MXC.L Regulatory News (MXC)

MGC Pharmaceuticals Ltd.

Full US$750k Cash Deposit Received for

First USA Commercial Order of CimetrA™

22 November 2021

ASX, LSE: MXC

Key Highlights:

· MGC Pharma confirms receipt of the full US$750k cash deposit due under the terms of the 3-year US$24M US Supply and Distribution Agreement with AMC

· The US$750k cash deposit is for prepayment on the first commercial order placed under the Year 1 US$3m Purchase Order of CimetrA™, announced in October

· AMC is committed to fund the remaining Year 1 Purchase Order balance of US$2.25m by way of a cash payment, or secured trade credit facility acceptable to MGC Pharma, upon receipt of the first CimetrA™ product shipment

· The US$3m Purchase Order is the first-year minimum amount committed to by AMC under the 3-year US$24m US Supply and Distribution Agreement announced on 26th August 2021

· AMC has engaged Morgan Lewis & Bockius, a leading US pharmaceutical sector law firm, to seek FDA approval for CimetrA™

MGC Pharmaceuticals Ltd ('MGC Pharma' or 'the Company'), a European based bio-pharma company specialising in the production and development of phytomedicines, confirms the Company has now received the full US$750,000 cash deposit from AMC Holdings Inc. ('AMC'), per the terms of the USA Supply and Distribution Agreement with AMC, announced on 26th August 2021. AMC will provide MGC Pharma with a further US$2.25 million financing for the balance of the Year 1 US$3 million order in the form of a cash deposit, Letter of Credit or other secured funding facility acceptable to MGC Pharma, on delivery of the first CimetrA™ shipment to the US.

In addition, AMC is working towards submission of MGC Pharma products to the University of South Florida's Internal Review Board for approval, the first step towards the University joining the international clinical trials for CimetrA™.

MGC Pharma was the first company to announce its submission for Emergency Use Authorisation to the Indian Registration Authority for a COVID-19 Investigational Oral Medicine (CimetrA™) for the treatment of mild-to-moderate COVID-19 in at risk adults. Submission to other National regulatory and medical agencies are currently underway for similar Emergency Use Authorisation for CimetrA™.

MGC Pharma Managing Director and CEO, Roby Zomer commented: "The receipt of the full US$750,000 cash deposit from AMC Holdings is further validation of our future partnership to supply MGC Pharma products into the largest market in the world. The agreement also provides us with a clinical platform for further research and development of MGC Pharma's products that will enable US patients to have access to our products imminently.

This is an exciting partnership in the US, with a highly credentialed group, for MGC Pharma and its investors, as we look to take CimetrA™ through the regulatory approval processes in both the USA and India, two of the largest pharmaceutical markets in the world. We believe CimetrA™ has the ability to be a gamechanger for the treatment of COVID-19 globally, and look forward to providing CimetrA™ to patients, at an affordable price."

AMC's General Counsel, Brent Yessin, confirmed that AMC had retained Morgan Lewis & Bockius, a leading US law firm to seek FDA approval for CimetrA™, and commented that "Public and private healthcare providers want access to a natural product that proved effective in Israeli and international trials, so we have built a Product Approval Team around one of the best FDA attorneys in the US, Kathy Sanzo. We have also hired experienced DC based regulatory affairs firms to assist in this process. This week, Dr. Bill Massey, a well-known neuro-pharmacologist, formerly with AstraZeneca, who has taken numerous drugs through the FDA process has joined our AMC team Internally, and will work with MGC's CRO and Ms. Sanzo to help get CimetrA™ into the hands of US based doctors and patients as soon as possible."

--Ends--

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About MGC Pharma

MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based bio-pharma company developing and supplying affordable standardised phytomedicines 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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About AMC Holdings

AMC Holdings, Inc. (AMC) is a privately held, US based distribution and marketing company bringing cutting edge bio-pharmaceutical products currently in clinical trials or commercial production overseas, into the US healthcare marketplace. AMC arranges for leading US researchers, academic institutions, and physicians to join existing clinical trials abroad, and establish US based trials for promising bio-pharmaceutical products that meet three key criteria:

· Address disease management for pressing healthcare needs that have proven intractable and expensive employing existing treatments or protocols.

· Offer botanical or bio-pharmaceutical solutions where none exists, or as alternatives to existing medications with negative side effects affecting patients' quality of life; and

· Offer the prospect of expanding access to novel treatments with lower cost alternatives to existing drugs or protocols.

AMC operates in 9 regional divisions and is actively scheduling clinical trials for MGC products at major academic centres and teaching hospitals in Florida, Texas, the New York City area and around the US. 

AMC retained Essex Capital, a Tampa-based financial advisory firm which has arranged over $1.5 Billion of financing for 150+ small and middle market companies and this week announced several additions to its compensated Board of Advisors:

· Dr. Bill Massey, PhD, of B.W. Massey and Co, with decades of experience in academic medicine and FDA approvals

· Giovanni LiDestri, an early investor, and owner of LiDestri Foods, a premier private label and contract manufacturer of food, beverages and spirits, supplying over 40 million cases of product each year

· Freddie "Chick" Garcia, an early investor, and retired USAF Lt. Col. with extensive experience and expertise in high technology strategic development. Mr Garcia founded and led Quantum Technology Sciences and Cyber Transitions.

· Joe Scott, former CEO of Jersey City Medical Center outside NYC, and Broward General in South Florida