toxicity, better than 70% ORR that the trial was configured to
show. We are excited because, to our knowledge, no other
combination has achieved this response rate with doublet checkpoint
inhibitors in unresectable metastatic melanoma. Confirmation of
this data in a larger cohort could make a significant impact on
melanoma patient survival, especially as melanoma is now the most
common cancer in young women and is increasing in incidence.
Our progress could not have been achieved without our talented
employees and I would like to thank them for their hard work and
dedication. In addition, the Board would like to thank all existing
shareholders, especially Redmile Group and Vulpes Life Sciences ,
for their continued support as we look forward to delivering on our
plans over the next 12 months and beyond.
Looking ahead we will remain focused on maintaining our momentum
for SCIB1 and Modi-1 whilst actively seeking out-licensing,
collaborations and partnerships to accelerate the development and
commercialisation of our products and platforms. We believe the
impressive data from the SCOPE trial, combined with further
near-term milestones and commercial opportunities will soon provide
exciting inflection drivers. We remain confident on achieving the
potential of these treatments for patients, whilst creating and
delivering significant long-term value for our shareholders.
Jean-Michel Cosséry
Chairman
CHIEF EXECUTIVE OFFICER'S REPORT
I am pleased to report that Scancell has delivered a strong
year, achieving significant clinical and commercial milestones. In
the period, the Company decided to concentrate its strategic focus
and resources on its lead cancer vaccines, SCIB1 and Modi-1 which
have shown positive early efficacy data. The decision to focus on
these assets reflects the need to manage our resources and cash in
a tough macroeconomic environment which is impacting ability to
access further capital. The Company has strong confidence in its
other assets and will continually assess partnering and
out-licensing options to drive these assets forward and add further
value.
Set out below is a summary of progress that has been made across
our innovative and proprietary vaccine and antibody platforms.
VACCINES
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, 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 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 the Company's
ImmunoBody(R)immunotherapy platform. It is currently being
evaluated in a Phase 2 SCOPE trial in the UK in combination with
checkpoint inhibitors for the treatment of advanced melanoma. The
SCOPE study is an open-label, multi-cohort, multicentre Phase 2
study. In June 2022, the Medicines and Healthcare products
Regulatory Agency (MHRA) approved a protocol amendment allowing the
trial to include a cohort of advanced 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
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(R)needle-free injection, which provides
enhanced patient acceptance versus electroporation.
In September 2023, Scancell reported positive data from the
first stage in its Phase 2 SCOPE trial, investigating SCIB1 in
combination with doublet therapy checkpoint inhibitors in advanced
melanoma. Initial data from 11 patients showed an 82% objective
response rate (ORR) to treatment, which is better than 70% ORR that
the trial was configured to show. The first milestone in the SCOPE
trial was to achieve responses in more than 8 out of 15 patients
which would suggest that SCIB1 in combination with doublet CPI
therapy might meaningfully improve current outcomes for these
patients. 16 stage IV metastatic patients received this
combination. 11 of these study patients have reached 13 weeks and
been evaluated at radiological imaging and nine have already shown
an objective response, equating to an ORR of 82% with no increase
in toxicity. At this time point the reduction in tumour volume was
31%-94%. Four patients reaching the 25 weeks imaging evaluation and
two reaching the 37 weeks evaluation have shown a 69%-94% and a
87%-94% reduction in total tumour burden, respectively. 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.
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. Based upon the first 11 patients there is a
greater than 90% probability that the second phase will also be
successful. The second stage of recruitment is expected to be
complete by the end of 2023 with data available in H1 2024.
If validated in the second stage of the SCOPE trial this will
provide confidence to initiate a randomised phase 2/3 adapted
registration programme in patients with unresectable melanoma. The
Phase 2 part of the adapted trial should take 18 months and we
anticipate it will generate significant partner interest.
iSCIB1+
iSCIB1+ is a modified version of SCIB1 developed using the
company's AvidiMab(R)platform. iSCIB1+ also includes more
melanoma-specific epitopes so it can be used by a broader patient
population rather than SCIB1 which is limited to the 40% of
patients who have the appropriate HLA. Furthermore, iSCIB1+ has
competitive advantages to SCIB1, including potentially increased
potency and extending the patent life by 15 years to 2031.
