Ananda Pharma PLC - Publication of Annual Report

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU, WHICH IS PART OF UNITED KINGDOM DOMESTIC LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

30 July 2025

ANANDA PHARMA PLC 

("Ananda" or the "Company") 

Publication of Annual Report

Ananda Pharma plc (AQSE: ANA, OTCQB: ANANF), a UK-based biopharmaceutical company developing regulatory approved, cannabidiol medicines to treat complex, chronic conditions, is pleased to announce its Annual Report and Accounts for the year ended 31 January 2025.

The information set out below has been extracted from the Group's annual report and audited consolidated accounts for the year ended 31 January 2025. The Company's Annual Report and Accounts for the year ended 31 January 2025, has been published on the Company's website and is available to read at https://investors.anandapharma.co.uk/s/65caf1.

Chairman's Statement

Dear Shareholders and other stakeholders,

Welcome to the Annual Report and Audited Consolidated accounts for the year ended 31^st January 2025 for Ananda Pharma plc (AQSE: ANA, OTCQB: ANANF) ('Ananda', the 'Company' or the 'Group').

Ananda is a UK-based biopharmaceutical company developing cannabidiol (CBD) based medicines for regulatory approval to treat complex, chronic conditions, CBD is a multimodal modulator of many parts of the immune system and inflammatory response that has potential applications in the treatment of many of the chronic conditions that plague the western world. Ananda has advanced its program markedly in the last year until January 2025. At the time of writing Ananda has progressed the manufacturing of its proprietary MRX1 CBD formulation through stability and its contract manufacturer, has made one batch of MRX1 as an Investigational Medicinal Product for use in our sponsored Phase 1 and our partner sponsored Phase 2 Clinical Trials. This is a big step in Ananda's goal to achieve regulatory approval for MRX1 in one of its targeted conditions.

Our aim is to develop the next CBD regulatory approved medicine - Epidiolex was the first CBD based product to be approved in 2018, it sold $972.4 million in 2024. We also know that in 2022 some 40% of the use of Epidiolex in the USA was off label - that is for uses other than the three epileptic conditions that it was licenced for. GW Pharmaceuticals ("GW") was the company that got Epidiolex licenced and since the end of the year Ananda has announced that it has recruited Chris Tovey, the ex-COO of GW, and Giles Moss, who was GM for Europe for GW as advisers. We believe that the addition of these two ex-GW executives provides significant strength to Ananda. Together, they will help guide the Ananda team with advice on the technical and regulatory aspects of drug licencing and strategy, as well as in financing and capital markets.

During the year Ananda has continued to progress the previously announced clinical trial with the University of Edinburgh and announced that it would carry out a Phase 1 trial in Australia to investigate the pharmacokinetics of MRX1 the latter we are delighted to announce commenced in July 2025. In addition Ananda was successful in being part of tender to provide its formulations to University College London and Great Ormond Street Hospital for two broad epilepsy trials, given our success in developing and supplying MRX1 to the standards required, we are confident that we can deliver these drugs too. Ananda is providing its formulations for the following clinical studies:

1.   The supply of MRX1, the Company's lead product, to a Phase 2a feasibility trial for endometriosis related pain. This study is being run by leading experts in endometriosis, Professor Andrew Home and Dr Lucy Whittaker, and is run through the University of Edinburgh (UofE) and is funded by NHS Scotland. The researchers on this trial sit within the Medical Research Council, one of the UK's foremost research bodies.

2.   The supply of MRX1, to a Phase 2 efficacy study, led by Professional Marie Fallon to investigate chemotherapy induced peripheral neuropathy (CIPN) also out of UofE and funded by National Institute for Health and Care Research NIHR.

3.   The supply of two cannabinoid-based medicines, MRX2 and MRX2T, to parallel Phase 3 clinical trials for refractory (drug-resistant) epilepsies. These trials are being run in a partnership between the Group, University College London (UCL), Great Ormond Street Hospital for Children (GOSH), the NHS and the NIHR. The lead investigators for these trials are two world leading experts in the field of neurology, Professors Finbar O'Callaghan and Helen Cross.

