Solvonis Therapeutics Plc · LSE:SVNS
Solvonis Therapeutics — Investor Presentation (September 2026)
26 slides from Solvonis Therapeutics's investor presentation, September 2026
Slide 1: A late clinical-stage CNS company building a leading AUD treatment franchise
LSE: SVNS A late clinical - stage CNS company building a leading AUD treatment franchise Repurposing for nearer -term clinical value. De novo discovery for longer -term optionality. Corporate presentation September 2026
Slide 2: Disclaimer
STRATEGY Disclaimer This presentation has been prepared by Solvonis Therapeutics plc (the “Company ”) for information purposes only. This document does not constitute, and should not be construed as, an offer to sell or issu e, or the solicitation of an offer to purchase, subscribe for, or otherwise
Slide 3: A late clinical-stage CNS company with two complementary development strategies
STRATEGY A late clinical - stage CNS company with two complementary development strategies Clinical - stage repurposing De novo drug development Developing differentiated ketamine - and esketamine -based treatments Creating proprietary NCEs with composition -of-matter filings in high- that build on
Slide 4: Pharma is acquiring differentiated neuropsychiatry assets across multiple development stages
INVESTMENT CASE Pharma is acquiring differentiated neuropsychiatry assets across multiple development stages c Date Acquirer Asset / company Transaction value Clinical focus Clinical-stage rapid -acting JUL 2026* Eli Lilly AtaiBeckley $2.8bn + up to $1.0bn therapies JUN 2026 Otsuka Transcend Therape
Slide 5: One Phase 3 asset anchors the pipeline; three earlier-stage programmes add optionality
PIPELINE One Phase 3 asset anchors the pipeline; three earlier - stage programmes add optionality DISCOVERY LEAD OPTIMISATION PHASE 1 PHASE 2 PHASE 3 SVN - 001 Severe AUD UK & EU Ongoing Phase 3 SVN - 002 Moderate - to- severe AUD US Phase 1 complete / Phase 2 planning SVN - 114 PTSD Lead selected S
Slide 6: Milestones across all four programmes de-risk the portfolio through 2031
CATALYST ROADMAP Milestones across all four programmes de - risk the portfolio through 2031 Programme Current / first milestone Next milestone Objective Value 2026 –28 2029 - 2030 2030 –31 Late -stage clinical SVN - 001 Recruitment and planned EU Planned Phase 3 readout UK and EU filings value expan
Slide 7: SVN-001 and SVN-002 de-risk the AUD opportunity by pursuing two markets and two regulatory pathways
REPURPOSING ENGINE SVN - 001 and SVN - 002 de - risk the AUD opportunity by pursuing two markets and two regulatory pathways in parallel Building the AUD treatment franchise SVN - 001 | UK / EUROPE SVN - 002 | US Defined ketamine + proprietary, manualised, CBT Proprietary esketamine film + digital s
Slide 8: SVN-001 programme: short ketamine plus CBT protocol for UK/EU authorisation
REPURPOSING ENGINE | PROGRAMME 1 OF 2 SVN - 001 | A short, defined ketamine - plus - CBT protocol designed for UK/EU marketing authorisation Integrated Treatment Three supervised IV ketamine sessions: 0.8 mg/kg over 40 minutes + Seven manualised relapse -prevention CBT sessions REGULATORY AND DEFENS
Slide 9: SVN-001: Ketamine may create a therapeutic window in which relapse-prevention CBT can be more effective
WHY THE COMBINATION SVN - 001 | Ketamine may create a therapeutic window in which relapse - prevention CBT can be more effective 01 02 03 Interrupt entrenched Create a plasticity window Build new responses responses Ketamine may temporarily reduce rigid, NMDA-receptor antagonism is thought to Manual
Slide 10: SVN-001: Randomised Phase 2 data support a durable six-month clinical signal
CLINICAL EVIDENCE SVN - 001 | Randomised Phase 2 data support a durable six - month clinical signal 96 adults with severe AUD | Randomised, double -blind, placebo-controlled four -arm study Three weekly IV doses | Six -month follow-up 67% 79.1% vs 58.5% 0 fewer heavy drinking days than days abstinen
Slide 11: SVN-001: The largest reported reduction among current and emerging AUD treatments
COMPETITIVE BENCHMARKING SVN - 001 | The largest reported reduction among current and emerging AUD treatments, with a fundamentally different dosing model Heavy drinking days in KARE versus established and emerging AUD pharmacotherapies A Relative reduction in heavy drinking days B Absolute heavy dr
Slide 12: SVN-001: A capital-efficient Phase 3 programme can unlock UK and EU regulatory value
DEVELOPMENT PATH SVN - 001 | A capital - efficient Phase 3 programme can unlock UK and EU regulatory value ONGOING TRIAL NOW UK Phase 3 ongoing 280 planned participants 2026 – 28 Recruitment; planned EU expansion Placebo -controlled Phase 3 2029 Potential Phase 3 readout UK NHS sites University of E
Slide 13: SVN-001: A large underserved market paired with a defensibility strategy
MARKET AND DEFENSIBILITY SVN - 001 | A large underserved market is paired with a regulatory and delivery strategy designed to resist substitution EUROPEAN OPPORTUNITY DEFENSIBILITY STRATEGY Full mixed application strategy; if successful, potential for eight years of data 2.6m UK severe AUD exclusivi
