TIDMMXC
RNS Number : 6436W
MGC Pharmaceuticals Limited
27 April 2021
27 April 2021 MGC Pharmaceuticals Ltd
ASX Code: March 2021 Quarterly Activity Report
MXC
LSE Code:
MXC
Key Highlights :
-- MGC Pharma becomes the first medicinal cannabis company to
list on the London Stock Exchange following a GBP6.5 million
(A$12m) Placement.
-- The Placement was strongly supported by UK funds and provides
MGC Pharma sufficient capital to expediate its clinical trials and
position the Company for growth.
-- Nicole Godresse appointed as Global Chief Sales Officer to
drive growth in new and existing markets.
-- Record quarterly sales of MGC Pharma's proprietary
phytomedicine product line delivering A$880,000 in revenue.
-- Master supply and distribution agreement secured with leading
European nutraceuticals producer and distributor, Swiss PharmaCan
AG for a minimum of 40,000 units of ArtemiC(TM) Rescue per quarter
of which the first batch has been delivered.
-- Ethics Committee approval from the Rambam Health Care Campus,
Haifa and Nazareth Hospital EMMS in Israel, for the Phase III
clinical trial to evaluate the efficacy and safety of IMP,
CimetrA(TM) .
-- Expanded in-vitro study into the use of SNEDD nano technology
for the treatment of aggressive glioblastoma brain cancer to
commence.
-- Research programs with RMIT and HUJI receive REDI grant from
the European Union to fund three PhD students to focus on research
programs developed on MGC Pharma's CannaHub platform.
MGC Pharmaceuticals Ltd (ASX, LSE: MXC, 'MGC Pharma' or 'the
Company'), a European based bio-pharma company specialising in the
production and development of phytocannabinoid-derived medicines,
is pleased to announce its Quarterly Activity report for the three
months ended 31(st) March 2021.
Roby Zomer, CEO of MGC Pharma , commented: "This has been a
historic quarter for MGC Pharma, following our listing on LSE,
along with record sales for our proprietary pharmaceutical
products. MGC Pharma is well positioned for the future, with
clinical trials for CannEpil Ò and CogniCann(TM) due to begin in
the coming quarter, alongside phase III clinical trials for
CimetrA(TM) , which have the potential to treat the many people
suffering as a result of Covid-19."
" MGC Pharma is now in an excellent position to realise its
potential and build on the foundations that have been set in the
past 12 months, as we remain on target to reach break even this
financial year."
Financial and corporate
The first medicinal cannabis company to list on the London Stock
Exchange
In a landmark achievement, MGC Pharmaceuticals successfully
completed a GBP6.5 million (A$12m) placement to become the first
medicinal cannabis company to list on the London Stock exchange on
the 9(th) of February 2021. MGC Pharma is now a dual listed company
on both the ASX and the LSE.
The placement was led by UK institutions, and supported by
family offices and high net worth investors. The Company issued 441
million new fully paid ordinary shares under the placement at an
issue price of GBP0.01475 per New Share (approximately
A$0.0266).
The completion of the placement and LSE listing puts the Company
in a strong position to continue to pioneer clinical research into
the use of medicinal cannabis, expand its range of proprietary
products and bolster its manufacturing capacities to meet the
rapidly increasing global demand.
Appointment of industry leading Global Chief Sales Officer
As part of its global sales strategy, MGC pharma appointed
industry leading sales executive Nicole Godresse as its Global
Chief Sales officer to implement a focused, global growth strategy,
beginning with Australia and New Zealand.
Nicole brings over 20 years' experience in the
pharmaceutical/healthcare industry, holding senior commercial roles
with major multi-national companies including Eli Lilly, Johnson
& Johnson, Schering-Plough, Merck Sharp & Dohme and most
recently Tilray.
Appointment of Senior Independent Director
In addition, Dr. Stephen Parker has been appointed as Senior
Independent Director in addition to his Chairmanship of the three
Governance Committees. In this role, Dr. Parker will be the first
point of contact for shareholders wishing to contact the company
regarding governance issues and he can be reached by email at
SID@mgcpharma.com.au .
