Oxford Cann Regulatory News (OCTP)

OXFORD CANNABINOID TECHNOLOGIES HOLDINGS PLC

("OCTP" or the "Company") 

Master Service Agreement and Work Order with Simbec Research Limited for Phase 1 Clinical Trials

Oxford Cannabinoid Technologies Holdings plc, the pharmaceutical company developing prescription cannabinoid medicines targeting the US$ multi-billion pain market, is pleased to announce that on 19 July 2022, it entered into a master service agreement and work order ("MSA") with Simbec Research Limited, part of Simbec-Orion Group Ltd ("Simbec-Orion") for its first-in-human Phase 1 clinical trial for its lead compound, OCT461201, due to commence in Q1 2023.

This Phase 1 first-in-human clinical trial will be performed in the UK in healthy volunteers, with a single ascending dose ("SAD"). The trial will be aimed at demonstrating the safety and tolerability of the drug product, while providing pivotal information on the pharmacokinetic profile of OCT461201 to confirm its value as a potential drug. The clinical trial is anticipated to commence in Q1 2023, following regulatory submission to the UK Medicines & Healthcare products Regulatory Agency (MHRA), with interim results expected by the end of March 2023 and the full report expected in Q2 2023.

Simbec-Orion is an award winning, full-service clinical research organisation ("CRO") with over 45 years' specialist expertise in clinical pharmacology and lab expertise and over 25 years' clinical development experience. With a combination of pharmacology first-in-man and patient, oncology and rare disease expertise in highly complex indications, the directors of OCTP are confident that Simbec-Orion is the right partner to help OCTP meet this significant milestone. OCTP's lead compound, OCT461201, is a selective cannabinoid receptor type 2 agonist which has shown potential as an effective therapy for chemotherapy induced peripheral neuropathy ("CIPN") as well as irritable bowel syndrome. The global market for CIPN alone was valued at US$1.61bn in 2020 and is forecasted to reach US$2.37bn by the year 2027.

Simbec-Orion's MHRA Phase I accredited clinical site, which includes in-house bioanalytical capabilities, is based in Merthyr Tydfil, Wales, UK. In addition, it has offices in the USA, France and Hungary which can support single and multiple-site clinical studies in Europe and in the US. Simbec-Orion will provide an end-to-end, full-service clinical development solution including project management, medical and technical writing, medical monitoring and pharmacovigilance, as well as bioanalytical and statistical activities to support pharmacokinetic studies.

Under the terms of the MSA Simbec-Orion shall provide services to OCTP on a call-off basis and as specified in individually agreed work orders. Work orders will specify, inter alia, scope of work to be performed as well as milestones to be achieved and fees payable. OCTP owns all data created and intellectual property rights generated under the MSA and any work order and the MSA includes standard confidentiality provisions. Both OCTP and Simbec-Orion give the standard indemnities, representations and warranties expected from agreements of this nature and OCTP is to comply with the ABPI guidelines for compensation of trial subjects. Quality agreements and transfer of regulatory obligations under a work order are each incorporated by reference. The MSA requires a specific data processing agreement under each work order for the processing of personal data of clinical trial subjects. The MSA also includes standard confidentiality provisions for trial site contract management, insurance and audit as well as a right to terminate the MSA and individual work orders for convenience for OCTP.

Dr John Lucas, Chief Executive Officer of OCTP, said: "We are very excited to partner with Simbec-Orion as we progress our drug candidates to the next crucial phase of their development - randomised, controlled clinical trials. This work with Simbec-Orion helps the Company deliver the targets we set out in our prospectus and meets the quality standards we set to safeguard patients.

"This is an important step along the development path for OCT461201, as we advance into clinical trials in healthy volunteers, getting us closer to the aim of providing a much-needed safe and effective pain treatment for patients whilst also, ultimately, generating value for shareholders."

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 OCTP 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.