30 October 2024
ANANDA DEVELOPMENTS PLC
("Ananda" or the "Company")
Unaudited Interim Results for the six months ended 31 July 2024
The Directors present the consolidated interim results of Ananda Developments Plc, together with its subsidiaries (the "Group") for the period from 1 February 2024 to 31 July 2024.
UPDATE ON OPERATIONS
Ananda is dedicated to developing medicines to treat complex, chronic inflammatory pain conditions. With 28 million people in the
We believe in the transformative potential of cannabinoids, supported by a growing body of clinical and real-world evidence. Our commitment is to deliver:
· Robust clinical trial evidence through partnerships with world-leading researchers and key opinion leaders
· The highest quality cannabinoid medicines, manufactured to the strictest pharmaceutical standards
· Licensed cannabinoid medicines available initially on the NHS before looking to the global market
Our patent-pending MRX1 CBD formulation is being used in two fully funded Phase II randomised controlled trials into:
· chemotherapy induced nerve pain; and
· endometriosis
As announced earlier this month our patent-pending MRX2 and MRX2T CBD and CBD + tetrahydrocannabinol (THC) formulations have been selected as the active pharmaceutical ingredients in two funded Phase III randomised controlled trials into:
· refractory (drug-resistant) early onset epilepsies; and
· refractory genetic generalised epilepsies
In these trials, which are funded by NIHR and NHS England, researchers will study whether MRX2 & MRX2T are safe and effective in reducing the number and severity of seizures experienced by people with epilepsy, as well as their effects on learning, sleep, behaviour, quality of life, stress, and anxiety.
The two studies will be the world's first double blind randomised controlled trials to investigate the use of CBD and THC together for epilepsy, and the first to evaluate the medicines in children and adults who have a broad range of difficult-to-treat epilepsies. Previously, double blind randomised controlled trials investigated the use of CBD-only in three rare conditions associated with drug-resistant epilepsy (Dravet Syndrome, Lennox Gastaut Syndrome, and tuberous sclerosis complex).
Over 18 months, 500 patients will be recruited across the
Also announced after the end of the period, our patent-pending MRX1 CBD formulation is to undergo pharmacokinetic assessment in a Phase I study.
Also announced during the period, positive pre-clinical study results were received for our patent-pending MRX1 CBD formulation in the potential treatment of Heart Fibrosis with Preserved Ejection Fraction.
We continue to investigate trials in other conditions including Heart Fibrosis with Preserved Ejection Fraction, as we aim to build a comprehensive pre-clinical pipeline.
During the 6 months to 31 July 2024, the team focused on advancing the two Phase II clinical trials. This involved work to ensure a robust supply chain for the manufacture of the investigative medicines, writing the Investigator Brochure and Investigational Medicinal Product Dossier for the patent-pending MRX1 CBD formulation, obtaining quotes for the pharmacokinetic study, liaising with the clinical trial teams at the University of
We have also been assessing regulatory, market access and pricing strategies with support of independent specialist advisors. We are working to ensure the clinical trials programme is designed in a way that is most likely to lead to marketing authorisations and healthcare provider uptake, principally via the NHS in the
During the period we announced the formation of Ananda's Scientific Advisory Board. Chaired by Ananda's independent non-executive director Professor Clive Page, we are fortunate to have the added guidance of Professor Trevor Jones and Professor Cherry Wainright as we work towards our objective of delivering licenced CBD drugs to the NHS to treat complex chronic inflammatory pain conditions. Ananda held its first Scientific Advisory Board meeting at the Royal College of Surgeons in
By collaborating with respected researchers, like Professor Fallon, we believe we are well positioned to secure NHS availability for our patent-pending CBD based medicines.
Throughout the period, we maintained active communication with our shareholders, providing updates and engaging through our Hub. This hub facilitates access to Company news, market data, and allows us to respond directly to shareholder questions. Please sign up for the Investor Hub here.
Through our Investor Hub, we published several blogs/presentations that form part of a series on clinical and pre-clinical trials and clinical development. So far we have released:
· An Introduction to Cannabidiol (CBD)
· What Happens Before a Clinical Trial Starts?
· What is the Purpose of a Pharmacokinetic Study?
· Why Run a Phase 1 Study in
· What Happens During a Pharmacokinetic Study?
