morokoy
3 years ago
During the quarter, MGC Pharma completed the 100% acquisition of the operating telehealth clinic-based assets, data and intellectual property of Medicinal Cannabis Clinics (MCC), a wholly owned subsidiary of Cannvalate Pty Ltd, with over 300 patient consults conducted since completion on the 23rd of November. This following the signing of a binding term sheet in July 2020. Consideration of $1m MGC Pharma Ordinary Shares (2/3 subject to trading restrictions) and $400,000 in cash has been paid for the acquisition.
Alongside revenue generated from consults, this acquisition provides MGC Pharma with an operating platform with both import and export capacity that will significantly expand market access and provide control of the supply chain from manufacturing through to patients.
The acquisition also allows the Company to continue providing its high-quality GMP certified medications to patients in Australia and further improves profit margins while keeping product at the current competitive prices.
The acquisition of the MCC Assets is the next step in building on-the-ground distribution assets allowing the Company to wholesale and distribute directly to other clinics and pharmacies to reduce storage and distribution costs.
Launch of CannEpil® App
As part of its ongoing work with the Royal Melbourne Institute of Technology (RMIT), MGC Pharma launched the CannEpil® App, and is providing medical access to the International Library of Cannabinoids (ILC).
The App is a cross platform application available to download from both the Apple App Store and Google Play Store and is designed to be used by patients (or the patient’s guardian) taking CannEpil® as a prescription treatment. The App will record patient responses to medical questionnaires as part of their treatment plan and the treating practitioner will be able to view the responses in real-time.
The ILC is a world first centralised platform compiling the diverse range of existing data on the therapeutic benefits of cannabinoids. The ILC database has been designed to collect comprehensive information about clinical trials, including details of diseases and follow up treatments, as well as product identifiers, including genetics, grow conditions and chemical profile to provide doctors with an encyclopaedia of exhaustive information on the best treatment for patients using cannabinoids.
First shipment of MP Line products directly to patients in Brazil
MGC Pharma’s first batch of MP Line products were shipped directly to patients in Brazil in October 2020, through its binding supply and distribution agreement with Brazil-based ONIX Empreendimentos e Participações (‘ONIX’). MGC Pharma is the first company globally to ship high THC formulations directly to a patient’s door in Brazil, without the need to visit a pharmacy.
The shipment was completed under Brazil’s Compassionate Use Program following the receipt of patients’ prescriptions provided by an ONIX referring doctor. ONIX currently has more than 100 referring doctors in Brazil able to prescribe cannabinoid products under the Compassionate Use Program and is targeting to have over 1,000 referring doctors by mid-2021.
Research and Development
Completion of Phase II clinical trial on COVID-19 patients
MGC Pharma’s Phase II double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of anti-inflammatory treatment, ArtemiCTM, on 50 patients diagnosed with COVID-19 has completed.
The trial included 50 patients of which 33 were in the treatment group and 17 in the placebo group and took place across three independent hospital sites across Israel and India.
The full results have demonstrated to improve the health status of COVID-19 patients delivering a NEWS score of less than or equal to 2. None of the patients in the treatment group required additional oxygen, mechanical ventilation or admission to intensive care where all of these events were reported in the placebo group. The average NEWS score of patients in the placebo group was 2.25 statistically significantly higher (p<0.04) than in the treatment group – 0/5.
The Trial met all the FDA requirements for a COVID-19 study including population diversity (age, medical history, and genetic diversity) and demonstrated a full safety profile with no drug related adverse events. This resulted due to ArtemiCTM and the trial being focused on the immunomodulation specific for the prevention of cytokines storm, as opposed to other immunomodulators.
These results also follow safety and toxicity testing completed on mice and in line with FDA requirements for product registration requiring two types of rodents in pre-clinical trials. MGC Pharma completed an in vivo safety and toxicity pre-clinical study, including histology testing, on 24 rats. This included four groups with three study drug dosages being 48ug, 96ug and 196ug per kg rat and a control group.
