Solvonis Therap Regulatory News (SVNS)

Solvonis Therapeutics plc

("Solvonis" or the "Company")

Solvonis' Novel Compound SVN-015 Accepted into US NIDA-Funded Addiction Treatment Discovery Program for Methamphetamine and Cocaine Addiction

Solvonis Therapeutics plc (LSE: SVNS), an emerging biopharmaceutical company developing novel medicines for high-burden central nervous system (CNS) disorders, announces that its novel AI-discovered compound, SVN-015, targeting methamphetamine and cocaine use disorders, has been accepted into the US National Institute on Drug Abuse's ("NIDA") Addiction Treatment Discovery Program ("ATDP"). Under the programme, NIDA, part of the US National Institutes of Health ("NIH"), will fund and conduct early preclinical evaluation of SVN-015.

Programme Overview

In the first stage of the programme, NIDA will fund and carry out in vitro predictive safety studies on SVN-015 to assess potential cardiovascular risks. These tests are the normal first step in the development of any new medicine. If the results are supportive, SVN-015 could advance into ATDP efficacy studies in validated preclinical models of methamphetamine and cocaine addiction.

If the efficacy studies are successful, Solvonis would be well positioned to compete for a non-dilutive NIH research grant, which can provide up to US$3 million per year for as long as five years. These grants are competitive, but completion of early preclinical studies would provide the type of safety and efficacy data needed to support Solvonis' grant application. This creates a potential pathway from funded NIDA preclinical work through to potential NIH-funded clinical trials in humans.

Strategic Significance

Acceptance of SVN-015 into the ATDP marks an important milestone for Solvonis as it expands the Company's research in addiction beyond alcohol use disorder ("AUD") into stimulant addictions - specifically methamphetamine and cocaine - which remain among the most severe psychiatric conditions with no approved drug treatments.

Professor David Nutt, Solvonis Chief Scientific Officer, commented "Being accepted into NIDA's ATDP for SVN-015 is a major step forward for Solvonis. ATDP provides a pathway for evaluating the therapeutic potential of SVN-015, starting with early preclinical testing and, if successful, creating the opportunity to progress towards NIH clinical development funding through the UG3/UH3 programme. For methamphetamine and cocaine addiction - where no approved drug treatments exist - this represents an important advance."

Enquiries:

About SVN-015

SVN-015 is the second compound emerging from Solvonis' AI-enabled drug discovery programme to progress into external validation, following the advancement of SVN-SDN-14 for Post-Traumatic Stress Disorder. It is a novel candidate designed to address stimulant addictions - including methamphetamine and cocaine dependence - areas with significant unmet need and no currently approved pharmacological treatments.

About NIDA

The US National Institute on Drug Abuse ("NIDA") is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world's research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science.

About Methamphetamine and Cocaine Addiction

Methamphetamine and cocaine addiction remain major public health challenges. There are no approved pharmacological treatments; patients are managed only with psychosocial interventions, which deliver limited and inconsistent outcomes. Both NIDA and the European Monitoring Centre for Drugs and Drug Addiction ("EMCDDA") identify stimulant use disorders as areas of critical unmet need, associated with high morbidity, mortality, and significant societal costs.

Epidemiological data highlights the scale of the problem. In the United States, the National Survey on Drug Use and Health ("SAMHSA 2022") estimates approximately 2.6 million people meet diagnostic criteria for cocaine or methamphetamine use disorders. In the EU5, EMCDDA data indicate 0.35-0.5 million patients, predominantly with cocaine dependence. In Japan, national data suggest around 0.1 million patients, largely with methamphetamine dependence. Taken together, this represents a combined total of around 3.0-3.2 million individuals across the seven major markets - a large population with no existing drug treatment options.

The content of this press release is solely the responsibility of Solvonis and does not necessarily represent the official views of the National Institutes of Health.

About Solvonis Therapeutics plc

Solvonis Therapeutics plc (LSE: SVNS) is an emerging biopharmaceutical company developing novel small-molecule therapeutics for high-burden central nervous system (CNS) disorders. Headquartered in London and listed on the main market of the London Stock Exchange, Solvonis is advancing a differentiated pipeline of repurposed and novel compounds across addiction, psychiatry, and neurology.

The Company's lead programmes address Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD), with additional discovery work supporting expansion into broader CNS indications. Its lead asset, SVN-001, is currently in Phase 3 for severe AUD in the UK, while SVN-002 is preparing for a Phase 2b trial in the US targeting moderate-to-severe AUD. The preclinical PTSD programme (SVN-SDN-14) leverages novel serotonin-dopamine modulators designed to enhance pro-social behaviour and long-term outcomes.

In parallel, Solvonis is advancing proprietary CNS discovery programmes built on a dedicated compound library to identify new small-molecule modulators of key neurotransmitter systems. This platform enables efficient early-stage innovation and supports the Company's integrated approach to developing therapies across its three strategic pillars.

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