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Another Monday quality(huge) RNS

Proactive tomorrow and AGM later this week.

Off to work I go.

Hold the fort guys & gals.

You can lead a horse to water….

One of the most compelling early investor stories out there imo.

The US Market is literally mouth watering.

Wake up and smell the coffee y’all 🇺🇸💵🤝💸

Could have opened at 0.50 and I’d still not be selling any, just thinking that’s a more realistic platform/springboard as to where our BOD want to take us!

Huge!!

The patent, expected to be granted in the coming months, will confer U.S. exclusivity through to at least 2043, reinforcing the long-term value of Solvonis' early-stage pipeline.

Solvonis Therapeutics plc

("Solvonis" or the "Company")

Allowance of U.S. patent covering AI-supported CNS discovery programme compounds

Solvonis Therapeutics plc (LSE: SVNS), a clinical-stage biopharmaceutical company developing novel medicines for addiction and mental health disorders, is pleased to announce that the U.S. Patent and Trademark Office (the "USPTO") has allowed a key patent application protecting compounds within the Company's AI-enabled CNS discovery programme.

The application-U.S. No. 18/838,986, titled "Bridged Ring Compounds and Their Therapeutic Use as CNS Agents"-received a first-action allowance with no objections or rejections. The claims cover composition of matter and methods of use for a family of novel morpholine-class compounds, originally developed by Awakn Life Sciences Corp. and now central to Solvonis' Central Nervous System ("CNS") library.

An "allowance" confirms that a patent will be granted, subject only to final administrative steps.

The CNS library, which includes multiple chemically distinct, preclinically validated series, underpins Solvonis' AI-supported drug discovery platform. The patent adds meaningful protection across novel CNS chemical space, especially in depression, stimulant use disorder and other neuropsychiatric conditions.

The patent, expected to be granted in the coming months, will confer U.S. exclusivity through to at least 2043, reinforcing the long-term value of Solvonis' early-stage pipeline.

Professor David Nutt, Chief Scientific Officer of Solvonis, commented: "This patent strengthens the foundation of our discovery platform and provides long-term protection for a chemically distinct series of CNS-active compounds already integrated into our AI-supported programme. The favourable examination outcome reflects the novelty and robustness of the underlying chemistry, which has now been further validated through translational screening and computational analyses."

Anthony Tennyson, Chief Executive Officer of Solvonis, added: "We are delighted by this outcome, which validates the early-stage innovation acquired through Awakn and enhances the strategic value of our AI-enabled platform. This grant provides additional confidence as we advance our discovery pipeline targeting major unmet needs in neuropsychiatry."

Thank you Nano!

Let’s hope this news filters into the proactive event this week, and look out for any ‘hints’ about near term, even nearer term now partnering opportunities for this excellent biotech company we’re invested in!

Happy Monday, here’s to a great week! 🤝📈🐎

Judging* not hiding 🦕😬

Thanks Nano for your Saturday morning post. I just logged in and hiding by the amount of posts I’d missed knew it would be useful and informative info.

As with most posters on here, great to read your contributions and further helps my resolve in holding this share through the rises and falls as we march hopefully to greatness, and wealthy-ness.

Have a great weekend all. Quality folks here 👏🏻🫡

Https://x.com/anthonytennyson/status/1935433155688694156?s=46

It may also be worthy of an RNS once timelines on our roadmap have been reviewed.

Hello Partners! 🤝🇺🇸

This is huge news for novel therapeutic biotech companies! Massive!

Investment 📈

🔔🔔🔔

Morning Llama,

This has extremely positive impacts to our timelines:

The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.

The Company's current focus is on Alcohol Use Disorder (AUD), which affects more than 40 million people across the US, UK, and EU4, and Post-Traumatic Stress Disorder (PTSD), impacting over 13million adults in the US and approximately 20 million across the same regions.Solvonis has three core R&D programmes and a proprietary library of preclinical drug candidates:

1. SVNS-001: A novel investigational combination therapy for the treatment of severe AUD, currently in Phase 3 clinical development. In a prior Phase 2 study, participants in the active treatment arm achieved 86% abstinence from alcohol in the six months post-treatment, compared to just 2% pre-trial.

 

A market analysis commissioned by Solvonis and conducted by PharmaVentures indicates that comparable late-stage UK/EU-focused assets in the substance use disorder space typically achieve total deal values of ~£60 million in upfront and milestone payments, in addition to royalties on net sales if successfully out licensed.

