REG - ReNeuron Group plc - Interim Results
30/11/2021 07:00
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RNS Number : 9492T ReNeuron Group plc 30 November 2021
ReNeuron Group plc
("ReNeuron" or "the Company")
Interim Results for the six months ended 30 September 2021
ReNeuron Group plc (AIM: RENE), a UK based leader in Stem Cell and Exosome
Technologies, announces its interim results for the six months ended 30
September 2021.
OPERATIONAL HIGHLIGHTS
hRPC stem cell therapy candidate for retinal disease
- In June, enrolment into the higher dose phase 2a extension study
was temporarily suspended due to a presumed case of bacterial interocular
infection
- Following a completed investigation, and with Data and Safety
Monitoring Board approval, by October the study was reopened in all
geographies
- First subject, post lifting of the suspension, was treated in
mid-October with early data from the extension study expected in late Q1 2022
Exosomes platform
- Seven collaborations now proceeding with global pharma, biotech
and academic institutions, with more expected in the coming 12 months
- Pre-clinical data indicates that ReNeuron's Exosome drug delivery
technology can effectively deliver therapeutic proteins to the brain to
potentially treat neurological diseases
Other operational updates
- Collaboration signed with University College London (UCL)
investigating the use of ReNeuron's induced pluripotent stem cell (iPSC)
platform to potentially generate CAR-T and/or CAR-NK cells
- Positive data from a separate UCL collaboration demonstrating that
ReNeuron's iPSCs can be differentiated into Schwann cells with potential
applications such as peripheral nerve damage repair
Corporate and Organisational Development
- In July Iain Ross was appointed as Non-Executive Chairman with Dr
Tim Corn stepping down but continuing to serve as Non-Executive Director.
Additionally Barbara Staehelin joined the board as Senior Independent
Non-Executive Director
- In May Dr Stefano Pluchino joined the executive team as Chief
Scientific Officer
- Post period end in October 2021, Catherine Isted, ACMA, joined the
Board, replacing Michael Hunt as Chief Financial Officer
- In October 2021, following nearly 9 years of service to the board,
Professor Sir Chris Evans OBE stood down as a Non-Executive Director,
remaining as an adviser to the Board
FINANCIAL HIGHLIGHTS
- Revenue for the period of £58,000 relating to royalty income (H1
2020: £41,000)
- Loss for the period of £5.2 million (H1 2020: loss of £7.1
million) driven by lower costs
- Reduced costs incurred in the period of £6.1 million (H1 2020:
£7.9 million) primarily driven by lower R&D spend following cessation of
the Company's stroke disability programme
- Increased net cash used in operating activities of £4.6 million
(H1 2020: £2.6 million) with H1 2020 benefitting from a £2.9m R&D tax
credit receipt
- Cash, cash equivalents and bank deposits at 30 September 2021 of
£17.4 million (31 March 2021: £22.2 million) providing at least a 12-month
runway
Olav Hellebø, Chief Executive Officer, said:
"The temporary suspension of our retinitis pigmentosa programme was an
unexpected challenge in the first half of 2021, but with recruitment now
resumed we look forward to reporting results from the high dose extension
part of this phase 2a trial. Meanwhile, exosomes are becoming an increasingly
exciting method for delivering payloads into patients and we are therefore
optimistic that we can increase the number of partnerships in this area while
continuing to progress our current collaborations toward the clinic. We feel
we are in the right place, at the right time, with the right technology to be
a leader in exosomes and look forward to providing further updates on our
progress as the excitement in this area continues to grow."
Analyst briefing
Olav Hellebø, Chief Executive Officer, Catherine Isted, Chief Financial
Officer and Dr Stefano Pluchino, Chief Scientific Officer will be hosting a
briefing for analysts which will take place at 85 Gresham Steet, London EC2R
7HE on Tuesday 30 November 2021 at 13.00 (GMT) / 08:00 EST. A live webcast of
the presentation will also be available for those unable to attend the meeting
in-person.
