Highlights 2
pre|CISION™ Technology 3
Affimer® Technology 5
Investment Proposition 7
Strategic Report (Section Cover) 9Chairman's Statement 10
Chief Executive Officer's Statement 11
Operational Review 15Business Overview 15
Therapeutics Division 15
AVA6000 Clinical Trial Update 16
Drug Development Collaborations 21
Diagnostics Division 21
Launch Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Coris BioConcept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Financial Review 21Principal Risks and Uncertainties 24
Governance (Section Cover) 29Board of Directors 30
Directors' Report 33
Corporate Governance Report 37
Audit Committee Report 45
Remuneration Committee Report 49
Statement of Directors' Responsibilities 54
Independent Auditor's Report to the Members of Avacta Group plc 55
Financial Statements (Section Cover) 65Consolidated Statement of Profit or Loss 66
Consolidated Statement of Other Comprehensive Income 67
Consolidated Statement of Financial Position 68
Consolidated Statement of Changes in Equity 69
Consolidated Statement of Cash Flows 68
Notes to the Consolidated Financial Statements 71
Company Balance Sheet 108
Company Statement of Changes in Equity 109
Notes to the Company Financial Statements 110
Shareholder Information 117Notice of Annual General Meeting 118
Notice of Meeting Notes 121
Shareholder Information: Secretary and Advisers 125
FY25 HighlightsResearch & Development (R&D) Highlights
Increased momentum and strengthened position as a pure-play oncology biopharmaceutical company by focusing on the Company's unique proprietary pre|CISION® peptide drug conjugate platform, with significant progress in R&D programs
Gen Two (AVA6103):
First patient received treatment in FOCUS-01, a multicenter, open-label Phase 1 clinical trial of AVA6103 (FAP-Exd, pre|CISION®-enabled exatecan)-March 2026.
The FOCUS-01 trial is enrolling patients with six advanced cancers that were selected by leveraging our strategic collaboration with Tempus AI
Presented highly favorable data from multiple preclinical studies compared to successful antibody drug conjugate, Enhertu®. Also presented further data comparing with another successful antibody drug conjugate, Datroway®.
Updated preclinical and translational data presented at the American Association of Cancer Research (AACR) Annual Congress in San Diego in April 2026
Gen One (AVA6000):
Reported highly encouraging efficacy and safety data from patients with salivary gland cancer
Program continued to enroll patients in the Phase 1b trial to assess the efficacy of AVA6000 (Faridoxorubicin, pre|CISION®-enabled doxorubicin) in more homogenous, defined patient populations
Positive Health Authority interactions resulted in the lifting of lifetime maximum dose due to highly favorable cardiac safety and agreement on dose selection for subsequent trials
Gen Three (AVA6207):
Demonstrated the dual payload technology incorporating the sustained release mechanism with multiple combinations of payloads with updated in vivo data
Intellectual property (IP) portfolio continued to grow and gain momentum measured by increased IP filings. These include two important advances in the pre|CISION® IP estate:
The sustained release mechanism of payload delivery and
The dual payload mechanism of delivery allowing the precise delivery of two payloads
Management and Board strengthening
Appointment of Brian Hahn as Chief Financial Officer (non-Board) in January 2025.
Appointment of David Liebowitz as Chief Medical Officer in July 2025.
Appointment of Francis Wilson as Chief Scientific Officer in February 2026.
Appointment of David Bryant and Richard Hughes as Non-Executive Directors of the Company in May 2025
Financial
Strengthened financial position to support our R&D programs.
Raised £22.5 million in new equity from a broad range of existing and new investors and renegotiated the terms of the convertible bond
March 2026-completed oversubscribed placing and subscription raising £10 million-extending cash runway into Q1 2027
Cash and short-term deposit balances at December 31, 2025, of £16.9 million (31 December 2024:
£12.9 million). As of April 30, 2026 cash held was £16.4 million
Financial and corporate highlights
The Company successfully raised £22.5 million in new equity during 2025 from a broad range of existing and new investors to support R&D programs and also renegotiated the terms of the convertible bond (link)
Reported loss from continuing operations of £36.26 million (2024: £29.43 million)
Loss per ordinary share from continuing operations of 9.07p (2024: 8.54p)
Cash and short-term deposit balances at 31 December 2025 of £16.9 million (31 December 2024:
£12.9 million)
Events after the reporting periodOn 27 March 2026, the Group announced the successful completion of an oversubscribed placing and subscription to raise gross proceeds of £10.0 million. A total of 15,000,000 new ordinary shares of 10p each were issued pursuant to the placing, together with a further 873,016 new ordinary shares issued under a director subscription, at an issue price of 63 pence per share.
On 13 May 2026, 1,604,063 new ordinary shares of 10p each were issued in settlement of a £1.20 million conversion in respect of the unsecured convertible bond.
Avacta's Proprietary pre|CISION® platform Concentrating highly potent warheads in the tumor microenvironmentThe Avacta pre|CISION® platform is a proprietary system designed to deliver an anticancer drug, commonly referred to as a payload or warhead, to tumors while limiting systemic exposure to the payload. Linking the active drug or payload to the pre|CISION® peptide has two advantages:
The drug is rendered inert by the conjugation to the peptide thereby reducing systemic toxicities; and
The restricted release of the payload in tumors results in high concentrations of the active payload in tumors with lower concentration in peripheral blood.
By applying pre|CISION®, we aim to reduce systemic exposure while enhancing exposure at the tumor site. This would address dose-limiting toxicities that both cause significant morbidity and may limit the ability to deliver more effective therapy. With this mechanism, the payloads and cytotoxic activity are only activated upon cleavage by FAP within the tumor environment. Further, given that the pre|CISION® "micropeptide" is comprised of only two amino acids and a capping group, one distinct advantage of the peptide design is that it is too small to be visible to the immune system and therefore cannot generate anti-drug immune responses.
Our pre|CISION® technology relies on FAP, a protease that is overexpressed in many solid tumors. Our pre|CISION® product candidates rely on the enzymatic activity of FAP to cleave the pre|CISION® peptide, which releases the warhead directly in tumors. The pre|CISION® peptide is engineered to be highly specific to FAP versus other related and unrelated proteases, thus limiting non-specific release of warhead that results in off-target toxicities with other, non-specific release approaches. Prior to activation by FAP, our pre|CISION® product candidates cannot enter cells, which prevents cytotoxic activity. These product candidates can be administered to patients and travel to tumor sites without exposing healthy tissues to the inherent toxic effects of their payloads. Only upon cleavage by FAP within tumors are their payloads and cytotoxic activity released.
AVA6000, a doxorubicin pre|CISION® product candidate
AVA6000 is a PDC pre|CISION® product candidate designed to deliver doxorubicin to FAP-expressing solid tumors. In a Phase 1 trial in patients with solid tumors, tumor concentrations of doxorubicin delivered this way were approximately 100-fold higher than plasma concentrations, consistent with tumor-specific release of doxorubicin from AVA6000. Patients dosed with AVA6000 had reduced rates of toxicities compared to those reported with standard doses of doxorubicin. Preliminary signs of clinical activity have been observed, including partial responses that showed over 50 percent reduction in tumor load. The relatively low rate of toxicities observed in the every-three-week dosing regimen has enabled a modification of the dosing regimen so that one ongoing arm of the trial now features biweekly dosing. Expansion arms in indications such as breast cancer, soft tissue sarcoma, and salivary gland cancer were opened to screening in December 2024 and began dosing patients early in 2025. The FDA has granted orphan drug designation to AVA6000 for the treatment of patients with soft tissue sarcoma.
