Corporate News & RNS

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse (amendment) (EU Exit) Regulations 2019/310 ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Fusion Antibodies plc (AIM: FAB), specialists in pre-clinical antibody discovery, engineering and supply for both therapeutic drug and diagnostic applications, announces its final results for the year ended 31 March 2025.

Commercial and operational highlights (including post period end)

• Audited revenues for FY2025 of £1.97m (FY2024: £1.14m) 
• Increased activity in the second half of FY2025 including the continuation of the collaboration agreement with the National Cancer Institute for the use of OptiMAL® 
• Placing announced in March 2025, raising £1.17m (before expenses) for general working capital and investment into commercial activities 
• Significant increase in sales pipeline opportunities during the second half of FY2025
•  Grant of U.S. Patent for OptiMAL®
• Cash position as at 31 March 2025 of £0.4m (31 March 2024: £1.2m)

Adrian Kinkaid, CEO of Fusion Antibodies commented: “We were very pleased to deliver an improved FY2025. We made significant progress in improving revenues and in Fusion’s strategic development in key new markets such as Diagnostics which has reduced our exposure to the more volatile VC funded biotech sector. We also announced large contract wins in May 2024 and again in February 2025, the latter being the source of three further contract wins announced on 27 August 2025.

“In addition, we secured significant grant funding through the excellent Future Medicines Institute (FMI) initiative announced in December 2024. This in turn helped Fusion to apply for a further grant in conjunction with Queen’s University Belfast for the DR5 project, which Fusion secured in the current financial year.  

“We also made very significant progress with our flagship OptiMAL® programme. This progress was achieved largely through Fusion’s collaboration with the National Cancer Institute (NCI) and the successful £1.17m fundraise. The successful fundraise allowed Fusion to increase its internal research and development (R&D) efforts to validate hits from the NCI as well as to commit to increased sales and marketing towards building a formal launch of OptiMAL® as a service later in 2025.

“We are increasingly positive about the improved position of the Company, and we look forward to realising the true potential of the business going forward. Lastly, we are always grateful to our dedicated shareholders for their constant support.”

Investor presentations (online and in-person)

The Company will host an online live investor presentation on Monday, 15 September 2025 at 11am BST, delivered by Dr Adrian Kinkaid, CEO and Stephen Smyth, interim CFO. The Company is committed to providing an opportunity for all existing and potential investors to hear directly from management.

The presentation will be hosted through the digital platform Investor Meet Company (“IMC”).

Investors can sign up to Investor Meet Company for free and add to meet Fusion Antibodies plc via the following link: https://www.investormeetcompany.com/fusion-antibodies-plc/register-investor.

For those investors who have already registered and added to meet the Company, they will automatically be invited. Questions can be submitted pre-event via your IMC dashboard or in real time during the presentation, via the "Ask a Question" function. Whilst the Company may not be in a position to answer every question it receives, it will address the most prominent within the confines of information already disclosed to the market through regulatory notifications. A recording of the presentation, a PDF of the slides used, and responses to the Q&A session will be available on the Investor Meet Company platform afterwards.

In-person London investor event

As announced by the Company on 26 August 2025, the Company will also host an in-person investor presentation in London on Wednesday, 17 September 2025 at 2.30pm. To register for this, please email [email protected].

Enquiries:

About Fusion Antibodies plc

Fusion is a Belfast based contract research organisation ("CRO") providing a range of antibody engineering services for the development of antibodies for both therapeutic drug and diagnostic applications.

The Company's ordinary shares were admitted to trading on AIM on 18 December 2017. Fusion provides a broad range of services in antibody generation, development, production, characterisation and optimisation. These services include antigen expression, antibody production, purification and sequencing, antibody humanisation using Fusion's proprietary CDRx ^TM platform and the production of antibody generating stable cell lines to provide material for use in clinical trials. Since 2012, the Company has successfully sequenced and expressed over 250 antibodies and successfully completed over 200 humanisation projects and has an international, blue-chip client base, which has included eight of the top 10 global pharmaceutical companies by revenue.

The Company was established in 2001 as a spin out from Queen's University Belfast. The Company's mission is to enable pharmaceutical and diagnostic companies to develop innovative products in a timely and cost-effective manner for the benefit of the global healthcare industry. Fusion Antibodies provides a broad range of services in antibody generation, development, production, characterisation and optimisation.

