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FulHold 2018-03-Investor-Update
FulHold 2018-03-Investor-Update
Fulhold Pharma Ltd ‐ Investor Update March 2018
1. Belvedere Managed Funds in Administration:
The majority of the liquidated shareholdings under consideration are in the process of being
transferred ‘in specie’ from the previous funds to the individual shareholders and we have been
working with the various bodies to complete this as quickly as possible. We have unofficially
been advised that a satisfactory conclusion has been reached regarding those shares within the
disputed loan‐to‐equity transaction into which we entered in good faith. This whole process has
taken far longer than we of course would have liked but it has always been our intention to
provide the highest levels of communication and co‐operation possible across the various
bodies and jurisdictions. This involves dealing with Price Waterhouse Coopers, Grant Thornton,
Deutsche Bank etc. across locations including Mauritius, Grand Cayman and Guernsey among
others. We are confident that the majority of the transfers will be completed by the end of April
this year. We will keep you informed of this situation as and when there are significant
developments.
2. Regulatory Update:
a) MHRA (The UK Medicines and Healthcare products Regulatory Agency):
Having prepared and submitted several documents to the MHRA Innovations team in the U.K.
we met with them in September 2017. And the MHRA team were positive, helpful and
supportive. In summary, they advised us to gain a better understanding of the quantification of
the components of CHD‐FA and that, in turn, will help determine how much data is needed on
each one. This is a significant milestone in the roadmap to CHD‐FA being recognised and
considered as a pharmaceutical agent and Imelda Jordaan is progressing the work to address the
detailed points the MHRA made.
b) FDA (The U.S. Food and Drugs Administration):
The potential DoD funding we were aiming for became unavailable, and, also as a result of the
MHRA advice mentioned above, we decided to seek consultancy support as to how best to
progress matters with the FDA.
We are delighted to now be working closely with Bill Gannon
(https://www.bloomberg.com/research/stocks/people/person.asp?personId=27349958&privca
pId=2387973).
We have just finalised a comprehensive pre‐IND (Investigative New Drug Application) submission
outlining CHD‐FA in general and its proposed use in a wound gel. Bill, along with Prof. David
Perlin and Prof. Jacques Snyman will be meeting with the FDA (dates tbd but hopefully in May of
this year) to seek advice as to how best progress this and secure IND status in order to attract
DoD funding and initiate clinical trials. The combination of the positive reaction and advice we
received from the MHRA, our more detailed understanding of the quantification of CHD‐FA, the
quality of the FDA submission and the profile of the team we are fielding gives us confidence
that this will result in another significant regulatory step for us.
N.B. We are now in conversation with the two of the world’s largest and most influential
Pharmaceutical Regulators with a wealth of credible evidence from which to draw. This is, of
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Fulhold Pharma Ltd ‐ Investor Update March 2018
course, the means to an end and not the end itself but at least now the end is beginning to be in
sight.
c) Recent Accreditations:
i. As a fully certified GMP facility for the manufacturing, formulation and packaging of
an Active Pharmaceutical Ingredient (API)
ii. Pharmacy Premises Licence
iii. Licence to Manufacture and Export Medicines
iv. Certification as a Disinfectant for the Food Industry (for our product, Fulvisan D for
which we have recently received test results showing it to be highly effective against
Listeria)
v. Halaal Certification ‐ renewal
vi. Food Safety Systems Certification (FSSC) – renewal
vii. Certification as 100% Organic ‐ renewal
viii. Registration as a Small/Medium Sized Enterprise (SME) with the European
Medicines Agency (EMA) – renewal
ix. We have had an application in with JECFA* for the last 2 years to have CHD‐FA
recognised as a Food Additive at a specific dosage. This is an intensive project with
regular interactions between the SA Department of Health and Fulvimed as only
governments can present to JECFA. It is hoped to have this completed in the next 18
months
* JECFA is an international scientific expert committee administered jointly by the
Food and Agriculture Organization of the United Nations (FAO) and WHO.
x. The application to have CHD‐FA included within the British Pharmacopeia as a new
drug has been completed and submitted. Recognition of CHD‐FA as an Active
Pharmaceutical Ingredient (API) will generate great interest in the pharmaceutical
world and we are confident that this will happen by the end of 2018.
3. Administration:
a) South African Business Performance:
You will recall from the last update that we have been experiencing a dramatic downturn in the
SA operations. We can confirm that agreements have been signed and we are now no longer
bound to any exclusivity agreements with both Ascendis as well as Dischem. The new Bio
Balance product range has been launched by Ascendis we have been assured that initial stock
level issues these have been sorted and all stores are now fully stocked. We have already started
receiving good news of repeat orders for some of the items already. We are confident that the
trading year 2017 to end Feb 2018, is the last year that we will ever see a loss in the South
African trading operations.
b) Tax / year‐end accounting:
February 2018 financial statements have been finalised and
submitted to Companies house. We are currently finalising the Annual Financial Statements for
all the group companies. The South African operations are complete and with the auditors. We
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Fulhold Pharma Ltd ‐ Investor Update March 2018
expect the final consolidated Financials to be ready by end of May this year. You will be advised
as soon as they are listed on the web site.
c) Location(s):
At this stage there is no change to our belief that the next plant we have to put up will be based
in the USA. We will make further plans after we understand the outcomes of our FDA meeting.