AVA6103, an exatecan pre|CISION® product candidateAVA6103 is a pre|CISION® product candidate that delivers exatecan, a chemotherapy drug with clinical antitumor activity in cancers such as breast, gastric, small cell lung and pancreatic cancers. AVA6103 was designed to improve the safety and efficacy of exatecan by enhancing its exposure in tumors through blocking its ability to enter cells before FAP activation and by altering its pharmacokinetics to increase its tumor residence time. In early 2025, we selected the clinical candidate and advanced AVA6103 into IND-enabling studies, with an IND filed with the FDA in late Q4 2025. Post-period end, we enrolled the first patient to be treated in a Phase 1 trial in Q1 2026.
Affimer® Technology
Affimer® reagents are small proteins that can be engineered to bind to a target molecule of interest, in the same way that an antibody does, but with a number of competitive advantages over antibodies. Affimer regents can be used to develop diagnostic and research assays, or products to enrich or purify a target from a complex mixture. If the target is involved in a disease pathway and binding by the Affimer® molecule activates, alters or blocks its function, then there is potential for the Affimer® molecule to provide therapeutic benefit as a drug.
Our biologic drug conjugates
The capping group can also be applied as a linker to a biologic molecule through standard cysteine-maleimide conjugation methods used in the antibody drug conjugate field. Our Affimer® molecules are small proteins that can be engineered to bind to the pre|CISION® peptide, in the same way that an antibody does, but with a number of competitive advantages over antibodies. Affimer® molecules are based on a naturally occurring human protein called stefin A which is engineered to display two loops that create an antigen binding surface. Affimer® molecules are considerably smaller and simpler than naturally occurring antibodies, offering several advantages in comparison.
Affimer® molecules are 10-fold smaller than antibodies
Advantages of Affimer® molecules compared to antibodies:
Desired specificity and affinity can be generated more rapidly. Antibodies are often generated by immunization of animals, a process which can take many months. Both the specificity and the affinity of antibodies identified by this method are limited by the immunological response in the particular animal used for production. By contrast, Affimer® molecules are generated by screening a pre-existing library of approximately 10 billion candidates, a process which takes weeks.
Potential to address a broader spectrum of targets. Antibodies that are generated by immunization have some fundamental limitations. These antibodies cannot be generated if they are toxic to the host animal in which they are created. In order to elicit an immune response and to avoid immunogenicity or attack on the animal's healthy tissues, antibodies must address targets that are sufficiently different than targets endogenous to the animal. These limitations do not apply to Affimer® because the screening of potential candidates is done in the laboratory in a process called in vitro phage display that does not use animals.
Smaller size and simpler manufacturing. Antibodies are typically produced by mammalian cell culture, a time consuming and expensive process. By contrast, Affimer® molecules have no post-translational modifications. Therefore, these molecules can be generated in bacterial cell culture. Along with having a smaller size, they are stable to extremes of pH and temperature, properties that are favorable both for purification and for chemical modification with drug payloads.
Potential for increased tissue penetration. One of the disadvantages of biologics, such as antibodies, is that their size limits their ability to penetrate poorly vascularized tissues such as tumors. Affimer® monomer molecules are 5-10 times smaller than antibodies, a size advantage that may allow them to penetrate target tissues more readily.
Engineered for precision modification. Affimer® molecules are engineered with specific sites that allow chemical modifications (cysteines), such as attachment of drugs, at specific sites. By contrast, antibodies are naturally occurring molecules that are not optimized for specific chemical modification. This property simplifies the ability to create product candidates that include both Affimer® and pre|CISION® technologies.
Affimers represent an efficient method of delivering pre|CISION® cytotoxins
Affimer® drug conjugates, or AffDCs, are pre|CISION® drug candidates that rely on Affimers as a means of targeting tumor-specific delivery; and those in which the Affimer® is intended to further extend plasma half-life. We believe that an Affimer® that directly targets tumor-associated antigens can lead to further increases in half- life by sequestration of drug molecules prior to activation by FAP. Furthermore, an Affimer® can be engineered to block signaling within the tumor, such as preventing PD-1/PD-L1 signaling, which we believe may lead to an increase antitumor activity. We have shown that we can create dual Affimers, enabling the inclusion of both types of functionality in a single AffDC product candidate.
AVA7100, an AffDC programWe are developing AVA7100 a dual Affimer® containing four sites to which a pre|CISION® exatecan drug conjugate can be linked. The FAP-targeting Affimer® domain of AVA7100 is designed to drive localization to FAP-expressing tumors. The second Affimer® domain binds albumin intended to improve pharmacokinetics by increasing plasma half-life.
Diagnostics DivisionDiagnostics Division Discontinued
In 2024, Avacta announced that it was exploring strategic options for the Diagnotics Division in a manner which maximised shareholder value. The Group classified the Diagnostics Division as held for sale and reported it as discontinued operations.
Avacta Diagnostics (the "Diagnostics Division"), included three components: Launch Diagnostics, Coris BioConcept, and our internal diagnostics group ALS-Dx
Launch Diagnostics: Launch Diagnostics Holdings Ltd ("Launch Diagnostics"), based in Kent, England, which was acquired in October 2022, was a leading independent in vitro diagnostic, or IVD, distributor in the United Kingdom, with over 30 years' experience in the industry. Launch Diagnostics provided immunodiagnostic and molecular test products, technical support and maintenance to healthcare providers. Launch Diagnostics served private and public sector customers throughout the United Kingdom, France, Belgium, Luxembourg and Republic of Ireland, with approximately 95% repeat business. Launch Diagnostics was sold on 24 March 2025 for £12,900,000.
Coris BioConcept: Coris BioConcept SRL ("Coris" or "Coris BioConcept"), based in Gembloux, Belgium and established in 1996, which was acquired in May 2023, developed, manufactured and marketed rapid diagnostic test kits, mainly lateral flow tests, for use by healthcare professionals. Coris was ISO 13485 certified and marketed its products through distributors in Europe, Asia, South America, Africa and Oceania. Coris BioConcept sold on 29 August 2025 for £2,150,000.
Up until the point of sales, the Diagnostics Division reported revenue of £6.2 million in 2025 (2024:
£24.3 million)
Investment Proposition Our MissionOur Mission is to improve patients' lives and grow shareholder value by developing novel cancer therapies to create a portfolio of product candidates using our proprietary Affimer® and pre|CISION™ platforms.
Investment opportunityAvacta Group has strategically transitioned to a pure-play oncology therapeutics company by completing the divestment of its diagnostics division. This move allows the company to concentrate resources on its proprietary pre|CISION® platform, aiming to revolutionize cancer treatment through targeted peptide drug conjugates (PDCs).