For more information and to register to attend the meeting in-person or
require the link to the live webcast, please email reneuron@walbrookpr.com
(mailto:reneuron@walbrookpr.com) or call +44 (0)20 7933 8785.
Investor Briefing
Management will be hosting a live online presentation relating to the interim
results via the Investor Meet Company platform at 15.00 (GMT) on Tuesday 30
November. The presentation is open to all existing and potential shareholders.
Investors can sign up to Investor Meet Company for free and register for the
presentation here:
https://www.investormeetcompany.com/reneuron-group-plc/register-investor
(https://www.investormeetcompany.com/reneuron-group-plc/register-investor)
Investors who already follow ReNeuron on the Investor Meet Company platform
will automatically be invited.
Enquiries:
ReNeuron www.reneuron.com/investors (http://www.reneuron.com/investors)
Olav Hellebø, Chief Executive Officer Via Walbrook PR
Catherine Isted, Chief Financial Officer
Stifel Nicolaus Europe Limited (NOMAD and Joint Broker) +44 (0)20 7710 7600
Ben Maddison, Stewart Wallace
Allenby Capital Limited (Joint Broker) +44 (0)20 3328 5656
James Reeve/George Payne (Corporate Finance)
Stefano Aquilino (Sales & Corporate Broking)
Walbrook PR (Media & Investor Relations) +44 (0)20 7933 8780 or reneuron@walbrookpr.com
(mailto:reneuron@walbrookpr.com)
Paul McManus, Alice Woodings +44 (0)7980 541 893 / +44 (0)7407 804 654
This announcement contains inside information. The person responsible for
arranging for the release of this announcement on behalf of the Company is
Olav Hellebø, Chief Executive Officer.
About ReNeuron
ReNeuron is a UK based Proprietary Stem Cell and Exosome Technologies company,
harnessing its unique stem cell technologies to develop 'off the shelf'
treatments for disease with significant unmet needs.
The Company's lead cell therapy candidate is in clinical development for the
blindness-causing disease, retinitis pigmentosa. The Company has also
out-licensed its CTX programme in stroke disability to Fosun in China.
ReNeuron's stem cell derived proprietary Exosome Technology platform offers a
delivery mechanism for a variety of payloads such as siRNA, mRNA, proteins,
small molecules and genes. The Company has a growing number of partner
collaborations with Global Pharma, Biotech and academic partners in this
fast-expanding area of scientific and commercial interest. ReNeuron also has
the ability through its conditionally immortalised induced pluripotent stem
cell (iPSC) platform to make allogeneic tissue cells of choice and has the
potential to produce exosomes with tissue specific targeting ability.
ReNeuron's shares are traded on the London AIM market under the symbol RENE.L.
For further information visit www.reneuron.com (http://www.reneuron.com)
This announcement contains forward-looking statements with respect to the
financial condition, results of operations and business
achievements/performance of ReNeuron and certain of the plans and objectives
of management of ReNeuron with respect thereto. These statements may
generally, but not always, be identified by the use of words such as "should",
"expects", "estimates", "believes" or similar expressions. This announcement
also contains forward-looking statements attributed to certain third parties
relating to their estimates regarding the growth of markets and demand for
products. By their nature, forward-looking also statements involve risk and
uncertainty because they reflect ReNeuron's current expectations and
assumptions as to future events and circumstances that may not prove
accurate. A number of factors could cause ReNeuron's actual financial
condition, results of operations and business achievements/performance to
differ materially from the estimates made or implied in such forward-looking
statements and, accordingly, reliance should not be placed on such statements.
Interim Results for the six months ended 30 September 2021
OVERVIEW
ReNeuron has seen encouraging results from all aspects of its operations with
strong progress in its seven Exosome collaborations and the resumption of its
retinitis pigmentosa extension study. The exosomes platform has generated
significant pre-clinical data in delivery of functional proteins to the brain
while the retinitis pigmentosa extension study is expected to produce initial
data by late Q1 2022.
