Solvonis Therapeutics (formerly Awakn)

Solvonis Therapeutics plc (LSE: SVNS): Positioned for value as neuropsychiatry market resets. The neuropsychiatry sector has shifted gears. In the past month, ATAI, COMPASS Pathways, and MindMed — high-profile Nasdaq CNS names — have gained 35–75%, reflecting rising investor conviction across three fronts: 🔹 Commercial proof: J&J’s Spravato® posted $320M in Q2 sales, now on a $1.3B run rate, with peak sales guidance of $3–3.5B. Esketamine is no longer theoretical — it’s commercial. 🔹 Regulatory momentum: RFK Jr.’s push for FDA reform is signaling broader support for modern CNS pathways. 🔹 Market rotation: Investors are moving from concept to execution — backing clinically active, capital-efficient platforms. Solvonis Therapeutics plc (LSE: SVNS) is built to align with these dynamics. We’re advancing a focused pipeline in addiction and mental health, including: -SVN‑001: Phase 3, Severe AUD (UK/EU) -SVN‑002: IND-ready, Moderate-to-Severe AUD (US) -SVN‑SDN‑014: Preclinical, PTSD -Plus an AI-driven CNS discovery programme With dual clinical tracks, regulatory clarity, and a high-need focus, Solvonis Therapeutics plc is structurally aligned with where the market is going — not where it’s been. 📈 Listed on the LSE Main Market (LSE: SVNS) 🧠 Led by a CNS-experienced team ⚙️ Executing with discipline and purpose “Investors want credibility, clarity, and clinical focus. We're building Solvonis with those principles at the core.” #Biotech #Neuropsychiatry #CNS #MentalHealth #AUD #PTSD #Spravato #505b2 #FDA #DrugDevelopment #Solvonis #SVNS #CapitalMarkets

Solvonis Therapeutics plc's SVN‑002: Advancing a differentiated esketamine treatment for Moderate to Severe Alcohol Use Disorder (AUD). Solvonis Therapeutics plc (LSE: SVNS) has initiated the next phase of development for SVN‑002, our sublingual esketamine oral thin film for moderate-to-severe AUD, as we prepare for a planned Phase 2b clinical trial in the US. SVN‑002 is planned to progress via the FDA’s 505(b)(2) pathway, using J&J's Spravato as a reference product — a drug that has become a key CNS franchise for J&J, approved specifically for Treatment-Resistant Depression (TRD). -Spravato Q2 2025 sales: $320M, tracking a $1.3B annual run rate -J&J now guides to $3B–$3.5B in peak sales, more than 50% above Street consensus But here’s the bigger picture: -Moderate-to-severe AUD affects ~20 million adults in the US -TRD affects ~4–6 million adults, or just 20–30% of those with depression Despite this, TRD has attracted significantly more investment and innovation than AUD. SVN‑002 is designed to change that, with: - A differentiated sublingual thin film formulation - A capital-efficient 505(b)(2) regulatory strategy - Psychosocial integration for meaningful clinical outcomes - A large, under-treated population with high public health impact “We believe this programme has the potential to reshape care for one of the most neglected public health challenges in mental health.” — Prof. David Nutt, Chief Scientific Officer #Biotech #AUD #SVN002 #Spravato #505b2 #Esketamine #Neuropsychiatry #AddictionMedicine #MentalHealth #ClinicalDevelopment #Solvonis #SVNS

Solvonis Therapeutics plc is advancing SVN‑002 under the FDA’s 505(b)(2) pathway, with Spravato® — J&J’s intranasal esketamine — as the proposed reference product. SVN‑002 is being developed specifically for moderate-to-severe Alcohol Use Disorder, with a differentiated formulation designed for delivery in addiction treatment clinics. Spravato® is one of J&J’s 26 blockbuster drugs, generating over $1B in annual sales — providing a potentially strong foundation for Solvonis’ regulatory and clinical strategy. #SVN002 #AUD #505b2 #Spravato #AddictionTreatment #Solvonis #SVNS

Alcohol Use Disorder Is the Public Health Crisis We Keep Ignoring. 29.5 million Americans meet the diagnostic criteria for Alcohol Use Disorder. Fewer than 5% receive treatment. The system isn’t reaching those who need it most. SVN‑002 is Solvonis Therapeutics plc's neuroscience-led response for the U.S. market: ✔ Novel sublingual esketamine-based therapeutic ✔ Delivered in real-world addiction clinics ✔ Pursuing FDA 505(b)(2) path, with Spravato® as reference — subject to scientific bridging It’s time for a treatment that fits the scale of the crisis — and the system we already have. #AUD #SVN002 #505b2 #AddictionTreatment #Solvonis #PublicHealth

