Argent Biopharma Ltd (MGCLF)

[Love3]

2 April 2019 ASX Code: MXC
MXC’s 2019 Pharma Product Commercialisation Strategy
Delivering Strong Pipeline of GMP Medicinal Cannabis Products
MGC Pharmaceuticals Ltd (ASX: MXC) (OTC: MGCLF) (“MGC Pharma” or “the Company”), a pure bio-pharma company focused on developing and commercialising a portfolio of cost-effective phytocannabinoid based medicines, is pleased to provide a positive update on its pharmaceutical operations and seed-to-pharmacy business plan.
• Established commercialisation strategy of focusing exclusively on two core divisions, Seed- to-Pharmacy Manufacturing and Research & Development, with the objective of becoming a leading supplier of cannabinoid based pharmaceutical products for medical markets in Europe, UK, and Australasia
• R&D division to deliver the production of cost-effective and affordable medicines in collaboration with leading internationally renowned research institutions and ensuring that MGC Pharma remains at the forefront of the sector
• Seed-to-pharmacy manufacturing focused on bringing affordable phytocannabinoid-based medicines to the global markets via cannabis cultivation, extraction, isolation and compounding through to a finished medicinal product
• Strong existing pipeline of phytocannabinoid based medicines targeting conditions such as epilepsy, Alzheimer’s, cancer and irritable bowel disease that all at present have no effective treatment. Products are poised for release into the European and Australian markets upon completion of testing and clinical trials, currently underway
• 2019 priority already commenced with patient recruitment into the CogniCannTM clinical trial and the progression and expansion of all RMIT projects following recent approval from the Office of Drug Control in Australia
Roby Zomer, Co-founder and Managing Director, MGC Pharmaceuticals commented
“MGC Pharma has delivered a very productive first quarter with key operational milestones being achieved for the commercialisation of its bio-pharma business. The recent sale of MGC Derma to CannaGlobal has enabled us to position ourselves as a pure pharmaceutical company as we direct our research and focus into our two core divisions.
“Receiving the necessary approvals from the Office of Drug Control in Australia to possess and handle phytocannabinoids for research purposes is integral to the work being undertaken by our R&D division as they continue the rapid development of treatments focusing on the neurological, oncological, dermatological and gastroenterological sectors.
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“Having secured an EU licence to produce non-sterile schedule two medicines, which includes all cannabinoids and the consolidation of our European activities in Malta, we are in a strong position to grow and develop our Seed-to-Pharmacy manufacturing division and make excellent progress in 2019.”
Research and Development (R&D) Division
The R&D division’s primary function is to ensure MGC Pharma remains at the forefront of pharmaceutical innovation within the cannabis for medicinal use sector. The R&D division is spearheaded by a team of highly experienced medical practitioners working alongside scientific departments and genetics teams from world leading universities. Importantly, a number of ground-breaking achievements have already been made including the establishment of several pioneering research programs and the development of new proprietary genetic strain MXC-10, containing industry high levels of THC.
Current research and development activities underway to create a pipeline of pharmaceutical and nutraceutical products include; the development of CannaHub, in collaboration with the Royal Melbourne Institute of Technology (RMIT) and the Hebrew University of Jerusalem (HUJ); the CogniCannTM clinical trial taking place with the University of Notre Dame in Western Australia; the CannEpilTM clinical trial taking place with the University of Ljubljana, Slovenia; the C4E education platform in collaboration with Epilepsy Action Australia and; MGC Pharma’s genetics development and registration activities with the University of Ljubljana’s biotechnical faculty in Slovenia.
The R&D division is currently focused on three sectors:
1. Neurological disorders
Based on the experience of three of our leading doctors Prf. Uri Kramer, Prof David Neubauer and Dr. Jonathan Grunfeld, MGC Pharma established its first clinical arm with Investigational Medicinal Product (IMP) CannEpilTM to treat Drug Resident Epilepsy (refectory epilepsy). It has subsequently developed a second product CogniCannTM, to improve the quality of life in mild cases of dementia and Alzheimer’s. Further products will be produced as part of a continuous development to target additional neurological indications.
2. Oncology and treatment side effects
Under the guidance of the Group’s CSO Dr. Jonathan Grunfeld, and utilising his vast experience in treatment of cancer patients in Israel, and the support equipment and sciences of RMIT and HUJ, MGC Pharma’s second clinical arm has been established to focus on oncological treatments. TetrinolTM, is the first drug in development for use in the treatment of cancer side effects such as cachexia and acute nausea. Additionally, MGC Pharma is developing medicine for the treatment of Melanoma and Prostate cancer which are part of a pre-clinical research with CannaHub (RMIT and HUJ) and a brain cancer research project with the National Institute of Biology (NIB) Slovenia.
3. Inflammatory and Autoimmune
Utilising data collected over time with CannaHub, MGC Pharma’s third clinical arm aims to treat one of the most rapidly emerging problems in the western but also in the eastern side of the world, which is the chronic Inflammation and Inflammation of the immune system. The Company’s first Anti-Inflammatory products are InCannTM, a BiActive microspheres capsule used to treat Inflammatory bowel disease (IBD) Crohn’s disease and colitis, and TopiCannTM, an Anti-inflammatory topical cream to treat Eczema and inflamed skin.
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ODC Approval Received
Royal Melbourne Institute of Technology (RMIT) has received approval from the Office of Drug Control (“ODC”) to possess and handle phytocannabinoids for research purposes. This is a significant milestone achieved for the advancement of all projects currently underway.
Following receipt of this approval, the core research activities at RMIT are:
1. Cancer
The use of nanotechnology in the development of drug delivery systems for the treatment of cancer using existing knowledge from HUJ. Current projects are focussed on researching treatments to inhibit the development of angiogenesis and inflammation in the progression of cancer, antiangiogenic and anti-cancer efficacy of CB2 agonists and Cannabinoid-induced targeted facilitated entry of cytotoxic compounds selectively into tumour cells.
2. Nanotechnology based drug delivery
Both RMIT and HUJ have divisions focussed on nanotechnology-based drug delivery for treatments of various disorders, such as Controlled Release Gastro-Retentive Swelling Dosage Forms for Optimising Therapy of Cannabinoids, targeting of cannabinoids to inflamed tissue: Elucidating the mechanism of immunomodulation and Targeting of nanoparticles containing cannabinoids to peripheral neuronal cells or the extracellular matrix.
3. Combined treatment: traditional medicine and cannabinoid therapy
A current project is underway at RMIT, focussed on researching the benefits and possibility of developing a new treatment that combines medicinal cannabis using traditional medical principles. The objective is to look at multiple compounds and assess how each can be enhanced and developed to create new innovative medicines.
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Clinical Trials Progress on Track
Recruitment for the Phase IIB CogniCannTM clinical trial has commenced. The trial remains on track and is scheduled to last 16 weeks focussing on the effects of CogniCannTM on 50 patients aged 65 and over with mild dementia and Alzheimer’s.
Seed-to-Pharmacy Manufacturing Division
The Seed-to-Pharmacy division capitalises on the intellectual property generated by the R&D division. Its operations encompass supply chain management and end-to-end cannabis production including cultivation, extraction, isolation and compounding the finished medicinal product. Furthermore, it is focussed on bringing a series of phytocannabinoid based medicines to market that are specifically designed to treat a range of neurological, inflammatory and physiological disorders.
Strategic overview
In order to commercialise its research findings, MGC Pharma has centralised its European operations and retained several operational branches in other strategic territories. Furthermore, the Company has been awarded an EU licence to produce non-sterile schedule two medicines, which includes all cannabinoids and noting this includes THC in particular. MGC Pharma is one of only a few companies to be awarded this licence and it enables the production of compound phytocannabinoid-based medicines.
This licence was issued to the Company’s Slovenian facility that contains a CO2 super-critical extraction and separation unit that isolates cannabinoids into purified compounds. These purified compounds can then be used as an Active Pharmaceutical Ingredient (API) and be compounded into end product medicines such as Investigational Medicinal Products (IMP).
Additionally, MGC Pharma’s operational strategy is to implement a fully integrated supply chain in order to provide cost effective medicines.
2019 to deliver strong progress in Malta – upgraded commercial facility approval
In support of its seed-to-pharmacy strategy, the Company will construct a facility in Malta on the land it was awarded by Malta Enterprise, which is expected to commence very shortly. The original approved 4,000m2 site footprint has been increased to 6,000m2 as a result of strong relationships established with the government agencies, and will be used for 5,000m2 EU GMP certified production and a 5,000m2 fully equipped cultivation site, all on the same plot in a multi-story facility. The land will be leased on a long-term basis at preferable cost to the Company with an option to acquire; this is testament to the support for the Company from Malta Enterprise and Malta Industrial Parks.
Aside from an ideal climate of extended sunlight hours and optimal temperatures, Malta also provides the most effective business “climate” due to its low corporate tax, which makes it suitable to be the “market-release” site for MGC Pharma’s products to all Europe and MENA countries, as it is part of the European Union.
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Malta is also home to one of the largest sea-ports in the Mediterranean and has direct access to Italy, providing the ideal central location for operations and logistics within Europe. As a result, MGC Pharma’s Maltese facility site will become its primary operation site, fully integrating its supply chain and providing easy access to European the global markets.
In preparation for the commencement of construction, the Company has successfully finished its geological survey on the land and has submitted the architectural plans to the relevant authorities for approval. MGC Pharma’s is now waiting for the Acquisition of Immovable Property, by Non-Residents (AIP) in order to sign the final agreement with Maltese Industrial Parks. On execution of these final agreements, the first stage construction activities will then commence.
The Company will update the market on developments in due course.
Strong commercial relationships for growth
As a bio-pharma company, MGC Pharma’s core focus is on the development and manufacturing of cutting edge phytocannabinoid based medicines and to support this, MGC Pharma has partnered with global pharmaceutical companies to generate global exposure within the sector.
MGC’s distribution network covers Europe, the United Kingdom, MENA
countries, Australia and New Zealand, providing it access to patients for its
medicinal cannabis products. Maintaining strong relationships with leading
pharmaceutical distributors globally also provides MGC Pharma; with the
ability to leverage these relationships and expand its operations, distribution and footprint globally.
Due to changes in TGA regulation pertaining to the promotion of IMPs and other non-registered medicinal products, the Company is no longer permitted to provide an update of the current status of any of its IMPs in market. All commercial successes will be reflected as cash inflows from ordinary operations in future Appendix 4C, Half Year and Full Year reporting submissions.
MXC’s Distribution footprint
For further information, please contact:
Media Enquiries
Justin Kelly
Media and Capital Partners
[phone] [e-mail]
About MGC Pharma
--End-- UK IR/Media Advisors
Gaby Jenner/ Catherine Leftley
St Brides Partners Ltd
[phone] [e-mail] [e-mail]
MGC Pharmaceuticals Ltd
Brett Mitchell
Executive Chairman
[phone] [e-mail]
MGC Pharmaceuticals Ltd (ASX: MXC) is an EU based BioPharma company with many years of technical clinical and commercial experience in the medical cannabis industry. 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 Cannabinoids based pharmaceuticals products for the growing demand in the medical markets in Europe, North America and Australasia.
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[Cooklamo]

