MXC.L Regulatory News (MXC)

MGC Pharmaceuticals Ltd.

June 2021 Quarterly Activity Report

26 July 2021

ASX, LSE: MXC

Key Highlights:

· June quarter delivers record sales of ~$945,000 in revenue, comprising ~$665,000 of phytocannabinoid medicines

· Second Wholesale purchase order received from leading European nutraceuticals producer and distributor, Swiss PharmaCan AG, for ArtemiCTM equating to total of ~$1,000,000 in revenue upon full delivery of product, expected during the September quarter

· Acquisition of global pharmaceutical clinical research company, MediCaNL, to deliver MGC Pharma significant cost synergies and expedited clinical trial processes

· CannEpil® added to the Primary Care Reimbursement Service in the Republic of Ireland making it free of charge for Irish patients prescribed the treatment under its Medical Cannabis Access Program

· Construction work significantly advanced at the Company's Malta GMP facility with completion scheduled to occur in October 2021

· Recruitment of patients into the CimetrATM Phase III clinical trial commenced at Rambam Health Care Campus and Nazareth Hospital EMMS in Israel

· 21 patients enrolled at the University of Notre Dame in Perth, Western Australia for MGC Pharma's CogniCann® phase II clinical trial on patients with dementia and Alzheimer's disease

· Patent Application submitted to the Slovenian Intellectual Property Office for CimetrATM

MGC Pharmaceuticals Ltd (ASX, LSE: MXC, 'MGC Pharma' or 'the Company'), a European based bio-pharma company specialising in the production and development of phytocannabinoid-derived medicines is pleased to provide its Quarterly Activity Report for the three months ended 30th June 2021.

Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: "During the June quarter MGC Pharma delivered a number of landmark achievements which highlight the progress that the Company has continued to deliver since its listing on the London Stock Exchange in February of this year. During the June quarter the Company achieved a number of significant milestones including the Republic Ireland adding CannEpil® to their Primary Care Reimbursement Service, which makes CannEpil free of charge when dispensed under Ireland's Medical Cannabis Access Program. In addition to this, the Company commenced the enrolment process for patients into both its CimetrATM and CannEpil® clinical trials.

These achievements, in conjunction with the record sales delivered during this Quarter has strengthened the Company's global pharmaceutical footprint, and ensures that MGC Pharma remains on a strong operational and commercial growth trajectory going into the new financial year."

Acquisition of Medical Research Company

During the quarter MGC Pharma, through it acquisition of MediCanNL Inc., acquired MediCaNL Israel 2019 Ltd (MediCaNL), an Israeli company operating in, and providing specialist services to the pharmaceutical sector for the development of new medicines. MediCaNL offers clinical and preclinical trial services, as well as providing assistance with clinical trials, including supplying research data from past Phase I to IV studies.

MediCaNL has an existing client base and is working on 40 different projects and clinical trials.

Dr Nadya Lisodover, CEO of MediCaNL Inc., has been working with MGC Pharma for over two years and will now work full time for MGC Pharma as its dedicated Chief Research Officer.

The acquisition of MediCaNL will enable MGC Pharma to streamline the process of bringing medicines and products to market by increasing its clinical trial capacity and making clinical trial performance and design an insourced activity. The acquisition will also deliver significant and ongoing cost savings to the Company, with MGC Pharma undertaking a number of Phase I, Phase II and Phase III clinical trials on a variety of its products over the remainder of the 2021 and future years.

Operations and Sales

The June quarter delivered the strongest quarterly sales revenue for MGC Pharma to date. The graph below illustrates the strong growth throughout the financial year from the Company's pharmaceutical grade phytocannabinoid products (excludes non-phytocannabinoid products such as ArtemiCTM), with Australia accounting for the majority sales.

Please see Figure 1: 12 Month Cumulative Phytocannabinoid Product Sales, and Figure 2: Phytocannabinoid Sales by Product for the June Quarter here:

http://www.rns-pdf.londonstockexchange.com/rns/4144G_1-2021-7-26.pdf

Global Phytocannabinoid sales for the June Quarter totalled ~$665,000, a 34% increase on the March Quarter. In addition to the Phytocannabinoid sales noted, an additional ~$280,000 in sales revenue was recognised in the June quarter for ArtemiCTM Rescue. This related to the final batch delivery from the first $1M bulk order for ArtemiCTM Rescue received from Swiss PharmaCan AG announced the March quarter.

