REG - Scancell Hlds - Interim Results
30/01/2025 07:00
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RNS Number : 1944V Scancell Holdings Plc 30 January 2025
30 January 2025
Scancell Holdings plc
("Scancell" or the "Company")
Interim Results for the six months ended 31 October 2024
Strong clinical, development and organisational progress in the period
supported by enhanced cash position leaves the company well positioned to
progress development of its lead and second products
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapy
products for the treatment of multiple cancers, today announces its interim
results for the six months ended 31 October 2024 and provides a business
update on progress achieved to date.
Highlights (including post period):
SCIB1/ iSCIB1+ (SCOPE trial)
· SCIB1, a DNA cancer vaccine, reported compelling positive interim
data in the ongoing SCOPE study for Advanced Melanoma, as follows:
o 80% Progression Free Survival (PFS) in 25 patients at 6 months with 20% of
patients achieving a complete response (CR).
o Disease control rate of 84% (stable disease or tumour regression, DCR) and
objective response rate (ORR) of 72%.
These results exceed the reported outcomes of double checkpoints alone where
the ORR is closer to 48%.
· SCIB1 in this first cohort now fully recruited with 43 patients
and 25-week ORR data expected mid-2025.
· iSCIB1+, a next generation vaccine, continues strong recruitment with
25-week ORR data expected H2 2025.
· Intradermal cohort with iSCIB1+ added to the study to provide
delivery route comparison. Early data from this additional cohort expected H2
2025.
· Strategic partnership signed with PharmaJet for use of the Stratis(®)
needle-free delivery securing supply through clinical development and
commercial use of our lead product.
· Manufacturing processes for iSCIB1+ improved in preparation for
late stage development.
Modi-1 (ModiFY trial)
· Modi-1, a citrullinated peptide off-the-shelf vaccine, continues
development in the expansion cohorts of ModiFY study for solid tumours,
administered along with checkpoint inhibitors (CPI).
· Modi-1 shows ORR of 43% at week 25 in 7 patients with Head and Neck
cancer versus a 19% historical response rate with CPI alone, thereby passing
non-futility at Simon Stage 1.
· Moditope(®) patent granted by U.S. Patent and Trademark Office.
Antibodies:
· Genmab exercised option to second anti-glycan antibody, SC2811, from
Scancell's proprietary Glymab(®) platform. Upfront payment of $6 million
received in total with up to $630 million in further development milestones
and single digit royalties.
· Development of SC129, out-licensed to Genmab in 2022, continues on
track towards clinical development with further milestones anticipated.
· GlyMab(®) and AvidiMab(®) platforms provide potential out-licensing
opportunities as well as in-house pipeline build. Active discussions ongoing
with pharmaceutical and biotech companies.
Corporate:
· Dr Phil L'Huillier commenced as Chief Executive Officer in mid-November
2024, bringing a wealth of leadership experience in the biotechnology and
pharmaceutical sectors, with a proven track record in business development,
financing, and driving innovation.
· Professor Lindy Durrant, having successfully guided the company into
clinical development with the vaccines portfolio, continues as Chief
Scientific Officer (CSO), working closely alongside Dr L'Huillier, and will
remain on the Company's Board of Directors.
· Enhanced organisational capabilities with key recruitments, including
the appointment of Dr Nermeen Varawalla as Chief Medical Officer in July 2024.
· Dr Florian Reinaud, Non-Executive Director representing Redmile,
appointed to the Board of Directors in July 2024, bringing over 20 years of
executive, non-executive and financial experience from the healthcare sector.
Financial:
· Operating loss for the six months ended 31 October 2024 of £10.5
million (six months ended 31 October 2023: £8.1 million).
· Group cash balance at 31 October 2024 was £9.1 million (30 April
2024: £14.8 million).
· Convertible loan note maturity dates extended by two years to
second half of 2027.
· In December 2024, the Company raised gross proceeds of £11.3 million
through an oversubscribed capital raise with significant participation from
both existing and new healthcare specialist investors.
· Cash runway to H2 2026 beyond multiple clinical milestones.
Phil L'Huillier, Chief Executive Officer, Scancell, commented: "I am pleased
with the progress achieved by the Company over the period as we drive for
further clinical validation through multiple milestones in 2025. The Phase 2
results with SCIB1 in combination with CPIs are excellent, showing 80% PFS
after 6 months, 84% DCR and 72% ORR. In addition, we have recruited strongly
with our next generation vaccine, iSCIB1+, with a readout expected in H2 2025.
