Member Info for LlamaFarmer

Mail On Sunday might be worth a read this weekend then?

What's their Sunday paper called ??

.

They are trying to low ball to fill Friday orders.

We have had the Charles Archer article at 1p

Today Singers note released at 1.6p Price target.

Investors will digest both over the weekend and realise this business model has double the chance over any over small cap Pharma and is running 3 X tests plus the full C.N.S. Library.

Next Mondays open will be interesting!

Spravato - Johnson & Johnson's new lead treatment as of Jan 2025 - Spravato!

SVN-001 – Phase 3 commences

 SVN-001 is now undergoing a phase 3 trial, led by the University of Exeter and is jointly funded by Awakn and the National Institute

for Health and Care Research (“NIHR”) (the British government’s major funder of clinical, public health, social care and translational

research) Efficacy and Mechanism Evaluation (EME) Programme (NIHR150193), a UK Medical Research Council and NIHR partnership.

 The trial is an n=280, two-armed randomised active placebo-controlled trial. It is being delivered across nine UK National Health

Services sites, and Awakn will contribute approximately £800,000 towards the costs of the trial, with the National Institute for Health Care

Research and Medical Research Counsel and University of Exeter contributing the balance of the costs. In November 2023, the trial

received clinical trial authorisation from the MHRA and ethical approval from the Health Research Authority in the UK.

 We expect the recruitment of the Phase 3 to be complete in early 2026 with a read-out of the trial by mid-27. Allowing for a

standard review time, we estimate that initial sales could be recorded in 2028.

SVN-002

SVN-002 has completed a Phase 1 trial with phase 2 trial planning underway with a pre-investigational new drug meeting with the US

Food and Drug Administration completed on 16th December 2024.

Esketamine and ketamine are chemically related drugs, but there are key differences in their structure, pharmacology, approval status, and

clinical use—especially in psychiatric treatment. Esketamine is the S(+) enantiomer6 of ketamine, believed to be more potent in its NMDA receptor antagonism.

Esketamine is marketed in the US as Spravato®, developed by Janssen Pharmaceuticals. It’s a groundbreaking treatment specifically approved

for treatment-resistant depression (TRD) and major depressive disorder (MDD) with suicidal ideation. Spravato has changed the landscape of

psychiatric treatment due to its rapid onset of action and novel mechanism.

Following the deal ( Buying Awakn ), Solvonis will have access to an exclusive license for use of a proprietary formulation of esketamine in an oral thin film

(“OTF”) for the treatment of addiction, anxiety, and eating disorders with a RIGHT OF FIRST REFUSAL for the treatment of PTSD from LTS Lohmann

Therapie-systeme AG. Included in the licenses is access to data from LTS Lohman’s successful Phase 1 trial and access to formulation patents

filed by LTS Lohman relating to the esketamine OTF.

Awakn has filed method of use patents in the US for the use of SVN-002 in the treatment

of Alcohol Use Disorder in the US. ( Just RNS its approved by SVNS )

If you are interested in investing in a Pharma this one is weighted in your favour.

Are there still risks - yes, there are risks in everything we invest in.

This one has the least risk and a great upside.

 SVN-001 is a novel investigational combination therapy for the treatment of severe AUD. It is targeting full mixed marketing authorisation

in the UK and EU, with expected regulatory protection to include eight years of data exclusivity in the EU and ten years of concurrent

market exclusivity in both regions.

 Based on a market analysis by PharmaVentures’, comparable transactions for late-stage UK/EU-focused assets in the substance use

disorder space, typically achieve a total deal value of approximately £60 million, in upfront and commercial milestone payments,

plus additional future material royalties on net sales.

 SVN-002 is a proprietary, investigational, patent-pending sublingual esketamine formulation designed for use alongside manualised

behavioural therapy in patients with moderate to severe AUD. It is currently in Phase 2b planning in the US and is expected to follow the

FDA's 505(b)(2) regulatory pathway.

 Based on a market analysis by PharmaVentures’, subject to the successful completion of the planned Phase 2b trial and based on

similar transactions for mid-stage assets, comparable assets typically achieve a total deal value of approximately £150 million, in

upfront and commercial milestone payments, plus additional future material royalties on net sales.

De-risked approach to drug development

Solvonis’ dual R&D strategy offers a de-risked approach to drug development by:

 Repurposing approved drugs and developing them for new indications, and

 Developing new drugs based on known pharmacology to address unmet needs that current therapeutic options do not address.

We note that repurposing drugs can provide a distinct advantage, as the compounds being developed, have often been approved or at least

been put through millions of dollars’ worth of preclinical and early clinical testing. As a result, repurposing can potentially be a cheaper and

faster method for a drug to reach market. Furthermore, the Company can leverage accelerated regulatory pathways and non-dilutive funding

to accelerate timelines and reduce costs.

