TIDMRENE
RNS Number : 5401E
ReNeuron Group plc
08 July 2021
ReNeuron Group plc
("ReNeuron" or "the Company")
Preliminary Results for the year ended 31 March 2021
ReNeuron Group plc (AIM: RENE.L), a UK-based global leader in
the development of cell-based therapeutics , announces its
preliminary results for the year ended 31 March 2021.
Operational highlights
hRPC stem cell therapy candidate for retinal disease:
-- Efficacy signal seen in phase 2a subjects reaching 12 months
follow up with some variability of response seen between
subjects
-- Regulatory approval has been received for the expanded Phase
2a study in US, UK and Spain. This Phase 2a extension study
incorporates a doubling of the previous dose, which with other
study elements was designed to build on the efficacy signal seen in
the earlier cohorts of the study whilst trying to remove some of
the variability
-- Four out of the nine additional subjects have been treated to
date but a presumed case of bacterial endophthalmitis led to
precautionary temporary study enrolment suspension; however,
following a completed investigation, and with Data & Safety
Monitoring Board approval, the study has reopened to enrolment in
the US with amendments being filed to reopen in the UK and
Spain
-- Three-month data from extension segment of Phase 2a study to be available in Q4 2021
Exosome and iPSC platforms:
-- Four additional collaboration agreements signed with major
pharmaceutical/biotechnology companies and two with leading
academic institutions exploring multiple methods of loading
exosomes
-- Positive early pre-clinical data have shown efficient loading
of nucleic acid payloads in its exosomes and these exosome
candidates have also demonstrated functional payload delivery
-- Exosome pre-clinical proof-of-concept data from current
research collaborations are expected during Q4 2021
-- New immortalised, licensable cell lines have been generated
from the Company's iPSC platform as potential therapeutic agents
for cancer immunotherapy and type 1 diabetes
CTX stem cell therapy candidate
-- Strategic decision in June 2020 to progress stroke disability
programme through regional partnerships
- Fosun Pharma to develop and commercialise CTX programme in
China under the exclusive out-licence agreement signed in April
2019
- CTX cell therapy candidate available for licensing in stroke
disability outside China and in all territories in other potential
indications
Board changes:
-- Non-executive Board membership reconfigured in September 2020
and CFO announced his retirement from the Board in March 2021
-- On 1 July 2021, Iain Ross appointed as Non-Executive Chairman
-- Recruitment of new Chief Financial Officer continues to progress well
Financial highlights
-- Successful fundraise in December 2020, raising approximately
GBP17.5 million (before expenses)
-- Loss for the year slightly lower than expectations at GBP11.3
million (2020: loss of GBP11.4 million, including an upfront
payment of GBP5.4 million, net of withholding tax, received through
the licence agreement for ReNeuron's CTX and hRPC cell therapy
programmes in Greater China with Fosun Pharma)
-- Reduced costs incurred in the period of GBP13.2 million (2020: GBP20.6 million)
-- Reduced cash used in operating activities of GBP6.1 million (2020: GBP14.3 million)
-- Cash, cash equivalents and bank deposits at 31 March 2021 of
GBP22.2 million (2020: GBP12.6 million), providing at least a
12-month runway from the date of this announcement
Commenting on the results, Olav Hellebø, Chief Executive
Officer, said:
"Over the previous financial year, we have been successful in
designing and implementing an extension cohort in the phase 2a
clinical trial of our hRPC cell therapy candidate in retinitis
pigmentosa, including doubling of the dose and other changes
designed to amplify the efficacy signal seen in earlier cohorts. We
have received regulatory approvals in the US, UK and Spain, and
have started enrolment in all countries. Although dosing was
temporarily suspended during the investigation of a presumed
bacterial infection, the clinical trial is being restarted, and we
expect subjects to be treated shortly, with further data to be
presented later in Q4 2021.
"Our exosome and iPSC platforms have also progressed well during
the period, with multiple industry-based collaborations now in
progress across both platforms and the prospect of pre-clinical
proof-of-concept data over the coming months.
