N4 Pharma PLC Interim Results (0639M)

TIDMN4P

RNS Number : 0639M

N4 Pharma PLC

12 September 2023

N4 Pharma Plc

("N4 Pharma" or the "Company")

Interim Results

N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company developing Nuvec(R), a novel delivery system for oncology, gene therapy and vaccines, announces its unaudited interim results for the six months ended 30 June 2023.

Highlights:

 
 --   Encouraging performance demonstrated in in vitro studies evaluating 
       Nuvec (R) loaded with two different clinically relevant siRNA, 
       epidermal growth factor receptor (EGFR) and BCL-2, namely 
       induction of apoptosis, similar to commercially available 
       small molecules 
 --   Successful demonstration of oral delivery of Nuvec(R) loaded 
       with a DNA plasmid in an animal model into the intestine to 
       produce transfection 
 --   Second Nuvec(R) patent granted in the US bringing this territory 
       in line with Europe, China and Japan, resulting in strong 
       IP protection in key territories around the world 
 --   Reduced operating loss for the period to GBP646,150 (30 June 
       2022: GBP750,102) and R&D and general expenditure in line 
       with budget 
 --   Cash position remains strong which at 30 June 2023 was GBP1,289,769 
       (31 December 2022: GBP1,919,529), again in line with budget

Nigel Theobald, Chief Executive Officer of N4 Pharma Plc, commented:

"We have continued to make excellent progress in the period with our pre-clinical work. In addition, our IP position has strengthened considerably with the granting of the second US patent. Encouraging results from our existing data package has prompted further exploratory conversations with potential collaborators.

"We believe in being prudent with our cash resources as far as possible whilst continually progressing our pre-clinical proof of concept data package with ongoing refinements to meet potential collaborators' requirements. In addition, we consider that focussing on our own product development (whether in partnership or on our own) for the continued development of Nuvec(R) is the right strategy for a company of our size. Nuvec(R) remains an exciting technology with huge potential as an alternate system for the delivery of nucleic acid-based therapies."

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 which has been incorporated into UK law by the European Union (Withdrawal) Act 2018. Upon the publication of this announcement via Regulatory Information Service, this inside information is now considered to be in the public domain.

Enquiries:

 
 N4 Pharma Plc                           Via IFC Advisory 
  Nigel Theobald, CEO 
  Luke Cairns, Executive Director 
 
 SP Angel Corporate Finance LLP          Tel: + 44 (0)20 3470 0470 
  Nominated Adviser and Joint Broker 
  Matthew Johnson/Kasia Brzozowska 
  (Corporate Finance) 
  Vadim Alexandre/Rob Rees (Corporate 
  Broking) 
 
 Turner Pope Investments (TPI) Limited   Tel: +44 (0)20 3657 0050 
  Joint Broker 
  Andy Thacker 
 
  IFC Advisory Limited                    Tel: +44 (0)20 3934 6630 
  Financial PR 
  Graham Herring 
  Zach Cohen

About N4 Pharma

N4 Pharma is a specialist pharmaceutical company developing a novel delivery system for oncology, gene therapy and vaccines using its unique silica nanoparticle delivery system called Nuvec(R).

N4 Pharma's business model is to partner with companies developing novel antigens in these fields to use Nuvec(R) as the delivery vehicle for these antigens. As these products progress through pre-clinical and clinical programs, N4 Pharma will seek to receive upfront payments, milestone payments and ultimately royalty payments once products reach the market.

Chairman's Statement

Half year results

I am pleased to report that in the six months ended 30 June 2023, the operating loss for the period has reduced to GBP646,150 (30 June 2022: GBP750,102) and R&D and general costs are in line with planned expenditure.

Our cash balance at 30 June 2023 was GBP1,289,769 (31 December 2022: GBP 1,919,529 ), again in line with budget.

Operational update

The Company has continued to add further pre-clinical proof of concept data to the significant data accumulated in the preceding periods in respect of the potential for the use of Nuvec(R). The Company's focus for 2023 was threefold:

-- to continue to expand its knowledge around Nuvec(R) in oncology and gene therapy using siRNA to silence genes;

-- to further explore the oral delivery of Nuvec(R) to the intestine to effect both local and systemic responses;

and

-- to investigate the use of Nuvec(R) to improve the performance of established, commercially-used viral vectors

siRNA

Having previously demonstrated the successful loading and gene silencing of Nuvec(R) loaded with two different generic siRNA, GFP (Green Fluorescent protein) and EHMT-2 (Euchromatic Histone Lysine Methyltransferase 2), we have progressed in this period to show how Nuvec(R) can load two clinically-relevant siRNA, epidermal growth factor receptor (EGFR) and BCL-2. We have demonstrated in vitro how each of these can be loaded onto Nuvec(R) and silence their respective genes producing similar apoptosis results to two commercially available small molecule drugs, Gefitinib for EGFR and Venetoclax for BCL-2.

