REG - Scancell Hlds - Results Year Ended 30 April 2024
24/09/2024 07:00
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RNS Number : 3329F Scancell Holdings Plc 24 September 2024
24 September 2024
Scancell Holdings plc
("Scancell" or the "Company")
Results for the Year Ended 30 April 2024
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer, today announces its final audited financial results
for the year ended 30 April 2024 as well as a business update on progress
achieved post-period.
Key highlights (including post-period)
SCIB1/ iSCIB1+ (SCOPE trial)
· SCIB1 reported positive data in combination with checkpoint
inhibitors (CPI) from the first stage of its Phase 2 SCOPE trial for advanced
melanoma, with an objective response rate (ORR) exceeding the 70% target set
for continuation of the study.
· iSCIB1+, a next generation vaccine expressing additional
melanoma-specific epitopes that make it suitable for a broader patient
population, added as additional cohort to the Phase 2 SCOPE trial.
· Agreed strategic partnership with PharmaJet for use of the
Stratis® needle-free delivery for clinical development and commercial sales
of SCIB1/iSCIB1+.
· Full cohort data with SCIB1 and iSCIB1+ expected in Q4 2024 and H1 2025, respectively.
· Phase 2/3 registration study in advanced melanoma planned to
begin in 2025 supported by strategic guidance from international key opinion
leaders.
Modi-1 (ModiFY trial)
· Modi-1 completed dose escalation and safety cohorts of the Phase
1/2 ModiFY trial and continues in the expansion cohorts.
· Early data from patients receiving Modi-1 as a monotherapy showed
good safety and ability to induce stable disease for long periods.
· A cohort in advanced renal cell carcinoma (RCC) patients
evaluating Modi-1 in combination with doublet CPI as a first line therapy
approved and added to the ModiFY study.
· RCC cohort dosing has commenced with early clinical read-out
expected in H1 2025.
Antibodies
· Active discussions ongoing with global pharmaceutical and biotech
companies for further licensing deals.
· Agreement with major international biotechnology company to
exclusively evaluate an antibody in the GlyMab(®) portfolio, receiving $1
million in July 2024.
· Development of SC129 with partner Genmab on track towards potential
clinical development.
Corporate
· Dr Florian Reinaud, Non-Executive Director, and Sath Nirmalananthan, CFO, appointed to the Board of Directors.
· Enhanced organisational capabilities with key recruitments,
including the appointment of Dr Nermeen Varawalla as Chief Medical Officer in
July 2024.
Financial
· Operating loss for the 12-month period to 30 April 2024 of £18.3
million (30 April 2023: operating loss of £11.9 million).
· Financing in late 2023 raised gross proceeds of £11.9 million
with participation from both existing shareholders and new healthcare
specialist investors.
· Group cash balance at 30 April 2024 was £14.8 million (30 April
2023: £19.9 million) with cash runway through to the third calendar quarter
of 2025 beyond near-term clinical milestones.
· Convertible loan note maturity dates extended post-period by two
years to second half of 2027.
Professor Lindy Durrant, Chief Executive Officer, Scancell, commented:
"Scancell has made strong clinical progress, especially with its lead cancer
vaccine SCIB1 for advanced melanoma. In the first stage of the Phase 2 study,
11 out of 13 patients achieved at least a partial response, exceeding the 70%
ORR that the trial was configured to show. During the period, we added
iSCIB1+, the next generation of SCIB1, as an additional cohort to the SCOPE
trial. The addition of SCIB1 or iSCIB1+ to CPI has the potential to set the
new standard for first line treatment of unresectable melanoma. We have also
taken steps to strengthen our organisational capabilities and ensure readiness
for a pivotal Phase 2/3 registration study in 2025. We are now well prepared
and well positioned for future development."
Professor Lindy Durrant, Chief Executive Officer, and Sath Nirmalananthan,
Chief Financial Officer, will host a live webcast and Q&A session for
analysts and investors today at 13:00 BST.
If you would like to join the webcast, please follow this link:
Scancell Holdings PLC Full Year Results | SparkLive | LSEG
(https://sparklive.lseg.com/ScancellHoldings/events/baa98ed1-bd91-413b-991e-1f7a4eb89d37/scancell-holdings-plc-full-year-results)
This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014 (MAR).
For further information, please contact:
Scancell Holdings plc +44 (0) 20 3709 5700
Professor Lindy Durrant, CEO
Dr Jean-Michel Cosséry, Non-Executive Chairman
Panmure Liberum Limited (Nominated Advisor and Joint Broker) +44 (0) 20 7886 2500
Emma Earl/ Freddy Crossley/ Will Goode/ Mark Rogers (Corporate Finance)
Rupert Dearden (Corporate Broking)
WG Partners LLP (Joint Broker) +44 (0) 20 3705 9330
David Wilson/ Claes Spang/ Satheesh Nadarajah/ Erland Sternby
ICR Consilium
Mary-Jane Elliott/ Angela Gray/ Lindsey Neville +44 (0) 20 37095700
scancell@consiliumcomms.com
About Scancell
Scancell is a clinical stage immunotherapy 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. 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 approaches
are that vaccines (ImmunoBody(®) and Moditope(®)) use unique receptors to
target antigens to activated antigen presenting cells 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(®)).