"Our decision in 2020 to focus the Company's resources on our
retinal disease programme and our exosome and iPSC platforms has
resulted in significantly lower operating costs, as reflected in
the results for the year. This renewed clarity of focus, together
with the fundraise in December, will enable us to reach important,
data-driven potential value inflection points across our programmes
over the next 12 months."
Investor presentation:
Olav Hellebø, Chief Executive Officer; Rick Beckman, Chief
Medical Officer; and John Hawkins, Financial Controller, will be
hosting a live online presentation at 4.30pm today via the Investor
Meet Company Platform. Investors can register for the meeting here:
https://www.investormeetcompany.com/reneuron-group-plc/register-investor
A recording of the presentation will also available on the
ReNeuron website in due course: www.reneuron.com .
ENQUIRIES:
ReNeuron www.reneuron.com/investors
Olav Hellebø, Chief Executive Officer Via Walbrook PR
Stifel Nicolaus Europe Limited (NOMAD
and Joint Broker)
Ben Maddison, Stewart Wallace +44 (0)20 7710 7600
Allenby Capital Limited (Joint Broker)
James Reeve/George Payne (Corporate
Finance)
Tim Sohal (Sales & Corporate Broking) +44 (0)20 3328 5656
Walbrook PR (Media & Investor +44 (0)20 7933 8780 or reneuron@walbrookpr.com
Relations)
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 global leader in cell-based therapeutics,
harnessing its unique stem cell technologies to develop 'off the
shelf' stem cell 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.
ReNeuron is also advancing its proprietary exosome technology
platform as a potential delivery system for drugs that treat
diseases of the central nervous system and other disorders. The
Company also has the ability through its conditionally immortalised
induced pluripotent stem cell (iPSC) platform to make allogeneic
tissue cells of choice; in-house programmes are currently focused
on treatments for blood cancers and diabetes.
ReNeuron's shares are traded on the London AIM market under the
symbol RENE.L. For further information visit 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
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.
CHAIRMAN'S STATEMENT
I am pleased to introduce the Group's Preliminary Results for
the year ended 31 March 2021. It was a challenging year for
everyone with the impact of the coronavirus pandemic and firstly,
on behalf of the Company and the Board, I would like to thank our
staff, our clinical trial subjects, our commercial and academic
partners, our advisors and our shareholders for their continued
commitment to the Company and for the resilience they have shown
over the past 12 months.
Despite the challenges, the year has again been one of
significant progress in both our clinical and strategic
development, giving us continued encouragement regarding the
potential of the Company's programmes in the short to medium term
and beyond.
We remain highly encouraged by the positive one-year data from
the initial cohorts of Phase 2a subjects treated in the ongoing
Phase 1/2 clinical trial with our hRPC cell therapy candidate for
retinitis pigmentosa. We were pleased to receive regulatory
approval from the FDA, MHRA and the Spanish Regulatory Agency to
expand the ongoing Phase 2a part of the study to treat patients
with retinitis pigmentosa (RP) at a higher dose level, at clinical
sites in the US, UK and Spain. We were disappointed that we
recently had to suspend dosing of subjects across all sites after a
subject unfortunately presented with a presumed case of bacterial
endophthalmitis. Following a completed investigation, and with Data
& Safety Monitoring Board approval, the study has reopened to
enrolment in the US with amendments being filed to reopen in the UK
and Spain . We look forward to reporting further Phase 2a data from
the study in Q4 2021, rather than Q3 2021 as originally
planned.
Our exosome technology is being exploited as a novel vector for
delivering third party biological drugs and this partnering
strategy reflects increasing industry interest in exosomes. We have
signed a number of collaboration agreements with major
pharmaceutical/biotechnology companies and academic institutions to
explore the potential of the Company's exosomes to deliver novel
therapeutic agents to the brain and other regions of the body.
Early pre-clinical data have been positive and further data across
the collaborations are expected in the coming months.
During the period, we have continued to progress our CTX
cell-based iPSC technology in a number of potential applications.
We are deploying this technology to develop new, immortalised
allogeneic cell lines of varying types as potential therapeutic
agents in diseases of unmet medical need for subsequent licensing
to third parties.