The Company is continuing to investigate these siRNA along with other potential candidates to continue to build the knowledge base that best showcases the potential of Nuvec(R) as a multiple loading nanoparticle that can deliver its dual or multiple payloads into individual cells.

Oral Studies at the University of Queensland ("UQ")

During the period, utilising the grant funding, UQ has made considerable progress in the longer-term study on oral applications for Nuvec(R). We have demonstrated via in vivo pre-clinical studies that Nuvec(R), loaded with McCherry DNA and formulated and administered in capsules, is able to pass into the small intestine and successfully transfect cells in the small intestine. We are now investigating the optimum dosage and timing to assess the duration of the effect in the intestinal mucosa.

The data emerging from the oral studies clearly shows the potential for Nuvec(R) in this space which will make the development of a product for the appropriate commercial market that much clearer. For example, for oral use conventional capsule technology will allow targeted release in the colon to provide local administration of SiRNA against key factors involved in Inflammatory Bowel Disease ("IBD"). We are looking at models to test this proof of concept in IBD currently. Similarly, there are animal models available to explore the treatment of colon cancer. We look forward to making further announcements on our oral studies as soon as they are available.

Viral Vectors

The market for manufacturing viral vectors, in terms of revenue, was estimated to be worth $5.5 billion in 2023 and is poised to reach $12.8 billion by 2028, growing at a CAGR of 18.2% from 2023 to 2028 according to a report by Markets and Markets. This is being fuelled by major investment in the gene therapy market.

Viral Vectors remain the "go to" delivery vehicle for use in gene therapy but they remain fraught with problems, including the high cost of goods and the risk of side effects due to their inflammatory nature. As a result, companies operating in this space are increasingly looking at non-viral delivery systems that can be used to replace viral vectors.

The Company believes that Nuvec(R) is able to address this area and it has taken a novel approach as to how Nuvec(R) might initially be used. Whilst Nuvec(R) has the potential to replace viral vectors as a delivery vehicle, the Company has shown that Nuvec(R) can be combined with the viral vector to significantly improve its efficiency. The Company has shown that Nuvec(R) loaded with an adenovirus viral vector can increase performance of the viral vector by 20-30 fold. This preliminary data suggests that products formulated with viral vectors could achieve the same efficacy using a reduced amount of viral vector, thereby significantly reducing the cost of manufacture and potentially reducing the unwanted side effects from the viral vector.

The Company is continuing to investigate this in collaboration with Brunel University and is now investigating the improvement of Adeno Associated Viruses (AAV).

Intellectual Property

During this period UQ informed the Company that it had been notified by the US Patent Attorney of the granting of its second patent application in relation to Nuvec(R) in the United States. This patent is for the matter of composition of the nanoparticle and follows the previous grant on how Nuvec(R) is made. This now brings the US alongside Europe, China and Japan. The granting of patents in these large markets gives the Company strong intellectual property protection in key territories around the world - a vital component for potential licensing deals.

New opportunities

The Company is continuing to investigate new opportunities to compliment Nuvec(R) and expand its portfolio of IP and further its strategy to bring a product into clinical development. Progress continues and we will announce as and when further developments are made.

Outlook and strategy

As we are a small company, we are mindful how we spend our resources. Our focus is predominantly in conducting in vitro proof of concept work and we have made huge progress, most recently with our siRNA programme. In addition, we have generated excellent data for the use of Nuvec(R) to enhance viral vectors to support our ongoing patent application in this area. Our in vivo work is continuing to make progress, albeit slower than we anticipated, but it is important to get this work right and we will be patient and diligent in doing this.

In Nuvec(R), we undoubtedly have an exciting technology that we have proven is easy to load with any nucleic acid, protects its payload and efficiently delivers it intracellularly. We have also shown how we can formulate potential products with Nuvec(R) and store it lyophilised for up to six months (to date) without any loss in performance of the payload.

Our business development outreach is ongoing, sharing the data we have with potential collaborators yet we realise the quickest way to get Nuvec(R) into clinic may be to do this ourselves in a step-by-step manner. We are considering how we might formulate an siRNA product for a combination therapy using multiple loaded siRNA, thereby utilising the direct competitive advantages Nuvec(R) has ourselves. We are also looking at the prospect of using our oral delivery work for a potential IBD product and we will also continue our acquisition search for new opportunities that might enable us to get into clinic as soon as possible.

Post period end, John Chiplin retired from the Board as Non-Executive Chairman and I assumed the role as Chairman. On behalf of myself and fellow directors, we thank John for his contributions over the years and wish him and his family all the very best for the future. As per our corporate governance policy, we are in the process of finding a new non-executive director to bring the appropriate skills to the Company and will advise when this is completed.

Finally, on behalf of the Board, I would like to thank all of our shareholders for their continued support and look forward to providing further updates on our progress.

Chris Britten

Chairman

12 September 2023