Ananda Developments - Quarterly Trading Statement to 31 January 2024

26 February 2024

ANANDA DEVELOPMENTS PLC

("Ananda" or the "Company")

Management accounts for the quarter ended 31 January 2024

Ananda Developments Plc (AQUIS: ANA), the company whose ambition is to be a leading provider of cannabinoid-based medicines for the treatment of chronic, complex inflammatory pain conditions, announces its unaudited management statements for the quarter ended 31 January 2024.

This announcement contains inside information for the purposes of the UK Market Abuse Regulation and the Directors of the Company are responsible for the release of this announcement.

To stay abreast of the latest developments at Ananda, we encourage you to follow our social media channels which are:  

·      Investor Hub: investors.anandadevelopments.com

·      Instagram: https://instagram.com/anandadevelopments?igshid=YmMyMTA2M2Y=   

·      LinkedIn: https://www.linkedin.com/company/anadevelopments/   

·      Twitter: https://twitter.com/AnandaPlc

·      Investor Meet Company: https://www.investormeetcompany.com/ananda-developments-plc/register-investor

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Directors Statement

Introduction

Ananda Developments Plc ("the Company" or "Ananda") is a company quoted on the Aquis Stock Exchange ("AQSE") Growth Market.  The Company was incorporated on 19 January 2018 and its shares were admitted to trading on 4 July 2019.

Below is a summary of activities during the period in question and certain post-period events.

Activities during the period

Ananda Corporate

Ananda will be attending and speaking at the Master Investor Show in London at The Business Design Centre 52 Upper Street London N1 0QH on the 9^th of March. The Company will be represented at the event by its CEO, Melissa Sturgess, and its Finance Director, Jeremy Sturgess-Smith.

To attend the show, please follow the following link: https://masterinvestorshow-2024.reg.buzz/?exhibitor-inviter=18f1c1fa-b9ee-11ee-9af7-000000000000

Ananda has recently opened its InvestorHub (the "Hub") for all shareholders, stakeholders and interested parties to sign up to. This was launched on 14 December 2023 with the intent to increase the Company's ability to engage directly with individual stakeholders. To join the Hub, follow the link here: https://investors.anandadevelopments.com/s/a66906

Also during, and just after, the period the Company announced the appointment of Professor Cherry Wainright and Dr Katie Sloper, PhD as Scientific Advisers (30 January 2024) to the Company, and Vitalii Ratushni as Data and Analytics Adviser (6 February 2024).

·    Professor Cherry Wainwright is a pharmacological research expert with over 42 years of experience and is the President Elect of the British Pharmacological Society ('BPS'). The mission of the BPS is to promote and advance the whole spectrum of pharmacology - the scientific study of the effects of drugs and chemicals on living organisms.  The BPS leads the way in the research and application of pharmacology around the world and has over 4,000 members from more than 60 countries worldwide.

Cherry will advise the Company on its drug development activities, areas of potential unmet need that could benefit from Ananda's medicines, and clinical trial activities including protocol development.

·    Dr. Katie Sloper, PhD is a medical research expert with a particular focus on the therapeutic profile of cannabis-based medicines and innovative approaches to cancer treatment. Katie's work with Ananda will focus on developing the Company's scientific understanding of cannabidiol and its mechanisms of action, with a particular focus on chronic pain and inflammation. Katie will help the Company to continually refine its scientific approach and identify potential new areas for clinical investigation.

·    Vitalii Ratushni is a data, analytics, and quantitative modelling expert. His appointment gives Ananda the analytical capability to better target its research activities by identifying potential current and new disease areas where cannabinoids may be efficacious. His expertise in big data will enable Ananda to assess patient populations in areas of unmet need and support new cannabinoid drug development. Vitalii's focus will be on creating a database of over 10,000 diseases which have symptoms for which cannabinoids may have potential for activity. The database will then be refined to conditions which have evidence that cannabidiol has treatment potential. Refinement and interrogation will provide Ananda with information sets to identify clinical trial research opportunities.

