This document is additional information and should be read in conjunction with the Fulhold Pharma GXG Admission Document. This document is for informational purposes only and is intended for existing shareholders of Fulhold Pharma PLC and certain other interested parties. This document is not an invitation to invest in securities of Fulhold Pharma PLC and neither should it be construed as an inducement to do so.
What is the nature of Fulhold Pharma’s business?
Fulhold Pharma Plc (‘Fulhold’) is a UK registered biotechnology company. Fulhold Pharma develops and commercialises the worldwide use of its patented active ingredient Carbohydrate Derived Fulvic Acid (CHD-FA) in Human and Animal Healthcare. CHD-FA is a type of Fulvic Acid that is pure, safe and manufactured to exacting reference standards. CHD-FA does not suffer from the variable quality and contamination that prevent environmental sources of Fulvic Acid being used in human medicine. It is a broad-spectrum anti-microbial and has anti-viral, anti-bacterial, anti-fungal and anti-inflammatory properties. CHD-FA can be used in many formulations and shows synergistic activity with other active ingredients that are no longer effective against drug-resistant organisms. It is also thought that it is highly unlikely that bacterial and fungal pathogens will develop any drug resistance to CHD-FA.
Fulhold Pharma owns international patents for the production and use of fulvic acid in the areas of human and animal health. CHD-FA is the only known pharmaceutical grade fulvic acid available. There is a strong and growing evidence base for its efficacy and this is supported by a comprehensive safety and toxicity profile. We have 13 years of research, a CHD-FA patent portfolio and ongoing research projects that are highly promising.
Fulhold Pharma aims to add and secure value for shareholders as it engages with projects at all stages of the pharmaceutical value chain in realising the potential of CHD-FA.
Fulhold’s focus is on the production of CHD-FA and marketing the active ingredient to its clients and partners.
The primary manufacturing operations of Fulhold are currently based in Stellenbosch, South Africa. The manufacturing and packaging processes have been assessed and certified as compliant with Food Safety System Certification (FSSC) 22000. The factory, as well as the patent records were inspected by representatives of the GXG as part of their due diligence prior to listing. The current production facility is awaiting Good Manufacturing Practices (GMP) inspection accreditation.
The current trading operations sell approximately USD 2 million of CHD-FA product per annum. We have built a new Active Pharmaceutical Ingredient (API) production facility in Mauritius and are currently developing its operational capability. This facility has been set up to meet future demand resulting from a series of discussions and negotiations with potential partners.
As there are many medicinal applications for the use of CHD-FA, Fulhold’s strategy is to create subsidiaries to concentrate on specific treatment areas, as well as to license specific applications to interested parties. The following are examples of the Research and Development work that Fulhold Pharma is conducting:
a) treatment of drug-resistant wound infections
Scientists at the New Jersey Medical School’s Public Health Research Institute (PHRI), led by Professor David Perlin, found that CarboHydrate Derived Fulvic Acid (CHD-FA) showed strong activity against a variety of bacterial and fungal pathogens and demonstrates reliable anti-inflammatory properties that promotes robust healing. Recent research has shown that CHD-FA is a promising topical agent for drug-resistant wound infections including
- Gram-negative bacteria such as: carbapenem-resistant E-Coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Multi-drug- resistant Acinetobacter baumanii, Enterobacter spp
- Gram-positive bacteria such as MRSA
- Gram-positive fungi such as azole-resistant Aspergillus fumigatus
At the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) in September 2014, an Abstract entitled “CHD-FA Is A Highly Effective Topical Broad-spectrum Antimicrobial For Drug-resistant Wound Infections” concluded, “The excellent broad-spectrum antimicrobial activity makes CHD-FA a promising topical agent for wound infections. Given its novel mechanism of action, the early use of CHD-FA is advantageous as it prevents the use of more specific but more limited spectrum antibiotics in individuals at risk for traumatic wound infections.” For more information, follow the link below:
b) development of a range of products for consumer oral healthcare
Minimum Inhibitory Concentration tests undertaken by Blu Test Laboratories Ltd, a leading microbiology contract research organization have recently been successfully concluded. These MIC tests were commissioned to confirm that Fulhold’s three prototype formulated mouthwash products, at optimal pH, would inhibit microbial growth in a group of pathogens that cause dental disease, namely :
- Streptococcus mutans, Streptococcus mitis, Porphyromonas gingivalis, Fusobacterium nucleatum, Candida albicans, Enterococcus faecalis, Capnocytophaga spp, Porphyromonas endodontalis, Peptostreptococcus micros, Aggregibacter actinomycetemcomitans and Prevotella intermedia.
