Oxford Cannabinoid
Technologies Holdings plc
("OCTP" or the
"Company")
Interim results for the six
months ended 31 October 2023
Oxford Cannabinoid Technologies
Holdings plc, the biotech company developing prescription
cannabinoid medicines for approval by global regulatory agencies
and targeting the US$ multi-billion pain market, is pleased to
announce its interim results for the six months ended 31 October
2023 (the "Period").
Operational Highlights
· Successful completion of the Company's first Phase I Single
Ascending Dose (SAD) clinical trial for its lead programme,
OCT461201 (programme 1)
· Discovery of a potential first-in-class immunotherapy agent
for the treatment of solid tumours
· Creation of the new role of Chief Medical Officer and the
appointment of Dr Tim Corn to the executive management
team
Financial Highlights
· Programme spend £1.1m on lead Programme OCT461201 to complete
phase I SAD
· Received R&D tax credit relating to FY2022 for £0.7m; 2023
Debtor of £1.3m approved by HMRC
· Working capital reduced (including salaries and overheads) as
costs managed to preserve cash runway
· Cash
balance of £1.1m at the end of October 2023 - runway extends
through end of Q1 2024
· Current liabilities are low at £0.8m
· No
long-term liabilities
· All
programme spend and administrative expenses in line with or below
budgeted levels
Post Period Highlights
· Appointment of Chief Medical Officer, Dr Tim Corn to the
Company's Board of Directors
· New
patent application for OCT130401
CEO, Clarissa Sowemimo-Coker, commented:
"It's been a
hugely exciting period of activity, and we are delighted with the
progress that has been made. In particular, successfully completing
our first clinical trial is a huge milestone for the Company and
the whole team is rightly proud of that
achievement."
Analyst Briefing, 09.30, Today 30 January 2024
Analysts interested in attending
OCTP's briefing should contact Acuitas Communications by emailing
oct@acuitascomms.com or by calling 020 3745 0293.
Investor Presentation, 13.30, Today 30 January
2024
A live online presentation to
existing and prospective shareholders will take place at 13:30 GMT
on Tuesday 30 January 2024 via the Investor Meet Company
platform.
Questions may be submitted online
pre-event via the 'Investor Meet Company' dashboard up to 09:00 the
day before the meeting or at any time during the live presentation.
Investors can sign up to Investor Meet Company for free and add to
meet Oxford Cannabinoid Technologies Holdings plc via:
https://www.investormeetcompany.com/oxford-cannabinoid-technologies-holdings-plc/register-investor
Investors who already follow OCTP on
the Investor Meet Company platform will automatically receive an
invitation to the event.
The unaudited interim report
for the six months ended 31 October 2023 is available on the
Company's website at: www.oxcantech.com and
in hard copy form at the Company's registered office at Prama
House, 267 Banbury Road, Oxford, OX2 7HT.
It is also available for inspection
at:
www.fca.org.uk/markets/primary-markets/regulatory-disclosures/national-storage-mechanism.
Prior to publication, the
information contained within this announcement was deemed by the
Company to constitute inside information for the purposes of Article 7 of EU Regulation 596/2014 (which
forms part of domestic UK law pursuant to the European Union
(Withdrawal) Act 2018). With the
publication of this announcement, this information is now
considered to be in the public domain.
The Directors of the Company accept
responsibility for the content of this announcement.
Enquiries:
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|
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Oxford Cannabinoid Technologies Holdings plc
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+44 (0)20 3034 2820
|
Clarissa Sowemimo-Coker
(CEO)
|
clarissa@oxcantech.com
|
|
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Cairn Financial Advisers LLP
|
|
Emily Staples
|
+44 (0)20 7213 0897
|
Jo Turner
|
+44 (0) 20 7213 0885
|
|
|
Axis Capital Markets Limited
|
|
Richard Hutchison
|
+44 (0)20 3026 0320
|
|
|
Acuitas Communications
|
020 3745 0293 / 07799
767676
|
Simon Nayyar
|
simon.nayyar@acuitascomms.com
|
Arthur Dingemans
|
arthur.dingemans@acuitascomms.com
|
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About Oxford Cannabinoid Technologies Holdings
Plc:
Oxford Cannabinoid Technologies
Holdings plc ("OCTP") is the holding company
of Oxford
Cannabinoid Technologies Ltd (together the
"Group"), a
pharmaceutical Group developing prescription cannabinoid medicines
initially targeting the US$ multi-billion global pain
market.
OCTP currently has a portfolio of
four drug development programmes. Its lead compound, OCT461201,
will initially target neuropathic and visceral pain (including
irritable bowel syndrome ("IBS") and chemotherapy induced
peripheral neuropathy ("CIPN"). The global market for CIPN alone
is currently forecast to reach US$1.17bn by 2028.
OCTP's drug development pipeline
comprises both natural and synthetic compounds, and includes
compounds targeting trigeminal neuralgia, a severe type of face
pain, and cannabinoid derivatives targeting pain and
potentially other therapeutic areas. Having established an
exclusive licence agreement with Canopy Growth Corporation for
their entire pharmaceutical cannabinoid derivative library, OCTP
now has a portfolio of almost five hundred derivatives and
intellectual property rights including fourteen patent families and
associated research data.
OCTP has a clearly defined path to
commercialisation, revenues and growth. The Group is developing
drug candidates through clinical trials to gain regulatory approval
(FDA/MHRA/EMA) that will enable medical professionals to prescribe
them with confidence. OCTP's portfolio aims to balance risk, value
and time to market, whilst ensuring market exclusivity around all
its key activities.
