Oxford Cannabinoid Technologies Holdings plc (“OCTP”) is the holding company of a pharmaceutical Group developing prescription cannabinoid medicines targeting the U$ multi-billion global pain market.

We have a portfolio of four drug development programmes. Our lead compound, OCT461201, will initially target neuropathic and visceral pain (including irritable bowel syndrome (“IBS”) and chemotherapy induced peripheral neuropathy ("CIPN"). The Phase I clinical trials process, aimed at demonstrating safety and tolerability in humans is about to start (Q1 2023). Trial results are expected in Q2 2023.  The global market for CIPN alone was valued at US$1.61bn in 2020 and is forecast to reach US$2.37bn by the year 2027.

Our 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 such as cancer and epilepsy. Having established an exclusive license agreement with Canopy Growth Corporation for their entire pharmaceutical cannabinoid derivative library, we now have a portfolio of over almost 500 derivatives and intellectual property rights including 14 patent families and associated research data.

We have 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. OCTP’s portfolio aims to balance risk, value and time to market, whilst ensuring market exclusivity around all its key activities.

As a pharmaceutical company there are important differences between us and a medical cannabis company and what we do.

First is that we are developing medicines to be prescribed by doctors and not oils or creams that you can buy in a health food store without prescription.

Medical cannabis companies can only work with the flower or extract of cannabis and harness what properties it may have naturally.   As a pharmaceutical company we can do this too but we can also chemically change and improve the structure of cannabinoids to target specific diseases and ensure market exclusivity for OCTP’s medicines.  Our aim is 1) to target those chronic pain conditions such as chemotherapy induced peripheral neuropathy (“CIPN”), where patients continue to suffer pain which is unresolved or resistant to current treatments and 2) to have market exclusivity in these indications.  

Unlike medical cannabis company products, all our medicines will be tested through robust clinical trials and approved by national medicines regulators, such as the FDA (USA), EMA (EU) or MHRA (UK).  By doing this, we can make evidence-based efficacy and safety claims about our medicines, which will target specific indications.  Importantly doctors will be able to prescribe our medicines rather than people having to pay out of their own pocket.  For countries with an insurance-based healthcare system, such as the US, the health insurance companies will be able to reimburse our medicines making them more accessible to many people suffering from chronic pain. 

Our first medicine, OCT461201 has just entered the Phase I clinical trials process (January 2023) and we expect it to be commercialised by 2027.  That is less than 5 years from now.  Normally the process takes 10-12 years. 

Our strategy of developing different cannabinoids and harnessing the skills from an extensive network of commercial and academic partners means we can pursue a fast-track growth strategy whilst lowering both developmental risk and costs and shortening the time frame to commercialisation, all without compromising on the crucial safety and efficacy studies required for regulatory approval.

Results from Phase I trials of OCT461201 are expected in Q2 2023.  This Phase I  trial will be followed  sequentially by Phase II and Phase III trials as is the requirement of the International medicines approval process.   

OCTP currently has a portfolio of four programmes in development. Its lead compound, OCT461201, will potentially target a number of different indications in neuropathic and visceral pain (including irritable bowel syndrome (“IBS”) and chemotherapy induced peripheral neuropathy (“CIPN”)). Phase I clinical trials, aimed at demonstrating safety and tolerability (in humans), have just begun. Trial results are expected in Q2 2023.  The global market for CIPN alone was valued at US$1.61bn in 2020 and is forecast to reach US$2.37bn by the year 2027.

Our drug development pipeline comprises both natural and synthetic compounds, and includes a compound targeting trigeminal neuralgia, a severe type of face pain, and cannabinoid derivatives targeting both pain and potentially other therapeutic areas such as cancer and epilepsy. Having established an exclusive license agreement with Canopy Growth Corporation for their entire pharmaceutical cannabinoid derivative library, OCTP now has a portfolio of almost 500 derivatives and intellectual property rights including 14 patent families and associated research data which it can draw on for future programmes to develop.

Humans have been using cannabinoids for many years to treat a variety of ailments, including pain.

With this wealth of understanding on cannabinoids available we have been able to carefully select four programmes for development, in the knowledge that we can:

• harness this understanding and reduce development risks and costs
• deliver medicines that will be first in class or uniquely positioned in the market
• target pain conditions that remain unresolved and resistant to current treatments

The global pain market is valued at US$59.5 billions. 

As a pharmaceutical company, we are following the rigorous regulatory process set out by national medicines regulatory agencies around the world such as the FDA (USA), MHRA (UK) and EMA(EU).