The rats were observed and tested for clinical changes over seven days. This study included pathological examination of the organs: liver, heart, brain, spleen, spinal cord, sciatic nerve, kidney (L+R), lungs and tongue.
Further successful results from pre-clinical glioblastoma research
Results from the ongoing pre-clinical research program focused on evaluating cannabinoid formulations in the development of a treatment of the most aggressive and therapeutically resistant brain tumour, glioblastoma, have shown further successful results.
The pre-clinical in-vitro research program is being conducted in collaboration with the National Institute of Biology (‘NIB’) and the Neurosurgery Department at the University Medical Centre in Ljubljana, Slovenia.
The results from 18 patient tumour samples show for the first time that the Company’s proprietary formulation, CBG, exerts a superior effect in impairing the major hallmarks of glioblastoma progression, i.e. fast proliferation and invasion, and particularly enhancing glioblastoma cell death. Moreover, CBG can destroy therapy-resistant glioblastoma stem cells, which are the root of cancer development and extremely resistant to various treatments of this lethal cancer. CBG should present a new yet unexplored modality of glioblastoma therapy that could replace Tetrahydrocannabinol (THC) as a more acceptable add-on or adjuvant treatment strategy.
Financial and Corporate
Completion of unmarketable share parcel
The Company completed the sale of 50,696,634 fully paid ordinary shares pursuant to the Company’s Unmarketable Parcel Sale Facility (UMP Facility). MGC Pharma confirms its shareholder base has now been reduced by 5,067 shareholders. This will significantly reduce the Company’s administrative and corporate costs moving forward.
Progress towards completion of MGC Nutraceuticals sale to Onassis
As announced on 2nd December 2020, under the terms of the sale and purchase agreement for the 100% sale of the Company’s subsidiary MGC Nutraceuticals, MGC Pharma will receive shares equating to a value of US$6 million in Onassis Holdings Corp and the Company has secured an exclusive supply agreement for the provision of its CBD, raw materials and proprietary production intellectual property (IP). This follows the signing of a binding acquisition and exclusive CBD supply agreement as announced on 18 June 2020.
During the quarter MGC Pharma provided the 30 June 2020 audited financial statements for MGC Nutraceuticals to Onassis and full settlement of the acquisition is expected to complete over the next quarter. During the December quarter Onassis has commenced the process of finalising the offering submissions for the capital raising with the US SEC. The process from submission to completion is currently expected to complete in H1 2021. Once the offering submission has been approved, Onassis will complete the capital raising which will enable the full and complete settlement of the MGC Nutraceuticals acquisition with MGC Pharma.
Long terms benefits from UN vote to reschedule cannabis
In early December 2020, the United Nations (UN) voted in favour of the removal of cannabis and its derivatives from schedule IV in recommendations from the World Health Organisation (WHO). Cannabis and its derivativities are now contained under Schedule I of the 1961 UN Single Convention on Narcotic Drugs.
This creates a significant opportunity for MGC Pharma by removing red-tape that creates logistical limitations of the movement of products and creates an open pathway for easier and cheaper global distribution. This will also enable significantly more commercial opportunities for MGC Pharma by allowing it to deliver its Mercury Pharma product line to new markets going forward.
Appendix 4C
The Company had $1.57m cash at the end of the December 2020 quarter, with access to $9.25m undrawn from its $15m financing facility with Mercer Street Opportunity Fund LLC (as announced to the ASX on 10 September 2020). In accordance with Section 6 of the attached Appendix 4C, the Company confirms the total $480k was for executive director fees, non-executive director fees and corporate costs during the quarter.
As detailed in the Appendix 4C, expenditure for the quarter has been spent on $1.484m for research and development, $1.363m for manufacturing and operating costs, $152k for advertising and marketing, $258k staffing costs and $852k for administration and corporate costs.
