REG - Scancell Hlds - Interim Results
25/01/2023 07:00
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RNS Number : 7483N Scancell Holdings Plc 25 January 2023
25 January 2023
Scancell Holdings plc
("Scancell" or the "Company")
Interim Results for the 6 months ended 31 October 2022
Strong clinical progress with ongoing ModiFY and SCOPE trials; further safety,
immune and clinical response data expected in 2023
Signed licensing agreement with Genmab to develop and commercialise an
anti-glycan mAb providing strong commercial validation of the Company's
scientific approach and strategy
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, today announces its interim
results for the 6 months ended 31 October 2022 and provides a business update
on progress achieved to date.
Highlights (including post period):
Vaccines:
· Fourteen patients enrolled and dosed in the expansion phase of
the monotherapy arms in the multicentre Phase 1/2 Modi-1 clinical trial
(ModiFY). First patient dosed in Cohort 3 of ModiFY in combination with a
checkpoint inhibitor (CPI). There have been no safety issues to date.
· Expansion of SCIB1 Phase 2 combination trial (SCOPE) protocol to
include SCIB1 in combination with checkpoint doublet therapy leading to
significantly increased recruitment rate.
· In-licensed the SNAPvax™ technology from Vaccitech plc to
formulate and manufacture Modi-2, with the aim of initiating a Phase 1
clinical study in cancer patients during H1 2024.
· Recruitment completed in COVIDITY Phase 1 clinical trial in South
Africa, with safety and immunogenicity data expected in Q1 2023, providing
read across to our second-generation ImmunoBody(®) platform.
Antibodies:
· Plans to take two GlyMab(®) monoclonal antibodies (mAbs), a
redirecting T-cell bispecific (TCB) antibody and a T cell costimulatory mAb
into the clinic, with initiation of TCB manufacturing in H1 2023 prior to
clinical evaluation in 2024.
· Signed licensing agreement with Genmab to develop and
commercialise an anti-glycan mAb, with the Company being eligible to receive
milestone payments of up to $208 million for each product developed and
commercialised, up to a maximum of $624 million if Genmab develops and
commercialises products across all defined modalities.
· AvidiMab(®) technology continues to be applied to the Company's
internal programmes whilst evaluating how AvidiMab(®) could be used to
enhance the efficacy of third-party antibodies.
· Preclinical data on GlyMab(®) and AvidiMab(®) antibody
platforms presented at PEGS Europe and EuroMAbNet Annual Meeting in H2 2022.
Corporate:
· John Chiplin has announced he will resign as Executive Chairman
for personal reasons but is staying on for an interim period until a new Chair
is appointed.
· Dr Richard Goodfellow, stepped down a Board Director at the 2022
Annual General Meeting (AGM).
· Susan Clement Davies, an independent Non-Executive Director and
Chair of the Audit Committee, appointed as Deputy Chair.
Financial:
· Reported loss for the 6-month period to 31 October 2022 of £3.2
million (31 October 2021 profit of £3.2 million).
· Received licence fee of £5.3 million relating to the up-front
payment receivable from Genmab following the signing of the licence agreement
in October 2022.
· Group cash balance at 31 October 2022 was £24.0 million (April
2022: £28.7 million) with a cash runway until Q1 2024.
Prof Lindy Durrant, Chief Executive Officer, Scancell, commented:
"We are pleased to report another period of progress for Scancell, including
strong clinical and commercial developments. We have continued to advance our
ModiFY Phase 1/2 trial for Modi-1 and the SCOPE Phase 2 trial for SCIB1 and
expect to generate safety, immune and clinical response results during 2023.
During the period, we also continued to progress our earlier stage pipeline
having signed an in-licensing agreement with Vaccitech.
"It has been a defining period for our proprietary antibody platform as we
have signed a licensing agreement for one of our anti-glycan mAbs with Genmab,
providing strong validation of the platform and the Company's scientific
approach. We remain one of only a few companies worldwide that has the
capability to produce high affinity, humanised anti-glycan antibodies and
continue to evaluate options and potential agreements for the Company's
GlyMab(®) antibodies in order to provide further third-party validation,
develop the business and generate revenues. We would like to thank our
shareholders for their continued support over the past 6 months and look
forward to updating the market on our future clinical and operational progress
during 2023."