 

2. SVNS-002: A proprietary, investigational, patent-pending sublingual/buccal esketamine formulation for use in combination with manualised therapy in treating moderate to severe AUD. This programme is in Phase 2b planning in the US and is expected to follow the FDA's 505(b)(2) regulatory pathway.

PharmaVentures estimates that, following successful Phase 2b completion, comparable mid-stage assets typically achieve total deal values of ~£150 million, plus future royalties if out licensed.

 

3. SVNS-SDN-14: A novel series of serotonin, dopamine, and noradrenaline receptor modulators, currently at preclinical stage, being developed to promote pro-social behavior and improve upon the safety profile of existing investigational PTSD treatments.

SVN-SDN-014 translational development plan. This latest phase involved the synthesis of a focused set of compounds for subsequent preclinical characterisation, including pharmacological and toxicological profiling.

The remaining stages for the programme are as follows:

1. In-vitro screening for SERT, DAT and NET re-absorption inhibition

2. In-vitro screening for SERT, DAT and NET release - expected to complete by the end of July 2025

3. Pre-clinical animal testing

4. Lead candidate selection - expected by the end of Q3 2025

4. Initiation of artificial intelligence supported CNS drug discovery programme

 

Solvonis Therapeutics plc (LSE: SVNS), a clinical-stage biopharmaceutical company developing novel medicines for addiction and mental health disorders, is pleased to announce the initiation of an artificial intelligence ("AI") supported drug discovery programme focused on its proprietary central nervous system ("CNS") compound library.

The library, acquired through the Company's recent acquisition of Awakn Life Sciences Corp. ("Awakn"), includes multiple patent-pending chemical series developed through a completed hit-to-lead programme. This body of work incorporated in silico design, in vitroscreening

In a nutshell, it’s the Nutts! Hence why it’s my biggest ever £ investment in a single share.

Exactly Llama Pharma!

I didn’t even mention the recent AI initiative with the CNS data.✅📈💪🏻🦄maker!

Who knows what this BOD may pull out of the hat, given there network and gravitas in the biotech space.

Mouth watering scenario unfolding right before our eyes.

Early investment gives you the best case scenario for ROI.

All imho of course!

VS

Reminder>taken from the RNS date 4th April, 2025

Adrian Dawkes, Managing Director of PharmaVentures, commented: "Based on market comparables and recent transactions in the substance use disorder space, our analysis highlights the significant commercial potential of these two clinical-stage programmes with potential value based on comparable assets of more than £200 million as well as future material royalties on net sales. Combined, AWKN-001 and AWKN-002 represent a significant commercial opportunity with potential for significant licensing deals with substantial future royalty streams."

Anthony Tennyson, CEO of Solvonis, added: "We are pleased to be working with PharmaVentures to unlock the full value of these transformative mental health treatments. Completing the market analysis phase marks an important milestone, and we're excited to share these encouraging results. Our mission remains clear: to bring life-changing therapies to patients while creating lasting value for our shareholders."

All in all, a very compelling investment case.

Stellar BOD with skin in the game ✅

Novel therepeutics with a huge market, currently unmet by big Pharma ✅

Phase 3 trial in progress with the NHS✅

Funding: Solvonis’ contribution is capped at £800,000 — unusually low for a Phase 3 trial — thanks to co-funding by UK public bodies ✅

Regulatory Path: SVN‑001 combines IV ketamine with relapse-prevention CBT; it has MHRA Innovative Licensing and Access Pathway (ILAP) support✅

Why It’s Significant:

Potential Breakthrough: In Phase 2, SVN‑001 showed dramatic improvements—abstinence soared from 2% at baseline to 86% six months post-treatment ✅

Cost Efficiency: Executing the trial within the NHS at such low cost is nearly unprecedented for a study of this scale ✅👏🏻

Public‑Private Collaboration: The funding model combines public investment with private development, aiming to reduce financial risk and speed access to treatment✅

Sell now if you want to, but at least consider what not holding this share in your portfolio may affect its future value.

Happy Tuesday SVNSer’s!

Just a mere rehearsal Tricky.

Big shoals holding here and it ain’t for a quick blip to 25’s.

True market value will come out when it is ready.

Don’t mess with my Two two!

Hold to the moon 🐎🐎🐎🦄🦄🦄

My venue suggestion for our social 🍻would be ‘The Blue Posts’ on Berwick street, London 🔵

Very apt! Plus there are 3 record shops on that street to boot 😇🙏🏻📈

Do know!* my god my brain! 😅