Evgen Pharma Regulatory News (EVG)

Evgen Pharma plc

("Evgen" or the "Company")

SFX-01 licensing deal for up to $160.5m in milestone paymentsexpands 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. 

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 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

-Ends-

Investor Presentation

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:

https://www.investormeetcompany.com/evgen-pharma-plc/register-investor.

Investors who already follow EVGEN PHARMA PLC on the Investor Meet Company platform will automatically be invited.

Enquiries:

Notes to Editors

About Evgen Pharma plc 

Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. 

The Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has completed, with a positive outcome, a Phase 2a clinical trial for oestrogen-positive (ER+) metastatic breast cancer. In September 2021 the FDA granted Orphan Drug status to SFX-01 in malignant glioma.

The Company also has a wide number of collaborations with leading academic centres in the UK, Europe and AsiaPac as part of the continuing strategy to build the data set of safety and efficacy around the compound. With respect to non-core areas, Evgen signed an outlicensing deal with JuvLife, the dietary products and functional foods division of Juvenescence Ltd, for the development of a naturally-sourced sulforaphane nutritional health supplement, stabilised using Evgen's Sulforadex® technology.

The Company has its headquarters and registered office at Alderley Park, Cheshire. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.

For further information, please visit: www.evgen.com. 

About Stalicla SA

STALICLA is a precision molecular neuroscience clinical stage biotech company, advancing the first precision medicine platform (DEPI) for patients with Neurodevelopmental Disorders (NDDs), and Neuropsychiatric Disorders.

STALICLA's unique approach is addressing the poor construct validity of behaviorally defined disorders through Its unique asset/platform converges molecular data with human genetic information to create testable clinical hypotheses in psychiatry / neuroscience.

With multiple clinical proof of concept, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder and their tailored treatment STP1 and STP2 both planned to enter clinical Phase 2 in 2023.

The DEPI platform has been validated in clinical setting showing high specificity, sensitivity and Positive predictive value in prospectively designed trials recalling of "high" responder patients to previously failed drug candidates.

STALICLA is currently engaged in preparing its next stage of growth to advance its pipelines and to scale its platform towards revenue generation.

For further information, see: https://stalicla.com/.