During the year, we announced our intention to focus the
Company's resources on our retinal disease programme and our
exosome and iPSC research platforms. Consequently, we halted the
PISCES III clinical trial of our CTX cell therapy candidate for
stroke disability in the US and looked for opportunities to
continue the programme through partnerships. We also announced our
intention to license out the CTX cell therapy candidate in other
indications.
During the COVID-19 pandemic, the safety of employees,
suppliers, clinical trial participants and all other people with
whom the Company interacts has been of over-riding importance to
us. The Company has adapted throughout the year to continue to
comply with governmental advice and requirements across its
operations in the UK, EU and US, without significant impact on our
priority internal research projects.
During the period, we reduced the non-executive membership of
the Board of the Company. As part of this reconfiguration, I became
Chairman of the Board and Mark Evans, the chairman of Obotritia
Capital KGaA ("Obotritia"), was appointed as a non-independent
Non-Executive Director of the Company in recognition of Obotritia's
significant shareholding and ongoing support for the Company.
Since then, we have further configured the Board and I would
like to welcome Iain Ross to the Board as Non-Executive Director
and Chairman of the Board of Directors. Iain is a highly
experienced board director with a career in the international life
sciences and technology sectors that spans 40 years. He will be an
excellent addition to the Board at a pivotal time for the Company
and I wish him the best in his endeavours.
In March, Michael Hunt, CFO of ReNeuron resigned to pursue other
projects. Michael joined ReNeuron in 2001 and with tenures over the
years as both CFO and CEO of the Company, Michael has played a key
role in the development of ReNeuron into the exciting business that
it is today. I would like to thank Michael for his very significant
contribution to the Company and wish him well in his future
endeavours.
ReNeuron has a clear focus to deliver value-generating data
across its programmes over the next twelve months and we look
forward to updating our shareholders as we continue to make
progress.
Dr Tim Corn
Outgoing Non-Executive Chairman and current Non-Executive
Director
NEW CHAIRMAN'S STATEMENT
I am delighted to be joining ReNeuron at such a pivotal time as
we look to ensure a significant uplift in shareholder value over
the next few years.
I would like to thank Tim for his work over the last 10 months
and will look forward to working alongside him as he continues his
role as Non-Executive Director, as well as the rest of the Board
and Management team.
Iain Ross
Newly Appointed Non-Executive Chairman, as of 1 July 2021
CHIEF EXECUTIVE OFFICER'S REVIEW
Review of clinical programmes
hRPC (human retinal progenitor cells) for retinal disease
The hRPC therapeutic candidate 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 and, prior to 2021,
has been conducted at two clinical sites in the US. Having received
regulatory approvals in the UK and in Spain, the Company now has
three clinical sites in the US, one in the UK and one in Spain.
In June 2020, we announced an update regarding the ongoing Phase
2a study of our hRPC cell therapy candidate in RP patients. The
data at that point continued to demonstrate the efficacy of the
therapy, with a clinically meaningful benefit being observed at all
time-points. In January 2021, we confirmed that all patients in the
study had reached 6 months follow-up post-treatment, eight patients
had reached 9 months follow-up, seven patients had reached 12
months follow-up and two patients had reached 18 months follow-up.
Following the commencement of the high dose extension of this Phase
2a study, we look forward to presenting further data from this
study later in Q4 2021.
In January 2021, the Company announced the completion of dosing
of the first cohort of three subjects in the Phase 2a extension
segment of the study. This segment of the study is treating up to
nine subjects with RP at a higher dose level than the first 10
subjects already treated in the study. In line with the clinical
trial protocol, the Data & Safety Monitoring Board for the
study has reviewed the short-term safety data from this first
cohort and gave its approval for the study to proceed to dosing the
next cohort.
Also in January 2021, the Company was pleased to report that a
subject had been dosed in the study at a new US site, the
prestigious Casey Eye Institute, Oregon Health & Science
University. The Principal Investigator at this new site is Mark
Pennesi, MD, PhD, Associate Professor of Ophthalmology, Kenneth C.