Fusion Antibodies growth strategy is based on combining the latest technological advances with cutting edge science to deliver new platforms that will enable Pharma and Biotech companies get to the clinic faster, with the optimal drug candidate and ultimately speed up the drug development process. 

The global monoclonal antibody therapeutics market was valued at $186 billion in 2021 and is forecast to surpass $445 billion in 2028, an increase at a CAGR of 13.2 per cent. for the period 2022 to 2028. Approximately 150 monoclonal antibody therapies are approved and marketed globally as of June 2022 with the top four antibody drugs each having sales of more than $3 bn in 2021.  

Chairman’s Statement

The financial year ended 31 March 2025 (“FY2025”) has overall been positive for the Company. While it has not necessarily been a smooth journey, we ended the financial year in line with market expectations in respect of revenue for FY2025, saw positive growth in one of our new markets, that of diagnostics, and saw exciting data from our US-based collaborators in relation to the OptiMAL^® library. On the back of these developments we have also been well supported by our shareholders, notably having successfully raised approximately £1.17 million in March 2025.

While the board of directors of Fusion (the “Board” or the “Directors”) are encouraged by the progress that we have made in FY2025, we are aware that we are living through ever-evolving economic circumstances. From the global market perspective, FY2025 started on a positive note and a slow recovery appeared to be the direction of travel, with the confidence of venture capital (VC) and other investors seeming to be improving. Against this backdrop, we were hopeful that investment into our customers’ early-stage therapeutic pipelines would start to grow. As we entered calendar year 2025, the global economic conditions became more uncertain and while we have not seen any clear indication that things are slowing down, we are very aware that this may change in the future. However, while this uncertainty may slow down the organic expansion of many of our therapeutic clients or prospective clients, we believe that they will continue to have a choice of either pausing certain development programs or to take the more flexible approach and outsource their development work to companies such as ourselves, thereby giving them greater control of their fixed cost base. Consequently, we view the threat of financial instability as a potential opportunity for Fusion. 

With the biotechnology drug development sector’s funding environment being uncertain, our diversification strategy is providing us with more growth opportunities as well as a buffer against the ups and downs of the investment community. Last year we explained that the Diagnostic sector uses antibodies for the majority of their tests and that they have a need to discover new versions, to improve the effectiveness of the antibodies that they already have and to develop stable versions for manufacturing, albeit in smaller quantities. What this means for Fusion is that many of our genetic engineering skills are as relevant to this market as to therapeutic market and as outlined later in the annual report, has started to show some positive results. The same applies to the veterinary market, and although we are finding some new prospects, it is a smaller and less established market and, therefore, will take us longer to make any significant gains. Furthermore, we believe that the increasing adoption of artificial intelligence and machine learning (AI and ML) approaches will play a key role in discovery and one that Fusion should be a part of. Our US collaboration gives us early exposure to in-silico antibody designs as we prepare for greater market acceptance in the in-silico approach to antibody design.  

Alongside economic risks we must also remember that we are working with Companies that are at the forefront of scientific endeavour and that by the very nature of the work there is always the prospect of scientific failures being the root cause of a program being paused or cancelled. As reported in the year-end trading statement on 6 May 2025, this scientific attrition can slow or delay pipeline projects and impact revenue forecasts. However, our diverse client base and market reach helps mitigate these risks. 

Business performance

The Company and all of its staff have risen to the challenge, and while the financial year ended 31 March 2024 (“FY2024”) was very focussed on cost cutting with the business in survival mode, the results for FY2025 are the beginning of Fusion’s turnaround phase, with the new commercial strategy delivering revenues of approximately £1.97m, representing a 73% increase on the previous financial year (FY2024: £1.14m). The diversification strategy has delivered significant growth from the Diagnostics sector, which represents 33% of our revenue for FY2025, and we have seen first signs of real interest from the Veterinary market, a promising sign that there is potential for further growth in this sector. While FY2025’s financial results are encouraging, we remain mindful of the ongoing economic challenges and the risks tied to our main business in therapeutic antibody development. For details on the Company’s Key Performance Indicators, please refer to page 34 of this report. 