This has the potential to provide long-term immune control of tumours and
improve patient outcomes in first line unresectable melanoma treatment. Modi-1
continues to demonstrate its potential successfully achieving Simon Stage 1 in
Head and Neck cancer and recruiting effectively in Renal Cell Carcinoma. This
strong clinical development is underpinned by the Glymab(®) platform with a
second collaboration with Genmab. The recent capital raise of £11.3 million
further enables us to deliver multiple key clinical milestones for our SCOPE
and ModiFY trials in 2025 and we look forward to sharing the results."
Phil L'Huillier, Chief Executive Officer and Sath Nirmalananthan, Chief
Financial Officer, will also host a live webcast and Q&A session for
analysts and investors today at 14:00 GMT. If you would like to join the
webcast, please follow this link:
https://www.lsegissuerservices.com/spark/ScancellHoldings/events/ed5646ee-d413-404a-8a95-73bfef540393
(https://www.lsegissuerservices.com/spark/ScancellHoldings/events/ed5646ee-d413-404a-8a95-73bfef540393)
A replay of the webcast will be made available shortly afterwards.
A full copy of the announcement can be found on the Scancell website:
www.scancell.co.uk (http://www.scancell.co.uk)
This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014 (MAR).
For further information, please contact:
Scancell Holdings plc +44 (0) 20 3709 5700
Phil L'Huillier, CEO
Sath Nirmalananthan, CFO
Dr Jean-Michel Cosséry, Non-Executive Chairman
Panmure Liberum (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500
Emma Earl, 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
ICR Healthcare +44 (0) 20 3709 5700
Mary-Jane Elliott, Angela Gray, Lindsey Neville scancell@consilium-comms.com (mailto:scancell@consilium-comms.com)
About Scancell
Scancell is a clinical stage biopharmaceutical company that is leveraging its
proprietary research, built up over many years of studying the human adaptive
immune system, to generate novel medicines to treat significant unmet needs in
cancer. 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/
CHIEF EXECUTIVE OFFICER'S STATEMENT
I am pleased to report the interim results for the six-month period ended 31
October 2024. During the period to date, Scancell achieved important clinical,
developmental and organisational milestones. Our lead cancer vaccine, SCIB1,
reported exceptional results in the Phase 2 SCOPE trial for advanced melanoma
and is supplemented by good clinical progress with the next generation iSCIB1+
and Modi-1 for Renal Cell Carcinoma and Head & Neck cancer. This leaves
multiple clinical milestones in 2025. The recently announced licensing deal
with Genmab for a second anti-glycan antibody and the capital raise of £11.3
million in gross proceeds provide us with a cash runway beyond these
milestones into H2 2026. Our recent enhancements to the leadership team
strengthens our organisational capability to realise the potential of our
vaccines and antibodies.
Set out below is a summary of progress that has been made with our lead cancer
vaccines and antibodies. Full details of the platforms and other assets are
detailed in the Company's 2024 Annual Report and website (www.scancell.co.uk
(http://www.scancell.co.uk/) ).
VACCINES
SCIB1 & iSCIB1+ (SCOPE trial)
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 (CPI) for the first-line treatment for unresectable melanoma. The
doublet therapy of ipilimumab (Yervoy(®)) and nivolumab (Opdivo(®)) 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.
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 30% of patients which have the appropriate HLA type. Further advantages of
iSCIB1+ over SCIB1 include potentially increased potency and an extended
patent duration.
In November 2024, the Company announced further positive data from Cohort 1,
where 25 patients receiving SCIB1 in combination with ipilimumab and
nivolumab, had reached the 25-week landmark point. These patients showed
progression free survival (PFS) of 80% at 6 months, with 5 (20%) complete
responders (CR). 21 of 25 patients (84%) have shown disease control (stable
disease or tumour regression, DCR). 18 out of 25 patients have shown a
clinical response which is an objective response rate (ORR) of 72%, with many
patients continuing to show tumour shrinkage over time.