Pharma operations
Record sales
The month of March delivered the best monthly sales revenue for
the Company to date from its pharmaceutical grade phytomedicine
products, with sales of the phytocannabinoid product line in
Australia driving its best monthly unit sales to date with almost
1,500 units sold.
Financial Year Cumulative Phytocannabinoid Product Growth
Graph
http://www.rns-pdf.londonstockexchange.com/rns/6436W_1-2021-4-26.pdf
Worldwide supply and distribution agreement for ArtemiC(TM)
Rescue
MGC Pharma signed a three-year exclusive worldwide supply and
distribution agreement with leading European nutraceuticals
producer and distributor, Swiss PharmaCan AG (SPC), for the
distribution of ArtemiC(TM) Rescue as a food supplement.
This Agreement represents the first sales of ArtemiC(TM) as a
food grade product and Swiss PharmaCan AG has agreed to a minimum
wholesale order quantity to MGC Pharma of 40,000 units per quarter
of ArtemiC(TM) Rescue. Soon after signing this agreement, Swiss
PharmaCan AG increased its initial purchase order by 85% from the
original wholesale order received which equates to whole revenue in
excess of A$425,000 (+ EUR275,000) to the Company. This product
revenue combined with its phytocannabinoid revenue has led to the
highest quarterly sales on record, of A$880,000, of which A$505,000
was received in cash during the quarter (30 day terms on
ArtemiC(TM) .
The Company will be responsible for providing ArtemiC(TM) Rescue
to SPC and has the ability to produce commercial scale batches of
both products through its current manufacturing capacity and
production facility in Slovenia.
Subsequent to the quarter end, MGC Pharma completed delivery of
the first bulk order to Swiss PharmaCan AG.
Malta Facility
As announced to the market on 10 December 2020, the Company has
received access to a cash grant to cover 80% of the construction
costs of an EU-GMP manufacturing facility up to the value of 3.1m
Euro (A$4.8m). The primary use of the facility will be to produce
CimetrA (TM) and other liquid dose medicines as required.
Construction of the facility is well underway, with almost half
of the grant received at 31 March 2021. It is expected that the
facility will be completed within budget, and operational later in
the year.
Research and development
Ethics committee approval for phase III clinical trial
During the quarter, MGC Pharma received Ethics Committee
approvals from Rambam Health Care Campus, Haifa and Nazareth
Hospital EMMS in Israel, for the Phase III clinical trial to
evaluate the efficacy and safety of CimetrA(TM) as a treatment for
moderate hospitalised patients diagnosed with COVID-19, and to
provide additional data for claims on the product as an
Investigational Medicinal Product (IMP).
Under the move to a Phase III clinical trial, the classification
of the product has changed from a food supplement to an IMP. As a
result, the product name under the Trial has changed from
ArtemiC(TM) to CimetrA(TM) . CimetrA(TM) becoming an IMP will
include changing the drug carrier to a new polymeric drug carrier
GraftBio(TM) (SNEDD - Self Nano Drug Delivery), with a view to
potentially being registered as a drug in the future.
The trial is expected to commence in April, with placement of
the clinical trial insurance now complete, and is to be evaluated
on a total target number of 252 patients infected with COVID-19,
across clinical sites in Israel and Brazil. The interim Trial
results are expected to be received and published by June 2021.
The trial will be conducted over a period of 28 days per patient
and is expected to conclude in September 2021, with results
released in October 2021.
In-vitro cannabinoid study on Glioblastoma treatment to
commence
MGC Pharma's research program into the use of cannabinoids in
the treatment of aggressive glioblastoma brain cancer has been
expanded to explore the use of nano technology during treatment, in
collaboration with the Slovenian National Institute of Biology and
Neurosurgery Department at the University Medical Centre.
The Study is focused on testing cannabinoid formulations on
fresh glioblastoma tumour tissues, obtained from patients after
surgical removal of the tumour to determine the optimal cannabinoid
preparation for the effective treatment of the remaining cancer.
