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| Date | 23 Sept 2022 |
| Time | 07:00:08 |
| Category | Miscellaneous |
| ID | 4303A |
MGC Pharmaceuticals Ltd.
US$550,000 in funding received under Mercer Facility
23 September 2022
ASX, LSE: MXC
MGC Pharmaceuticals Ltd (ASX, LSE: MXC, 'MGC Pharma' or 'the Company'), a European based bio-pharma company specialising in the production and development of plant based medicines, confirms that it has received a further US$550,000 of funding under the US$10 million Convertible Securities Financing Facility with Mercer Street Global Opportunity Fund, LLC, a fund managed by Mercer Street Capital Partners, LLC, a United States-based institutional fund manager (together, "Mercer") announced on 29 July 2022 (US$10m Financing Agreement).
Under the terms of the US$10m Financing Agreement the Company will now proceed to issue Mercer 605,000 convertible notes with a face value of US$1.00 each.
The US$550,000 of funds received from Mercer will be used as working capital to fund MGC's ongoing operations, including Clinical Trials.
--Ends--
Authorised for release by the Chairman, for further information please contact:
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MGC Pharmaceuticals Ltd Roby Zomer CEO & Managing Director +61 8 6382 3390 |
MGC Pharmaceuticals Ltd David Lim Company Secretary +61 8 6382 3390 |
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UK Broker - Turner Pope Andy Thacker +44 203 657 0050 |
UK PR Advisors - Tavistock Charles Vivian / Tim Pearson +44 207 920 3150
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About MGC Pharma
MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based bio-pharma company, focused on developing and supplying affordable (Accessible) and Ethically Produced Plant Inspired Medicines, which combining Inhouse Research with Innovative technologies, with the goal to find treatments to Unmet medical conditions.
The Company's founders and executives are key figures in the global pharmaceuticals industry and the core business strategy is to develop and supply high quality plant inspired medicines for the growing demand in the medical markets in Europe, North America and Australasia.
MGC Pharma has a robust development pipeline targeting two widespread medical conditions - epilepsy and dementia - and has further products under development. Employing its 'Nature to Medicine' strategy, MGC Pharma has partnered with renowned institutions and academia to optimise the development of targeted plant inspired medicines, to be produced in the Company's EU-GMP Certified manufacturing facilities.
MGC Pharma has a number of research collaborations with world renowned academic institutions, recent research highlights include the potential impact of using specific 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
Facebook: @mgcpharmaceuticals
LinkedIn: MGC Pharmaceuticals Ltd.
Instagram: @mgc_pharma
Annexure A
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Protocol Title |
A Phase IIb, double blind, placebo-controlled clinical study designed to evaluate the effect of CimetrA in patients diagnosed with COVID-19 |
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Study Arms |
STUDY DRUG - CIMETRA will be administrated as the following: Arm 1: CimetrA-1, with a total dose containing a combination of Curcuma longa rhizome dry extract 28 mg, Boswellia serrata resin dry extract 60 mg in spray administration - divided in 4 separate doses given as an add on therapy, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). Arm 2: CimetrA-2, with a total dose containing a combination Curcuma longa rhizome dry extract 19.6 mg, Boswellia serrata resin dry extract 42 mg in spray administration - divided in 4 separate doses given as an add on therapy, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). Arm 3: Placebo, composed of the same solvent but without active ingredients, given as an add on therapy in spray administration, total of 4 doses over 48 hours (day 1 and day 2), twice a day (morning and evening). Patients will be randomized in 1:1:1 ratio to one of the three arms. |
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Study Purpose |
This study designed to evaluate the efficacy, pharmacokinetic parameters, and safety of CimetrA on patients diagnosed with COVID-19. |
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Methodology and study procedures |
· Multi-center multinational-controlled study in Israel, Russia, South-Africa and the United States. · 240 adult patients who suffer from moderate COVID-19 infection. · Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs. · After Screening visit, the study drug will be administrated twice a day morning and evening (every 12 hours) during (day 1 and day 2) · The patients will be randomized in 1:1:1 ratio to study drug (CimetrA) in two dosages in addition to Standard of Care - Arm 1, 2 or (Placebo) in addition to Standard of Care- Arm 3. |
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Study Duration |
Study will take place during patient's hospitalisation due to COVID-19 infection. The study will last up to 4 weeks, until conclusion on day 28. In case of hospital discharge within the study period, follow up will continue per protocol until day 28 wherever the subject will be located, performed via phone call or in-clinic, depending on the status of the patient and study schedule. |
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Study Endpoints |
The primary outcomes: Efficacy endpoint: - Change in WHO Ordinal Scale for clinical improvement (measured on days 1, 7, 14, 28) - Change in COVID-19-Related Symptoms score (measured on days 1,7, 14, 28) Safety endpoint: will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs. The secondary outcomes: · Number of participants with depending on oxygen supplementation through day 28 since onset of symptoms · Change in inflammatory marker levels - IL-6, IL-1β, IL-12, TNF α, IFN-γ, CRP, NLR (Neutrophil / Lymphocyte ratio) at days 1, 2, 4, 7, compared to baseline · Pharmacokinetic profile of the study drug on day 1 through 24 Hrs. · Incidence and duration of mechanical ventilation · Incidence of Intensive Care Unit (ICU) stay during COVID-19 complication · Percentage of participants with definite or probable drug related adverse events · Long term adverse events of COVID-19 on Day 28 · The impact of COVID-19 on quality of life of patients on Days 1, 14 and 28. The exploratory outcomes: · Course of change in D Dimer levels compared to baseline · Occurrence of secondary infections |