A full copy of the announcement can be found on the Scancell website:
www.scancell.co.uk (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 3727 1000
Dr John Chiplin, Executive Chairman
Professor Lindy Durrant, CEO
Stifel Nicolaus Europe Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7710 7600
Nicholas Moore/Samira Essebiyea/William Palmer-Brown (Healthcare Investment
Banking)
Nick Adams/Nick Harland (Corporate Broking)
Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
FTI Consulting +44 (0) 20 3727 1000
Simon Conway/Rob Winder/Alex Davis
About Scancell
Scancell is a clinical stage biopharmaceutical company that is leveraging its
proprietary research, built up over many years of studying the human adaptive
immune system, to generate novel medicines to treat significant unmet needs in
cancer and infectious disease. The Company is building a pipeline of
innovative products by utilising its four technology platforms: Moditope(®)
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/)
CHAIRMAN'S STATEMENT
I am pleased to report the Group's interim results for the 6-month period
ended 31 October 2022. During the period, Scancell has continued to make good
clinical trial progress with recruitment accelerating in the ongoing ModiFY
and SCOPE trials, and the completion of dosing in the COVIDITY Phase 1 study.
In addition, we have signed two encouraging deals, with Genmab which has
accelerated one of our antibodies into development, and post-period with
Vaccitech plc to streamline the future manufacture of Modi-2. In our early
stage pipeline, it is exciting to see Scancell's T cell bispecific (TCB)
redirecting programme advancing towards identification of the lead product for
our in-house clinical development. We are indebted to our staff in all aspects
of the Company for their hard work, creative ideas and thoughtful approach to
working with their fellow employees to help achieve this strong progress.
Set out below is a summary of progress that has been made across our
innovative and proprietary vaccine and antibody platforms.
VACCINES
Moditope(®) platform
Moditope(®) is a versatile proprietary cancer vaccine platform that targets
stress-induced post-translational modifications (siPTMs) of proteins. This
discovery has allowed us to develop a completely new class of potent and
selective therapeutic vaccines. Examples of such modifications include
citrullination, an enzyme-based conversion of arginine to citrulline, and
homocitrullination, in which lysine residues are converted to homocitrulline.
Vaccination with peptides containing these modifications have been
demonstrated to induce potent CD4 cytotoxic T cells that induce anti-tumour
activity without any associated toxicity in preclinical models.
Modi-1
Modi-1, which targets citrullinated cancer antigens, is the first therapeutic
vaccine candidate to emerge from Scancell's Moditope(®) platform. The ModiFY
study is a multicentre Phase 1/2 first-in-human clinical trial, with Modi-1
being administered alone or in combination with checkpoint inhibitors (CPIs)
in patients with head and neck, triple negative breast and renal tumours, as a
monotherapy in patients with ovarian cancer where there are no approved CPI
therapies and in patients with the other tumour types where CPIs are not
indicated. This open label study will recruit up to 138 patients in up to 20
clinical trial sites across the UK. Nine sites are actively recruiting with
another three being set up and expected to initiate screening during 2023. To
date, 21 patients have been immunised in the ModiFY study and a further 16
have been recruited.
As previously reported, Cohort 1 of the study confirmed the safety profile of
a low dose of two citrullinated vimentin peptides. The objective for Cohort 2
of the trial was to assess the safety of the two citrullinated vimentin
peptides plus an enolase peptide at a higher dose. We are pleased to announce
that all three patients in Cohort 2 have now successfully received multiple
doses and the injections were well tolerated with no safety concerns. The head
and neck patient in Cohort 2 has now shown a confirmed partial response with
further regression of their tumour at week 16 whilst one ovarian patient in
Cohort 1 and one in Cohort 2 have stable disease.
Based on the safety data analysed from Cohort 2, post-period the ModiFY trial
was expanded at this dose for Modi-1 monotherapy in three tumour types. To
date, 13 ovarian, two breast and three head and neck patients, including one
in Cohort 3 in combination with a CPI, have been dosed with no safety issues.
Modi-1 stimulates CD4 T cells which may directly impact tumour growth.
However, in some patients these T cells may need to be protected by CPIs if
the tumour environment is highly immunosuppressive.
Modi-1 peptides are linked to AMPLIVANT(®), a potent adjuvant which enhanced
the immune response 10-100-fold and resulted in highly efficient tumour
clearance, including protection against tumour recurrence, in preclinical
models. AMPLIVANT(®) is the subject of a worldwide licensing and
collaboration agreement with ISA Pharmaceuticals for the manufacturing,
development, and commercialisation of Modi-1.