Scancell is headquartered in Oxford, United Kingdom and is listed on AIM
(LSE.SCLP.L). For further information about Scancell, please visit:
https://www.scancell.co.uk. (https://www.scancell.co.uk)
CHAIR'S STATEMENT
Immunotherapy is a growing and important treatment option for the unmet needs
of cancer. Cancer vaccines are a promising class of immunotherapy designed to
stimulate the body's immune system to fight against cancer, with long-lasting
durable immune responses resulting in improved patient outcomes. We are
developing two distinct cancer vaccines: SCIB1/iSICB1+ and Modi-1, each with
unique characteristics aimed at addressing specific unmet needs in cancer
treatment.
Scancell has made significant progress over the last 18 months. We have
delivered impressive results with SCIB1 from the first stage of the Phase 2
SCOPE trial for advanced melanoma while strengthening our organisational
capabilities and ensuring readiness for a pivotal Phase 2/3 registration
study.
We were very encouraged by initial data from the ongoing SCOPE trial with 11
of the first 13 patients receiving SCIB1 in the ongoing SCOPE trial showing at
least a partial response, surpassing the 70% objective response rate (ORR)
that the trial was configured to show. This has the potential to set the new
benchmark for first-line unresectable melanoma treatment.
In addition to the strong progress with SCIB1, we have continued the clinical
development of Modi-1, including the addition of a RCC cohort with checkpoint
inhibitors, and we continue to seek partners for our other assets. In June
2024, we signed an agreement with a major international biotechnology company
to evaluate another antibody from the GlyMab(®) platform under exclusivity,
further validating the potential of our antibody platform to create novel,
differentiated antibody products.
Alongside the strong development progress, we have been building and enhancing
our organisational capability. We have made key hires including the
recruitment of a Chief Medical Officer, a Chief Financial Officer, a Head of
Business Development and a Head of Development. This leaves us well positioned
and equipped as we head into a pivotal time for the company with a Phase 2/3
registration study firmly in sight.
Of course, our progress could not have been achieved without our talented
employees, and I would like to thank them for their hard work and commitment.
In addition, the Board would like to thank all existing shareholders,
including Redmile Group, Vulpes Life Sciences, and those that participated in
the fundraising in December 2023, for their support.
We strongly believe we will continue to demonstrate the therapeutic potential
of SCIB1/iSCIB1+ in advanced melanoma and deliver one of the world's first
off-the-shelf cancer vaccines while creating and delivering significant
long-term value for our shareholders.
Jean-Michel Cosséry
Chairman
CHIEF EXECUTIVE OFFICER'S REPORT
We are pleased to report strong clinical progress in the period, especially
with our lead cancer vaccine SCIB1 for the treatment of advanced melanoma.
SCIB1, our non-personalised DNA cancer vaccine from the ImmunoBody(®)
platform, reported exceptional results in the first stage of the SCOPE study,
surpassing the target ORR of 70% with 11 out of 13 patients achieving at least
a partial response. iSCIB1+, a modified version of SCIB1 which includes more
melanoma-specific epitopes, has now been added as a cohort to the study and is
recruiting well. The addition of SCIB1/ iSCIB1+ to checkpoint inhibitors (CPI)
has the potential to improve patient outcomes for those not responding to CPI
alone and set the new standard for first line treatment of unresectable
melanoma. We expect full cohort data with SCIB1 and iSCIB1+ in Q4 2024 and H1
2025 respectively. Following the data, we will progress to a late-stage
registration study in 2025 and evaluate partnering, out-licensing or further
financing options.
Modi-1, our non-personalised citrullinated peptide vaccine from the
Moditope(®) platform, continues to be evaluated in the ModiFY study for the
treatment of various solid tumours. A cohort in renal cell carcinoma (RCC) in
combination with double CPIs has been added. Modi-1 has been shown to be safe
and to induce stable disease for long periods in many patients receiving
monotherapy. Further data from the study is expected in H1 2025.
Whilst we have decided to concentrate our strategic focus and resources on
SCIB1/iSCIB1+ and Modi-1, we have strong confidence in our other assets. We
continue to assess partnering or out-licensing options to drive these assets
forward and add further value. There is strong commercial interest in our
GlyMab(®) antibodies with active discussions ongoing, building on our
out-licensing deal with Genmab. We recently announced another agreement with
an undisclosed major international biotechnology company who are exclusively
evaluating another antibody from the GlyMab platform. These opportunities
provide a source of potential non-dilutive funding for the company.
The financing in late 2023 raised gross proceeds of £11.9 million with
participation from both existing shareholders and new healthcare specialist
investors. This leaves the company funded through the data readout from the
SCOPE trial and early data from the new renal cohort of the ModiFY trials. In
addition, it has allowed us to enhance our organisational capabilities with
key recruitments and we are well prepared and well positioned for the next
phase of development.
Set out below is a summary of operational progress that has been made across
our proprietary vaccine and antibody platforms. Full details of the Company's
platforms and studies are available on the Company website and Annual Report.