Great news!

Go MGC!!!

[rushmann]

Welcome to 2019 MGC'ers!! It should be a very good year for continued new developments and execution of projects already in the works. Today, the fins came across US newswires which is a first for this Australian company. New eyes will be exposed to MGC today and going forward which is huge as is being off the pinks and finally on the QB. With any luck, we can maybe move up to the QX by EOY/early 2020. Good luck to us all!!

MGC

[cbdstockswatcher]

As we progress further into 2019, we’d like to update you on the progress of our MGC Botanic division:

In 2018, our cannabis crop in the Czech Republic delivered 30% more flowers than the 2017 harvest and is being prepared for immediate transportation to its Slovenian extraction facility.

In addition, the Slovenian Ministry of Health has awarded us a permit for the extraction of phytocannabinoids for the creation of MXC’s own proprietary APIs (Active Pharmaceutical Ingredients).

We’re also pleased to report that we have successfully developed a new proprietary genetic strain, MXC-10, containing the highest level of THC (>35%) of any MXC strand launched to date.

The next step for our Botanic division is to begin the process of registering our four unique Cannabis Sativa strains (bred in the University of Slovenia Biotechnical faculty) in Europe for medical purposes — an enormous production and distribution milestone for MGC Pharma.

See the full update here: http://snip.ly/46iz47

[cbdstockswatcher]

"Today we’re pleased to report that three landmark milestones have now been met by MGC Pharma.

1. Our CTN (Clinical Trial Notification) for CogniCann™ into Alzheimer’s and dementia at the University of Notre Dame is now available in the Clinical Trials Repository.

2. We are one of the first EU facilities to be granted a full API extraction permit to develop our own THC, CBD and other Phytocannabinoids for use in CannEpil™, CogniCann™ and future phytomedicines.

3. We have received SME certification from the European Medicines Agency (EMA) for the scientific advice, drug evaluation and registration of CannEpil™, CogniCann™ and additional Phytomedicines that the Company is developing.

These are landmark milestones for the MGC Pharma company and are a testament to the continuous hard work we’re putting in to become a global market leader in phytocannabinoids."

Read the full announcement here: http://snip.ly/bx35d9

[cbdstockswatcher]

Sale is complete.

"We’re pleased to report that the sale of MGC Derma to CannaGlobal has officially reached completion.

We have now been issued shares in CannaGlobal totalling 10% of their outstanding share capital, making us a strategic shareholder in the global business and symbolising a significant milestone for MXC as we can now focus on our corporate strategy of becoming a world-leading, European based bio-pharma company."

Read the full announcement here: http://snip.ly/k453ar

[Love3]

Huge News
22 January 2019 ASX Code: MXC
Major Regulatory Milestones Achieved for Pharma Business
? TGA has approved TGO93 Declaration Form, advising that our CTN (Clinical Trial Notification) for CogniCannTM into Alzheimer’s and dementia at the University of Notre Dame has been processed and is available in the Clinical Trials Repository
? Government approval for API Extraction at MXC’s European Facility - now one of the first EU facilities to be granted a full API extraction permit, issued by the Slovenian Ministry of Health. MXC can now develop its own THC, CBD and other Phytocannabinoids as API’s for the formulation of CannEpilTM, CogniCannTM and
future phytomedicines
? SME certification issued by the European Medicines Agency (EMA); providing access for scientific advice, drug evaluation and registration of CannEpilTM, CogniCannTM and additional Phytomedicines that the Company is developing. It also provides MXC the opportunity to obtain fee reductions up to 100% in the development and registration of priority medicines (PRIME)
? Each achievement delivers on the Board’s strategy and commitment to the growth of MXC’s pharma business and demonstrates the Company’s progress to deliver near-term commercial outcomes on its seed-to-pharma strategy

[Love3]