This business model also reduces the riskiness of drug development, and per reviewed publications repurposed compounds have

significantly higher probabilities of success associated with their development.

Figure 1: Probability of Success (PoS): Repurposed drugs have higher probability of getting to market

Probability of Success

Transition Phase NME Repurposed

Preclinical-> Ph 1 63% 85%

Ph 1-> Ph 2 30% 55%

Ph 2-> Ph 3 30% 40%

Ph 3->Approval 65% 80%

Overall 10% 21%

Source: Rao at al., 2022. Pharm Chem J. 2022 Dec 7; 56 (9):1203-1214

These numbers vary based on therapeutic area and regulatory path (e.g., 505(b)(2) in the US can accelerate repurposing efforts).

Key factors contributing to the higher PoS include:

 Known Safety Profile: Phase 1 trials are often skipped or abbreviated since toxicity data is already available.

 Established Manufacturing: Reduces

Executive Summary

Solvonis is an innovative biotechnology company focused on developing groundbreaking medicines for addiction and mental health disorders.

The focus on addiction and mental health disorders is timely, given the prevalence of both addiction and mental health disorders is on the

rise. A significant number of individuals present experiencing co-occurring conditions. While the relationship between addiction and mental

health is complex, with both conditions potentially influencing or exacerbating the other, it's crucial to understand the increasing burden of

these disorders1

. The number of adults in contact with drug and alcohol services has increased, with a rise in the number of individuals entering

treatment.

Alcohol Use Disorder is one of the most prevalent substances use disorders globally, though rates vary considerably by region, age group, and

gender. The World Health Organization (WHO) estimated that in 2016 about 283 million people worldwide had an alcohol use disorder, equal

to roughly 5.1% of the adult population. This global figure includes both mild and severe cases. More recent analyses suggest the number

remains in the hundreds of millions; for instance, in 2019 an estimated 2.6 million deaths (4.7% of all global deaths) were attributable to alcohol

and about 209 million people were living with alcohol dependence (the most severe form of AUD). Men are disproportionately affected:

globally about 7.8% of men vs 1.5% of women suffer from alcohol use disorders. This gender gap is consistent across most regions due to

cultural and biological factors influencing drinking behaviour.

Post-traumatic stress disorder (PTSD) is a mental health condition that can develop after experiencing or witnessing a traumatic event. It is

characterized by a range of symptoms, including intrusive thoughts and memories, avoidance behaviours, and changes in mood and arousal.

These symptoms can significantly impact a person's daily life and relationships. According to DSM-5, PTSD is diagnosed if symptoms persist

for more than one month and cause significant impairment. It is estimated that approximately 60% of people in the United States experience

at least one severe trauma in their lifetime, of which approximately 9% meet full diagnostic criteria for PTSD. Prevalence varies by a population's

traumatic exposure but is estimated to be 12% to 14% among troops returning from battle zones, 12% of patients in primary care, 38.6% of

patients screened in primary care for depression and anxiety and, internationally.

Factors contributing to drug and alcohol misuse include:

 Increased Awareness and Diagnosis: Greater awareness and improved diagnostic tools may lead to more individuals being identified

with both addiction and mental health disorders,

 Social Determinants: Social factors like poverty, lack of access to healthcare, and high levels of stress can contribute to the development

and worsening of both addictio

PE of 25!

What has happened to forecasts?

 No forecasts are available

How does the market view Solvonis Therapeutics?

The market's view of Solvonis Therapeutics PLC is currently cautious, reflecting both the company's potential in developing treatments for

mental health disorders and the inherent risks associated with early-stage biotechnology ventures.

How do we view Solvonis Therapeutics?

Solvonis Therapeutics offers an asymmetric risk-reward profile for early-stage investors. With a credible lead program, expanding pipeline,

experienced team, and positioning in one of the most exciting and socially relevant areas of biotech, the company presents a compelling

speculative opportunity—especially if it executes successfully on its Phase 3 trial and begins monetising its assets.

What are the pivotal issues?

The key near term issues focus on accessing additional capital, driven by demonstration of clinical efficacy and Phase 3 trial success.

Commercialisation strategy requires a third party to deliver so successful business development will be a key metric of success, providing

external validation and a typical deal structure consisting of upfront payments, development milestones and royalties on sales.

Pivotal issues: Accessing additional capital; Partnering; Clinical success

How do we value Solvonis Therapeutics?

 rNPV of pipeline using 15% discount rate and 25x PE multiple

 Industry standard royalty rates used as base assumption on

out-licensing terms

 Comparable peer group analysis

Https://telegram.org/

Can show docs on there, none of the poison that is twitter - worth persevering with.