Caution regarding forward looking
statements
Certain statements in this
announcement, are, or may be deemed to be, forward looking
statements. Forward looking statements are identified by their use
of terms and phrases such as ''believe'', ''could'', "should"
''envisage'', ''estimate'', ''intend'', ''may'', ''plan'',
''potentially'', "expect", ''will'' or the negative of those,
variations or comparable expressions, including references to
assumptions. These forward-looking statements are not based on
historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of
operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof),
competitive advantages, business prospects and opportunities. Such
forward looking statements reflect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
CEO's Interim Management
Statement
As CEO of Oxford Cannabinoid
Technologies Holdings plc (OCTP or Company), I am immensely proud
of our progress during the six months to 31 October 2023.
It has been a period of progress and achievement
for the Company and our talented team who have worked hard to build
on our previous successes. Their efforts helped us reach further
key milestones as we continue our journey to harness the
therapeutic power of cannabinoids to deliver treatments for people
living with debilitating conditions.
The key milestone during the period
centred around our lead candidate OCT461201 (Programme 1)
successfully completing its Phase I single ascending dose (SAD)
clinical trial, a key waypoint along the path to regulatory
approval. Our team is proud to have reached this watershed moment
fewer than 30 months since OCTP's flotation and we intend to
continue to make resourceful and energetic progress on our drug
development programmes.
During the period we were also
pleased to appoint Dr Tim Corn to the newly created role of Chief
Medical Officer (CMO), which reflects the fact that the business is
now moving from its pre-clinical stages into clinical development.
Dr Corn has held senior positions in both large and small pharma
organisations; in particular, he has served as CMO at Jazz
Pharmaceuticals plc, EUSA Pharma Inc and Zeneus Pharma Ltd. Dr Corn
has also played a key role in securing more than twenty regulatory
approvals in the US and Europe and is the author of more than forty
scientific publications. His appointment brings invaluable
experience and expertise to the Company.
As we advanced OCT461201 into the
clinic, targeting a first-in-class treatment for chemotherapy
induced peripheral neuropathy (CIPN), we were also pleased to
announce the appointment of Dr Paul Farquhar-Smith, an
internationally recognised expert in CIPN, as an external adviser
to the Company. Dr Farquhar-Smith is a consultant in pain and
anaesthetics at The Royal Marsden Foundation NHS Trust where he
leads the only dedicated CIPN clinic in the UK. His appointment
expands upon our longstanding commitment to pursuing a
patient-centric approach to drug development.
Programme 1
OCT461201 is a 'cannabinoid-like'
new chemical entity (NCE) for neuropathic and visceral pain
conditions. OCT461201's performance in a significant number of
pre-clinical studies conducted by the Company has demonstrated that
it is well positioned to tackle small fibre neuropathies as it was
shown to successfully reduce pain in a model of CIPN. CIPN is the
consequence of damage caused to the nerves by common
chemotherapeutic drugs and has a global market forecast to reach
US$1.17bn by 2028. Pre-clinical studies on OCT461201 have also
demonstrated its potential in irritable bowel syndrome (IBS) with
its global market currently valued at US$2.6bn.
There has been significant progress
in the development of OCT461201 during the period. In May 2023, we
announced that the Medicines and Healthcare Products Regulatory
Agency (MHRA) had approved our combined Phase I clinical trial
application. Soon afterwards, in July, we announced that the
first-in-human dose of OCT461201 had been successfully
administered, as part of the Phase I SAD trial being conducted by
Simbec Research Limited (part of Simbec-Orion Group
Ltd).
In September 2023, in line with our
planned timeframes, we announced the successful administration of
the final dose of OCT461201 and in October we were pleased further
to report that dosing of all the
cohorts of the Phase I SAD study had been successfully completed.
No safety or tolerability concerns were exhibited with any dose tested and OCT461201 is, therefore, now able
to proceed safely to the next stage of its clinical
development.
We are excited about the potential
apparent in OCT461201 and look forward to continuing our research
and development on the drug candidate.
Programme 2
OCT130401 is a combination of
synthetic phytocannabinoids (pCBs) and a medical device for the
effective, safe, and non-addictive treatment of chronic and severe
pain conditions. The initial target for OCT130401 is trigeminal
neuralgia (TN). TN is a chronic pain condition that causes an
excruciating, stabbing, electric shock-like facial pain and has a
fast and unexpected onset, making it difficult to treat. Each
episode may only last a few seconds, but some people will suffer
multiple (up to 100) episodes during a single day and,
disturbingly, it is on the rise, with between approximately 10,000
and 15,000 new cases in the United States diagnosed each year. We
estimate that there are over 65,000 people currently living with
the condition in the UK.
The pCBs will be delivered to the
lungs via inhalation using a simple pressurised metered dose
inhaler (pMDI) similar to an asthma inhaler. This alternative route
of administration bypasses issues associated with oral delivery of
cannabinoids (e.g. onset
time, poor bioavailability and high first-pass metabolism). Fast
onset of the medicine is particularly important for indications
where the pain is sudden and severe, as is the case with TN, and
the low-dosage administration of OCT130401 is aimed at achieving a
therapeutic effect while mitigating side effects and managing the
risk of abuse. pMDIs have a long history of use and a
straightforward regulatory pathway, giving us further confidence
about the potential of this treatment to help people living with
TN.