SCIB1/iSCIB1+
SCIB1, and its next generation, iSCIB1+, are the lead non-personalised DNA
cancer vaccines from the Company's ImmunoBody(®) platform. They are being
evaluated in the Phase 2 SCOPE trial, in combination with the checkpoint
inhibitors, ipilimumab (Yervoy(®)) and nivolumab (Opdivo(®)), for the
first-line treatment for unresectable melanoma. The doublet therapy of
ipilimumab and nivolumab, is the preferred treatment option in the first line
setting for unresectable melanoma. The addition of SCIB1 or iSCIB1+ to this
treatment option has the potential to improve patient outcomes and set the new
standard for first line treatment. First-line unresectable melanoma impacts
approximately 60,000 patients a year.
SCIB1 incorporates specific epitopes from the proteins gp100 and TRP-2 which
play key roles in the production of melanin in the skin and were identified
from T cells of patients who achieved spontaneous recovery from melanoma skin
cancers.
iSCIB1+ is a modified version of SCIB1 developed using the company's
AvidiMab(®) platform. iSCIB1+ has more melanoma-specific epitopes so it can
be used by a broader patient population compared with SCIB1, which is suitable
for 40% of patients which have the appropriate HLA type. Furthermore, iSCIB1+
has advantages over SCIB1, including potentially increased potency and an
extended patent duration.
As previously reported, the SCIB1 cohort of the SCOPE trial reported
exceptional results in the first stage of the study with 11 out of 13 patients
showing at least a partial response which is an objective response rate (ORR)
of 85%, exceeding the 70% ORR that the trial was configured to show. This
compares to an ORR of 50% reported in patients receiving doublet CPI therapy
alone in the real world setting with a progression free survival time of 11.5
months.
Both the SCIB1 and iSCIB1+ cohorts are in the second stage of the study
recruiting a total of 43 patients each with a study design able to demonstrate
that SCIB1 or iSCIB1+, in combination with doublet therapy, exceeds currently
reported ORRs with doublet CPI alone, in a statistically significant manner.
There are currently 36 and 27 patients recruited in the SCIB1 and iSCIB1+
cohorts respectively. Following completion of the SCIB1 recruitment, the
remaining patients with the SCIB1 HLA haplotype will be recruited to test the
efficacy of iSCIB1+ in the entire patient population.
A Phase 2/3 adaptive, randomised registration study in patients with
unresectable melanoma will be initiated based on the full data analysis from
the SCOPE study. Plans for the Phase 2/3 registration study have been further
strengthened through an international clinical advisory board comprised of
melanoma key opinion leaders held at ASCO 2024.
Ahead of the registrational study, a strategic agreement with PharmaJet has
been secured for use of the Stratis(®) needle-free system for delivery of
SCIB1 or iSCIB1+ for melanoma for both clinical development and commercial
use. The PharmaJet Stratis(®) needle-free system is today the only technology
which has shown effective uptake of the DNA vaccine through intramuscular
delivery allowing native cellular machinery to express the target antigen and
induce a potent anti-tumour response. The Stratis® system has U.S. FDA 510(k)
marketing clearance, CE Mark, and World Health Organization Prequalification
to deliver medications and vaccines either intramuscularly or subcutaneously
and has been widely accepted and favoured by patients and clinicians
throughout the SCOPE Study.
We expect full cohort data with SCIB1 and iSCIB1+ in Q4 2024 and H1 2025
respectively. Following the data, we will progress to a late stage
registrational study in 2025 and evaluate partnering, out-licensing or further
financing options.
SCOPE Study
The SCOPE study is an open-label, multi-cohort, multicentre Phase 2 study
designed to assess whether the addition of SCIB1 or iSCIB1+ treatment to
doublet CPI, considered standard of care, results in an improvement in patient
outcomes for patients with metastatic advanced melanoma. The primary endpoint
of the trial is objective response rate (ORR) with secondary endpoints
including progression-free survival (PFS) and overall survival (OS) in
patients with advanced melanoma. The trial cohorts include SCIB1 or iSCIB1+
plus doublet checkpoint therapy consisting of ipilimumab plus nivolumab and
SCIB1 with pembrolizumab (Keytruda®).
MODI-1
Modi-1 is the first therapeutic vaccine candidate to emerge from the Company's
Moditope(®) platform.
Modi-1 targets citrullinated peptides from two different proteins which have
been combined to reduce the possibility of tumour escape and have each been
conjugated to a toll-like receptor (TLR) 1/2 agonist, which acts as an
adjuvant. Potent T cell responses and strong anti-tumour activity have been
observed in several cancer models of different tumour types, including
melanoma, ovarian, lung, pancreatic and triple negative breast cancer,
following administration of the Modi-1 vaccine.
Modi-1 has completed the dose escalation and safety cohorts of the Phase 1/2
ModiFY trial and continues to be evaluated in the expansion cohorts. Clinical
data from patients receiving Modi-1 as a monotherapy showed good safety and
ability to induce stable disease for long periods.
The cohort of 16 ovarian cancer patients receiving Modi-1 has now been fully
recruited. 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. Based on this it has been decided to evaluate Modi-1 in
combination with checkpoint inhibitors, as first line therapy in advanced
cancer.
