Solvonis Therapeutics plc Announces US Patent Office Allows Ketamine Patent Across All Behavioural Addictions

(LSE: SVNS) Solvonis Therapeutics plc, a clinical-stage biotechnology company based in the United Kingdom, announced that the US Patent and Trademark Office (USPTO) has allowed its method-of-use patent application covering the treatment of all behavioural addictions with ketamine at dissociative doses of at least 50 mg. The allowed claims provide Solvonis with a broad US patent position across behavioural addictions, including binge eating, gambling, gaming, and compulsive sexual behaviour disorders, using racemic ketamine, esketamine, or arketamine, by any route, with or without psychotherapy. The patent grant is expected in Q1 2027, subject to final formalities, with an anticipated patent term to May 2042. Over 48 million Americans are estimated to be affected by behavioural addictions, including gambling and food-related compulsive behaviours. US research estimates that 1.2% of adults are affected by binge eating disorder annually and 2.8% during their lifetime, with lisdexamfetamine being the only FDA-approved medicine for moderate-to-severe binge eating disorder in adults. Approximately 9 million Americans experience problem gambling, including around 2.5 million adults with severe problems, and there is currently no FDA-approved medicine for gambling disorder. The patent allowance supports Solvonis' commercial strategy to protect new treatment uses, build clinical evidence, and pursue partnering and out-licensing opportunities. The company’s Phase 3 alcohol trial for SVN-001 is co-funded by Solvonis, the National Institute for Health and Care Research (NIHR), and the Medical Research Council (MRC), while the US National Institute on Drug Abuse (NIDA) funds and conducts further preclinical studies of SVN-015 for cocaine and methamphetamine addiction. Solvonis retains ownership of its compounds and intellectual property. The patent application was originally filed in May 2022 by Awakn Life Sciences, now part of Solvonis. Commercial precedent is cited with Otsuka’s June 2026 acquisition of Transcend for US$700 million upfront plus up to US$525 million in sales-related payments, following a granted US method-of-use patent and positive Phase 2 results. Solvonis’ pipeline includes SVN-001 (ketamine-based, Phase 3 for severe alcohol use disorder in the UK), SVN-002 (esketamine oral thin film, Phase 2b planning for moderate-to-severe AUD in the US, with FDA-agreed 505(b)(2) pathway and formulation patents granted in the US and Europe), SVN-015 (proprietary compound in NIDA-funded preclinical studies for cocaine and methamphetamine addiction and a separate programme for major depressive disorder with anhedonia), and SVN-114 (preclinical novel entactogen for PTSD). All programmes are investigational and have not received regulatory approval. Professor David Nutt, Chief Scientific Officer, and Anthony Tennyson, Chief Executive Officer, commented on the significance of the patent milestone and the company’s strategy to pursue non-dilutive funding and partnerships to build clinical evidence and long-term shareholder value.

Solvonis Therapeutics Plc — US Patent Office allows ketamine patent

(LSE:SVNS) Solvonis Therapeutics PLC announced that the United States Patent and Trademark Office (USPTO) has allowed a method-of-use patent covering the treatment of all behavioural addictions with ketamine at dissociative doses of at least 50 mg. The patent claims include racemic ketamine, esketamine, and arketamine. Grant of the patent is expected in Q1 2027. The expected patent term extends to May 2042. The patent underpins potential partnerships and licensing opportunities across an estimated addressable US population of over 48 million people. The addressable population includes binge eating disorder, with a 1.2% annual prevalence and 2.8% lifetime prevalence, and gambling disorder, with approximately 9 million affected and approximately 2.5 million considered severe. The patent complements Solvonis's Phase 3 alcohol programme and NIDA-funded work. The company states that this increases prospects for non-dilutive deals and commercialisation. The announcement references precedent M&A transactions with $700 million upfront plus up to $525 million contingent. The company highlights the potential for partnerships and licensing based on the breadth of the patent claims and the size of the addressable market.

Solvonis Therapeutics Plc — MOU Reached with ICAD

(LSE: SVNS) Solvonis Therapeutics plc has signed a Memorandum of Understanding (MoU) with ICAD, Portugal’s National Addiction Institute, and Panegreen – Health & Wellness Solutions, Lda. to assess the addition of Portuguese trial sites to the MORE-KARE UK Phase 3 trial of SVN-001 for severe alcohol use disorder (AUD). ICAD, attached to Portugal’s Ministry of Health, will help evaluate referral pathways and patient recruitment, while Panegreen, which operates The Clinic of Change in Lisbon, will coordinate the Portuguese work. The assessment will cover treatment capacity, start-up timelines, costs, potential investigators and trial sites, recruitment, treatment delivery, staffing and training, pharmacy and controlled-drug requirements, translation of trial materials, and Portuguese regulatory and ethics requirements. Solvonis will assess whether the cost per participant at Portuguese sites could be broadly in line with that charged by NHS sites in the UK. Final costs and funding arrangements remain subject to agreement. The MoU formalizes the European expansion plan announced on 25 August 2026, turning it into a signed framework with partners in Portugal in under two months. 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. The planned inclusion of Portuguese patients in MORE-KARE would add EU clinical data to SVN-001’s Phase 3 evidence base, aiming to strengthen future marketing authorisation applications in selected EU countries or across the EU. 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. Solvonis will now take the proposal to the University of Exeter, NIHR, and MRC, with the assessment informing their consideration of Portuguese participation. SVN-001 combines ketamine with structured psychological therapy for severe AUD and is being evaluated in 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). Solvonis’ pipeline also includes SVN-002, advancing towards a planned Phase 2b trial in the United States for moderate-to-severe AUD, SVN-114 as a lead compound for PTSD, and SVN-015 for stimulant use disorder (StUD) and depression (MDD), with preclinical studies for StUD funded by the U.S. National Institute on Drug Abuse (NIDA). The company is also advancing proprietary CNS discovery programmes supported by a dedicated compound library and AI-enabled discovery capabilities.

