Solvonis Therapeutics Plc

Solvonis Therapeutics plc (“Solvonis” or the “Company”) Announces Positive Bridging Data Supporting Planned U.S. 505(b)(2) Pathway Towards Phase 2b PK Data Support Scientific Bridge to Approved Intranasal Esketamine Reference Product LONDON – 22 June 2026 – Solvonis Therapeutics plc (LSE: SVNS), a late clinical-stage biopharmaceutical company developing novel small-molecule therapeutics for high-burden central nervous system (“CNS”) disorders, announces positive pharmacokinetic (“PK”) data from the preclinical bridging study for its SVN-002 development programme. SVN-002 is Solvonis’ proprietary esketamine oral thin-film (“OTF”) formulation being developed for moderate-to-severe Alcohol Use Disorder (“AUD”) in the United States. It is designed for supervised, clinic-administered sublingual-buccal dosing. The programme also incorporates a structured alcohol education component, intended for future remote digital access by patients. The programme is being advanced under a planned U.S. Food and Drug Administration (“FDA”) 505(b)(2) regulatory pathway referencing the FDA-approved intranasal esketamine product, Spravato®. Key Study Results and Regulatory Alignment The nonclinical study was designed to assess whether the intended combined sublingual-buccal administration of SVN-002 could generate systemic esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. The results were positive. At the same nominal dose level, combined sublingual-buccal administration of SVN-002 produced rapid systemic exposure to parent esketamine. Exposure levels for parent esketamine and the key measured metabolites, noresketamine and hydroxynoresketamine, were within the range observed for the intranasal esketamine comparator arm, providing important translational support for the planned scientific bridge. At the December 2024 Type B pre-IND meeting held with the FDA by Awakn Life Sciences, prior to the asset's acquisition by Solvonis, FDA identified systemic exposure to esketamine and relevant metabolite exposure as key considerations for the initial Investigational New Drug ("IND") package. Solvonis believes these newly generated data provide important translational support in relation to the FDA-identified exposure considerations and strengthen the planned initial IND package for SVN-002. Next Steps Following these positive results, Solvonis will seek further FDA feedback on the scope and scale of the remaining nonclinical toxicology work required for the initial IND submission. Subject to FDA feedback and successful completion of this targeted toxicology package, Solvonis plans to submit an IND to support the initiation of a Phase 2b clinical trial of SVN-002 in patients with moderate-to-severe AUD in the United States. Commercial Context and the 505(b)(2) Advantage AUD represents a major and underserved U.S. market opportunity characterised by limited pharmacological innovation. According to the 2024 U.S. National Survey on Drug Use and Health, approximately 27.9 million people aged 12 and older in the U.S. had Alcohol Use Disorder in the past year. Solvonis estimates that approximately 15 million U.S. adults fall within the programme’s target moderate-to-severe AUD population. Spravato® provides a relevant commercial reference point for supervised, clinic-administered esketamine treatment models. Johnson & Johnson reported worldwide Spravato® sales of approximately US$1.7 billion in 2025 for depression-related indications. Solvonis estimates that SVN-002’s target U.S. moderate-to-severe AUD population is approximately five times larger than the estimated U.S. treatment-resistant depression comparator population of approximately 2.8 million people. The planned 505(b)(2) pathway is central to the capital efficiency of the SVN-002 development strategy. A successful 505(b)(2) route may allow Solvonis to rely, in part, on the FDA’s prior findings of safety and/or effectiveness for the approved intranasal esketamine reference product, provided a suitable scientific bridge is established. Solvonis intends to build the SVN-002 package using existing third-party preclinical data, in-licensed Phase 1 clinical data, and targeted SVN-002 bridging and toxicology studies, rather than duplicating a full conventional de novo development package. The Company believes this approach has the potential to reduce development expenditure and support a more capital-efficient route towards Phase 2b. Anthony Tennyson, Chief Executive Officer of Solvonis Therapeutics, said: "This is an important