Given the significant improvements in potency, utility and
patent life with iSCIB1+, the Company plans to include an iSCIB1+
cohort in the SCOPE trial once a protocol amendment has been
approved by the MHRA. The amendment to the current trial protocol,
to include a new parallel cohort with the double CPIs with iSCIB1+,
has been submitted to the MHRA and we are awaiting a response.
The unresectable melanoma market represents a potential $1.5
billion per annum market.
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 the Company 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 Company's
Moditope(R)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 peptides are linked to AMPLIVANT(R), a potent adjuvant which,
in preclinical models, enhanced the immune response of Modi-1
10-to-100 fold and resulted in highly efficient tumour clearance,
including protection against tumour recurrence. 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 ModiFY study is an open-label, multicohort, 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. Modi-1 stimulates CD4 T cells which may directly impact
tumour growth however in some patients if the tumour environment is
highly immunosuppressive, these T cells may need to be protected by
CPIs. This open label Phase 1/2 study is assessing the safety and
immunogenicity of two citrullinated vimentin peptides and
citrullinated enolase peptide. This open label study will recruit
over 100 patients in up to 20 UK clinical trial sites. In addition,
the effect of Modi-1 in promoting T-cell infiltration into the
tumour will be assessed in a neoadjuvant cohort in which a further
30 patients with head and neck cancer will be treated with Modi-1
with or without CPI, prior to their first surgical resection.
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 (HGSOC) and triple negative breast cancer
(TNBC). The cohort of 16 ovarian cancer patients receiving Modi-1
has now been fully recruited. All patients had failed on previous
treatments and their disease was actively progressing when they
entered the study. Following treatment with Modi-1 44% of patients
achieved stable disease for at least 8 weeks, with some patients
experiencing a longer duration of disease stability for 4 months or
more. The number of patients who have experienced long periods of
stable disease following monotherapy with Modi-1 is encouraging in
this difficult to treat cancer and the Company believes that
combination therapy with checkpoint inhibitors, which are not
currently approved for the treatment of ovarian cancer, could
further improve outcomes for this patient group. Evaluation of
Modi-1 plus checkpoint inhibitors in other tumour types in the
ongoing Phase 1/2 study, will provide supporting data for this
proposed combination use.
In the other monotherapy cancer cohorts, a total of eight
patients have received full dose Modi-1. One TNBC patient remains
on trial with stable disease beyond 35 weeks. One head and neck
patient achieved a partial response. Recruitment is ongoing.
In July 2023, the ModiFY study moved into the expansion cohorts,
following approval by the safety review committee. The expansion
cohorts include Modi-1 in combination with checkpoint inhibitors
(CPI) and in the neoadjuvant setting. All three patients in Cohort
4 have now successfully received two doses of Modi-1 plus CPI and
the treatments were well tolerated with no safety concerns. 21
patients will be recruited into each cohort. Patients with triple
negative breast cancer will not be included in this part of the
study as these patients receive checkpoints in combination with
chemotherapy which may induce citrullination in normal cells and
induce toxicity.
This study will recruit 30 patients who will be randomised at
diagnosis to receive either two doses of Modi-1 three weeks apart
or two doses of Modi-1 plus one dose of CPI. Tumour biopsies will
be taken prior to immunisation and from the tumour resection 6
weeks following the initial vaccination. The two tumour samples
will allow the extent of T cell infiltration and activation pre-
and post-Modi-1 vaccination to be assessed with and without a
checkpoint inhibitor.
Early clinical data with Modi-1 expected to be available in
2024.
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.
In November 2022, the Company 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 agreement allows Scancell to
formulate and manufacture Modi-2. 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 formulation issues associated with
immunogenic peptide antigens, which are often highly hydrophobic
and prone to manufacturing challenges with conventional
formulations. Modi-2 will 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 Modi-2 with a highly
effective platform for inducing T cells (Vaccitech's SNAPvax(TM)
technology) will lead to a potentially superior therapeutic vaccine
candidate.
COVIDITY
As previously disclosed, the Company has decided not to take
this vaccine forward in house due to the large size of later stage
trials and the competitive Covid-19 landscape, however the previous
positive data in February 2023 for COVIDITY demonstrates the
validation of the vaccine platform, including AvidiMab(R). The
Company will now seek a partner to progress the COVIDITY vaccine
programme.
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 create upfront, milestone and revenue
generating partnerships with other companies in areas such as drug
targeting to capitalise on other groups expertise. The
GlyMab(R)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 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.
