SFX-01 licensing deal for up to $160.5m in milestone payments
expands lead asset into neurodevelopmental disorders
Deal with Stalicla underpins potential of SFX-01 outside oncology and inflammation
Alderley Park, UK – 10 October 2022 : 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 Stalicla SA (“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.
· 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 neuropsychiatric condition, 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.
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain
CEO Dr Huw Jones, CBO Dr Helen Kuhlman and CFO Richard Moulson will provide a live presentation about the terms and rationale for the licensing deal with Stalicla via the Investor Meet Company platform on 12th Oct 2022 at 1:00pm BST.
The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9am the day before the meeting or at any time during the live presentation.
Investors can sign up to Investor Meet Company for free and add to meet EVGEN PHARMA PLC via:
Investors who already follow EVGEN PHARMA PLC on the Investor Meet Company platform will automatically be invited.
Evgen Pharma plc
Dr Huw Jones, CEO
Richard Moulson, CFO
Tel: +44 1625 466591
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