technical and regulatory milestone for SVN-002. "The study was designed to test whether our intended combined sublingual-buccal delivery could generate esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. The data support that objective and provide an important basis for the next stage of regulatory engagement, including FDA feedback on the remaining toxicology package. "SVN-002 targets a large and poorly served U.S. Alcohol Use Disorder market through a differentiated thin-film product and a planned capital-efficient 505(b)(2) regulatory pathway. Subject to successful completion of the required toxicology work, our plan is to submit an IND to support a Phase 2b trial in moderate-to-severe AUD." Professor David Nutt, Chief Scientific Officer of Solvonis Therapeutics, added: "The pharmacokinetic profile observed in this study is very encouraging. Combined sublingual-buccal administration produced rapid systemic exposure to parent esketamine and supports the core rationale for SVN-002 as a transmucosal thin-film product. "These results provide important translational evidence for our planned U.S. regulatory pathway and support SVN-002's continued development as a supervised, clinic-administered treatment candidate for AUD.” Enquiries: Solvonis Therapeutics plcAnthony Tennyson, CEO & Executive Directorinfo@solvonis.comSinger Capital Markets (Broker)Russell Cook+44 (0) 20 7496 3000 About Solvonis Therapeutics plc Solvonis Therapeutics plc (LSE: SVNS) is a late-clinical stage biopharmaceutical company developing 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 discovery-stage compounds across addiction and psychiatry. The Company’s lead programmes target Alcohol Use Disorder (“AUD”) and Post-Traumatic Stress Disorder (“PTSD”), with additional development and discovery work supporting expansion into further addiction and psychiatric indications, including stimulant use disorder and depressive disorders. Its lead asset, SVN-001, is currently in Phase 3 for severe AUD in the UK, while SVN-002 is being advanced towards a planned Phase 2b trial in the United States targeting moderate-to-severe AUD. The Company’s PTSD discovery programme has identified SVN-114 as a lead compound, emerging from a proprietary compound series designed to modulate key brain signalling systems associated with emotional processing and social behaviour. In parallel, Solvonis is advancing proprietary CNS discovery programmes supported by a dedicated compound library to identify new small-molecule modulators of key neurotransmitter systems. This platform supports the Company’s integrated approach to developing therapies across addiction and psychiatry.

LONDON – June 19, 2026 – Solvonis Therapeutics plc (LSE: SVNS) (“Solvonis” or the “Company”), a late clinical stage biopharmaceutical company developing novel small-molecule therapeutics for high-burden central nervous system ("CNS") disorders, announces that at the Annual General Meeting of the Company held earlier today, all resolutions put to shareholders were duly passed. Voting on all resolutions was conducted by way of a poll. Full details of the poll results are set out below. Dennis Purcell, Non-Executive Chairman of Solvonis, commented: “On behalf of the Board, I would like to thank shareholders for their continued support at today’s Annual General Meeting. “The past year has been an important period in the development of Solvonis, during which the Company completed its transition into a focused CNS therapeutics business and established a broader, more coherent portfolio across addiction and psychiatry. “We are pleased with the balanced progress being made across the portfolio, including our later-stage clinical programmes in Alcohol Use Disorder and our emerging discovery and preclinical opportunities in PTSD, stimulant use disorder and depression. “The Board remains focused on disciplined execution, capital-efficient development and creating long-term value for shareholders. We look forward to updating the market, as appropriate, on continued progress across the portfolio through the remainder of 2026.” The Company’s strategy is to build a differentiated CNS therapeutics portfolio across areas of high unmet need, with later-stage clinical assets complemented by internally generated discovery programmes. Solvonis’ current portfolio includes SVN-001, its lead programme in severe Alcohol Use Disorder; SVN-002, its U.S.