Swan Endowed Professor and Chief, Paul H. Casey Ophthalmic Genetics
Division.
We have previously announced that we have received regulatory
approval to expand the Phase 2a study in the UK and regulatory
approval has also been received to expand the Phase 2a study in
Spain. The Company has activated two new sites in the UK and in
Spain (The Oxford Eye Hospital and The Institut de la Màcula,
Barcelona) to expand the Phase 2a extension study outside the US,
thus representing a total of four active sites worldwide.
In early June 2021, we announced that unfortunately, following a
successful surgical procedure, the most recently enrolled subject
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 we temporarily suspended the dosing of further
subjects in the study while we 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 agreed that the study may proceed. The study has reopened for
enrolment in the US and regulatory filings are being made to reopen
the study in the UK and Spain. It is anticipated that this process
will conclude in August and if so this would allow dosing to resume
in all three territories.
There is a pipeline of subjects in screening which gives the
Company confidence that following the impending re-start of the
Phase 2a study, all subjects will be treated within the next
quarter. Data from the earlier cohorts of subjects indicate that
3-month data have been a good predictor for 12-month data and the
plan is to present a minimum of 3-month data for the subjects from
the extension segment of the Phase 2a study.
The Company anticipates that, subject to the sufficiency of this
expanded Phase 2a data, it will be able to seek regulatory approval
to commence a pivotal clinical study in the second half of 2022
with its hRPC cell therapy candidate in RP. The pivotal study will
be designed to demonstrate further the safety and efficacy of this
treatment and, assuming a successful outcome, enable ReNeuron to
seek marketing approvals for its hRPC cell therapy candidate in RP
in selected major markets.
Our hRPC cell therapy candidate offers a number of potential
advantages over alternative approaches to the treatment of RP.
Firstly, our cell therapy candidate is independent of the many
specific genetic defects that collectively define RP as a disease,
thereby allowing a much broader potential patient population to be
eligible for the treatment. Secondly, the cells are cryopreserved,
enabling on-demand shipment and use at local surgeries and
hospitals. Finally, the cells are injected directly to the site of
retinal degeneration, allowing a greater chance of anatomic
restoration of photoreceptor function.
Our RP clinical programme has been granted Orphan Drug
Designation in both Europe and the US, as well as Fast Track
designation from the FDA in the US. Orphan Drug Designation
provides the potential for a significant period of market
exclusivity once the therapy is approved in those territories. Fast
Track designated products may also be eligible for accelerated
approval and priority review processes at FDA.
During the period, we were pleased to announce that the US
Patent and Trademark Office (USPTO) had completed its examination
of the Company's patent application (14/379,239), entitled
"Phenotype profile of human retinal progenitor cells", and the
patent was granted in September 2020 (patent number 10,758,572).
The allowed patent protects the composition of our hRPC cell
therapy candidate for retinal diseases and adds further
intellectual property protection to the hRPC technology, which
already has patent protection in a number of other major
territories including Europe, Japan and Australia.
Exosome platform
ReNeuron is developing its exosome platform in collaboration
with pharmaceutical, biotechnology and academic partners as a novel
delivery vehicle for third party therapeutic agents targeting the
brain and other parts of the body. The Company's proprietary cell
lines produce a panel of distinct exosome drug delivery candidate
tools with commercial potential, and the Company's iPSC programme
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.
ReNeuron is exploring multiple strategies for loading exosomes
and has signed a further four separate research collaboration
agreements with major pharmaceutical/biotechnology companies on
these projects during the period.
These collaborations have demonstrated efficient loading of
nucleic acid payloads in the Company's exosomes and functional
payload delivery, in vivo, to the brain and peripheral tissues via
systemic administration.
Specifically, target knockdown by exosome candidates was
assessed in multiple brain regions and in key peripheral tissues
including the heart, the kidney and the skeletal muscle. Evidence
of target knockdown was observed in each of these organs suggesting
these exosomes have the potential to deliver payloads to
therapeutically-meaningful levels to a variety of tissues. These
studies have also anticipated that exosomes are well-tolerated,
laying the foundation for expansion to functional delivery
studies.