Please see Figure 3: Global Revenue by Quarter here:

http://www.rns-pdf.londonstockexchange.com/rns/4144G_1-2021-7-26.pdf

During early July, MGC Pharma implemented a couple of new strategic commercial initiatives which are aimed at enhancing sales growth in the Company's key Australian market.

The first of these, saw MGC Pharma enter into a Contract Sales Team Agreement (CSTA) with A. Menarini Australia Pty Ltd. (Menarini), the Australian arm of global pharmaceutical company, Menarini Group. Under the CSTA, Menarini will supply eight additional sales personnel to the Australian sales team. This team is supported by the Company's newly appointed Key Account Manager.

MGC Pharma has also recently launched globally, as part of its medical cannabis product portfolio, a new form factor, MGC THC 20 whole flower. The whole flower form factor is better suited to acute/breakthrough symptoms as compared to oral and sub mucosal spray form factors.

MGC Pharma expects to see strong revenue growth of its phytocannabinoid products in the coming months on the back of these commercial changes, particularly within the Australian market.

CannEpil® added to Primary Care Reimbursement Service in Ireland

During the June quarter MGC Pharma's proprietary cannabis derived epilepsy Investigational Medicinal Product (IMP) CannEpil® was added to the Republic of Ireland's Health Service Executive (HSE) following the incorporation of the Medical Cannabis Access Programme (MCAP) into the HSE's Service Plan.

CannEpil® is a phytocannabinoid derived IMP, approved for medical use and designed to treat Drug Resistant Epilepsy with a high CBD, low THC formulation, will be available free of charge to patients under the Long‐Term Illness Scheme, GMS (Medical Card) Scheme, and the Drugs Payment Scheme on a named patient basis.

Wholesale order of ArtemiC™ from Swiss PharmaCan

MGC Pharma received a second large wholesale order for its anti-inflammatory supplement, ArtemiCTM range of products, from Swiss PharmaCan AG (SPC) equating to approximately $1,000,000 in sales revenue during the quarter. This is the second wholesale purchase order received by the Company under its Master Supply and Distribution Agreement (Master Agreement) with SPC, with the initial order under the agreement, for ~A$425,000, received in February 2021.

ArtemiCTM Rescue are food grade supplements (nutraceutical, dietary supplement, natural health product) containing four natural based ingredients consisting of Artemisinin, Curcumin, Boswellia serrata, and Vitamin C, which is designed to target viral infections with inflammatory complications and was successfully evaluated on COVID-19 infected patients in a double-blind, placebo controlled, Phase II Clinical Trial in late 2020. This trial, on 50 COVID-19 infected patients, across 3 independent hospital sites in Israel and India (which included 33 patients in the treatment group and 17 in the placebo group) demonstrated that ArtemiCTM improved the health status of patients infected with COVID-19, with none of the patients in the treatment group requiring additional oxygen, mechanical ventilation or admission to intensive care, whereas 23.4% of placebo group required further assistance. (refer to MGC's ASX Announcement dated 15 December 2020 for further details)  

Under the terms of the three-year Master Agreement, SPC is required to order a minimum of 40,000 wholesale units of ArtemiCTM per quarter, which has been fulfilled for the June quarter.

The Company completed the delivery of the initial circa $425,000 (~ €275,000) order of ArtemiCTM to SPC in June 2021, and anticipates delivering the balance of the second~$1,000,000 bulk order during the September 2021 quarter.

ArtemiC™ was submitted to Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) on March 11, 2021. The application, which is currently under review by Health Canada, included ArtemiC™ supporting COVID-19 Phase II clinical trial results. Under Canadian regulations, all Non-prescription Health Products (NHP) must obtain premarket approval from Health Canada to assure they are safe, effective and of high quality before being allowed to be sold in Canada. Once Health Canada makes this assessment, the NHP is licensed and issued a National Product Number.