AskMuncher
4 years ago
$MGCLF Global Arena Holdings Subsidiary Global Election Services Engages DigitalAMN for Strategic Advisory
Press Release | 10/09/2020
NEW YORK, NY, Oct. 09, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire – Global Arena Holding, Inc. (the “Company”) (OTC PINK: GAHC) a growth oriented, acquisition minded Company, focused on specific niche markets offering exponential growth — is pleased to announce that its subsidiary, Global Election Services, Inc. (“GES”) has entered into a strategic advisory agreement with Digital Asset Monetary Network, Inc. (DigitalAMN), to help further the deployment of the GES’ business model.
Currently, GES is internally preparing its application to the Election Assistance Commission. If approved, GES would then have the ability to provide election services to municipal jurisdictions in states using absentee and mail-in ballots for their government elections. GES’ proprietary registration and tabulation system helps to mitigate fraud and outside interference, while allowing Americans voters to continue practicing social distancing during times of pandemic, confidently knowing that their votes ballots are being counted.
DigitalAMN (OTCMKTS: DATI) will look to help GES leverage the success that GES they had in providing election services to many clients including the Firehouse Caucus in March 2020, for the North Dakota Democratic-NPL Presidential Primary election – highlighting GES’ proprietary voter registration and voter tabulation software – whereby the state recognized its largest voter turnout for a primary in over a decade. Furthermore, given GES’ efficient and effective election process for ballots sent through the United States Postal Service and in-person ballots, GES was successful at ensuring a fair and safe election, void of any identifiable voter fraud, hacking, or outside interference that could have impeded the election process.
“We have a good and longstanding history with the CEO of DigitalAMN, who in the past, has been effective in assisting us with both GAHC and GES,” stated John Matthews, Chairman and CEO of Global Arena Holding, Inc. “We believe GES will greatly benefit from the strategic business development, capital sourcing, and market development management services that DigitalAMN will provide.”
GES intends to leverage the extensive expertise of its senior management and its proprietary software to administer election services at state and local levels. There are approximately 3,080 municipal jurisdictions located throughout the United States that are responsible for managing the election process at the state and local levels for an average of 8 to 12 elections that are held each year. These annual elections may include competitive races for School Board Elections, local Mayor, Village Officers, Supervisors, County Executives, County legislators, Governor, State Assembly, State Senate, and US House of Representatives and US Senate, to name a few. As more states increase the adoption of absentee and/or mail-in ballots as an effective option, the opportunity that GES may be retained by municipal jurisdictions grows, affording the Company the ability to increase its absentee, mail-in ballot and in-person business for government elections.
Ajene Watson, CEO of DigitalAMN stated, “I believe that globally, there is roughly $10B in virtually untapped market potential for Universal Absentee, Mail-In Ballots and in-person voting for governmental elections. I also know that GES’ senior staff has an expertise in this area of election services, has been supervising elections since 1981, and has had over 8,500 labor elections certified by the US Dept. of Labor with, impressively, not one labor election ever being overturned due to actions by GES’ senior management. Equally as exciting, GES is capable of providing election services on an International scale as well.
“This all encourages me to leverage the full force of our growing ecosystem to assist GES with its continued business development, visibility, capital formation requirements, and their next stage of growth into governmental elections.”
Management has indicated that the compensation to DigitalAMN for its strategic advisory services can be found in the Company’s most recent filings and includes a retainer, warrants, monthly compensation, and revenue share from new governmental election services.
For more information on these and other developments, please visit: http://GlobalArenaHolding.com, where you can also access all of the Company’s SEC filings, as management continues to pursue a more effective investor relations initiative.
ABOUT GAHC
Global Arena Holding, Inc. trades on the OTC Pink Sheets under the ticker symbol GAHC. The Company has been publicly traded since 2011 and holds a number of interests, including Global Elections Services, Inc., Tidewater Energy Group Inc., and GAHI Acquisition Corp. Please find the Company’s filings at SEC.gov
ABOUT Digital Asset Monetary Network, Inc.