The Company expects further safety, immunogenicity and efficacy data from the
ModiFY study to be available during 2023.
Modi-2
Modi-2, which targets homocitrullinated cancer antigens, is the second
therapeutic vaccine candidate from the Company's Moditope(®) platform and has
the potential to address different cancer indications to Modi-1, including
tumours with a particularly immunosuppressive environment. During the period,
internal preclinical research and formulation development work has continued
to progress Modi-2 towards the clinic.
Post period, we were pleased to announce that we had in-licensed the
SNAPvax™ technology from Vaccitech plc, a clinical-stage biopharmaceutical
company engaged in the discovery and development of novel immunotherapies and
vaccines.
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 historic formulation issues associated with immunogenic
peptide antigens, which are often highly hydrophobic and prone to
manufacturing challenges with conventional formulations. For Modi-2, the
Company plans to use SNAPvax™ to co-deliver homocitrullinated peptide
antigens and TLR-7/8a adjuvants in self-assembling nanoparticles designed to
prime tumour killing T cells. The Company expects that the combination of
Scancell's Modi-2 with a highly effective platform for inducing T cells will
lead to a potentially superior therapeutic vaccine candidate.
Homocitrullination is a process that occurs by a different mechanism compared
to citrullination (Modi-1) and is therefore applicable to a distinct set of
highly immune suppressed tumours. Scancell will leverage its deep
understanding of T cell immunology and cancer immunotherapy together with its
strong development capabilities to bring Modi-2 to clinical validation, adding
value to the entire Moditope(®) platform. The agreement with Vaccitech plc,
signed in November 2022, will allow Scancell to formulate and manufacture
Modi-2, with the aim of initiating a Phase 1 clinical study in cancer patients
in H1 2024.
ImmunoBody(®) 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. Each ImmunoBody(®) vaccine can be designed to
target a particular cancer in a highly specific manner, offering the potential
for enhanced efficacy and safety compared with more conventional approaches.
These vaccines have the potential to be used as monotherapy or in combination
with CPIs and other agents. The Board believe that this platform has the
potential to enhance tumour destruction, prevent disease recurrence and extend
survival rates for patients.
Scancell's ImmunoBody(®) vaccine approach can also be exploited to induce
immune responses against infectious diseases. As research data emerged at the
beginning of the COVID-19 pandemic, it was clear that the induction of potent
and activated T cells could play a critical role in the development of
long-term immunity and clearance of virus-infected cells. Scancell therefore
used its proven cancer vaccine concept to design a vaccine against SARS-CoV-2,
the virus that causes COVID-19.
SCIB1 and iSCIB1+
SCIB1 is the lead product from the Company's ImmunoBody(®) immunotherapy
platform, which uses the body's immune system to identify, attack and destroy
tumours and is currently being evaluated in a Phase 2 clinical trial ('SCOPE')
in the UK in combination with a CPI for the treatment of metastatic melanoma.
Following the approval of a protocol amendment by the UK's Medicines and
Healthcare products Regulatory Agency (MHRA), the trial now includes a cohort
of melanoma patients who will receive SCIB1 plus doublet therapy consisting of
ipilimumab (Yervoy(®)) plus nivolumab (Opdivo(®)), in addition to the cohort
who will receive SCIB1 with pembrolizumab (Keytruda(®)). This protocol
amendment reflects changes in the current treatment landscape for metastatic
melanoma patients. The Phase 2 study is designed to assess whether the
addition of SCIB1 treatment to CPI standard of care results in an improvement
in outcomes for patients with metastatic disease. The primary objectives of
the SCOPE trial are tumour response rate, progression-free survival and
overall survival in patients with advanced melanoma.
Under the updated protocol the Company is now also testing the SCIB1 vaccine
delivered via needle-free injection, using a PharmaJet(®) device. Prior to
the amendment, SCIB1 had been delivered using electroporation to enhance the
uptake and presentation of the DNA vaccine to the immune system and, although
electroporation is a proven delivery method, the Company believes that
needle-free injection (such as the PharmaJet(®) device) could provide
enhanced patient acceptance and uptake. Eight sites are currently recruiting
with a further six in the set-up stage. Although recruitment remains
challenging, the recent protocol changes have resulted in an uplift in
enrolment rates in the SCOPE study.