In the period ReNeuron welcomed Iain Ross as the Company's new Chairman and
also Barbara Staehelin joined the board as the Senior Independent
Non-Executive Director. Additionally, in October, Catherine Isted joined
ReNeuron as Chief Financial Officer. Financially ReNeuron ended the period
with cash of £17.4 million, providing a cash runway of in excess of 12 months
and the Company looks forward to the year ahead maximising and building on the
foundations of the year to date.
CHAIRMAN'S STATEMENT
Having been appointed as the new Chairman in July 2021, I am absolutely
committed to working with an effective Board and management team to accelerate
the development of this business and to create realisable value for all
shareholders. I have been impressed by the quality of the science, the breadth
of the Company's proprietary stem cell based technology platforms and the
skills and competencies of our scientific team. Our priority now is to focus
on the immediate key growth drivers, including securing long-term industrial
partnerships and investing in those assets with inherent and potential
realisable value.
Retinitis pigmentosa has a devastating impact on patients' lives and we have
been encouraged by the early stage Phase 2a clinical data generated to date.
We recognise that the clinical data generated over the next few months will
determine the most appropriate strategy to take this programme forward. In
addition, our differentiated exosome technology platform presents us with a
unique opportunity to compete in an exciting and fast developing sector and as
a result we intend to build on the momentum already generated through the
partnerships we have established and those we intend to target over the coming
months.
Despite the breadth of our stem cell based platforms, if we are to succeed, we
need to be prepared to make tough decisions and only progress and invest in
those programmes whereby true value can be created. Accordingly, where
necessary we will look to share the value creating potential of our assets to
secure substantive third-party collaborations, thereby increasing
significantly the probability of success in terms of product development and
value creation. The Board and management team will continue to assess all
opportunities to create value through organic growth but also, as appropriate,
explore technology licensing and acquisition opportunities to accelerate and
enhance the overall value proposition of our Company.
I look forward to continuing to work with the ReNeuron team and all our
stakeholders.
Iain Ross
Chairman
OPERATIONAL REVIEW
hRPC (human retinal progenitor cells) for retinal disease
In the period the Company continued to progress its hRPC therapeutic candidate
which is currently undergoing Phase 2a clinical evaluation for the treatment
of the inherited blindness-causing disorder retinitis pigmentosa (RP). The
study uses a cryopreserved hRPC formulation, enrols subjects with advanced RP
with some remaining central vision. A high dose extension study looking to
enrol nine subjects is currently ongoing.
In early June 2021, ReNeuron announced that following a successful surgical
procedure, the fourth subject enrolled in the extension arm of the study
presented with a presumed bacterial intraocular infection in the treated eye
which impacted their vision, and was treated initially with an appropriate
regimen of antibiotics, to which they responded with clinical improvement.
Systemic anti-inflammatory therapy was subsequently added, and the subject
continues to improve on this regimen.
As a precaution the Company temporarily suspended the dosing of further
subjects in the study while it undertook an investigation into the cause of
the event. The origin of the presumed infection is not clear however
investigations have shown no evidence of a causal link to the drug product.
The conclusions of the investigation were submitted to the Data & Safety
Monitoring Board (DSMB) and the DSMB subsequently agreed that the study may
proceed. The study was reopened and in early October 2021 following receipt of
regulatory approval to restart the study in all geographies.
Post period end in October the Company announced the first subject had been
treated at the Oxford eye hospital with other surgeries planned prior to the
end of 2021. ReNeuron is looking to enrol the remaining subjects in the
extension trial prior to the end of the calendar year, with early efficacy
data expected in late Q1 2022.
The data from the extension study and the earlier lower dose cohort will
inform the Company as to the preferred dosing based on its efficacy and safety
profile, whether sub-retinal delivery provides the optimal efficacy and
duration of action and the commercial potential. The data will support the
decision whether to move straight into a pivotal trial or whether additional
subjects should be treated to garner further sub-retinal data and also whether
to investigate further a move into the clinic with an intravitreal dosing
regimen.