Digital Asset Monetary Network, Inc. (OTCMKTS: DATI) is the first company to utilize the Public Accelerator-Incubator (PAI) model, with the intent to follow the global success of accelerators and incubators around the world, adding niche opportunities to both the microcap and startup communities. As a PAI, Digital Asset Monetary Network will develop and acquire innovations that solve problems through digital platforms and other electronic applications.
Safe Harbor Statement
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements related to the future anticipated direction of the industry, plans for future expansion, various business development activities, planned or required capital expenditures, future funding sources, anticipated sales growth, and potential contracts. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future and, accordingly, such results may differ from those expressed in any forward-looking statements made by, or on behalf of, the company. These risks and uncertainties include, but are not limited to, those relating to development and expansion activities, dependence on existing management, financing activities, domestic and global economic conditions, and other risks and uncertainties described in the Company's periodic filings with the Securities and Exchange Commission.
CONTACT
Global Arena Holding, Inc.
208 East 51st St.
Suite 112
New York, NY 10022
kathryn@globalarenaholding.com
Tel: 646-801-5524
www.globalarenaholding.com
cash4
4 years ago
MGC Pharmaceuticals (ASX:MXC) receives Phase II trial approval for COVID-19 patients
https://themarketherald.com.au/mgc-pharmaceuticals-asxmxc-receives-phase-ii-trial-approval-for-covid-19-patients-2020-04-17/?fbclid=IwAR3SJ9Okpd9XHjtBCOEJv8CCQ9uaTMxT5WrLtosJNOmak7tFss0SPMfh-uI
Ashleigh Melanko
Markets Reporter
ashleigh.melanko@themarketherald.com.au
17 April 2020 13:09
MGC Pharma (ASX:MXC) - Co Founder and Managing Director, Roby Zomer - The Market Herald
Co Founder and Managing Director, Roby Zomer
Sourced: FinFeed
MGC Pharmaceuticals (MXC) will be conducting a Phase II placebo-controlled clinical trial to evaluate the safety and efficacy of ArtemiC in COVID-19 patients
This trial follows the company's recent approval from an Israel-based hospital
ArtemiC, which is a natural anti-infective formulation, is used to target viral infections
The trial is expected to begin this month and finish in September
Results will then be available the following month
Despite there being a pause in trade, MGC Pharma shares have soared 36 per cent and are currently trading for 3.4 cents each
MGC Pharmaceuticals (MXC) will be conducting a Phase II placebo-controlled clinical trial to evaluate the safety and efficacy of ArtemiC in COVID-19 patients.
This trial comes after the company was granted Human Research Ethics Committee approval from Nazareth Hospital EMMS in Israel.
Due to the trial being classified as a "Special Clinical Trial", no more approvals need to be granted before it can begin.
On April 4 2020, MGC Pharma entered a binding agreement with Micelle Technology to provide research support, and commercial manufacturing and distribution of the product.
ArtemiC is a natural, anti-infective formulation that is made up of Artemisinin (a drug derived from a fern-like plant and is used against malaria) and Curcumin (bright yellow chemical which provides anti-inflammatory and antioxidant effects).
It is then mixed with Vitamin C and Boswellia serrata (herbal extract used to treat inflammatory illnesses) as taking Artemisinin by itself may do more harm than good.
Both MGC Pharma and Micelle have begun planning for testing programs to evaluate ArtemiC's anti-infective, anti-viral and anti-inflammatory properties, including on patients with COVID-19.
The Trial
The Phase II trial will evaluate the safety and efficacy of ArtemiC in patients with COVID-19.
The trial is expected to begin this month, following the recruitment of 50 patients with COVID-19.
The trial will be conducted over a period of two weeks per patient and it is expected to finish in September 2020 with results available in October 2020.
If the trial is successful then both MGC Pharma and Micelle will make a decision, based off the results, about future trials.
The end goal for both companies is to achieve full marketing authorisation, however, it was announced that successful outcomes do not necessarily guarantee regulatory approval.
If the trial is unsuccessful then MGC Pharma will examine the results and decide whether to proceed.