18 January 2019 ASX Code: MXC
December 2018 Quarterly Activity Report
? The December quarter delivers strong progress across the Company with a number of significant milestones achieved on its seed-to-pharma business model
? CannEpilTM is now available for supply in Australia under the Authorised Prescriber Scheme following its first importation from MXC’s GMP certified European manufacturing facility in December. This follows confirmation of the authorisation from the TGA and successful independent tests certifying CannEpilTM as GMP compliant
? Divestment of MGC Derma announced during the quarter will enable the Company to focus on becoming a pure bio-pharma company, and to capitalise on the growth and expansion of the medicinal cannabis products sector
? Key management personnel appointments and internal role transitioning completed, to support the management and implementation of the Company’s future European and Australian bio-pharma, research and botanical operations
? An important and unique Research & Development (R&D) project, CannaHub, launched with RMIT and the Hebrew University of Jerusalem to ensure MXC builds a strong foundation of pharmaceutical innovation, and securing a strategic product pipeline for generation of new industry technologies and applications
? An educational platform, Cannabis for Epilepsy (C4E), launched with Epilepsy Action Australia, to provide education and information on medicinal cannabis and epilepsy
MGC Pharmaceuticals Ltd (ASX: MXC or “the Company”) has today published its Appendix 4C for the three months ended 31 December 2018 and provides an overview of its operational highlights for the period.
Operational Update
The Company achieved two significant milestones during the December quarter, signing a binding sale agreement for MGC Derma and importing the first batch of CannEpilTM, following confirmation of the authorisation from the TGA for its supply in Australia.
The Company has focussed on streamlining its operations in order to deliver and commercialise its seed-to-pharma strategy in 2019 and beyond.
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Binding Agreement Executed to Sell MGC Derma to CannaGlobal
On 13 November the Company signed a binding Share Purchase Agreement for the sale of MGC Derma d.o.o (“MGC Derma”) to CannaGlobal Canada Co Inc. (“CannaGlobal”). CannaGlobal, founded by Canadian cannabis industry leader Lorne Gertner, is a diversified, growth-focused Toronto-based holding company, with a global portfolio of cannabis assets, one of which will be MGC Derma upon settlement.
In December 2018, the Company announced the intention to lodge all formal and legally binding documents to sell MGC Derma to CannaGlobal with the Slovenian courts, for the completion of formal settlement. These documents included the executed Share Purchase Agreement and formal share transfer documents that were required to be translated, notarised and lodged under Slovenian company law to legally ratify the change of MGC Derma shareholding. Following lodgement of these executed documents with a court notary in December, the Company was instructed additional original documents were needed to be notarised and apostilled in Australia and the United Kingdom, for the formal settlement to be completed by the Slovenian court.
These additional documents have since been executed and are now in the process of being notarised and apostilled in Australia and the UK. Once completed, the documents will be re-submitted to the court and the Company now expects this to take place before the end of January. On completion of the MGC Derma sale, now expected to occur by the end of January 2019, 100% ownership of MGC Derma will be transferred in exchange for 10% of the ordinary shares in CannaGlobal. This 10% equity holding is based on completion of all acquisitions and investments CannaGlobal was concluding at the time of executing the MGC Derma Binding Sale Agreement.
The Company also received the first C$0.5 million from CannaGlobal for the first order of CBD and cosmetic materials under the CannaGlobal 5-year Supply Agreement, executed as part of this transaction.
The divestment of MGC Derma represents a significant milestone for the Company, freeing resources to focus on delivering its corporate strategy to become a world leading bio-pharma company.
CannEpilTM available for supply in Australia
In a landmark achievement, MXC’s first Investigational Medicinal Product (IMP) CannEpilTM has been successfully imported into Australia and is available for supply under the Authorised Prescriber Scheme. CannEpilTM has been independently tested and certified as compliant with quality guidelines and strict European GMP standards allowing Authorised Prescribers to prescribe CannEpilTM to suitable patients under their care.
Some of the Authorised Prescribers of CannEpilTM were first endorsed by the Human Research Ethics Committee at St Vincent’s Hospital, Melbourne.
MXC will work with HL Pharma to coordinate the supply of CannEpilTM in Australia to eligible Authorised Prescribers, as per the Heads of Agreement signed on the 1st of November 2017.
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The arrival of CannEpilTM also represents a significant milestone for the Company and its development as an accomplished European-based bio-pharma company.
Maltese operations progress on track
The Company has completed all architectural plans for its GMP certified Production and Manufacturing facility following the release of the guidelines on the manufacturing and production of cannabis for medicinal and research purposes, by the Maltese Medical Authority. This follows legislative changes enacted by Maltese Parliament in May 2018.
This represents the last legislative step required by the Maltese Government and the Company is poised to move to the next phase of the project which will be the execution of a long-term lease agreement on the approved land followed by the commencement of construction of the large scale, GMP cultivation and manufacturing facility. Initial ground work will commence on the facility site in the coming weeks.
Change in Executive Roles and Growth of New MGC Management Team
During 2018, the Board completed a number of key management level appointments to drive the Company’s operational plans across its Pharma, Research and Botanical divisions. Effective 1 January 2019, this new management team will hold key responsibilities for the management of the Company’s future operations and the commercialisation of the Company’s key business units. These appointments mark the transition of some key responsibilities to management, which until recently have been performed by the Company’s Executive Directors. The need to bolster the Company’s management level resourcing is a direct result of significant growth and development in both Pharma and Botanical business operations in 2018, both across Europe and Australia and focusses this experienced management team on delivering MXC’s seed-to-pharma strategy.
With the transition of responsibilities completed during the December quarter and the resulting change to executive responsibility at the board level, the roles and remuneration structure for MXC’s Executive Directors has been materially revised to reflect a transition of key responsibilities to the new management team, effective 1 January 2019.
Details of this are reflected below.
? Roby Zomer - Managing Director
Annual remuneration of $300,000 with additional performance shares (equating to 30% of annual salary) based on share performance and operational milestones.