Pre-clinical work on OCT130401 was
successfully completed in December 2022. We partnered with Charles
Rivers Laboratories Edinburgh Ltd (Charles Rivers) for the
preclinical safety and pharmacological work for the pMDI which was
developed with Purisys LLC, which provided the current Good
Manufacturing Practice active product ingredients, and Oz UK Ltd,
which developed the formulation and the device. We are particularly
pleased with the 'device through life', with each canister
comfortably delivering in excess of 160 actuations, well over the
120 required by regulatory agencies.
This programme is now ready to enter
Phase I clinical trials, which we anticipate will take place in
Australia. During the period, we completed the administrative steps
necessary to conduct clinical trials in Australia, including
incorporating a wholly owned subsidiary, OCT Victoria PTY Ltd and
initiating a comprehensive tender process with Contract Research
Organisation partners who could conduct the trial.
Programmes 3 and 4
We continued to make steady progress
on both Programmes 3 and 4 during the period, continuing our work
with Dalriada Drug Discovery Inc (Dalriada) to screen our
proprietary cannabinoid derivative library for potential new drug
candidates. The library includes 475 molecules and 14 patent
families,
Programme 3 is a dual CB1 and CB2
agonist targeting an undisclosed neuropathic pain indication, which
is active at 3mg/kg by oral administration in animal models. In our
early studies, Programme 3 has demonstrated very good
bioavailability via oral administration and displays a better
profile than tetrahydrocannabinol (THC) (intraperitoneal;
absorption bypassed) in terms of analgesia and behavioural
alterations. We are continuing to work on further in vitro studies to advance
development of this interesting compound which shows great
potential as an alternative non-addictive treatment for serious
chronic pain conditions.
In July we announced that the
screening work on Programme 4 had identified a potential 'first in
class' immunotherapy agent for the treatment of solid tumours which
marked our expansion into oncology - an important milestone and new
frontier for the Company. Our analysis of the initial data shows
excellent drug-like potential in terms of in vitro potency and selectivity to
target, as well as in vivo
availability in blood in animal models. This implies substantive
potential for the development of a cannabinoid-based medicine that
could be taken at home, as a tablet. This programme is targeting a
share of a market of therapies against solid tumours projected to
be worth US$532bn by 2032. Attention will now focus on further
in vitro and in vivo studies to define the full
potential of this lead candidate.
In July, as part of our ongoing
commitment to stakeholder engagement, our Chief Scientific Officer,
Dr Valentino Parravicini and our Chief Medical Officer, Dr Tim
Corn, presented a comprehensive programme update to investors via
the Investor Meet Company platform.
Principal Risks and Uncertainties
The principal risks and
uncertainties of the Group are as set out in the Annual Report
& Accounts and are summarised below. These risks and
uncertainties are reviewed throughout the year and, since the
Annual Report for the period ended 30 April 2023 was published, no
new principal risks have been identified.
The principal risks are as
follows:
· fundraising;
· key
staff dependency;
· unsuccessful or delayed development of programmes;
· quality assurance; and
· cash
management.
Related Party transactions
There were no related party
transactions in the period or changes in the related party
transactions described in the last annual report that have had or
could have a material effect on the financial position or
performance of the Group.
Related party disclosures for prior
periods are given in note 8.
Going Concern and Viability
Statement
The Group's business activities,
together with the factors likely to affect its future development,
performance and position, are set out in the Annual Report
(accessible via www.oxcantech.com)
and remain unchanged for the six months ended 31 October
2023. Further disclosure is given in note 2(b).
The Group prepares budgets and
cashflow forecasts to ensure that the Group can meet its
liabilities as they fall due, for at least twelve months from the
date of signing of these unaudited condensed consolidated interim
financial statements. Cash resources remain within forecast at
£1.1m and, in line with our previous forecasts. The Board expects
to conclude the next fund raising during Q1 2024.
Outlook
Successful completion of our first
Phase I clinical trial in Q4 2023, on time, on budget, and fewer
than 30 months since OCTP's flotation, was a significant
achievement. This milestone is not just another step in the
regulatory process: it is a beacon of hope for countless people
living with debilitating conditions around the world. The data we
have gathered regarding the safety, tolerability, and
pharmacokinetic profile of OCT461201 will be instrumental in
shaping the subsequent phases of clinical development and
supporting our indication expansion strategy, enabling us to help
even more patients with unmet needs. Furthermore, our pipeline of
drug candidates is robust and diverse, reducing the Company's risk
profile and enabling further extension of our scope such as our
recent expansion, in the period, into oncology (Programme 4). With
the insights gained from our Scientific Advisory Board (SAB) and
the continuing support of our partners, we are well positioned to
explore new therapeutic avenues and further expand our
portfolio.
Our commitment to innovation in
cannabinoid medicines remains unwavering, and we will continue to
explore the therapeutic potential of cannabinoids in addressing a
range of conditions. In a cannabis market where unlicensed
medicines remain abundant and unproven, our underlying philosophy
remains unchanged: that it is only the development of
cannabinoid-based medicines through regulatory channels of licensed
drug development that allows the medical community to prescribe
drugs with confidence, scientific rigour and in volume.
In conclusion, the Board anticipates
a bright future for OCT, in the vanguard of developing licensed
cannabinoid-based medicines and therapies. With a strong pipeline,
a committed team, and a clear vision, we are well positioned to
make significant further strides forward with our drug development
programmes and our focus remains steadfast on helping people living
with debilitating pain through harnessing the therapeutic power of
cannabinoids.