The objective of the pre-clinical in-vitro research is to develop
novel formulations and define the clinical protocols for clinical
trials for the treatment of high-grade brain tumours with
cannabinoids.
The Study has now been expanded to include testing the effect of
both cannabidiol ('CBD') and cannabigerol ('CBG') on tumour cells
when delivered via a nanoparticle delivery system. Nanoparticles
are believed to improve the bioavailability of the drug in
overcoming brain barrier issues. This is being optimised using
SNEDD (Self Nano-Emulsifying Drug Delivery).
The in-vitro preclinical study will be focused on defining the
most efficient cannabinoid nano-emulsion preparations of CBD and
CBG that are likely to benefit to each individual patient that
differ in (a) glioblastoma sub-types and (b) most relevant
cannabinoid receptors.
European Union REDI grant to advance research Programs
MGC Pharma, in collaboration with the Royal Melbourne Institute
of Technology (RMIT) and The Hebrew University of Jerusalem (HUJI),
has been awarded a REDI grant from the European Union, which funds
three Doctoral candidates for three years, with a focus on research
programs developed on MGC Pharma's CannaHub platform.
This presents a great opportunity for MGC Pharma to
significantly expedite the progress of its ongoing research
projects by working with leading academic institutions, and will
raise the level of academic engagement for cannabinoids by
providing further legitimacy for the industry.
MGC Pharma will also be involved in the scientific publication
of projects as researchers publish their findings while retaining
the right to fully commercialise any and all IP developed under the
program .
Conversion of Options
During the quarter, the Company received A$918,329 following the
conversion of 16,162,864 unlisted and listed options at various
prices.
Appendix 4C
The Company had A$10.5m cash at bank at the end of the March
2021 quarter following the completion of the GBP6.5m LSE IPO
capital raising and its operating activities for the quarter, with
access to an additional A$9.25m undrawn from its A$15m financing
facility with Mercer Street Opportunity Fund LLC, which as
announced on 9 March 2021 the Company has no plans to draw down on
following its successful LSE listing and capital raising. The
Company also received A$918k during the quarter via the conversion
of both unlisted and listed options, and A$1.2m from Malta
Enterprises as a grant for the Malta facility.
In accordance with Section 6 of the attached Appendix 4C, the
Company confirms during the quarter payment to related parties
totalling A$300k relates to four (4) months expenditure of
Executive Director fees, Non-Executive Director fees and corporate
costs. As detailed in the Appendix 4C, expenditure for the quarter
has been spent on A$1.5m for research and development, A$1.05m for
manufacturing and operating costs (including inventory), A$100k for
advertising and marketing, A$570k staffing costs and A$918k for
administration and corporate costs (including Director fees).
--Ends--
Authorised for release by the Board, for further information
please contact:
MGC Pharmaceuticals Ltd UK PR Advisors - Tavistock
Roby Zomer Charles Vivian
CEO & Managing Director +44 207 920 3150
+61 8 6382 3390 Charles.Vivian@tavistock.co.uk
info@mgcpharma.com.au
UK Broker - Turner Pope Australian IR Advisors - Media
Andy Thacker & Capital Partners
+44 203 657 0050 Rod Hinchcliffe
www.turnerpope.com +61 412 277 377
Rod.Hinchcliffe@mcpartners.com.au
About MGC Pharma
MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based
bio-pharma company developing and supplying affordable standardised
phytocannabinoid derived medicines to patients globally. The
Company's founders were key figures in the global medical cannabis
industry and the core business strategy is to develop and supply
high quality phytocannabinoid derived medicines for the growing
demand in the medical markets in Europe, North America and
Australasia. MGC Pharma has a robust product offering targeting two
widespread medical conditions - epilepsy and dementia - and has
further products in the development pipeline.
Employing its 'Nature to Medicine' strategy, MGC Pharma has
partnered with renowned institutions and academia to optimise
cultivation and the development of targeted phytocannabinoid
derived medicines products prior to production in the Company's
EU-GMP Certified manufacturing facility.