Exosome Platform
The Company's proprietary exosome platform continues to move from strength to
strength. Seven collaborations with global pharma, biotech and academic
institutions now use ReNeuron's exosomes as a delivery vehicle for their
therapeutic agents targeting the brain and other parts of the body. The whole
field of the use of exosomes to deliver various payloads is expanding rapidly
and the Company is well positioned to benefit from this growing area of
science.
The Company's proprietary cell lines produce a panel of distinct exosome drug
delivery candidate tools with commercial potential and combined with the
Company's iPSC platform provides an opportunity to generate additional bespoke
tissue-specific exosomes. This extensive repertoire of exosome candidates has
the potential to target a variety of indications and tissues.
Exosomes produced by the Company's neural stem cell line, CTX, can be
manufactured through a fully qualified, xeno-free, scalable process and loaded
with a variety of payloads, such as nucleic acids (including siRNA, mRNA and
miRNA), proteins (such as Cas9, antibodies and peptides) as well as small
molecules. These exosomes have also been shown to exhibit a natural ability to
cross the blood brain barrier.
Post period end in October, the Company announced positive data from its
collaboration with the University of Salamanca that provided clear
pre-clinical proof-of-concept that ReNeuron's novel exosome drug delivery
technology can effectively deliver therapeutic proteins to the specific region
of the brain affected by several neurological diseases such as stroke,
Parkinson's disease and Huntington's disease. These in vivo results are key in
showing that ReNeuron's exosome delivery technology offer a striking higher
stability, more targeted delivery, and an increase in potency, therefore
potentially solving the delivery issues that can be experienced with
therapeutic proteins.
Major pharmaceutical companies have identified therapeutic proteins that are
effective in treating a variety of neurological diseases. However, there are
major issues associated with the delivery of these protein therapeutics, which
include the poor stability in living organisms, given that proteins rapidly
break down and do not last long in the body; as well as issues surrounding
poor tissue distribution due to an inability to target specific tissues.
Whilst these issues cannot be overcome by simply administering more protein,
as this can have unwanted side-effects, ReNeuron believes that its proprietary
exosomes have the potential to address both these issues due to their natural
tissue-targeting ability and superior stability characteristics (as evidenced
from Reneuron's pre-clinical studies).
ReNeuron looks to expand the number of partner programmes utilising its
exosome technology platform and will continue to invest in expanding this
platform to best meet partner needs.
Other Operational updates
While earlier stage than the Exosomes platform, ReNeuron continues to process
development of the CTX cell-based Induced Pluripotent Stem Cell (iPSC)
technology platform in a number of potential applications and are deploying
this technology to develop new, immortalised allogeneic cell lines of varying
types as potential therapeutic agents in diseases of unmet medical need.
ReNeuron's CTX-iPSCs can be differentiated into hematopoietic stem cells,
lymphoid progenitors and, of great interest for cancer immunotherapy, NK and
killer T-cells. The Company has also produced pancreatic progenitor cells from
ReNeuron's CTX-iPSCs and continues to work on the scale up of the production
of insulin producing β-islet cells prior to phenotype analysis and
confirmation of their glucose responsiveness.
Post period end in October the Company announced that it had entered into a
collaboration agreement with UCL to conduct research into the generation of
immune cells from iPSCs for anti-cancer cell therapies. ReNeuron will be
providing UCL with iPSCs from its CTX immortalised neural progenitor cell line
which UCL will use to assess the ability to differentiate into functional T
cells and Natural Killer ('NK') cells. If successful, the CXT-iPSC cell lines
will be used to generate chimeric antigen ('CAR') T cells and/or CAR-NK cells.
Additionally in November a separate collaboration with UCL demonstrated that
iPSCs can be differentiated into Schwann cells with potential applications in
areas such as peripheral nerve damage repair.
Fosun Pharma continues to develop CTX in stroke disability in China following
the out-licence agreement signed with ReNeuron in 2019. The Company continues
to look to progress this programme in other geographies though regional
partnerships.