In addition, to further increase eligibility the Company has been developing
iSCIB1+, an AvidiMab(®) modified version of SCIB1, which is expected to
increase both the potency of SCIB1 and extend its patent life. This
modification also includes multiple epitopes so it can be used to treat all
patients rather than being limited to the 40% of patients who have the
appropriate human leukocyte antigen (HLA) type for treatment with SCIB1. Given
the significant potential improvements in potency, utility and patent life
with iSCIB1+, the Company plans to transition the SCOPE trial to the iSCIB1+
product during 2023.
The current modifications to the SCOPE protocol have significantly increased
the recruitment rate into the ongoing Phase 2 trial at the existing UK sites
and the transition to iSCIB1+ during 2023 is also expected to further increase
patient enrolment rates. As a result, the Company intends to withdraw the open
Investigational New Drug (IND) application in the US for the SCIB1 product and
focus its resources on continuing to expand recruitment in the UK for SCIB1
and transitioning the iSCIB1+ product into the existing SCOPE study.
COVIDITY
The COVIDITY programme, focusing on the Company's novel COVID-19 vaccine
candidates SCOV1 and SCOV2, recently completed dosing in South Africa and we
expect to report safety and immunogenicity data in Q1 2023. As previously
disclosed, given the large size of later stage trials and the competitive
landscape the Company does not intend to do further trials and will focus its
resources on the oncology platforms. The Company has successfully used
PharmaJet(®) needle-free injection systems in this trial and is now using it
in the SCOPE trial of SCIB1.
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 partner with other companies in areas such as drug targeting to
combine our novel platform with other groups' expertise. The GlyMab(®)
antibodies bind to sugar motifs, rather than peptide epitopes, found on the
surface of glycosylated proteins and lipids that are implicated as drug
targets in particular cancers and potentially other diseases. As such, this
novel proprietary platform expands on the Company's innovative approach to
developing ground-breaking therapies for cancer and infectious disease.
The Company currently has a pipeline of five anti-glycan monoclonal antibodies
(mAbs): SC129, SC134, SC88 and SC27 that target solid tumours including
pancreatic, small cell lung, colorectal and gastric cancers, and SC2811 that
targets a glycolipid present on T cells. A robust portfolio of patents and
applications, as well as know-how, surround the GlyMab(®) platform and
generated drug candidates. All five drug candidates have been successfully
humanised and are ready for the Company or a partner to take them to next
stage of development.
In October 2022 we were pleased to have granted Genmab the exclusive rights to
develop and commercialise one of Scancell's antibodies, in multiple novel
potential therapeutic products for any and all potential disease areas,
excluding cell therapy applications. Under the terms of the agreement,
Scancell has received an up-front payment of $6 million and will be eligible
to receive potential development and commercialisation milestone payments, as
well as royalties on products sold. The potential milestone payments will be
up to $208 million for each product developed and commercialised, up to a
maximum of $624 million if Genmab develops and commercialises products across
all defined modalities. In addition, Scancell will also receive single digit
royalties from Genmab on net sales of all commercialised products. This first
license agreement with GlyMab(®) provides strong validation for our
proprietary platform and our ability to utilise this technology to support the
creation of novel, differentiated antibody products in a range of disease
areas.
In addition, Scancell plans to take two of these five mAbs a redirecting TCB
antibody and a T cell costimulatory mAb into the clinic. It is anticipated
that manufacturing will start in H1 2023 with a view to entering the clinic in
2024.The Board believes that this could be a promising new therapeutic
approach for treating cancer. TCB antibodies have dual-binding specificity
which crosslinks tumour cells via their glycans with an activating receptor
CD3 on T cells. This results in activation of killer T cells and tumour cell
death. These antibodies are particularly potent in tumours which have lost the
T cell recognition molecule major histocompatibility antigen or where there is
limited T cell infiltration as they by-pass normal T cell activation pathways
and redirect the host immune system to the tumour. Scancell will combine its
proprietary GlyMab(®) antibodies with in-licenced Fc silencing technology
from Oxford-based mAbsolve Limited. The technology from mAbsolve Limited
reduces the likelihood of toxicity caused by cytokine storms, which can be
associated with clinical antibodies engaging the immune system.
AvidiMab(®)
AvidiMab(®) is a versatile 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.