These results compare favourably with reported outcomes from the double
checkpoints alone, namely PFS of 65%, CR of 16%, DCR of 58% and ORR of 48%,
respectively. The PFS and accumulating number of complete responders indicates
that the combination of SCIB1 with double checkpoints gives sustained and
durable responses which are improved when compared to double checkpoints
alone. Cohort 1 of the SCOPE trial has now completed recruitment of 43
patients, and it is anticipated that all of these patients will reach the
week-25 ORR readout mid-2025.
Cohort 2, investigating SCIB1 in combination with pembrolizumab, has
recruited 10/44 patients and Cohort 3, investigating the next generation
iSCIB1+ in combination with ipilimumab and nivolumab, has recruited 40/43
patients. The iSCIB1+ cohort has predominantly recruited the non-HLA.A2
matched patients as these patients were being enrolled in Cohort 1. Now
recruitment in Cohort 1 is complete, HLA.A2 patients are being recruited to
complete Cohort 3 to give a representative sample of the advanced melanoma
patient population. It is anticipated that all Cohort 3 patients will reach
the week-25 ORR readout during H2 2025. This will allow the Company to select
the best vaccine for our randomised studies on the path to registration.
In addition to the existing cohorts, an intradermal cohort with iSCIB1+ has
been added to the SCOPE study. This cohort will use the Tropis(®) ID injector
from PharmaJet. The results will allow the Company to determine the best
delivery method of iSCIB1+, with patient experience in mind, prior to further
development. In preclinical findings, intradermal delivery also improved
response rates of DNA vaccines. Early results from this additional cohort are
expected in H2 2025 to coincide with the timing of the iSCIB1+ Cohort 3
readout.
During the period and ahead of the randomised 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 Company has optimised and scaled-up a commercially
viable manufacturing process for iSCIB1+ which will support late-stage
clinical trials. All analytical test methods (including a relevant biological
potency test) have been successfully qualified or validated. Long-term
stability data shows that SCIB1/iSCIB1+ remains stable at -20 ± 5°C.
We expect full cohort data with SCIB1 and iSCIB1+ around mid-2025 and H2 2025,
respectively. Following the data, we plan to progress to a randomised study on
the path to registration, whilst evaluating partnering, out-licensing and
further financing options.
Modi-1 (ModiFY study)
Modi-1, which targets citrullinated cancer antigens, is the first therapeutic
vaccine candidate to emerge from Scancell's Moditope(®) platform. Modi-1
consists of three citrullinated tumour-associated peptides exploiting the
normal immune response to stressed cells, which is largely mediated by
cytotoxic CD4 T cells.
Modi-1 in the ModiFY trial has completed its dose escalation and safety
cohorts. Data from patients receiving the Modi-1 cancer vaccine as a
monotherapy showed that it was safe and well tolerated and demonstrated
encouraging early efficacy in a head and neck cancer patient and in other
hard-to-treat cancers such as high grade serous ovarian carcinoma and triple
negative breast cancer.
In January 2025, Modi-1 successfully achieved Simon Stage 1 suggesting the
combination of Modi-1 and checkpoint blockade is beneficial in HPV negative
head and neck squamous cell carcinoma (HPV (-) SCCHN). The cohort
investigating HPV (-) SCCHN was designed to determine if the objective
response rate (ORR) in patients could be improved by combining Modi-1 with
standard of care single agent checkpoint inhibitor pembrolizumab. Three of the
seven evaluable patients that have received immunisation with Modi-1 combined
with a checkpoint inhibitor (CPI) have demonstrated a partial response as
determined by RECIST 1.1 tumour assessment at their 25-week scan. This equates
to an ORR of 43% compared to historical ORRs of 19% for pembrolizumab and 13%
for nivolumab. In view of the significant improvement in response rate and the
good safety and tolerability, this study is well positioned to continue
enrolment into Simon Stage 2. These encouraging early results will be further
verified upon completion of this HPV (-) SCCHN Modi-1 + CPI cohort, after a
total of up to 21 patients have been vaccinated. In addition, there is
investigator interest to evaluate Modi-1 in the neoadjuvant setting for this
indication.
The Company believes that combination therapy with CPIs, could further improve
outcomes for this patient group. With this intention, Modi-1 in renal cancer
in combination with ipilimumab (Yervoy(®)) plus nivolumab (Opdivo(®)) CPI
cohort was added to the study. This is partly due to a change of standard of
care within the treating community and partly because the SCOPE study results
suggest that the double checkpoints are ideal in synergising with vaccines.
