Behavioural addictions estimated to affect over 48 million Americans¹

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London, United Kingdom--(Newsfile Corp. - November 5, 2026) - Solvonis Therapeutics plc (LSE: SVNS), a clinical-stage biotechnology company developing psychedelic therapeutics for addiction, post-traumatic stress disorder ("PTSD") and depression, announces 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 allowance marks a major milestone for Solvonis, providing a broad US patent position across behavioural addictions, with substantial patient populations, significant unmet medical need and scope for multiple potential partnerships and licensing deals. Binge eating and gambling disorders are the first commercial priorities, representing large, underserved markets with limited or no approved medicines.

The opportunity extends well beyond these initial indications. The breadth of the claims provides a foundation for building a substantial behavioural-addiction business alongside Solvonis' Phase 3 alcohol programme and NIDA-funded work on cocaine and methamphetamine addiction, significantly expanding the Company's commercial potential.

Highlights

• Over 48 million Americans estimated to be affected: a published expert estimate illustrates the scale of behavioural addictions, including gambling, food-related and other compulsive behaviours.¹

• Binge eating disorder — substantial need, one approved medicine: US research estimated 1.2% of adults affected annually and 2.8% during their lifetime. Lisdexamfetamine is the only FDA-approved medicine for moderate-to-severe binge eating disorder in adults.²

• Gambling disorder — millions affected, no approved medicine: approximately 9 million Americans experience problem gambling, including around 2.5 million adults with severe problems. There is no FDA-approved medicine for gambling disorder.³

• Broad US patent position: allowed claims cover all behavioural addictions at dissociative ketamine doses of at least 50 mg, by any route, with or without psychotherapy. Grant is expected in Q1 2027, subject to final formalities, with an expected patent term to May 2042.

Broad patent claims, multiple commercial opportunities

The claims span conditions including binge eating, gambling, gaming and compulsive sexual behaviour disorders. The application expressly includes racemic ketamine, esketamine and arketamine.

This breadth supports development and licensing across multiple indications. It also complements Solvonis' global exclusive rights to SVN-002, its esketamine oral thin film, in addiction, anxiety and eating disorders.

The allowance follows the international application filed in May 2022 by Awakn Life Sciences, now part of Solvonis.

Commercial precedent for known compounds

Transcend developed methylone-a previously known compound-for PTSD, supported by a granted US method-of-use patent covering that indication. Following positive Phase 2 results and progression into Phase 3, Otsuka acquired Transcend in June 2026 for US$700 million upfront plus up to US$525 million in sales-related payments.⁴

Solvonis is pursuing a similar commercial strategy with ketamine: protect new treatment uses, build clinical evidence and pursue partnering and out-licensing.

Building on an established addiction business

Solvonis already has experience of externally supported development. SVN-001's Phase 3 alcohol trial is co-funded by Solvonis, the National Institute for Health and Care Research ("NIHR") and the Medical Research Council ("MRC").

Separately, 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 the compound and its intellectual property.

Professor David Nutt, Chief Scientific Officer of Solvonis, said: "Addiction traps people in patterns they struggle to break. Ketamine may open a window to change those patterns. Our work in alcohol addiction gives us a strong foundation to investigate binge eating and gambling. The goal is lasting change, not just short-term relief."

Anthony Tennyson, Chief Executive Officer of Solvonis, said: "This is a major milestone for Solvonis. These broad allowed US claims create scope for multiple potential partnerships and licensing deals. Binge eating and gambling are our starting point-not the limit of the opportunity.

"Alongside our Phase 3 alcohol programme and NIDA-funded work on cocaine and methamphetamine addiction, this significantly expands our commercial opportunity. We will pursue non-dilutive funding and partners to build clinical evidence and long-term shareholder value."

About Solvonis Therapeutics plc

Solvonis Therapeutics plc (LSE: SVNS) is a clinical-stage biotechnology company developing psychedelic therapeutics for addiction, PTSD and depression. Headquartered in London and listed on the Main Market of the London Stock Exchange, it combines value-added medicines, developing differentiated treatments from established medicines, with de novo drug development, creating proprietary new compounds.

SVN-001 is a ketamine-based treatment in Phase 3 for severe alcohol use disorder ("AUD") in the UK. The trial is sponsored by the University of Exeter. Portuguese sites are being assessed as part of proposed European expansion, intended to generate European clinical data supporting potential future marketing-authorisation applications.

SVN-002 is an esketamine oral thin film in Phase 2b planning for moderate-to-severe AUD in the US, with an FDA-agreed 505(b)(2) pathway based on a scientific bridge to SPRAVATO® and formulation patents granted in the US and Europe.

SVN-015 is a proprietary new compound undergoing further NIDA-funded preclinical studies for cocaine and methamphetamine addiction. A separate programme is developing the same compound for major depressive disorder with anhedonia.

SVN-114 is a preclinical novel entactogen for PTSD.

All programmes described above are investigational. Their safety and efficacy for the proposed indications have not been established, and none has received regulatory approval for those indications. Patent allowance does not constitute regulatory approval. SPRAVATO® is a trademark of Johnson & Johnson.

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Sources and notes

¹ Grant, J. E., Johns Hopkins University Press, 22 June 2020. Historical expert estimate, not a current national diagnostic survey; includes behaviours not all classified as standalone addictions under DSM criteria.

² NIMH, citing Hudson et al. (2007), based on the 2001-2003 National Comorbidity Survey Replication. Approved-medicine information: American Psychiatric Association and FDA.

³ National Council on Problem Gambling (2025); American Psychiatric Association. Problem gambling includes people who do not meet the full diagnostic criteria for gambling disorder.

⁴ Otsuka, 12 June 2026; US patent 11,707,446; international patent publication WO1996039133. The acquisition concerned a clinically advanced business, with additional payments contingent on future sales. It is a commercial precedent, not a direct valuation comparison with Solvonis.

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