Clarissa Sowemimo-Coker
Chief Executive Officer
29 January 2024
Financial and Operational
Highlights
Operational and financial highlights
for the six months ended 31 October 2023 are as follows:
· OCTP
entered into its first-in-human Phase I
clinical trial for its lead compound, OCT461201 in partnership with Simbec Orion as
the CRO with the SAD study concluded in the period;
· In
view of the continuing market uncertainty and an increasingly
challenging macro-economic outlook the Board agreed to temporarily
delay Phase I clinical trials of OCT130401, its second programme,
having completed the pre-clinical stage as well as the
administrative steps required to commence trials in Australia,
enabling cash to be preserved until the end of Q1
2024;
· Development work for Programmes 3 and 4 continued, with the
Company still on target to progress to pre-clinical stage for both
programmes;
· During
the six-month period, key staff at director and operational level
remained stable, the executive team was strengthened with the
appointment of a Chief Medical Officer - Dr Tim Corn as OCT moved
into clinical phase of the lead programme OCT461201 alongside a
change in public relations adviser;
· OCTP
continued to utilise its Scientific Advisory Board with ad-hoc
meetings held during this period;
· Research costs of £1,172k were incurred, of which £1,060k
relates to OCT461201 (Programme 1), with progress being made across
all four of the Group's programmes;
· Overall, administrative costs reduced to £1,183k compared to
£1,338k in the 6 months to 31 October 2022 with the main costs in
the reported six months relating to salaries and associated
expenses (£532k);
· The
Group has accrued a Research and Development ("R&D") tax credit
of £385k in the six months. There was a debtor of £1,474k at the
period end relating to R&D tax credits (October 2022: £1,599k);
and
· Cash
absorbed from operating activities was £1,163k (30 April 2023:
£6,868k) (6 months to 31 October 2022 £4,233k) and cash reserves
stood at £1,134k at 31 October 2023 (30 April 2023:
£2,298k).
Paul Smalley
Finance Director
29 January 2024
Directors' Statements
Responsibility Statement
The current Directors, whose names
and functions are set out below, with the registered office located
at Prama House, 267 Banbury Road, Oxford OX2 7HT, accept
responsibility for the information contained in this unaudited
interim report and condensed financial statements, which have not
been audited by an independent auditor, for the six months ended 31
October 2023. To the best of the knowledge of the
Directors:
· the
unaudited condensed consolidated interim financial statements are
prepared in accordance with the applicable set of accounting
standards (including UK adopted IAS 34 Interim Financial
Reporting), and give a true and fair view of the assets,
liabilities, financial position and profit or loss of the
Group and the undertakings included in the consolidation taken
as a whole; and
· the
CEO's Interim Management Report includes a fair review of the
information required under rules 4.2.7 and 4.2.8 of the Disclosure
Guidance and Transparency Rules (being: (1) indication of the
important events during the first six months, and their impact on
the unaudited condensed interim financial statements: (2) a
description of principal risks and uncertainties for the remaining
six months of the year; (3) related parties' transactions that have
taken place in the first six months of the current financial year
and that have materially affected the financial position or the
performance of the entity during that period; and (4) any
changes in the related parties' transactions described in the last
annual report that could have a material effect on the financial
position or performance of the enterprise in the first six months
of the current financial year).
The Directors confirm that the
condensed interim financial statements comply with the above
requirements.
Directors and their
functions:
· Julie
Pomeroy - Non-Executive Chairperson
· Clarissa Sowemimo-Coker - Chief Executive Officer
· Paul
Smalley - Finance Director
· Dr
Timothy Corn - Chief Medical Officer (appointed 14 November
2023)
· Bishrut Mukherjee - Non-Executive Director
· Neil
Mahapatra - Non-Executive Director
· Charanjit Cheryl Dhillon - Non-Executive Director
· Richard Hathaway - Non-Executive
Director
Forward Looking Statements
Certain statements in this
announcement are forward-looking statements. Such statements may
relate to OCTP's business, strategy and plans.
Statements that are not historical
facts, including statements about OCTP's or its management's
beliefs and expectations, are forward-looking statements. Words
such as 'believe', 'anticipate', 'estimates', 'expects', 'intends',
'aims', 'potential', 'will', 'would', 'could', 'considered',
'likely', and variations of these words and similar future or
conditional expressions are intended to identify forward-looking
statements but are not the exclusive means of doing so.
By their nature, forward-looking
statements involve a number of risks, uncertainties or assumptions,
some known and some unknown, many of which are beyond OCTP's
control that could cause actual results or events to differ
materially from those expressed or implied by the forward-looking
statements. These risks, uncertainties or assumptions could
adversely affect the outcome and financial effects of the plans and
events described herein.
Forward-looking statements contained
in these interim financial accounts regarding past trends or
activities should not be taken as a representation that such trends
or activities will continue in the future. Nor are they indicative
of future performance and OCTP's actual results of R&D and
financial condition and the development of the industry and markets
in which OCTP plans to operate may differ materially from those
made in or suggested by the forward-looking statements.
You should not place undue reliance
on forward-looking statements because such statements relate to
events and depend on circumstances that may or may not occur in the
future. Except as required by law, OCTP is under no obligation to
update (and will not) or keep current the forward-looking
statements contained herein or to correct any inaccuracies which
may become apparent in such forward-looking statements.
Forward-looking statements reflect OCTP's judgement at the time of
preparation of these unaudited interim condensed financial
statements and are not intended to give any assurance as to future
results.