MGC Pharma has a number of research collaborations with world
renowned academic institutions, and including recent research
highlighting the positive impact of using specific phytocannabinoid
formulations developed by MGC Pharma in the treatment of
glioblastoma, the most aggressive and so far therapeutically
resistant primary brain tumour.
MGC Pharma has a growing patient base in Australia, the UK,
Brazil and Ireland and has a global distribution footprint via an
extensive network of commercial partners meaning that it is poised
to supply the global market.
Follow us through our social media channels
Twitter: @MGC_Pharma
Facebook: @mgcpharmaceuticals
LinkedIn: MGC Pharmaceuticals Ltd.
Instagram: @mgc_pharma
Appendix 4C
Quarterly report for entities subject to Listing Rule 4.7B
Name of entity
------------------------------------------------------
MGC PHARMACEUTICALS LTD
ABN Quarter ended ("current quarter")
---------------- ----------------------------------
30 116 800 269 31 MARCH 2021
----------------------------------
Consolidated statement of cash Current quarter Year to date
flows $A'000 (9 months)
$A'000
1. Cash flows from operating
activities
1.1 Receipts from customers 505 1,369
1.2 Payments for
(a) research and development (1,542) (3,836)
(b) product manufacturing
and operating costs
i) cost of sales / inventory (499) (1,717)
ii) operating costs (544) (1,110)
(c) advertising and marketing (103) (322)
(d) leased assets - -
(e) staff costs (570) (1,383)
(f) administration and corporate
costs (918) (2,342)
1.3 Dividends received (see note - -
3)
1.4 Interest received 1 4
Interest and other costs of
1.5 finance paid (2) (4)
1.6 Income taxes paid - -
Government grants and tax
1.7 incentives 1,209 2,698
1.8 Other (provide details if - -
material)
---------------- -------------
Net cash from / (used in)
1.9 operating activities (2,463) (6,643)
----- -------------------------------------- ---------------- -------------
2. Cash flows from investing
activities
2.1 Payments to acquire:
(a) entities - -
(b) businesses (200) (400)
(c) property, plant and equipment (157) (2,020)
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
2.2 Proceeds from disposal of:
(a) entities - -
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - 312
(e) intellectual property - -
(f) 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)
---------------- -------------
Net cash from / (used in)
2.6 investing activities (357) (2,118)
------- ------------------------------------ ---------------- -------------
3. Cash flows from financing
activities
Proceeds from issues of equity
securities (excluding convertible
3.1 debt securities) 11,722 11,723
Proceeds from issue of convertible
3.2 debt securities - 5,750
Proceeds from exercise of
3.3 options 918 920
Transaction costs related
to issues of equity securities
3.4 or convertible debt securities (792) (852)
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 (loan to third party) (38) (38)
---------------- -------------
Net cash from / (used in)
3.10 financing activities 11,810 17,503
------- ------------------------------------ ---------------- -------------
4. Net increase / (decrease)
in cash and cash equivalents
for the period
Cash and cash equivalents
4.1 at beginning of period 1,571 1,887
Net cash from / (used in)
operating activities (item
4.2 1.9 above) (2,463) (6,643)
Net cash from / (used in)
investing activities (item
4.3 2.6 above) (357) (2,118)
Net cash from / (used in)
financing activities (item
4.4 3.10 above) 11,810 17,503
Effect of movement in exchange
4.5 rates on cash held (87) (155)
---------------- -------------
Cash and cash equivalents
4.6 at end of quarter 10,474 10,474
------- ------------------------------------ ---------------- -------------
5. Reconciliation of cash and Current quarter Previous quarter
cash equivalents $A'000 $A'000
at the end of the quarter
(as shown in the consolidated
statement of cash flows) to
the related items in the accounts
5.1 Bank balances 10,419 1,516
5.2 Call deposits 55 55
5.3 Bank overdrafts - -
5.4 Other (provide details) - -
---------------- -----------------
Cash and cash equivalents
at end of quarter (should
5.5 equal item 4.6 above) 10,474 1,571
---- ----------------------------------- ---------------- -----------------
6. Payments to directors of the entity and Current quarter
their associates $A'000
Aggregate amount of payments to related
parties and their associates included in
6.1 item 1 300
----------------
6.2 Aggregate amount of payments to related -
parties and their associates included in
item 2
----------------
Note: if any amounts are shown in items 6.1 or 6.2, your
quarterly activity report must include a description of,
and an explanation for, such payments
-------------------------------------------------------------------
7. Financing facilities available Total facility Amount drawn
Note: the term "facility' amount at quarter at quarter end
includes all forms of financing end $A'000
arrangements available to $A'000
the entity.
