REG - Solvonis Therapeutic - Research and Development Update – Q4 2025

Solvonis TherapeuticsAnnouncement

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RNS Number : 3621M  Solvonis Therapeutics PLC  22 December 2025

22 December 2025
Solvonis Therapeutics plc

("Solvonis" or the "Company")

 

Research and Development Update - Q4 2025

Pipeline advancing across addiction and psychiatry with multiple 2026
catalysts

 

Solvonis Therapeutics plc (LSE: SVNS), an emerging biopharmaceutical company
developing novel medicines for high-burden central nervous system ("CNS")
disorders, provides an update on progress across its development pipeline and
discovery programmes as the Company concludes 2025 and enters a catalyst-rich
period in 2026.

 

Pipeline development advancing across addiction and psychiatry

 

SVN-001 | Severe Alcohol Use Disorder (AUD) - UK & EU

 

The Company's lead programme, SVN-001, continues to advance through a
potentially pivotal Phase 3 clinical trial for severe AUD in the United
Kingdom, addressing a large and underserved patient population across the UK
and EU. In parallel, the Company continues to progress licensing and
commercial-partnership discussions.

 

Recruitment remains ongoing in this NHS-based study, conducted in
collaboration with the University of Exeter ("UoE") and co-funded by the
National Institute for Health and Care Research ("NIHR"), the Medical Research
Council ("MRC"), and Solvonis. Top-line results are anticipated in late 2027 /
early 2028. In parallel, with potential partners in UK and internationally.

 

SVN-002 | Moderate-to-Severe AUD - Global (ex-UK & EU) | Initial focus:
United States

 

SVN-002, Solvonis' proprietary esketamine oral thin-film programme, is being
advanced under a planned U.S. FDA 505(b)(2) regulatory pathway referencing
Johnson & Johnson's blockbuster esketamine product, Spravato®.

 

During Q4 2025, preparatory work continued with WuXi AppTec on a
pharmacokinetic bridging programme to support regulatory alignment. Initial
data are expected in Q1 2026, with further progress through Q2 2026.

 

If the scientific bridge to Spravato® is successfully established the Company
plans to promptly seek approval from the US Food and Drug Administration
("FDA") for a Phase 2b trial, thereby potentially avoiding the significant
costs associated with pre-clinical programmes and Phase1 and Phase 2a trials.

 

The programme targets approximately 15 million adults in the United States
living with moderate-to-severe AUD and represents a differentiated,
clinic-based therapeutic approach within a large and underserved market.

 

SVN-015 | Stimulant (Methamphetamine and Cocaine) Use Disorder

 

In December 2025, Solvonis announced that SVN-015, a novel compound emerging
from its AI-enabled discovery programme, was accepted into the U.S. National
Institute on Drug Abuse's ("NIDA") Addiction Treatment Discovery Program
("ATDP").

 

Under the programme, NIDA - part of the U.S. National Institutes of Health
("NIH") - will fund and conduct a standard package of preclinical safety and
pharmacology studies, including cardiovascular risk assessment. Initial
results are expected in Q1 2026. Subject to supportive outcomes, SVN-015 may
progress into further NIDA-funded efficacy testing in validated models of
methamphetamine and cocaine addiction.

 

Acceptance into ATDP represents an important external validation of Solvonis'
proprietary discovery platform and expands the Company's pipeline beyond
alcohol use disorder into stimulant addictions, which remain among the most
severe psychiatric conditions with no approved pharmacological treatments.

 

Successful completion of the ATDP programme would position Solvonis to compete
for subsequent NIH development funding, including potential UG3/UH3 awards,
providing a non-dilutive pathway from preclinical validation toward clinical
development.

 

SVN-SDN-14 | Post-Traumatic Stress Disorder (PTSD)

 

Following the announcement of positive preclinical data in August 2025,
Solvonis' proprietary serotonin-dopamine-noradrenalin modulator programme
continues to progress through final in-vivo studies designed to support
lead-candidate selection.

 

Four compounds are currently being evaluated in rat brain microdialysis
studies to confirm central pharmacokinetics and target engagement across
relevant monoaminergic pathways. Lead-candidate selection is expected in Q1
2026, after which the Company intends to advance the selected compound into
IND-enabling studies.