As Managing Director, Roby remains responsible for the execution of the Board’s strategy and operations across the Company’s entire operations.
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? Brett Mitchell - Executive Chairman
Annual remuneration of $240,000 with additional performance shares (equating to 30% of annual
salary) based on share performance and operational milestones.
As Executive Chairman, Brett will continue to be responsible for the Company’s financing, corporate strategy and development.
? Nativ Segev - Director and Business Strategy Manager
Annual remuneration of $240,000 with additional performance shares (equating to 30% of annual
salary) based on share performance and operational milestones.
Nativ in his new role will act as the business strategy advisor to the Board utilising his vast experience and extensive network of industry experts in the medicinal cannabis sector. This role has been created to ensure the Company remains at the forefront of industry innovation and development. Further to this, as the Company’s project in Malta will be the focus of 2019, Nativ will be responsible for the Malta project construction and operation, ensuring it meets the required KPIs.
Additionally, to expedite commercialisation of MXC’s pharma division, Dr Jonathan Grunfeld has been promoted to Chief Scientific Officer (CSO) of research operations, effective from 1st of January 2019.
Dr Grunfeld graduated from the Tel Aviv University Sackler Faculty of Medicine with an M.D. in 1996 and went on to qualify as a neurologist after completing his 5-year residency at the University of Tel Aviv teaching hospital. Jonathan then went on to complete a clinical Fellowship in neuro-oncology at the M.D. Anderson Cancer Center in Houston, Texas in 2004.
Dr Grunfeld currently works within oncological palliative care at the Cancer Institute of the Assaf HaRofeh Medical Center, Israel and has been authorised to issue prescriptions for the use of medical cannabis since 2010. He has extensive direct experience treating multiple conditions with cannabis to over 4,500 patients during this tenure. Jonathan will be responsible for envisioning and developing research capabilities.
Additionally, other key management appointments in 2018 have included Keren Bar-Zakay as General Manager of Australian Operations, Rutchi Kaushal as Group CFO, Ron Lipsky as General Manager of Global Business Development and Irena Pribošic as the Head of Pharma Quality Assurance.
MXC commences trading on US OTC market
On the 18th of December, MXC commenced trading on the OTCQB? Venture Market in the United States under the ticker MGCLF. The OTC Markets Group operates a number of markets for the utilisation of global securities as a way to increase exposure and credibility within the US.
Trading on this international market provides greater global exposure, increased access to institutional investors and the ability to generate a broader shareholder base through increased liquidity.
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The ASX remains the Company’s primary exchange and this OTC listing will not impact its compliance with ASX Listing Rules.
Research and Development initiatives – Launch of CannaHub Tech Incubator with RMIT Agreement signed with RMIT to launch international cannabinoid research library - CannaHub
As an extension to its current research and development projects, the Company signed a binding partnership agreement with RMIT (Royal Melbourne Institute of Technology) and HUJ (The Hebrew University of Jerusalem), to create an international research hub focussed on innovation and technology within the medicinal cannabis industry.
CannaHub will take the form of an international shared library containing research, data and analytical information on medicinal cannabis and its potential uses. Research departments within leading universities and industry bodies will be invited and incentivised to join CannaHub and participate in ground-breaking research, increasing the credibility and exposure of the hub.
CannaHub is set to become MXC’s primary R&D engine with all findings, outcomes and conclusions to remain the property of the CannaHub partners. MXC will hold the first right to use or acquire any data or findings from the hub for commercial purposes.
Educational platform launched with Epilepsy Action Australia (C4E)
As an extension to current projects, MXC formally partnered with Epilepsy Action Australia (EAA) and created an online platform dedicated to providing education and information on medicinal cannabis and epilepsy.
The platform is taking the form of an EAA website designed for healthcare practitioners and patients and will contain information under its ‘Get Educated’ and ‘Get Access’ portals. The portals will provide easily- packaged and user-friendly information on medicinal cannabis news, research breakthroughs, available treatments, clinical trials and information on how to access medicinal cannabis as a patient.
The platform was launched during CannaTech in Sydney in October 2018.
The Company is dedicated to transforming the lives of epilepsy patients and the launch of this website supports its business model of helping patients by providing a range of premium CBD, GMP certified medicinal products where current medicines are ineffective.
Financial Update
As at 31 December 2018, MXC had cash of c. $6.9 million, leaving the Company well-funded to continue building out its seed-to-pharma operations, and commence construction of its Maltese medical cannabis production and cultivation facility in the coming months, once all formal agreements are signed with the Maltese Government and its agencies.
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Outlook
The December quarter has been important for the Company and its growth both domestically and internationally. It has surpassed a number of significant operational milestones which have enabled the Board to streamline the Company to deliver on its seed-to-pharma commercialisation strategy.
The sale of MGC Derma enables MXC to dedicate all its resources into strengthening its pharmaceutical pipeline of products and delivering on its growth strategy by generating material revenues.
Confirmation of the authorisation from the TGA to supply products under the Authorised Prescriber Scheme will be transformational for MXC’s operations going forward and with the approval for the Company’s first IMP CannEpilTM representing the first of a pipeline of products to be commercialised by the Company.
The Board and Senior Management team are fully committed to the growth and expansion plans of MXC’s pharma operations in 2019 in Europe, and following the sale of MGC Derma and the successful importation of its first GMP certified medicinal cannabis product to Australia, the Company will focus on commencing the construction of its Maltese manufacturing and cultivation facility in the coming months.
For further information, please contact:
Media Enquiries
Justin Kelly
Media and Capital Partners
[phone] [e-mail]
About MXC
MGC Pharmaceuticals Ltd
Brett Mitchell
Executive Chairman
[phone] [e-mail]
-Ends-
MGC Pharmaceuticals Ltd (ASX: MXC) is an EU based Bio-Pharma company with many years of technical clinical and commercial experience in the medical cannabis industry. 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 Cannabinoids based pharmaceuticals products for the growing demand in the medical markets in Europe, North America and Australasia.
Follow us through our social media channels
6 - 6