In March 2025, Avacta sold its UK-based diagnostics unit, Launch Diagnostics, for £12.9 million (net
£9.5 million) in cash to Duomed Belgium NV. This sale represented a significant step toward Avacta's goal of becoming a dedicated biotechnology company.
In August 2025, Avacta sold its Belgium-based diagnostic unit, Coris BioConcept to 3B BlackBio Dx Ltd for an upfront cash consideration of £2.15 million (net £0.5 million).
Technology platformsAvacta has two proprietary platform technologies-the Affimer® and pre|CISION™ platforms-which are being used to deliver a robust portfolio of products that address multi-billion-dollar markets.
The pre|CISION™ platform is a highly specific substrate for fibroblast activation protein (FAP) which is highly upregulated in most solid tumours compared with healthy tissues. The pre|CISION platform harnesses this tumour-specific protease to activate pre|CISION peptide drug conjugates and pre|CISION antibody drug conjugates in the tumour microenvironment, reducing systemic exposure and toxicity, allowing dosing to be optimised to deliver the best outcomes for patients.
Affimer® molecules are engineered alternatives to antibodies that have significant competitive advantages including size, stability, versatility, rapid development and ease of production.
Our StrategyOur goal is to develop and ultimately commercialize a broad portfolio of product candidates based on the ability of our pre|CISION® technology to deliver potent warheads to tumors. In principle, if applied to all patients whose tumors overexpress FAP, our approach could lead to treatments for hundreds of thousands of patients. Our strategy to achieve this goal is as follows:
- Continue to develop AVA6000 for the treatment of breast cancer, head and neck cancers and other tumors sensitive to doxorubicin. Interim data from our ongoing Phase 1 trial indicates that AVA6000 delivers high concentrations of released doxorubicin directly to tumors in human subjects resulting in fewer toxicities than reported in the literature for conventional doxorubicin administration. We have observed clinically meaningful antitumor activity in the Phase 1a portion of this trial. To confirm this activity, we opened the indication-specific dose expansion cohorts to screening in December 2024 and began dosing patients early in 2025. We have reported ongoing results and will be releasing more data in the first half of 2026.
Advance AVA6103 into and through clinical development. We have demonstrated the ability of our pre|CISION® technology to be applied to other warheads through the creation of AVA6103, an exatecan derivative. We selected a product candidate in the second half of 2024 and subsequently filed an IND in late 2025 and initiated a Phase 1 trial of AVA6103 in the first quarter of 2026.
Advance AVA7100 into clinical development. We believe AVA7100, utilizing our Affimer® proteins, will have the potential to impart tumor-antigen-specific targeting of pre|CISION® drug conjugates with improved pharmacokinetics that will optimize targeting of tumor types that have lower expression of FAP. We continue pre-clinical activites to optimize our product candidate.
Establish product-based partnerships on pre|CISION® product candidates. We believe that the broad applicability of our pre|CISION® technology can drive the creation of a number of product candidates. We may seek to accelerate the development of some of these product candidates with corporate partners with clinical expertise in certain therapeutic areas or geographies.
Explore additional technology-based collaborations surrounding our pre|CISION® and Affimer® platforms. We believe that the broad potential of these technology platforms may serve as the basis for future partnerships outside of our core area of focus. For example, we have previously licensed our pre|CISION® technology to POINT Biopharma Inc., or POINT, for the development of radiopharmaceutical product candidates; and we have partnerships with both Pharmaceutical Co. Ltd., or Daewoong, and LG Chem Life Sciences, or LG Chem, focused on generation of therapeutics based on our Affimer® technology.
(Section Cover)
Chairman's Statement 10
Chief Executive Officer's Statement 11
Operational Review 15Business Overview 15
Therapeutics Division 15
AVA6000 Clinical Trial Update 16
Drug Development Collaborations 21
Diagnostics Division 21
Launch Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Coris Bioconcept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Financial Review 21Principal Risks and Uncertainties 24
Chairman's statementAvacta has made great strides forward in 2025 and into 2026. The Company has developed into a pure-play therapeutics biotechnology force with two clinical stage programs, a developing pipeline of pre|CISION medicines and a broadening IP portfolio that will drive value for patients and shareholders, boosted by raising £32.5 million over the last 18 months to support our R&D programs.
The Company has moved the numerous development initiatives forward faster than industry norms and has increasing confidence in the growing class of drugs in the peptide drug conjugate field-the combination of an oncology drug and our pre|CISION peptide. The Board believes the pre|CISION-enabled technology makes the drug conjugate model considerably more advantageous.
Avacta's profile across the sector is now also gaining real momentum and it is in discussions with numerous parties over commercial partnering agreements which, if secured, will support the Company's development as well as widen the scope to exploit its technologies.
Board and employeesIn January 2025 Brian Hahn was appointed Chief Financial Officer (non-Board), in July of 2025 David Liebowitz was appointed Chief Medical Officer. In April 2025, Dr Trevor Nicholls retired and Mark Goldberg took over as Chair of the Remuneration Committee. In May 2025, David Bryant and Richard Hughes were appointed Non-Executive Directors.
On behalf of the Board, I would like to thank all our employees in the UK and the US. We have some of the leading international scientists in biotech, their expertise, creativity and commitment have enabled the business to move faster than expected and also drive numerous innovative developments.
The delivery from concept to IND application (Investigational New Drug-the submission to the US Food and Drug Administration) for the AVA6103 program in less than 12 months from candidate selection is a strong illustration of the team's capabilities. A second example is the innovative use of AI to recreate a synthetic comparator arm which allows a direct comparison of the AVA6103 data with the published data of other oncology drugs, Enhertu® and Datroway®, rather than repeating their experiments in-house.
OutlookAs I stated last year, Avacta has a clear value proposition and world-class scientific capabilities. It is supported by robust data and an innovative platform.
The coming 9-12 months are crucial for the Company as we anticipate seeing the first evidence of the real potential for our innovative Gen Two pre|CISION platform from our exatecan program, AVA6103.
Clinical testing has now started in the AVA6103 program based on the sustained release delivery mechanism and we expect initial evidence in late H2 2026. This innovation opens up the full potential for the platform by enabling multiple payloads to be delivered as either single or dual platforms, driving value for both patients and shareholders alike
We expect multiple data updates in the AVA6000 program in all groups from the Phase 1b expansion cohorts, in H1 2026.
Our team continues to explore multiple commercial opportunities with potential strategic partners. Our new data in both clinical programs are anticipated to be significant advances in moving these ongoing conversations forward.
Shaun Chilton
Shaun Chilton,
Chairman
Chief Executive Officer's statementAvacta is making excellent progress and gaining real momentum as we invest in and develop our unique proprietary industry-leading protein-drug conjugate technology platform, pre|CISION®.
We are building a substantial portfolio of related intellectual property (IP) and currently have two programs in clinical development, our lead candidate AVA6000 (faridoxorubicin) and our Gen Two sustained release program, AVA6103 (FAP-Exd).