Corporate and Organisational Development
During the period, ReNeuron has reconfigured the Board by appointing Iain Ross
as Non-Executive Chairman and Barbara Staehelin as Senior Independent
Non-Executive Director. Following the appointment of Iain Ross, Dr Tim Corn
stepped down as Chairman but continues to serve as a Non-Executive Director.
The Company welcomed Dr Stefano Pluchino as Chief Scientific Officer in May
2021 and post period end in October 2021 Catherine Isted, ACMA, joined the
Board, replacing Michael Hunt as Chief Financial Officer. Also, in October
2021 Professor Sir Chris Evans OBE stood down as a Non-Executive Director. He
will remain as an adviser to the Board.
Outlook
On the Company's programme in retinitis pigmentosa, early data from the
Company's extension study is expected in late Q1 2022 and following analysis
of this data, the Company will decide on the most appropriate next steps to
progress this programme to the next stage.
ReNeuron is encouraged by the progress made on its proprietary Exosomes
platform over the last year and the growing excitement in the Exosomes field.
The Company looks to capitalise on the potential it sees in this field by
progressing its current collaborations and additionally by adding new partner
collaborations. The Company will continue to expand its expertise in the
Exosomes field organically through internal research but also potentially
inorganically if a suitable opportunity arises.
The Company looks forward to the coming 12 months as it continues to build and
grow on the foundations and developments achieved in the year to date.
Olav Hellebø
Chief Executive Officer
FINANCIAL REVIEW
During the first half of the financial year costs continue to be closely
controlled with spend primarily directed towards progressing the Group's hRPC
therapeutic candidate and proprietary exosome platform. The total
comprehensive loss for the period reducing to £5.2 million (H1 2020: £7.1
million).
At 30 September 2021, the Group had cash, cash equivalents and bank deposits
of £17.4 million providing at least a 12-month runway from the date of this
announcement.
FINANCIAL HIGHLIGHTS Six months ended 30 September 2021 Six months ended 30 September 2020 Year ended 31 March
(£'000) 2021
Revenue 58 41 257
Total comprehensive loss 5,234 7,092 11,347
Operating expenses 6,128 7,859 13,249
Net cash used in operating activities
4,599 2,588 6,052
Cash, cash equivalents & bank deposits
17,418 9,768 22,203
Revenue and Other Operating Income
In the six months to 30 September 2021, revenues, which relate to royalty
income, were £58,000 (H1 2020: £41,000). No grant income was received in the
period. In 2020, £78,000 was received under the Government's Coronavirus Job
Retention Scheme and is shown as other operating income.
Operating expenses
Total operating expenses reduced in the period to £6.1million (H1 2020: £7.9
million).
This reduction in costs follows a review of programme priorities and resource
requirements, with the Group making the decision to primarily focus its
resources on its hRPC therapeutic candidate and proprietary exosome platform
following the cessation of the stroke disability programme.
Research and development (R&D) expenditure reduced to £4.3 million (H1
2020: £5.9 million), primarily reflecting the refocussing of activities as
described above, together with consequent cost reductions.
General and administrative expenses declined in the period to £1.8 million
(H1 2020: £1.9 million). The current year period also included £0.3 million
in respect of the cost of a payment in lieu of notice for the former CFO.
Finance income/expense
Finance income represents income received from the Group's cash and
investments and gains from foreign exchange, with losses from foreign exchange
shown in finance expense.
Finance income was £124,000 in the period (H1 2020: £16,000). The current
period includes foreign exchange gains of £112,000 (H1 2020: interest
receivable only). In the current period, finance expense solely comprises
lease interest of £18,000 (2020: £243,000, which included £225,000 foreign
exchange losses).
Taxation
Taxation for the period at £0.7 million primarily comprises R&D tax
credit (H1 2020: £0.9 million). The amount of the R&D tax credit reducing
in line with the reduction in research and development spend.
Cash flow
Net cash used in operating activities in the period increased to £4.6 million
(H1 2020: £2.6 million), the 2020 figure benefitting from an R&D tax
credit receipt of £2.9 million due for the financial year ended 31 March
2019.