"Following our recently announced agreement with Micelle, this approval to proceed immediately with a Phase II clinical trial of ArtemiC is a major milestone," Co-Founder and Managing Director Roby Zomer commented.
"This trial will evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19 and we look forward to updating the market with developments," he added.
Despite there being a pause in trade, MGC Pharma shares have soared 36 per cent and are trading for 3.4 cents each at 12:45 pm AEST.
Love3
5 years ago
An EU-based BioPharma company, MGC Pharmaceuticals Ltd (ASX: MXC) is an expert in the medical cannabis industry. The company’s strategy is to deliver high-quality cannabinoids-based pharmaceuticals products in the European, North American and Australasian medical markets.
MGC Pharmaceuticals announced on 6 May 2019 that it has entered into an exclusive distribution agreement with Grow Biotech and IPS (‘the Parties’) – leaders in UK medical cannabis market. The two parties have an extensive distribution network of above 5,500 pharmacies. As per the agreement, MXC can now have direct access to their distribution channels in the growing UK medical cannabis market.
As per the agreement, Grow Biotech and IPS would render medical import and distribution services to MXC. This would allow the patients residing in the UK to have access to MGC’s propriety products like CannEpilTM for people suffering from epilepsy and CogniCannTM for people suffering from Dementia and Alzheimer.
On 12th April 2019, the MGC Pharmaceuticals obtained a permit to import epilepsy drug into the UK. The company also got its first formal purchase orders from Australia and the UK for CannEpilTM.
Post-UK regulation changes on 1st November 2018, Grow Biotech and IPS provided medicines to the patients directly on 15th February 2019, due to which the specialist doctors got permission to prescribe medical cannabis to their patients. Grow Biotech and IPS were the first companies that imported a bulk shipment of medical cannabis to the UK market. They have an on-site pharmacy to deliver prescriptions directly to a patient’s door.
As indicated in the agreement, Grow Biotech and IPS would ensure that MGC Pharma’s proprietary products would be registered, imported and delivered directly to the end patient. In an effort to support the products’ reception in the UK market, Grow Biotech would offer educational support and would provide product information to UK prescribing doctors.
The initial prescriptions for CannEpilTM have already been received by the Parties. MGC Pharma would help the board Centre for Medical Cannabis, a UK industry membership body in the formation of a supportive regulatory framework. This would enable patients to have smooth access to cannabis-based medications.
According to Roby Zomer, Co-founder and Managing Director of MGC Pharma, this partnership has placed the company as a proven expert in importing medical cannabis products into the UK market.
The terms of the agreement are highlighted below:
Grow Biotech and IPS – exclusive importer and distributor of MGC Pharma’s proprietary Investigational Medicinal Products (‘IMPs’) in the UK.
Grow Biotech and IPS would offer scientific education services and clinic support during the duration of the agreement.
The term of the agreement spans across 5 years of timeframe.
Existence of termination rights in certain cases.
The company is entitled to pay success fees upon specified sales-based milestones.
No specified minimum contract amounts or volumes in the agreement.
The UK medical cannabis market is anticipated to reach €8.8B by 2028, which provides a significant opportunity for MGC Pharma in the UK market. Also, over 500,000 people in the UK are currently diagnosed with epilepsy that can benefit from the CannEpilTM product.
Recently, MGC Pharma had also signed two strategic supply agreements with two medicinal cannabis distribution and logistics companies – Cannvalate and Health House International. Following the contract, MXC’s phytocannabinoid-based products would be accessible under the Special Access Scheme.
A few days ago, the company also partnered with Chinese e-commerce import platform, YuShop Global. The partnership enabled MXC to market and distribute its nutraceuticals CBD based products in the Chinese health products market.
The company also announced its 2019 commercialisation strategy on 2nd April 2019. The strategy was centred around the company’s two core divisions, Seed-to-Pharmacy Manufacturing and Research & Development.
The company’s stock is currently trading at AUD 0.051 (as on 6th May 2019, 3:15 PM AEST), up by 2 percent.
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