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B
+Rule 4.7B
Appendix 4C
Quarterly report for entities subject to Listing Rule 4.7B
Introduced 31/03/00 Amended 30/09/01, 24/10/05, 17/12/10, 01/09/16
Name of entity
ABN Quarter ended (“current quarter”)
MGC PHARMACEUTICALS LTD
30 116 800 269
31 DECEMBER 2018
Consolidated statement of cash flows
Current quarter $A’000
Year to date (6 months) $A’000
1. Cash flows from operating activities
1.1 Receipts from customers
(a) Pharma division
(b) Derma division
(c) Other - CannaGlobal receipt for first order of CBD and cosmetics raw materials
1.2 Payments for
(a) research and development
(b) product manufacturing and operating costs i) cost of sales
ii) operating costs
(c) advertising and marketing
(d) leased assets
(e) staff costs
(f) administration and corporate costs
1.3 Dividends received (see note 3)
1.4 Interest received
1.5 Interest and other costs of finance paid
1.6 Income taxes paid
1.7 Government grants and tax incentives: - Research and development rebate
1.8 Other (provide details if material)
1.9 Net cash from / (used in) operating activities
177 29
538
(530)
(141) (717)
(164) - (154) (752) - 57 - - 117
-
263 78
538
(856)
(182) (1,179)
(252) - (285) (1,156) - 110 - - 117
-
(1,540)
(2,804)
+ See chapter 19 for defined terms
1 September 2016
Page 1

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
Current quarter $A’000
Year to date (6 months) $A’000
2. Cash flows from investing activities
2.1 Payments to acquire:
(a) property, plant and equipment
(b) businesses (see item 10)
(c) investments
(d) intellectual property
(e) other non-current assets
2.2 Proceeds from disposal of:
(a) property, plant and equipment (b) businesses (see item 10)
(c) investments
(d) intellectual property
(e) other non-current assets
2.3 Cash flows from loans to other entities
2.4 Dividends received (see note 3)
2.5 Other (provide details if material)
2.6 Net cash from / (used in) investing activities
(115) - - - -
- - - - - - - -
(155) - - - -
- - - - - - - -
(115)
(155)
3. Cash flows from financing activities
3.1 Proceeds from issues of shares
3.2 Proceeds from issue of convertible notes
3.3 Proceeds from exercise of share options
3.4 Transaction costs related to issues of shares, convertible notes or options
3.5 Proceeds from borrowings
3.6 Repayment of borrowings
3.7 Transaction costs related to loans and borrowings
3.8 Dividends paid
3.9 Other
3.10 Net cash from / (used in) financing activities
- - -
- - -
- - -
- - -
(5) - -
- - -
-
(5)
+ See chapter 19 for defined terms
1 September 2016 Page 2

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows
Current quarter $A’000
Year to date (6 months) $A’000
4. Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of quarter/year to date
4.2 Net cash from / (used in) operating activities (item 1.9 above)
4.3 Net cash from / (used in) investing activities (item 2.6 above)
4.4 Net cash from / (used in) financing activities (item 3.10 above)
4.5 Effect of movement in exchange rates on cash held
4.6 Cash and cash equivalents at end of quarter
8,572 (1,540) (115) - 34
9,859 (2,804) (155) (5) 56
6,951
6,951
5. Reconciliation of cash and cash equivalents
at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts
Current quarter $A’000
Previous quarter $A’000
5.1 Bank balances
5.2 Call deposits
5.3 Bank overdrafts
5.4 Other (provide details)
5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above)
1,377 5,574 - -
1,330 7,242 - -
6,951
8,572
Current quarter $A'000
344
-
6. Payments to directors of the entity and their associates
6.1 Aggregate amount of payments to these parties included in item 1.2
6.2 Aggregate amount of cash flow from loans to these parties included in item 2.3
6.3 Include below any explanation necessary to understand the transactions included in items 6.1 and 6.2
+ See chapter 19 for defined terms
1 September 2016 Page 3
Director and executive services fees, and reimbursement of corporate administrative costs