Robin Bennett
Company Secretary
29 January 2024
Unaudited Condensed Consolidated
Statement of Comprehensive Income
|
|
6 months
ended 31
October
2023
|
|
6 months
ended 31 October 2022
|
|
Year
ended 30 April
2023
|
|
Notes
|
£000's
|
|
£000's
|
|
£000's
|
|
|
Unaudited
|
|
Unaudited
|
|
Audited
|
|
|
|
|
|
|
|
Revenue
|
|
-
|
|
-
|
|
-
|
Research costs
|
|
(1,172)
|
|
(3,147)
|
|
(4,304)
|
Gross loss
|
|
(1,172)
|
|
(3,147)
|
|
(4,304)
|
Administrative expenses
|
|
(1,183)
|
|
(1,338)
|
|
(2,670)
|
Exceptional items
|
4
|
(39)
|
|
(61)
|
|
(64)
|
Operating loss
|
|
(2,394)
|
|
(4,546)
|
|
(7,038)
|
Finance income
|
|
9
|
|
-
|
|
4
|
Finance costs
|
|
-
|
|
-
|
|
-
|
Loss before taxation
|
|
(2,385)
|
|
(4,546)
|
|
(7,034)
|
Income tax
|
5
|
385
|
|
840
|
|
1,089
|
Loss for the period
|
|
(2,000)
|
|
(3,706)
|
|
(5,945)
|
Other comprehensive income
|
|
-
|
|
-
|
|
-
|
Items that may be reclassified to
profit or loss
|
|
-
|
|
-
|
|
-
|
Total comprehensive income for the period attributable to
owners of the Group arising from continuing
operations
|
|
(2,000)
|
|
(3,706)
|
|
(5,945)
|
|
|
|
|
|
|
|
Loss per share attributable to the ordinary equity holders of
the Company:
|
|
|
|
|
|
|
Basic loss per share from continuing
and total operations
|
6
|
(0.208p)
|
|
(0.386p)
|
|
(0.619p)
|
Diluted loss per share from
continuing and total operations
|
|
(0.208p)
|
|
(0.386p)
|
|
(0.619p)
|
Unaudited Condensed Consolidated
Statement of Financial Position
|
|
6 months ended 31
October
2023
|
6 months ended 31
October
2022
|
Year
ended
30
April
2023
|
|
Notes
|
£000's
|
£000's
|
£000's
|
|
|
Unaudited
|
Unaudited
|
Audited
|
|
|
|
|
|
Non-current assets
|
|
|
|
|
Intangible assets
|
|
-
|
26
|
7
|
|
|
-
|
26
|
7
|
Current assets
|
|
|
|
|
Trade and other
receivables
|
|
1,656
|
2,467
|
2,191
|
Cash and cash equivalents
|
|
1,134
|
4,933
|
2,298
|
|
|
2,790
|
7,400
|
4,489
|
Total assets
|
|
2,790
|
7,426
|
4,496
|
Current liabilities
|
|
|
|
|
Trade and other payables
|
|
840
|
1,279
|
584
|
Total current liabilities
|
|
840
|
1,279
|
584
|
Total liabilities
|
|
840
|
1,279
|
584
|
|
|
|
|
|
Net
assets
|
|
1,950
|
6,147
|
3,912
|
|
|
|
|
|
Equity
|
|
|
|
|
Called up share capital
|
|
9,604
|
9,604
|
9,604
|
Share premium account
|
|
11,877
|
11,877
|
11,877
|
Share based payment
reserve
|
9
|
1,553
|
1,510
|
1,515
|
Other reserve
|
|
643
|
643
|
643
|
Retained earnings
|
|
(21,727)
|
(17,487)
|
(19,727)
|
Total equity
|
|
1,950
|
6,147
|
3,912
|
These unaudited condensed six-months
financial statements were approved and authorised for issue by the
Board of Directors on 29 January 2024 and were signed on its behalf
by:
Paul Smalley
Finance Director
Company Registration No.
13179529
Unaudited Condensed Consolidated
Statement of Changes in Equity
|
Share
capital
|
Share
premium account
|
Share
based payment reserve
|
Other
reserve
|
Retained
earnings
|
Total
|
|
£000's
|
£000's
|
£000's
|
£000's
|
£000's
|
£000's
|
|
|
|
|
|
|
Unaudited
|
|
|
|
|
|
|
|
At
1 May 2022
|
9,604
|
11,877
|
1,451
|
643
|
(13,782)
|
9,793
|
Loss for the period
|
-
|
-
|
-
|
-
|
(5,945)
|
(5,945)
|
Other comprehensive
income
|
-
|
-
|
-
|
-
|
-
|
-
|
Total comprehensive loss
|
-
|
-
|
-
|
-
|
(5,945)
|
(5,945)
|
Transactions with owners
|
|
|
|
|
|
|
Share-based payment charge
(warrants)
|
-
|
-
|
12
|
-
|
-
|
12
|
Share-based payment charge
(options)
|
-
|
-
|
52
|
-
|
-
|
52
|
Total transactions with
owners
|
-
|
-
|
64
|
-
|
-
|
64
|
Balance at 30 April 2023
|
9,604
|
11,877
|
1,515
|
643
|
(19,727)
|
3,912
|
|
Share
capital
£000's
|
Share
premium account
£000's
|
Share
based
payment
reserve
£000's
|
Other
reserve
£000's
|
Retained
earnings
£000's
|
Total
£000's
Unaudited
|
At
1 May 2023
|
9,604
|
11,877
|
1,515
|
643
|
(19,727)
|
3,912
|
Loss for the period
|
-
|
-
|
-
|
-
|
(2,000)
|
(2,000)
|
Other comprehensive
income
|
-
|
-
|
-
|
-
|
-
|
-
|
Total comprehensive loss
|
-
|
-
|
-
|
-
|
(2,000)
|
(2,000)
|
Transactions with owners
|
|
|
|
|
|
|
Share-based payment charge
(warrants)
|
-
|
-
|
-
|
-
|
-
|
-
|
Share-based payment charge
(options)
|
-
|
-
|
38
|
-
|
-
|
38
|
Total transactions with
owners
|
-
|
-
|
38
|
-
|
-
|
38
|
Balance at 31 October
2023
|
9,604
|
11,877
|
1,553
|
643
|
(21,727)
|
1,950
|
Unaudited Condensed Consolidated
Statement of Cash Flows
|
|
6 months ended 31
October
2023
£000's
|
6 months
ended 31
October
2022
£000's
|
Year
ended
30 April
2023
£000's
|
|
|
Unaudited
|
Unaudited
|
Audited
|
|
|
|
|
|
Cash flows from operating activities
|
|
|
|
|
Cash absorbed from
operations
|
|
(1,932)
|
(4,403)
|
(7,042)