We have always been very proud of our scientific expertise, and this was truly exemplified by the award of the Future Medicines Institute (FMI) grant announced by the Company in December 2024. This approval recognises that we have a strong scientific reputation, technical ability and that we can play a significant part in The Northern Ireland Precision Biomarkers and Therapeutics consortium’s goals, which includes Fusion. The FMI project has been designed to support platform development in diagnostics and therapeutics and so maps very closely to the ambitions of the Company. It has the benefit of bringing in approximately £1m of direct non-dilutive funding to the Company, access to relevant expertise and use of to up to £5m of new capital equipment within Queen’s University Belfast (QUB) and the consortium, something that would normally be out of reach for us.  

One of our most exciting scientific development projects is the OptiMAL® library, which is being developed to allow the direct and fast discovery of complete human antibodies against a target of choice using a cell-based screening process. This is expected to remove the need for animals and humanisation of a non-human antibody, speed up the discovery phase plus the unique choice of library has the potential to develop antibodies that are already human in structure, stable and suitable for their purpose. The OptiMAL® library has attracted the interest of our now collaborator, the National Cancer Institute (NCI), who recently provided us with the first independently derived positive cells from the OptiMAL® platform against a cancer related target of their choice. The Company confirmed their results and took it one step further by using the DNA sequences obtained from the positive cells to synthesise the antibodies through an independent transient gene expression process. These antibodies were subsequently shown to bind to the protein antigen, completing the process. Although further validation work is required, this represents a significant step in the independent validation of the OptiMAL® platform.  

Building on the work being carried out on our OptiMAL® library, our ’Opti’ technology for library design is well suited for phage display screening platforms. While phage libraries only produce antibody fragments, which have to be further developed to generate full antibodies, it is a well-established format within the market and often the preferred choice for some customers. The first OptiPhage^TM library contract was for non-human antibodies for a leading antibody research Company, with the client having an option to license the library on an exclusive basis. It is anticipated that the Project will provide the client with an alternative pathway to produce high quality antibodies, reducing its need to run animal-based antibody generation. Fusion remains free to develop further OptiPhage^TM libraries for its own use or for other clients as it adds this service to its increasingly comprehensive range of offerings. 

New Funding

Having last year reduced the cost base of the Company to a minimum operational level, R&D resources were stretched for the work on OptiMAL® and the anticipated further positive cells from NCI would further compound this. To build on the positive data coming from the NCI laboratories and to ensure effective and efficient internal R&D work on the OptiMAL® development, together with enhancing the commercial activities, the Board decided that it would be to the benefit of the shareholders to raise some further funds. The equity fundraise, announced on 18 March 2025, raised approximately £1.17m (before expenses) by way of a placing (the “Placing”) of a total of 17,365,228 new ordinary shares of 4 pence each in the Company (“Ordinary Shares”) at a price of 6.75 pence per new Ordinary Share for this additional R&D work, some general working capital and to invest into commercial activities, especially to support OptiMAL® should the validation prove successful. The Placing was very well supported by existing institutional investors and VCT funds and the issue price of the Placing was not discounted with the price equal to the closing mid-market price of an Ordinary Share on 17 March 2025.  

We very much appreciate the confidence that our shareholders have in the Company, and it is always our objective to keep all shareholders up to date with any significant progress. This year, to help facilitate this, we introduced the new interactive Investor Hub which brings all the Company’s existing content into a single integrated platform and will enable investors and stakeholders to be better informed and engaged in the Company’s business. It is worth noting at this point that the Company is committed to continuing to keep shareholders up to date via announcements made of any significant news or of a regulatory nature through the regulatory news service (RNS) in line with its obligations under the AIM Rules for Companies and the UK Market Abuse Regulation (UK MAR). 

Board and Employees

There have been no changes to the Board this year and the effort, dedication and hard work they have put in during the year is much appreciated. For FY2025 the NEDs continued to demonstrate their commitment and belief in the Company and helped to minimise the outgoing costs for the second year by taking their remuneration as part salary and part new Ordinary Shares. This structure will cease to continue going forward and they will be paid their full remuneration entirely in cash for the financial year ending 31 March 2026 (“FY2026”). 