7.2 Aggregate amount of cash flow from loans to these parties included in item 2.3
7.3 Include below any explanation necessary to understand the transactions included in items 7.1 and 7.2
8. Financing facilities available
Add notes as necessary for an understanding of the position
8.1 Loan facilities
8.2 Credit standby arrangements
8.3 Other (please specify)
8.4 Include below a description of each facility above, including the lender, interest rate and whether it is secured or unsecured. If any additional facilities have been entered into or are proposed to be entered into after quarter end, include details of those facilities as well.
Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B
Current quarter $A'000
-
-
7. Payments to related entities of the entity and their associates
7.1 Aggregate amount of payments to these parties included in item 1.2
NIL
Total facility amount at quarter end $A’000
Amount drawn at quarter end $A’000
NIL
NIL
-
-
-
-
NIL
9. Estimated cash outflows for next quarter
$A’000
9.1 Research and development
9.2 Product manufacturing and operating costs
9.3 Advertising and marketing
9.4 Leased assets
9.5 Staff costs
9.6 Administration and corporate costs
9.7 Other – Malta facility construction
9.8 Total estimated net cash outflows
371
273
11
72
491
447
100
1,765
+ See chapter 19 for defined terms
1 September 2016 Page 4

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.
Sign here: ............................................................ Date: 18 January 2019 Chief Financial Officer
Print name: Rutchi Kaushal
Notes
1. The quarterly report provides a basis for informing the market how the entity’s activities have been financed for the past quarter and the effect on its cash position. An entity that wishes to disclose additional information is encouraged to do so, in a note or notes included in or attached to this report.
2. If this quarterly 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 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.
Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B
10. Acquisitions and disposals of business entities
(items 2.1(b) and 2.2(b) above)
Acquisitions
Disposals
10.1 Name of entity
-
-
10.2 Place of incorporation or registration
-
-
10.3 Consideration for acquisition or disposal
-
-
10.4 Total net assets
-
-
10.5 Nature of business
-
-
+ See chapter 19 for defined terms
1 September 2016 Page 5

[cbdstockswatcher]

MGC Nutraceuticals website has been updated:

www.mgcnutraceuticals.com


Facebook and Instagram accounts have also been created:

https://www.instagram.com/mgcnutraceuticals/

https://www.facebook.com/MGC-Nutraceuticals-1199013120254983/

[BullMarket34]

You still following LDS* Boston ?

[cbdstockswatcher]

CannaGlobal introductory video!

[cbdstockswatcher]

CannaGlobal introductory video

[cbdstockswatcher]

CannaGlobal introductory video

[rushmann]

It's great to see MGC come through with it's first delivery of Cannepil before year end!! 2018 has been a huge banner year for MGC with many milestones accomplished. We enter into 2019 with everything in place!! Congratulations to all Longs holding!!! See you in 2019!

MGC

[Love3]

MXC First CannEpilTM Product arrives in Australia

? In a significant milestone event for the Company, the first shipment of CannEpilTM was officially exported from Slovenia on Friday to arrive in Australia today, Monday 24 December
? All Australian import authorisations are in place to allow immediate transport to a secure facility at St Vincent’s Hospital, Melbourne
? CannEpilTM is available for supply through Authorised Prescribers, endorsed by the
Human Research Ethics Committee at St Vincent’s Hospital
? CannEpilTM is a Cannabinoids based IMP Phytomedicine developed by MXC
? Some Australian medical practitioners have already been granted approval as Authorised Prescribers of CannEpilTM
? MXC and specialist pharmaceutical distributor, HL Pharma, are now able to arrange the supply of CannEpilTM for patients who have been prescribed the product by an Authorised Prescriber
MGC Pharmaceuticals Ltd (ASX: MXC or “the Company”) is pleased to announce that its first investigational medicinal product (IMP) CannEpilTM has been successfully exported from Slovenia and imported into Australia today for the first time, after completing the validation process. The Company’s first batch of CannEpilTM will arrive in Australia today after being air freighted from Slovenia over the weekend.
MXC manufactures high quality products in accordance with European GMP standards. CannEpilTM is a Cannabinoids based IMP Phytomedicine developed by MXC.
MXC and HL Pharma will work together to arrange for the supply of CannEpilTM in Australia to eligible Authorised Prescribers.
Authorised Prescribers may prescribe CannEpilTM to suitable patients under their care.
Some of the Authorised Prescribers of CannEpilTM were first endorsed by the Human Research Ethics Committee at St Vincent’s Hospital, Melbourne.
1 - 2

The arrival of CannEpilTM into Australia for the first time represents a significant milestone for the Company and its development as an accomplished European-based biopharma company with more than a decade of clinical experience and a leading Board of scientific advisors.
Who is an Authorised Prescriber?
An Authorised Prescriber is a medical practitioner who has been authorised to prescribe a medicine which has not otherwise been approved for use in Australia by the Therapeutic Goods Administration (TGA). In order to obtain authorisation to be an Authorised Prescriber, a medical practitioner must obtain endorsement from an Ethics Committee, which requires the medical practitioner seeking to become an Authorised Prescriber to demonstrate the safety of the medicine and their expertise to prescribe it.
The Company continues to focus on research, development and production of further medicinal cannabis- based products to bring them to market in Australia and internationally.
Roby Zomer, Co-founder and Managing Director, MGC Pharmaceuticals commented
“The arrival of CannEpil in Australia is a great achievement for us on our pathway to growing and commercialising MXC as a European-based biopharma company. The team has been working extremely hard to get to this stage and we are all very excited that CannEpil is now available for supply to patients in Australia, which is the first key market for the Company to deliver CannEpil into with more to follow during 2019.”
For further information, please contact:
Media Enquiries
Justin Kelly
Media and Capital Partners
[phone] [e-mail]
About MXC
MGC Pharmaceuticals Ltd
Brett Mitchell
Executive Chairman
[phone] [e-mail]
--Ends—
MGC Pharmaceuticals Ltd (ASX: MXC) is an EU based bio-pharma company with many years of technical clinical and commercial experience in the medical cannabis industry. The Company’s founders are key figures in the global medical cannabis industry and the core business strategy is to develop and supply high quality cannabinoid-based pharmaceutical products for the growing demand in the medical markets in Europe, North America and Australasia.
Follow us through our social media channels
2 - 2