MRX Medical (MRX)

Clinical Trials

During the period, MRX continued to progress its two already announced clinical trials and to put the foundations in place for future clinical trials in other conditions. As a reminder, Ananda announced during 2023 that MRX will be supplying its patent-pending MRX1 cannabidiol oil to two Phase II trials. Those trials are investigating:

·    The pain relieving effects of MRX1 on sufferers of endometriosis. The RCT, funded by a £300,000 non-dilutive grant from the Chief Scientist Office in Scotland, is being led by Dr Lucy Whitaker, a Senior Clinical Research Fellow at the Centre for Reproductive Health, University of Edinburgh. The trial will be a pilot trial, with the end goal being to assess the feasibility of running a further nation-wide trial on the use of CBD versus placebo in the treatment of endometriosis-associated pain. The study will be located at NHS Lothian and NHS Grampian with a 100‑patient recruitment plan.

Endometriosis is a condition where tissue similar to the lining of the uterus grows outside the uterus. It can cause severe pain in the pelvis and affect fertility. Globally, 10% of women suffer from endometriosis* and currently the only treatments are surgery, hormonal treatment or pain killers. The global market of 190 million sufferers was valued at $1.05bn in 2020 and is expected to achieve CAGR of 9.6% from 2020-2030**. 

·    The pain relieving effects of MRX1 on sufferers of Chemotherapy Induced Peripheral Neuropathy ("CIPN"). This trial, funded by a £1.25m non-dilutive grant, is being led by Professor Marie Fallon who is a leading researcher at the University of Edinburgh (the "UoE") and the St Columba's Hospice Chair of Palliative Medicine as well as Honorary Consultant in Palliative Care with 256 publications and over 10,000 citations. The trial will be a double-blind crossover trial, located at Western General Hospital with a 92 patient recruitment plan. CIPN is a common and debilitating side effect of chemotherapy with approximately 160,000 new cases per year in the UK, with a prevalence of 60% 3 months after chemotherapy treatment.  

Signing of Drug Supply Agreement

On 14 November 2023, the Company announced that MRX has signed a Drug Supply Agreement ("DSA") with the UoE and the Lothian Health Board ("LHB"). This agreement provides the legal framework for the provision of MRX1 to UoE for the CIPN trial and confirms that MRX has been granted a licence over all arising (generated from the trial) Intellectual Property ("IP") for internal research and development purposes, as well as an option to licence the arising IP for all commercial purposes. MRX will maintain full ownership of all IP as relates to the Investigative Medicinal Product (MRX1) and its matching Placebo. There are no preventative treatments for CIPN and symptom management is commonly ineffective. The CIPN global market was valued at US$1bn in 2021 and is estimated to reach US$1.5bn in 2030 and, given most treatments are ineffective, the Directors believe that this figure may not accurately reflect the true market size.

Patents

On 8 November 2023, the Company announced that MRX has filed a fifth patent application with the UK Government's Intellectual Property Office. The application covers a new cannabinoid formulation known as MRX2T. This formulation is based on MRX's patent pending MRX2 cannabidiol formulation, with the addition of tetrahydrocannabinol ("THC"). This formulation has been developed for use in Randomised Controlled Trials ("RCTs"). This application is in addition to four previous applications which cover the proprietary formulation methodology and three different cannabinoid formulations known as MRX1, MRX2 and MRX3.

Throughout the remainder of the period the team at MRX pressed on diligently with MRX's research partners, and we look forward to bringing all our shareholders more information on this and any other developments at MRX as soon as possible.

DJT

At the beginning of the period, on 1 November 2023, the Company announced that Ananda and DJT had signed a Memorandum of Understanding ("MOU") with Nottingham Trent University ("NTU") to pursue third-party grant funding to progress DJT's medical cannabis breeding programme and its low-carbon medical cannabis cultivation and manufacturing. The shared vision, beyond the MOU, is to create a formal strategic partnership and the establishment of a Cannabinoid Centre of Excellence at NTU.

Throughout the period the Company's Head of Operations continued discussions with NTU's Grant Capture department to begin assessing which grants were most appropriate for DJT to apply for. Our Finance Director has also worked to reduce DJT's monthly cash burn as far as possible to preserve Company cash.

Whilst we continue to believe that DJT shows incredible promise as a business unit, until the market demand increases and the regulatory framework becomes less opaque the Directors believe that MRX is the Company's core value driver and the Company will be applying most of its efforts and resources in this area in the near term.

Melissa Sturgess

Chief Executive Officer

* https://www.who.int/news-room/fact-sheets/detail/endometriosis

**https://www.globaldata.com/store/report/endometriosis-market-analysis/#:~:text=What%20is%20the%20endometriosis%20market,9%25%20during%202020%2D2030.