The Company raised £22.5 million in equity during 2025 to support our investment programs which was supplemented by the recent raise of a further £10 million in March 2026, meaning that Avacta now has cash resources to support its development until early Q1 2027.
pre|CISION® is a highly innovative, versatile and unique platform, through which we are seeking to deliver clinical results across our two lead programs.
Vision and strategyOur vision Is to conquer cancer with existing therapies while preserving patient vitality and healing. In a world where effective cancer therapy often means a difficult trade-off between efficacy and safety, pre|CISION has the potential to offer something different: Hope without compromise.
Our strategy is to develop and ultimately commercialize a broad portfolio of drugs, based on the ability of pre|CISION® technology to repurpose a range of oncology drugs to significantly reduce toxicity and side effects by concentrating the payload in the tumor, and so improving efficacy and patient tolerability.
We are challenging the current drug delivery methods with the goal of expanding the reach of high potent anticancer therapies. In principle, if applied to all patients whose tumors overexpress fibroblast activation protein (FAP), a common tumor-associated protein, our approach could ultimately lead to treatments for nearly all patients across a wide range of cancers.
A unique approach to treating cancer-our proprietary technology pre|CISION®A key challenge in oncology is that it is the most effective therapies which cause the most toxicity in normal tissues. Our approach leverages existing cancer drugs that are delivered precisely to the tumor using our proprietary pre|CISION® platform.
The key aspect of our pre|CISION® peptide drug conjugate (PDC) technology is that the conjugated drug (the combination of the oncology drug and our peptide) is inert. Our innovative technology links a dipeptide to an existing cancer drug to inactivate it. It is incapable of entering cells and killing, until the peptide is specifically released when it comes into contact with FAP, in or near the tumor.
Our platform is based on a highly successful drug class in oncology, known as the antibody drug conjugate or ADC. The ADC delivery mechanism was founded on the premise that an antibody directed at a tumor antigen can deposit or release a highly potent payload in the tumor. Our platform seeks to move this premise further by creating a highly selective release mechanism that leverages a key tumor-specific enzyme, FAP. Antibodies are comprised of 1300-1400 amino acids, whereas the pre|CISION peptide contains only 2 amino acids, resulting in better tumor penetration, higher maximal concentrations of released payload and simpler, less expensive manufacturing for use in patients.
When a pre|CISION® PDC encounters FAP in the tumor microenvironment (TME), the peptide is cleaved and active payload is released. The release of the payload from the pre|CISION® product in the TME results in higher concentration of the drug at the tumor and lower blood and healthy tissue levels than would be achievable with standard systemic administration. Our pre|CISION technology is designed to concentrate the active drug in the tumor while maintaining the inactive pre|CISION-enabled drug in the bloodstream.
Our clinical data with the first pre|CISION medicine AVA6000 demonstrates that pre|CISION is capable of delivering higher drug levels within tumors which will lead to improved antitumor activity while reducing systemic toxicities. This will dramatically widen the all-important therapeutic index and efficacy of a given anticancer drug.
Therapeutic index (TI) is a quantitative measurement of a drug's relative safety, comparing the dose that produces a toxic effect to the dose that produces a desired, effective response. A higher TI indicates a wider, safer margin between effectiveness and toxicity.
In addition to the impact on the TI with our newly developed sustained release mechanism, we have demonstrated that pre|CISION® is also capable of delivering improved release kineticsthe rate and mechanism of active pharmaceutical ingredients exiting a formulation, which is crucial for optimizing therapeutic efficacy. This addresses issues associated with the pharmacokinetics (how the body interacts with a drug throughout its exposure) of an agent in the clinic in addition to the impact on the TI.
Additionally, our pre|CISION® platform has been demonstrated to have four key advantages over the ADC drug class:
tumor-specific release leading to very low peripheral exposure to the payload;
rapid tumor penetration and release of payload with demonstrated higher maximal tumor concentration;
an optimized bystander effect, allowing effective killing of antigen (FAP)-negative tumor cells; and
a large market opportunity based on FAP expression noted in 90% of solid tumors and the ability to link multiple payloads to the pre|CISION® peptide
We believe there are no other technologies that can deliver cancer treatment drugs directly into the tumor at the concentrations that our payloads enable without causing highly toxic side effects.
Our strategic collaboration with Tempus, a technology company leading the adoption of artificial intelligence to advance precision medicine and patient care, has also enabled us to better understand the large addressable patient population for the full suite of pre|CISION® medicines.
Opportunities and business developmentThe recent advances in our R&D are allowing us to "pre|CISION-enable" a number of different therapies. We now believe that some 90% of solid tumors are potentially treatable by our pre|CISION® platform, as demonstrated by multiple indications across a wide range of solid tumors.
Our IP portfolio continued to grow and gain momentum measured by increased IP filings, including two important advances in the pre|CISION® IP estate:
the sustained release mechanism of payload delivery piloted in our AVA6103 program, and
our dual payload mechanism of delivery allowing the precise delivery of two payloads to the tumor from a single FAP cleavage event with our pre|CISION® technology.
These advances have led to new and increasingly valuable IP being developed around our foundational pre|CISION technology, the Company's most valuable asset. The advances we have made in the last year and a half are remarkable and open up a wealth of opportunities for the platform, both with single-agent delivery mechanisms as well as our new dual payload system. The latter allows our scientists to design drugs that attack cancer at the same time as treating the resistance mechanism.
Avacta has an active business development program as it looks to enhance its position and develop the numerous opportunities by working with other companies in the sector. The unique nature of the dual payload program is also generating interest with potential partners.
ProgramsAVA6000 (Faridoxorubicin)-FAX-Dox
AVA6000, our lead product candidate, is a peptide drug conjugate form of doxorubicin, an approved cancer drug with known severe toxicities.
Doxorubicin was selected as the first candidate because:
it is an approved drug with known activity in a set of solid tumors
the chemistry and half-life of the drug was highly amenable to peptide conjugation and
there is a distinct serious toxicity (cardiac failure) that would represent proof of concept, if pre|CISION® enabling could eliminate this toxic effect.
The program continues to demonstrate excellent progress in the clinic with the lead indication selected, salivary gland cancer (SGC). We have seen a significant gain in progression free survival over existing therapy.
We have also cleared significant regulatory hurdles with the cardiac lifetime maximum limit of doxorubicin exposure removed during Phase 1 testing and we have agreed with the regulators on the dose selection for further study.
In December 2025, we reported highly encouraging efficacy and safety data from the cohort of patients enrolled with SGC where a disease control rate of 90% is maintained in the full cohort.
The program continued to enroll patients in the Phase 1b expansion cohorts, to assess the efficacy of AVA6000 in more homogenous, defined patient populations to better predict the magnitude of efficacy anticipated in larger Phase 2/3 trials.
Further data will be presented by the end of the 1H 2026, in particular an update on the Phase 1b cohorts, including the lead indication, salivary gland cancer. In addition, we will present the full cardiac safety data and clinical pharmacology data that led to the lifting of the cardiac dosing limitation.
AVA6103 (FAP-Exd)
AVA6103 is our second program. Exatecan (Exd) is a potent topoisomerase I inhibitor (a chemotherapy drug that interrupts DNA replication and transcription leading to DNA damage and cancer cell death).