The Company has initiated two additional collaborations with
leading academic institutions in the UK and mainland Europe. One
key aim of these studies is to consolidate data from a recent pilot
study which showed that exosome-loaded growth factors can engage
target receptors in the CNS. Confirmation of these findings will
enable further studies examining functional delivery of growth
factors by the Company's exosomes.
In addition to exploiting natural exosome tissue specificity,
ReNeuron has also now successfully decorated the surface of its
neural stem-cell derived exosomes with a specific tissue-targeting
peptide. This proprietary peptide was modified to enhance binding
to the exosome surface, resulting in a several fold increase in
surface binding compared with unmodified peptide. This complex has
been shown to be stable, enabling the next phase of this
collaboration, which aims to confirm that the peptide promotes
exosome targeting to additional tissues in vivo. This peptide
platform has the potential to generate further targeting peptides
that would rapidly expand the therapeutic reach of ReNeuron's
exosome candidates.
Further data across these collaborations are expected during the
course of the next six months, which, if positive, will enable
subsequent potential out-licensing deals with the Company's exosome
platform.
Induced Pluripotent Stem Cell (iPSC) Platform
During the period, we have also progressed our CTX cell-based
iPSC technology in a number of potential applications. We are
deploying this technology to develop new, immortalised allogeneic
cell lines of varying types as potential therapeutic agents in
diseases of unmet medical need for subsequent licensing to third
parties.
Our CTX-iPSCs can be differentiated into hematopoietic stem
cells, lymphoid progenitors and, of great interest for cancer
immunotherapy, NK and killer T-cells. We are currently
collaborating with a commercial third party to explore the
possibility of large-scale in vitro expansion of CTX-iPSC-derived
hematopoietic stem cells and discussions are ongoing with other
interested parties in the immunotherapy field.
We have also produced pancreatic progenitor cells from our
CTX-iPSCs and from these, insulin-producing <BETA>-islet
cells. We are currently scaling up this process prior to phenotype
analysis and confirmation of the glucose responsiveness of these
derived, mature <BETA>-islets.
Other activities
During the period, we announced that, following a review of
programme priorities and resource requirements, we intended to
focus the Company's resources on our retinal disease programme and
our exosome and iPSC platforms. As a result, we have closed down
the PISCES III clinical trial of our CTX cell therapy candidate for
stroke disability in the US and our stroke disability programme
will now only continue through partnerships, as it is our stated
intention to license out the CTX cell therapy candidate in other
indications.
Financial review
Revenues in the year amounted to GBP0.3 million representing
royalties from non-therapeutic licensing activities and income from
research collaboration activities (2020: GBP6.1 million; GBP0.1
million of royalties plus an upfront licence fee of GBP6.0 million
received from Fosun Pharma in respect of the above-mentioned
licence agreement signed with that company in April 2019). Grant
income of GBP0.1 million (2020: GBP0.1 million) was received in the
period and is shown as other operating income. The 2021 figure
represents funds received under the Government's Coronavirus Job
Retention Scheme.
Total operating costs reduced in the period to GBP13.2 million
(2020: GBP20.6 million). This reduction in costs follows a review
of programme priorities and resource requirements, with the Company
making the decision to focus its resources on its retinal disease
programme and its exosome and iPSC platforms. Research and
development costs in the year reduced to GBP9.5 million (2020:
GBP16.3 million), primarily reflecting the cost savings achieved as
a result of this review and accounting for 72% of operating
expenses (2020: 79%). General and administrative expenses reduced
to GBP3.7 million (2020: GBP4.2 million).
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
GBP20,000 in the period (2020: GBP0.6 million). In 2020, finance
income included foreign exchange gains of GBP0.3 million. In 2021,
the movement in exchange rates has led to a foreign exchange loss
of GBP0.5 million, which is therefore included in finance expense.
Finance expense also includes lease interest of GBP32,000 (2020:
GBP42,000). The Group holds cash and investments in foreign
currencies in order to hedge against operational spend and the
strengthening of sterling against the US dollar during the period
has resulted in a relative devaluation of the Group's foreign
currency deposits.
