TIDMOCTP
RNS Number : 7401Y
Oxford Cannabinoid Tech.Holdings
18 January 2022
18 January 2022
Oxford Cannabinoid Technologies Holdings plc
("OCTP" or the "Company")
Trading Update
&
Change of Accounting Year-End
Oxford Cannabinoid Technologies Holdings plc, the pharmaceutical
company developing prescription cannabinoid medicines for approval
by global regulatory agencies and targeting the US$ multi-billion
pain market, is pleased to provide a trading update ahead of the
publication of its interim results for the six months ended 30
November 2021.
Financial update
The Group has continued to build on the positive start made to
the current financial year. The board of directors ("Board")
expects to report financial results in line with management
expectations for the 6 month period ended 30 November 2021. During
these first six months, approximately GBP920k of R&D costs were
incurred, primarily on the Group's lead drug candidate OCT461201,
which accounted for approximately GBP604k of the total, with
progress being made on all four programmes.
At the period-end, OCTP and its subsidiary, Oxford Cannabinoid
Technologies Ltd. ("OCT"), (together, "the Group") had total cash
reserves of approximately GBP12 million and no debt, having repaid
a Government bounce-back loan of GBP50k in full. The Company's
ability to meet short term liabilities with its current assets
remains strong and spend is in line with the Group's strategy, as
set out in the IPO Prospectus dated 17 May 2021.
The Group's cost base is also continually being reviewed in
order to maximise the financial resources available to further
advance its drug development programmes.
Progress for OCT461201: cannabinoid-like compound for
neuropathic and visceral pain ("Programme 1")
OCT entered into a GBP2.6 million contract research agreement
with Aptuit (Verona) SRL, a subsidiary of Evotec SE (together
"Evotec") in July 2021. The planning phase has been completed and
"wet-work", manufacturing process development and crystallisation
development have been initiated. It is now anticipated that Evotec
will provide the Company with a submission-ready regulatory
document and an approved batch of drug product that is ready for
phase 1 clinical trials by Q1 2023. Due to technical issues
requiring additional optimisation of the crystal development for
scale-up manufacturing, which has been now successfully
implemented, the start of the phase 1 clinical trials is now
expected to commence in Q1 2023 rather than Q3 2022. However, the
Board does not believe this will affect the time to phase 2
clinical trials, there is no material cash flow impact and,
importantly, the time to market is currently anticipated to remain
the same.
The Company's work with Voisin Consulting SARL ("VCLS") remains
on track. VCLS has generated the risk and gap analysis and the
clinical roadmap to support the ongoing pre-clinical package for
Programme 1 and has also undertaken activities in preparation for
the commencement of the phase 1 clinical trials. In addition, VCLS
is providing the Group with regulatory support to address immediate
priorities for filing and registration of Programme 2's metered
dose inhaler in the UK and US market.
Inhaled phytocannabinoids for Trigeminal Neuralgia: ("Programme
2")
In October 2021, the Company announced trigeminal neuralgia
("TN") as the initial target for Programme 2. TN is a chronic pain
condition that causes an excruciating, stabbing, electric
shock-like facial pain. It has a fast and unexpected onset and
because of this has been difficult to treat. Each episode may only
last a few seconds, but some people will suffer multiple (up to
100) episodes during one day. It is on the rise with between
approximately 10,000 and 15,000 new cases in the United States
diagnosed each year. The Directors estimate that in 2021 there were
between 60,000 to 95,000 people living with the condition in the
UK.
In January 2022, the Company entered into a drug development
agreement with Charles Rivers Laboratories Edinburgh Ltd ("Charles
Rivers"). Charles Rivers will complete the preclinical safety and
pharmacological work for the metered dose inhaler developed with
Purisys LLC, which provides the current Good Manufacturing Practice
(cGMP) active product ingredients, and Oz UK Ltd, which is
developing the formulation and the device, as the Company prepares
Programme 2 for Phase 1 clinical trials anticipated in Q4 2022.
This short delay from Q3 2022 is due to unforeseen challenges in
the capacity of partners caused by the increased demand in
laboratory time generated by the ongoing Covid-19 pandemic. The
Board does not believe this will affect the time to phase 2
clinical trials, there is no material cash flow impact and,
importantly, the time to market is currently anticipated to remain
the same.