Solvonis Therapeutics Plc — Vital Patent milestone achieved– SVN 114

(LSE: SVNS) Solvonis Therapeutics plc announced that the European Patent Office has issued a Notice of Allowance for composition-of-matter patent application EP 22730070.4, arising from the Company's proprietary Post-Traumatic Stress Disorder (PTSD) programme, whose lead candidate is SVN-114. The EPO allowance covers composition-of-matter claims, which are widely regarded as the strongest form of pharmaceutical patent protection. PTSD affects an estimated 15.8 million people across the U.S., UK, EU4 and Japan. The allowance adds to the proprietary chemistry estate supporting Solvonis' lead PTSD candidate, SVN-114. The Company has developed three additional chemically distinct supporting patent families through its PTSD programme, and following the latest European allowance, each of these three families has now achieved composition-of-matter grant or allowance in the U.S. or Europe. Otsuka Pharmaceutical's US$1.225 billion acquisition of PTSD-focused Transcend Therapeutics, including US$700 million upfront and up to US$525 million in contingent consideration, highlights the strategic value being placed on next-generation PTSD treatments. Transcend's lead asset, methylone-based TSND-201, is in Phase 3 development for PTSD following positive Phase 2 results. Eli Lilly's agreed acquisition of AtaiBeckley for up to US$3.8 billion further demonstrates pharmaceutical investment in next-generation neuropsychiatry assets. Solvonis intends to progress SVN-114 through further pharmacology, pharmacokinetic and brain-exposure studies, safety pharmacology and formal abuse-liability assessment. The Company intends to seek non-dilutive grant and research funding in the UK, European Union and United States to advance SVN-114 towards IND-enabling development.

Solvonis Therapeutics Plc — Solvonis Raises £1.3 Million

(LSE: SVNS) Solvonis Therapeutics plc has conditionally raised gross proceeds of £1.3 million through a placing of 1,083,333,333 new Ordinary Shares at a placing price of £0.0012 per share with new and existing investors. The Fundraising includes participation from a noted UK institutional investor as a new entrant to the Company's shareholder register. Turner Pope Investments (TPI) Limited acted as sole bookrunner to the Fundraising and has been appointed as the Company's corporate broker with immediate effect. The net proceeds will principally support the assessment and potential addition of selected international sites, including sites in the European Union, to progress the ongoing SVN-001 Phase 3 study, the advancement of SVN-002 towards an Investigational New Drug (IND) submission and Phase 2b readiness in the United States, and the progression of SVN-015 alongside the US National Institute on Drug Abuse (NIDA). The Company has agreed to settle fees for services provided amounting to £15,000 through the issue of 10,000,000 new ordinary shares at an issue price of £0.0015 per share. Turner Pope is being granted warrants to subscribe for 78,333,333 new Ordinary Shares at the Issue Price, in whole or in part, at any time in the 5 years from Admission. Following Admission, the Company's enlarged issued ordinary share capital will comprise 7,899,736,826 ordinary shares of £0.001 each.

Solvonis Therapeutics Plc — Research Coverage Initiation

(LSE: SVNS) Solvonis Therapeutics plc announced that Water Tower Research LLC has initiated research coverage of the company. WTR recorded Solvonis' market value at approximately US$15 million and benchmarked the company against US-listed advanced-stage CNS companies valued between approximately US$369 million and US$5.9 billion, Altimmune at approximately US$600 million, and Indivior at approximately US$5 billion. The report also referenced the proposed European commercialisation framework for Adial Pharmaceuticals' pre-Phase 3 AUD asset, with total potential value of up to approximately US$60 million. Solvonis is currently advancing a Phase 3 programme, a US-focused clinical-stage programme preparing for Phase 2b development, and a proprietary CNS discovery pipeline. The scale of the Alcohol Use Disorder opportunity addressed by Solvonis includes approximately 27.9 million people aged 12 and over with AUD in the United States, an estimated 11-12 million people with moderate-to-severe AUD in the US target market for SVN-002, and an estimated 13 million people with severe AUD across the UK and selected European markets addressed by SVN-001. The economic burden is measured in the hundreds of billions of dollars across the company's principal target markets. The company projects progression of SVN-002 towards a US Phase 2b trial, increased engagement with US capital markets, broader access to US investors, and the future SVN-001 Phase 3 readout as important potential value inflection points.

CSO Speaks at National Research Meeting

Solvonis Therapeutics plc (LSE: SVNS), an emerging biopharmaceutical company, announced that its Chief Scientific Officer, Professor David Nutt, is scheduled to speak at a major U.S. National Institutes of Health (NIH) addiction research meeting on 6 May 2026. Professor Nutt will be the sole external speaker at the 14th Joint Meeting / 13th CRAN of the National Advisory Council on Alcohol Abuse and Alcoholism, the National Cancer Advisory Board, and the National Advisory Council on Drug Abuse. The NIH is described as the world's largest single public funder of biomedical and behavioural research, with an annual budget of more than US$47 billion. NIDA's FY2025 budget request is approximately US$1.67 billion and NIAAA's FY2025 appropriation is approximately US$595 million. Solvonis' pipeline includes late-stage and preclinical programmes targeting Alcohol Use Disorder and stimulant-use disorders, with clinical trials ongoing in the UK and United States.

Appointment of Water Tower Research

(LSE:SVNS) Solvonis Therapeutics PLC announced the appointment of Water Tower Research.