The Company is now evaluating Modi-1 in advanced renal cell carcinoma (RCC) in
the first line setting. Doublet CPI is the standard of care for advanced RCC,
and this trial will determine the additional efficacy benefit of Modi-1
immunisation in this most common type of kidney cancer and provide validation
of the Moditope platform in combination with CPIs. The study protocol to
evaluate a cohort of 44 patients received regulatory approval in May 2024 and
has started enrolling patients with a preliminary read-out expected in H1
2025.
ModiFY Study
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. This open label Phase 1/2 study is
assessing the safety and immunogenicity of citrullinated peptides.
ANTIBODIES
The GlyMab(®) platform has generated a series of high affinity tumour
specific monoclonal antibodies (mAb) targeting glycans that are over-expressed
on cancer cells. Supported with a robust patent portfolio and compelling proof
of concept data for development as therapeutics, GlyMab antibodies support the
clinical pipeline and the opportunity to generate non-dilutive revenue through
partnerships with global pharma and biotech. Development under the commercial
license agreement with Genmab with potential milestone payments of up to $624
million remains on track, and the GlyMab platform has been further validated
through an agreement signed in June 2024 with a major international
biotechnology company to exclusively evaluate another antibody in the GlyMab
portfolio for $1 million.
GlyMabs offer interesting commercial opportunities as each antibody has high
specificity for particular glycan molecules, making each of them attractive
development candidates. In addition to being potential therapies in their own
right, the specificity of the anti-glycan enables their development into a
range of antibody-based therapies with differing mechanisms of action, such as
antibody drug candidates, CAR-T, radioimmunotherapy and T-cell re-direction.
SC134 is the GlyMab lead asset and has strong potential as an effective
therapeutic antibody for small cell lung cancer with in vivo data
demonstrating anti-tumour activity as a T cell engager and an antibody drug
conjugate. This data has generated broad commercial interest which will be
pursued for partnership opportunities and licensing deals. Data demonstrating
SC134 as effective T cell engager for small cell lung cancer has been
published in a high-impact peer-reviewed international journal in August 2024.
CORPORATE
During the period, the Company has enhanced its organisational capabilities
through key appointments to the Board of Directors and the Senior Management
team, bringing 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.
Dr Florian Reinaud, Non-Executive Director, and Sath Nirmalananthan, CFO, were
appointed to the Board of Directors. Dr Florian Reinaud (representing Redmile,
Scancell's leading investor) brings over 20 years of executive, non-executive
and financial experience from the healthcare sector. Sath Nirmalananthan has
served as the Company's Chief Financial Officer since 29 August 2023 and
brings more than 15 years' experience in the healthcare sector at FTSE and
NASDAQ listed companies.
In July 2024, Scancell appointed Dr Nermeen Varawalla as Chief Medical
Officer. She brings over 25 years of clinical development experience,
including the conduct of numerous registration studies in oncology, and has
worked across global large pharma, healthcare business consultancy and
clinical trial services. The appointment enhances Scancell's capabilities for
its Phase 2/3 registration trial following clinical results from SCIB1 and
iSCIB1+ cohorts.
Other key appointments include appointing Dr Callum Scott as Head of
Development and Dr Mandeep Sehmi as Head of Business Development, who both
bring highly relevant pharmaceutical industry experience that will further
enhance the Company's commercial capabilities as it develops to being a
late-stage clinical company.
FINANCE
R&D expenditure increased by £1.3 million to £12.9 million (2023: by
£2.1 million to £11.6 million). In 2024, the number of employees engaged in
development increased, and we continued to incur costs for our SCOPE and
ModiFY clinical trials. The most significant increase in development costs in
2024 was scaling up SCIB1 and iSCIB1+ manufacturing capabilities in
preparation for the Phase 2/3 registration trial and commercialisation. The
increase in R&D spend was smaller than the increase in 2023 due to
prioritisation of projects with a focus on the more advanced clinical assets.
At 30 April 2024, the Group had cash and cash equivalents of £14.8 million
(2023: £19.9 million). The £5.1 million decrease for 2024 was due to £17.4
million of cash used in operations, which was largely a result of continued
R&D expenditure. This was offset by £11.3 million of net proceeds
following an open offer and placing in December 2023. By comparison, there was
an £8.8 million decrease in cash for 2023 due to continued development
expenditure, which was partly offset by the revenue received from Genmab. The
estimated cash runway of the Group is into the third calendar quarter of 2025.
Further details of the Board's going concern assessment are provided in Note 1
to the Financial Information.
In July 2024, the maturity of the Group's convertible loan notes was extended
to the second half of 2027. Under the amended terms, the Group repaid
approximately £0.5m of notes and is not required to make any further payments
until maturity. There were £19.2 million of convertible loan notes
outstanding following the extension. At 30 April 2024, the convertible loan
notes reported in the Consolidated statement of financial position on an
amortised cost basis totalled £19.0 million.
In June 2024, the Company entered into a revenue generating agreement with an
international biotechnology company. The agreement provided a seven-month
exclusive evaluation period for one of the anti-glycan monoclonal antibodies
in exchange for $1 million (£0.8 million), which was received in July 2024.
An option to fully license the antibody for further payments is possible under
the agreement.
The Group's overall loss for 2024 was £5.9 million, compared to £11.9
million in 2023. The £6.0 million reduction in loss was largely generated by
finance income of £9.9m following remeasurement of convertible loan note
derivative liabilities. This was offset by a £5.3 million reduction in
revenue. Revenue from the licencing deal with Genmab significantly reduced
2023's loss, whereas there was no such revenue for 2024.
