Mgc Pharmaceuticals Share Discussion Threads

[looneytune] 07/5/2023 15:07

It’s Roby Zomer that’s driving this company. It takes time.

[sloppyjoe2] 07/5/2023 14:59

Well if more significant progress - ie approvals, sales - isn't made in say the next 6-12 months, then a change at the top would be necessary...

[scooby25] 07/5/2023 14:02

As they said they seem to be on the right track however it's been a very long journey up to this point. I wonder if a change of CEO would do any good

[sloppyjoe2] 07/5/2023 13:19

Scooby - that's what I'd hope for. But for that to happen they will need approvals in more markets and to sell a *lot* more product...

[scooby25] 07/5/2023 11:46

What's the expectation here ? Takeover and 10-20p sale price or is that too optimistic.

[sloppyjoe2] 05/5/2023 14:03

Must confess, didn't expect it to keep falling. Looks to me like the pieces are falling into place - but WTF do I know?

[sloppyjoe2] 03/5/2023 16:48

Bought another 111-thousand odd shares. Hopefully with the Malta plant now approved, OTC approval for the EU may follow?

[sloppyjoe2] 03/5/2023 00:38

Yes, I expected to see a tick up, if only a couple of points...

[kenbos] 02/5/2023 23:58

No market reaction and a couple of million plus trades

[sloppyjoe2] 02/5/2023 09:16

Looks like good news to me!

[looneytune] 02/5/2023 06:00

MXC New Announcement - [Price Sensitive] - Malta Production Facility Receives EU-GMP Approval
MGC’s Maltase fully automated, large scale pharmaceutical production facility has now been granted EU-Good Manufacturing Practice (GMP) certification.

• Formal grant of GMP accreditation, an internationally recognised standard, guarantees high quality, standardised production protocols and further enables quality control of MGC
proprietary products within key markets globally.

• The facility was built with the support of an 80% EU cash funded grant from Malta Enterprises, with the facility commissioned during 2022.

• The facility will be able to produce all MGC medicines and supplements and will be able to provide third party production services for other pharmaceuticals companies – adding a new potential revenue stream for MGC Pharma.

• MGC’s in house production capacity in Malta is now over 20,000 units a day of finish dose forms, which can support all future needs of CannEpil® and CimetrA™ once marketing
authorisation is obtained in USA and Europe.

[sloppyjoe2] 01/5/2023 14:42

It does seem as though there is growing interest in the whole cannabis sector. Of course there's a world of difference between retail (ie selling weed to people) and the Pharma side of things - but hopefully increased interest in the former might help raise the profile of the latter...

[sloppyjoe2] 30/4/2023 20:34

Good link pillow, thank you.

[pillow] 30/4/2023 13:59

https://www.ft.com/content/1b2e8e3e-27c8-404b-b90d-cb89352b8b9f

[marvelman] 30/4/2023 09:15

Pillow..thanks for those links...both interesting

[sloppyjoe2] 29/4/2023 18:45

Scooby - who knows? I'm invested, so obviously I hope it will, but there's a long way to go yet. So far, though, the company does seem to be doing everything right. If the Malta facility is approved to schedule (ie H1 this year) that will be a big milestone IMO. After that, we'll just have to wait and see. IF it all goes well then yes, in a year or two or three this could be a major winner...

[pillow] 29/4/2023 16:04

https://stockhead.com.au/experts/moneytalks-two-biotechs-and-a-fitness-stock-that-are-set-to-blast-off-according-to-brokers/

[pillow] 29/4/2023 15:40

https://www.telegraph.co.uk/global-health/science-and-disease/india-covid-wave-deaths-variant-latest/

[scooby25] 29/4/2023 14:13

Do you think this will actually come good though ? I have a funny feeling it might.

[pierre oreilly] 29/4/2023 10:11

It's usually those who invested a hundred quid at a far higher price and can't take their loss. So they blame the company, other posters and anyone else except themselves. They should stop cutting themselves up, sell their remaining five quids worth and find another hobby rather than investment.

[sloppyjoe2] 28/4/2023 14:47

Marvelman - good summary.