|
Interest received
|
|
9
|
|
4
|
Tax refunded
|
|
760
|
170
|
170
|
Net
cash outflow from operating activities
|
|
(1,163)
|
(4,233)
|
(6,868)
|
Cash flows from investing activities
|
|
|
|
|
Proceeds from disposal of property,
plant and equipment
|
|
-
|
-
|
-
|
Interest received
|
|
-
|
-
|
-
|
Net
cash inflow from investing activities
|
|
-
|
-
|
-
|
Cash
flows from financing activities
|
|
|
|
|
Repayment of borrowings
|
|
-
|
-
|
-
|
Lease liability payments
|
|
-
|
-
|
-
|
Net
cash used in financing activities
|
|
-
|
-
|
-
|
Net
decrease in cash and cash equivalents
|
|
(1,163)
|
(4,233)
|
(6,868)
|
Cash and cash equivalents at the
beginning of the period
|
|
2,297
|
9,166
|
9,166
|
Cash and cash equivalents at the end
of the period
|
|
1,134
|
4,933
|
2,298
|
Notes to the Interim Condensed
Consolidated Financial Statements
1 General
Information
Oxford Cannabinoid Technologies
Holdings Plc is a public limited company limited by shares,
incorporated and domiciled in England and Wales. Its
registered office and principal place of business is Prama House,
267 Banbury Road, Oxford OX3 7HT. Incorporated on 4 February 2021,
the Company's shares were admitted to trading on the Main Market of
the London Stock Exchange on 21 May 2021.
All press releases, financial
reports (including the Annual Report and Financial Statements for
the year ended 30 April 2023) and other information are available
at our Shareholder Centre on our website: www.oxcantech.com.
The condensed consolidated interim
financial statements are presented in thousand pounds Sterling
(£'000).
2 Summary of
Significant Accounting Policies
The accounting policies applied by
the Group in these condensed consolidated interim financial
statements are consistent with those applied by the Group in its
consolidated financial statements for the year ended 30 April 2023
and are those which will form the basis of the financial statements
for the year ending 30 April 2024.
2(a) Basis of
preparation
Compliance with UK Adopted IFRS
These unaudited condensed
consolidated interim financial statements for the six months ended
31 October 2023 have been prepared in accordance with UK Adopted
IAS 34 'Interim Financial Reporting', and the Disclosure Guidance
and Transparency Rules ("DTR") of the Financial Conduct Authority,
the Listing Rules, and UK adopted International Accounting
Standards.
These unaudited condensed
consolidated interim financial statements should be read in
conjunction with the Annual Report and financial statements for the
year ended 30 April 2023, which were prepared in accordance with UK
adopted International Accounting Standards and the applicable legal
requirements of the Companies Act 2006. These condensed
consolidated interim financial statements do not comprise statutory
accounts within the meaning of Section 435 of the Companies Act
2006.
The Annual Report and financial
statements for the year ended 30 April 2023 were reported upon by
the Group's auditor and delivered to the Registrar of Companies.
The report of the auditor on the annual report and financial
statements for the year ended 30 April 2023 was unqualified but
with a disclaimer of opinion, did not include a reference to any
matters to which the auditor drew attention by way of emphasis
without qualifying their report, and did not contain statements
under Section 498 (2) or (3) of the Companies Act 2006.
The accounting policies used and
presentation of these condensed consolidated half year financial
statements (including principles of consolidation and equity
accounting) are consistent with the accounting policies applied by
the Group in its consolidated Annual Report and financial
statements as at, and for the year ended, 30 April 2023, and comply
with UK adopted International Accounting Standards.
The half year report for the six
months ended 31 October 2023 was approved for release by the
Directors on 29 January 2024. The figures for the six months ended
31 October 2023 and those for the six months ended 31 October 2022
are neither audited nor reviewed by auditors
pursuant to the Financial Reporting Council guidance on Review
of Interim Financial Information.
2(b) Going concern
The Directors are required to
satisfy themselves that it is reasonable for them to conclude
whether it is appropriate to prepare the financial statements on a
going concern basis, and as part of that process they have followed
the Financial Reporting Council's guidelines ("Guidance on the
Going Concern Basis of Accounting and Reporting on Solvency and
Liquidity Risk" issued April 2016).