Administrative expenditure for 2024 increased to £5.4 million (2023: £5.0
million) due to additional professional fees, additional recruitment and other
overheads.
The fair value of the Group's derivative liabilities associated with its
convertible loan notes significantly decreased in 2024, resulting in non-cash
finance income of £9.9 million (2023: finance expense of £1.5 million). The
value of derivative liabilities decreased following a reduction in the
Company's share price and the time for noteholders to exercise. After the
extension of the convertible loan notes in July 2024 and an increase in the
Company's share price, the Group could experience significant changes in
convertible loan related financial statement balances in the year ended 30
April 2025.
The loss before taxation amounted to £9.1 million (2023: £14.3 million) and
R&D tax credits increased by £0.9 million to £3.3 million (2023: £2.4
million), reflecting an increase in qualifying expenditure identified in 2024.
We received £2.4 million of tax credits relating to 2023 in June 2024 and a
further £0.5 million of credits in September 2024.
The Group had an overall net liability position (£3.5 million in 2024 and
£9.6 million in 2023), primarily due to non-cash fluctuations in its embedded
derivative liabilities, which represent the fair value of the conversion
feature of the convertible loan notes.
OUTLOOK
Given the significant clinical and commercial milestones achieved in the
period, positive early efficacy data, and sufficient resources to fund the
current strategy, the Company is confident it will achieve its near-term
milestones.
Key milestones for the following 18 months include:
· Full cohort data with SCIB1 and iSCIB1+ in Q4 2024 and H1 2025,
respectively;
· Phase 2/3 seamless registration trial with SCIB1 or iSCIB1+ to
begin in 2025;
· ModiFY study data in RCC in combination with checkpoint
inhibitors expected in H1 2025;
· Continue assessment for partnering or out-licensing options for
the GlyMab® and AvidiMab® platforms and financing needs.
Professor Lindy Durrant
Chief Executive Officer
Consolidated Statement of Comprehensive Loss for the year ended 30 April 2024
2024 2023
Notes £'000 £'000
Revenue - 5,271
Cost of sales - (525)
Gross Profit - 4,746
Research and development expenses (12,871) (11,645)
Administrative expenses (5,396) (5,021)
Operating loss 2 (18,267) (11,920)
Interest receivable and similar income 355 284
Interest expense (1,089) (1,215)
Finance income / (expense) relating to derivative liability revaluation 9,884 (1,453)
Loss and total comprehensive loss before taxation (9,117) (14,304)
Taxation 3 3,258 2,368
Loss for the year (5,859) (11,936)
Loss per ordinary share (pence)
Basic
4 (0.68)p (1.50)p
Diluted
4 (1.43)p (1.50)p
Consolidated Statement of Financial Position 30 April 2024 2023 Restated 2022
£'000 £'000 Restated
£'000
Assets
Non-current assets
Tangible fixed assets 862 1,246 1,579
Right-of-use assets 847 1,003 1,165
Total non-current assets 1,709 2,249 2,744
Current assets
Trade and other receivable 1,378 538 647
Taxation receivable 5,672 4,148 2,990
Cash and cash equivalents 14,817 19,920 28,725
Total current assets 21,867 24,606 32,362
Total assets 23,576 26,855 35,106
Liabilities
Non-current liabilities
Convertible loan notes (17,366) (16,888) (16,437)
Derivative liabilities (2,860) (10,900) (9,770)
Lease Liabilities (466) (746) (856)
Total non-current liabilities (20,692) (28,534) (27,063)
Current Liabilities
Convertible loan notes (1,606) (1,593) (1,420)
Derivative liabilities (1,256) (3,100) (2,777)
Trade and other payables (3,099) (2,970) (2,137)
Lease Liabilities (428) (306) (315)
Total current liabilities (6,389) (7,969) (6,649)
Total liabilities (27,081) (36,503) (33,712)
Net (liabilities) / assets (3,505) (9,648) 1,394
Shareholders' equity
Called up share capital 929 819 815
Share premium 71,927 60,695 60,533
Merger reserve 5,043 5,043 5,043
Share option reserve 2,783 2,123 1,395
Retained losses (84,187) (78,328) (66,392)
Total shareholders' (deficit) / equity (3,505) (9,648) 1,394
Further information on the restated 2023 and 2022 Consolidated statements of
financial of position is provided in Note 9.
Consolidated Statement of Changes in Equity for the year ended 30 April 2024
Share Share Share Merger Retained Total
Capital Premium Option Reserve Reserve Losses
(Restated) (Restated) (Restated)
£'000 £'000 £'000 £'000 £'000 £'000
At 1 May 2022 (as reported) 815 65,019 1,395 - (62,420) 4,809
Prior period restatement - (4,486) - 5,043 (3,972) (3,415)
At 1 May 2022 (restated) 815 60,533 1,395 5,043 (66,392) 1,394
Loss for the year - - - - (11,936) (11,936)
Transactions with owners:
Share option exercises 4 162 - - - 166
Share based payment - - 728 - - 728
At 30 April 2023 (restated) 819 60,695 2,123 5,043 (78,328) (9,648)
- - - - (5,859) (5,859)
Loss for the year
Transactions with owners:
Share placing and open offer, net of issuance costs (Note 5) 108 11,143 - - - 11,251
Share option exercises 2 89 - - - 91
Share based payment - - 660 - - 660
At 30 April 2024 929 71,927 2,783 5,043 (84,187) (3,505)
Further information on the restated balances at 1 May 2022 and 30 April 2023
is provided in Note 9.
