Oxford Cann Regulatory News (OCTP)

26 August 2022

Oxford Cannabinoid Technologies Holdings plc

("OCTP" or "the Company")

Strategic budget review to extend cash runway

&

Directorate Change

Brings OCT461201 through Phase I and significantly extends current cash runway in line with contingency funding strategy 

Oxford Cannabinoid Technologies Holdings plc, the pharmaceutical company developing prescription cannabinoid medicines targeting the US$ multi-billion pain market, announces a strategic re-allocation of its drug development resources and changes to the composition of its Board of Directors.

Budget Review

To date, development work and expenditure has progressed across all four current programmes in line with the Company's stated strategy at the time of its IPO in May 2021. However, continuing market uncertainty and an increasingly challenging macro-economic outlook have led the Board to review the allocation of its existing budget.

Following this review, the Board considers it prudent to temporarily delay Phase I clinical trials of OCT130401, its second programme. Phase I clinical trials for the Company's lead programme, OCT461201 remain on track and on budget, and are due to commence in January 2023, with interim results anticipated in April 2023. This decision is consistent with the contingency financial planning outlined by the Chair in her Statement in the 2022 Annual Report to consider the re-allocation of resources.

Extension of cash runway

Taking this action means that existing funds, which would otherwise have been fully utilised by April 2023, will now extend to Q4 2023. Pre-clinical work for OCT130401 will continue, ensuring that Programme 2 is Phase I ready in early 2023. Development work for Programmes 3 and 4 will also continue, 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.

Directorate Change

The Company also announces that Karen Lowe, currently Group Finance Director, has informed the Board of her wish to step down from her role in order to pursue her NED career and consultancy business. The recruitment of her successor is already underway and a further announcement will be made in due course.

Julie Pomeroy, Non-Executive Chair of OCTP commented: "The re-allocation measures that the Company has announced are both forward looking and precautionary, reflecting the duty we have to our stakeholders, and the Board's commitment to delivery of our current programmes. These steps are prudent and ensure that OCTP is best placed for long term success.

I would also like to wholeheartedly thank Karen for her contribution to the Company. Karen has been a valued colleague at OCTP since initially agreeing to join us as a non-executive director in February 2021. Her swift transition from potential NED to Group Finance Director is indicative of the regard we have for Karen and her significant contribution to the Company during her tenure. I would like to take this opportunity to thank Karen, on behalf of the Board and her colleagues across OCTP, for her commitment and contribution during her time here. She leaves us with our very best wishes for the future."

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.

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About Oxford Cannabinoid Technologies Holdings plc:

Oxford Cannabinoid Technologies Holdings plc ("OCTP") is the holding company of Oxford Cannabinoid Technologies Ltd ("OCT") (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 OCT in a solid oral dosage form. OCTP 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.