Update on FDA Pre-IND Meeting for Awakn

• FDA supports AWKN-002's progression to Phase 2b clinical trial without requirement for additional clinical data
• FDA endorses use of 505(b)(2) NDA pathway, enabling a streamlined regulatory process and potential for faster market access
• AWKN-002 is being developed for the treatment of alcohol use disorder in the U.S.

Solvonis Therapeutics plc (LON: SVNS), ("Solvonis" or the "Company") an innovative biotechnology company co-developing therapeutics for mental health disorders, is pleased to announce that Awakn Life Sciences Corp. ("Awakn"), the company Solvonis plans to acquire, has reached a significant regulatory milestone. Awakn announced a positive outcome from a Pre-Investigational New Drug ("Pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") regarding AWKN-002, a proprietary oral thin film ("OTF") formulation of esketamine, designed for sublingual and buccal administration in combination with structured alcohol education. This drug candidate is being developed for the treatment of moderate to severe alcohol use disorder ("AUD") with a focus on U.S market.

The Pre-IND meeting, held on 16 December 2024, marks a critical step in the U.S. drug development process. During the meeting, Awakn received positive feedback from the FDA regarding its development strategy for AWKN-002. Notably, the FDA confirmed that no additional clinical data are required prior to initiating a Phase 2b trial for AWKN-002 in patients with moderate to severe AUD enabling Awakn to expedite its clinical development program. This decision provides a clear path forward for advancing the drug to the next phase of clinical testing.

Additionally, the FDA agreed that AWKN-002 can be reviewed under the 505(b)(2) New Drug Application (NDA) approval pathway. This pathway allows data from an approved esketamine product to support the development of AWKN-002 for AUD treatment, provided a scientific bridge is established between AWKN-002 and the reference product. This regulatory pathway is expected to streamline the process and potentially reduce time to market.

This outcome represents a major milestone for Awakn and, by extension, for Solvonis, highlighting AWKN-002's potential as a breakthrough treatment for AUD, a condition with significant unmet medical need. The positive feedback from the FDA reinforces the scientific and clinical promise of AWKN-002, enhancing its value as Solvonis continues with its proposed acquisition of Awakn, as announced on 16 December 2024.

Anthony Tennyson, Chief Executive Officer of Solvonis, commented: "We are very pleased with the successful outcome of Awakn's Pre-IND meeting with the FDA. The FDA's support for Awakn's development strategy, particularly their confirmation that AWKN-002 can proceed to Phase 2b once a suitable scientific bridge to the product has been established. This marks a significant milestone for Awakn and by extension Solvonis."

Prof. David Nutt, Senior Scientific Advisor of Solvonis, commented: "The outcome of Awakn's Pre-IND meeting with the FDA is a significant advancement for AWKN-002 as a potential treatment for AUD. The FDA's support for the 505(b)(2) pathway is a valuable endorsement of the scientific approach behind AWKN-002. This progress is a promising development not only for Awakn but also for Solvonis as we continue to develop transformative solutions for substance use disorders."

Further updates will be provided as the regulatory process progresses and additional clinical milestones are achieved.

AUD is a chronic, relapsing brain health disorder characterised by compulsive alcohol use, loss of control over drinking, and negative emotional states when not using alcohol. It affects individuals across diverse demographics and can lead to a wide range of physical, psychological, and social consequences. AUD affects approximately 29 million[1] adults in the U.S. with Awakn estimating a current affected population of 40 million in the US and UK and key European markets. Despite this high prevalence treatment success rates are very low with up to 75% of patients with AUD returning to harmful drinking within 12 months of treatment[2]. This high prevalence rate and low treatment success rate creates a significant unmet medical need, a significant public health concern, and an enormous economic cost $249 billion in the U.S[3].

About Awakn Life Sciences Corp.

[1] Substance Abuse and Mental Health Administration, 2022 National Survey on Drug Use and Health (NSDUH).

[2] Treatment rates for alcohol use disorders: a systematic review and meta-analysis, (Mekonen et al., 2021).

[3] National Institute for Alcoholism and Alcohol Abuse (NIAAA), Economic Burden of Alcohol Misuse in the United States