[marvelman] 28/4/2023 12:55

Yes indeed Heatwave. Unfortunately it touches us all in one way or another. I cannot fathom why people take so much pleasure in extolling their hate on these BB's but it has always been that these pitiful people have done so. I do filter and ignore and never tempted to open their case again. I wish more would do so. Anyway, after a long period of absence I have re-entered with a very token purchase. Clearly the constant request for funds and the sources they come from with the associated freebies are the big issue. However, the product and offering is beyond question so its a question of patience with a watchful eye. Regards.

[heatseek77] 28/4/2023 12:39

Hi marvelman thank you. I am but not to extent a year half ago....
Tbh I've lost many friends and family to cancer (one at 21 + one 32) so anything that may take the pain, help with inflammation, etc away Id support

[marvelman] 28/4/2023 09:53

A few Plus Coins for you Heatseek to counter the vile ramblings of some on this BB. I assume you are still invested?

[heatseek77] 28/4/2023 07:33

RNS Number : 8526X

MGC Pharmaceuticals Limited

28 April 2023

MGC Pharmaceuticals Ltd.

March 2023 Quarter Activity Report and

Cash Flow Statement

28 April 2023

ASX, LSE: MXC

Key Highlights :

-- Clinical trials to be used in the US FDA Investigational New Drug submission continue to demonstrate the efficacy and the anti-inflammatory effects of CimetrA(TM); these include pharmacokinetic profile and Mechanism of Action studies.

-- Over the Counter Status granted to COVID-19 treatment ArtemiC(TM) in the USA, can now be stocked on USA pharmacy shelves; supply and distribution partner, AMC, has submitted a purchase order to the value of US$2 million following the listing on the National Drug Code Database.

-- First patient enrolled in the ZAM app in association with an observational trial for CannEpil(R) on patients with Refractory, or drug resistant, Epilepsy.

-- MGC Pharma concluded a successful fundraise of c. GBP2.09m post quarter end supported by new and existing shareholders, brokers, and high net worth individuals in both the UK and Australia.

MGC Pharmaceuticals Ltd (' MGC Pharma' or ' the Company ') a European based pharmaceutical company specialising in the production and development of plant inspired medicines is pleased to provide its Quarterly Activity Report for the three months ending 31(st) March 2023.

Roby Zomer, co-founder, Managing Director and CEO of MGC Pharmaceuticals, commented : "The March quarter has proved significant for the Company as we advance progress toward Investigational New Drug (IND) submission with the FDA for key proprietary products, CimetrA(TM) and ArtemiC(TM). This clinical trial pathway and pipeline have been major catalysts in the fundraise and activities post quarter end, and we will continue to build on this momentum, increasing our global retail footprint and meeting the highest standards of pharmaceutical excellence."

Company Activities

CimetrA(TM)

MGC Pharma completed pre-clinical rodent studies on CimetrA(TM) in January, a major step in the clinical pathway to the targeted US Food and Drug Administration (FDA) IND Submission. Research using rodent and mammalian models were used to delineate the pharmacokinetic profile and general safety of the drug, as well as identifying toxicity patterns over a given period for the treatment before it advances to the next stage of trials, as stipulated in the FDA criteria. No anomalies were observed over the course of the study, nor were any clinical or behavioural adverse events recorded.

In March, the Company completed the pre-clinical study on CimetrA(TM), exploring the Mechanism of Action (MoA) of the product. The study showed that the administering of CimetrA(TM) following a stimulated immune response resulted in a significant decrease in IL-32 mRNA expression and a subsequent decrease in inflammation. This study was the final preclinical mechanism of action study and will enable the Company to expand future trials to show its efficacy against further indications. The study results will form part of the FDA application to register CimetrA(TM) as an IND.

ArtemiC(TM)

In March, ArtemiC(TM) , MGC Pharma's proprietary, clinically tested COVID-19 treatment, was granted over-the-counter (OTC) status on the National Drug Code Database (NDC) of the FDA, facilitated by MGC Pharma's supply and distribution partner, AMC Pharma, LLC. ArtemiC(TM) can now be found on the FDA National Drug Code Directory under the code: 83278.

OTC status means that AMC will be able to sell ArtemiC(TM) via US-based Pharmacy Benefit Management (PBM) networks, including prescription discount services, from April 2023. AMC are negotiating with the largest US pharmacy networks, and independent pharmacies for the inclusion of ArtemiC(TM) in shelf space now that the NDC has been listed, increasing retail access and subsequent sales.

