Solvonis Therapeutics Plc · LSE:SVNS
Solvonis Therapeutics — Investor Presentation (October 2026)
38 slides from Solvonis Therapeutics's investor presentation, Oct 13, 2026
Slide 1: A clinical-stage psychedelics company developing therapeutics for addiction, PTSD and depression
LSE: SVNS A clinical-stage psychedelics company developing therapeutics for addiction, PTSD and depression An alcohol use disorder franchise across the UK, Europe and the U.S. A de novo engine of proprietary new medicines. Corporate presentation October 2026
Slide 2: Disclaimer
IMPORTANT NOTICE Disclaimer This presentation has been prepared by Solvonis Therapeutics plc (the “Company”) for information purposes only. It is not an offer or invitation to buy, sell or subscribe for any securities, in any jurisdiction, and does not form the basis of, or a reason to rely on it in
Slide 3: Late-stage clinical assets, scientifically de-risked, with near-term milestones
KEY CHARACTERISTICS Late-stage clinical assets, scientifically de-risked, with near-term milestones 01 02 03 04 Late-stage clinical assets Scientifically de-risked Near-term milestones Attractive entry point SVN-001 is in Phase 3 in severe Built on ketamine, a WHO Essential SVN-015: further studies
Slide 4: Pharma is paying for psychedelic and rapid-acting neuropsychiatry assets
WHY NOW Pharma is paying for psychedelic and rapid-acting neuropsychiatry assets Date Acquirer Asset / company Transaction value Clinical focus Psychedelic-derived therapies; lead in SEP 2026 Eli Lilly AtaiBeckley $2.8bn + up to $1.0bn depression JUN 2026 Otsuka Transcend (methylone) $700m + up to $
Slide 5: A clinical-stage psychedelics company with two complementary development strategies
STRATEGY A clinical-stage psychedelics company with two complementary development strategies Scientific leadership: Professor David Nutt, Chief Scientific Officer, and Edmond J Safra Professor of Neuropsychopharmacology at Imperial College London Value-added medicines: the AUD franchise De novo drug
Slide 6: Five programmes: an alcohol use disorder franchise and a de novo engine
PIPELINE Five programmes: an alcohol use disorder franchise and a de novo engine AUD franchise De novo engine Discovery Lead optimisation Phase 1 Phase 2 Phase 3 SVN-001 Severe AUD UK (EU sites proposed) Ongoing UK Phase 3; MoU signed to assess Portuguese sites SVN-002 Moderate-to-severe AUD U.S. Ph
Slide 7: Where each programme stands and what comes next
CATALYST ROADMAP Where each programme stands and what comes next All milestones and timings are prospective, and subject to the availability of capital, regulatory feedback and trial progress. Programme Delivered (as at 13 Oct 2026) Next milestone Indicative timing UK Phase 3 recruiting (280 planned
Slide 8: AUD is a large, underserved market: only 1 in 6 receive treatment
AUD FRANCHISE | MARKET AUD is a large, underserved market: worldwide, only 1 in 6 people with AUD receive treatment UK AND EU4 | SEVERE AUD UNITED STATES | MODERATE-TO-SEVERE AUD 12.5m people aged 15+ with severe AUD (Company estimate) 11.3m people aged 12+ with past-year moderate-to-severe AUD, 202
Slide 9: Building a protected AUD franchise: SVN-001 in the UK and Europe, SVN-002 in the U.S.
