TIDMEVG
RNS Number : 2587C
Evgen Pharma PLC
10 October 2022
Evgen Pharma plc
("Evgen" or the "Company")
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.
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(R)
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(R) 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(R), 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:
Evgen Pharma plc Tel: +44 1625 466591
Dr Huw Jones, CEO
Richard Moulson, CFO
FinnCap (Nominated Advisor and Tel: +44 20 7220 0500
Broker)
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane/Nigel Birks/Harriet
Ward (ECM)
Tel: +44 207 457 2020
Instinctif Partners Evgen@Instinctif.com
Melanie Toyne-Sewell / Rozi Morris
/ Agnes Stephens / Adam Loudon
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(R),
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(R) 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/ .
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END
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