I would like to thank the team at Ananda for the extraordinary progress the Company has made in the last year, in particular I would like to thank my wife Melissa Sturgess as CEO, Jeremy Sturgess-Smith, Jack Morgan and Nick Clarkson. As a company, in its stages, they often have to work multiple different roles at once and their ability to operate so effectively and cohesively has been the reason for our progress. I would also like to thank the support and guidance of the Board of Directors and our external advisors.

Company Highlights (Financial and Operational)

Ananda is, in all but some minor sales of MRX1 through private prescriptions, a pre-revenue company with the Group running an operating loss of £3,770,487 for the year, a significant reduction from the operating loss of

£6,932,067 recorded in the previous year. The most significant variations underlying these numbers come from a smaller depreciation, amortisation and impairment line for this year vs last, down to £633,966 from £5,063,971. The£5,063,971 from last year was made up mostly of the full impairment of the DJT Plants Limited assets which was required following our decision to pause operations in that entity. Outside of impairment, depreciation and amortisation the other significant changes in 2025 in comparison to 2024 are the halving of the wages bill, down to

£150,234 from £374,068, though this is a trend that I expect will be reverse in the year ahead as we look to grow the operational team once the trials begin dosing and we need to up headcount to ensure we manage our responsibilities in the trials properly, whilst still leaving sufficient capacity in the Group to continue to develop our go- to-market strategy and handle all the regulatory hurdles that we need to pass on our route to market. Furthermore, the recent increase in employer national insurance contributions will increase our wage bill independently of us adding extra team members.

In the year ending 31stJanuary 2025 we nearly tripled our R&D expenditure from £123,000 in 2024 to £298,814 in 2025, as we continued the development process of MRX1, MRX2 and MRX2T. It is important to note that this number does not contemplate any of the indirect R&D expenditure incurred through the use of consultants and the days dedicated to the development work by our team. This is why the R&D claim we will be submitting to HMRC as part of our tax return of £86,121.16 is significantly higher than 10% of our logged £298,814 of R&D expenditure.

In September 2024 we raised c.£2.15m plus a broker option placing of £79,966. Funds raised were to finance the Group's:

·    Manufacture of MRX1 drug candidate for a Phase 1 study and to prepare for clinical trials in patients with Chemotherapy Induced Peripheral Neuropathy & Endometriosis Phase II studies;

·    Preparation for the initiation of a pharmacokinetic study for Ananda's leading drug candidate MRX1 in Australia which commenced in July 2025;

·    Further pre-clinical Heart Fibrosis with preserved Ejection Fraction studies;

·    Regulatory guidance for MHRA, NICE & NHS approvals and planning for further Phase II & III studies;

·    Commencement of a partnering strategy for further studies;

·    Initial planning for Phase III studies; and

·    General Working Capital

Whilst I was the main investor for this round, we were extremely pleased with the take up from a number of high net worth individuals and as always we were delighted by the strong retail demand through the Winterfloods WRAP programme.

I am also happy to report that we have put the money raised to strong use, contracting Southern Star Research to act as our Contract Manufacturing Organisation in Australia and via them, securing a first rate Phase 1 trial unit to run our Phase 1 PK study in healthy volunteers. We also continued at pace with the development of MRX1 for use in human studies, surpassing a number of key stability milestones for MRX1 and delivering some extremely strong data points via two pre-clinical studies investigating MRX1 as a treatment for Heart Failure with Preserved Ejection Fraction (HFpEF).

The HFpEF projects were particularly gratifying as this was the first ever data generated for MRX1 and showed a strong efficacy profile for MRX1 in mice with this form of heart failure. This data sets us up to begin assessing the most appropriate path forward into a human study for MRX1 and HFpEF.

The most significant operational achievement for Ananda during the year was undoubtedly the announcement of 21^st October 2024, when we revealed to the market that we had won a tender submission to supply two investigational products, MRX2 and MRX2T, plus matched placebos to two Phase 3 trials being led by UCL and GOSH. These trials, which are due to begin recruiting in late 2025 and led by Professors Finbar O'Callaghan and Helen Cross are to investigate the effectiveness of CBD and CBD + THC, in a 50:1 ratio, in adults and children with drug-resistant epilepsy. Key points here:

a) We are being paid to supply the drugs and placebos to the trial

b) All formulation IP is retained by MRX and MRX retains an option to use the trial data for commercial purposes

c) The aim of the trials is to expand access to cannabinoid medicines for epilepsy beyond Lennox-Gastaut, Dravet and tuberous sclerosis complex. It will be MRX's responsibility to pursue an MHRA licence for MRX2 and/or MRX2T following the completion of the trials

These trials therefore represent a significant, company transforming opportunity for the Group. Where we are able to move immediately into a large population, late stage clinical trial, whilst being paid to participate and provides us with our clearest path to near-term significant revenues.