In all cases we have an ongoing dialogue with the regulatory agency to ensure that our medicines meet their strict criteria for safety and efficacy.  As part of this, each medicine will go through sequential steps before being approved for use with people.  After each step a thorough and independent review of the data collected is completed before starting the next step.

• Pre-clinical trials – These are studies in test tubes and animals to provide data on the safety and efficacy of the trial medicine
• Phase I clinical trial – This is the first study in a small number of humans and primarily provides information on the safety and tolerability of the medicine to allow it to be tested more widely.  The people involved in this study are what are known as ‘healthy volunteers’.  Phase I only needs to be completed once even if a medicine is being considered for different indications.
• Phase II clinical trial – There are different types of Phase II clinical trials.  These are the first studies in people with the condition that a medicine is aiming to treat / prevent or diagnose.  Primarily researchers will be gathering information on the safety and efficacy of the medicine in people with the particular condition e.g. what dose of the medicine to use to elicit a therapeutic response from the patient. 
• Phase III clinical trial – This is the largest trial of the three phases and, like Phase II studies people with the specific condition.  The Phase II study will have provided important information for the Phase III study on the appropriate dosing and treatment regimen to be used.  People in the Phase III study will either be assigned to a group receiving the trial medicine or to a placebo group.  The process of assigning people is usually done randomly and without the person knowing which group they are in.  This is what is known as a Randomised Controlled Trial (RCT).  Primarily Phase III studies aim to demonstrate whether or not a medicine offers a treatment benefit to a specific group of patients and to provide more detailed safety data.
• Application for licence – Once the trials are completed, a Licence Application is completed and submitted to the regulatory agency for consideration. 
• Approval and Use – Once approved, regulatory authorities will grant a licence for a medicine defining its indication and terms of how it should be prescribed.   

Humans have been using cannabinoids for many years to treat a variety of ailments, including pain.  With this wealth of understanding on cannabinoids available we have been able to carefully select four programmes for development, in the knowledge that we can:

• harness this understanding and reduce development risks and costs
• deliver medicines that will be first in class or uniquely positioned in the market
• target pain conditions that remain unresolved and resistant to current treatments

By taking a pharmaceutical research approach to the development of our drug candidates we will be working within a robust and tight regulatory structure to prove the efficacy, safety and value of each compound as a therapeutic.  Science is driving and guiding our efforts. Before embarking on a new programme, we go through an early medicine evaluation exercise which analyses different criteria to create confidence that a programme has a chance of success. We look at different parameters such as the strength of the data in the literature, in terms of both non-clinical and clinical research, but also whether a compound (or a family of compounds) can be successfully put through a development programme which delivers a commercial drug and not just an active molecule. This analysis also helps us in defining the profile of our product in terms of target identification and validation, validity on non-clinical translational models, unmet medical needs, clinical trial design and robustness, dosage and efficacy readouts, and also commercial and IP landscapes. The end result is a target product profile which forms an integral part of our risk and gap analysis and helps design our action plan.

Being a pre revenue pharmaceutical company, we have a milestone driven business model. As we move our drug development programmes through the various research stages we de-risk the company and increase its value. The operational outlook for the business remains extremely positive.  We have set out our detailed plan for development of our four drug programmes.  We have recently announced the start of our first clinical trials for OCT461201  (January 2023).  This follows positive pre-clinical results for our lead drug candidate, which reaffirms the potential of OCT461201 in multiple indications.  Results from this Phase I trial are expected in Q2 2023.

In August 2022, we announced that, from a cash perspective, our focus would remain on our lead compound OCT461201, meaning that, although pre-clinical work for our second compound OCT130401 continues, we anticipate that Phase I study for OCT130401 won’t start until Q4 2023.   Development work for Programmes 3 and 4 is also continuing, with the Company still on target to be at pre-clinical stage (for programme 3) and lead stage (for programme 4) with these programmes during Q2 2023.

The Company remains well capitalised with existing funds extending to Q1 2024. Since IPO we have been very busy and have put in place, for example, external partnerships and deals that will not only enhance our existing programmes but expand our ability to expand our drug development programmes as well as prepare us for regulatory submissions.

As we move our drug development programmes through the research stages we will also have opportunities to partner with third-parties or out-licence candidates that we choose not to take forward in house.

It is possible that potential new drug candidates will come to the fore between now and the planned commercialisation of our lead drug which is scheduled for 2027. We continue to develop our drug pipeline and proprietary, unique library of cannabinoid derivative compounds. Furthermore, we have visibility over a number of exciting developments and a clear path to growth so there may well be opportunities to generate additional revenue streams.

By utilising a range of inputs, we are creating a drug development portfolio that is intended to maximise the therapeutic potential of cannabinoids, long-term market value and market exclusivity across our activities.