The Group's business activities
together with factors that are likely to affect its future
development and position are set out in the CEO's Review and the
Financial Review. Budgets and detailed cashflow forecasts
that look to January 2025, have been prepared and used when
considering the Group's ability to meet its liabilities as they
fall due, without further funding. The Directors have made various
assumptions in preparing these forecasts, using their view of both
the current and future economic conditions that may impact on the
Group during the forecast period.
As detailed in the Directors'
Report, the Board have, however, identified that a material
uncertainty exists with regard to the Company's ability to continue
as a going concern in relation to working capital. The
Company's cash runway will extend three months beyond signing these
interim financial statements and therefore, the Company may be
unable to realise its assets and discharge its liabilities in the
normal course of business without a further fundraise within the
next three months. The
Board is in the process of raising additional
funds within this period to provide further financial resources to
progress with the next stages of the research programmes. Further
controls over discretionary spend will be implemented to extend the
current cash resources if required. Given the mitigating
controls that are in place for a successful fundraise and the
strength of controls that exist over cash management (as detailed
in Principal Risks and Uncertainties), the Board is confident that
preparing the financial statements on a going concern basis remains
appropriate.
Key risks and potential scenarios
that could negatively impact on the Group's ability to continue to
research and ultimately develop and retail prescribed medicines
within the timescales previously
presented have been considered. The signing
of the agreement with Evotec
for one of the Group's leading drug candidates
(OCT 461201) is an example of where the Directors have actively
managed some key external risk factors by selecting a partner who
offers an integrated drug development process, with acceleration
through to clinical trial stage.
After making enquiries including
detailed consideration of the Group's cashflow, solvency and
liquidity position, the Board has a reasonable expectation that the
Group as a whole has adequate resources to continue in operational
existence for at least twelve months with further fundraising from
the date of signing of these financial statements.
As such, the Board continues to adopt the going
concern basis in preparing the unaudited condensed six-monthly
financial statements.
2(c) New and forthcoming standards
and interpretations
New and amended standards adopted by the
Group
There were no new or amended
standards adopted by the Group during the review period.
New standards and interpretations not yet
adopted
A number of new accounting
standards, amendments to accounting standards and interpretations
have been issued by the International Accounting Standards Board
with an effective date after the date of these financial
statements. The Directors have chosen not to early adopt these
standards and interpretations, the Directors do not expect them to
have a material impact on the entity in the current or future
reporting periods and on foreseeable future
transactions.
|
Effective
date
|
|
|
|
IAS 1
|
Presentation of
Financial Statements - amendments
regarding the classification of liabilities
|
1 January
2024
|
IAS 1
|
Presentation of
Financial Statements - amendments
regarding the non- current liabilities with
covenants
|
1 January
2024
|
IFRS 16
|
Lease Liability in
a Sale and Leaseback
|
1 January
2024
|
3 Critical Estimates and
Judgements
The preparation of financial
statements requires the use of accounting estimates which, by
definition, will seldom equal the actual results. Management also
needs to exercise judgement in applying the Group's accounting
policies. However, uncertainty about these assumptions and
estimates could result in outcomes that would require a material
adjustment to the carrying amount of the asset or liability in
future periods.
Estimates and judgements are
continually evaluated. They are based on historical experience and
other factors, including expectations of future events that may
have a financial impact on the entity and that are believed to be
reasonable under the circumstances. The areas involving significant
estimates or judgements which management consider may have a
significant risk of causing a material adjustment to the reported
amounts in the period were:
Going concern basis
As outlined in note 2(b), judgement
has been applied in accounting for the Group as a going
concern. In reaching the decision the Directors have
considered current cash reserves and forecast cashflow, solvency and liquidity. The forecasts are based on
various assumptions including charges from research partners, rate
of progression through to commercialisation, external economic
conditions and the Group's ability to fundraise.
Research & development costs
Judgement is used in the
classification and hence treatment of costs incurred in the
research and development of the core programmes outlined in the
CEO's Interim Management Statement. During the period, all of
the £1,172k costs incurred were accounted for as research costs and
expensed to profit or loss, on the basis that none of the
programmes were yet at a stage of having gained regulatory approval
for commercialisation.
R&D tax credits receivable
Judgement is applied in calculating
the tax credits that the Group consider to be receivable from HMRC
in relation to research costs incurred. Evidence is retained
to support the methodology adopted by the Group in calculating
R&D tax relief claims, part of which involves the judgement of
experienced senior managers and Directors in articulating the
scientific advancements and uncertainties for the wider market of the Group's research programmes based
on contemporaneous evidence. At the period
end there was a tax credit receivable of £1,474k (2022:
£1,599k).
Impairment of intangible fixed assets
Judgement is involved in determining
the useful economic life and no impairment of the licence
intangible asset, held by the Group, is required because the assets
are held at a net book value of £Nil, having been fully amortised
in the period. This includes consideration of the
continuing likelihood of the asset to generate
value to the Group and the adherence to the terms of the agreement
or any other event which may have a detrimental effect on the
carrying value of the asset.
Warrants and share options
The Black-Scholes model is used to
calculate the appropriate charge of the warrants and share
options. The calculation involves a number of estimates and
judgements to establish the appropriate inputs to be entered into
the model, including the use of an appropriate interest rate,
expected volatility, exercise restrictions and behavioural
considerations. A significant element of judgement is therefore
involved in the calculation of the charge. The estimates used
remain unchanged from those applied in the Annual Report and
financial statements.
4 Exceptional
Items
The Condensed Consolidated Statement
of Comprehensive Income includes exceptional items totalling £39k
(31 October 2023) comprised entirely of a share-based payment
charge (30 April 2023: £64k).
