Fusion Antibodies Regulatory News (FAB)

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

("Fusion" or the "Company")

OptiMAL® R&D Update 

Validation of OptiMAL® for the isolation of specific antibodies against proteins and peptides

On track for the commercial launch of OptiMAL® in December 2025

Fusion Antibodies plc (AIM: FAB), specialists in pre-clinical antibody discovery, engineering and supply for both therapeutic drug and diagnostic applications, provides an update to the OptiMAL® project being performed under the collaboration agreement (the "Agreement") with the National Cancer Institute ("NCI"), details of which were originally announced on 28 November 2023.

Having already demonstrated superior single digit nM affinities for antibodies against protein targets, as detailed in the announcement on 17 September 2025, the Company can report that OptiMAL® has been now shown to be similarly successful with smaller peptide targets.

Peptides are often used as antigens as they can be designed to represent specific epitopes (regions of the protein) for the antibodies generated. They are also easier and more cost effective to synthesize. However, they are less immunogenic which can result in poorer antibodies. This is not the case with OptiMAL® as no immune response is required.

This evidence will better enable Fusion to propose the use of OptiMAL® for a wider range of targets, thereby broadening the accessible market and increasing revenue potential. The next steps are to test the antibodies in cell-based assays at the NCI, to evaluate their potential to become therapeutic drug candidates.

This latest finding provides further validation of OptiMAL® as a platform for the isolation of specific antibodies against proteins and peptides and places the Company on track for the commercial launch of OptiMAL® at the Antibody Engineering and Therapeutics conference in December 2025. Work continues within Fusion to further optimise and expand the OptiMAL® platform.

NCI, part of the US National Institutes of Health, is the US federal government's principal agency for cancer research and training. Pursuant to the Agreement, Fusion has provided NCI with access to OptiMAL® for use in the discovery of novel antibodies against targets selected by NCI. This Agreement is due to continue until November 2025, however, the NCI has asked to extend its use of the OptiMAL® platform for use against further targets in the coming years. Negotiations are underway to establish mutually agreeable terms for an extended agreement.

Dr. Adrian Kinkaid, CEO of Fusion Antibodies plc, commented: "We are again delighted with the performance of the OptiMAL® platform providing very high affinity antibodies against peptides, a prevalent but challenging target class. The latest developments provide us with a more solid foundation with which to address a wider market and positions OptiMAL® as the potential front line discovery platform of choice for human therapeutic antibody discovery."

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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.