During the period, Scancell presented preclinical data on its antibody
platforms at 14(th) Annual PEGS (Protein & Antibody Engineering Summit)
Europe in Barcelona, Spain and 12(th) EuroMAbNet Annual Meeting in Hamburg,
Germany which demonstrated the versatility and specificity of the Company's
platforms in generating novel antibody drug candidates using its GlyMab(®)
technology and enhancing their anti-cancer potential with AvidiMab(®).
Looking forward, Scancell is planning to increase the value of this rich
pipeline of products through the generation of further early-stage clinical
data, either alone or in combination with strategic partners.
CORPORATE
Directorate changes
As announced in October 2022, prior to the Company's Annual General Meeting
(AGM), I notified the Board of my intension to resign as Executive Chairman
and Non-Executive Director of the Company for personal reasons. I remain
confident in the future prospects of Scancell and will be staying on for an
interim period until a new Chair is appointed. The Board has subsequently
initiated a formal search for a new Chair and a further announcement regarding
details and timings will be made when appropriate. At the Company's AGM, Dr
Richard Goodfellow who had been a Director at Scancell since 1999 decided not
to stand for re-election and retire. In addition, we strengthened the
leadership of the Board and appointed Susan Clement Davies, an independent
Non-Executive Director and Chair of the Audit Committee, as Deputy Chair.
Zakari Therapeutics Limited
The Board felt that there was no further need to retain the Zakari
Therapeutics subsidiary company. Therefore, application has been made to the
Registrar of Companies for Zakari Therapeutics Limited, a non-trading
subsidiary of Scancell Limited, to be dissolved.
FINANCIAL REVIEW
Profit or Loss and Other Comprehensive Income Statement
The Group made an operating loss for the 6-month period to 31 October 2022 of
£1.97 million (6-month period to 31 October 2021: loss of £5.4 million).
The licence fee of £5.3 million (2021: £nil) relates to the up-front payment
receivable from Genmab following the signing of the Licence Agreement in
October 2022.
Development expenditure has increased to £4.9 million (2021; £4.0 million)
as a result of an increase in research staff numbers together with increased
costs on the Modi-1 clinical trial and the GlyMab(®) and AvidiMab(®)
platforms.
The increase in administrative expenditure to £2.4 million (2021: £1.9
million) is due to the increased share option charge in the period.
Interest payable of £1.3 million (2021: £1.7 million) relates to the
interest on the Convertible Loan Notes (CLNs). The interest is lower as a
result of the maturity date of the CLNs being extended from 2022 to 2025 in
October 2021.
The finance expense of £0.9 million (2021: credit £2.4 million) relates to
the derivative liability and is the fair value adjustment of the derivative
liability at the respective period ends. The finance expense is not a cash
item and has no impact on the Company's cashflow.
The loss before taxation for the period amounted to £4.1 million (2021:
profit £2.5 million). The R&D tax credit increased to £0.9 million
(2021: £0.7 million) as a result of an increased level of development
expenditure claimable in the 6-month period.
Overall, the loss post tax for the 6-month period was £3.2 million (2021:
profit £3.2 million).
Statement of Financial Position
At 31 October 2022, the net assets of the Group amounted to £15.4 million (30
April 2022: £18.1 million) including cash at bank of £24.0 million (30 April
2022: £28.7 million).
Within trade and other receivables is an amount of £5.3 million (2021: £nil)
in respect of the up-front licence fee which was received in November 2022.
Current assets include tax receivable due at the end of the period of £2.76
million (April 2022: £2.99 million) and relate to the R&D tax credit for
the year ended 30 April 2022 amounting to £1.70 million and an estimate of
the amount recoverable at 31 October 2022.
Within liabilities are CLNs and Derivative Liabilities. The total amount of
the CLNs which remain outstanding is £19.65 million which are due to be
redeemed in August 2025 (£1.75 million) and November 2022 (£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 increased to £2.51 million (April
2022: £2.1 million). The increase reflects additional accruals recognised at
the month-end. All balances owing to suppliers at the end of the 6-month
period were paid in accordance with their terms and conditions.
Consolidated Cash Flow Statement
As at 31 October 2022, Company bank balances amounted to £24.0 million (April
2022: £28.7 million). The reduction in bank balances during the 6-month
period is primarily due to net cash used in operating activities of £4.4
million (30(t) April 2022: £10.20 million). This expenditure has been offset
by the R&D tax credit received of £1.2 million (30(t) April 2022: £1.3
million).
