REG - Oxford Cannabinoid - Half-year Report
30/01/2024 07:15
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RNS Number : 2986B Oxford Cannabinoid Tech.Holdings 30 January 2024
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
(https://urldefense.proofpoint.com/v2/url?u=http-3A__www.oxcantech.com_&d=DwMGaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=7Um2a7LLyUH5SxHgl6zdagatUzGQxXwYgU_CeVAgL9Q&m=kR_Hjjn07Jsd47IiTGeyUKC3Q2HOmc2k-HnXXjfJDbg&s=GFxut1xAl8isFgEqBSPyHxyd4L-9l0Z2IYjrRdaKm1E&e=)
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
(https://urldefense.proofpoint.com/v2/url?u=http-3A__www.fca.org.uk_markets_primary-2Dmarkets_regulatory-2Ddisclosures_national-2Dstorage-2Dmechanism&d=DwMGaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=7Um2a7LLyUH5SxHgl6zdagatUzGQxXwYgU_CeVAgL9Q&m=kR_Hjjn07Jsd47IiTGeyUKC3Q2HOmc2k-HnXXjfJDbg&s=z7lAUYO9aq6HBtuB_Hq8I10m4igZv3uixdkqQJaliao&e=)
.
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:
Oxford Cannabinoid Technologies Holdings plc +44 (0)20 3034 2820
Clarissa Sowemimo-Coker (CEO) clarissa@oxcantech.com
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
020 3745 0293 / 07799 767676
Acuitas Communications
Simon Nayyar simon.nayyar@acuitascomms.com
Arthur Dingemans arthur.dingemans@acuitascomms.com
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 (http://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 6 months ended 31 October 2022 Year
ended 31 October ended 30 April
2023 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 (2,000) (3,706) (5,945)
arising from continuing operations
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 6 months ended 31 October Year
2023 2022 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 Retained Total
reserve earnings
£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 Share premium account Share based Retained earnings Total
£000's £000's payment reserve Other £000's £000's
£000's reserve Unaudited
£000's
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 6 months Year
2023 ended 31 October ended
£000's 2022 30 April
£000's 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
(http://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 1 January 2024
of liabilities
IAS 1 Presentation of Financial Statements - amendments regarding the non- current 1 January 2024
liabilities with covenants
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 6 months Year
to 31 Oct 2023 to 31 Oct 2022 to 30 April 2023
£ £ £
Unaudited Unaudited Audited
6(a) Basic loss per share
Basic loss per share attributable to the ordinary equity holders of the (0.00208) (0.00619)
Company
(0.00386)
6(b) Diluted loss per share
From continuing operations attributable to the ordinary equity holders of the (0.00208) (0.00619)
Company
(0.00386)
Total diluted loss per share attributable to the ordinary equity holders of (0.00208) (0.00619)
the Company
(0.00386)
6(c) Reconciliations of loss used in calculating loss per share
6 months 6 months Year
to 31 Oct to 31 Oct to 30 April
2023 2022 2023
£000's £000' £000's
Unaudited Unaudited Audited
Basic loss per share
Loss attributable to the ordinary equity holders of the Company used in (2,000) (3,706) (5,945)
calculating basic loss per share:
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 (2,000) (3,706) (5,945)
calculating diluted loss per share
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
6(th) 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 1(st) August 2023)
8 St James' Square
London, SW1Y 4JU
Brokers
Axis Capital Markets Ltd
St Clements House
27 St Clements Lane
London EC4N 7AE
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