The Group had cash, cash equivalents and bank deposits totalling £17.4
million as of 30 September 2021 (31 March 2021: £22.2 million), providing at
least a 12-month runway from the date of this announcement.
Statement of financial position
Non-current assets - Property, plant and equipment have increased as we invest
in equipment to further develop the hRPC drug product manufacturing process.
Current assets - Corporation tax receivable of £2.6 million comprises the
amount due from R&D tax credits for the full year ended 31 March 2021 plus
the credit due for the current period (2020: £3.8 million). This debtor is
lower than 2020 due to the reduction in research and development expenditure
following cessation of the stroke programme.
Current liabilities - Trade and other payables at £6.6 million are lower than
30 September 2020 but have increased since the start of the financial year.
These movements primarily reflect changes in the level of accruals relating to
clinical trials.
Catherine Isted
Chief Financial Officer
Interim Financial Statements
Unaudited Consolidated Statement
of Comprehensive Income
for the six months ended 30 September 2021
Six months ended Six months ended Year ended
30 September 30 September 31 March
2021 2020 2021
Note £'000 £'000 £'000
Revenue 4 58 41 257
Other operating income 6 - 78 78
Research and development costs (4,340) (5,941) (9,503)
General and administrative costs (1,788) (1,918) (3,746)
Operating loss (6,070) (7,740) (12,914)
Finance income 7 124 16 20
Finance expense 8 (18) (243) (516)
Loss before income taxes (5,964) (7,967) (13,410)
Taxation 9 730 875 2,063
Loss and total comprehensive loss for the period (5,234) (7,092) (11,347)
Loss and total comprehensive loss attributable to equity owners of the company (5,234) (7,092) (11,347)
Basic and diluted loss per ordinary share 10 (9.2p) (22.3p) (29.0p)
Unaudited Consolidated Statement of Financial Position
as at 30 September 2021
30 September 30 September 31 March
2021 2020 2021
Note £'000 £'000 £'000
Assets
Non-current assets
Property, plant and equipment 325 314 213
Right-of-use asset 11 423 529 473
Intangible assets 186 186 186
934 1,029 872
Current assets
Trade and other receivables 517 835 444
Corporation tax receivable 2,565 3,778 1,832
Investments - bank deposits 6,000 - 7,500
Cash and cash equivalents 11,418 9,768 14,703
20,500 14,381 24,479
Total assets 21,434 15,410 25,351
Equity
Equity attributable to owners of the company
Share capital 12 569 319 569
Share premium account 12 113,925 97,904 113,904
Capital redemption reserve 40,294 40,294 40,294
Merger reserve 2,223 2,223 2,223
Accumulated losses (142,858) (134,111) (138,085)
Total equity 14,153 6,629 18,905
Liabilities
Current Liabilities
Trade and other payables 6,646 7,987 5,727
Lease liabilities 145 159 157
6,791 8,146 5,884
Non-current liabilities
Lease liabilities 490 635 562
490 635 562
Total liabilities 7,281 8,781 6,446
Total equity and liabilities 21,434 15,410 25,351
Unaudited Consolidated Statement of Changes in Equity
for the six months ended 30 September 2021
Share Capital
Share premium redemption Merger Accumulated Total
capital account reserve reserve losses Equity
£'000 £'000 £'000 £'000 £'000 £'000
As at 1 April 2020 318 97,890 40,294 2,223 (127,502) 13,223
Exercise of employee share options 1 14 - - - 15
Credit on share-based payment - - - - 483 483
Loss and total comprehensive loss for the period - - - - (7,092) (7,092)
As at 30 September 2020 319 97,904 40,294 2,223 (134,111) 6,629
Issue of share capital 250 17,229 - - - 17,479
Transaction costs - (1,237) - - - (1,237)
Exercise of employee share options - 8 - - - 8
Credit on share-based payment - - - - 281 281
Loss and total comprehensive loss for the period - - - - (4,255) (4,255)
As at 31 March 2021 569 113,904 40,294 2,223 (138,085) 18,905
Exercise of employee share options - 21 - - - 21
Credit on share-based payment - - - - 461 461
Loss and total comprehensive loss for the period - - - - (5,234) (5,234)
As at 30 September 2021 569 113,925 40,294 2,223 (142,858) 14,153
Unaudited Consolidated Statement of Cash Flows
for the six months ended 30 September 2021
Six months ended Six months ended Year ended
30 September 30 September 31 March