OUTLOOK
The Company has made good progress during the period turning our scientific
expertise into world leading vaccines and antibodies targeting
post-translational modifications, and so continuing our journey towards the
goal of building a sustainable company which delivers both patient outcomes
and shareholder value.
Looking forward, it is anticipated that during 2023 we will progress towards
key clinical milestones by continuing to recruit patients to our ongoing
ModiFY and SCOPE clinical trials, and generating safety, immune and clinical
response results for our current Moditope(®) and ImmunoBody(®) vaccine
candidates. In our earlier stage pipeline, with the recent in-licensing of the
SNAPvax™ technology from Vaccitech plc, we expect to accelerate the
development of Modi-2 and progress a redirecting TCB antibody and a T cell
costimulatory mAb to the clinic. In addition, the Board continues to evaluate
further potential deals to develop the business, generate revenue and provide
further third-party validation of our platforms.
The Board is pleased with the progress that the Company has achieved over the
period and would like to thank our shareholders once again for their continued
support.
John Chiplin
Chairman
24 January 2023
Scancell Holdings plc
Consolidated Profit or Loss and Other Comprehensive Income Statement
for the 6-month period to 31 October 2022
Unaudited Unaudited Audited
6 months 6 months Year to
31/10/2022 31/10/2021 30/04/2022
£'000 £'000 £'000
Continuing operations
Licence fees 5,271 - -
Development expenses (4,872) (4,029) (9,477)
Administrative expenses (2,373) (1,916) (4,787)
Grant income - 550 965
OPERATING LOSS (1,974) (5,395) (13,299)
Interest receivable and similar income 81 2 4
Interest payable (1,343) (1,728) (2,882)
Finance (expense)/ gain relating to revaluation of derivative liability (910) 2,443 5,243
Gain on substantial modification of convertible loan notes - 7,166 7,166
(LOSS)/PROFIT BEFORE TAXATION (4,146) 2,488 (3,768)
Tax on loss on ordinary activities 980 719 1,703
(LOSS)/PROFIT FOR THE PERIOD (3,166) 3,207 (2,065)
EARNINGS PER ORDINARY SHARE (PENCE) Note 2
Basic (0.39)p 0.39p (0.25)p
Diluted (0.39)p 0.38p (0.25)p
Scancell Holdings plc
Consolidated Statement of Changes in Equity
for the 6-month period to 31 October 2022
Share Share
Share premium option Retained Total
capital account reserve earnings Equity
£'000 £'000 £'000 £'000 £'000
Unaudited Unaudited Unaudited Unaudited Unaudited
At 1 May 2022 815 65,019 1,395 (49,119) 18,110
(Loss) for the period (3,166) (3,166)
Share option costs 481 481
At 31 October 2022 815 65,019 1,876 (52,285) (15,425)
At 1 May 2021 815 65,019 705 (47,054) 19,485
Profit for the period 3,207 3,207
Share option costs
At 31 October 2021 815 65,019 705 (43,847) 22,692
Audited Audited Audited Audited Audited
At 1 May 2021 815 65,019 705 (47,054) 19,485
(Loss) for the year (2,065) (2,065)
Share option costs 690 690
At 30 April 2022 815 65,019 1,395 (49,119) 18,110
Scancell Holdings plc
Consolidated Statement of Financial Position
as at 31 October 2022
Unaudited Unaudited Audited
31/10/2022 31/10/2021 30/04/2022
£'000 £'000 £'000
ASSETS
Non-current assets
Tangible fixed assets 1,467 1,324 1,579
Right of use assets 1,124 1,532 1,165
Goodwill 3,415 3,415 3,415
6,006 6,271 6,159
Current assets
Trade and other receivables 5,612 853 647
Income tax assets 2,760 2,007 2,990
Cash and cash equivalents 24,035 35,570 28,725
32,407 38,430 32,362
TOTAL ASSETS 38,413 44,701 38,521
LIABILITIES
Non-current liabilities
Convertible Loan note (8,322) (6,423) (7,008)
Derivative liability (11,005) (12,895) (10,095)
Lease liabilities (831) (1,093) (856)
(20,158) (20,411) (17,959)
Current liabilities
Trade and other payables (2,511) (1,148) (2,137)
Lease liabilities (319) (450) (315)
(2,830) (1,598) (2,452)
TOTAL LIABILITIES (22,988) (22,009) (20,411)
NET ASSETS 15,425 22,692 18,110
TOTAL EQUITY
Called up share capital 815 815 815
Share premium account 65,019 65,019 65,019
Share option reserve 1,876 705 1,395
Retained earnings (52,285) (43,847) (49,119)
15,425 22,692 18,110
Scancell Holdings plc