AUD FRANCHISE | OVERVIEW Building a protected AUD franchise: SVN-001 in the UK and Europe, SVN-002 in the U.S. East and west: one mechanism, two products, two regulatory pathways SVN-001 | UK / EUROPE SVN-002 | U.S. Esketamine oral thin film (OTF) + at-home digital psychosocial PRODUCT Ketamine IV +
Slide 10: How ketamine-based treatment works: it opens a window of plasticity
AUD FRANCHISE | MECHANISM OF ACTION How ketamine-based treatment works: it opens a window of plasticity, and psychosocial support is designed to work inside it FROM NMDA BLOCK TO NEW LEARNING WHAT THIS MEANS IN AUD 01 Blocks NMDA receptors on inhibitory interneurons Stronger prefrontal control Relea
Slide 11: SVN-001 Phase 2a/b: a completed, academic-led trial in 96 patients with severe AUD
AUD FRANCHISE | SVN-001 PHASE 2A/B TRIAL DESIGN SVN-001 Phase 2a/b: a completed, academic-led, investigator-initiated trial in 96 patients with severe AUD FO U R ARM S , 9 6 PATI E NTS WHO RAN IT With therapy With alcohol education Investigator-initiated trial: academic investigators at two UK sites
Slide 12: What was published: one of two co-primary endpoints met
AUD FRANCHISE | SVN-001 PHASE 2A/B AS PUBLISHED What was published: one of two co-primary endpoints met, with more days abstinent on ketamine EN D P O I NT 1 : DAYS AB STI N ENT EN D P O I NT 2 : C O N F I RM ED REL AP S E Percentage of days over six months, higher is better Percentage of patients a
Slide 13: The same two arms on heavy drinking days
AUD FRANCHISE | SVN-001 HEAVY DRINKING DAYS The same two arms on heavy drinking days (the Phase 3 primary endpoint): fewer than placebo in every four-week window, and 55% fewer over the last two months; post hoc PUBLISHED COMPANY ANALYSIS · WEEKS 1–16 WEEKS 17–24 55% Published Weeks 17–24: Morgan &
Slide 14: The published trial was an academic proof of concept; Phase 3 is built around heavy drinking days
AUD FRANCHISE | SVN-001 FROM PHASE 2A/B TO PHASE 3 The published trial was an academic proof of concept; Phase 3 is built around heavy drinking days, an EMA primary variable Published Phase 2a/b Phase 3 (Solvonis progressing) Academic investigators at two UK sites; Medical Research Council Exeter-sp
Slide 15: Phase 3 tests the leading Phase 2a/b regimen against an active low-dose control
AUD FRANCHISE | SVN-001 PHASE 3 DESIGN Phase 3 tests the leading Phase 2a/b regimen against an active low-dose control, on heavy drinking days, an EMA primary variable ONGOING TRIAL NOW UK Phase 3 recruiting; MoU signed to assess Portuguese sites (13 Oct 2026) 280 planned participants 2026–28 Recrui
Slide 16: A full-mixed UK and EU route, with the same data and market protection as a new medicine
AUD FRANCHISE | SVN-001 ROUTE AND PROTECTION A full-mixed UK and EU route, with the same data and market protection as a new medicine Full-mixed Protected Established UK and EU applications Data and market protection A WHO Essential Medicine The Phase 2a/b and Phase 3 clinical data plus 8 years’ dat
Slide 17: The same approach, built for the U.S.: SVN-002 brings esketamine to moderate-to-severe AUD
AUD FRANCHISE | SVN-001 AND SVN-002 The same approach, built for the U.S.: SVN-002 brings esketamine to moderate-to-severe AUD SVN-001 | UK AND EUROPE SVN-002 | UNITED STATES One four-week course: ketamine IV plus relapse-prevention therapy + Esketamine OTF plus digital psychosocial support Positive
Slide 18: Esketamine OTF: peak levels in line with SPRAVATO®, and a strong psychedelic-type experience
AUD FRANCHISE | SVN-002 CLINICAL DATA Esketamine OTF: peak levels in line with SPRAVATO®, and a strong psychedelic-type experience PEAK PLASMA LEVEL PSYCHEDELIC-TYPE EXPERIENCE PHASE 1 TOLERABILITY 96 vs 101 95 vs 24 0 ng/mL: 50 mg OTF vs SPRAVATO® 84 mg, mystical-experience score (0–150): OTF vs se
Slide 19: FDA agreed the 505(b)(2) route, and no additional clinical data are needed before Phase 2b