2021 2020 2021
Note £'000 £'000 £'000
Cash flows from operating activities
Cash used in operations 13 (4,578) (5,493) (12,075)
Overseas taxes paid (3) (3) (5)
Income tax credit received - 2,926 6,061
Interest paid (18) (18) (33)
Net cash used in operating activities (4,599) (2,588) (6,052)
Cash flows from investing activities
Capital expenditure (238) (3) (25)
Interest received 3 23 27
Net cash (used in)/generated by investing activities (235) 20 2
Cash flows from financing activities
Proceeds from the issue of ordinary shares 21 15 17,502
Transaction costs - - (1,237)
Bank deposits matured/(placed) 1,500 - (7,500)
Lease payments (84) (79) (154)
Net cash generated by/(used in) financing activities 1,437 (64) 8,611
Net (decrease)/increase in cash and cash equivalents 14 (3,397) (2,632) 2,561
Effect of foreign exchange rates 112 (225) (483)
Cash and cash equivalents at the start of period 14,703 12,625 12,625
Cash and cash equivalents at the end of period 15 11,418 9,768 14,703
Notes to the Interim Financial Statements
for the six months ended 30 September 2021
1. General information and basis of preparation
ReNeuron Group plc is an AIM listed company incorporated and domiciled in the
United Kingdom under the Companies Act 2006. The Company's registered office
and its principal place of business is Pencoed Business Park, Pencoed,
Bridgend CF35 5HY. Its shares are listed on the Alternative Investment Market
("AIM") of the London Stock Exchange.
These Interim Financial Statements were prepared by the Directors and approved
for issue on 30 November 2021. They have not been audited.
These Interim Financial Statements do not comprise statutory accounts within
the meaning of section 434 of the Companies Act 2006. Statutory accounts for
the year ended 31 March 2021 were approved by the Board of Directors on 6
August 2021 and delivered to the Registrar of Companies. The report of the
auditors on those accounts was unqualified and did not contain statements
under 498 (2) or (3) of the Companies Act 2006.
As permitted, these Interim Financial Statements have been prepared in
accordance with UK AIM rules and with International Accounting Standard 34
"Interim financial reporting". They should be read in conjunction with the
Annual Financial Statements for the year ended 31 March 2021, which have been
prepared in accordance with International Accounting Standards in conformity
with the Companies Act 2006 (IFRS) and the applicable legal requirements of
the Companies Act 2006.
2. Accounting policies
The accounting policies applied are consistent with those of the Annual
Financial Statements for the year ended 31 March 2021, as described in those
Annual Financial Statements. Where new standards or amendments to existing
standards have become effective during the year, there has been no material
impact on the net assets or results of the Group.
3. Going concern
The Group is expected to incur significant further costs as it continues to
develop its therapies and technologies through clinical development. The
operations of the Group are currently being financed from funds that have been
raised from share placings, commercial partnerships and grants.
The Group actively seeks further business development and fundraising
opportunities in order to support its ongoing development programmes. The
Board places considerable emphasis on communication with shareholders,
potential investors and other commercial organisations in order to maximise
the chances of success in exploiting these opportunities. The Group had cash,
cash equivalents and bank deposits totalling £17.4 million at half year (31
March 2021: £22.2 million).
Based on the above and taking into consideration that certain of the forecast
costs within the next 12 months are within the control of the Group, the
Directors expect that the Group's current financial resources will be
sufficient to support operations for at least the next 12 months from the date
of these financial statements and the Directors are continually reviewing
options to secure further funding to finance the future needs of the business.
The Group therefore continues to adopt the going concern basis in the
preparation of these financial statements.