Consolidated Statement of Cash Flows for the year ended 30 April 2024
2024 2023
Note £'000 £'000
Cash flows from operating activities
Loss before tax (9,117) (14,304)
Adjustments for:
Interest receivable and similar income (355) (284)
Interest expense 1,089 1,215
Finance (income)/expense relating to derivative liability revaluation (9,884) 1,453
Depreciation of tangible fixed assets 561 536
Depreciation of right-of-use asset 405 366
Share-based payment charge 660 728
Other items (42) -
Cash used in operations before changes in working capital (16,683) (10,290)
(Increase)/Decrease in trade and other receivables (840) 111
Increase in trade and other payables 129 829
Cash used in operations (17,394) (9,350)
Tax credits received 1,734 1,210
Net cash used in operating activities (15,660) (8,140)
Investing activities
Purchase of tangible fixed assets (177) (203)
Interest received 355 284
Net cash generated from investing activities 178 81
Financing activities
Proceeds from issuance on placing and open offer 5 11,898 -
Costs of share issuances 5 (647) -
Proceeds from share option exercises 91 166
Interest paid (595) (537)
Lease principal payments (357) (375)
Net cash generated from / (used in) financing activities 10,390 (746)
Net decrease in cash and cash equivalents (5,092) (8,805)
Net foreign exchange difference on cash held (11) -
Cash and cash equivalents at beginning of the year 19,920 28,725
Cash and cash equivalents at end of the year 14,817 19,920
NOTES TO THE FINANCIAL INFORMATION
for the year ended 30 April 2024
1 BASIS OF PREPARATION
These financial results do not comprise statutory accounts for the year ended
30 April 2024 within the meaning of Section 434 of the Companies Act 2006 as
it does not contain all the information required to be disclosed in the
financial statements prepared in accordance with UK adopted International
Accounting Standards. The financial information in this announcement has been
extracted from the audited financial statements for the year ended 30 April
2024. The report of the auditor on the 30 April 2024 statutory financial
statements was unqualified, and did not contain a statement under Section
498(2) or Section 498(3) of the Companies Act 2006, but did draw attention to
the Group's ability to continue as a going concern by way of a material
uncertainty paragraph. The statutory accounts for the year ended 30 April 2024
have not yet been delivered to the Registrar of Companies.
The financial information for the year ended 30 April 2023 and 2022 has been
extracted from the Group's audited statutory financial statements which were
approved by the Board of Directors on 30 October 2023, and which have been
delivered to the Registrar of Companies for England and Wales. Adjustments to
these numbers are detailed in Note 9. The report of the auditor on these
financial statements was unqualified and did not contain a statement under
Section 498(2) or Section 498(3) of the Companies Act 2006.
This announcement was approved by the board of directors and authorised for
issue via RNS on 23 September 2024.
Going concern
During the year ended 30 April 2024, the Group incurred an operating loss of
£18.3 million and cash used in operating activities was £15.7 million. As a
clinical stage immuno-oncology Group, Scancell has incurred net operating
losses since inception and expects such losses in future periods. At 30 April
2024, the Group's retained losses were £84.2 million and it held £14.8
million of cash and cash equivalents. In July 2024, the maturity of Group's
outstanding convertible loan notes was extended to 2027.
The Group allocates most of its financial resources to research and
development expenditure on its ImmunoBody, Moditope and monoclonal antibody
platforms. While a portion of expenditure is committed, the timing and extent
of uncommitted expenditure surrounding development work on these platforms and
the Group's clinical trials afford significant flexibility in the allocation
of resources.
The Group finances its operations through share issuances, convertible loan
notes and collaboration revenue. In the second half of 2020, the Group raised
£46.1 million in net proceeds from issuances of shares and convertible loan
notes. In November 2023, a further £11.3 million in net proceeds was raised
from an open offer, placing and subscription of ordinary shares. The Group
continues to advance its clinical trials and generate successful data, and it
expects to report further findings in late 2024 and early 2025. Following the
data, the Group will evaluate partnering and out-licensing opportunities as
well the need to obtain significant further financing from share issuances if
required.
In November 2022, the Group received a £5.3 million upfront payment under a
collaboration with Genmab A/S ("Genmab"), and in July 2024, the Company
received £0.8m under another collaboration in exchange for granting an
evaluation period over one of several anti-glycan monoclonal antibodies in its
portfolio. The Board believes the Group could receive further significant
payments as existing collaborations progress or as future collaborations are
agreed.