· Therapeutic Potential of CBD
We intend to publish more blogs and presentations in the coming months. These will cover the work that goes on before, during and after clinical trials as well as why we take certain steps in the development pathway. All will be available on our Hub, so please sign up!
Also during the period, we announced the encouraging results of a pre-clinical study we ran in partnership with Robert Gordon University. This trial investigated the use of MRX1, our patent pending CBD-based formulation, in mice with Heart Fibrosis with preserved Ejection Fraction ('HFpEF'). In summary:
· Administration of MRX1 has shown significant cardioprotective effects in a mouse study, demonstrating its potential as a treatment for patients with heart failure with preserved ejection fraction (HFpEF).
· The research involved detailed assessments of cardiac function, plasma CBD levels, and molecular markers of heart failure, fibrosis, and inflammation.
· MRX1 exhibited multiple traits which indicate an effectiveness in mitigating cardiac fibrosis and improving heart health.
· These data have been included in Ananda's International Patent Application for MRX1.
· The data was presented on 25 June 2024 for the first time at the 9th Federation of European Pharmacological Societies (EPHAR) conference in
· The successful outcomes suggest MRX1 could be a valuable therapeutic option for HFpEF and other cardiac conditions. Ananda is currently investigating next steps on how to bring this promising treatment to clinical use.
Earlier this year Ananda joined the Cannabinoid Research and Development Group, which is co-Chaired by Professor Trevor Jones and George Freeman MP. The group is executing a strategy to establish the
On the 15 July 2024, the Company published its annual report and audited accounts. The report contains a compelling case study for CBD on pages 7&8, which makes particularly worthwhile reading.
After the end of the reporting period we announced the completion of a capital raising. The fund raising of
In the period, the Group incurred a loss of
On behalf of the board,
Melissa Sturgess, Chief Executive Officer
30 October 2024
Directors Report
The directors present their consolidated interim financial statements of the Group for the period from 1 February 2023 to 31 July 2024.
Directors of the company
The directors who have served during the period and up to the date of approval were as follows:
Charles Morgan
Melissa Sturgess
John Treacy
Stuart Piccaver
Clive Page
Jeremy Sturgess-Smith
Results
The consolidated statement of comprehensive income is set out below and shows the loss for six-month period to 31 July 2024. The directors consider the loss for the period to be line with expectations. The directors do not recommend the payment of a dividend.
This report was approved by the Board and signed on its behalf.
Melissa Sturgess, Chief Executive Officer
30 October 2024
Consolidated Interim Statement of Comprehensive Income
|
|
|
|
Group 6 months to 31 July 2024
Unaudited |
Group Year ended 31 January 2024
Audited |
Group 6 months to 31 July 2023
Unaudited |
|
|
Note |
|
£ |
£ |
£ |
|
|
|
|
|
|
|
|
Revenue |
|
|
764 |
|
|
|
Administrative expenses |
|
|
(756,938) |
(1,729,317) |
(844,456) |
|
|
|
|
|
|
|
|
Impairment |
|
|
- |
(3,873,816) |
|
|
Depreciation |
|
|
(315,808) |
(1,190,155) |
(101,025) |
|
Interest payable |
|
|
(144,129) |
(138,806) |
(44,412) |
|
Interest receivable |
|
|
167 |
27 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(1,215,944) |
(6,932,067) |
(989,893) |
|
|
|
|
|
|
|
|
Taxation |
|
|
2,697 |
781,280 |
- |
|
|
|
|
|
|
|
|
Other Comprehensive Income |
1 |
|
|
|
|
|
R&D repayment |
|
|
- |
6,624 |
- |
|
Royalties |
|
|
(23) |
- |
- |
|
|
|
|
|
|
|
|
Total loss for the period |
|
|
(1,213,270) |
(6,144,163) |
(989,893) |
|
Earnings per share |
|
|
|
|
|
|
Basic and diluted earnings per share (pence) |
2 |
|
(0.04p) |
(0.23p) |
(0.08p) |
There was no other comprehensive income in the period.
The notes form part of these consolidated interim financial statements.