A big thank you also goes to all the staff who have diligently and creatively worked to deliver services to our clients, often under significant pressure, and achieved the revenue targets for the year. Their efforts have been instrumental in this year's turnaround and recovery. Despite the significantly reduced headcount, they have demonstrated flexibility and undergone extensive cross-training to ensure that the Company can continue to offer its full range of services. 

Finally, it is worth mentioning and thanking our auditors, Kreston Reeves LLP, who quickly grasped our business needs last year and have proven to be an excellent fit. They replaced PwC last year, as we determined a smaller, more cost-effective firm was better suited to our limited resources and future direction. After an extensive search, Kreston Reeves LLP was chosen for their size, commitment and relevant experience in Life Sciences. We would like to thank PwC for all they did for us over their 17-year tenure.

Corporate governance

The long-term success of the business and delivery on strategy depends on good corporate governance. The Company complies with the Quoted Companies Alliance Corporate Governance Code as explained more fully in the Governance Report.

Post year end and outlook

On 7 April 2025, at the Company's general meeting, all resolutions in connection with the issue of the 8,416,020 second tranche placing shares were approved. As a result, the 8,416,020 second tranche placing shares were issued and admitted to trading on AIM on 9 April 2025, completing the approximately £1.17m raise (before expenses). This cash boost at the start of FY2026, along with the first FMI grant payments, positions the Company well for the current financial year.

On 24 April 2025, the Company announced the approval of an Innovate UK Launchpad grant led by the Company in collaboration with Queen’s University Belfast (“QUB”) to develop a humanised antibody targeting and activating the DR5 protein on cancer cells for the treatment of cancers. The total funding being made available under the Grant is over £808k, with up to £545k expected to be provided to Fusion over a period of approximately 18 months. The antibody asset generated under the Grant project will be jointly owned by Fusion and QUB although the ownership ratios are still to be determined. This antibody asset goes alongside our grant-based collaboration with Finn Therapeutics, who are developing the antibody against RAMP which is protected by a Fusion patent. Any additional grants that become available will be identified and applied for within the next 12 months.  

We were excited to announce on 5 August 2025 that the United States Patent and Trademark Office has granted the Company's U.S. OptiMAL^® patent application. The application entitled "Antibody Library and Method", concerns the library of antibodies that is currently screened within the OptiMAL^® platform, as well as the method for the design of additional libraries. This is key to Fusion's offering to provide "Opti" designed libraries for a range of applications including Antibody Discovery, Affinity Maturation, and Sequence Optimisation.

While the Board is mindful of the potential global economic challenges, with our core new technologies strengthening and a solid sales pipeline we remain confident that Fusion can continue its growth and build on last year's performance.

Simon Douglas
Chairman
03 September 2025

CEO’s report

The overall market in which we operate stabilised and started to recover during FY2025. Fusion’s revenues recovered rather more effectively than the overall market with Fusion reporting revenues of approximately £1.97m for FY2025, representing a 73% increase from the previous financial year. This achievement was due to the dedication and ability of our team combined with several successful initiatives including additional efforts in the diagnostics sector and the research antibodies field, more so than the overall market changes alone. We specialise in antibodies and, as antibodies have a diverse and varied application, there is demand for our services in each of those sectors. The recovery is ongoing, and the outlook appears positive although we, like many in our sector, remain somewhat cautious reflecting the disruption in geopolitical and economic circles, which could have an impact on our client base despite its enhanced diversity.

On the R&D front, FY2025 has been an excellent year. We received a significant boost from the award of the Future Medicines Initiative (FMI) grant to the consortium led by Queen’s University Belfast. This recognised the highly applicable and innovative nature of our proprietary technologies and Fusion’s ability to convert cutting edge innovations into class leading services and products. The FMI grant also provides us with approximately £1m of direct non-dilutive funding and access to up to £5m of capital equipment at no cost to Fusion. Additionally, being a founding member of the FMI gives us access to a superb array of talent and expertise, some of which will be used to develop a phage display panning laboratory which we can use to screen the OptiPhageTM library as and when required. This negates the need to undertake building work at our own facility, which would have been needed to modify air handling systems to secure effective separation of air flows between bacterial and mammalian cell laboratories. We had previously estimated such work would have required a budget of around £300,000, but due to the FMI grant this is no longer needed.

