Investee Company Update: Little Green Pharma Ltd

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

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   or contact:

Ed McDermott Lance de Jersey	SEED Innovations Ltd	E: [e-mail]
James Biddle Roland Cornish	Beaumont Cornish Limited, Nomad	T: (0)20 7628 3396
Isabella Pierre Damon Heath	Shard Capital Partners LLP Broker	T: (0)20 7186 9927
Catherine Leftley Isabelle Morris Max Bennett	St Brides Partners Ltd, Financial PR	E: [e-mail]

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/

 

END

 

 

MSCUPURWPUPWGCQ