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.
27 November 2025
ANANDA PHARMA PLC
("Ananda" or the "Company")
Initial Data from Phase 1 Study
Ananda Pharma plc (AQSE: ANA, OTCQB: ANANF), a UK-based biopharmaceutical company developing regulatory approved, cannabidiol medicines to treat complex, chronic conditions with a focus on endometriosis and chemotherapy induced peripheral neuropathy, is pleased to announce that its first in-human clinical trial has shown that its MRX1 investigational product demonstrates a favourable safety profile.
In the population of healthy volunteers dosed in the study, MRX1 appeared to have a favourable adverse event profile following twice daily dosing for 6 days at dosing levels of 2.5 mg/kg and 7.5 mg/kg per dose under fasted conditions, and following a single dose at 2.5 mg/kg under fed conditions. All reported treatment-emergent adverse events (TEAEs) were mild in severity (Grade 1), with no moderate or severe TEAEs reported. No serious adverse events were reported, and there were no further adverse events leading to discontinuation of treatment or the study.
Ananda expects to receive the full final clinical study report in Q2 2026, which will contain the final reporting of adverse events as well as pharmacokinetic results. The Company does not expect any major changes from these preliminary safety results.
Ananda's CEO, Melissa Sturgess commented: "Ananda is now a clinical stage biotech with its lead drug candidate MRX1 demonstrating a favourable safety profile. The team is delighted with this result and looks forward to keeping shareholders updated with the full Phase 1 study readout which remains on track for delivery in Quarter 2, 2026."
The Phase 1 study was designed to assess the pharmacokinetics, safety and tolerability of multiple doses of MRX1 in healthy adult volunteers. Two dose levels were tested, 2.5 and 7.5 mg/kg of body weight. The effect of food was also assessed for lower dose level (2.5 mg/kg). A total of 20 participants received at least one dose of MRX1, with 10 participants receiving 2.5 mg/kg twice daily and 10 participants receiving 7.5 mg/kg twice daily. After a 14-day wash-out period, 9 of the 10 participants who had previously been dosed with MRX1 2.5 mg/kg in Period 1 received a single dose of MRX1 2.5 mg/kg under fed conditions in Period 2 (i.e., consumed a standardised high-fat, high-calorie meal within 30 minutes before dosing).
The Company announced on 24 November 2025 that it would be seeking approval from its shareholders to delist from the Aquis exchange. If shareholders approve the delisting at the general meeting to be held on 12 December 2025, then the delisting will be effective at 8.00 a.m. on 22 December 2025.
About Ananda Pharma
Ananda Pharma (AQSE: ANA) is a UK-based biopharmaceutical company developing regulatory approved, cannabidiol medicines to treat complex, chronic conditions, including 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.
For more information, please visit our website:
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· 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
· Investor Meet Company: https://www.investormeetcompany.com/ananda-pharma-plc/register-investor
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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 |
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| Corporate Finance |
+44 (0)20 3470 0470 |
| Richard Morrison |
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| Josh Ray |
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| Corporate Broking |
+44 (0)20 3470 0534 |
| Vadim Alexandre |
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| Abigail Wayne |
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| Rob Rees
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https://investors.anandapharma.co.uk/link/epJb6P