Consolidated Cash Flow Statement
for the 6-month period to 31 October 2022
Unaudited Unaudited Audited
6 months 6 months Year to
31/10/2022 31/10/2021 30/04/2022
£'000 £'000 £'000
Cash flows from operating activities
(Loss)/Profit before tax for the period (4,146) 2,488 (3,768)
Adjustments for:
Finance income (81) (2) (4)
Lease interest paid 28 48
Convertible Loan note interest 1,315 1,728 2,834
Finance expense/(gain) relating to derivative 910 (2,443) (5,243)
Gain on substantial modification of CLNs - (7,166) (7,166)
Depreciation 261 141 381
Amortisation of right of use asset 197 149 359
Share based payment charge 481 - 690
Cash used in operations before changes in working capital (1,035) (5,105) (11,869)
(Increase)/decrease in trade and other receivables (4,965) 115 321
Increase/(decrease) in trade and other payables 373 (939) 51
Cash used in operations (5,627) (5,929) (11,497)
Tax credits received 1,210 1,301 1,304
Net cash used in operating activities (4,417) (4,628) (10,193)
Cash flows from investing activities
Purchase of tangible fixed assets (149) (774) (1,268)
Finance income 81 2 4
Net cash (used in) investing activities (68) (772) (1,264)
Financing activities
Convertible loan interest paid - - (537)
Lease payments (205) (140) (391)
Net cash generated from financing activities (205) (140) (928)
Net increase/(decrease) in cash and cash equivalents (4,690) (5,540) (12,385)
Cash and cash equivalents at beginning of the year 28,725 41,110 41,110
Cash and cash equivalents at end of the period 24,035 35,570 28,725
Scancell Holdings plc
Notes to the Interim Financial Statements
for the 6-month period to 31 October 2022
1 Basis of preparation
This interim statement for the 6-month period to 31 October 2022 is unaudited
and was approved by the Directors on 24 January 2023. The financial
information contained in the interim report has been prepared in accordance
with the accounting policies set out in the annual report and accounts for the
year ended 30 April 2022.
The financial information contained in the interim report does not constitute
statutory accounts as defined in section 434 of the Companies Act 2006. The
financial information for the full preceding year is based on the statutory
accounts for the year ended 30 April 2022, upon which the auditors, BDO LLP,
issued an unqualified audit opinion which did not contain any statement under
section 498(2) or 498(3) of the Companies Act 2006. The audited statutory
accounts for the year ended 30 April 2022 have been submitted to the Registrar
of Companies.
As permitted, this interim report has been prepared in accordance with AIM
Rule 18 and not in accordance with IAS 34 "Interim Financial Reporting"
therefore it is not fully in compliance with IFRS as adopted by the European
Union.
2 Earnings per share
Basic earnings per share, from continuing operations, is calculated by
dividing the earnings attributable to ordinary shareholders by the weighted
average number of ordinary shares outstanding during the year.
The calculations of earnings per share are based on the following losses and
numbers of shares.
6 months to 6 months to Year ended
31/10/2022 31/10/2021 30/04/2022
£'000 £'000 £'000
(Loss)/Profit after taxation (3,166) 3,207 (2,065)
Number Number Number
Weighted average number of shares used in basic eps
815,218,831 815,218,831 815,218,831
Weighted average number of shares used in diluted eps
815,218,831 853,247,713 815,218,831
Basic earnings per share (0.39)p 0.39p (0.25)p
Diluted earnings per share (0.39)p 0.38p (0.25)p
At 31 October 2022 the Company had 815,218,831 Ordinary Shares of 0.1p in
issue.
3 Taxation
Taxation for the 6 months ended 31 October 2022 is based on the effective
rates of taxation which are estimated to apply for the year ended 30 April
2023.
4 Interim results
These results were approved by the Board of Directors on 24 January 2023.
Copies of the interim report are available to the public from the Group's
registered office and the Group's website, www.scancell.co.uk
(http://www.scancell.co.uk) .
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