The GlyMab(R)antibodies can be developed into redirecting T cell
bispecific (TCB) antibodies with the potential of entering the
clinical trials providing 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 (MHC) 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. SC134 has now
been successfully developed in the lab as a TCB.
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(R)platform, for the development and
commercialisation of novel therapeutic products. The Company
received
GBP5.3 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.
AvidiMab(R)
AvidiMab(R)is a versatile proprietary 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.
AvidiMab(R)platform successfully applied to internal programmes,
including iSCIB1+ and COVIDITY, and holds potential to enhance the
efficacy of third-party antibodies.
CORPORATE
The Company has been building its organisational capabilities
through key appointments to the Board and Leadership teams.
During the year Jean-Michel Cosséry was appointed as the
Non-Executive Chairman. Jean-Michel brings to Scancell over 25
years of experience in the pharmaceutical and biotechnology
industries and a sustained global track record of success in
commercial operations as well as in capital raising, US and
European public offerings, business development and M&A. We are
already capitalising on his experience as we continue on our
journey to deliver the next stage of growth.
The Company has also recently appointed Sath Nirmalananthan as
Chief Financial Officer and Dr Mandeep Sehmi as Head of Business
Development. Both appointments bring highly relevant experience
from the pharmaceutical sector to the company that will further
enhance its commercial capabilities and accelerate the Company
forward in achieving its strategic objectives.
FINANCIAL REVIEW
Profit or Loss and Other Comprehensive Income Statement
The Group made an operating loss for the year to 30 April 2023
of GBP11.9 million (2022: operating loss of GBP13.3 million).
Revenue from the licencing deal with Genmab of GBP5.3 million
reduced the operating loss significantly.
The increase in development expenditure to GBP11.6 million
(2022: GBP9.5 million) reflects an increase in average numbers of
research and clinical staff from 33 to 43 together with additional
costs incurred with increased recruitment in the SCOPE and ModiFY
clinical trials and completion of the COVID clinical trial.
Administrative expenditure has increased by 4% to GBP5.0 million
(2022: GBP4.8 million).
During the previous year the group received grant income of
GBP0.97 million from Innovate UK. This ceased at 31 March 2022.
Interest payable of GBP1.2 million (2022 restated: GBP1.8
million) largely relates to the effective interest on the
convertible loan notes (CLNs) which were issued in August and
November 2020. The interest paid on the Convertible Loan Notes in
the year amounted to GBP0.5 million (2022: GBP0.5 million)
The finance expense of GBP1.5 million (2022 restated: finance
income GBP16.0 million) relating to the derivative liability is the
fair value adjustment of the derivative liability at 30 April 2023.
The finance expense and prior year's credit are not cash items and
have no impact upon the Company's cashflow.
The restated loss on the substantial modification of the CLNs
for the year ended 30 April 2022 amounting to
GBP7.2 million arose from accounting adjustments from the
replacement of the CLNs in existence at 27 October 2021 with new
CLNs with a later maturity date.
The loss before taxation amounted to GBP14.2 million (2022
restated: GBP6.3 million) and the R&D tax credit increased to
GBP2.4 million (2022: GBP1.7 million). This increase reflects the
increased development expenditure incurred during the year.
Overall, the loss for the year was GBP11.9 million (2022
restated: loss GBP4.6 million).
Statement of Financial Position
At 30 April 2023, the Group had net liabilities of GBP6.2
million (2022 restated: GBP4.8 million net assets) including cash
at bank of GBP19.9 million (2022: GBP28.7 million). The net
liabilities have arisen at 30 April 2023 as a result of amending
the convertible loan notes' derivative liability valuation, as
described further below and incurring losses of GBP11.9 million for
the year.
The tax receivable due at the end of the year amounted to GBP4.2
million (2022: GBP3.0 million) and relates to the R&D tax
credit for the 2021/22 tax year plus the tax credit for the year to
30 April 2023. The 2021/22 tax credit of GBP1.7million has been
received post year-end.
The increase in Trade and other payables to GBP3.0 million
(2022: GBP2.1 million) is due to increased expenditure during the
year as development activities have increased.
The Derivative Liabilities represents the fair value of the
conversion feature of the CLNs with changes in value being shown in
the Consolidated Profit or Loss and Other Comprehensive Income
Statement as a finance income or expense.