Perhaps the icing on the FMI cake is the PhD studentships which comes fully funded as part of the FMI programme. The FMI grant provides for a total of 20 PhD studentships across the consortium. These are expected to be run in two or three cohorts each starting around a year apart. We are currently seeking applications for two of these PhD studentships in the first cohort for two projects designed and nominated by Fusion creating important opportunities for our development, again at no direct cost to the Company.

The Board believes that if it was not for the FMI grant, the Company would have required to have spent at least £6 million in capital to receive the same benefits of the FMI grant.

As significant as the FMI grant is for the business, progress made this year with our flagship OptiMAL® platform has far more potential. Due to the rescaling of the business in the previous financial year, our internal R&D resources had been significantly reduced. It was therefore hugely advantageous to have the collaboration agreement with the National Cancer Institute USA (NCI), announced toward the end of November 2023, to pursue the validation of the platform at minimal cost to the Company. The Director of the Antibody Engineering program at the NCI is Dr. Mitchell Ho: our principal point of contact. Mitchell is a highly respected world leader in both mammalian display and antibody generation. The work undertaken through the collaboration has demonstrated the utility of the OptiMAL® platform and that it can be used to identify cell-bound antibodies for a range of targets. Many of these antibodies have been isolated and verified by Fusion and the NCI is now seeking to demonstrate their functional utility. We look forward to further updates from the NCI and once this work is complete, patent applications filed, peer reviewed publications submitted and to their independent statements which we are confident will formally validate OptiMAL®.

The OptiMAL® Human Antibody Discovery Process

In the meantime, the Company is pressing ahead with the commercialisation plans for OptiMAL® which is scheduled for launch at a significant conference for the industry: the Antibody Engineering and Therapeutics conference in San Diego in December 2025. We have secured booth space and a presentation within the conference’s scientific programme. Prior to this taking place we are continuing to diligently gather as much scientific data as possible to highlight the advantages of the platform in the discovery of antibodies for our clients.

It is also worth highlighting the importance of the ability to transfer the OptiMAL® technology to other laboratories, which was also demonstrated as part of the validation project with the NCI. The capability to transfer the technology means that we can seek to exploit a much wider market than would be possible if all screens were to be run within the Fusion laboratories, which itself would require significant scaling of resources in terms of personnel, capital equipment and consumables. Moving to a technology licensing model will allow us to bypass the restrictions on capacity due to internal resources.

Market outlook: growth prospects by sector
We were very pleased to announce, on 27th August 2025, that we had secured three follow-on contracts from an existing client providing combined anticipated further revenues of nearly $460,000. These are significant amounts and bear testimony to our commitment to our clients, building long term relationships with them, and the high-quality standards to which we hold ourselves. It is also worth noting that this win was achieved while the market is very competitive.

Even in the most competitive of times, our clients such as pharmaceutical and biotech companies constantly develop their pipelines while committing significant proportions of their available resource in this respect. This may become exaggerated as various pharmaceutical companies around the globe face a number of their lead products coming off patent in the period to 2030 and will want to fill this gap in their product line up with new patented products. It is anticipated that the closing of this gap will require the acquisition of products from biotechnology companies who in turn will wish to replenish their own discovery pipelines, deploying the revenues from the sale of their more developed assets. Consequently, it is reasonable to align with reports stating that the market for antibody discovery, including services such as those offered by Fusion, will grow significantly in the coming years. Many market reports testify to this outlook. Two examples of these market reports include reports from Precedence Research and The Business Research Company. These estimate the market in the current year, 2025, to be worth $9.06Bn with a CAGR of 8.3%, and $9.87Bn with a CAGR of 10.3% respectively. Whilst it is wise to treat such forward looking projections as no more than estimates, the trends are reassuring.

Furthermore, these reports and others, delve into market segments such as phage display, hybridomas and humanisation, as well as the putative underlying causes for growth. Growth drivers are predominantly reported as being new technology, such as AI/ML and new discovery technology, and the increase in precision medicines with more patient stratification being better met through more specifically targeted antibody drugs. The split in the Antibody Discovery market between phage display and the use of hybridomas is significant. Phage display enables the use of partial human sequences, but only for fragments of antibodies which then require reconstructing into the final product and not all fragments are compatible with other fragments found through this method. The challenges associated with this complex process are likely a significant contributor to the apparently lower historical returns from Phage Display versus the hybridoma approach which has arguably yielded more drug registrations.