[Love3]

• In a significant milestone event for the Company, the first shipment of CannEpil™was officially exported from Slovenia on Friday to arrive in Australia today, Monday24 December

• All Australian import authorisations are in place to allow immediate transport to asecure facility at St Vincent’s Hospital, Melbourne

• CannEpilTM is available for supply through Authorised Prescribers, endorsed by theHuman Research Ethics Committee at St Vincent’s Hospital

• CannEpilTM is a Cannabinoids based IMP Phytomedicine developed by MXC

• Some Australian medical practitioners have already been granted approval asAuthorised Prescribers of CannEpilTM

• MXC and specialist pharmaceutical distributor, HL Pharma, are now able to arrangethe supply of CannEpilTM for patients who have been prescribed the product by anAuthorised Prescriber

[Cooklamo]

THAT IS AWESOME!!!

GO MGC!

[rushmann]

MGC NOW TRADING ON THE OTCQB!!!!!!!

MGC

[Jmk2454]

There is a video available on Facebook - I don’t know how to post a link, but if you go to Facebook and search “Lorne Gertner kicking off Cannatech Hong Kong” you should find it. There are two speakers before Gertner. He talks about Cannaglobal among other things.

[Jmk2454]

New update available - MGC Derma Sale Update.

[Love3]

Agreement signed with renowned research universities
19 November 2018 ASX Code: MXC
?
? ?
?
?
?
?
MGC Pharmaceuticals Ltd (ASX: MXC or “the Company”) is pleased to announce it has signed a binding partnership agreement with the Royal Melbourne Institute of Technology and The Hebrew University of Jerusalem to form a joint international medical research hub for medicinal cannabis innovation and technologies.
As an extension to MXC existing collaboration with RMIT, the new research hub, to be known as ‘CannaHub’, is a collaborative centre between MXC, RMIT and HUJ and will be an international shared library of research, data and analytics on medicinal cannabis and its uses including future medical applications and treatments.
to launch CannaHub
An international research hub formed for the development of world leading medicinal
cannabis research, technologies and innovations
Highlights
MXC has signed a partnership agreement with the Royal Melbourne Institute of Technology (RMIT) and The Hebrew University of Jerusalem (HUJ) to create and launch ‘CannaHub’, an international research hub for medicinal cannabis and its
future applications in the field of medicine and patient treatment
CannaHub is a new addition to the MXC projects currently underway with RMIT,
and will be formally launched in Q1 2019
CannaHub’s research projects will initially focus on the use of medicinal cannabis in the treatment of cancer, the effectiveness of traditional and medicinal cannabis
combination treatments and drug delivery systems
Partnering with world renowned Hebrew University of Jerusalem in a research
collaboration project further strengthens the Company’s business strategy to
become a leading bio-pharma, and product development company
Represents a key milestone for the Company as CannaHub will act as MXC’s primary research and new product development engine, supporting its seed-to- pharma business model through the innovation and development of new
medicinal cannabis products and technologies
All findings, outcomes and conclusions remain the property of CannaHub partners
MXC, RMIT and HUJ
MXC holds the first right to use or acquire all data, technology, or findings
generated from CannaHub with potential commercial applications

[Jmk2454]

So there is a lot not happening with MGC right now. Anybody have any thoughts?

[GuiNoir]

With the American penny pot stocks heating up (KGKG VATE SIPC etc.) there doesn't seem to be any reason to hold MGCLF. So I got out. Good luck to all longs!

[Love3]

Market Announcement 1 November 2018
MGC Pharmaceuticals Ltd (ASX: MXC) – Trading Halt
Description
The securities of MGC Pharmaceuticals Ltd (‘MXC’) will be placed in trading halt at the request of MXC, pending it releasing an announcement. Unless ASX decides otherwise, the securities will remain in trading halt until the earlier of the commencement of normal trading on Monday, 5 November 2018 or when the announcement is released to the market.
Issued by
Sandra Wutete
Senior Adviser, Listings Compliance (Perth)

[Love3]

https://hotcopper.com.au/documentdownload?id=uOMxKKzFkiWRTLKhOROKAxjvTDYD4wi7wBaZre96ke92GA%3D%3D


MXC partner with Epilepsy Action Australia to launch medical
30 October 2018 ASX Code: MXC
cannabis education platform
? MXC collaborates with Epilepsy Action Australia to design and build an online education platform for medicinal cannabis and epilepsy
? The Platform will be designed for the everyday use of healthcare professionals and epilepsy patients, as a gateway to knowledge on epilepsy and access to medical cannabis treatments
? Showcases MXC’s commitment to providing education and improving the lives of epilepsy sufferers
? MXC committed to finance phase one of the project with Epilepsy Action Australia
? Phase one of the project will be presented at the CannaTech conferences, hosted in
Sydney between 28th – 30th October
MGC Pharmaceuticals Ltd (ASX: MXC or “the Company”) is pleased to announce it has partnered with Epilepsy Action Australia (EAA) to create an online platform dedicated to providing information and education on medicinal cannabis and epilepsy.
The platform will take the form of an EAA website and is designed as an effective online educational tool that provides easily packaged, accessible, user-friendly information about epilepsy and medicinal cannabis.
The platform is intended for healthcare practitioners and patients suffering from epilepsy and will provide information via its ‘Get Educated” and ‘Get Access’ portals. These portals will consist of news, research breakthroughs and information on how to access medicinal cannabis treatments and clinical trials.
The website will be populated by epilepsy and pharmaceutical experts and phase one of the project will be presented at the CannaTech conference on the 28th – 30th October in Sydney.
The Company has committed to finance phase one of the EAA project and design and development has already commenced.
1 - 2

