Q&A

Octavian is a biopharmaceutical company focused on developing innovative prescription medicines that target the Endocannabinoid System (ECS). We are advancing our drug candidates through a regulatory pathway, with a particular emphasis on chronic neuropathic pain—a debilitating condition where existing treatments may lead to opioid dependence, severe side effects, or loss of efficacy. The global market for pain treatments is valued at nearly US$60bn, expected to grow to US$75bn by 2027. Our aim is to develop non-addictive medicines to address this significant unmet need.

We have multiple active programmes in development and have established an exclusive license agreement with Canopy Growth Corporation, granting access to their pharmaceutical cannabinoid derivative library. This portfolio includes approximately 2,000 compounds, with over 500 proprietary derivatives and 14 patent families, alongside valuable research data.

Our path to commercialisation, revenues, and growth is clearly defined. We are developing drug candidates through clinical trials to gain regulatory approval (FDA/MHRA/EMA), ensuring they can be prescribed with confidence by medical professionals. Our portfolio is designed to balance risk, value, and time to market, while securing market exclusivity across all key activities.

As a biopharmaceutical company, there are fundamental differences between Octavian and a medical cannabis company.

First, we develop prescription medicines that are rigorously tested and approved by regulators, not oils, creams, or other cannabis-based products that can be purchased over the counter in health stores. Our goal is to bring evidence-based, clinically validated treatments to market that can be prescribed by doctors and reimbursed by insurers.

Medical cannabis companies are restricted to using the natural flower or extracts of the cannabis plant, harnessing only what properties they contain. As a biopharmaceutical company, we can do this too, but we also go further—we have the ability to chemically modify and optimise cannabinoid-based compounds to target specific diseases. This allows us to create medicines with greater efficacy, improved drug-like characteristics, and market exclusivity.

Our primary focus is on chronic neuropathic pain conditions, where existing treatments are inadequate, leaving patients with unresolved pain. By developing patentable, regulator-approved medicines, we ensure that doctors can prescribe them rather than relying on self-pay models.

Unlike medical cannabis products, all our medicines undergo robust clinical trials and must be approved by leading regulatory agencies such as the FDA (USA), EMA (EU), and MHRA (UK). This enables us to make scientifically validated claims about their safety and efficacy. In countries with insurance-based healthcare systems, such as the US, insurers will be able to reimburse our medicines—making them more accessible to the millions of people suffering from chronic pain.

Humans have used compounds that interact with the Endocannabinoid System (ECS) for many years to treat a variety of ailments, including pain.

Building on this wealth of scientific understanding, we have carefully selected our active programmes for development, ensuring that we can:

• Leverage existing knowledge to reduce development risks and costs.

• Develop first-in-class medicines or treatments that are uniquely positioned in the market.

• Target pain conditions that remain unresolved and resistant to current treatments.

The global pain market is currently valued at US$59.5 billion, highlighting the urgent need for innovative, non-addictive pain therapies.

As a biopharmaceutical company, we follow the rigorous regulatory process set out by national medicines regulatory agencies worldwide, including the FDA (USA), MHRA (UK), and EMA (EU).

We maintain ongoing dialogue with regulatory agencies to ensure our medicines meet their strict criteria for safety and efficacy. Each medicine progresses through a sequential approval process, with thorough, independent reviews of data at each stage before advancing to the next step.

• Preclinical Studies – Conducted in laboratory models and animals, these studies assess the safety, efficacy, and pharmacological properties of the investigational medicine before it is tested in humans.

• Phase I Clinical Trial – The first study in humans, primarily focused on safety and tolerability. A small group of healthy volunteers is given the medicine to assess its effects. This phase only needs to be completed once, even if the medicine is later studied for different indications.

• Phase II Clinical Trial – The first study in patients with the target condition. Researchers gather safety and efficacy data, determining the optimal dosage and therapeutic effect of the medicine.

• Phase III Clinical Trial – A large-scale study involving patients with the specific condition. In a Randomised Controlled Trial (RCT), participants are assigned to either the treatment or placebo group, ensuring robust, unbiased results. This phase is crucial for confirming the medicine’s effectiveness and safety in a real-world setting.

• Application for Licence – Once clinical trials are successfully completed, a Licence Application is submitted to the regulatory agency for formal review and approval.

• Approval and Use – Once approved, regulatory authorities grant a licence, defining the indications and prescribing guidelines for the medicine.

This structured approach ensures that our medicines are scientifically validated, safe, and effective, enabling healthcare professionals to prescribe them with confidence.