Consolidated Cash Flow Statement
As at 30 April 2023 bank balances amounted to GBP19.9 million
(2022: GBP28.7 million). As can be seen in the Consolidated Cash
Flow Statement, there has been a decrease in cash and cash
equivalents of GBP8.8 million (2022: decrease GBP12.3 million). The
Company has been able to progress on all research and development
platforms with the cash used for this being GBP9.4 million (2022:
GBP11.5 million), purchase of fixed assets amounting to
GBP0.2million (2022: GBP1.3 million), and payment of interest on
the Convertible Loan Notes of GBP537k (2022: GBP537k).
Prior Period Restatement
The Company and its auditor reviewed the valuation and
accounting for convertible loan notes and identified certain
corrections required to the current and prior periods' Group and
company results, as fully described in note 24 to the consolidated
financial statements, included in the Report and Accounts for the
year ended 30 April 2023 which are now available on the Company's
website..
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.
There was no impact on cash itself and the prior period restatement
does not impact the convertible loans' notional amounts or maturity
dates disclosed.
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
milestones for the following 18 months include:
-- Second stage of SCOPE study in advanced melanoma with SCIB1
anticipated to complete recruitment by the end of 2023 with data
available in H1 2024
-- iSCIB1+ planned to be included in the SCOPE study. Protocol amendment pending MHRA approval
-- Phase 2/3 seamless adaptive registration trial with SCIB1 or iSCIB1+ to begin in 2024
-- ModiFY trial to continue recruitment in the expansion cohorts
with early clinical data expected in 2024
-- Continue to assess out-licensing options for the GlyMab (R)
and AvidiMab (R) platforms providing a source of non-dilutive cash
to drive our 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 shareholders
once again for their continued support.
Professor Lindy Durrant
Chief Executive Officer
CONSOLIDATED PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
STATEMENT for the
year ended 30 April 2023
Notes 2023 2022
GBP'000 GBP'000
Restated(1)
Revenue 5,271 -
Cost of sales (525) -
------------------- ------------
Gross Profit 4,746 -
Development expenses (11,645) (9,477)
Administrative expenses (5,021) (4,787)
Grant income - 965
------------------- ------------
OPERATING LOSS 2 (11,920) (13,299)
Interest receivable and similar income 284 4
Interest payable (1,215) (1,777)
Loss on substantial modification of convertible
loan notes - (7,244)
Finance (expense) / income relating to derivative
liability revaluation (1,453) 16,044
------------------- ------------
LOSS BEFORE TAXATION (14,304) (6,272)
Taxation 3 2,368 1,703
------------------- ------------
LOSS FOR THE YEAR AND TOTAL COMPREHENSIVE LOSS (11,936) (4,569)
------------------- ------------
LOSS PER ORDINARY SHARE (pence) 4
Continuing
Basic (1.50)p (0.56)p
--------- ---------
Diluted (1.50)p (0.56)p
--------- ---------
1 Please refer to note 5 for further details on the prior period
restatement
CONSOLIDATED STATEMENT OF FINANCIAL
POSITION As at 30 April 2023
2023 2022 2021
GBP'000 GBP'000 GBP'000
Restated(1) Restated(1)
ASSETS
Non-current assets
Tangible fixed assets 1,246 1,579 692
Right-of-use assets 1,003 1,165 283
Goodwill 3,415 3,415 3,415
---------- ----------- -----------
5,664 6,159 4,390
---------- ----------- -----------
Current assets
Trade and other receivables 538 647 968
Income tax assets 4,148 2,990 2,590
Cash and cash equivalents 19,920 28,725 41,110
---------- ----------- -----------
24,606 32,362 44,668
---------- ----------- -----------
TOTAL ASSETS 30,270 38,521 49,058
---------- ----------- -----------
LIABILITIES
Non-current liabilities
Convertible Loan note (18,481) (17,857) (15,119)
Derivative liability (14,000) (12,547) (22,893)
Lease liabilities (746) (856) (63)
---------- ----------- -----------
(33,227) (31,260) (38,075)
---------- ----------- -----------
Current liabilities
Trade and other payables (2,970) (2,137) (2,087)
Lease liabilities (306) (315) (208)
---------- ----------- -----------
(3,276) (2,452) (2,295)
---------- ----------- -----------
TOTAL LIABILITIES (36,503) (33,712) (40,370)
---------- ----------- -----------
NET (LIABILITIES)/ASSETS (6,233) 4,809 8,688
---------- ----------- -----------
SHAREHOLDERS' EQUITY
Called up share capital 819 815 815
Share premium account 65,181 65,019 65,019