The Group operates two share option
schemes for its Directors and senior employees - one relating to
options transferred from OCT and a new scheme for OCTP. In
addition, warrants were issued as part of the listing in May 2021
(as detailed in the Annual Report and financial
statements).
5 Income Tax
The Group is pre-revenue generating,
but on target to reach regulatory approval in 2027. The Group
benefits from research and development corporation tax relief, in
both the current period and prior years, claimed by the Group on
allowable research expenditure. A deferred tax asset is not
recognised due to the uncertainty of the timing of future taxable
profits.
6 Loss Per Share
|
6 months
to 31 Oct
2023
£
Unaudited
|
6
months
to 31
Oct 2022
£
Unaudited
|
Year
to 30
April 2023
£
Audited
|
6(a)
Basic loss per share
|
|
|
|
Basic loss per share attributable to
the ordinary equity holders of the Company
|
(0.00208)
|
(0.00386)
|
(0.00619)
|
|
|
|
|
6(b)
Diluted loss per share
|
|
|
|
From continuing operations
attributable to the ordinary equity holders of the
Company
|
(0.00208)
|
(0.00386)
|
(0.00619)
|
Total diluted loss per share
attributable to the ordinary equity holders of the
Company
|
(0.00208)
|
(0.00386)
|
(0.00619)
|
6(c) Reconciliations of loss used
in calculating loss per share
|
6 months
to 31
Oct
2023
£000's
Unaudited
|
6
months
to
31 Oct
2022
£000'
Unaudited
|
Year
to
30 April
2023
£000's
Audited
|
Basic loss per share
|
|
|
|
Loss attributable to the ordinary
equity holders of the Company used in calculating basic loss per
share:
|
(2,000)
|
(3,706)
|
(5,945)
|
Diluted loss per share
|
|
|
|
Loss from continuing operations
attributable to the ordinary equity holders of the
Company:
|
|
|
|
Used in calculating basic loss per
share
|
(2,000)
|
(3,706)
|
(5,945)
|
Used in calculating diluted loss per
share
|
(2,000)
|
(3,706)
|
(5,945)
|
Loss attributable to the ordinary
equity holders of the Company used in calculating diluted loss per
share
|
(2,000)
|
(3,706)
|
(5,945)
|
6(d) Weighted average number of shares used as the
denominator
|
31 Oct 2023
|
31 Oct
2022
|
30 April
2023
|
|
Number
|
Number
|
Number
|
Weighted average number of ordinary
shares used as the denominator in calculating basic loss per
share
|
960,415,644
|
960,415,644
|
960,415,644
|
Adjustments for calculation of
diluted loss per share:
|
-
|
-
|
-
|
Weighted average number of ordinary
shares and potential ordinary shares used as the denominator in
calculating diluted loss per share
|
960,415,644
|
960,415,644
|
960,415,644
|
7 Events Occurring After the
Reporting Period
On 14 November 2023, the Group
announced the appointment of Dr Tim Corn, Chief Medical Officer
(CMO) as an executive director. On 10 January 2024, the Group
announced it had filed a European application directed to Programme
2 (OCT130401). The patent application is
directed to a composition containing Delta-9-tetrahydrocannabinol
(THC) and Cannabidiol (CBD).
8 Related Party
Transactions
The Group is headed by
Oxford Cannabinoid Technologies Holdings Plc, the
ultimate parent entity. There is no ultimate controlling
party.
There were no related party
transactions in the period or changes in the related party
transactions described in the last annual report that have had or
could have a material effect on the financial position or
performance of the Group.
The following transaction occurred
with other related parties in a prior period:
Between December 2021 and January
2022, the Group paid £35,994 for professional services on behalf of
Kingsley Capital Partners (KCP) (shareholder). This was
included as a receivable in the Unaudited Condensed Consolidated
Statement of Financial Position at the period end.
9 Share based payments
During the six-month period ended 31
October 2023, no new options or warrants were issued and none of
the existing options and warrants were exercised.
As detailed in the Annual Report,
the Group operates an equity-settled share-based remuneration
scheme for employees. On 21 May 2021,
OCTP issued a total of 33,307,275 warrants all with an exercise
price of £0.05 and a five-year exercise period, vesting on the day
of issue.
During the period, the Group
recognised share-based payment expense of:
· £38,782 (31 October 2022: £48,382) in relation to options;
and
· £Nil
(31 October 2022: £12,153) in relation to the warrants.
Directors and Professional
Advisers
Directors
Julie Pomeroy
Clarissa Sowemimo-Coker
Paul Smalley
Dr Timothy Corn (appointed 14 Nov
2023)
Neil Mahapatra
Bishrut Mukherjee
Charanjit Cheryl Dhillon
Richard Hathaway
Secretary
Robin Bennett
Company number
13179529
Registered office
Prama House
267 Banbury Road
Oxford
OX2 7HT
Auditor
Moore Kingston Smith LLP
6th Floor
9 Appold Street
London EC2A 2AP
Financial Advisers
Cairn Financial Advisers
LLP
107 Cheapside
London EC2V 6DN
Principal Bankers
Barclays Bank
1 Churchill Place
Canary Wharf
London, E14 5HP
Public Relations Advisers
Acuitas Communications Ltd (since
1st August 2023)
8 St James' Square
London, SW1Y
4JU
Brokers
Axis Capital Markets Ltd
St Clements House
27 St Clements Lane
London EC4N 7AE