Ananda Pharma PLC - First Participant Dosed in MRX1 CBD Phase 1 Study

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.

 15 July 2025

ANANDA PHARMA PLC 

("Ananda" or the "Company") 

First Participant Dosed in MRX1 CBD Phase 1 Pharmacokinetic Study

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 first subject has been dosed in its Phase 1 pharmacokinetic (PK) study of its lead cannabidiol (CBD) drug candidate, MRX1 at the clinical site in Melbourne, Australia.

MRX1 is already advancing into Phase 2 clinical trials in endometriosis and chemotherapy-induced peripheral neuropathy (CIPN). The new PK study is designed to characterise systemic exposure and support future dose optimisation across indications. Importantly, the PK study will run independently of the ongoing Phase 2 trials and will not affect their timelines or execution.

To view the supporting video and ask questions please go to our Hub: https://investors.anandapharma.co.uk/link/WrAj7P

The start of the Phase 1 study marks a major milestone in the clinical development of MRX1. While there is a large amount of data available to support the safety and tolerability of CBD in humans, this first-in-human study will deliver critical data for future clinical development and regulatory submissions to the FDA, EMA and MHRA.

The Phase 1 study is an open-label, multiple dose study designed to assess the PK, safety, tolerability and food effect of MRX1 in healthy adult volunteers. Initial results are anticipated in Q1 2026.

The dosing of the first participant follows the recent delivery of GMP-manufactured MRX1 to the Australian trial site. The study is now continuing in accordance with the study protocol and site schedule.

Ananda's CEO, Melissa Sturgess commented: "We are delighted to have dosed the first participant in our Phase 1 trial using MRX1. This study is a strategic addition to the MRX1 program and sees us move from formulation development into full clinical execution. Importantly, it brings us one step closer to delivering a placebo controlled clinical trial tested, regulatory approved CBD medicine for women suffering from endometriosis and people struggling with chemotherapy induced peripheral neuropathy to market."

Study Design and Methodology

The primary objective of the study is to assess the pharmacokinetic profile of MRX1 at two doses when administered twice daily in healthy adults. The secondary objectives are to assess the safety and tolerability of MRX1 and to characterise the effect  on the pharmacokinetic profile of a single dose of MRX1 when taken with food vs without.

A total of 20 healthy volunteers (10 male and 10 female) have been sequentially enrolled into 2 treatment groups, with 5 males and 5 females in each group.

The duration of the study is up to 52 days per participant for Group A and 37 days per participant for Group B, including screening and follow up. Last participant last dose is expected to be completed within three months.

The Phase 1 study is being sponsored by the Company's wholly owned Australian subsidiary, Tiamat Australia Pty Ltd.

About Ananda Pharma

Ananda Pharma (AQSE: ANA) is a UK-based biopharmaceutical company developing regulatory approved, cannabinoid medicines to treat complex, chronic conditions, including endometriosis (funded by NHS Scotland), chemotherapy pain (funded by NIHR) and epilepsy (trials funded by NHS England and 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.