The total tax credit for the period was GBP2.0 million (2020:
GBP3.0 million). The figure in 2020 was offset by overseas taxes
paid of GBP0.6 million, related to the income received from Fosun
Pharma, to give a net reported tax credit of GBP2.4 million. The
reduction in the tax credit reflects the reduction in research and
development costs.
As a result of the above, the total comprehensive loss for the
year reduced marginally to GBP11.3 million (2020: GBP11.4
million).
Net cash used in operating activities in the period reduced to
GBP6.1 million (2020: GBP14.3 million), broadly reflecting the
above-mentioned reduction in operating costs and the receipt during
the period of the GBP2.9 million tax credit due for the year ended
31 March 2019; the figure in 2020 being net of the Fosun Pharma
licence fee of GBP5.4 million (net of withholding tax).
The Group had cash, cash equivalents and bank deposits totalling
GBP22.2 million at the year-end (2020: GBP12.6 million). In
December 2020, the Company raised GBP17.5 million, before expenses,
by means of a placing, subscription and open offer.
Summary and outlook
During the period under review, we have continued to generate
encouraging positive efficacy data from the initial cohorts of
subjects in the ongoing Phase 2a clinical trial of our hRPC cell
therapy candidate in RP. Having received regulatory approvals in
the UK and Spain to expand the ongoing study outside the US, we
look forward to continuing treatment of patients at a higher dose
level and will be pleased to present further data from this
extended study in Q4 2021. The enhanced data set will inform the
design of the subsequent pivotal Phase 3 study required for
marketing approval, which is anticipated to commence in H2
2022.
Our exosome and iPSC platforms have also progressed well during
the period, with multiple industry-based collaborations now in
progress across both platforms and the prospect of pre-clinical
proof-of-concept data over the coming months.
Our decision earlier this year to focus the Company's resources
on our retinal disease programme and our exosome and iPSC platforms
has resulted in significantly lowered operating costs, as reflected
in the results for the year. This renewed clarity of focus,
together with the fundraise in December, will enable us to reach
important, data-driven potential value inflection points across our
programmes over the next 12 months.
Olav Hellebø
Chief Executive Officer
Group Statement of Comprehensive Income for the year ended 31
March 2021
2021 2020
Note GBP'000 GBP'000
------------------------------------------------ ----- --------- ---------
Revenue 257 6,065
Other income 78 100
Research and development costs 4,5 (9,503) (16,335)
General and administrative costs 5 (3,746) (4,239)
------------------------------------------------ ----- ---------
Operating loss (12,914) (14,409)
Finance income 20 593
Finance expense (516) (42)
------------------------------------------------ ----- ---------
Loss before income tax (13,410) (13,858)
Taxation 6 2,063 2,446
------------------------------------------------ ----- ---------
Loss and total comprehensive loss for
the year (11,347) (11,412)
------------------------------------------------ ----- --------- ---------
Loss and total comprehensive loss attributable
to equity owners of the Company (11,347) (11,412)
------------------------------------------------ ----- --------- ---------
Basic and diluted loss per ordinary share 7 (29.0p) (35.9p)
------------------------------------------------ ----- --------- ---------
Group Statement of Financial Position as at 31 March
2021 2020
Note GBP'000 GBP'000
---------------------------------------------- ----- ---------- ----------
Assets
Non-current assets
Property, plant and equipment 213 452
Right-of-use asset 473 591
Intangible assets 186 186
872 1,229
---------------------------------------------- ----- ---------- ----------
Current assets
Trade and other receivables 444 696
Income tax receivable 1,832 5,826
Investments - bank deposit 7,500 -
Cash and cash equivalents 14,703 12,625
---------------------------------------------- ----- ---------- ----------
24,479 19,147
---------------------------------------------- ----- ---------- ----------
Total assets 25,351 20,376
---------------------------------------------- ----- ---------- ----------
Equity
Equity attributable to owners of the Company
Share capital 569 318
Share premium account 113,904 97,890
Capital redemption reserve 40,294 40,294
Merger reserve 2,223 2,223
Accumulated losses (138,085) (127,502)