Share option reserve 2,123 1,395 705
Retained losses (74,356) (62,420) (57,851)
-------- -------- --------
TOTAL SHAREHOLDERS' (DEFICIT) / EQUITY (6,233) 4,809 8,688
-------- -------- --------
1 Please refer to note 5 for further details on the prior period
restatement
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended 30 April 2023
Share Share Share Retained
Capital Premium Option losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
---------- ------------ ----------- ------------- ----------
Balance 1st May 2021 815 65,019 705 (47,054) 19,485
Prior Year Adjustment - - (10,797) (10,797)
---------- ------------ ----------- ------------- ----------
Balance 1st May 2021
(restated 1 ) 815 65,019 705 (57,851) 8,688
Share option credit - - 690 - 690
Loss for the year and
other comprehensive loss - - - (4,569) (4,569)
---------- ------------ ----------- ------------- ----------
Balance 30 April 2022
(restated 1 ) 815 65,019 1,395 (62,420) 4,809
Share issue 4 162 - - 166
Loss for the year and
other comprehensive loss - - - (11,936) (11,936)
Share option credit - - 728 - 728
---------- ------------ ----------- ------------- ----------
Balance 30 April 2023 819 65,181 2,123 (74,356) (6,233)
---------- ------------ ----------- ------------- ----------
1 Please refer to note 5 for further details on the prior period
restatement
2023 2022
GBP'000 GBP'000
Cash flows from operating activities Restated(1)
Loss before tax (14,304) (6,272)
Adjustments for:
Finance income (284) (4)
Lease interest paid 54 48
Convertible loan interest payable 1,161 1,729
Finance expense / (income) for derivative liability
revaluation 1,453 (16,044)
Loss on substantial modification of convertible
loan notes - 7,244
Depreciation 536 381
Amortisation of right-of-use asset 366 359
Share-based payment charge 728 690
---------------------- ------------
Cash used in operations before changes in
working capital (10,290) (11,869)
Decrease in other receivables 111 321
Increase in accounts and other payables 829 51
---------------------- ------------
Cash used in operations (9,350) (11,497)
Tax credits received 1,210 1,304
---------------------- ------------
Net cash used in operating activities (8,140) (10,193)
---------------------- ------------
Investing activities
Purchase of tangible fixed assets (203) (1,268)
Finance income 284 4
---------------------- ------------
Net cash generated from / (used in) investing
activities 81 (1,264)
---------------------- ------------
Financing activities
Proceeds from issue of share capital 166 -
Convertible loan interest paid (537) (537)
( 3 2 7 5
Lease payments ) ) (391)-
---------------------- ------------
Net cash (used in) financing activities (746) (928)
---------------------- ------------
Net (decrease)/increase in cash and cash equivalents (8,805) (12,385)
Cash and cash equivalents at beginning of
the year 28,725 41,110
---------------------- ------------
Cash and cash equivalents at end of the year 19,920 28,725
---------------------- ------------
1 Please refer to note 5 for further details on the prior period
restatement
1 BASIS OF PREPARATION
These financial results do not comprise statutory accounts for
the year ended 30 April 2023 within the meaning of Section 434 of
the Companies Act 2006. The financial information in this
announcement has been extracted from the audited financial
statements for the year ended 30 April 2023. The auditors reported
on those accounts and their report (i) was unqualified; (ii) did
not include references to any matters to which the auditors drew
attention by way of emphasis without qualifying their report and
(iii) did not contain statements under section 498 (2) or (3) of
the Companies Act 2006. The statutory accounts for the year ended
30 April 2023 have not yet been delivered to the Registrar of
Companies.
The financial statements have been prepared on the going concern
basis on the grounds that the directors have reviewed the funding
available and the group's cash flow forecast and are content that
sufficient resources are available to enable the group to continue
in operation for at least twelve months from the date of approval
of these financial statements.
These financial statements have been prepared in accordance with
UK adopted international accounting standards applicable to
companies reporting under IFRS. Assets and liabilities are
initially recognised at historical cost or transaction value unless
otherwise stated in the relevant accounting policies.
