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.
23 June 202 5
ANANDA PHARMA PLC
("Ananda" or the "Company")
Key Milestone on Path to Delivery of MRX1 to Clinical Trials
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 forty litres of its lead investigational product, MRX1, and forty litres of a matched placebo have been manufactured in compliance with pharmaceutical Good Manufacturing Practices ('GMP').
To view the supporting video and ask questions please go to our Hub: https://investors.anandapharma.co.uk/link/qy1RDe
The manufacture of these clinical-grade batches marks a significant milestone in Ananda's pharmaceutical development programme. The 40-litre scale represents the largest volume of MRX1 and placebo produced by Ananda to date and is the first to receive GMP validation, a requirement for use in human clinical trials.
The MRX1 formulation is Ananda's lead investigational medicinal product ('IMP') and will be used in the Company's planned Phase 2 randomised controlled trials for chemotherapy induced peripheral neuropathy and endometriosis-associated pain. The matched placebo is a critical component of the double-blind design of both the Phase 2 trials. A portion of the MRX1 batch will also be used in the Phase 1 trial the Company is running in Australia.
The manufacture was conducted at the certified GMP facility of Ananda's Contract Development and Manufacturing Organisation, and the bottling process has been completed in full compliance with the required regulatory standards. The material will now be held under controlled storage conditions until release to the clinical trial sites. The Company will keep shareholders informed on the progress of IMP logistics and delivery, and will notify the market via RNS when IMP is received at a clinical trial site - whether in Scotland or Australia.
Ananda's CEO, Melissa Sturgess commented : "The regulatory pathway is central to our strategy. Our goal is to secure approval for MRX1 as a CBD formulation from the FDA, EMA, and MHRA. Achieving this requires meticulous and high-precision work to ensure that we develop a CBD-based medicine accessible to all who need it, not just those who can afford it. Every regulatory milestone we meet enhances the product's value - and this represents a particularly significant milestone.".
MRX1 IMP versus 'medical cannabis oil'
Manufacturing MRX1 as an IMP requires a far stricter regulatory oversight than manufacturing unlicenced specials (the category under which most cannabis-based medicines are prescribed). In the UK, IMPs require release by a Qualified Person (QP) which is a legal role ensuring each batch meets GMP and clinical trial standards under Annex 13 of the EU Guidelines to Good Manufacturing Practice and Regulation (EU) 536/2014. Specials, by contrast, do not require QP sign-off and follow lighter, less resource-intensive GMP suited to one-off or patient-specific manufacture.
Specials are intended solely for clinical use in individual patients where no licensed alternative exists, not for research purposes and cannot be used in a clinical trial to assess efficacy as part of a regulatory approved drug development programme.
About Ananda Pharma
Ananda Pharma (AQSE: ANA, OTCQB: ANANF) 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.
To stay up to date with the latest developments at Ananda, we encourage you to follow our social media channels which are:
· Investor Hub: https://investors.anandapharma.co.uk/s/ea8f93
· Instagram: https://www.instagram.com/anandapharmaplc/
· LinkedIn : https://www.linkedin.com/company/anandapharma
· X : https://twitter.com/AnandaPlc
-Ends-
For the purposes of UK MAR, the Directors of the Company accept responsibility for the contents of this announcement.
| ANANDA PHARMA PLC |
+44 (0)7463 686 497 |
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| Chief Executive Officer |
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| Melissa Sturgess |
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| Finance Director |
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| Jeremy Sturgess-Smith |
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| SP ANGEL CORPORATE FINANCE LLP |
+44 (0)20 3470 0470 |
| Corporate Finance Richard Morrison Josh Ray |
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| Corporate Broking Abigail Wayne Rob Rees
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| VIRIDIAN CAPITAL ADVISORS Scott Greiper
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+1 646 330 0704 sgreiper@viridianca.com |
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YELLOW JERSEY PR (media enquiries) Sarah MacLeod Charles Goodwin Zara McKinlay |
+44 (0)20 3004 9512 ananda@yellowjerseypr.com |
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