---------------------------------------------- ----- ---------- ----------
Total equity 18,905 13,223
---------------------------------------------- ----- ---------- ----------
Liabilities
Current liabilities
Trade and other payables 5,727 6,280
Lease liabilities 157 166
5,884 6,446
---------------------------------------------- ----- ---------- ----------
Non-current liabilities
Lease liabilities 562 707
---------------------------------------------- ----- ---------- ----------
562 707
---------------------------------------------- ----- ---------- ----------
Total liabilities 8 6,446 7,153
---------------------------------------------- ----- ---------- ----------
Total equity and liabilities 25,351 20,376
---------------------------------------------- ----- ---------- ----------
Group Statement of Changes in Equity
Share Capital
Share premium redemption Merger Accumulated Total
capital account reserve reserve losses equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------------ -------- -------- ----------- -------- ------------ ---------
As at 1 April 2019 316 97,704 40,294 2,223 (117,293) 23,244
Issue of ordinary
shares 2 186 - - - 188
Credit on share-based
payment - - - - 1,203 1,203
Loss and total comprehensive
loss for the year - - - - (11,412) (11,412)
As at 31 March 2020 318 97,890 40,294 2,223 (127,502) 13,223
Issue of ordinary
shares 251 17,251 - - - 17,502
Costs of share issue - (1,237) - - - (1,237)
Credit on share-based
payment - - - - 764 764
Loss and total comprehensive
loss for the year - - - - (11,347) (11,347)
As at 31 March 2021 569 113,904 40,294 2,223 (138,085) 18,905
------------------------------ -------- -------- ----------- -------- ------------ ---------
Group Statement of Cash Flows for the year
ended 31 March
2021 2020
Note GBP'000 GBP'000
Cash flows from operating activities
Cash used in operations 9 (12,075) (13,651)
Overseas taxes paid (5) (611)
Income tax credit received 6,061 -
Interest paid (33) (42)
Net cash used in operating activities (6,052) (14,304)
Cash flows from investing activities
Capital expenditure - Fixed Assets (25) (119)
Interest received 27 300
Net cash generated from investing activities 2 181
Cash flows from financing activities
Proceeds from the issue of ordinary
shares 17,502 188
Costs of share issue (1,237) -
Bank deposit (invested)/matured (7,500) 6,093
Lease payments (154) (144)
Lease finance - 12
Net cash generated from financing activities 8,611 6,149
---------------------------------------------- ----- --------- ---------
Net increase/(decrease) in cash and
cash equivalents 2,561 (7,974)
Effect of FX movements on cash balances (483) 167
Cash and cash equivalents at the start
of year 12,625 20,432
Cash and cash equivalents at the end
of the year 14,703 12,625
---------------------------------------------- ----- --------- ---------
Notes to the financial information for the year ended 31 March
2021
1. General information
ReNeuron Group plc ("the Company") and its subsidiaries
(together "the Group") are engaged in the research and development
of therapies using stem cells. The Company is a public limited
company incorporated and domiciled in England with registered
number 05474163. Its shares are admitted to trading on the AIM
market of the London Stock Exchange.
2. Basis of preparation
The unaudited financial information included in this preliminary
results announcement for the year ended 31 March 2021 and audited
financial information for the year ended 31 March 2020 does not
comprise statutory accounts within the meaning of section 434 of
the Companies Act 2006. The information has been extracted from the
draft statutory financial statements for the year ended 31 March
2021 which will be delivered to the Registrar of Companies in due
course. Statutory financial statements for the year ended 31 March
2020 were approved by the Board of directors on 12 August 2020 and
have been delivered to the Registrar of Companies. The report of
the auditors on these financial statements was unqualified but did
include an emphasis of matter paragraph regarding a material
uncertainty related to going concern.
The financial statements 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.
Whilst the financial information included in this preliminary
announcement has been prepared in accordance with IFRS, this
announcement does not contain sufficient information to comply with
IFRS. The accounting policies used in the preparation of these
unaudited financial statements are consistent with those used in
the preparation of the audited financial statements for the year
ended 31 March 2020.