Excluding potential financing from these sources, the Group's two-year cash
flow forecast with cash preservation measures in areas of uncommitted
expenditure suggests it could continue to operate with cash currently held
until August 2025, which is less than a year from the date of approval of
these financial statements. While the Group has historically succeeded in
securing further cash, financing from such sources is dependent on market
conditions and the decisions of the Group's existing shareholders, potential
investors, and existing or future potential collaboration partners. These
stakeholders and potential receipts are not controlled by the Group, and
material uncertainties therefore exist that may cast significant doubt on its
ability to continue as a going concern. Since these options continue to
represent realistic and effective sources of future financing which, despite
the uncertainty, would ensure the Group and Company have sufficient funds to
continue operating for at least a year, the Board has prepared the financial
statements on a going concern basis
2 OPERATING LOSS
2024 2023
£'000 £'000
Operating Loss is stated after charging:
Depreciation on tangible fixed assets 561 536
Depreciation of right-of-use assets 405 366
Foreign exchange losses 5 358
Auditors' remuneration - fee payable for audit of the company 80 42
Auditors' remuneration - fee payable for audit of the subsidiary 18 41
3 TAXATION
The tax credit on the loss for the year was as follows:
2024 2023
Current tax £'000 £'000
UK corporation tax credits due on R&D expenditure 2,811 2,399
Adjustment in respect of prior years 447 (31)
Tax credit 3,258 2,368
The tax credit for 2024 is higher (2023: lower) than the
applicable rate of corporation tax in the UK applied to the Group's loss
before tax, and a reconciliation explaining these is differences is provided
below.
2024 2023
£'000 £'000
Loss on ordinary activities before tax (9,117) (14,304)
(2,279) (2,788)
Tax at the standard rate of corporation tax of 25% (2023: 19.49%)
Effects of:
Exempted (income)/disallowed expenditure on convertible loans (2,213) 510
Other disallowed expenditure 136 172
Other timing differences 92 49
Enhanced tax relief on R&D expenditure (205) (929)
Adjustments in respect of prior years (447) 31
Unrelieved losses carried forward 1,658 587
Tax credit (3,258) (2,368)
The Group has tax losses, which can be carried forward indefinitely, of £43.9
million (2023: £38.5 million) to utilise against future profits. 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 utilise them. The estimated value of the unrecognised deferred tax asset
measured at the prevailing rate of tax when the timing differences are
expected to reverse is £10.8 million (2023: £9.8 million). This is based on
the substantively enacted rates at the balance sheet date. The current UK
corporation rate is 25%, effective from 1 April 2023, as set out in the
Finance Bill 2021 which was substantively enacted on 24 May 2021.
The Group has a potential future tax deduction on share options of £0.3
million (2023: £2.0 million) representing an unrecognised deferred tax asset
of £0.1 million (2023: £0.5 million) at 30 April 2024. The Group also has a
deferred tax liability of £0.2 million (2023: £0.2 million) arising from
timing differences against which a deferred tax asset has been offset,
resulting in an overall recognised deferred tax balance of nil.
The Group received £2.4 million of tax credits relating to 2023 in June 2024,
and a further £0.5 million of credits in September 2024.
4 LOSS PER SHARE
The earnings and weighted average number of ordinary shares used in the
calculation of basic and diluted loss per share are set out in the tables
below.
Basic loss per share 2024 2023
£'000 £'000
Loss used in calculation of basic loss per share
(5,859) (11,936)
Number Number
Weighted average number of ordinary shares
862,484,430 816,051,311
Basic loss per share (pence)
(0.68) (1.50)
Diluted loss per share 2024 2023
£'000 £'000
Loss for the year
Adjustment for the effect of convertible loan notes
Adjusted loss used in the calculation of diluted loss per share (5,859) (11,936)
(8,853) -
(14,712) (11,936)
Number Number
Basic weighted average number of ordinary shares
862,484,430 816,051,311
Adjustment for convertible loan notes with dilutive effect
167,310,035 -
Diluted weighted average number of ordinary shares
1,029,794,465 816,051,311
Diluted loss per share (pence) (1.43) (1.50)
Convertible loan notes in the year ended 30 April 2024 had a dilutive effect
on loss per share. Dilutive loss per share assumes that the notes had been
converted at the start of the year, which would have resulted in an increase
in loss for the year following the removal of post-tax derivative finance
income and loan interest expense. The effect of share options has been
excluded from the calculation of diluted loss per share, since such options
would have the effect of reducing the loss per share.
5 AUTHORISED ISSUED SHARE CAPITAL
In December 2023, the Group completed an open offer, placing and subscription
of 108,156,516 ordinary shares, raising £11.3 million after deductions for
attributable issuance costs of £0.6 million.
At 30 April 2024, there were 928,979,977 ordinary shares issued and
outstanding.
6 EVENTS AFTER THE REPORTING PERIOD
In June 2024, the Group entered into a revenue generating agreement with an
international biotechnology company. The agreement provided a seven-month
exclusive evaluation period for one of the Group's anti-glycan monoclonal
antibodies in exchange for $1 million (£0.8 million), which the Group
received in July 2024. An option to license the antibody and further payments
are possible under the agreement.
In July 2024, in July 2024, the Group entered into a deed of amendment
relating to all outstanding convertible loan notes. The outstanding notes are
held by funds managed by the Company's largest shareholder, Redmile Group, LLC
("Redmile"). Under the deed of amendment:
§ the maturity of the notes was extended by a further two years so that the
first tranche of convertible loan notes became repayable by the Company on 12
August 2027 and the second tranche became repayable on 10 November 2027
§ the terms of the second tranche were revised to enable Redmile to convert
the notes at any time prior to maturity
§ interest terms were revised to accrue until maturity rather than require
annual repayment
§ the Company was required to pay £450,000 of outstanding loan notes in July
2024.
