Ananda Pharma PLC - MRX1 Delivered to Clinical Trial Site

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.

 1 July 2025

ANANDA PHARMA PLC 

("Ananda" or the "Company") 

MRX1 Delivered to Clinical Trial Site

Ananda Pharma plc (AQSE: ANA, OTCQB: ANANF), a UK-based biopharmaceutical company developing regulatory approved cannabinoid medicines to treat complex, chronic conditions, is pleased to announce that the MRX1 investigational product manufactured from its first Good Manufacturing Practice (GMP) batch of MRX1 has been successfully delivered to the clinical trial site in Australia. This shipment supports the initiation of Ananda's Phase 1 pharmacokinetic (PK) study of MRX1. Participant screening is now underway at the clinical trial site in preparation for first participant first dose.

To view the supporting video and ask questions please go to our Hub: https://investors.anandapharma.co.uk/link/MP7Z0r

This milestone marks the first delivery of GMP-certified MRX1 to a trial site and is a critical step in Ananda's clinical development programme. The Phase 1 study will evaluate the PK, safety, tolerability and food effect of MRX1 in healthy adult volunteers. The next step for this trial is first participant first dose, which is expected to take place in July. The Company will provide further updates when first participant first dose has been confirmed.

The MRX1 investigational drug has been manufactured to GMP standards and released for use in the clinical trial. The successful delivery to the trial site in Australia confirms that the Company's supply chain is operational and in place to also support the Company's two Phase 2 trials being run in partnership with the University of Edinburgh.

Ananda's CEO, Melissa Sturgess commented: "We have now successfully moved our investigational medicinal product MRX1 seamlessly across country borders, with no delays.  A great effort all round. Next step is to start dosing trial participants."

Study Design and Methodology

The study has been designed to assess the PK, safety, tolerability and food effect of MRX1 in 20 healthy adult volunteers. Due to known sex differences in CBD metabolism, the study will comprise 10 biological males and 10 biological females.

The study will include standard safety parameters and plasma pharmacokinetic parameters of CBD and its metabolites. Characterising the effect of a high fat, high calorie meal has also been included as a secondary objective, due to the known food effect on the pharmacokinetics of CBD.

The Phase 1 study is sponsored by the Company's wholly owned Australian subsidiary, Tiamat Australia Pty Ltd and eligible expenditure on this project in Australia is eligible for an R&D tax rebate of up to 43.5%.

About Ananda Pharma

Ananda Pharma (AQSE: ANA) is a UK-based biopharmaceutical company developing regulatory approved, cannabinoid 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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For the purposes of UK MAR, the Directors of the Company accept responsibility for the contents of this announcement.