MGC Pharmaceuticals Ltd (LON:MXC), a European based pharmaceutical company specialising in the production and development of plant derived medicines, has provided its Quarterly Activity Report for the three months ending 30th June 2023.
Key Highlights:
· CannEpil®, MGC Pharma’s Investigational Medicinal Product (“IMP”) is now available in the United Kingdom by Named Patient Request to be prescribed by doctors on The General Medical Council (“GMC”) specialist register across the UK.
· The first UK patient has received CannEpil® through the ‘I AM Billy Foundation’, supporting the RESCAS study.
· MGC’s Maltese fully automated, large scale pharmaceutical production facility has now been granted EU-Good Manufacturing Practice (GMP) certification.
· MGC Pharma has received permission from the Slovenian Ministry of Health to undergo research with Psilocybin.
· UK led fundraising closed on 13 April 2023, raising a total of £1,204,525 (A$2,204,281) (before expenses).
Roby Zomer, Managing Director and CEO of MGC Pharma, commented: “We are delighted to report on a very productive June quarter for the business. Cannepil is now available in the UK and can be prescribed by doctors on the GMC and it has been received by the first UK patient through the ‘I AM Billy Foundation’. The Company has also received permission from the Slovenian Ministry of Health to undergo research with Psilocybin which reinforces our commitment to growth and innovation as we look to expand our presence in the growing industry of Psychedelics.”
Key Company Activities
CannEpil® Approved to Specialist Register for GMC Prescription in the UK
CannEpil®, MGC Pharma’s Investigational Medicinal Product (“IMP”) is now available in the United Kingdom by Named Patient Request to be prescribed by doctors on The General Medical Council (“GMC”) specialist register across the UK. The products will be supplied in order to meet the needs of individual patients where an unmet medical need exists. The availability via Named Patient Request follows the announcement that MGC Pharma is providing CannEpil® to an observational trial supported by the ‘I am Billy Foundation’.
As announced on 31 May 2023 CannEpil®, MGC Pharma’s Investigational Medicinal Product (“IMP”) has now been successfully imported and received by its first patients in the United Kingdom. The first UK patient has received CannEpil® through the ‘I AM Billy Foundation’, supporting the RESCAS study. Additionally, the Company has delivered CannEpil® to its first patient in the UK via the Named Patient Request programme.
CannEpil® is in the process of a clinical development programme for patients suffering from refractory (or drug-resistant) epilepsy.
Malta Production Facility- EU GMP Approval Granted
MGC’s Maltese fully automated, large scale pharmaceutical production facility has now been granted EU-Good Manufacturing Practice (GMP) certification.
A formal grant of GMP accreditation, an internationally recognised standard, guarantees high quality, standardised production protocols and further enables quality control of MGC proprietary products within key markets globally. The facility was built with the support of an 80% EU cash funded grant from Malta Enterprises, with the facility commissioned during 2022.
The facility will be able to produce all MGC medicines and supplements and will be able to provide third party production services for other pharmaceutical companies – adding a new potential revenue stream for MGC Pharma. MGC’s in house production capacity in Malta is now over 20,000 units a day of finished dose forms, which can support all future needs of CannEpil® and CimetrA™ once marketing authorisation is obtained in the USA and Europe.
Slovenian Ministry of Health approval for research with Psilocybin
MGC Pharma has received permission from the Slovenian Ministry of Health to undergo scientific research development on the psychedelic compound Psilocybin. The permission granted covers the development of analytical methods, research of physical-chemical properties of Psilocybin and development of pharmaceutical forms that would be suitable for administration.
MGC Pharma is one of the first companies to obtain permission to undertake pharmaceutical research on Psilocybin and the first in Slovenia. The company plans to work with other pharmaceutical businesses to collaborate and provide research capabilities for understanding the properties of Psilocybin. This approval will allow MGC to take the Psychedelic industry one step closer to the pharmaceutical industry by helping to develop and research new medicines based on Psilocybin, and for MGC to provide such services to the growing industry of Psychedelics.