Roby Zomer, Co-founder and Managing Director, MGC Pharmaceuticals commented
“I am delighted to announce we have everything in place to begin the design and development of our education project in collaboration with Epilepsy Action Australia. We are dedicated to improving the lives of epilepsy sufferers and will continue to research, develop and progress the clinical epilepsy market.”
Carol Ireland, CEO and Managing Director of Epilepsy Action Australia commented
“Epilepsy patients are always looking for reliable and trusted information and new research and we have noticed an influx of patients seeking information on medical cannabis. Partnering with MGC Pharma and launching the platform will allow us to provide patients with a portal to access all the information they need to help them better understand what options and alternatives are available to them.”
For further information, please contact:
Media Enquiries
Rosa Smith
Media and Capital Partners
[phone] [e-mail]
About MXC
MGC Pharmaceuticals Ltd
Brett Mitchell
Executive Chairman
[phone] [e-mail]
--Ends—
MGC Pharmaceuticals Ltd (ASX: MXC) is an EU based BioPharma company with many years of technical clinical and commercial experience in the medical cannabis industry. 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 Cannabinoids based pharmaceuticals products for the growing demand in the medical markets in Europe, North America and Australasia.
Follow us through our social media channels
2 - 2
insert-text-here

[rushmann]

Fantastic article!! Very detailed regarding our MGC. There is a ton of potential here and Mgt is executing very well on initiatives that were put in place the last few years. Pps is at a great entry point and also perfect for accumulation for Longs. The time to much greater awareness is coming fast!!

MGC

[Cooklamo]

https://www.edisoninvestmentresearch.com/researchreports/AU000000MXC6MGC%20Pharmaceuticals221018initiation.pdf

[londonohoyos]

https://stockhead.com.au/health/mgc-is-undervalued-as-pharma-and-cannabis-ingredients-business-expands-analyst/

[londonohoyos]

https://www.fool.com.au/2018/10/26/these-small-cap-asx-shares-are-ending-the-week-on-a-high/

[londonohoyos]

MGC Pharmaceuticals Ltd (ASX: MXC or “the Company”) has today published its
Appendix 4C for the three-months ended 30 September 2018 and provides an overview
of its operational highlights for the period.
Operational Update
The Company achieved a number of significant milestones during the quarter on its path
towards becoming a world-leading pure Bio-Pharma company and demonstrating its full
seed-to-pharma capabilities.

[GonzoinHD]

Looks like a couple people need beer money for the weekend this morning. Staring at my calendar, realizing that including today, we are 9 business days away from the announcement.

[GonzoinHD]

Thank you for the update. October 31st is just around the corner! Plenty of time for people to load up!

[Jmk2454]

An announcement from MGC tonight said the date had been moved back and everything will be finalized October 31 with CannaGlobal. CannaTech is in Sydney October 28-30 with some big names in the Cannabis industry. Lorne Gertner is one of the speakers. The timing makes sense knowing that.

[GonzoinHD]

Cannaglobalco.com

[rushmann]

What's the website?

MGCLF

[GonzoinHD]

I’m suppose we’ll all be checking it multiple times daily now, lol

[GonzoinHD]

Hmmmm......... I see Cannaglobal has finally got what resembles a website up. Unfortunately not much to see or interact with yet. You can sign up for company news though, I’m sure in the coming days it will be well expanded.

[GuiNoir]

624,223 volume today is much higher than most days. Maybe somebody knows something?

[rushmann]

Trading halt may be due to the 1 mil Cannaglobal payment, but I have a feeling it may be more than that. Maybe news getting over to the US, or maybe another aspect of the Cannaglobal deal, or perhaps uplisting off the pinks. IDK, something is a brewing my MGCLF brothers and sisters!! We should know tomorrow night.

MGC

[GonzoinHD]

I agree with you that Australia is no doubt really big news. I feel it’s only the tip of the iceberg though. Much going on below the surface and behind the scenes that we’re not even privy to yet. It’s getting very interesting to say the least.

[GuiNoir]

Still think the really big news is getting the epilepsy drug approved in Australia. Another GW Pharma in the making?

[GonzoinHD]

Couple the news of the UK legalizing MM come November 1st (which will be far less restrictive than Australia) and the company’s previous news release of striking a distribution deal with A.M. Mangion (look em up) and it’s easy to read the writing on the wall.

IMHO MGCLF is sitting steadily on the launching pad and the countdown has begun.

[GonzoinHD]

Ok, for those who haven’t figured it out on their own. The trading “pause” yesterday was implemented by the ASX in order for them to inquire MGC as to a reason for the sudden increase in sp and volume on MXC yesterday. MGC has gotten back to them in a very timely manner and with good explanation. MXC, after the pause in trading, initiated a trading halt at their own request pending a new announcement.

“ the securities will remain in trading halt until the earlier of the commencement of normal trading on Thursday, 18 October 2018 or when the announcement is released to the market.”

Based on the action on the ASX yesterday, I would venture to guess the news is very, very good, and probably contains more than just an announcement that the 1 mil from Cannaglobal has been received and is now on our books. A 5 year supply agreement with Cannaglobal is bigger than I think people realize.

[GonzoinHD]

The announcement is a trading halt. I’m sure it has something to do with the 1 mil from Cannaglobal, maybe more..........

[Love3]

Market Release Oct 16, 2018
MGC PHARMACEUTICALS LTD
Security Code: MXC
Pause in Trading
Trading in the securities of the entity will be temporarily paused pending a further announcement.
Isabelle Andrews
ASX Listings Compliance
Oct 16, 2018 Market Announcement 1/1

[GonzoinHD]

New announcement coming any moment. Trading paused on the ASX right now.

[GonzoinHD]

Exciting to watch the action in Australia tonight. Sittin pretty at 8 cents right now.

[rushmann]

Typical pink sheet move. US investors know very little about this ticker at the moment. That will change very soon IMO which should help support the MGCLF ticker.

MGC

[rushmann]

GonzoinHD...congrats!!! PM your cell#, if you want, and I'll text you my #. Welcome aboard!

MGCLF

[GuiNoir]

MXC gets approval for its epilepsy drug in Aussie land and MXC goes down in the U.S.???