REG - Seed Innovations Ltd - Investee Company Update: Little Green Pharma Ltd

Seed InnovationsAnnouncement

06/02/2023 14:45

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RNS Number : 0633P  Seed Innovations Limited  06 February 2023

 

6 February 2023

 

SEED Innovations Limited

("SEED" or the "Company")

Investee Company Update: Little Green Pharma Ltd

SEED Innovations Ltd, the AIM-quoted company investing in fast-growing and
industry-leading businesses with a focus on the medical cannabis, health, and
wellness space, is pleased to note an announcement released on the ASX by its
portfolio company, Little Green Pharma Ltd ('LGP').

The Company owns 7,324,796 ordinary shares in LGP representing 2.8% of LGP's
issued share capital.

The following extract from the announcement is set out without material
changes or adjustments and the announcement in full can be accessed from the
following link
https://investor.littlegreenpharma.com/site/investor-centre/asx-announcements
(https://investor.littlegreenpharma.com/site/investor-centre/asx-announcements)

 

Psilocybin and MDMA down-scheduled

GP's psychedelics subsidiary Reset Mind Sciences welcomes the TGA's decision
to down-schedule psilocybin and MDMA.

Little Green Pharma (ASX: LGP) and its psychedelics focused subsidiary Reset
Mind Sciences Limited ("Reset Mind Sciences") welcome Friday's decision by the
Therapeutic Goods Administration ("TGA") to change the classification of
psilocybin and MDMA to allow prescribing by authorised psychiatrists.

A copy of the media release is available here:
https://www.tga.gov.au/news/media-releases/changeclassification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists

The announcement means Australia will become the first market in the world to
recognise psychedelics as medicines and paves the way for the use of
psilocybin for the treatment of treatment resistant depression and MDMA for
PTSD outside of a clinical trial environment from 1 July 2023.

The TGA's decision to re-classify psilocybin and MDMA has come significantly
earlier than expected by industry, given the TGA's decision in late December
2021 not to reclassify and limit use to clinical trials only. However, the
unexpected change uniquely positions Reset compared to other psychedelic
companies in Australia given both its Schedule 9 licence, authorizing it to
cultivate and supply psilocybin, and its impending clinical trial, enabling
Reset to validate its treatment protocols for the use of psilocybin in
connection with treatment resistant depression. These developments now allow
Reset to accelerate and implement its commercialisation plans far earlier than
expected.

Reset Mind Sciences CEO Mr. Shaun Duffy said, "The announcement by the TGA is
truly groundbreaking in the field of psychedelics and I welcome their
decision. There is a significant body of research emerging in Australia and
globally for the use of psychedelics to treat mental health conditions and
this decision allows the use of these drugs for the mental health conditions
that have demonstrated the most potential in the research."

Reset Mind Sciences is in the advanced stages of preparations for a Perth
based clinical trial using psilocybin for treatment resistant depression, the
condition the TGA has identified as permissible for treatment under its
prescribed parameters.

Mr. Duffy said, "We have put more than 18 months of detailed planning into our
trial with a focus on testing, refining and developing the therapy protocols
that go along with the administration of psilocybin. This is a specialised
field of expertise in itself that should not be underestimated and our trial
provides an environment to optimise our protocols. We have assembled an
outstanding team of therapists that are trained and ready to go once we
finalise the ethics approval process. Given the comments from the Ethics
Committee to date we hope and expect that's not far away."

The trial's Principal Investigator is the University of Western Australia's
Professor Sean Hood who will have oversight of responsible governance and
treatment delivery.

"It is incumbent on the industry to proceed in a professional and responsible
manner with this treatment and ensure those administering it have the
necessary skills" added Mr Duffy.

In addition, Reset Mind Sciences is in the final stages of commissioning
construction of a bespoke mushroom cultivation facility which is expected to
be on site at LGP's existing cannabis cultivation facility in the coming
weeks. Reset is one of a very limited number of Australian companies legally
permitted to cultivate psilocybin containing mushrooms. Reset's objective is
to be able to produce GMP grade psilocybin from its mushrooms as soon as
possible.

 

Mr. Duffy added, "Reset is fortunate that its clinical trial indication focus
on treatment resistant depression matches the TGA's psilocybin policy, as well
as deciding to obtain a Schedule 9 supply and manufacturing licence in 2019 to
enable progress of its inhouse psilocybin production capability.We believe the
advanced stage of Reset's treatment ecosystem puts the company in a strong
leadership position for this significant therapeutic development.

"We're still working through the full implications of the TGA's decision for
our strategy moving forward but suffice to say it's a very positive
development for us and will result in an acceleration of our plans."

Little Green Pharma has previously announced its intention to demerge Reset by
way of an inspecie distribution of its current ownership out to its
shareholder base. If approved by LGP shareholders, the effect would be that
eligible LGP shareholders on a certain record date (to be determined) would
receive a separate direct shareholding in Reset Mind Sciences and the
opportunity to invest additional funds into it.

"Given this regulatory development and that Reset is on the precipice of
becoming operational on both the clinical trial and cultivation fronts, we
believe the time is right to move ahead with the demerger of Reset Mind
Sciences from Little Green Pharma into a standalone dedicated psychedelics
company."

Reset Mind Sciences is in the advanced stages of preparations for a Perth
based clinical trial using psilocybin for treatment resistant depression, the
condition the TGA has identified as permissible for treatment under its
prescribed parameters.

- Ends -

For further information on the Company please visit:  www.seedinnovations.com
(http://www.seedinnovations.com/)   or contact:

 

 Ed McDermott       SEED Innovations Ltd         E: info@seedinnovations.co

 Lance de Jersey
 James Biddle       Beaumont Cornish Limited,    T: (0)20 7628 3396

 Roland Cornish     Nomad
 Isabella Pierre    Shard Capital Partners LLP   T: (0)20 7186 9927

 Damon Heath        Broker
 Catherine Leftley  St Brides Partners Ltd,      E: info@stbridespartners.co.uk

 Isabelle Morris    Financial PR

 Max Bennett

 

 

Notes

Seed Innovations Ltd

SEED Innovations is an AIM quoted investment company focused primarily on
disruptive high growth life sciences and technology businesses particularly
within the medical cannabis arena. The Company's strategy is to identify
early-stage opportunities that have an upcoming investment catalyst and grow
its portfolio in terms of value whilst limiting the number of investee
companies to a level where relevant time can be devoted to each.

About Little Green Pharma

Little Green Pharma is a global, vertically integrated and geographically
diverse medicinal cannabis business with operations from cultivation and
production through to manufacturing and distribution.

The Company has two global production sites for the manufacture of its
own-branded and white-label ranges of GMP-grade medicinal cannabis products,
being a 21,500m2 cultivation and 4,000m2 GMP manufacturing facility capable of
producing over 30 tonnes of medicinal cannabis biomass per annum located in
Denmark (EU) and an indoor cultivation and manufacturing facility located in
Western Australia capable of producing ~3 tonnes of medicinal cannabis biomass
per annum.

Little Green Pharma products comply with all required Danish Medicines Agency
and Therapeutic Goods Administration regulations and testing requirements.
With a growing range of products containing differing ratios of active
ingredients, Little Green Pharma supplies medical-grade cannabis products to
Australian, European and overseas markets.

The Company has a strong focus on patient access in the emerging global
medicinal cannabis market and is actively engaged in promoting education and
outreach programs, as well as participating in clinical investigations and
research projects to develop innovative new delivery systems.

For more information about Little Green Pharma go to:
www.littlegreenpharma.com

For more information about Reset Mind Sciences go to:
https://www.resetmind.com.au/

 

 

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