Conventional exatecan has demonstrated clinical activity in the original Phase 1-3 trials enrolling patients with cancers such as breast, gastric, lung and pancreatic cancers. However, dose-limiting toxicities and challenging dosing regimens required based on the short drug half-life led to discontinuation of its development.
We believe that exatecan represents a good candidate for our pre|CISION® technology because:
This drug has demonstrated single agent activity in a set of Phase 1 and 2 trials
A closely related payload, deruxtecan has demonstrated significant activity in two approved top-selling antibody drug conjugate medicines (Enhertu® and Datroway®) including potent bystander effects
The pharmacokinetic challenges and systemic toxicities of exatecan can be potentially solved by the sustained release mechanism in the pre|CISION® technology.
The first patients have been treated in Phase 1a of the program with the FOCUS-01 trial initiating in Q1 2026 as planned. This pre|CISION drug moved from concept to clinical trial enrollment in only 24 months, and our final drug candidate to first patient in less than 12 months, both time frames were considerably faster than the standard industry timelines.
The clinical development of AVA6103 is a true catalyst for the Company, given the exceptional innovative chemistry that was developed by our team using the clinical and translational data collected in the AVA6000 clinical trial and this chemistry enables many more payloads to be implemented as pre|CISION® medicines. Crucially, the AVA6000 trial data has enabled the discovery of our newest innovation, the sustained release mechanism of AVA6103.
The innovation of this program and the sustained release mechanism of delivery are critically important to the next stage of the pre|CISION® platform development for three reasons:
the development of the suite of chemical linkers that sit in the active site between the FAP-cleavable peptide and the payload, dramatically widens the types of payloads that can be attached to the pre|CISION® mechanism,
the sustained release mechanism of the capping group (the therapeutic molecules added to improve stability and effectiveness) and linker together allows our scientists to dial-in the exact kinetics of release desired for a given payload, and
the linker chemistry developed allows the attachment of two payloads that can be released simultaneously with one FAP cleavage event allowing combination therapy in a single pre|CISION® molecule
We believe that AVA6103 will enable patients to obtain the therapeutic benefit associated with delivering exatecan directly to tumors in a sustained release mechanism, while limiting systemic exposure that was associated with poor tolerability in the original development of conventional exatecan.
The clinical data with AVA6103 in the chemistry allows many more payloads to be delivered through a pre|CISION® mechanism and the exact kinetics to be designed into the peptide drug conjugate in both single and dual payload formats.
In December 2025, we published new pharmacology data in support of the IND process and the design of the Phase 1 trial. Clinical testing has now started at a number of US specialty oncology centers covering four cancer tumor types: pancreatic, gastric, small cell lung and cervical.
ExpertiseOur recent updates from both programs demonstrate the unwavering commitment of the management team and their attention to both flawless execution in the clinic and a highly favorable regulatory interaction.
This was demonstrated by the recent lifting of the lifetime maximum of doxorubicin exposure in the AVA6000 program and rapid filing and efficient clearance of the AVA6103 IND to allow clinical development of this program to commence quickly at our US sites.
We have strengthened our team with the appointments of Brian Hahn as Chief Financial Officer (non-Board) (CFO), Francis Wilson as Chief Scientific Officer (CSO) and David Liebowitz as Chief Medical Officer.
Mr. Hahn, appointed in January 2025, brings 25 years' senior financial and operational experience, including a 15-year tenure as CFO and Senior Vice President of GlycoMimetics, Inc., where he led the company's 2014 initial public offering (IPO) on Nasdaq and the build-out of its finance, accounting, investor relations and corporate affairs functions.
Dr. Wilson joined Avacta in September 2022 as Vice President of Chemistry and has been one of the key drivers in the chemistry field of our platform, notably the development of the sustained release mechanism. He was appointed CSO in February 2026.
Dr. Liebowitz is a seasoned hematologist-oncologist and drug development leader with more than 30 years of experience across academia and industry and has contributed to the successful filing of more than 25 Investigational New Drug (IND) applications. He was appointed CMO in July 2025.
We are exceptionally proud of the efforts and innovation of our team at Avacta, our team is a great advantage. This team has driven several creative initiatives to drive our business forward at speeds not seen in traditional drug development, including two examples here of the use of large data and AI in drug development:
Our strategic collaboration with Tempus has allowed us to access very large data sets and manipulate these data to answer key pipeline strategy questions; and
The recent use of data mining and synthetic comparator arms which have enabled the direct comparison of the kinetics of the pre|CISION® payload release with data published by the developers of the highly successful ADCs, Enhertu® and Datroway®.
The coming period promises to be transformative for Avacta and our patients, and we look forward to reporting further significant progress in the months ahead.
Christina Coughlin
Christina Coughlin,
Chief Executive Officer
Operational Review Business overviewAvacta is a clinical stage biopharmaceutical company developing precision oncology therapies designed to be specifically activated by protease cleavage in solid tumours. Our proprietary pre|CISION® platform enables the creation of peptide drug conjugates, or PDCs, that are dependent on the activity of a common tumour-associated protein known as fibroblast activation protein, or FAP, for activation. Activation of pre|CISION® product candidates in the tumour results in higher local concentrations of anticancer, cytotoxic, or targeted drugs (commonly known as payloads or warheads) and lower systemic levels than those safely achievable with standard systemic administration. We believe that these higher intratumoral drug levels will lead to improved antitumor activity while reducing systemic toxicities. Our lead product candidate AVA6000 is a PDC form of doxorubicin which is an approved cancer drug with known severe toxicities. AVA6000 has been well-tolerated in an ongoing Phase 1 trial in patients with solid tumours and promising antitumor activity has been observed during the dose-escalation portion of this trial. Addition of the pre|CISION® peptide to doxorubicin in AVA6000 has allowed doses that are over three-fold higher than those safely achieved with conventional doxorubicin in routine clinical use. The Phase 1 trial of AVA6000 has moved to expansion cohorts following the completion of enrolment in the Phase 1a dose escalation. The trial is continuing to enrol in the expansion cohorts for patients with triple negative breast cancer, or TNBC, high grade soft tissue sarcoma and salivary gland cancer.
Our pre|CISION® product candidates are created by conjugating a drug or payload with the pre|CISION® "micropeptide," a sequence of two amino acids and a cap that is specifically designed to bind to the active site and be cleaved by the action of the protease FAP within tumours. When a pre|CISION® PDC encounters FAP in the tumour, it binds to the active site, the peptide is cleaved, and active warhead is released. Two factors that dictate the antitumor potential of pre|CISION® PDCs are the expression of FAP and the inherent susceptibility of the associated tumours to the drug that is released. We are generating a differentiated portfolio of product candidates that combine the pre|CISION® peptide with various anticancer drugs to enable the treatment of a broad spectrum of FAP-positive solid tumours.
