REG - Scancell Hlds - Results for the Year Ended 30 April 2023
31/10/2023 07:15
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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® and AvidiMab® 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 £11.9
million (30 April 2022: operating loss of £13.3 million)
· Group cash balance at 30 April 2023 was £19.9 million (30 April
2022: £28.7 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® 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/ (http://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®and AvidiMab®, 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(®) 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 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®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®) 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 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®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(®) platform
Moditope®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®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®, 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®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®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™ 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™ 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™ 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™ 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®. The Company will now seek a partner to progress the
COVIDITY vaccine programme.
ANTIBODIES
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
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®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®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.
AvidiMab(®)
AvidiMab®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®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.
AvidiMab®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 £11.9
million (2022: operating loss of £13.3 million). Revenue from the licencing
deal with Genmab of £5.3 million reduced the operating loss significantly.
The increase in development expenditure to £11.6 million (2022: £9.5
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 £5.0 million (2022: £4.8
million).
During the previous year the group received grant income of £0.97 million
from Innovate UK. This ceased at 31 March 2022.
Interest payable of £1.2 million (2022 restated: £1.8 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 £0.5 million (2022: £0.5 million)
The finance expense of £1.5 million (2022 restated: finance income £16.0
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
£7.2 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 £14.2 million (2022 restated: £6.3
million) and the R&D tax credit increased to £2.4 million (2022: £1.7
million). This increase reflects the increased development expenditure
incurred during the year.
Overall, the loss for the year was £11.9 million (2022 restated: loss £4.6
million).
Statement of Financial Position
At 30 April 2023, the Group had net liabilities of £6.2 million (2022
restated: £4.8 million net assets) including cash at bank of £19.9 million
(2022: £28.7 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 £11.9 million for the
year.
The tax receivable due at the end of the year amounted to £4.2 million (2022:
£3.0 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
£1.7million has been received post year-end.
The increase in Trade and other payables to £3.0 million (2022: £2.1
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 £19.9 million (2022: £28.7
million). As can be seen in the Consolidated Cash Flow Statement, there has
been a decrease in cash and cash equivalents of £8.8 million (2022: decrease
£12.3 million). The Company has been able to progress on all research and
development platforms with the cash used for this being £9.4 million (2022:
£11.5 million), purchase of fixed assets amounting to £0.2million (2022:
£1.3 million), and payment of interest on the Convertible Loan Notes of
£537k (2022: £537k).
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® and
AvidiMab® 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
£'000 £'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 (11,920) (13,299)
LOSS
2
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 2,368 1,703
3
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
£'000 £'000 £'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
£'000 £'000 £'000 £'000 £'000
Balance 1st May 2021 815 65,019 705 (47,054) 19,485
Prior Year Adjustment - - (10,797) (10,797)
Balance 1st May 2021 (restated1) 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 (restated1) 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
£'000 £'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)
Lease payments (3275) ) (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
£'000 £'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
£'000 £'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
£'000 £'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 £38.53 million (2022:
£35.22 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
£9.8 million (2022: £8.8million). 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 £1,961,000 (2022: £1.397,000) and a
deferred tax asset of £490,000 (2022: £349,000) 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 £4,147,700 (2022: £2,990,000).
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
£'000 £'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
(http://www.scancell.co.uk/) together with copies of the Report and Accounts
for the year ended 30 April 2023.
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