-focused Alcohol Use Disorder programme; and discovery and preclinical programmes including SVN-114 in PTSD and SVN-015 in stimulant use disorder and depression. Voting Results: Resolution Votes for % Votes Cast Votes against % Votes Cast Total Votes Votes withheld Resolution 1 (Ordinary)To receive the report and accounts for the year ended 31 December 2025 1,155,565,533 96.16% 46,093,340 3.84% 1,201,658,873 1,589,104 Resolution 2 (Ordinary)To approve the remuneration policy 1,113,689,240 95.46% 52,967,133 4.54% 1,166,656,373 36,591,604 Resolution 3 (Ordinary)To approve the remuneration report 1,113,689,240 95.46% 52,967,133 4.54% 1,166,656,373 36,591,604 Resolution 4 (Ordinary)To re-appoint Kreston Reeves LLP as auditor 1,197,595,249 99.53% 5,652,728 0.47% 1,203,247,977 0 Resolution 5 (Ordinary)To re-appoint Paul Carter as a director 1,151,080,001 95.66% 52,167,976 4.34% 1,203,247,977 0 Resolution 6 (Ordinary)To re-appoint Anthony Tennyson as a director 1,151,313,351 99.49% 5,934,626 0.51% 1,157,247,977 46,000,000 Resolution 7 (Ordinary)To re-appoint Nicholas Nelson as a director 1,151,080,001 95.66% 52,167,976 4.34% 1,203,247,977 0 Resolution 8 (Ordinary)To authorise the directors to allot equity 1,146,194,662 95.26% 57,053,315 4.74% 1,203,247,977 0 Resolution 9 (Special)That a general meeting, other than an AGM, may be called on not less than 14 days’ notice 1,162,592,749 96.62% 40,655,228 3.38% 1,203,247,977 0 Resolution 10 (Special) To disapply pre-emption rights 1,026,314,705 94.85% 55,700,737 5.15% 1,082,015,442 121,232,535 Resolution Votes for % Votes Cast Votes against % Votes Cast Total Votes Votes withheld Resolution 1 (Ordinary) To receive the report and accounts for the year ended 31 December 2025 1,155,565,533 96.16% 46,093,340 3.84% 1,201,658,873 1,589,104 Resolution 2 (Ordinary) To approve the remuneration policy 1,113,689,240 95.46% 52,967,133 4.54% 1,166,656,373 36,591,604 Resolution 3 (Ordinary) To approve the remuneration report 1,113,689,240 95.46% 52,967,133 4.54% 1,166,656,373 36,591,604 Resolution 4 (Ordinary) To re-appoint Kreston Reeves LLP as auditor 1,197,595,249 99.53% 5,652,728 0.47% 1,203,247,977 0 Resolution 5 (Ordinary) To re-appoint Paul Carter as a director 1,151,080,001 95.66% 52,167,976 4.34% 1,203,247,977 0 Resolution 6 (Ordinary) To re-appoint Anthony Tennyson as a director 1,151,313,351 99.49% 5,934,626 0.51% 1,157,247,977 46,000,000 Resolution 7 (Ordinary) To re-appoint Nicholas Nelson as a director 1,151,080,001 95.66% 52,167,976 4.34% 1,203,247,977 0 Resolution 8 (Ordinary) To authorise the directors to allot equity 1,146,194,662 95.26% 57,053,315 4.74% 1,203,247,977 0 Resolution 9 (Special) That a general meeting, other than an AGM, may be called on not less than 14 days’ notice 1,162,592,749 96.62% 40,655,228 3.38% 1,203,247,977 0 Resolution 10 (Special) To disapply pre-emption rights 1,026,314,705 94.85% 55,700,737 5.15% 1,082,015,442 121,232,535 As at 19 June 2026, there were 6,806,403,493 ordinary shares in issue. Shareholders are entitled to one vote per share. Votes withheld are not votes in law and have not been included in the calculation of the proportion of votes for or against a resolution. The full text of each resolution is available in the Notice of Annual General Meeting, published on the Company's website. Enquiries: Solvonis Therapeutics plcAnthony Tennyson, CEO & Executive Directorinfo@solvonis.comSinger Capital Markets (Broker)Russell Cook+44 (0) 20 7496 3000 About Solvonis Therapeutics plc Solvonis Therapeutics plc (LSE: SVNS) is a late clinical-stage biopharmaceutical company developing 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 across addiction and psychiatry, combining later-stage clinical programmes with proprietary discovery-stage assets. The Company’s lead clinical programme, SVN-001, is currently in Phase 3 for severe Alcohol Use Disorder (“AUD”) in the UK, while SVN-002 is being advanced towards a planned Phase 2b trial in the United States targeting moderate-to-severe AUD. Solvonis is also advancing proprietary discovery and preclinical programmes across Post-Traumatic Stress Disorder (“PTSD”), stimulant use disorder and depressive disorders. These include SVN-114, a lead candidate from the Company’s PTSD discovery programme, and SVN-015, a novel serotonin-dopamine reuptake inhibitor being evaluated for stimulant use disorder, with additional depression-related optionality. In parallel, Solvonis is continuing to build its proprietary CNS discovery platform, supported by a dedicated compound library, to identify and develop new small-molecule modulators of key neurotransmitter systems relevant to addiction and psychiatry.