Add notes as necessary for
an understanding of the sources
of finance available to the
entity.
7.1 Loan facilities - -
------------------- ----------------
7.2 Credit standby arrangements - -
------------------- ----------------
7.3 Other (please specify) 15,000 -
------------------- ----------------
7.4 Total financing facilities 15,000 -
------------------- ----------------
Unused financing facilities available at
7.5 quarter end 9,250
----------------
7.6 Include in the box below a description of each facility
above, including the lender, interest rate, maturity date
and whether it is secured or unsecured. If any additional
financing facilities have been entered into or are proposed
to be entered into after quarter end, include a note providing
details of those facilities as well.
---- ------------------------------------------------------------------------
A$15M Convertible note facility with Mercer Street Opportunity
Fund LLC. Refer to ASX announcement on 10 September 2020 for
further information.
8. Estimated cash available for future $A'000
operating activities
Net cash from / (used in) operating
8.1 activities (Item 1.9) (2,460)
Cash and cash equivalents at quarter
8.2 end (Item 4.6) 10,474
Unused finance facilities available
8.3 at quarter end (Item 7.5) 9,250
Total available funding (Item 8.2
8.4 + Item 8.3) 19,724
Estimated quarters of funding available
8.5 (Item 8.4 divided by Item 8.1) 8.02
---- -------------------------------------------------------
8.6 If Item 8.5 is less than 2 quarters, please provide answers
to the following questions:
1. Does the entity expect that it will continue to have
the current level of net operating cash flows for the
time being and, if not, why not?
-------------------------------------------------------------------
Answer:N/A
-------------------------------------------------------------------
2. Has the entity taken any steps, or does it propose
to take any steps, to raise further cash to fund its operations
and, if so, what are those steps and how likely does it
believe that they will be successful?
-------------------------------------------------------------------
Answer: N/A
-------------------------------------------------------------------
3. Does the entity expect to be able to continue its operations
and to meet its business objectives and, if so, on what
basis?
-------------------------------------------------------------------
Answer: N/A
-------------------------------------------------------------------
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.
27 April 2021
Date:
...................................................................................
[lodged electronically without signature]
Authorised by:
...................................................................................
Roby Zomer - Managing Director
Notes
1. This quarterly cash flow report and the accompanying activity
report provide a basis for informing the market about the entity's
activities for the past quarter, how they have been financed and
the effect this has had on its cash position. An entity that wishes
to disclose additional information over and above the minimum
required under the Listing Rules is encouraged to do so.
2. If this quarterly cash flow 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 cash flow 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.
4. If this report has been authorised for release to the market
by your board of directors, you can insert here: "By the board". If
it has been authorised for release to the market by a committee of
your board of directors, you can insert here: "By the [name of
board committee - eg Audit and Risk Committee]". If it has been
authorised for release to the market by a disclosure committee, you
can insert here: "By the Disclosure Committee".
5. If this report has been authorised for release to the market
by your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance
Council's Corporate Governance Principles and Recommendations, the
board should have received a declaration from its CEO and CFO that,
in their opinion, the financial records of the entity have been
properly maintained, that this report complies with the appropriate
accounting standards and gives a true and fair view of the cash
flows of the entity, and that their opinion has been formed on the
basis of a sound system of risk management and internal control
which is operating effectively.
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END
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