Cannabinoid derivatives for pain and other therapeutic areas
("Programmes 3 and 4")
In September 2021, OCTP announced its exclusive agreement with
Canopy Growth Corporation ("Canopy Growth"). OCTP has an exclusive
license to Canopy Growth's cannabinoid library, including 335
derivatives and 14 patent families. The Company has started
screening the drug-like compounds in multiple therapeutic areas,
including pain, neurology, immune-inflammation and oncology. As
announced in November 2021, OCTP is working with Dalriada Drug
Discovery Inc ("Dalriada"), to screen the Canopy compounds and
OCT's existing proprietary cannabinoid library. Dalriada previously
designed, synthesised, and experimentally tested all of the
compounds in the Canopy library and as such, OCT will be able to
leverage Dalriada's existing knowledge and experience as it
continues its experimental research. The aim is to identify two
drug candidates for pre-clinical development by the end of
2022.
The drug development agreement with Oxford Stemtech Ltd
("Stemtech") announced in November 2021, is supporting R&D for
all the Company's drug development programmes, with a particular
focus on Programmes 3 and 4. Stemtech's "Pain-in-a-dish" model
replicates human pain using stem cells from volunteers that are
re-programmed into pain neurons. This agreement also marks an
evolution of OCTP's relationship with Oxford University Professor,
Dr Zameel Cader.
Admission to Trading on the US OTC QB Market
The Company's shares were admitted to the OTC QB Market under
the ticker symbol "OCTHF" on 1 December 2021 to provide more
efficient access for US investors and increased liquidity for all
shareholders. OCTP appointed Harbor Access LLC, based in Stamford,
Connecticut, as its US investor relations adviser. Introductory
meetings with potential US investors commenced in January 2022.
Year End Change
The Group's financial accounting period has been shortened from
31 May to 30 April with the aim of delivering efficiencies in the
financial reporting and audit process. The Company will therefore
be required to announce its final results for the 11 months to 30
April 2022 by 31 August 2022.
Directors and proposed Scientific Advisory Board
The Company is in the process of putting together its Scientific
Advisory Board and expects to announce details by the end of Q1
2022.
The notice periods for Chief Financial Officer, Karen Lowe,
Chief Scientific Officer, Valentino Parravicini, Chief Executive
Officer, John Lucas and Chief Operating Officer, Clarissa
Sowemimo-Coker have been extended from six to nine months from 14
January 2022 to better allow for succession planning. We are also
pleased to note that Karen Lowe, Chief Financial Officer, has
increased her time involvement with the Group, which negates the
need to employ external resources, and she is being paid on the
basis of her time worked.
Following his exit from Imperial Brands Ventures Limited in
September 2021, non-executive Director, Bishrut Mukherjee, is being
paid the commensurate non-executive director fee of GBP 25,000 per
year as from October 2021.
This announcement contains 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).
The Directors of the Company accept responsibility for the
content of this announcement.
Enquiries:
Oxford Cannabinoid Technologies +44 (0)20 3034 2820
Holdings plc john@oxcantech.com
Dr John Lucas (CEO) clarissa@oxcantech.com
Clarissa Sowemimo-Coker (COO)
Cairn Financial Advisers
Emily Staples +44 (0)20 7213 0897
Jo Turner +44 (0) 20 7213 0885
Walbrook PR Limited +44 (0)20 7933 8780
Paul Vann +44 (0)7768 807631
Nicholas Johnson oxcantech@walbrookpr.com
Harbor Access LLC +1 (203) 862 0492
Jonathan Paterson Richard.Leighton@harboraccessllc.com
Richard Leighton
About Oxford Cannabinoid Technologies Holdings Plc :
Oxford Cannabinoid Technologies Holdings plc is the holding
company of Oxford Cannabinoid Technologies Ltd, a pharmaceutical
company developing prescription cannabinoid medicines for approval
by key medicines regulatory agencies worldwide and targeting the U$
multi-billion pain market (together the "Group"). Cannabinoids are
compounds found in the cannabis plant that have been shown to have
a range of therapeutic effects on the body, including pain relief.
The Group 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.
The Group's portfolio aims to balance risk, value and time to
market, whilst ensuring market exclusivity around all its key
activities. The Group's lead compound, OCT461201, is a highly
potent and selective CB2 agonist and is being developed by OCT in a
solid oral dosage form. OCT is conducting pre-clinical testing and
development with clinical trials scheduled for Q1 2023. The Group's
product pipeline also uses a balanced drug product strategy that
employs both natural and synthetic compounds for the treatment of
rare diseases and includes chemically modified phytocannabinoids
with improved drug-like characteristics and a proprietary library
of cannabinoids.
OCTP operates a partnership model with external academic and
commercial partners.
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identi ed 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 re ect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
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END
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