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Ananda Exits Landmark NHS-Funded Epilepsy Trial and Public Markets

Ananda Pharma, one of the UK’s leading clinical-stage pharmaceutical cannabis companies, has announced a string of strategic pivots, including stepping away from a flagship UK clinical trial into epilepsy. 

After nearly four years, it has also announced plans to exit the ACQUIS stock exchange, while doubling down on its lead asset, MRX1, for pain treatment in endometriosis and chemotherapy-induced peripheral neuropathy.

It marks the latest example of a cannabis biotech company being forced to pivot in the face of adverse conditions, adding to the growing exodus of promising early-stage companies from public markets. 

Government-funded epilepsy trial breaks down

On 26 September, Ananda announced that it had terminated its relationship with the contractor that had been supplying MRX2 and MRX2T formulations for epilepsy studies at University College London (UCL) and Great Ormond Street Hospital (GOSH).

Ananda confirmed it had received formal notification from UCL that it was no longer involved in the studies, and that the contractor had been unable to fulfil its obligations under its agreement with UCL/GOSH. While Ananda is no longer involved, the trials are expected to be continued and an ‘alternative supplier’ is now being sought. 

The trials were announced to considerable fanfare in October 2024, following years of promises from multiple governments and false starts. 

As recently as last week, these trials were referenced by members in Parliament in response to calls for greater action on medical cannabis. 

In February 2024, the National Institute for Health and Care Research (NIHR) confirmed to The Pharmaceutical Journal that no publicly-funded medical cannabis trials had yet produced an outcome.

The two epilepsy trials that would eventually select Ananda as a supplier were described as ‘still under operational consideration’ but had yet to begin.

This pattern of delays in cannabis-based clinical trials goes beyond epilepsy, though.

In September 2018, the NIHR awarded funding for the CANTOP-RCT study, which aimed to evaluate cannabidiol as a treatment for psychosis. That trial never proceeded, with the NIHR citing ‘difficulties in securing a supply of cannabidiol for the study, and developments in the research landscape which impacted the original funding rationale.’

An NIHR call for proposals on medical cannabis research, open from October 2018 to July 2019, attracted only one application, which was subsequently declined. The declined proposal had planned to research cannabidiol for smoking cessation in generalised anxiety disorder.

By the time Ananda’s involvement was announced in October 2024, the epilepsy trials had been in planning for years.

Co-funded by the National Institute for Health and Care Research (NIHR) and the NHS, they were designed to evaluate the safety and efficacy of Ananda’s cannabinoid medicines in refractory epilepsy across up to 500 patients at multiple NHS sites.

At the time, these were positioned as the largest trials of their kind globally and the first major UK trials into the condition since GW Pharmaceuticals’ widely cited research on Epidyolex. 

Crucially, these trials were designed to go beyond GW’s original work, focusing on a much broader range of epilepsies rather than just Dravet Syndrome and Lennox-Gastaut Syndrome. 

Chief Executive Melissa Sturgess explained in a previous interview: “As I understand it, these trials were first planned back in 2019 or 2020—a long time ago. They were initiated because the BPNA (British Paediatric Neurology Association) wanted to see more comprehensive data across a broader range of epilepsies before they felt comfortable recommending their specialists prescribe CBD-based drugs for conditions beyond Dravet Syndrome and Lennox-Gastaut Syndrome.

“A significant amount of time was spent finding a formulation that would meet the regulator’s requirements, which has been a major challenge. We were invited to tender to supply the drug for these trials and were fortunate to be successful.

“In the UK, it is very difficult for specialists to prescribe off-label, especially for a drug that has been approved for an orphan indication. The goal here is to provide the necessary data to support CBD as a treatment for a broader range of epilepsies, which could significantly improve access for patients.”

First patient dosing in these trials is now not expected before 2027, having originally been scheduled to commence this year.

Readouts, similarly, are now unlikely until 2029.

Combined with what the Company describes as intellectual property constraints in the epilepsy indication, management determined that continuing involvement represented an unacceptable opportunity cost.

Sturgess said in Ananda’s September announcement: “While it is disappointing that the epilepsy programme has stalled, this outcome allows us to focus our resources where the opportunity is strongest and the path to market is clearer.

“We wish UCL and GOSH well in their continued efforts in refractory epilepsies and remain available to support them in any way we can.”

Cannabis sector public market exodus continues

Ananda’s most recently published financial figures for the six months to 31 July 2025, saw the company report a loss before tax of £1.95m on revenues of just £5,135, with net assets falling from £2.13m to £295,383 and cash declining from £1.66m to £613k.

The clinical-stage company also reported  £2.85m in current liabilities.

During the period, Ananda completed development work for MRX1, gathering two years of required stability data and producing three consistent trial manufacturing batches. A 40-litre GMP batch was manufactured for use across all three MRX1 clinical trials.

On 10 November, Ananda announced it had received an R&D tax refund of AUD340,166 (£168,066) from the Australian Tax Office, with a further AUD500,000 expected in Q3 2026. Australia’s 43.5% refundable tax rebate for eligible R&D expenditure provided valuable non-dilutive funding.

The Phase 1 study, conducted through Ananda’s Australian subsidiary in partnership with CRO Southern Star Research, dosed 19 participants between July and October 2025.

On 24 November, Ananda announced proposals to withdraw from the AQSE Growth Market and re-register as a private limited company.

As we have seen with a growing number of publicly traded cannabis companies outside of North America in recent years, the board cited a failure to attract institutional capital via a public listing. 

The Company traded with minimal liquidity, the share price offered little information value, and regulatory costs consumed resources better deployed into clinical development.

Executive Chairman Jeremy Sturgess-Smith, who spearheaded the IPO in June 2021 and has funded Ananda with more than £10m over eight years, said: “Despite our best efforts, we have not managed to gain the funding support of the public markets, so we intend to delist the Company while we progress MRX1 development and our clinical trials.”

The move is expected to save around £500,000 per annum, roughly 25% of the Company’s operating expense run rate.

Sturgess-Smith committed to maintaining quarterly communications and offering existing shareholders the opportunity to participate in future funding rounds on the same terms. The delisting is now scheduled to take effect on 22 December 2025.

Phase 1 results show promise for MRX1

Three days after the delisting announcement, on 27 November, Ananda delivered initial data from its Phase 1 clinical study showing MRX1 demonstrated a favourable safety profile.

Following dosing at 2.5 mg/kg and 7.5 mg/kg twice daily for six days, all reported treatment-emergent adverse events were mild (Grade 1). No moderate or severe adverse events, serious adverse events, or discontinuations occurred across 20 participants.

Ananda expects the full clinical study report in Q2 2026, and celebrated the results as a significant milestone, stating that ‘Ananda is now a clinical stage biotech’. 

Its exit from the epilepsy trials and renewed focus on MRX1 put a much greater weight on the success of its other clinical trials. 

Two Phase 2 randomised controlled trials are being conducted by the University of Edinburgh with £1.55m in funding (endometriosis from NHS Scotland, CIPN from NIHR). The Company expects ethics approvals before year-end, with recruitment starting in Q1 2026.

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