FAP is highly expressed in many types of solid tumors. Unlike many tumor-specific antigens, FAP is not typically expressed by cancer cells themselves but rather by cancer-associated fibroblasts, or CAFs, which can make up a significant fraction of solid tumors. Although techniques to assess FAP expression, such as immunohistochemistry of tumor samples or PET scanning with PET-active FAP inhibitors, have been developed, our initial clinical development is focused on cancer types in which FAP is expressed so broadly that we believe assessment of FAP expression will not be necessary
Therapeutics DivisionAvacta Therapeutics Division aims to leverage its two proprietary technology platforms, pre|CISION™ and Affimer®, to develop innovative oncology therapies that make a significant difference to cancer patients' treatment experience and outcomes.
Our pre|CISION® platformOur pre|CISION® platform is a proprietary system designed to deliver an anticancer drug, commonly referred to as a payload or warhead, to tumors while limiting systemic exposure to the payload. Linking the active drug or payload to the pre|CISION® peptide has two advantages:
The drug is rendered inert by the conjugation to the peptide thereby reducing systemic toxicities; and
The restricted release of the payload in tumors results in high concentrations of the active payload in tumours with lower concentration in peripheral blood.
By applying pre|CISION®, we aim to reduce systemic exposure while enhancing exposure at the tumour site. This would address dose-limiting toxicities that both cause significant morbidity and may limit the ability to deliver more effective therapy. With this mechanism, the payloads and cytotoxic activity are only activated upon cleavage by FAP within the tumor environment. Further given that the pre|CISION® "micropeptide" is comprised of only two amino acids and a capping group, one distinct advantage of the peptide design is that it is too small to be visible to the immune system and therefore cannot generate anti-drug immune responses.
AVA6000, a doxorubicin pre|CISION® product candidateAVA6000 is a PDC pre|CISION® product candidate designed to deliver doxorubicin to FAP-expressing solid tumours. In a Phase 1 trial in patients with solid tumours, tumour concentrations of doxorubicin delivered this way were approximately 100-fold higher than plasma concentrations, consistent with tumour-specific release of doxorubicin from AVA6000. Patients dosed with AVA6000 had reduced rates of toxicities compared to those reported with standard doses of doxorubicin. Preliminary signs of clinical activity have been observed, including partial responses that showed over 50 percent reduction in tumour load. The relatively low rate of toxicities observed in the every-three-week dosing regimen has enabled a modification of the dosing regimen so that one ongoing arm of the trial now features biweekly dosing. Expansion arms in indications such as breast cancer, soft tissue sarcoma, and salivary gland cancer were opened to screening in December 2024 and will begin dosing patients early in 2025. The FDA has granted orphan drug designation to AVA6000 for the treatment of patients with soft tissue sarcoma.
Doxorubicin background
Doxorubicin, an anthracycline-based chemotherapeutic drug, has been a mainstay of cancer treatment for the past 50 years. It is still widely used to treat various types of cancers including breast cancer, sarcomas, hematologic malignancies and carcinomas. Doxorubicin, a highly cytotoxic drug, has a multifaceted mechanism of action. It intercalates into DNA; inhibits activity of an enzyme called topoisomerase II; causes DNA strand breaks; disrupts mitochondrial function; and, finally, increases the production of oxidative damage through the creation of chemicals called free radicals that arise in response to treatment and can be highly toxic.
Doxorubicin is associated with an extensive list of side effects including cardiomyopathy, secondary malignancies, severe myelosuppression, extravasation and tissue necrosis and alopecia. While cardiotoxicity is associated with nearly all chemotherapeutic agents, the cardiotoxic effect of anthracyclines is particularly concerning. Cardiac toxicity manifests as both acute reversible effects that occur within days and delayed irreversible cardiomyopathy that can occur months after doxorubicin treatment.
Approximately 11 percent of patients experience acute cardiac toxicity. Cardiac event rates increase with cumulative doses with a rate of 7 percent at 150 mg/kg, 18 percent at 350 mg/kg and 65 percent at 550 mg/kg. Paediatric populations receiving anthracycline chemotherapy remain at elevated risk of developing heart failure decades after receiving a cancer cure. When congestive heart failure develops after doxorubicin administration, the one-year mortality rate is approximately 50 percent.
A number of methods have been used to try to mitigate the cardiotoxicity of doxorubicin, but these measures have had limited impact.
Prolonged infusion duration. Administering doxorubicin over 24, 48 or 96 hours can help reduce peak levels and decrease cardiac toxicity.
Liposomal formulations. Using liposomal formulations encapsulates the drug in a lipid membrane, which alters its tissue distribution and helps to reduce its effects on normal tissues.
Cardioprotective agents. Combining doxorubicin with cardioprotective agents like dexrazoxane can help reduce its cardiotoxic effects.
Dose adjustment and monitoring. Adjusting doses and closely monitoring cardiac function during treatment can help manage and reduce toxicity.
In general, these modifications are used in specific situations. For example, liposomal doxorubicin is recommended in elderly patients and in patients with risk factors for cardiac disease. Although altered dosing of conventional doxorubicin can decrease the risk of cardiac toxicity in some patients, it increases hospitalization costs as well as the risks of other toxicities such as mucositis. The cardioprotective agent dexrazoxane is not widely used due to the lack of rigorous clinical evidence of safety and its effects on antitumor activity of doxorubicin in cases where it might be most beneficial, despite its approval in 1995 prescribed receive conventional dosed doxorubicin. Mitigating the cardiac toxicity with this agent remains a substantial unmet need in multiple diseases including breast cancer, soft tissue sarcoma and head and neck cancer (salivary gland cancers).
Post-period end the Company announced that patients are now being dosed in a two-weekly dose escalation study with the aim of defining the recommended Phase 2 dose (RP2D), allowing dose expansions to begin in H2 2026 followed by the Phase 2 efficacy study, subject to FDA approval, in a selected orphan indication.
Our solution, AVA6000AVA6000 is a pre|CISION® product candidate designed to deliver doxorubicin directly in tumours, thereby reducing systemic exposure with the aim of reducing toxicities, such as cardiotoxicity, while potentially increasing antitumor activity. AVA6000 does not enter cells and thus is not cytotoxic on its own. It is designed to be specifically cleaved by membrane-bound FAP expressed on the cell surface of CAFs in tumours, where upon unmodified doxorubicin is released into the TME. Once released, doxorubicin can penetrate cells, leading to their destruction.
AVA6103, an exatecan pre|CISION® product candidateAVA6103 is a pre|CISION® product candidate that delivers exatecan, a chemotherapy drug with clinical antitumor activity in cancers such as breast, gastric, small cell lung and pancreatic cancers. AVA6103 was designed to improve the safety and efficacy of exatecan by enhancing its exposure in tumours through blocking its ability to enter cells before FAP activation and by altering its pharmacokinetics to increase its tumour residence time. In early 2025, we selected the clinical candidate and advance AVA6103 into IND-enabling studies, with an IND filed with the FDA in late Q42025. Post-period end, in Q1 2026, Avacta enrolled the first patient to be treated in a Phase 1 trial.