Two of the three products tested were efficacious against all pathogens tested:
These findings dovetail with Prof Ramage’s conclusions in the PhD and other research from the Glasgow University Dental Hospital : “CHD-FA has broad spectrum activity against bacterial and fungal biomass… Dentracine mouthwash was equally effective against bacteria that cause oral disease as it was against fungi that cause oral disease. Dentracine Mouthwash was active against a range of oral bacterial biofilms, responsible for caries, periodontal disease and failed root canal treatment. Images revealed changes in bacterial structure after Dentracine Mouthwash treatment kill kinetics were similar to those carried out in Candida. Dentracine Mouthwash was also effective against the multi-species periodontal biofilm model, previously developed by the group.”
Dr Leighann Sherry, as part of Professor Ramage’s team, has completed a PhD programme which evaluated the antimicrobial, toxicological and immunomodulatory properties of CHD-FA. Key findings from the study include:
- Exceptional antifungal activity against fungal biofilms
- A time dose dependent kill profile that was better than other antifungal drug classes
- Established Mode Of Action (non specific membrane disruption)
- Resistance mechanisms (including Efflux pump activity inhibitor, Matrix studies (FKS1), stress responses (Hsp90) and Chitin synthesis inhibition) play a minimal role in antifungal activity
- CHD-FA was equally effective against Oral bacteria as it was against fungal pathogens
- CHD-FA had no toxic effect against epithelial and monocyte cell lines
- Immunomodulatory properties were demonstrated
Potential CHD-FA consumer oral healthcare applications:
- Impregnated floss /tape
- Chewing gum
Potential CHD-FA clinical applications:
- Impregnated collagen
- Peri-operative gels
c) treatment of infectious diseases in humans
Testing is underway with a Global Pharmaceutical organisation to test CHD-FA against a range of infectious diseases. Both parties are under a non-disclosure agreement regarding this initiative.
d) Research Pipeline
In addition, Fulhold Pharma is in discussion with third parties with the intention of creating partnerships to investigate the use of CHD-FA :
- in combination with existing antibiotics as a resistance-breaker
- in both general and specific anti-inflammatory treatments
- in the treatment of Haemorrhagic viral fevers
- in the treatment of Influenza
- in the treatment of Tuberculosis
- in the treatment of Malaria
- in the treatment of ‘neglected diseases’ (e.g. Chagas, Leishmaniasis etc.)
- in the treatment of diabetic ulcers
- in agricultural applications
- in veterinarian applications
Why did Fulhold Pharma list?
- To develop and expand its core business which is the production and distribution of pure CHD-FA for other parties to undertake further processing into a range of products as well as into products in other industries from both the existing and new facilities such as the one we are currently developing in Mauritius.
- To provide the funds to buy out minority shareholders in subsidiary companies
- To provide the Company with working capital to conduct further research and development
- To recruit experienced management staff
- Fulhold Pharma holds a valuable set of internationally registered Patents and Trademarks. It is our intention to renew and expand our patent protection
- Institutional investors often cannot invest in non-listed entities and so this is a pool of potential investment now available to us as a listed entity.
Why choose the Danish GXG for the listing of Fulhold Pharma?
Why did Fulhold Pharma choose Belvedere to assist with its listing on GXG?
What role did / does Belvedere play?
Why did Fulhold Pharma choose Curzon to assist with its listing on GXG?
What role did / does Curzon play?
How was the valuation of Fulhold Pharma done and by whom and how was this accepted by the GXG?
Why did Fulhold Pharma not raise money in the Listing process?
How does Fulhold Pharma plan to raise the necessary investment?
Why is there a reported FulholdPharma $5m loss?
The true value of the future potential income and profit lies in the value of the pipeline of research that has been carried out. In accordance with standard international accounting practice the value of the assets has been written down to the values as reflected. Besides this one off entry the business trades profitably, as can be seen from the original admissions document where the actual audited trading results for the past 2 years have been disclosed. The consolidated group financial statements for PLC for the year ended February 2015 are currently in process and should be ready for submission in the next few weeks.