Outlook for the Year Ahead

Following the end of the period, we continued to make significant strides in all areas of work. We appointed three key advisors in Chris Tovey (ex-COO of GW Pharmaceuticals), Giles Moss (ex GM Europe for GW Pharmaceuticals) and Andy Rust, we finished off our pre-clinical manufacturing preparatory work with the final technical batch of MRX1 being completed in late February 2025. We have manufactured to Good Manufacturing Practices (GMP) standards our first batch of MRX1 which will be used for the Phase 1 trial in Australia and both of our Phase 2 UofE trials. We have also now successfully dosed the first participants in the Phase 1 study! We have appointed a leading, US based, cannabis focused investment bank in Viridian Capital Advisors and commenced trading on the US based exchange, OTCQB. The U.S. pharmaceutical and healthcare industries are the largest single market in the world and it would be acting against the best interests of Ananda were we as a board not planning for an expansion into the market.

The first and last two points in the above demonstrate what I believe will be the key focus area for Ananda for the year ahead - that being the build out and development of our US market approach. It is an undeniable fact that the United States of America is the single largest, most important and most influential market for pharmaceuticals. Ananda is now developing a strategy for increasing our footprint in the US. Three parts of that approach have already been announced - those being the appointments of Chris Tovey, Giles Moss and Viridian, plus the admission to OTCQB. We are now starting on the regulatory path, something that Chris Tovey and Giles Moss have a lot of experience in. Giles recently took a cannabinoid drug candidate through the Pre- Investigational New Drug ('IND') and IND processes with the FDA. We have begun drafting documents and with consultants. I look forward to updating the market on these activities over the coming year.

Alongside our US strategy, our two UofE trials should have commenced recruitment and dosing before the end of the year. Lastly, we are looking forward to continuing to engage with UCL on the Phase 3 trials and will be lending them all the energy and effort from Ananda that we can provide to continue to drive the epilepsy trials forward as efficiently as possible.

Governance and Board Matters

The Company adopts the Quoted Company's Alliance Governance Code available to review as part of the Director's report. Whilst the Company and the Board have always adhered to rigorous governance standards, the formally adoption of the Code allowed the Company to graduate to the Apex segment of the AQSE Growth Market, a significant step in the maturation of the Company.

On the board more specifically, it is my opinion as Chair that the Board has continued to perform as required for a quoted company, with a strong line up of independent directors and non-executives to guide Melissa, Jeremy and myself as the executive board team.

During the period, the board as a whole, apart from me, were invited to participate in the Company's share option scheme, and all Directors elected to participate. These options were issued in amounts that would not create a conflict and jeopardize the independence of the two independent directors, for more details on the options issued to individual directors please consult the Director's Report below.

The Board met every month for the period and as both a group and as individuals, all board members have engaged proactively and impressively with the Company.

It is my opinion also that independent directors continue to maintain their independence.

Closing Remarks

Thank you to all of our shareholders both old and new for your ongoing support for Ananda. As a serial entrepreneur, I strongly believe that we are on the verge of something monumental and we could not be doing what we are doing without each and every name on the register. Thanks also to the entire Ananda team, your dedication, resolve and aspiration is what drives the wheels of Ananda.

Charles Morgan,

Chairman

About Ananda Pharma

Ananda Pharma (AQSE: ANA) is a UK-based biopharmaceutical company developing regulatory approved, cannabidiol medicines to treat complex, chronic conditions, including epilepsy (trials funded by NHS England and NIHR), endometriosis (funded by NHS Scotland) and chemotherapy pain (funded by NIHR).  The Company is led by successful entrepreneurs and is working with a team of world-class scientists, including globally respected Key Opinion Leaders at the University of Edinburgh, Great Ormond Street Hospital for Children and University College London.

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-Ends-

For the purposes of UK MAR, the Directors of the Company accept responsibility for the contents of this announcement.  

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