Consolidated Interim Statement of Financial Position
|
|
|
|
Group 6 months to 31 July 2024
Unaudited |
Group Year ended 31 January 2024
Audited |
Group 6 months to 31 July 2023
Unaudited |
|
|
|
|
£ |
£ |
£ |
|
Non-Current assets |
|
|
|
|
|
|
Tangible assets |
|
|
1,466,641 |
1,566,303 |
1,664,405 |
|
Intangible assets |
|
|
1,675,182 |
1,874,839 |
5,827,228 |
|
Investments in subsidiaries |
|
|
- |
- |
- |
|
|
|
|
3,141,823 |
3,441,142 |
7,491,633 |
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
|
48,017 |
84,431 |
11,519 |
|
Assets under construction |
|
|
- |
- |
47,080 |
|
Trade and other receivables |
|
|
69,724 |
77,380 |
221,783 |
|
|
|
|
117,741 |
161,811 |
280,382 |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Trade and other payables |
|
|
3,388,129 |
2,565,666 |
2,136,161 |
|
Convertible loan notes |
|
|
685,005 |
636,507 |
- |
|
|
|
|
4,073,134 |
3,202,173 |
2,136,161 |
|
Non-Current liabilities |
|
|
|
|
|
|
Convertible loan notes |
|
|
- |
- |
- |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
46,739 |
49,436 |
793,000 |
|
|
|
|
|
|
|
|
Total assets less liabilities |
|
|
(860,309) |
351,344 |
4,842,854 |
|
|
|
|
|
|
|
|
Capital and reserves |
|
|
|
|
|
|
Share capital |
|
|
5,756,057 |
5,756,057 |
5,756,057 |
|
Share premium |
|
|
5,328,996 |
5,328,996 |
5,328,996 |
|
Equity to be issued |
|
|
|
- |
100,000 |
|
Share option reserve |
|
|
50,015 |
48,398 |
51,357 |
|
Retained earnings |
|
|
(11,995,377) |
(10,782,107) |
(6,393,556) |
|
|
|
|
|
|
|
|
Total equity and liabilities |
|
|
(860,309) |
351,344 |
4,842,854 |
|
|
|
|
|
|
|
The consolidated interim financial statements were approved and authorised for issue by the Board and were signed on its behalf by:
Melissa Sturgess
Chief Executive Officer
[ [[30 October 2024
The notes form part of these consolidated interim financial statements.
Consolidated Interim Statement of Changes in Equity
|
GROUP |
Share Capital |
Share Premium |
Share Option Reserve |
Retained Earnings |
Total |
|
|
£ |
£ |
£ |
£ |
£ |
|
As at 1 February 2024 |
5,756,057 |
5,328,996 |
48,398 |
(10,782,107) |
351,344 |
|
|
|
|
|
|
|
|
Total comprehensive loss for the period |
- |
- |
- |
(1,213,270) |
(1,213,270) |
|
|
|
|
|
|
|
|
Share based payment |
- |
- |
1,617 |
- |
1,617 |
|
|
|
|
|
|
|
|
Balance at 31 July 2024 |
5,756,057 |
5,328,996 |
50,015 |
(11,995,377) |
(860,309) |
|
GROUP |
Share Capital |
Share Premium |
Share Option Reserve |
Retained Earnings |
Total |
|
|
£ |
£ |
£ |
£ |
£ |
|
As at 1 February 2023 |
2,341,110 |
3,468,944 |
32,499 |
(4,637,944) |
1,204,609 |
|
|
|
|
|
|
|
|
Total comprehensive loss for the year |
- |
- |
- |
(6,144,163) |
(6,144,163) |
|
|
|
|
|
|
|
|
Proceeds from share issue |
3,414,947 |
1,860,052 |
- |
- |
5,274,999 |
|
Issue of share options |
- |
- |
15,899 |
- |
15,899 |
|
|
|
|
|
|
|
|
Balance at 31 January 2024 |
5,756,057 |
5,328,996 |
48,398 |
(10,782,107) |
351,344 |
|
GROUP |
Share Capital |
Share Premium |
Share Option Reserve |
Retained Earnings |
Total |
|
|
£ |
£ |
£ |
£ |
£ |
|
As at 1 February 2023 |
2,341,110 |
3,468,944 |
32,499 |
(5,403,663) |
438,890 |
|
|
|
|
|
|
|
|
Total comprehensive loss for the period |
- |
- |
- |
(989,893) |
(989,893) |
|
|
|
|
|
|
|
|
Proceeds from share issue |
3,414,947 |
1,860,052 |
- |
- |
5,274,999 |
|
Issue of share options |
- |
- |
18,858 |
- |
18,858 |
|
Equity to be issued |
- |
- |
100,000 |
- |
100,000 |
|
|
|
|
|
|
|
|
Balance at 31 July 2023 |
5,756,057 |
5,328,996 |
151,357 |
(6,393,556) |
4,842,854 |
The following describes the nature and purpose of each reserve within owners' equity:
|
Reserve |
Description and purpose |
|
Share capital |
This represents the nominal value of shares issued. |
|
Share premium |
Amount subscribed for share capital in excess of nominal value. |
|
Retained earnings |
Cumulative net gains and losses recognised in the statement of comprehensive income. |
The notes form part of these consolidated interim financial statements.