Exatecan backgroundExatecan is an inhibitor of topoisomerase I, a protein involved in DNA replication and the target of irinotecan, which is similar to exatecan, is a derivative of camptothecin. Irinotecan, however, is not an ideal drug due to high variability in its metabolism and weak activity. Deruxtecan, another derivative of irinotecan, has been used to generate ADC drugs. For example, both Enhertu® and Trodelvy® are ADCs that incorporate deruxtecan. They function by targeting HER2-expressing tumors where deruxtecan leads to killing of HER2-expressing cells, as well as nearby cells, through a bystander effect. Exatecan is a more potent cytotoxin than irinotecan, however, its development did not progress beyond Phase 3 clinical trials due to dose limiting toxicities and lack of therapeutic benefit in combination with gemcitabine
Our solution, AVA6103AVA6103 was designed to overcome the dose-limiting toxicities of exatecan by using pre|CISION® technology to deliver it directly to tumors. In addition to limiting systemic exposure to exatecan, AVA6103 was engineered to improve the half-life of exatecan, which in the unconjugated state is less than 10 hours, to increase its cytotoxic activity using the addition of a capping group. In addition, the rate of cleavage of the pre|CISION® peptide from the active exatecan moiety is modulated by a self-immolative linker group.
We demonstrated in preclinical studies that AVA6103 did not have in vitro cytotoxic activity against Mia PaCa-2 pancreatic tumor cells that do not express FAP. Cytotoxicity of Mia PaCa-2 cells through a bystander effect was activated upon addition of FAP expressing CAFs. The dependence of this cytotoxicity on the protease activity of FAP was confirmed by the addition of a small molecule inhibitor of FAP to block the cell killing activity of AVA6103 even in the presence of CAFs.
A key limitation of exatecan is its short half-life of less than 10 hours. Topoisomerase I inhibitors, such as exatecan, function by trapping topoisomerase onto DNA. During DNA replication, these topoisomerase/ DNA complexes cause lethal DNA strand breaks. However, topoisomerase inhibition by these drugs is readily reversible, so, in order to exert its effect, the drug must be present when the cell is in the DNA synthesis phase of cell division. Previous Phase 2 clinical trials of exatecan found that antitumor effects were enhanced when repeat doses of exatecan were administered with intravenous infusions each day for five days. However, over 45 percent of patients experienced dose-limiting hematologic toxicity when subject to this dosing regimen.
We believe that AVA6103 addresses both the need for a long half-life and the need for reduced systemic toxicity. The inclusion of an albumin-binding domain in AVA6103 was found to increase its half-life by several hours in preclinical models. Furthermore, the pre|CISION® peptide conjugate blocked the cytotoxic activity of exatecan, only releasing it in the presence of FAP-expressing cells in tumors. In a repeat dosing study in non-tumor bearing mice, the MTD of AVA6103 dosed daily was 15 mg/kg which was 75-fold higher than observed with exatecan. The MTD was not reached with biweekly doses of 50 mg/kg of AVA6103, whereas 3 mg/kg was determined to be the MTD for exatecan with this dosing schedule.
We intend to evaluate AVA6103 as a potential therapy for a number of solid tumors for which there is clinical data supporting the antitumor activity of topoisomerase I inhibitors. These tumors include TNBC, gastric cancer, small cell lung cancer and pancreatic cancer. We anticipate initiating a Phase 1 monotherapy trial in patients with FAP-positive tumors in the first half of 2026.
AVA6000 Clinical Trial UpdateWe are conducting a Phase 1 trial of AVA6000 in the United Kingdom and the United States to evaluate the safety, tolerability, pharmacokinetics and early efficacy in patients with cancers known in the literature to be high in FAP. These cancers include sarcomas, liposarcomas and colorectal, salivary gland, pancreatic and biliary tract cancers. The Phase 1a segment of this trial has two dose escalation arms: one in which AVA6000 is administered as monotherapy every three weeks, which is similar to the approved dosing regimen for doxorubicin, and a second arm in which AVA6000 is administered biweekly. Such an increase would, we believe, potentially expand the therapeutic benefit of being treated with a doxorubicin-linked product candidate without increasing the risk of exposure. In tandem, this opens possible future combination therapy that would not be amenable to the every-three-week schedule. The Phase 1b segment of this trial comprises of one to three indication-specific expansion cohorts. We are carrying out this part of the trial to obtain further safety and efficacy data of AVA6000 at a dose recommended based on observed safety and tolerability. Both arms in the Phase 1a segment of the trial have completed enrolment and no maximum tolerated dose, or MTD, has been determined for either arm.
Clinical proof of mechanism for pre|CISION®
Key to the success of AVA6000 and other product candidates based on pre|CISION® is the ability to selectively target delivery of the warhead to tumors. There is extensive evidence that cytotoxic compounds which we are delivering using pre|CISION®, such as doxorubicin in the case of AVA6000, have potent antitumor activity. However, the selected warheads have a narrow therapeutic window due to toxicities associated with systemic exposure. Through pre|CISION®, we aim to increase this therapeutic window by dosing patients with peptide conjugated warheads that are inactive until they reach tumors where they are activated through enzymatic cleavage by FAP.
Based on interim data collected during our ongoing Phase 1 trial, we found that the intratumoral levels of free doxorubicin were approximately a median of 100-fold higher than plasma levels in subjects treated with AVA6000. Among the 11 subjects for whom post-treatment tumor biopsies were available, there was no significant difference between subjects with tumors referred to in the literature as having high levels of FAP expression and those with intermediate levels of FAP. We believe that this is an important finding which suggests that our pre|CISION® technology may be applicable across a wide range of tumors with varying degrees of FAP expression.
Clinical development plan
The Phase 1 trial of AVA6000 has moved to expansion cohorts following the completion of enrollment in the Phase 1a dose escalation. Based on all of the available data, despite not identifying an MTD, the dose of 310 mg/ m2 administered every three weeks was chosen for further study based on safety, tolerability, preliminary efficacy and pharmacokinetics. The trial is continuing to enroll in the expansion cohorts for patients with TNBC, high grade soft tissue sarcoma and salivary gland cancer and data is expected in the early second half of 2026.
Breast cancer disease backgroundAccording to World Health Organization, breast cancer is the second most common cancer in the world and the most prevalent cancer in women, with an estimated 2.3 million new cases diagnosed annually. In 2024, it is estimated that there will be over 310,000 new cases of breast cancer and 42,250 deaths in the United States. The expression of targets for two classes of therapeutics is used to stratify breast cancers into subtypes. Tumors that express high levels of human epidermal growth factor receptor 2, or HER2, are considered to be HER2+ and make up approximately 21 percent of all cases of breast cancer. Tumors that lack or express low levels of HER2 but express at least one of two other hormone receptors, the estrogen receptor or the progesterone receptor, are considered to be hormone positive, or HR+, a profile that is representative of about 74 percent of cases of breast cancer. Tumors that lack or express low levels of HER2 and the estrogen and progesterone hormone receptors are classified as triple negative breast cancers, or TNBC.
The lack of HER2 and the estrogen and progesterone hormone receptors eliminates the potential to use HER2 or estrogen-targeted therapies to treat TNBC, depriving patients of many of the benefits achieved in the treatment of other breast cancers over the past several decades. Standard therapy for TNBC includes cytotoxic chemotherapy, surgery and radiation. The five-year survival rate for TNBC patients is approximately 77 percent. The survival rates drop off sharply in patients with metastatic disease with an average five-year survival rate of 12 percent.