Hybridomas are, however, restricted by the immune responses of the hosts, typically mice or rabbits, for those now approved as therapeutics. The use of animals is something that the pharmaceutical companies try to avoid as much as possible. Furthermore, the innate function of the immune system to avoid auto-immune disease means that output is focussed on the differences between the human antigen and the host equivalent protein. Whilst this is eminently sensible from an evolutionary perspective it is not advantageous to our industry. We consequently see antibody development teams turning to more and more evolutionarily distinct host species, such as chickens and sharks, in order to improve the scope for more diverse immune responses. However, this also makes the humanisation process concomitantly more challenging. In this context, it is my belief that the industry would significantly benefit from a system capable of delivering fully intact human antibodies without the compromises and complications of the existing approaches. This is what we have set out to provide in developing OptiMAL® as the technological solution to the industry wide problem.

OptiMAL® and Mammalian Display: the right products at the right time.
I believe that the time is right for just such a disruptive antibody discovery platform which could allow human sequences to be used, without the auto-immune filter of a host animal or the restriction in fragment size. Such a platform would instead deliver full antibody sequences, ideally expressed by mammalian cells. This is what OptiMAL® offers the market.

Where more is known about the target antigen, there is scope for a more focused approach utilising artificial intelligence (AI) and/or machine learning (ML). These novel design methods are intended to generate full length antibody sequences which need to be synthesised in the real world for testing. This can be achieved through our AI/ML-AbTM platform utilising the same mammalian display technology developed for OptiMAL®.

It is fair to say that our AI/ML-AbTM has not yet delivered its full potential. This will take time. It is widely recognised that while there has been considerable excitement about the potential capability of AI, like many new technologies, the uptake and confidence in the approach is building cautiously. Antibody design, especially de novo design, is no exception. Nevertheless, many antibody experts believe that AI/ML will be a key part of the mix of approaches for antibody discovery and development going forward. It is important therefore that Fusion remains active in the field. Our collaboration with a leading US-based AI/ML business announced in 2023 is still in place and will use our proprietary Mammalian Display platform to enable screening of designs derived from AI/ML. Our AI based research project with Oxford University is similarly progressing well with in silico designs being successfully expressed in our laboratories in Belfast and generating data which will be used to improve the novel algorithms and their outputs so adding value to our services in the future.

Developing a Fusion asset
On 24th April 2025 we announced the approval of a grant to support the development of an antibody against DR5 (death receptor 5) as a potential therapeutic and or diagnostic antibody for certain types of cancer. The award of the grant followed on from the successful identification of a lead antibody with some exceptional biological properties. The grant funding will allow the Company to progress this interesting lead molecule by humanising it and, accessing expertise at Queen’s University Belfast, demonstrate its potential efficacy in vivo. The ambition is to have a clinic ready asset available for partnering from late FY2027.

Conclusion
In conclusion, I firmly believe that Fusion has the proven capabilities, track record and an improving business performance to provide the Company with a stable foundation from which to launch groundbreaking disruptive technologies. In my opinion, the most significant of these is OptiMAL® complemented by the underlying mammalian display and the Opti-library, which is also applicable to phage display. The range of services we offer our clients is increasingly comprehensive and highly complementary to diverse antibody development strategies positioning us well to continue to gain traction with a broad client base across Therapeutics, Diagnostics and Research antibody sectors. The year ahead is an exciting one for the business. We will continue to support our existing client bases, appeal to wider markets through technological differentiation which provides significant benefits to our existing and new clients. We will also use the OptiMAL® technologies, and such assets as may be available, to position the Company for a transition from a service provider with repeat business to a technology licensor with recurring revenues.

Adrian Kinkaid
Chief Executive Officer
03 September 2025

Statement of Profit or Loss and Other Comprehensive Income
For the year ended 31 March 2025

Statement of Financial Position
As at 31 March 2025

Statement of Changes in Equity
For the year ended 31 March 2025

Statement of Cash Flows
For the year ended 31 March 2025