Construction of production and manufacturing plant in Malta

Construction of MGC Pharma's state-of-the-art production and manufacturing facility in Malta is now significantly advanced and is on track for completion in October of 2021. The foundations, walls, cleanroom, HVAC and mezzanine level have all been successfully installed.

Work now to be completed on the facility prior to its commissioning includes installation of electrical systems and generator, connection to municipality electrical and water infrastructure, validation of facility infrastructure and HVAC, and delivery and installation of machinery and equipment. With the relevant health, safety and regulatory approvals expected to be granted soon afterwards.

Research and Development

CimetrATM - Phase III controlled clinical study

MGC Pharma's Phase III Clinical Trial to evaluate the efficacy and safety of CimetrATM as a treatment for hospitalised patients diagnosed with moderate forms of COVID-19 received approval from the Israeli Ministry of Health during the quarter and will shortly commence at Rambam Health Care Campus and Nazareth Hospital EMMS.

The trial will enrol a total of 252 patients and will be conducted over a 28-day period. The process to enrol patients into the trial commenced in late June 2021, with the first patient enrolled in early July.

The Company intends to expand the CimetrATM Phase III trial to other strategic global jurisdictions, and as such has applied for eight additional clinical sites in Brazil.

During the June quarter MGC Pharma released further results from its Phase II clinical and preclinical studies on ArtemiCTM which support ArtemiCTM being effective for addressing cytokine over production in all tested COVID patients.

The Preclinical Trial "Evaluation the Efficacy of ArtemicTM Treatment in ARDS Model in Mice" was performed in the SIA preclinical Lab (GLP certified) in Israel.

The ARDC model is the recommended preclinical animal model for cytokine storm, for the prediction of the human model of COVID-19 patients. The level of the pro-inflammatory markers was measured in blood and BALF (bronchoalveolar lavage fluid) of the mice going through the cytokine storm. The results demonstrated decreased blood and BALF cytokine levels in the study arm treated by ArtemicTM (Refer to the Company's ASX Announcement dated 7 May 2021 "Further findings on ArtemiCTM Rescue as anti-inflammatory agent for COVID-19 and post COVID-19 syndrome").

These findings support the understanding of the mechanism of action of ArtemiCTM and additional potential application of the Study Product.

CannEpil® - Phase IIb randomised, double blind, placebo controlled clinical study

On May 26 2021, MGC Pharma announced the receipt of Ethics Committee approval for its Phase IIB Clinical Trial for CannEpil®. CannEpil® is a phytocannabinoid derived IMP, designed to treat Drug Resistant Epilepsy with a high CBD, low THC formula. The Phase IIb clinical trial for CannEpil® will take place at the Schneider Children's Medical Hospital in Israel and will focus on the safety and efficacy of CannEpil® as an add-on treatment for children and adolescents with treatment resistant epilepsy, also known as refractory epilepsy. The Phase IIb trial is targeting the recruitment of more than 100 patients.

The Study Drug import process has commenced following Israeli Ministry of Health approval. The Clinical Trial will be initiated in July and the first patient is expected to be enrolled in Q3 of this year.

MGC has already initiated a Driving Safety study of CannEpil® in Australia following the reopening of universities after the COVID-19 lockdowns. This trial involves healthy volunteers and aims to demonstrate the safety of CannEpil® in order to provide supportive data to the regulatory authorities.

CogniCann® - Phase II clinical trial

CogniCann® is a formulation of phytocannabinoids that has been developed with the specific aim of treating the symptoms of both of these diseases. CogniCann® is currently undergoing a Phase II clinical trial at the University of Notre Dame in Perth, Western Australia which has 21 patients currently enrolled and is designed to evaluate the potential behavioural benefits of CogniCann® on patients with dementia and Alzheimer's disease. The randomised double blind, crossover, placebo-controlled Clinical Trial will enrol 50 patients over its duration and is expected to last until Q4 2021.

CannEpil® - Driving performance study in Australia suspended due to ongoing COVID lockdowns

Recently MGC Pharma was advised by the Swinburne University of Technology in Melbourne that a collaborative study being undertaken with the MGC, to assess the effect of CannEpil® on driving performance, had been paused due to restrictions put in place by the Victorian State Government to deal with a further recent outbreak of COVID-19. The Company has been advised that the study will recommence once the easing of restrictions allows for it.