AUD FRANCHISE | SVN-002 FDA PRE-IND FEEDBACK FDA agreed the 505(b)(2) route, and no additional clinical data are needed before Phase 2b Dec 2024 Jul 2025 Jun 2026 2027 FDA pre-IND meeting: 505(b)(2) Bridging programme started Positive preclinical bridging data IND planned, then a randomised, route a
Slide 20: Granted patents to ~2041, and potential Orange Book listing
AUD FRANCHISE | SVN-002 PROTECTION Granted patents to ~2041, and potential Orange Book listing Granted Filed Potential Formulation patents Method-of-use applications Orange Book listing Covering the esketamine OTF formulation, Esketamine OTF combined with Eligible patents can be listed in the FDA gr
Slide 21: A U.S. population about 4× that of treatment-resistant depression, and an established supervised-treatment model
AUD FRANCHISE | SVN-002 MARKET AND DELIVERY A U.S. population about 4× that of treatment-resistant depression, and an established supervised-treatment model PEOPLE WITH THE CONDITION, U.S. $1.7bn 11.3m SPRAVATO® worldwide sales in 2025³ Moderate-to-severe alcohol use disorder, ages 12+¹ 2.8m about o
Slide 22: A de novo engine of proprietary new medicines across addiction and psychiatry
DE NOVO ENGINE A de novo engine of proprietary new medicines across addiction and psychiatry Proprietary new chemical entities from Solvonis’ own discovery work, each with a composition-of-matter filing. NIDA funds and conducts the SVN-015 studies; Solvonis retains ownership and IP. Programme Compou
Slide 23: A new cocaine and methamphetamine addiction candidate in further NIDA-funded studies
DE NOVO ENGINE | SVN-015 StUD A new cocaine and methamphetamine addiction candidate in further NIDA-funded studies, after encouraging initial screening THE DEVELOPMENT PROBLEM THE SVN-015 RESPONSE A new dopamine and serotonin reuptake inhibitor, evaluated by 59% NIDA of U.S. overdose deaths (2021 to
Slide 24: Engineering a proprietary, potentially more scalable alternative to MDMA
DE NOVO ENGINE | SVN-114 PTSD Engineering a proprietary, potentially more scalable alternative to MDMA THE OPPORTUNITY THE SVN-114 PRODUCT THESIS Retain the therapeutically relevant serotonergic profile while designing around MDMA-assisted therapy has MDMA’s limitations generated clinical interest i
Slide 25: Same molecule, second programme: an exploratory antidepressant-like signal
DE NOVO ENGINE | SVN-015 MDD Same molecule, second programme: an exploratory antidepressant-like signal THE UNMET NEED THE EARLY EVIDENCE In one mouse study, treatment with SVN-015 reduced forced-swim immobility, as did Anhedonia is an unmet need fluoxetine, an approved SSRI antidepressant used as t
Slide 26: An alcohol use disorder franchise at the clinical core, with a de novo engine behind it
SUMMARY An alcohol use disorder franchise at the clinical core, with a de novo engine behind it 01 02 03 04 Late-stage clinical assets Scientifically de-risked Near-term milestones Attractive entry point The AUD franchise: SVN-001 in Ketamine (a WHO Essential The de novo engine: SVN-015 in Pharma ha
Slide 27: Leadership combines psychedelic science, public-company execution and commercial experience
LEADERSHIP Leadership combines psychedelic science, public-company execution and commercial experience Anthony Tennyson Professor David Nutt Ryan Neates Chief Executive Officer Chief Scientific Officer Chief Financial Officer Public-company leadership; biopharma capital Edmond J Safra Professor of P
Slide 28: 7.90bn shares are in issue, and 9.31bn on a fully diluted basis
CAPITAL STRUCTURE 7.90bn shares are in issue, and 9.31bn on a fully diluted basis As at 28 August 2026. The fully diluted total assumes exercise of all outstanding warrants and options. Class Number % of fully diluted Common shares 7,899,736,826 84.9% Warrants 1,111,298,765 11.9% Options 298,000,000