4. Research & Development / Opportunity Pipeline:
a) Regulatory R&D:
Both the preparation for and advice so far from the regulatory interactions have driven the need
to increase our understanding of the exact composition of CHD‐FA which we now know to be a
complex mixture comprising many different structures. Clearly, the more we understand, the
more opportunity there is for the Regulators to just keep asking for more definition. Thus, this
work is being progressed with a view to reaching an agreed end‐point for an acceptable
regulatory definition of CHD‐FA as soon as possible.
b) Veterinary:
Progress has very much been in line with what was set out in our last investor communication
although we have not as yet been able to finalise arrangements with Afrivet and Khathalele. We
now have a total of 8 approved and accepted / registered products. The trial with De Heus was
successful and as a result a much larger trial is planned. The necessary approvals have been
obtained and it is expected that this will commence in the next 2 months. This operation has
been profitable in its first year of Trading and expect it to grow substantially during the coming
years. There are also potential opportunities arising internationally with New Zealand, for
example, planning to heavily restrict antibiotic use in cattle.
c) Sports / Nutrition:
Talks with potential partners have repeatedly come to nothing. To this end we have now
developed 6 of our own new sports formulations and plan to go to market (initially in South
Africa) with our own branded range within the next 3 months.
d) Household Disinfectant Range:
In light of the current water shortage in South Africa and our recent disinfectant product
registration it has been decided to launch a range of household products. These will be listed
under the FulviGuard brand name. The first will be FulviGuard – Happy Loo. For our South
African investors and residents – please look out for it in your local supermarkets / restaurants /
clubs / hotels etc. and please give it as much support as possible. We will also be launching a
major internet / social media drive. We hope to launch about 6 new products in this range over
the next 12 months.
e) Food Industry:
Fulvisan D is a Fulhold product which has recently been awarded certification as a cleaning
chemical in the food industry after lab results showing it to be highly effective in killing the
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Fulhold Pharma Ltd ‐ Investor Update March 2018
pathogen Listeria Monocytogenes. Listeria infects thousands of people worldwide each year and
is responsible for over 180 deaths in the past year in South Africa alone.
http://www.bbc.co.uk/news/world‐africa‐43279627
f) Novel Food / Food Additive / Ingredient:
We are currently exploring how best to enter the EU market (initially) as a supplier of CHD‐FA as
an ingredient in foods, cosmetics, devices and medicinal products. Given the purity of CHD‐FA
the rationale is that there is a good opportunity to firstly compete with other fulvic acid
ingredient suppliers and then to expand the use of CHD‐FA as an ingredient in existing and new
products.
g) Alzheimer’s Disease
Researchers from the University of Santiago, Chile have published several medical scientific
articles relating to environmental fulvic acid being used as a possible treatment for Alzheimer’s
disease. Other articles and anecdotal evidence including from a medical practitioner in South
Africa with whom we have spoken suggest that this is an opportunity worth pursuing. We are
currently, therefore, seeking opportunities for collaboration and funding for this initiative.
h) Cystic Fibrosis
For the last 10 years, Jason van Slot, born with 40% lung function due to Cystic Fibrosis has been
nebulising with CHD‐FA to kill bacteria infecting his lungs where antibiotics were failing. From
never being able to play sport, after 1 year of nebulising he was able to take up cycling and since
then has completed many endurance races including the Cape Epic, regarded as one of the
toughest cycle races in the world.
In September 2017 Jason was invited to speak at a Cystic Fibrosis conference in Cape Town,
following which Fulhold engaged with several of the delegates, most notably Andrea Miller from
New Zealand who has had previous Biotech success. She has received samples for testing and
will be visiting SA sometime in April with a view to a joint venture to raise capital in New Zealand
leading to clinical trials.
5. Infringement of Fulhold Patents:
Fulvic Force, a South African trading entity, is selling coal‐derived fulvic acid products in South
Africa and it is our opinion that they are infringing our patents. We approached them politely at
first to enter into a dialogue but to no avail. We have served an infringement notice on them and
have had various communications with their attorneys and ours. We realise this is a costly process
as well as very time consuming one but we believe that in the interests of securing our patents we
need to continue down this route. One of our problems is the citing of Prior art. Unfortunately,
with the ever‐increasing amount of data on the internet some old Chinese patents have emerged
which were never picked up previously by either the USA or EU patent authorities to which we
have to now respond. This is ongoing and we will keep you posted of the outcome.
6. New Shareholders:
We are delighted to welcome the following new shareholders:
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Fulhold Pharma Ltd ‐ Investor Update March 2018
Andrew Kearns, Prof. Iain Squire, Tony Kallis, Ian Williams, Chris McGee, William McGee, Adele
Ravenscroft, Paul Mills
We would also like to thank existing shareholders who took up further allocations of shares at the
last issue. We can advise that the current price for existing shareholders wishing to acquire any
additional shares is £1.50 per share while new shareholders will only be allowed in at above this
level. We are currently negotiating with potential new investors at £1.80 per share but this is not
yet final.
Regards,
David, Hans & Stephen
Author: David Squire, March 2018
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