Financial and Corporate

CimetrATM Patent Application submitted

Durin the quarter the Company submitted a Patent Application for CimetrATM with the Slovenian Intellectual Property Office (SIPO).

The Patent Application was accepted by SIPO on 30 June 2021 (file number: P-202100096) which is the priority date for the Patent, giving the Company priority to file subsequent patent applications for CimetrATM in other jurisdictions and to other IP Agencies, as such, MGC Pharma anticipates the Patent being granted within the next 12 months.

Research and Development Grant

MGC Pharma successfully applied for a research and development grant from the Australian Taxation Office in relation to Australian research and development activities undertaken during the 2020 financial year. During the quarter, MGC Pharma successfully received a cash grant of $507,252 in relation to those activities.

Conversion of Options

During the quarter, the Company received $117,498 in relation to the exercise of unlisted and listed options at various prices.

Appointment of Company Secretary

Mr David Lim CPA AGIA was appointed as joint Company Secretary of the Company. Mr Lim is a finance and corporate governance professional with over 15 years of experience working for ASX Listed companies. He has previously performed the role of Group CFO and Company Secretary at a number of ASX listed businesses.

Appendix 4C

The Company had ~$5.5m cash at bank at the end of the June 2021 quarter, with access to an additional $9.25m undrawn from its $15m financing facility with Mercer Street Opportunity Fund LLC (Mercer Facility). The Company has no plans to draw down on the Mercer Facility following its successful LSE listing and capital raising in February 2021. The Company also received $117k during the quarter via the conversion of options, and $541k in government grants.

In accordance with Section 6 of the attached Appendix 4C, the Company confirms that during the quarter payments to related parties totalling $380k relates to Executive Director fees and payments, Non-Executive Director fees and corporate costs. As detailed in the accompanying Appendix 4C, expenditure for the Quarter includes $1.3m for research and development, $1.7m for manufacturing and operating costs (including inventory), $215k for advertising and marketing, $653k staffing costs and $1.3m for administration and corporate costs (including Director fees).

--Ends--

Authorised for release by the Board, for further information please contact:

About MGC Pharma

MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based bio-pharma company developing and supplying affordable standardised phytocannabinoid derived medicines to patients globally. The Company's founders were key figures in the global medical cannabis industry and the core business strategy is to develop and supply high quality phytocannabinoid derived medicines for the growing demand in the medical markets in Europe, North America and Australasia. MGC Pharma has a robust product offering targeting two widespread medical conditions - epilepsy and dementia - and has further products in the development pipeline.

Employing its 'Nature to Medicine' strategy, MGC Pharma has partnered with renowned institutions and academia to optimise cultivation and the development of targeted phytocannabinoid derived medicines products prior to production in the Company's EU-GMP Certified manufacturing facility.

MGC Pharma has a number of research collaborations with world renowned academic institutions, and including recent research highlighting the positive impact of using specific phytocannabinoid formulations developed by MGC Pharma in the treatment of glioblastoma, the most aggressive and so far therapeutically resistant primary brain tumour.

MGC Pharma has a growing patient base in Australia, the UK, Brazil and Ireland and has a global distribution footprint via an extensive network of commercial partners meaning that it is poised to supply the global market.

Follow us through our social media channels:

Twitter: @MGC_Pharma

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LinkedIn: MGC Pharmaceuticals Ltd.

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Appendix 4C

Quarterly cash flow report for entities

subject to Listing Rule 4.7B

Compliance statement

1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.

2 This statement gives a true and fair view of the matters disclosed.

26 July 2021

Date: ...................................................................................

[lodge electronically without signature]

Authorised by: ...................................................................................

Roby Zomer - Managing Director

Notes

1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity's activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so.

2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.

3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity.

4. If this report has been authorised for release to the market by your board of directors, you can insert here: "By the board". If it has been authorised for release to the market by a committee of your board of directors, you can insert here: "By the [name of board committee - eg Audit and Risk Committee]". If it has been authorised for release to the market by a disclosure committee, you can insert here: "By the Disclosure Committee".

5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council's Corporate Governance Principles and Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively.