Trading Update

RNS Number : 2871J

Oxford Cannabinoid Tech.Holdings

12 December 2022

 

Oxford Cannabinoid Technologies Holdings plc

("OCTP" or the "Company")

Trading Update

Continued progress, commencement of clinical trials of lead drug candidate imminent

Financial and operational targets remain on track and on budget

Oxford Cannabinoid Technologies Holdings plc, the pharmaceutical company developing prescription cannabinoid medicines targeting the US$ multi-billion pain market, announces a positive trading and operational update for the six months ended 31 October 2022 ("the Period").

Financial Highlights

The budget review, announced on 26 August 2022, realigned the Company's development and expenditure programme to focus on bringing the Company's lead compound, OCT461201, through Phase I clinical trials. Taking this action meant that funds, which would otherwise have been fully utilised by April 2023, are now expected to extend to Q4 2023.

Importantly, the Company remains on track and on budget to commence clinical trials for OCT461201 in January 2023, with publication of its interim results for the period ended 31 October 2022 also anticipated in January 2023.

During the Period, the Group incurred c.£3.1 million of R&D costs, with progress being made on all four programmes. As at 31 October 2022, OCTP and its subsidiary, Oxford Cannabinoid Technologies Ltd. ("OCT"), (together, "the Group") had total cash reserves of approximately £5 million and remained debt free.

Operational update

Operational progress has been consistent with the Board's expectations and the Board remains confident that OCTP will achieve the milestones set out in its current development timeline.

Work under the Group's £2.6 million contract research agreement with Aptuit (Verona) SRL, a subsidiary of Evotec SE (together "Evotec"), which commenced in July 2021 is now almost complete. Evotec will provide the Company with a submission-ready regulatory document by the end of December 2022 and will deliver an approved batch of drug product to the OCT461201 Programme 1 Phase I clinical trial unit during Q1 2023.

In addition to the progress made on OCT461201, pre-clinical work for OCT130401 is almost complete, ensuring that Programme 2 will be Phase I ready in early 2023 at which time further development will be placed on hold in order to preserve cash. Development work for Programmes 3 and 4 has also continued, with the Company still on target to be at pre-clinical stage (for programme 3) and lead stage (for programme 4) with these programmes by Q2 2023.

Clarissa Sowemimo-Coker, Interim CEO of OCTP, said: " We are incredibly pleased with the ongoing progress and the fact that we remain on track to meet our financial and operational targets. This is a big achievement and is testament to the adaptability, skill, and "can do" attitude of Dr Valentino Parravicini, his team, and our external partners.

"As OCTP nears a critical juncture in its journey to introduce prescription cannabinoid medicines to the US$ multi-billion pain market, we are carefully managing cash and are well placed to deliver on our key objectives. I look forward to updating the market on our continued progress with the half-year results."

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 Holdings plc Clarissa Sowemimo-Coker (Interim CEO)	[phone] [e-mail]
Cairn Financial Advisers LLP Emily Staples Jo Turner	[phone] [phone]
Axis Capital Markets Limited Kamran Hussain Richard Hutchison finnCap Ltd Geoff Nash/Fergus Sullivan Nigel Birks (ECM) Walbrook PR Limited Paul Vann/Nick Rome	[phone] [phone] [phone] [phone] [e-mail]

About Oxford Cannabinoid Technologies Holdings Plc :

Oxford Cannabinoid Technologies Holdings plc is the holding company of Oxford Cannabinoid Technologies Ltd (together the "Group"), a pharmaceutical Group developing prescription cannabinoid medicines for approval by key medicines regulatory agencies worldwide and targeting the U$ multi-billion pain market . 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 OCTP in a solid oral dosage form. OCTP is conducting pre-clinical testing and development with a clinical trial 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.

 

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