 

AI-enabled CNS discovery platform

 

Beyond SVN-015 and SVN-SDN-14, Solvonis continues to advance its AI-enabled
discovery programme, generating novel small-molecule candidates targeting key
neurotransmitter systems relevant to addiction and psychiatry. Exploratory
work is also underway to assess potential applications in neurology.

 

Further updates on discovery-stage progress are expected during H1 2026 as
compound evaluation and prioritisation continue.

 

Anthony Tennyson, Chief Executive Officer of Solvonis Therapeutics plc,
commented: "2025 has been a transformative year for Solvonis. The completion
of the acquisition of Awakn Life Sciences in May materially reshaped the
Company, establishing a differentiated CNS platform spanning late-stage
clinical development, earlier-stage discovery, and multiple regulatory
pathways.

 

"Over the course of the year, we have advanced our clinical programmes with
discipline, strengthened our balance sheet, and progressed our proprietary
discovery capability, including securing external validation through the
acceptance of SVN-015 into the U.S. National Institute on Drug Abuse's
Addiction Treatment Discovery Program.

 

"As we look ahead to 2026, the Company is entering a period with multiple
clearly defined catalysts across regulatory, preclinical, and discovery
activities. Our strategy remains centred on capital efficiency, clear
regulatory pathways, and partnering optionality, which we believe provides
near, medium, and long-term shareholder value creation opportunities."

 

Outlook

Solvonis enters 2026 with a diversified CNS pipeline spanning late-stage
clinical development, near-term regulatory catalysts, and early-stage
discovery programmes supported by external validation and non-dilutive funding
pathways.

 

The Company remains focused on disciplined execution across its addiction and
psychiatry programmes while continuing to selectively expand its proprietary
discovery platform.

Enquiries:

 Solvonis Therapeutics plc                                       Via Walbrook
 Anthony Tennyson, CEO & Executive Director

 Singer Capital Markets (Broker)                                 +44 (0) 20 7496 3000
 Phil Davies

 Walbrook PR (PR/IR advisers)  Tel: +44 (0)20 7933 8780 or solvonistherapeutics@walbrookpr.com
                               (mailto:solvonistherapeutics@walbrookpr.com)
 Anna Dunphy                                                     Mob: +44 (0)7876 741 001
 Lianne Applegarth                                               Mob: +44 (0)7584 391 303
 Rachel Broad                                                    Mob: +44 (0)7747 515 393

 

About Solvonis Therapeutics plc

 

Solvonis Therapeutics plc (LSE: SVNS) is an emerging biopharmaceutical company
developing novel small-molecule therapeutics for high-burden central nervous
system (CNS) disorders. Headquartered in London and listed on the main market
of the London Stock Exchange, Solvonis is advancing a differentiated pipeline
of repurposed and novel compounds across addiction, psychiatry, and neurology.

 

The Company's lead programmes address Alcohol Use Disorder (AUD) and
Post-Traumatic Stress Disorder (PTSD), with additional discovery work
supporting expansion into broader CNS indications. Its lead asset, SVN-001, is
currently in Phase 3 for severe AUD in the UK, while SVN-002 is preparing for
a Phase 2b trial in the US targeting moderate-to-severe AUD. The preclinical
PTSD programme (SVN-SDN-14) leverages novel serotonin-dopamine modulators
designed to enhance pro-social behaviour and long-term outcomes.

 

In parallel, Solvonis is advancing proprietary CNS discovery programmes built
on a dedicated compound library to identify new small-molecule modulators of
key neurotransmitter systems. This platform enables efficient early-stage
innovation and supports the Company's integrated approach to developing
therapies across its three strategic pillars.

 

With a capital-efficient model, dual development strategy, and near-term
partnering opportunities, Solvonis is positioned to deliver sustained value
through innovation in CNS therapeutics.

solvonis.com (https://solvonis.com) | LinkedIn
(http://www.linkedin.com/company/solvonis-tx) | X (Twitter)
(https://x.com/Solvonis)

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