4. Revenue
Six months Six months
Ended Ended Year ended
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
Royalty income 58 41 89
Income incidental to development activities - - 168
58 41 257
Royalty income is derived from the licensed sale of the Group's products to
customers in the USA.
Income incidental to development activities relates to fees received under
research agreements.
5. Segment information
The Group has identified the Chief Executive Officer as the Chief Operating
Decision Maker (CODM). The CODM manages the business as one segment, the
development of cell-based therapies. Since this is the only reporting segment,
no further information is included. The information used internally by the
CODM is the same as that disclosed in the Interim Financial Statements. The
Group's revenue derives wholly from assets located in the United Kingdom.
Revenue is analysed in note 4 above. Analysed by location of customer all
royalty income is derived from the United States of America.
6. Other operating income
Six months Six months
Ended Ended Year ended
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
Government grants - 78 78
In the prior period, £78,000 was received under the Government's Coronavirus
Job Retention Scheme.
7. Finance income
Six months Six months
Ended Ended Year ended
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
Interest received 12 16 20
Foreign exchange gains 112 - -
124 16 20
8. Finance expense
Six months Six months
Ended Ended Year ended
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
Lease interest 18 18 32
Foreign exchange losses - 225 484
18 243 516
9. Taxation
Six months Six months
Ended Ended Year ended
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
R & D tax credit 733 878 2,068
Foreign taxation (3) (3) (5)
730 875 2,063
10. Basic and diluted loss per share
The basic and diluted loss per share is calculated by dividing the loss for
the financial period of £5,234,000 (September 2020: £7,092,000, March 2021:
£11,347,000) by 56,907,676 shares (September 2020: 31,846,537 and March 2021:
39,128,925 shares), being the weighted average number of ordinary 1p shares in
issue during the period. Potential ordinary shares are not treated as dilutive
as the entity is loss-making.
11. Right-of-use-asset
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
At beginning of the period 473 591 591
Additions - - -
Depreciation charge (50) (62) (118)
At end of the period 423 529 473
The net book value of the underlying assets is as follows:
30 September 30 September 31 March
2021 2020 2020
(124)461 £'000 £'000 £'000
Land and buildings 421 516 469
Computer and office equipment 2 13 4
At end of the period 423 529 473
12. Share capital and share premium
Number of shares Share capital Share premium Total
£'000 £'000 £'000
As at 30 September 2020 31,874,324 319 97,904 98,223
Issue of new shares - equity fund raising 24,970,381 250 17,229 17,479
Transaction costs - - (1,237) (1,237)
Issue of new shares - share options exercised 11,000 - 8 8
As at 31 March 2021 56,855,705 569 113,904 114,473
Issue of new shares - share options exercised 80,697 - 21 21
As at 30 September 2021 56,936,402 569 113,925 114,494
13. Cash used in operations
Six months Six months
Ended Ended Year ended
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
Loss before income tax (5,964) (7,967) (13,410)
Adjustment for:
Finance income (124) (16) (20)
Finance expense 18 243 516
Depreciation of property, plant and equipment 126 141 262
Depreciation of right-of-use asset 50 62 118
Loss on disposal of fixed assets - - 2
Share-based payment charges 461 483 764
Changes in working capital:
Receivables (64) (146) 245
Payables 919 1,707 (552)
Cash used in operations (4,578) (5,493) (12,075)
14. Reconciliation of net cash flow to movement in net debt
Six months Six months
Ended Ended Year ended
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
Decrease in cash and cash equivalents (3,397) (2,632) 2,561
Effect of foreign exchange rates 112 (225) (484)
Lease repayments 102 97 187
Lease interest (18) (18) (32)
Net funds at start of period 13,984 11,752 11,752
Net funds at end of period 10,783 8,974 13,984
15. Analysis of net funds
Six months Six months
Ended Ended Year ended
30 September 30 September 31 March
2021 2020 2021
£'000 £'000 £'000
Cash and cash equivalents 11,418 9,768 14,703
Lease liabilities (635) (794) (719)
Net funds 10,783 8,974 13,984
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