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 GBP22.2 million at the
year-end (2020: GBP12.6 million). In December 2020, the Company
raised GBP17.5 million, before expenses, by means of a placing,
subscription and open offer.
Based on the above, 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. Research and development costs
All research and development costs incurred in the year have
been charged directly to the Group Statement of Comprehensive
Income.
5. Operating expenses
2021 2020
GBP'000 GBP'000
---------------------------------------------- -------- --------
Loss before income tax is stated after
charging:
---------------------------------------------- -------- --------
Research and development costs:
Employee benefits 3,258 4,502
Depreciation of property, plant and equipment 216 228
Depreciation of right-of-use asset 19 25
Lease payment 6 -
Other expenses 6,004 11,580
---------------------------------------------- -------- --------
Total research and development costs 9,503 16,335
---------------------------------------------- -------- --------
General and administrative costs:
Employee benefits 2,190 2,166
Legal and professional fees 653 911
Depreciation of property, plant and equipment 46 59
Depreciation of right-of-use asset 99 100
Loss on disposal of fixed assets 2 -
Other expenses 75 1,003
---------------------------------------------- -------- --------
Total general and administrative costs 3,746 4,239
---------------------------------------------- -------- --------
Total research and development costs and
general and administrative costs 13,249 20,574
---------------------------------------------- -------- --------
6. Taxation
No corporation tax liability arises on the results for the year
due to the loss incurred.
As a loss-making small and medium-sized enterprise, the Group is
entitled to research and development tax credits at 14.5% (2020:
14.5%) on 230% (2020: 230%) of qualifying expenditure for the year
to 31 March 2021.
2021 2020
GBP'000 GBP'000
--------------------------------------- -------- --------
UK research and development tax credit
at 14.5% (2020: 14.5%) 2,068 3,057
Overseas taxation (5) (611)
--------------------------------------- -------- --------
2,063 2,446
--------------------------------------- -------- --------
The tax credit compares with the loss for the year as
follows:
2021 2020
GBP'000 GBP'000
---------------------------------------------- -------- --------
Loss before income tax 13,410 13,858
---------------------------------------------- -------- --------
Loss before income tax multiplied by the
main rate of corporation tax of 19% (2020:
19%) 2,548 2,633
---------------------------------------------- -------- --------
Effects of:
- difference between depreciation and capital
allowances (33) (22)
- expenses not deductible for tax purposes (132) (612)
- losses not recognised (550) 900
- adjustments in respect of prior year 236 158
Overseas taxes paid (5) (611)
---------------------------------------------- -------- --------
Tax credit 2,063 2,446
---------------------------------------------- -------- --------
No deferred tax asset has been recognised by the Group as there
are currently no foreseeable trading profits.
7. Basic and diluted loss per ordinary share
The basic and diluted loss per share is calculated by dividing
the loss for the financial year of GBP11,347,000 (2020: 11,412,000)
by 39,128,925 shares (2020: 31,811,456 shares), being the weighted
average number of 1p Ordinary shares in issue during the year.
Potential Ordinary shares are not treated as dilutive as the
entity is loss making.
8. Ageing profile of financial liabilities
2021 2020
GBP'000 GBP'000
------------------------------------------ -------- --------
Trade and other payables due within three
months 5,727 6,280
Current lease liabilities - due within
one year 157 166
Non-current lease liabilities - due after
more than one year 562 707
------------------------------------------ -------- --------
6,446 7,153
------------------------------------------ -------- --------
9. Cash used in operations
Year Year
ended ended
31-Mar 31-Mar
2021 2020
GBP'000 GBP'000
Loss before income tax (13,410) (13,858)
Adjustments for:
Finance income (20) (593)
Finance expense 516 42
Depreciation of property, plant and
equipment 262 287
Depreciation of Right-of-use-asset 118 125
Loss on disposal of fixed assets 2 -
Share-based payment charges 764 1,203
Changes in working capital:
Receivables 245 126
Payables (552) (983)
Cash used in operations (12,075) (13,651)
--------------------------------------- --------- ---------
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July 08, 2021 02:00 ET (06:00 GMT)
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