MOU Reached with ICAD

Solvonis and Portugal’s National Addiction Institute sign an MoU to advance planned European expansion of SVN-001 Phase 3 trial

Agreement with ICAD and clinical partner Panegreen to assess adding Portuguese sites to the alcohol addiction trial

Highlights

The right partners in Portugal: ICAD, attached to Portugal’s Ministry of Health, will help assess referral pathways and patient recruitment; Panegreen, which runs The Clinic of Change, a ketamine-assisted psychotherapy clinic in Lisbon, will coordinate the Portuguese work.

European regulatory strategy: Adding EU patient data to the Phase 3 trial is intended to strengthen future marketing authorisation applications for SVN-001 in selected EU countries or across the EU in due course.

Delivery and costs: Assessment will cover treatment capacity, start-up timelines and costs, including whether cost per participant could be broadly in line with UK NHS trial sites.

From plan to signed agreement: The MoU turns the European expansion plan announced on 25 August 2026 into a signed framework with partners on the ground in Portugal, in under two months.

Public-sector partners in two countries: With ICAD on board, SVN-001’s Phase 3 programme now works with national public bodies in both the UK (NIHR and MRC) and Portugal.

LONDON – 13 October 2026 – Solvonis Therapeutics plc (LSE: SVNS), a late clinical-stage biopharmaceutical company developing small-molecule therapeutics for high-burden central nervous system (“CNS”) disorders, announces that it has signed a Memorandum of Understanding (“MoU”) with ICAD, Portugal’s public addiction institute, and Panegreen – Health & Wellness Solutions, Lda. (“Panegreen”) to assess adding Portuguese trial sites to MORE-KARE, the UK Phase 3 trial of SVN-001 for severe alcohol use disorder (“AUD”).

The agreement advances the Company’s plans to add European sites to the trial, announced on 25 August 2026 and reiterated on 29 September 2026. The parties will now assess how Portuguese services and clinical facilities could support the programme.

SVN-001 and European development

SVN-001 combines ketamine with structured psychological therapy for severe AUD. It is being evaluated in MORE-KARE, a 280-participant UK Phase 3 trial sponsored by the University of Exeter and co-funded by Solvonis, the National Institute for Health and Care Research (“NIHR”) and the Medical Research Council (“MRC”).

The planned inclusion of Portuguese patients in MORE-KARE would add EU clinical data to SVN-001’s Phase 3 evidence base. The objective is to strengthen the evidence supporting future marketing authorisation applications, with the aim of improving the prospects of securing approval in selected EU countries or across the EU in due course.

The MoU

ICAD – Instituto para os Comportamentos Aditivos e as Dependências, I.P. – is attached to Portugal’s Ministry of Health. It will help assess potential public addiction-treatment services, referral pathways and patient recruitment. Panegreen, which operates The Clinic of Change, a ketamine-assisted psychotherapy clinic in Lisbon, will coordinate the Portuguese work.

The assessment will consider how Portugal’s clinical development expertise and infrastructure could support MORE-KARE. It will cover potential investigators and trial sites, recruitment, treatment delivery, staffing and training, pharmacy and controlled-drug requirements, translation of trial materials, Portuguese regulatory and ethics requirements, start-up timelines and indicative costs.

Solvonis will assess whether the trial could be conducted at Portuguese sites at a cost per participant broadly in line with that charged by NHS sites in MORE-KARE. Final costs and funding arrangements remain subject to agreement.

Next steps

With the MoU signed, Solvonis will now take the proposal to the University of Exeter, NIHR and MRC, with the assessment informing their consideration of Portuguese participation.

The MoU has an initial six-month term and does not create a binding commitment to proceed with Portuguese trial participation. Any participation remains subject to sponsor and funder agreement and the required ethics, regulatory, contractual, funding and governance approvals. The Company will update the market as appropriate.

Anthony Tennyson, Chief Executive Officer of Solvonis Therapeutics, said: “Signing this MoU moves our European plans forward. We now have a framework with Portugal’s public addiction institute and a local clinical partner to assess how Portuguese sites could join SVN-001’s Phase 3 trial.

“The focus is practical: patients, treatment capacity, timelines and costs. We look forward to working with ICAD and Panegreen. Having Portugal’s national addiction institute alongside us is a strong vote of confidence in our European plans for SVN-001, and we will now take the proposal to the University of Exeter and our public funding partners.”

Dr Renata Crome, Independent Non-Executive Director of Solvonis and former Global Head of Development Operations at Roche, added: “In my time at Roche, when we wanted to add international sites to a clinical trial, Portugal was one of the first countries we would consider. It has experienced clinical investigators and clinical development infrastructure, a well-organised health system and EU-standard regulation, and it brings European patients into the study. ICAD and The Clinic of Change are exactly the partners I would want for that.”