Oxford Cann Regulatory News (OCTP)

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 £920k of R&D costs were incurred, primarily on the Group's lead drug candidate OCT461201, which accounted for approximately £604k 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 £12 million and no debt, having repaid a Government bounce-back loan of £50k 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 £2.6 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 £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:

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 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.