Solvonis Therapeutics plc Congratulates Chair Dennis Purcell on $1.9B IGI–AbbVie Deal Congratulations to our Chair, Dennis Purcell, on the announcement of a landmark $1.9 billion global licensing deal between IGI (Ichnos Glenmark Innovation) and AbbVie. Under the terms of the agreement, AbbVie has secured exclusive rights to ISB 2001, a first-in-class CD38×BCMA×CD3 trispecific antibody, across North America, Europe, Japan, and Greater China. Deal highlights: 💰 $700 million upfront payment 📈 Up to $1.225 billion in development, regulatory, and commercial milestones 📊 Tiered, double-digit royalties on future net sales Dennis Purcell serves as a Non-Executive Director at IGI and brings unmatched experience in scaling breakthrough science across global markets. This deal is further testament to the calibre of strategic leadership Dennis brings to the sector — and to Solvonis Therapeutics plc. We're proud to have him lead our Board as we advance our differentiated pipeline of repurposed and novel compounds targeting high-burden neuropsychiatric conditions with significant unmet need. #Solvonis #SVNS #DennisPurcell #AbbVie #IGI #BiotechLeadership #AddictionTreatmentInnovation #MentalHealthTreatmentInnovation #CNS https://lnkd.in/eH-Km6ki

Solvonis Therapeutics plc Chair Dennis Purcell joins biotech luminaries at Lucid Capital Markets LLC exclusive event We’re proud to share that our Chairman, Dennis Purcell, will appear alongside Dr. Jeremy M. Levin and Stelios Papadopoulos in an exclusive Lucid Capital Markets LLC event hosted by Elemer Piros, one of the sector’s most respected #biotech analysts. 📅 Thursday, July 17th at 2:00pm ET 🧬 Hosted by Lucid Capital Markets This panel brings together three of the most influential figures in global biopharma — leaders who have shaped the trajectory of our industry over the last three decades. Dennis’ inclusion reflects his unmatched credibility, having led Aisling Capital, deployed over $15B in ~200 biotech investments, and supported the growth of some of the sector’s most successful companies. We’re honoured to have his strategic guidance as Chair of Solvonis Therapeutics plc as we advance our mission to build a differentiated CNS drug development pipeline. #Solvonis #SVNS #DennisPurcell #LucidCapitalMarkets #BiotechLeadership #AIinBiotech #MentalHealthInnovation #AddictionTreatmentInnovation #CNS

29.5M Americans meet the diagnostic criteria for #AlcoholUseDisorder | Only 5% Treated | Time for a New Paradigm. In 2022, 29.5M people in the U.S. met criteria for #AlcoholUseDisorder (AUD). Yet only 1 in 20 received any treatment (Substance Abuse and Mental Health Services Administration (SAMHSA), 2022). #SVN‑002 is Solvonis Therapeutics plc’s acute, neuroscience-based response — being designed for real-world clinical deployment for the #US market. #AUD #505b2 #PublicHealth #Solvonis #AddictionTreatmentInnovation

Why is our lead programme #SVN‑001 different? #SevereAlcoholUseDisorder (#SAUD) remains one of the most challenging #mentalhealth conditions to treat. Current therapies frequently fail to deliver lasting abstinence — particularly in high-relapse populations. SVN‑001 is a novel combination therapy: → Racemic ketamine to promote neuroplastic reset → Structured psychotherapy to support relapse prevention This is more than symptom management — it’s a targeted strategy designed to enable durable #recovery. In a prior Phase 2 study → 86% average abstinence at 6 months post-treatment → versus just 2% pre-treatment baseline A fully powered n=280 Phase 3 trial is now underway in #NHS #England. The trial is co-funded by Solvonis Therapeutics plc and the UK Department of Health and Social Care, via the NIHR and MRC, and is being conducted by the University of Exeter's Clinical Trials Unit. SVN‑001 is targeting a mixed-full marketing authorisation in the #UK and #EU — which, if successful, could provide 8–10 years of regulatory data and market protection across both regions. 🔗 Learn more → solvonis.com #SVN001 #Solvonis #SevereAUD #AddictionTreatmentInnovation #MentalHealthInnovation #DrugDevelopment #LSE #CNS

The case for better Severe AUD treatment is clear. At Solvonis Therapeutics plc (LSE: SVNS), we’re targeting the most underserved end of the #AlcoholUseDisorder spectrum — #SevereAUD, a condition with disproportionate public health and societal impact. 📊 The scale of the challenge: • ~40 million people live with #AUD across the hashtag #US, #UK, and #EU4 • ~13 million suffer from #SevereAUD — the hardest to treat and highest-risk group • 300,000+ deaths/year are attributable to alcohol • In #England alone, alcohol-related costs exceed £27.4 billion/year Despite the burden, treatment innovation remains limited — and long-term abstinence outcomes are poor. #SVN‑001, our lead candidate now in Phase 3 in the #UK, aims to deliver a new standard of care through a novel combination of racemic ketamine and structured psychotherapy. 🔗 Learn more → solvonis.com #Solvonis #SVN001 #SevereAUD #AUD #PublicHealth #AddictionTreatmentInnovation #MentalHealthInnovation #DrugDevelopment #LSE #CNS #BiotechPipeline

Solvonis Therapeutics plc (LSE: SVNS) is pleased to share that Singer Capital Markets has today initiated equity research coverage on the Company. The initiation note, titled “Psyching Up for Success”, has been authored by Dr. Karl Keegan, Head of Life Sciences Research at Singer Capital Markets. The research note provides an overview of Solvonis’ differentiated pipeline, strategic model, and positioning in the neuropsychiatry landscape. The note is currently available to eligible institutional investors and will be made publicly available via Singers next week. #Solvonis #Biotech #Neuropsychiatry #AddictionTreatment #MentalHealthInnovation #LSE #LifeSciences #CapitalMarkets #EquityResearch https://lnkd.in/e4KSbNBa