Evgen licenses the global rights for lead asset SFX‐01 in neurodevelopmental disorders and schizophrenia to Stalicla SA

Alderley Park, UK ‐  Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane‐based medicines for the treatment of cancer and other indications, has licensed the global rights for lead asset SFX‐01 in neurodevelopmental disorders and schizophrenia to StaliclaSA (“Stalicla”), a Swiss company specialising in the identification of specific phenotypes of autism spectrum disorder (ASD), using its proprietary precision medicine platform. Evgen retains the global rights for all other indications.

Key financial elements of the transaction

• $0.5m upfront, $0.5m on completion of the, already fully financed, Evgen‐sponsored human volunteer Phase 1 study (anticipated during Q2 2023)
• Milestone payments up to commercial launch are $26.5m,including $5m on grant of IND by the FDA (anticipated in late 2023)
• Total milestones of $160.5m are payable to the Company in relation to the first neurodevelopmental disorder indication under the license
• Royalties payable to Evgen on sales are in the low to medium double‐digit range in all scenarios,including on‐licensing by Stalicla and use of SFX‐01 in further licensed indications.

Other Highlights

• SFX‐01 is a patented composition of synthetic sulforaphane and alpha‐cyclodextrin and is the only grade of sulforaphane suitable for clinical research and eventual approval as a medicine. Previous studies with other sources of sulforaphane have shown evidence of clinical efficacy in improving symptoms of ASD (e.g. Singh et al 2014). However, patient heterogeneity provides a challenge in identifying those individuals most likely to respond to therapy.
• Stalicla has a unique, proprietary technology to identify ASD patients who are most likely to respond to SFX‐01. This screening approach has already been used successfully to identify ideal patients for other ASD drug trials and is a key differentiator for Stalicla in developing drugs for such a wide spectrum disorder as ASD.
• Evgen’s partnership with Stalicla will enable the targeting of patient groups most likely to benefit from SFX‐01, not only de‐risking the clinical development but potentially bringing a therapeutic option to those individuals who are currently underserved, in a quick and efficient manner.
• Evgen and Stalicla will collaborate initially on a clinical programme in ASD, with Stalicla funding all clinical development activities. This licensing deal is further validation of Evgen’s stated strategy of early partnering of indications with high quality partners who can add significant value to its programmes. This follows the 2020 deal with JuvLife for use of the Sulforadex® technology in nutraceutical markets.

Dr Huw Jones, Evgen CEO, commented: “This is an exciting opportunity to work with Stalicla to develop a potential treatment for ASD and other neuropsychiatric disorders. There are no current approved treatments for ASD but a molecular target activated by SFX‐01 offers considerable promise in alleviating some of the complex behavioural challenges experienced by people with these conditions.”

“Stalicla is a unique partner in ASD, with its proprietary technology for screening those patients who are most likely to respond to SFX‐01. This recognition of SFX‐01 as a potential treatment for a major neuropsychiatr iccondition, demonstrates the variety of potential uses of our Sulforadex® platform, along with our ability to execute on our business model. Entering the CNS (Central Nervous System) space with this partnership is especially compelling due to the promising clinical data for sulforaphane in this area in earlier studies.”

Autism spectrum disorder is a group of neurodevelopmental disorders (NDDs) currently diagnosed based on core behavioural features, without specific biological criteria. Stalicla has identified several subgroups, or phenotypes, which the Company targets through various treatment strategies.

Evgen’s core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. Sulforaphanes have shown potential benefits in Neurodevelopmental disorders, oncology and inflammatory conditions.