Slide 14: One shared mechanism, two purpose-built molecules differentiated for two markets
REPURPOSING ENGINE One shared mechanism, two purpose - built molecules — differentiated for two markets 01 02 03 A racemic molecule A more potent enantiomer Two purpose - built products Ketamine is manufactured and S -ketamine binds the NMDA receptor with SVN -002 leverages esketamine’s FDA administ
Slide 15: SVN-002: A proposed 505(b)(2) pathway bridges to established U.S. esketamine precedent
REPURPOSING ENGINE | PROGRAMME 2 OF 2 SVN - 002 | A proposed 505(b)(2) pathway bridges SVN - 002 to established U.S. esketamine precedent 01 Clinical experience 150 mg Two proof -of-concept studies included 32 people with AUD; a Phase 1 PK, safety and tolerability study included 20 healthy volunteer
Slide 16: SVN-002: FDA engagement and IP filings are de-risking the path to a 2027 IND
DEVELOPMENT AND PROTECTION SVN - 002 | FDA engagement and IP filings are de - risking the path to a 2027 IND CLINICAL Three studies 32 AUD patients plus 20 healthy volunteers FDA feedback informed the proposed 505(b)(2) pathway, Phase 2b plan and DEC 2024 FDA pre -IND bridging scope 2025 – 26 Bridge
Slide 17: SVN-002: The U.S. opportunity combines a large patient population with an established treatment analogue
COMMERCIAL CONTEXT SVN - 002 | The U.S. opportunity combines a large patient population with an established supervised - treatment analogue 11.3m ~4 × $1.7bn ~14,000 people aged 12+ with past-year the estimated U.S. treatment - SPRAVATO® worldwide sales in U.S. substance -use treatment moderate -to-
Slide 18: SVN-015 and SVN-114 build two proprietary NCE platforms, protected by composition-of-matter IP
DE NOVO ENGINE SVN - 015 and SVN - 114 build two proprietary NCE platforms, protected by composition - of- matter IP SVN - 015 | StUD SVN - 114 | PTSD A DAT -focused NCE engineered for a differentiated cardiac A proprietary monoamine -releaser engineered as a and off-target profile scalable alternat
Slide 19: SVN-015: Designed for the cardiac and off-target liabilities that stalled earlier DAT candidates
DE NOVO ENGINE | PROGRAMME 1 OF 2 SVN - 015 | Designed for the cardiac and off - target liabilities that stalled earlier DAT candidates THE DEVELOPMENT PROBLEM THE SVN - 015 RESPONSE No approved medication Designed to combine meaningful DAT activity with a differentiated cardiac and off - target pro
Slide 20: SVN-015: Initial screening supported progression into further NIDA-funded work
SVN - 015 | DE- RISKING AND NEXT WORK SVN - 015 | Initial screening supported progression into further NIDA - funded work INITIAL SCREENING TESTED THE FIRST DEVELOPMENT RISK THE NEXT STUDIES ADDRESS TRANSLATION 01 Cardiac ion -channel screening Confirm DAT binding and functional activity hERG, hNav1
Slide 21: SVN-114: Engineering a proprietary, potentially more scalable alternative to MDMA
DE NOVO ENGINE | PROGRAMME 2 OF 2 SVN - 114 | Engineering a proprietary, potentially more scalable alternative to MDMA THE OPPORTUNITY THE SVN - 114 PRODUCT THESIS MDMA - assisted therapy has Retain the therapeutically relevant serotonergic profile while designing around MDMA's limitations generated
Slide 22: Early data suggest SVN-114 keeps MDMA's serotonin signal while cutting dopamine release
SVN - 114 | SAME- ASSAY RELEASE PROFILE Early data suggest SVN - 114 keeps MDMA’s therapeutic serotonin signal while cutting the dopamine release linked to abuse potential CONCENTRATION - RESPONSE CURVES MAXIMUM RELEASE, EMAX (% OF CONTROL) Near - MDMA serotonin release; approximately half the maxim
Slide 23: Leadership combines CNS science, public-company execution and commercial experience
LEADERSHIP Leadership combines CNS science, public - company execution and commercial experience Anthony Tennyson Prof. David Nutt Ryan Neates Chief Executive Officer Chief Scientific Officer Chief Financial Officer Public -company leadership; biopharma Neuropsychopharmacology; addiction and Public
Slide 24: Capital Structure
CAPITAL STRUCTURE Common shares 7,899,736,826 Warrants 1,111,298,765 Options 298,000,000 Fully Diluted Capital Structure 9,309,035,591 As at 28 September 2026 . 24
Slide 25: References: Clinical, regulatory and programme evidence
References Clinical, regulatory and programme evidence SVN -001 | Slides 8–13 SVN -002 | Slides 7 and 15–17 Grabski M, McAndrew A, Lawn W, et al. “Adjunctive Ketamine With Relapse Prevention - U.S. Food and Drug Administration. SVN -002 pre -IND written feedback, December 2024. Based Psychological T
Slide 26: References: Market, epidemiology and transaction evidence
References Market, epidemiology and transaction evidence Alcohol use disorder | Slides 10, 13 and 17 Commercial and other epidemiology | Slides 17, 19 and 21 Transactions and capital markets | Slides 4 and 24 World Health Organization Regional Office for Europe. “Adults in Zhdanava M, et al. “The Pr
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