Oxford Cann Regulatory News (OCTP)

Oxford Cannabinoid Technologies Holdings plc

("OCT" or the "Company")

Appointment of Phase I Clinical Trial CRO

&

Change of Accounting Reference Date

Oxford Cannabinoid Technologies Holdings plc (LSE:OCTP), a clinical stage biopharmaceutical company focused on the development and commercialisation of innovative cannabinoid medicines, today announces that, through its subsidiary, OCT Victoria Pty Ltd, it has entered into agreement with iNGENū CRO Pty Ltd (iNGENū), to conduct a Phase I randomised, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability and pharmacokinetics of OCT130401.

iNGENū is an Australia-based, globally focused contract research organisation (CRO) possessing extensive experience working in the cannabinoid pharmaceutical drug development and clinical research industry. The appointment follows a meticulous vendor selection process, which included a detailed competency-based assessment of prospective CROs' credentials, of their cost-effectiveness and of appropriate regulatory pathways.

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), which is a chronic pain condition that causes an excruciating, stabbing, electric shock-like facial pain. TN has a fast and unexpected onset, making it difficult to treat and each episode may last only a few seconds, but some people will suffer multiple (up to 100) episodes during a single day.

Clarissa Sowemimo-Coker, Chief Executive Officer of OCT, said:

"I am pleased to announce that OCT has selected iNGENū as its CRO partner for our Phase I clinical trial for our second programme, OCT130401, targeting Trigeminal Neuralgia. iNGENū is a well-recognised CRO, with a specific expertise in cannabinoids and the Australia regime also affords a direct path to US FDA approval which is an important target for the Company. Today's appointment and our confirmation that clinical trials will begin in Q2 2024 demonstrate that OCT continues to hit its milestones and is making good progress."

Dr Sud Agarwal, Chief Executive Officer of iNGENū, said:

"We are delighted to be OCT's CRO partner in its first Australia-based clinical trial. Whilst many people are aware of the financial benefits of the Australian research regime, many are less aware of the world-class clinical research units and the favourable regulatory laws, allowing rapid study start-up. We look forward to kicking off this work, which is aiming to meet a significant unmet need for people living with Trigeminal Neuralgia."

Change of accounting reference date

In order to align the Group's accounting period with that of its Australian subsidiary, OCT Victoria Pty Ltd, OCT and its UK subsidiary, Oxford Cannabinoid Technologies Ltd, will amend their accounting reference date and financial year-end from 30 April to 30 June, with immediate effect. This change will generate reporting efficiencies and provide for direct comparability of the Group's reporting across future periods. 

As a result of this change, the Group's next financial reporting events will be as follows:

  ● Publication of audited accounts for the fourteen months ended 30 June 2024 by 31 October 2024; and

 ● Publication of unaudited interim accounts for the six months ended 31 December 2024 by 31 March 2025.

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 ("OCT") is the holding company of Oxford Cannabinoid Technologies Ltd and OCT Victoria Pty Ltd (together the "Group"), a pharmaceutical Group developing prescription cannabinoid medicines initially targeting the US$ multi-billion global pain market.

OCT 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 chemotherapyinduced peripheral neuropathy ("CIPN"). The global market for CIPN alone is currently forecast to reach US$1.17bn by 2028.

OCT'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.

OCT 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. OCT's portfolio aims to balance risk, value and time to market, whilst ensuring market exclusivity around all its key activities.