Following this repayment, a total of £19.2 million notes remained
outstanding, representing £1.75 million of August 2020 CLN 1 notes and
£17.45 million November 2020 CLN 2 notes. No adjustments to the conversion
price were made to either tranche under the deed of amendment.
In September 2024, the Group signed a strategic partnership with PharmaJet for
the supply of the Stratis® Intramuscular (IM) Needlefree Injection System for
delivery of Scancell's Immunobody® SCIB1/iSCIB1+ DNA vaccine for both
clinical development and commercial use under which development milestones and
royalties are payable.
7 DELIVERY OF ACCOUNTS
The audited statutory accounts in respect of the prior year ended 30 April
2023 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.
8 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 2024.
9 PRIOR PERIOD RESTATEMENTS
The Group has adjusted prior periods in its financial statements. The
adjustments had no impact on prior statements of comprehensive loss or
statements of cash flow.
IAS 1 amendments and reclassification of convertible loan liability and
derivative balances
The Group early-adopted amendments to IAS 1 for the year ended April 2024. The
amendments were applied retrospectively to the financial statements and
resulted in the reclassification of the host loan liability and the derivative
liability for convertible loan notes issued in August 2020 from non-current to
current in the consolidated statements of financial position. The amendments
had no impact on the consolidated statements of changes in equity, cash flow
or statements of comprehensive loss.
While these notes were due to mature at a date greater than a year from the
statement of financial position date, they were convertible at the election of
the noteholder at any time and the associated conversion option is not
classified as an equity instrument. Exercise of the conversion option, which
could occur in a period of less than a year, would settle the host loan
liability and therefore the loan liability component of the notes and the
embedded derivative have been reclassified as current.
The effect of the restatement associated with these amendments is summarised
in the table below for 2023 and 2022.
Consolidated Statement of financial position
2023 Adjustments 2023
As previously reported Restated
£'000 £'000
LIABILITIES
Non-current liabilities
Convertible loan notes (18,481) 1,593 (16,888)
Derivative liability (14,000) 3,100 (10,900)
Current Liabilities
Convertible loan notes - (1,593) (1,593)
Derivative liability - (3,100) (3,100)
2022 Adjustments 1 May 2022
As previously reported Restated
£'000 £'000
LIABILITIES
Non-current liabilities
Convertible loan notes (17,857) 1,420 (16,437)
Derivative liability (12,547) 2,777 (9,770)
Current Liabilities
Convertible loan notes - (1,420) (1,420)
Derivative liability - (2,777) (2,777)
9 PRIOR PERIOD RESTATEMENTS (continued)
Goodwill and historical equity balances
Scancell Holdings Plc was incorporated in 2008 to enable shares to be listed
on the PLUS exchange. Shortly after incorporation, Scancell Holdings Plc
issued shares in exchange for Scancell Limited's shares, and the previous
owners of Scancell Limited shares became owners of Scancell Holdings Plc
shares. In previous IFRS financial statements, the Group recognised goodwill
as an asset for this transaction in its Consolidated statement of financial
position and excluded the pre-acquisition retained losses of Scancell Limited.
IFRS does not provide specific guidance for such reorganisations, and
companies are required under IAS 8, Accounting Policies, Changes in Accounting
Estimates and Errors, to develop a policy that reflects the economic substance
of transactions and not merely the legal form. On review of goodwill in 2024,
management determined that treating the reorganisation as a regular way
acquisition and recognising goodwill as an asset did not reflect the substance
of the reorganisation and that it only represented the legal form. Having
reviewed the requirements of other IFRSs, the IASB's Conceptual Framework, and
other standard setting bodies, the Board noted that the principles of
predecessor accounting feature under several reporting frameworks, including
the merger accounting method under UK GAAP. The Board has therefore chosen to
adopt these principles and the consolidated statements of financial position
and equity have been restated to:
§ remove goodwill on consolidation;
§ consolidate the historical losses of Scancell Limited prior to its legal
acquisition;
§ record merger reserves in equity in the Consolidated statement of financial
position for the difference between the nominal value of shares issued by
Scancell Holdings Plc for the transaction and the share capital and share
premium of Scancell Limited.
The effect of the restatement to goodwill and equity balances is summarised
below for 2023 and 2022.
Consolidated Statement of financial position
2023 Adjustments 2023
As previously reported Restated
£'000 £'000
ASSETS
Non-current assets
Goodwill 3,415 (3,415) -
SHAREHOLDERS' EQUITY
Share premium 65,181 (4,486) 60,695
Merger reserve - 5,043 5,043
Retained
losses
(74,356)
(3,972) (78,328)
2022 Adjustments 2022
As previously reported Restated
£'000 £'000
ASSETS
Non-current assets
Goodwill 3,415 (3,415) -
SHAREHOLDERS' EQUITY
Share premium 65,019 (4,486) 60,533
Merger reserve - 5,043 5,043
Retained
losses
(62,420) (3,972)
(66,392)
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