2 OPERATING LOSS
2022 2021
GBP'000 GBP'000
Operating Loss is stated after charging/(crediting):
Grant income - (965)
Depreciation on tangible fixed assets 536 381
Amortisation of right-of-use asset 366 360
Research and development 11,645 9,477
Foreign exchange losses / (gains) 358 (2)
Auditors' remuneration - fee payable for audit
of the company 42 32
Auditors' remuneration - fee payable for audit
of the subsidiary
company 41 32
Auditors remuneration - non -audit services - 8
Directors' remuneration 757 1,185
3 TAXATION
The tax credit on the loss on ordinary activities for the year
was as follows:
2023 2022
Current tax
GBP'000 GBP'000
UK corporation tax credits due on R&D expenditure 2,399
1,754 Adjustment to prior year
(31) (51)
2,368 1,703
3 TAXATION (continued) Factors affecting the tax credit
The tax assessed for the year is lower than the applicable rate
of corporation tax in the UK. The difference is explained
below:
2023 2022
GBP'000 GBP'000
Loss on ordinary activities before tax (14,304) (6,272)
Loss on ordinary activities multiplied by
the small company rate of
tax in the UK (19.49%) (2022: 19%) (2,788) (1,192)
Effects of:
Disallowed (income)/expenditure on convertible
loan 510 (1,345)
Other disallowed expenditure 172 131
Other timing differences 49 23
Enhanced tax relief on R&D expenditure (929) (771)
Prior year (under)/ over provision 31 51
Unrelieved losses carried forward 587 1,400
Current tax (credit) (2,368) (1,703)
The Group has tax losses to carry forward against future profits
of approximately GBP38.53 million (2022:
GBP35.22 million).
A deferred tax asset has not been recognised in respect of these
losses as the Group does not anticipate sufficient taxable profits
to arise in the foreseeable future to fully utilise them.
The estimated value of the deferred tax asset not recognised
measured at the prevailing rate of tax when the timing differences
are expected to reverse is GBP9.8 million (2022: GBP8.8million).
This is based on the substantively enacted rates at the balance
sheet date. The current UK corporation rate is 25%, effective from1
April 2023, as set out in the Finance Bill 2021 which was
substantively enacted on 24 May 2021.
In addition to the deferred tax asset on losses, the Group has a
potential future tax deduction on share options of GBP1,961,000
(2022: GBP1.397,000) and a deferred tax asset of GBP490,000 (2022:
GBP349,000) thereon. The additional tax deduction will crystallise
at the point the options are exercised. As the utilisation of this
additional deduction against taxable profits in the Group is
uncertain, no deferred tax asset has been recognised in respect of
the future tax deduction on share options.
Taxation receivable is GBP4,147,700 (2022: GBP2,990,000).
4 LOSS PER SHARE
Basic loss per share
The earnings and weighted average number of ordinary shares used
in the calculation of basic loss per share is as follows:
2023 2022
GBP'000 GBP'000
Restated
Loss used in calculation of basic loss
per share (11,936) (4,569)
Number Number
Weighted average number of ordinary shares
of 0.1p each
for the calculation of basic loss per
share 816,051,311 815,218,831
4 LOSS PER SHARE (continued)
Diluted loss per share
As the Group is reporting a loss from continuing operations for
both years 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 year end the issued share capital amounted to 818,903,461
ordinary shares.
5 PRIOR PERIOD RESTATEMENT
The Company and its auditor reviewed the valuation and
accounting for convertible loan notes and identified certain
corrections required to the current and prior periods' Group and
company results, as fully described in note 24 to the consolidated
financial statements, included in the 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.
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 (see note 7).
6 DELIVERY OF ACCOUNTS
The audited statutory accounts in respect of the prior year
ended 30 April 2022 have been delivered to the Registrar of
Companies. The auditors issued an unqualified audit opinion which
did not contain any statement under section 498(2) or 498(3) of the
Companies Act 2006.
7 AVAILABILITY OF ACCOUNTS
This announcement is not being posted to shareholders. Copies of
this announcement can be downloaded from the Company's website:
www.scancell.co.uk together with copies of the Report and Accounts
for the year ended 30 April 2023.
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END
FR FDSEESEDSEIS
(END) Dow Jones Newswires
October 31, 2023 03:00 ET (07:00 GMT)
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