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Fulhold Pharma PLC ‐ Investor Update June 2017
1. Belvedere Managed Funds in Administration
Dual Star and Alexander High Yield Funds, managed by Belvedere Fund Managers, had committed to
an investment in Fulhold at its proposed listing on the GXG. Fulhold’s intention was to use some of
the funds raised at listing to pay off long‐standing, minority shareholders. There was a significant
delay in the listing process (circa 1 year) and it was agreed by those managing the Dual Star and
Alexander High Yield to advance the agreed investment as a loan / upfront payment. The listing was
then aborted due to the collapse of the GXG. In line with the original undertakings made with
Belvedere it was subsequently agreed to continue with the conversion of the loans (in total circa
£700k) to equity at the listing valuation price, as that was the basis of the original agreement as well
as the main purpose of the listing. The agreement was entered into in in good faith, verbal and we
never saw or received any documentation from the Fund Manager, Belvedere. The validity of the
loan conversion is now being disputed by the Administrators of the funds. We have been in
conversation with them for some weeks now and are working to resolve this situation to the
satisfaction of Fulhold, the Administrators and the underlying shareholders of the funds in question.
The Administrators have agreed to allow the underlying shareholders to begin looking at Fulhold and
we are hopeful that, if we can communicate with them directly, they will understand the value of
their investment and agree to formalize their shareholding. We will keep you informed of this
situation as and when there are significant developments.
2. Research & Development Update:
a) Wound Treatment:
The research led by Professor David Perlin and funded by the U.S. Department of Defense (DoD)
has been successfully completed and the results have again been presented to the DoD. There
was a strong consensus that we are ready for a Phase 2 clinical trial and the DoD have asked for
a pre‐proposal white paper that would address a target patient population with a budget of $5‐7
million. If selected, we would be required to submit a full proposal in Q4 2017. However, they
will only consider proposals in which an IND has been submitted to the FDA.
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved
/approvalapplications/investigationalnewdrugindapplication/default.htm
We have submitted the IND application and are awaiting meeting dates with the FDA. David
Perlin will be on the team involved in those meetings. This is a huge step for us as our Regulatory
data is now to the required standard and levels of completion to be talking to both the FDA and
the MHRA (see section on Regulatory).
b) Oral Health:
On hold pending finding a suitable formulation company to improve taste and ‘mouthfeel’.
c) Xylella:
Abandoned due to repeated difficulties in importing the bug and growing the required cultures.
Author: David Squire, June 2017
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Fulhold Pharma PLC ‐ Investor Update June 2017
N.B. Due to the need to focus resource on 2a) (above) and 3.&4. (below), all other R&D is on hold.
3. Regulatory Activities:
Imelda and Stefan, working with Stellenbosch University, Jenson R+ and others have made huge
progress on our understanding of the chemical processes and Regulatory documentation with our
advisors, Jenson. As mentioned previously we are awaiting meeting dates with the FDA to secure
the IND waiver and we have also approached the MHRA Innovations team in the U.K. for advice on
taking the drug master file to the EMA and others for approval. This is critically important for all of
our future Regulatory submissions and it should be underestimated the efforts and progress which
have been made nor the value this will achieve.
4. Good Manufacturing Practice (GMP) Accreditation:
After repeated requests, the factory and team was notified about a Medicines Control Council
(MCC) GMP inspection early in 2017. As this inspection was on an Active Pharmaceutical Ingredient
(API), it was elevated to an international inspection. The MCC decided to do a contact visit first to
determine the readiness of the factory to receive an international inspection and the factory
passed this so the actual inspection involving an inspector from the Netherlands took place from
22 – 24 March 2017. The audit report had 28 findings none of which was critical but these findings
had to be closed within 30 days. The reply was submitted and passed the first peer reviewed
process within the MCC. This will now go to a GXP Committee on 13/14 June and, if passed, to the
full board of the MCC on 28/29 July for approval. Feedback from the auditor is that we stand a very
good chance. Once a license is granted Fulvimed will be one of the first to receive the licence under
the new regulations.
5. Administration:
a) Sales:
South African sales have suffered a sharp decline due mainly to the non‐performance of
Ascendis. Ascendis sales dropped substantially mainly due to the fact that GEMS (government
funded medical aid) stopped all payments for ‘unscheduled’ drugs. As a result, Ascendis were
dramatically affected and in turn Fulvicare as a supplier to Ascendis. After much negotiation we
have agreed with Ascendis to terminate their exclusivity in CHD‐FA in South Africa and we have
subsequently come to agreement to supply Dischem (https://dischem.co.za/article/24101‐new‐
biogen‐biomune‐cold‐flu‐shield). The new range has just entered the stores.
Although this has resulted in the first loss in the South African operations for the last number of
years, we believe that we should see the SA operations back in profit during the course of
2018/2019.
b) Tax / year(s)‐end accounting: February 2017 financial statements have been finalised and
submitted to Companies house. The fall in the Rand against the pound makes our financial
performance appear worse than it was.
Author: David Squire, June 2017
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Fulhold Pharma PLC ‐ Investor Update June 2017
c) Group Structure:
As discussed earlier in the year the PLC is no more and we have a lower cost, simpler limited
company structure. Our strategy of creating value through ‘application companies’ is, however,
exactly as before.
d) Location(s):
In view of the FDA activity it is highly probable that we will open a plant in Delaware, USA.
Regards,
David, Hans & Stephen
Author: David Squire, June 2017
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