US CNS Executive Order

Welcomes President Trump's Executive Order as a positive signal for rapid-acting CNS therapies in the United States

Solvonis Therapeutics plc (LSE: SVNS), an emerging biopharmaceutical company developing novel small-molecule therapeutics for high-burden central nervous system ("CNS") disorders, views the Executive Order signed by President Donald Trump on 18 April 2026, "Accelerating Medical Treatments for Serious Mental Illness," as a major and highly encouraging signal for the growing regulatory, commercial and strategic importance of the sector in which the Company operates, particularly in the strategically important U.S. market. The Executive Order states that it is U.S. policy to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs for serious mental illness, and includes measures relating to review prioritisation, Right to Try access pathways, federal-state collaboration funding, data sharing and rescheduling review following successful Phase 3 trials.

In Solvonis' view, the Executive Order is a powerful indication that rapid-acting CNS and psychedelic-adjacent therapies are moving more firmly into the strategic, regulatory and policy mainstream in the world's most important pharmaceutical and capital-markets arena for this category. The Company believes this development is significant not only because of the specific measures announced, but because it reflects a broader shift in U.S. policy attention toward accelerating innovation in serious mental illness and addiction. The Order itself refers to major depressive disorder and substance abuse disorder among the conditions for which innovative methods are needed beyond existing prescription medications.

While the Executive Order does not relate directly to any specific Solvonis programme, the Company believes it is highly relevant to the therapeutic areas in which it operates, including addiction, PTSD and broader psychiatry. Solvonis' pipeline spans addiction and psychiatry, including SVN-001 in severe alcohol use disorder, SVN-002 in moderate-to-severe alcohol use disorder in the United States, SVN-015 in stimulant addiction with optionality in depression, and SVN-114 in PTSD.

In particular, Solvonis believes the improving U.S. backdrop is relevant to SVN-002, its U.S.-focused programme being advanced through a 505(b)(2) strategy designed to bridge to an established U.S. esketamine framework. The Company also believes the increasing U.S. focus on innovative treatments for addiction and serious mental illness is supportive of the broader long-term positioning of programmes such as SVN-015, its stimulant addiction programme, which was accepted into the U.S. National Institute on Drug Abuse's ("NIDA") Addiction Treatment Discovery Program ("ATDP"). Under the programme, NIDA, part of the U.S. National Institutes of Health ("NIH"), will fund and conduct early preclinical evaluation of SVN-015, including initial in vitro predictive safety studies, with potential progression into efficacy studies in validated preclinical models of methamphetamine and cocaine addiction if results are supportive.

Solvonis also believes the Executive Order reinforces a wider strategic reality: the United States remains the most attractive long-term commercial, regulatory and capital-markets environment globally for innovative CNS therapeutics. As policy support, regulatory engagement and investor attention continue to evolve, the Company believes the opportunity set for well-positioned businesses in this space may expand materially.

Anthony Tennyson, CEO of Solvonis Therapeutics plc, commented: "We welcome the White House Executive Order as a major positive signal for the broader sector and as further evidence that rapid-acting CNS and psychedelic-adjacent therapies are gaining real momentum in the United States.

While this is not a programme-specific announcement for Solvonis, it is highly relevant in strategic terms. It reinforces our view that the broader backdrop is improving, particularly in the United States, and highlights the increasing importance of companies able to build differentiated positions across addiction, PTSD and psychiatry.

With SVN-001, SVN-002, SVN-015 and our broader pipeline, we believe Solvonis is building a highly differentiated portfolio with meaningful optionality in an area of increasing regulatory, commercial and policy importance. As the sector continues to mature, we believe businesses with credible programmes, clear execution pathways and strong U.S. relevance are likely to be well placed, and we believe Solvonis is one of them."

The Company will continue to monitor U.S. policy, regulatory and market developments in this area and assess their relevance to its pipeline, strategic positioning and long-term capital-markets plans.