Acquisition delivers scale; focus now on execution

The acquisition of Awakn Life Sciences broadened the pipeline and expanded the commercial

potential, with value inflection points anticipated over the next 18-24 months. According to

Precedence Research, the global addiction treatment market size is predicted to increase from

$9.97bn in 2025 to approximately $16.22bn by 2034 (5.56% CAGR).

Pipeline-derisked as lead drug is already approved

The pipeline focuses AUD & PTSD, psychiatric indications with high unmet needs, backed up by

significant supporting evidence from the literature and previous clinical data. The two lead

programmes (repurposing the use of ketamine) pose 2.5x higher probability of success compared to

novel drugs. SVN-001 is currently undergoing a pivotal trial combining IV ketamine with copyrighted

manualized relapse prevention cognitive behavioural therapy (CBT) targeting both the biological and

psychosocial aspects of AUD, an approach which has demonstrated improved outcomes compared to

the use of these approaches in isolation. We believe that this business model provides a suitable

balance between innovating to address unmet medical need versus de-risking drug development and

commercialisation risks.

SCM view: Significantly undervalued

We value Solvonis using our risk-adjusted pipeline valuation model, which is underpinned by an in-

depth patient-based model. We also review comparable companies within the mental health space to

provide context to the investment case that Solvonis appears significantly undervalued with additional

value acceleration such as progressing clinical programmes and accelerating business development,

including asset out licensing and additional pipeline assets. We value Solvonis using a blend of our

rNPV model of the two clinical stage assets and a risk adjusted patient based forecast model.

Solvonis Therapeutics is an innovative biotechnology company focused on developing

groundbreaking medicines for addiction and mental health disorders. The current focus is on

novel therapeutics to address: Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder

(PTSD). The former impacts c. 5% of the global population. The therapeutic approach for AUD

is a first-of-its-kind combination therapy combining IV ketamine with copyrighted manualized

relapse prevention cognitive behavioural therapy (CBT). This approach targets both the

biological and psychosocial aspects of AUD, an approach which studies have confirmed results

in better outcomes than either alone. The business strategy is to utilise an efficient and de-

risked model through repurposing approved drugs and leveraging accelerated regulatory

pathways. The commercial strategy is to outlicense at appropriate inflection points to

accelerate value creation. We initiate with a BUY recommendation and a PT of 1.6p using our

risk adjusted valuation of the pipeline.

H t t p s : / / t . m e /

join this telegram group, its on there, with all rhe other research notes.

*************+8fd4qmxncorkymm0

SCM perspective

 Regulatory risk is a reality of the drug development process. Solvonis is using ketamine, a drug that has bene approved and has been

used for many years. Furthermore, the more recent availability of Spravato in the US prides us with confidence that regulators are open

to the use of ketamine to treat neurological conditions.

SCM perspective

We believe the risk in the EU is minimised as the ketamine therapy is available and the use a structured session using the Solvonis

proprietary manual minimises the risk of adverse events whilst the scientific literature highlights that therapy combined with ketamine yields

results that are superior to either modality alone. The success of Spravato in the US suggests to us that ketamine-based therapeutics are

accepted by clinicians and patients. The commercial success speaks for itself.

This is going to rip today, the Singer Capital Market note is very, very good.

SCM perspective

Raising finance is part of the biotech journey and the leadership team has experience in raising capital. As mentioned above, the lead assts are

re-purposed and repurposing can potentially be a cheaper and faster method for a drug to reach market. Furthermore, the Company can

leverage accelerated regulatory pathways and non-dilutive funding to accelerate timelines and reduce costs. Execution on business

development can also be a means of providing external validation and extending the cash runway.

Both SVN 001 and 002 protocols now patented as well, FDA to be officially confirmed shortly, that in itself might trigger a partnership offer from J & J as sublingual esketamine is a lower dosage that their more expensive to produce nasal spray.

They can only bury it, if they own it!

Spravato cost and why Johnson & Johnson may need to buy out SVN 002 bear in mind SVNS IS THREE treatments of ketamine and 7 therapy sessions, they are offering a cure more than a treatment for 86% of their patients.

top para of article mentions Spravato...

The total annual drug cost of esketamine is between $18,564 to $45,591 in year 1, and $14,196 to $42,588 in subsequent years based on a unit price of $273.00 per 28 mg. In the model, the sponsor considered the average cost of esketamine as $30,019 in year 1 and $24,625 in subsequent years based on the average number of treatment sessions and devices per session obtained from the TRANSFORM-2 and SUSTAIN-1 clinical trials.

https://www.ncbi.nlm.nih.gov/books/NBK572201/