Solvonis Therapeutics plc (“Solvonis” or the “Company”) Solvonis Chief Scientific Officer Professor David Nutt to Speak at U.S. National Institutes of Health Addiction Research Meeting Professor Nutt to speak on psychedelic therapy for addictions at major U.S. federal addiction-research forum Solvonis’ Chief Scientific Officer to participate alongside senior leaders from NIDA, NIAAA and NCI, the principal U.S. federal bodies shaping addiction research Solvonis Therapeutics plc (LSE: SVNS), an emerging biopharmaceutical company developing novel small-molecule therapeutics for high-burden central nervous system (“CNS”) disorders, notes that Professor David Nutt, Chief Scientific Officer of Solvonis, is scheduled to speak at a high-profile public addiction research meeting convened by the U.S. National Institutes of Health (“NIH”). Professor Nutt is expected to speak on psychedelic therapy for addictions 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, taking place on 6 May 2026. The NIH is the principal medical research agency of the United States government and the world’s largest single public funder of biomedical and behavioural research, with an annual budget of more than US$47 billion. CRAN — Collaborative Research on Addiction at NIH — is the NIH partnership through which the National Institute on Alcohol Abuse and Alcoholism (“NIAAA”), the National Institute on Drug Abuse (“NIDA”) and the National Cancer Institute (“NCI”) coordinate research across substance use, misuse, addiction and related health consequences. The meeting brings together senior U.S. federal leaders in addiction-related research, including Dr Nora Volkow, Director of NIDA, and Dr George Koob, Director of NIAAA. Professor Nutt is the sole external speaker, placing Solvonis’ Chief Scientific Officer in a prominent U.S. forum alongside senior figures who help shape the U.S. national scientific and funding priorities for alcohol, drug-use and addiction-related disorders. Relevance to Solvonis For UK investors, the relevance is clear. Solvonis is a London-listed CNS biopharmaceutical company focused on high-burden addiction and psychiatric disorders, operating in therapeutic areas attracting increasing scientific, policy and commercial attention in the United States and globally. NIDA and NIAAA are among the most influential addiction-research institutions in the world. Published U.S. budget materials show the scale of these organisations, with NIDA’s FY2025 budget request at approximately US$1.67 billion and NIAAA’s FY2025 appropriation at approximately US$595 million. Professor Nutt’s participation highlights the calibre, relevance and international profile of Solvonis’ scientific leadership. His expected presentation on psychedelic therapy for addictions is directly relevant to the field in which Solvonis is developing its addiction-focused pipeline: innovative CNS pharmacology combined, where appropriate, with structured psychosocial support. Solvonis’ addiction-focused pipeline includes: · SVN-001, the Company’s late-stage ketamine-assisted therapy programme for severe Alcohol Use Disorder, currently being evaluated in a UK Phase 3 study; · SVN-002, the Company’s U.S.-focused esketamine oral thin film programme for moderate-to-severe Alcohol Use Disorder, which is being developed with structured psychosocial support; and · SVN-015, the Company’s preclinical programme for stimulant-use disorders, which has been selected for evaluation through the U.S. National Institute on Drug Abuse’s Addiction Treatment Discovery Program. Together, these programmes position Solvonis across alcohol and substance-use disorders, with a pipeline spanning late-stage clinical development, U.S.-focused mid-clinical development and earlier-stage discovery in areas of significant unmet medical need. CEO Comment Anthony Tennyson, Chief Executive Officer of Solvonis, commented: “This is a high-profile U.S. addiction-research forum convened through the NIH’s cross-institute CRAN initiative, bringing together NIDA, NIAAA and NCI — the principal U.S. federal bodies active in addiction-related research. “Professor Nutt’s participation as the sole external academic speaker listed for the public session reflects his international standing in addiction neuroscience, neuropsychopharmacology and psychedelic-assisted therapy. “For Solvonis, this is highly relevant. We are a UK-listed CNS biopharmaceutical company advancing programmes across Alcohol Use Disorder, addiction and psychiatry, including a NIDA-linked preclinical programme in stimulant-use disorders. “This does not imply endorsement of Solvonis or its programmes by NIH, NIDA, NIAAA or NCI. It does, however, underline that the scientific themes central to our strategy are being discussed at the highest levels of the U.S. addiction-research community.” Important Notice Professor Nutt is listed by NIH in his academic capacity at Imperial College London. This announcement does not imply endorsement of Solvonis, its programmes, its product candidates or its development strategy by NIH, NIDA, NIAAA, NCI or any U.S. government agency. Enquiries: Solvonis Therapeutics plcAnthony Tennyson, CEO & Executive Directorinfo@solvonis.comSinger Capital Markets (Broker)Phil Davies+44 (0) 20 7496 3000 About Solvonis Therapeutics plc Solvonis Therapeutics plc (LSE: SVNS) is an emerging biopharmaceutical company developing 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 discovery-stage compounds across addiction and psychiatry. The Company’s lead programmes target Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD), with additional development and discovery work supporting expansion into further addiction and psychiatric indications, including stimulant use disorder and depressive disorders. 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 United States targeting moderate-to-severe AUD. The Company’s PTSD discovery programme has identified SVN-114 as a lead compound, emerging from a proprietary compound series designed to modulate key brain signalling systems associated with emotional processing and social behaviour. In parallel, Solvonis is advancing proprietary CNS discovery programmes supported by 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 addiction and psychiatry. With a capital-efficient development model and a focus on partnering opportunities, Solvonis aims to deliver sustained value through innovation in CNS therapeutics.