June Quarter Sales Update
June Quarter Sales Update MGC Pharma revenue in the June quarter were in line with the quarterly average sales.
Funding and Cash Flow Reporting
As announced on 11 April 2023, the Company successfully raised £1.2 million (A$2.7m) (before expenses) by way of a conditional placing of 476,132,620 new ordinary shares of no-par value in the capital of the Company at a price of 0.44 pence (0.8 cents) per Placing Share, and 238,066,311 Fundraise Options. The Placing was supported by a mix of new and existing institutional and high net worth shareholder in both the UK and Australia, including Premier Miton and Cantheon Capital, in addition to the supplementary Broker Option raise.
At the end of the June, the Company has ~A$259k of cash on hand, and ~A$7.7m (US$5.2m) of funding capacity available under the Mercer US$10m Convertible Securities facility.
Accompanying this Activity Report is a Cash Flow Report for the Quarter ending 30 June 2023.
In accordance with ASX Listing Rule 4.7C.3 the Company advises that during the June 2023 quarter, payments to related parties totalled A$196k, which consisted of fees paid to executive and non-executive directors of the Company.
As detailed in the accompanying Appendix 4C (Quarterly Cashflow Report), cashflows during the quarter included A$404k cash outflows associated with inventory production, A$921k for administration costs (including product registration costs), and cash inflows of A$3.4m including funding received from the Placement conducted in April.
Activities Post Quarter End
Post quarter end, the Company conditionally raised £0.65 million (A$1.24 million) (before expenses) by way of a placing (Placing) and subscription (Subscription) of 541,666,667 new ordinary shares of no-par value (Ordinary Shares) in the capital of the Company (Fundraising Shares) at a price of 0.12 pence (0.23 cents) per Fundraising Share (“Issue Price”). The Company also agreed to issue one free attaching option exercisable at 0.12 pence (0.23 cents) with an expiry date of 14 July 2026 for every one Fundraising Share subscribed for under the Placement and Subscription.
Additionally, the Company has raised £50,000 (A$95,000) from Roby Zomer, CEO and Managing Director of the Company, pursuant to a convertible loan agreement (CLA). The CLA allows Mr Zomer to provide an investment without requiring advanced shareholder approval, which would otherwise be required for a direct subscription. Additionally, certain members of the Company’s management team are subscribing for Ordinary Shares directly with the Company pursuant to subscription letters.
Corporate and Commercial News
Appointment of Joint Broker
As stated on 30 May 2023, Oberon Capital has been appointed as a joint broker in the UK with immediate effect alongside Peterhouse Capital.
Appointment of Public and Investor Relations Advisor
IFC Advisory has been appointed as the Company’s new UK-based Public and Investor Relations advisers. The IFC team have in-depth experience in the pharmaceutical sector and will support MGC in its stated forward trajectory.
Personnel changes
On 1 June 2023 Mr Brett Mitchell and Mr Nativ Segev, stepped down from the Board, reflecting the changing direction of the Company as MGC Pharmaceuticals moves away from the medicinal cannabis sector toward a more pharma-focused business strategy.
Dr Stephen Parker, currently Non-Executive Director of the Company, has replaced Mr Mitchell as interim Non-Executive Chair. The Company will appoint a new Australian non-executive director ensuring compliance with section 201A(2) of the Corporations Act and the ASX Listing Rules.
MGC Pharmaceuticals has also appointed Mr. Layton Mills as a Non-Executive Director of the Company. Mr. Mills is an experienced life-sciences executive, having worked in the biotechnology and life sciences industries for over 15 years, developing significant experience across human and animal health in pharmaceutical and consumer healthcare.
Change of Australian Registered Office and Principal Place of Business
The Company’s Australian registered office and principal place of business have changed to the following:
| Registered Office: Suite 1, 295 Rokeby Road Subiaco WA 6008 | Postal Address: Suite 1, 295 Rokeby Road Subiaco WA 6008 | Telephone: +61 8 6555 2950 | Fax: +61 8 6166 0261 |