Early clinical data in RCC with Modi-1 plus CPIs is anticipated in H2 2025.
During the period, the US Patent and Trademark Officer (USPTO) granted
Scancell's application for a patent to Moditope(®). The patent will add to
the protection of the Company's pipeline of Moditope(®) vaccines for the
treatment of cancer, which has already been granted by the European Patent
Office and in China, Japan and Australia.
ANTIBODIES
GlyMab(®)
The GlyMab(®) platform provides a powerful and versatile approach to
generating novel antibody drug candidates for our own clinical pipeline and to
creating 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.
In December 2024, Genmab exercised its option to license a second anti-glycan
monoclonal antibody, SC2811, generated via Scancell's proprietary GlyMab(®)
platform. Genmab has been granted worldwide exclusive rights for development
and commercialisation and has paid upfront payments of $6 million to date.
This upfront payment comprised of $1 million (£0.8 million) for an exclusive
evaluation period and $5 million (£3.9 million) on exercising its option for
a full license. Further development, regulatory and commercial milestone
payments of up to a maximum of $630 million are receivable if Genmab develops
and commercialises products across all defined modalities. Scancell will also
receive low single-digit royalties from Genmab on net sales of all such
commercialised products.
This is the second commercial license with Genmab, who previously entered into
a commercial license agreement for SC129 in October 2022. Development of this
first antibody remains on track as it progresses towards potential clinical
development with further milestones anticipated.
CORPORATE
The Company has enhanced its organisational capabilities through key
appointments to the Senior Management team and the Board of Directors,
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.
In November 2024, Dr Phil L'Huillier joined as Chief Executive Officer (CEO)
and a member of the Company's Board of Directors, bringing 30 years of
pharmaceutical industry leadership experience. Professor Lindy Durrant will
continue her position as Chief Scientific Officer (CSO), working closely
alongside Dr L'Huillier, and will remain on the Company's Board of Directors.
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
registrational trials following clinical results from SCIB1 and iSCIB1+
cohorts.
Dr Florian Reinaud, Non-Executive Director representing Redmile, was appointed
to the Board of Directors in July 2024. Dr Florian Reinaud (representing
Redmile, Scancell's leading investor) brings over 20 years of executive,
non-executive and financial experience from the healthcare sector.
FINANCIAL REVIEW
Profit or Loss and Other Comprehensive Income Statement
The Group recorded an operating loss for the six-month period to 31 October
2024 of £10.5 million (six-month period to 31 October 2023: loss of £8.1
million).
Research and development ("R&D") expenditure increased to £8.0 million
(2023: £5.7 million) due to increased manufacturing and clinical costs on the
SCOPE trial. Administrative expenses remained consistent at £2.5 million
(2023: £2.4 million).
Interest expenses of £0.8 million (2023: £0.5 million) primarily relate to
the non-cash effective interest recognised on the Group's modified convertible
loan notes. These notes were substantially modified following a two-year
extension in July 2024 and a change in terms allowing Redmile to convert all
notes at any time prior to maturity and also resulted in the deferral of
interest payments to maturity. The loss on derivative revaluation of £4.5
million (2023: gain of £4.9 million) relates to the derivative liability
arising from the convertible loan notes, representing the non-cash fair value
adjustment to the derivative liability at the respective period ends. There
was also a gain on substantial modification of the notes of £1.8 million for
the difference between the recorded value of the notes under previous terms at
the date of the amendments in July 2024 and the value of the notes on a
remeasured basis at the same time.
The loss before taxation amounted to £13.8 million (2023: £3.6 million). The
variance to the prior period was largely driven by the non-cash fluctuations
in the convertible notes described above.
Estimated R&D tax credits increased to £1.3 million (2023: £1.0 million)
due to higher development expenditure, and the overall loss after tax for the
six-month period was £12.5 million (2023: £2.5 million).
Statement of Financial Position
At 31 October 2024, net liabilities of the Group amounted to £15.5 million
(30 April 2024: £3.5 million) and the Group held cash of £9.1 million (30
April 2024: £14.8 million).
Since the reporting date of 31 October 2024:
· The Company raised gross proceeds of £11.3 million in December 2024
through a capital raise with significant participation from both existing and
new healthcare specialist investors;
· A further £3.9 million ($5 million) was received in December
2024 following Genmab's exercise of an option to take exclusive license under
a second collaboration agreement;
· R&D tax credits relating to the year ended 30 April 2024 of
£2.7 million were received in January 2025.
Current assets include tax receivable at the end of October 2024 of £4.1
million (30 April 2024: £5.7 million) relating to R&D tax credits for the
year ended 30 April 2024 and an estimate of a further amount receivable for
the six months to 31 October 2024.
The total amount of convertible loan notes outstanding is £19.2 million
(recorded as £14.8 million on an amortised cost basis in the Consolidated
statement of financial position). These notes are due to be repaid in August
2027 (£1.75 million) and November 2027 (£17.45 million) unless converted
into ordinary shares.
Derivative liabilities totalling £11.2 million (30 April 2024: £4.1 million)
represent the fair value of the conversion feature of the convertible loan
notes at the respective period ends.
Deferred revenue of £0.8 million ($1 million) relates to an upfront payment
received under our second Genmab collaboration agreement in July 2024. This
amount, and £3.9 million ($5 million) received in December 2024, will be
recognised as revenue in the 6 months ended 30 April 2025 following Genmab's
option exercise and the grant of an exclusive license to develop and
commercialise the Group's SC2811 antibodies.
Trade and other payables increased to £4.5 million (April 2024: £3.1
million) due to higher accruals for unbilled clinical trial and in-licensed
technology costs.
Consolidated Cash Flow Statement
The reduction in cash balances from £14.8 million to £9.1 million during the
six-month period is primarily due to net cash used in operating activities of
£5.0 million (year ended 30 April 2024: £15.7 million). Operating
expenditure in the period was offset by R&D tax credits received of £2.9
million (year ended 30 April 2024: £1.7 million) and an upfront payment of
£0.8 million ($1 million) under our second Genmab collaboration.
OUTLOOK
Given the significant clinical and commercial milestones achieved in the
period, positive early efficacy data, and with sufficient resources to fund
our current strategy, the Company is confident it will achieve its near-term
clinical milestones.
Key near-term milestones include:
· SCIB1 full Cohort 1 data in 43 patients reaching 25-week ORR
mid-2025.
· iSCIB1+ full Cohort 3 data in 43 patients reaching 25-week ORR in
H2 2025.
· iSCIB1+ early Cohort 4 (intradermal delivery) data in H2 2025.
· Modi-1 early renal cell carcinoma with double CPIs cohort data
expected in H2 2025.
The Company will continue to explore business development opportunities and
strategic options to drive development of its products and unlock shareholder
value.
Phillip L'Huillier
Chief Executive
Officer
Scancell Holdings plc
Consolidated Statement of Comprehensive Loss
for the six-month period to 31 October 2024
Unaudited Unaudited Audited
6 months 6 months Year to
31/10/2024 31/10/2023 30/04/2024
£'000 £'000 £'000
Note
R&D expenses (8,043) (5,693) (12,871)
Administrative expenses (2,502) (2,427) (5,396)
OPERATING LOSS (10,545) (8,120) (18,267)
Interest receivable and similar income 159 161 355
Interest expense (793) (493) (1,089)
Finance (expense) / gain relating to revaluation of derivative liability 4 (4,474) 4,864 9,884
Gain on substantial modification of convertible loan notes 4 1,816 - -
Loss and total comprehensive loss before tax (13,837) (3,588) (9,117)
Taxation 5 1,334 1,040 3,258
LOSS FOR THE PERIOD (12,503) (2,548) (5,859)
EARNINGS PER ORDINARY SHARE (PENCE)
Basic 3 (1.35)p (0.31)p (0.68)p
Diluted 3 (1.35)p (0.70)p (1.43)p
Scancell Holdings plc
Consolidated Statement of Financial Position
as at 31 October 2024
Unaudited Unaudited Audited
31/10/2024 31/10/2023 30/04/2024
Restated1
£'000 £'000 £'000
ASSETS Note
Non-current assets
Intangible assets 6 1,514 - -
Tangible fixed assets 578 983 862
Right-of-use assets 672 845 847
Total non-current assets 2,764 1,828 1,709
Current assets
Trade and other receivables 608 476 1,378
Taxation receivable 5 4,130 3,454 5,672
Cash and cash equivalents 9,103 13,079 14,817
Total current assets 13,841 17,009 21,867
TOTAL ASSETS 16,605 18,837 23,576
LIABILITIES
Non-current liabilities
Convertible notes - loan liabilities 4 - (17,393) (17,366)
Derivative liabilities 4 - (6,928) (2,860)
Lease liabilities (278) (562) (466)
Total non-current liabilities (278) (24,883) (20,692)
Current liabilities
Deferred revenue 2 (782) - -
Convertible notes - loan liabilities 4 (14,844) (1,554) (1,606)
Derivative liabilities 4 (11,217) (2,208) (1,256)
Trade and other payables (4,544) (1,664) (3,099)
Lease liabilities (440) (306) (428)
Total current liabilities (31,827) (5,732) (6,389)
TOTAL LIABILITIES (32,105) (30,615) (27,081)
NET LIABILITIES (15,500) (11,778) (3,505)
EQUITY
Called up share capital 930 820 929
Share premium account 71,954 60,729 71,927
Share option reserve 3,263 2,506 2,783
Merger reserve 5,043 5,043 5,043
Retained losses (96,690) (80,876) (84,187)
Total Equity (15,500) (11,778) (3,505)
Scancell Holdings plc
Consolidated Statement of Changes in Equity
for the six-month period to 31 October 2024
Share
Share Share option Merger Retained Total
capital premium reserve reserve earnings Equity
£'000 £'000 £'000 £'000 £'000 £'000
Unaudited Unaudited Unaudited Unaudited Unaudited Unaudited
At 1 May 2024 929 71,927 2,783 5,043 (84,187) (3,505)
Share issue 1 27 - - - 28
Loss for the period - - - - (12,503) (12,503)
Share option costs - - 480 - - 480
At 31 October 2024 930 71,954 3,263 5,043 (96,690) (15,500)
At 1 May 2023 819 65,181 2,123 - (74,356) (6,233)
Prior Period Restatement - (4,486) - 5,043 (3,972) (3,415)
At 1 May 2023 (Restated)1 819 60,695 2,123 5,043 (78,328) (9,648)
Loss for the period - - - - (2,548) (2,548)
Share option exercises 1 34 - - - 35
Share option costs - - 383 - - 383
At 31 October 2023 (Restated) 820 60,729 2,506 5,043 (80,876) (11,778)
Audited Audited Audited Audited Audited Audited
At 1 May 2023 819 60,695 2,123 5,043 (78,328) (9,648)
Subscription and open offer 108 11,143 - - - 11,251
Share option exercises 2 89 - - - 91
Loss for the year - - - - (5,859) (5,859)
Share option costs - - 660 - - 660
At 30 April 2024 929 71,927 2,783 5,043 (84,187) (3,505)
Scancell Holdings plc
Consolidated Cash Flow Statement
for the six-month period to 31 October 2024
Unaudited Unaudited Audited
6 months 6 months Year to
31/10/2024 31/10/2023 30/04/2024
£'000 £'000 £'000
Cash flows from operating activities
Loss before tax for the period (13,837) (3,588) (9,117)
Adjustments for:
Interest receivable and similar income (159) (161) (355)
Interest expense 793 492 1,089
Gain on substantial modification of convertible loan notes (1,816) - -
Finance expense/(gain) relating to derivative liability revaluation 4,474 (4,864) (9,884)
Share based payment charge (Note 7) 480 383 660
Depreciation of tangible fixed assets 284 276 561
Depreciation of right-of-use assets 195 158 405
Other items 60 - (42)
Cash used in operations before changes in working capital (9,526) (7,304) (16,683)
Decrease/(increase) in trade and other receivables 770 62 (840)
Increase/(decrease) in deferred revenue and other operating payables 910 (1,306) 129
Cash used in operations (7,846) (8,548) (17,394)
Tax credits received 2,876 1,734 1,734
Net cash used in operating activities (4,970) (6,814) (15,660)
Cash flows from investing activities
Purchase of intangible license assets (197) - -
Purchase of tangible fixed assets - (13) (177)
Interest received 159 161 355
Net cash (used in)/from investing activities (38) 148 178
Financing activities
Proceeds from issuance on placing and open offer - - 11,898
Costs of share issuances - - (647)
Proceeds from share option exercises 28 35 91
Convertible loan repayments (450) - -
Interest paid (28) - (595)
Lease principal payments (196) (210) (357)
Net cash (used in)/ from financing activities (646) (175) 10,390
Net decrease in cash and cash equivalents (5,654) (6,841) (5,092)
Net foreign exchange difference on cash held (60) - (11)
Cash and cash equivalents at beginning of the year 14,817 19,920 19,920
Cash and cash equivalents at end of the period 9,103 13,079 14,817
Scancell Holdings plc
Notes to the Interim Financial Statements
for the six-month period to 31 October 2024
1 Basis of preparation
This interim report for the six-month period to 31 October 2024 is unaudited
and was approved by the Directors on 29 January 2025. The financial
information contained in the interim report is consistent with the accounting
policies set out in the annual report and financial statements for the year
ended 30 April 2024 and reflects policies expected to apply to the Group's
financial statements for the year ended 30 April 2025. As permitted, this
interim report has been prepared in accordance with AIM Rule 18 and not in
accordance with IAS 34 "Interim Financial Reporting", and therefore, it is not
fully in compliance with UK adopted international accounting standards.
The financial information for the full preceding year is based on the
statutory accounts 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 Board has prepared the interim financial information on a going concern
basis. Following the Group's recent equity financing and upfront payment
received from Genmab in December 2024, the Board has determined that there is
no longer material uncertainty that may cast significant doubt on the Group's
ability to continue operating for at least a year from the date of approval of
this report.
2 Deferred revenue
In July 2024, Scancell Limited ("Scancell") and Genmab A/S ("Genmab") entered
into an exclusive option and license agreement. Under the agreement, Genmab
was permitted to evaluate Scancell's SC2811 antibodies over a seven-month
period with the option to acquire exclusive license to develop and
commercialise these antibodies. £0.8 million ($1 million) was payable at
inception, which the Company received in July 2024. In December 2024, Genmab
exercised its exclusive option and a further £3.9 million ($5 million) was
received.
The license agreement provides Genmab with the right to use the antibodies
with immaterial ongoing Scancell involvement. Promises under the agreement
were determined to represent a combined performance obligation to provide an
exclusive option to Genmab to acquire a license to develop, manufacture and
commercialize the antibodies. This obligation will be satisfied and revenue
recognised at the point in time that Genmab can fully benefit from the license
after completion of its option exercise. Deferred revenue of £0.8 million ($1
million) was recognised in the Consolidated statement of financial position on
entitlement to the initial upfront payment and the Group expects to recognize
this amount, and the £3.9 million ($5 million) received in December 2024
following Genmab's option exercise, as revenue in the Consolidated statement
of comprehensive loss in the six months ended 30 April 2025.
3 Earnings per share
Basic earnings per share is calculated by dividing the earnings attributable
to ordinary shareholders by the weighted average number of ordinary shares
outstanding during the period.
The calculations of earnings per share are based on the following losses and
numbers of shares.
Basic loss per share
6 months to 6 months to Year ended
31/10/2024 31/10/2023 30/04/2024
£'000 £'000 £'000
Loss after taxation (12,503) (2,548) (5,859)
Number Number Number
Weighted average number of shares used in basic loss per share
929,404,542 819,024,113 862,484,430
Basic loss per share (1.35)p (0.31)p (0.68)p
Diluted loss per share
6 months to 6 months to Year ended
31/10/2024 31/10/2023 30/04/2024
£'000 £'000 £'000
Loss after taxation (12,503) (2,548) (5,859)
Adjustment for the effect of convertible loan notes - (4,396) (8,853)
Adjusted loss used in the calculation of diluted loss per share (12,503) (6,944) (14,712)
Number Number Number
Basic weighted average number of ordinary shares
929,404,542 819,024,113 862,484,430
Adjustment for convertible loan notes with dilutive effect
- 167,310,035 167,310,035
Diluted weighted average number of ordinary shares
- 986,334,148 1,029,794,465
Diluted loss per share (1.35)p (0.70)p (1.43)p
Convertible loan notes in the year ended 30 April 2024 and the six months
ended 31 October 2023 had a dilutive effect on loss per share. Diluted 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 these periods following
the removal of post-tax derivative finance income and loan interest expense.
Convertible loan notes in the six months ended 31 October 2024 and the effect
of share options in all periods have been excluded from the calculation of
diluted loss per share in all periods since these would have the effect of
reducing the loss per share.
At 31 October 2024, the issued share capital amounted to 929,599,977 ordinary
shares.
4 Convertible loan note liabilities and derivatives
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 rather than at maturity;
§ interest terms were revised to accrue until maturity rather than
require annual repayment; and
§ 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 remain 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.
The Group evaluated the changes in terms of the notes and determined that the
deed of amendment represented a substantial modification for both sets of
convertible loan notes. As a result:
§ The previous notes were derecognised in July 2024;
§ The amended notes were recognised as a new loan note liability at
fair value using an estimate of interest for a loan without a conversion
feature;
§ Derivative liability balances referenced to previous terms were
derecognised and were replaced by the fair value of derivatives based on the
amended terms; and
§ The differences in both the carrying values of the loan note
liabilities and the derivatives have been reflected as an overall gain on
substantial modification in the Consolidated statement of comprehensive loss.
Since exercise of the conversion option on the notes repayable in November
2027, which could occur in a period of less than a year following the deed of
amendment, would settle the host loan liability, the loan liability component
of these notes and the embedded derivative liability have been presented as
current liabilities in the Consolidated statement of financial position.
5 Taxation
Taxation for the 6 months ended 31 October 2024 is based on the effective
rates of taxation expected to apply for the year ended 30 April 2025.
In January 2025, the Group received £2.7 million of the £4.1 million
taxation receivable at 31 October 2024 in the Consolidated statement of
financial position. The Group expects to receive the remaining tax credits in
the year ended 30 April 2026.
6 Intangible assets
Intangible assets represent separately acquired technology licenses from
PharmaJet and other partners. Intangible assets are assessed for recognition
when the associated costs arise.
7 Share options
The share based payment expense for the six months ended 31 October 2024 was
£480,000 (six months ended 31 October 2023: £383,000).
During the six months ended 31 October 2024, the Group granted a total of
19,500,000 options with a weighted average exercise price of 14.3 pence per
option and a weighted average fair value of 9.6 pence per option. Of these
awards, 1,000,000 options at an exercise price of 10.1 pence were granted to
Sath Nirmalananthan, who serves as a director of Scancell Holdings Plc and the
Group's Chief Financial Officer. Options granted in the period vest over a
period up to three years.
At 31 October 2024, a total of 63,310,475 options were outstanding (30 April
2024: 44,564,544 options).
8 Prior Period Restatement
The Group has adjusted numbers previously reported at 31 October 2023 in these
financial statements. The adjustments had no impact on prior statements of
comprehensive loss or statements of cash flow. See Appendix 1 for details.
9 Interim Results
These results were approved by the Board of Directors on 29 January 2025.
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) .
10 Events after the reporting period
In December 2024, the Group raised gross proceeds of £11.3 million in
aggregate (before expenses) through a capital raise. This comprised of (i)
gross proceeds of £10.3 million in aggregate through a placing and
subscription with significant participation from both existing and new
healthcare specialist investors and (ii) gross proceeds of £1 million through
a Retail Offer reflecting renewed support from existing shareholders.
Following the capital raise, the issued share capital of the company was
1,036,781,403.
Following the capital raise, the conversion price of the Group's convertible
loan notes due to mature in November 2027 was adjusted from 13 pence to 12.7
pence and the conversion price of the notes due to mature in August 2027 was
adjusted from 5.9 pence to 5.76 pence.
In December 2024, Genmab exercised its exclusive option under a second license
collaboration agreement and a further payment of £3.9 million ($5 million)
was received.
Appendix 1: Impact of Prior Period Restatements
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 31 October 2023.
Consolidated Statement of financial position
31 October 2023 Adjustments 31 October 2023
As previously reported Restated
£'000 £'000
LIABILITIES
Non-current liabilities
Convertible loan notes (18,947) 1,554 (17,393)
Derivative liability (9,136) 2,208 (6,928)
Current Liabilities
Convertible loan notes - (1,554) (1,554)
Derivative liability - (2,208) (2,208)
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 31 October 2023.
Consolidated Statement of financial position
31 October 2023 Adjustments 31 October 2023
As previously reported Restated
£'000 £'000
ASSETS
Non-current assets
Goodwill 3,415 (3,415) -
SHAREHOLDERS' EQUITY
Share premium 65,215 (4,486) 60,729
Merger reserve - 5,043 5,043
Retained losses
(76,904) (3,972)
(80,876)
1 Please refer to note 8 for further details on the prior period restatement
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