ACCOUNTING POLICIES
General information
Ananda Developments Plc's consolidated interim financial statements are presented in British Pound Sterling (GBP) which is the functional currency of the parent company. These consolidated interim financial statements were approved for issue by the Board of Directors on 30 October 2024.
The financial information set out in these interim financial statements does not constitute statutory accounts as defined in Section 434 of the Companies Act 2006. The Company's statutory financial statements for the year ended 31 January 2024 have been filed with the Registrar of Companies. The auditor's report on those financial statements was unqualified and did not contain a statement under Section 498(2) of the Companies Act 2006.
These interim results have not been audited nor have they been reviewed by the Company's auditors under ISRE 2410 of the Auditing Practices Board.
Basis of preparation
These consolidated interim financial statements are for the six-month period ended 31 July 2024. They have been prepared following the recognition and measurement principles of FRS 102. They do not include all the information required for full annual financial statements and should be read in conjunction with the audited consolidated financial statements for the period ended 31 January 2024.
These unaudited consolidated interim financial statements have been prepared on a going concern basis which the Directors believe to be appropriate.
These unaudited consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the consolidated financial statements for the period ended 31 January 2024.
The principal accounting policies applied in the preparation of these Interim financial statements are the same as those applied in preparation of the group's annual financial statements.
1. Foreign currency transactions
Transactions in foreign currencies are translated to GBP at the exchange rates at the dates of the transactions. Monetary assets and liabilities denominated in foreign currencies at the reporting date are translated to GBP at the exchange rate on that date. Foreign exchange differences arising on translation are recognised in the statement of comprehensive income.
2. Earnings per share
The calculation of earnings per share is based on the loss attributable to ordinary shareholders divided by the average number of shares in issue during the period.
SUBSEQUENT EVENTS
Raise via subscription and placing
Successfully raised gross proceeds of
Highlights:
· Ananda successfully raised gross proceeds of
· In addition to the Fundraise, the Company offered additional shares to existing shareholders through a retail offering on the Winterflood Retail Access Platform
· Charles Morgan and Melissa Sturgess (CEO) also agreed to capitalise all unsecured debt owed to them, with additional share authorities being granted at a general meeting on 8 October 2024. The capitalisation of this debt significantly strengthened the Company's balance sheet
· Proceeds of this Fundraise and WRAP Retail Offer will be used to manufacture MRX1 for CIPN and Endometriosis Phase II studies, execute a pharmacokinetic study for MRX1 in
working capital
· The Company has also issued options to key management personnel
Ananda cannabinoid medicines to be used in NHS epilepsy trials
On 21 October 2024, Ananda announced that two of its patent pending cannabinoid medicines, MRX2 and MRX2T, will be used in two NIHR- & NHS-funded Phase IIIa epilepsy clinical trials involving up to 500 patients in total. The trials will be run by investigators at University College London and Great Ormond Street Hospital.
The objective of the trials is to test the safety and efficacy of Ananda's specific cannabidiol (CBD) and CBD plus THC formulations for two treatment-resistant epilepsy groups in children and adults. If the results are favourable, they will pave the way for a submission of these medicines to the MHRA and other regulatory bodies for regulatory approval.
The trials are being funded by a partnership between NHS England and National Institute for Health and Care Research (NIHR) and will be co-led by Professor Finbar O'Callaghan and Professor Helen Cross of University College London (UCL) and Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH).
Highlights:
· MRX formulations will be used as the investigational medicinal products (IMPs) in two NIHR/NHS funded Phase III randomised controlled trials (RCTs) investigating the treatment of complex epilepsies
· Trial 1: MRX2 (CBD), MRX2T (CBD + THC) versus placebo in patients with refractory (drug-resistant) early onset epilepsies.