Following the NDC Listing, AMC submitted a purchase order for US$2m of ArtemiC(TM), with production to commence immediately, for delivery in two instalments in Q3 and Q4 of this year. The NDC status is a major breakthrough for the company, as MGC Pharma works to expand global footprint and retail access.

CannEpil(R) and ZAM

The first patient was enrolled in the Company's proprietary d ata collection app and machine learning algorithm, ZAM, in order to log the data from an observational study monitoring the effects of CannEpil(R), MGC Pharma's epilepsy treatment. The app is recording daily metrics from patients, their symptoms, and the impact of their treatment in order to establish a baseline. This will provide both MGC Pharma and medical practitioners with a detailed record of the study and an enhanced understanding of the effects of CannEpil(R) on Refractory Epilepsy patients.

March Quarter Sales Update

MGC Pharma revenue in the March quarter was lower than average mainly due to seasonality issues with new year sales and establishing new pharma regulatory approvals and distribution channels for CannEpil in the UK and key EU markets, core activities that will build strong foundation for future growth.

Admin, staff and corporate costs were reduced by 3% in the March quarter due to a costs rationalisation review.

Funding and Cash Flow Reporting

Using the US$10 million Convertible Securities Financing Facility with Mercer Street Global Opportunity Fund, LLC, a fund managed by United States-based institutional fund manager Mercer Street Capital Partners, LLC, MGC Pharma drew down US$1,100,000 during the quarter. This will be used to fund working capital requirements and to further our clinical trial pathway and pipeline.

At the end of March, the Company had A$315K of cash on hand, and A$7.65m (US$5.05m) of funding capacity available under the Mercer US$10m Convertible Securities facility.

Accompany this Activity Report is a Cash Flow Report for the Quarter ending 31 March 2023.

In accordance with ASX Listing Rule 4.7C.3 the Company advises that during the March 2023 quarter, payments to related parties totalled A$172K, which consisted of fees paid to executive and non-executive directors of the Company.

As detailed in the accompany Appendix 4C (Quarterly Cash Flow Report), cashflows during the quarter included $38K cash outflows associated with inventory production, A$2.46m for administration costs (including product registration costs), and cash inflows A$1.58m in funding received from the drawdown of the Mercer Convertible Security facility.

Activities Post Quarter End

Post quarter end, the company successfully ra ised an aggregated GBP2.09 million (A$ 3.82m ) by way of a conditional placing of 476,132,620 new ordinary shares of no par value in the capital of the Company at a price of 0.44 pence (0.8 cents) per Placing Share, and 238,066,311 Fundraise Options . The Placing was supported by a mix of new and existing institutional and high net worth shareholders in both the UK and Australia, including Premier Miton and Cantheon Capital, in addition to the supplementary Broker Options raise.

Corporate and Commercial News

Over the course of the quarter, a number of personnel and advisor changes were announced:

Appointment of Auditor

The Company appointed Australian Chartered Accounting firm, Hall Chadwick Chartered Accounts ("Hall Chadwick"), as its external financial auditor, following a review of the Company's external auditor arrangements, and its cost reduction strategy. The board has selected Hall Chadwick based on their expertise, capacity to undertake the 31 December 2022 audit review, and fee structure. Hall Chadwick is also the Company's incumbent Australian taxation advisor, which is expected to provide synergies in service delivery.

Personnel changes

The Board announced the resignation of non-executive director Mr Evan Hayes, as part of the Company's transition to a dedicated life sciences pharmaceuticals company. As a result of Mr Hayes' departure, MGC Pharma's board will be reduced to 5 directors, with the Company continuing to evaluate the composition of the board over the next 6 months to ensure that it reflects its position as a European based life sciences pharmaceutical company.

Company Secretary and CFO

Tom Cairns, previously MGC's Group Financial Controller, was promoted to MGC Pharma's Chief Accounting Officer (CFO equivalent).

Messrs Rowan Harland and Arron Canicais of SmallCap Corporate Pty Ltd, a Perth based corporate advisory firm, have been appointed Joint Company Secretaries.