Slide 29: Appendix
SLIDE APPENDIX CONTENT SUPPORTS 30 SVN-001 | Heavy drinking days and EU expansion Slides 13–15 31 SVN-001 | Heavy drinking days over six months, all four arms Slide 13 Appendix 32 SVN-001 | Heavy drinking days against other AUD trials Slide 13 33 SVN-001 | From Phase 2a/b to Phase 3 Slides 14 and 15
Slide 30: Why heavy drinking days matter for EU expansion: the regulatory case and post hoc data
APPENDIX | SVN-001 | DETAIL FOR SLIDES 13–15 Why heavy drinking days matter for EU expansion: the regulatory case and post hoc data behind slides 13–15 WHY HEAVY DRINKING DAYS MATTER IN THE EU PHASE 2A/B HEAVY DRINKING DAYS, % OF DAYS, BY WINDOW (POST HOC) 01 A recognised regulatory endpoint Phase 2
Slide 31: All four arms over six months: heavy drinking days and days abstinent
APPENDIX | SVN-001 | DETAIL FOR SLIDE 13 All four arms over six months: heavy drinking days and days abstinent, behind slide 13 Company analysis of the KARE daily drinking diaries, all four arms, observed cases. Weeks 17–24 for ketamine plus therapy versus placebo plus education are also published (
Slide 32: Context for slide 13: three infusions in four weeks, set against months of chronic dosing
APPENDIX | SVN-001 | CONTEXT FOR SLIDE 13 Context for slide 13: three infusions in four weeks, set against months of chronic dosing (indirect comparison) Heavy drinking days in the Phase 2a/b versus established and emerging AUD pharmacotherapies A Relative reduction in heavy drinking days B Absolute
Slide 33: How Phase 2a/b leads into Phase 3: the regimen, results and endpoint carried forward
APPENDIX | SVN-001 | DETAIL FOR SLIDES 14 AND 15 How Phase 2a/b leads into Phase 3: the regimen, results and endpoint carried forward on slides 14 and 15 PHASE 2A/B SECONDARY: KETAMINE + THERAPY (N=24) VS PLACEBO + EDUCATION (N=25) WHAT PHASE 3 CARRIES FORWARD As published (Grabski et al.) Ketamine
Slide 34: Why two molecules: one shared mechanism, each built for its own market
APPENDIX | SVN-001 AND SVN-002 | DETAIL FOR SLIDES 9 AND 17 Why two molecules: one shared mechanism, each built for its own market (slides 9 and 17) 01 02 03 A racemic molecule A more potent enantiomer Two differentiated products Ketamine is manufactured and administered as S-ketamine binds the NMDA
Slide 35: The NIDA programme in detail: encouraging initial screening; further NIDA-funded studies
APPENDIX | SVN-015 StUD | DETAIL FOR SLIDE 23 The NIDA programme in detail: encouraging initial screening; in further NIDA-funded studies (slide 23) WHAT HAS BEEN ANNOUNCED FURTHER NIDA-FUNDED STUDIES (ANNOUNCED 6 AUGUST 2026) Study What it assesses 01 Accepted into NIDA’s Addiction Treatment Discov
Slide 36: The early data behind slide 24: serotonin release comparable to MDMA with a lower dopamine maximum
APPENDIX | SVN-114 | DETAIL FOR SLIDE 24 The early data behind slide 24: serotonin release comparable to MDMA with a lower dopamine maximum CONCENTRATION-RESPONSE CURVES FITTED MAXIMUM RELEASE, EMAX (% OF CONTROL) Serotonin release comparable to MDMA; lower fitted dopamine maximum Serotonin SVN-114
Slide 37: References: Clinical, regulatory and programme evidence
REFERENCES Clinical, regulatory and programme evidence SVN-001 | Slides 3, 6, 7, 9–17 and 30–34 SVN-002 | Slides 3, 6, 7, 9, 17–21 and 34 Grabski M, McAndrew A, Lawn W, et al. “Adjunctive Ketamine With Relapse Prevention-Based Psychological Solvonis Therapeutics plc. Update on FDA Pre-IND Meeting fo
Slide 38: References: Market, epidemiology and transaction evidence
REFERENCES Market, epidemiology and transaction evidence Alcohol use disorder | Slides 8, 17 and 21 Commercial and stimulant data | Slides 21 and 23 Transactions and capital structure | Slides 3, 4 and 28 World Health Organization Regional Office for Europe. “Adults in the Zhdanava M, et al. “The Pr
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