· Trial 2: MRX2 (CBD), MRX2T (CBD + THC) versus placebo in patients of normal cognitive ability with refractory genetic generalised epilepsies.
· Existing evidence suggests cannabis-based medicinal products are promising treatments for difficult to treat epilepsies, with one CBD-only medicine already licenced to treat three rare conditions associated with drug-resistant epilepsy
· Should the trials deliver successful results, MRX intends to progress further regulatory and commercial development activities of these medicines via a licensing option that has been granted by UCL over any IP arising from these trials
In combination, the trials will involve up to 500 patients from across the
Graduation to APEX segment of the AQUIS Stock Exchange
On 5th August, trading in the Company's shares was moved to the senior Apex segment of the Aquis Stock Exchange ("AQSE") Growth Market.
The Apex segment is reserved for larger, more established businesses with a proven growth strategy and which meet higher standards of corporate governance.
Phase 1 Pharmacokinetic Study of MRX1
On 9th October 2024, the Company announced that Ananda's Australian subsidiary had signed a contract with Southern Star Research Pty Ltd('SSR'), a leading Australian Contract Research Organisation, to carry out a Phase 1 clinical trial investigating the pharmacokinetic ("PK") profile, tolerability and safety of the Company's lead investigative asset,MRX1.
Highlights:
· Contract signed for Phase 1PK study
· The clinical trial will investigate the PK profile, tolerability and safety of MRX1 in healthy
volunteers
· The data generated will inform future clinical trials in patients and form an integral part of
any future regulatory applications, including with the MHRA in the
in
· Collected data will form part of Ananda's MRX1 patent estate and wider intellectual property
portfolio
· Significant financial advantages of running the study in
Incentive of up to 43.5% of eligible research and development costs
Addition to Scientific Advisory Board
Lastly, Professor Marie Fallon has agreed to join the Company's Scientific Advisory Board ("SAB") to provide the Company with expert technical advice and guidance. The SAB is Chaired by Professor Clive Page, a non-executive director of Ananda Developments plc and it held its first meeting in
Prof. Fallon is also the lead investigator for Ananda's Phase II study investigating the pain-relieving effects of MRX1 in patients with Chemotherapy Induced Peripheral Neuropathy.
Professor Marie Fallon
Marie Fallon (MD FRCP(Glas) FRCP(E) MRCGP DCH DRCOG). Marie is a Professor of Palliative Medicine at the
University of
Centre. Marie has played a significant role in research, leading both national and international research studies around pain and cachexia in cancer patients. Marie has led the development of international palliative care guidelines such as ESMO for cancer pain and ASCO for cachexia.
Marie has been Joint Editor of four editions of the Oxford Textbook of Palliative Medicine which is the reference textbook in the specialty. Prof. Fallon has edited several other books and sits on numerous grant committees, as well as being an editorial board member of the BMJ Supportive and Palliative Care journal. Finally, of note, much of Marie's recent and current research relates to Low- and Middle-Income Countries (LMICs), where she is seeking to address the issue of poor opioid availability in LMICs.
-Ends-
To stay abreast of the latest developments at Ananda, we encourage you to follow our social media channels which are:
· Investor Hub: investors.anandadevelopments.com
· Instagram: https://instagram.com/anandadevelopments?igshid=YmMyMTA2M2Y=
· LinkedIn: https://www.linkedin.com/company/anadevelopments/
· Twitter: https://twitter.com/AnandaPlc
· Investor Meet Company: https://www.investormeetcompany.com/ananda-developments-plc/register-investor
-Ends-
The Directors of the Company accept responsibility for the contents of this announcement.
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ANANDA DEVELOPMENTS PLC |
+44 (0)7463 686 497 |
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ir@anandadevelopments.com |
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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 |
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Corporate Finance |
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Richard Morrison |
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Caroline Rowe |
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Corporate Broking |
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Abigail Wayne |
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Rob Rees
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Yellow Jersey PR (media enquiries) Sarah MacLeod Charles Goodwin Zara McKinlay |
+44 (0)20 3004 9512 ananda@yellowjerseypr.com |
About Ananda Developments
Ananda is an AQSE-listed life sciences company focused on the research and clinical development of CBD-based therapies for a range of complex inflammatory pain conditions.
For more information, please visit: https://anandadevelopments.com
https://investors.anandadevelopments.com/link/7PlxkP
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