Additional funding, molecules designed and antibacterial coatings

Hear from CEO Dr Michael Murray, about updates from MetalloBio on the most recent quarter.

“This quarter marks significant movement across both our pharma and non-pharma pipelines. Our commercial strategy is delivering clear results, and agreeing the basis of a deal structure with a medical manufacturer proves that the industry is actively seeking alternatives for silver ions. We will use this approach in parallel non-pharma commercial engagements. Scalable, cost-effective manufacturing is now in reach and our second-generation coatings are exceeding performance benchmarks” says Dr Michael Murray.

Executive Summary

Work to zone in on the molecular target of KLS-116 has started.  Identifying this molecule or biological structure in bacterial membranes will allow us to apply for a number of non-dilutive grants where this piece of data is a minimum entry requirement.  It will also support future partnering discussions with pharma companies as their drug development framework is heavily reliant on a drug target approach.

New funding this year so far is over £560,000; a sum that includes two grant awards, including a prestigious grant from the National Biofilms Innovation Centre (NBIC) - one of only seven grants awarded by them this year.  The grant funding is supporting further research into the effects of both our compound series on biofilms – protective barriers that colonies of bacteria develop in vivo and which are notoriously difficult to breach.  Breaking biofilms reduces persistence and recurrence of infections.

Our commercial strategy of focusing on manufacturers of medtech products reliant on silver ions as antibacterial agents is producing results. This is based on the potential that silver ions may be phased out by regulators within the next 5-7 years or so.

This is about the same length of time required to get a medical product with a replacement antibacterial technology developed and onto the market.  The deal structure has been accepted by one party whereby they will pay commercial rates for the supply of KLS-2 compound for an initial assessment. If they wish to progress to the demonstration phase of testing, they will pay IP and technology licence fees.  In due course, they will pay royalties on any product that carries our additives or coatings.  This paradigm can be repeated with numerous companies in parallel.  We are in discussions with several other companies with similar interests.

Pharma Programme: Preclinical Studies 

(i). One aspect of the KLS-1 compounds’ antibacterial activity that has not yet been resolved is: What is the molecular target for KLS-116?  The company started a project in this quarter in which a library of gene knock-out strains of an exemplar Gram-negative bacterium, E. coli, is being screened.  We already know that KLS-116 severely and rapidly damages membranes, and we have already identified a biochemical pathway implicated in the pharmaceutical action of KLS-116. The gene knock-out study promises either to identify the initial drug target for our most advanced drug candidate or will narrow our focus on the likely identity of the drug target.  This is important because regulatory authorities require this information, preferably before we apply to run our first clinical trial.  It is also of interest to potential pharmaceutical company partners.  Pharma companies design a vast majority of their drug development around molecular targets.  Knowing the KLS-116 target represents a risk-reducing step and will enable a smoother alignment with the big pharma mindset around clinical development.

(ii). Another area of further development concerns the in vivo dynamics of KLS-116.  We are working towards improving the amount of compound which, once injected into the blood stream*, gets to the site of bacterial infections.  An advantage of having more than 40 compounds in the KLS-1 series of molecules is that they represent chemical variations around a core functional antibacterial structure some of which are likely to include characteristics that support better distribution in the bloodstream.  We have entered discussions with expert commercial groups in this area of R&D.

*We are aiming for two forms of drug administration: intravenous (IV; for hospital use) and direct-to-bladder (for hospital and community use).  For an initial clinical safety trial, we will be required to use the IV method.

Non-Pharma Programme

(i). Additives

As previously reported, we are in commercial discussions with a number of companies that are interested in assessing our antibacterial KLS-2 compounds as additives in plastics used in the manufacture of medical tubing (for example, catheters and surgical drains).  This requires us to have very large quantities of our compounds.  The switch up is from milligramme level of production to multi-kilogramme amounts of active compounds.  This is normally a fairly challenging transition to make.  

However, based on further improvements this quarter to the synthetic routes for the manufacture of MetalloBio compounds we do not expect any significant difficulties, and this has been confirmed by the CRMs we are interviewing.

The synthesis improvements have reduced the unit cost of compound production even further and have created additional intellectual property of great value. We are in the process of engaging a third-party contractor for large-scale production; initially of 0.5 to 1.0kg, then up to 10kg.  This transforms our ability to enter commercial revenue-bearing licences with medtech companies.  We expect to commission a CRM this coming quarter.

(ii). Coatings

A second generation of antibacterial coatings has advanced rapidly based on the R&D learnings from the first generation.

The new coatings have fewer components and are composed of GRAS (generally recognised as safe – a US FDA designation) biocompatible elements which should make for a smoother passage through regulatory assessment. Testing shows these new coatings to have the same or superior antibacterial performance when compared with marketed technologies. The new coatings also use lower amounts of our KLS-2 compound – a further commercial benefit.

Intellectual Property (IP)

MetalloBio’s IP strategy is to initiate patent applications, based on existing inventions, in a controlled time sequence in the coming months and years.  This maximises the IP protection and will extend the commercial lifetime for both our drug candidates and our additives and coatings.  Since the last report, we have identified additional new patent positions related to our scale-up chemistry.  For now, these innovations will be protected as confidential information within the company.  

Grant Awards

The work covered by the reported grant for conducting detailed market analysis and regulatory requirements started in this quarter and will be completed by the end of October 2026.

In addition, MetalloBio and our long-term collaborators at Nottingham Trent University (NTU), secured one of only 7 grants awarded in August by the National Biofilms Innovation Centre (NBIC).  This prestigious funding comes ultimately from the Biotechnology and Biological Sciences Research Council (BBSRC) and Innovate UK and recognises the successful delivery by MetalloBio and NTU in the past in this field.  This takes MetalloBio’s total new funding to just over £560,000 this year so far.

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