Soft tissue sarcoma backgroundSoft tissue sarcomas can develop from soft tissues like fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues. They can be found in any part of the body, including in the arms, legs, or abdomen with 60 percent of tumors found in the lower limbs.
The National Cancer Institute estimates that there will be approximately 13,590 new cases of soft tissue sarcoma and 5,200 deaths in the United States in 2024. Five-year survival for all stages of soft tissue sarcoma is 65.9 percent, but this falls to 16.7 percent for patients with late-stage metastatic disease.
Primary treatments are surgery with the goal of complete resection of the tumor while sparing the limb, cytotoxic chemotherapy, radiation therapy or combinations of these treatments. Of the patients who are treated with complete resection and radiation therapy, between 10 percent and 15 percent will experience tumor recurrence. Anthracycline-based cytotoxic chemotherapies, such as doxorubicin, have been the main type of chemotherapy used for nearly 40 years. The median overall survival for patients with metastatic soft tissue sarcoma treated with doxorubicin is 12 to 16 months.
Salivary gland cancer backgroundSalivary gland cancer is a rare cancer with approximately 2,000 to 2,500 cases in the United States each year. Surgery is the primary treatment for salivary gland cancer with complete resection as the goal. Adjuvant radiation therapy is often used for patients with advanced or high-grade cancers. The five-year survival rate is approximately 90 percent, but this drops to 43 percent for patients with metastatic disease.
Drug Development Collaborations Our platform technology serves as the foundation for collaborations
Our pre|CISION® and Affimer® technologies are also being used to create drug products that extend to areas beyond our key focus in delivering cytotoxins to tumors. We have established several partnerships to accelerate development of approaches to use our technologies to deliver differentiated payloads. Our partnerships include the following:
AffyXell Therapeutics Co., Ltd., a joint venture we established with Daewong to develop mesenchymal stem cell therapies that combine Daewong's expertise in stem cell technology with our Affimer® technology. AffyXell's product candidates are designed to secrete immuno-modulatory Affimer® molecules that increase the therapeutic benefits of mesenchymal stem cell therapies.
A strategic partnership with LG Chem to develop a number of Affimer®-based therapeutics; and
A licensing agreement with POINT to provide access to pre|CISION® technology to develop radiopharmaceuticals that require cleavage by FAP to enable binding to their receptors. POINT's acquisition by Eli Lilly has not affected the licensing arrangements.
Avacta Diagnostics, the Company's Diagnostics Division, included three components: Launch Diagnostics, Coris BioConcept and ALS-Dx.
As announced, the Group's strategy is to focus its cash resources on growing the Therapeutics Division which the Board believes is now the main value driver of the Group.
The Groups internal diagnostics development group (ALS-Dx) ceased operations during the prior year, reducing significant workforce and facility expenses.
In March 2025 Avacta completed the sale of Launch Diagnostics and its subsidiaries, its UK-based and largest diagnostics unit, for £12.9 million (net £9.5 million) in cash to Duomed Belgium NV, a subsidiary of Palex Healthcare Group S.L.U
In August 2025 Avacta completed the sale of Coris BioConcept and its subsidiary, its Belgium-based diagnostics business, for £2.2 million (net £0.5 million) in cash to 3B BlackBio Dx Ltd, completing the Company's transition to a pure play therapeutics business.
Financial ReviewReported Group revenues for the year ended 31 December 2025 was £6.31 million (2024: £24.42 million), This includes contributions from both continuing and discontinued operations.
Revenues for the continuing operations of the Therapeutics Division were £0.11 million (2024:
£0.11 million).
Revenues for the discontinuing operations of the Diagnostics Division were £6.20 million (2024:
£24.31 million). The decrease is due to them being sold part year.
Overall, the loss before tax from continuing operations for the year were £36.05 million (2024:
£28.98 million)
Research costsDuring the year, in continuing operations the Group expensed through the income statement
£18.76 million (2024: £14.27 million) research costs relating to the ongoing expansion of the preCISIONTM and Affimer® therapeutic programmes with AVA6103 and increased clinical and CMC expenses related to AVA6000, which are expensed given their early stage in the development pathway.
Selling, general and administrative expensesAdministrative expenses have decreased during the year in continuing operations to £9.24 million (2024:
£12.05 million). The decreases are primarily due to costs incurred during 2024 relating to personnel expenses due to executive management changes and additional legal and professional expenses related to the strategic shift toward becoming a pure-play biotech company.
Amortisation and impairment expenseAmortisation charges of £0.01 million (2024: £0.02 million) have been recognised in the period. In the prior year Launch Diagnostics Holdings Ltd and its subsidiary entities and Coris Holdings SRL and its subsidiary entity were all held for sale at 31 December 2024. The fair value less costs to sell were compared with the net asset value of the entities based on the latest information available during the divestment process. This resulted in total impairment charges in the prior year of £22.41 million, of which
£15.64 million related to Launch Diagnostics and £6.77 million related to Coris Holding respectively.
Share of loss of associateThe share of loss of associate of £0.45 million (2024: £0.75 million) arises from the Group's equity-accounted investment in AffyXell Therapeutics Co., Ltd. The share of losses reflects the Group's 21% ownership share of the losses accumulated in the year. The Group investment remained at 21% at 31 December 2025. The carrying value of the investment has been assessed for impairment and no impairment has been recognised.
Share-based payment expenseThe non-cash charge for the year from continuing operations decreased to £2.13 million (2024:
£4.11 million), this decreased was due to modifications to certain executive options awards and new options issued to the hiring of new executives in the prior year
The non-cash charge for the year from discontinued operations decreased to £0.07 million (2024:
£0.87 million), the prior year charge was due to both additional option awards and modification to existing agreements.
Convertible bondIn October 2022, the Group issued senior unsecured convertible bonds (the "Bonds") with a principal value of £55.00 million to a fund advised by Heights Capital Ireland LLC. The Bonds were issued at 95% of par, generating net proceeds of £52.25 million after placement fees, and bear interest at a fixed coupon of 6.5% per annum, payable quarterly in arrears. The Bonds have an original maturity of five years and are subject to mandatory quarterly amortisation repayments of principal and interest over the term.
The Bonds are repayable in either cash or, at the Group's option, in ordinary shares of Avacta Group plc. Where repayments are settled in shares, the number of shares issued is determined in accordance with the contractual terms of the bond and is linked to the market price of the Company's ordinary shares. The Bonds also include bondholder conversion rights allowing partial conversion of the Bonds at the holder's discretion.
The convertible bond is accounted for as a hybrid financial instrument comprising a host debt liability and an embedded derivative representing the equity linked conversion and settlement features. The host debt liability is measured at amortised cost, while the embedded derivative is measured at fair value through profit or loss. The embedded derivative is valued using a Monte Carlo option pricing model and is classified as a Level 3 fair value measurement under the IFRS fair value hierarchy.
On 28 August 2025, the Group announced amendments to the terms of the Bonds. The revised terms became effective on 20 October 2025 following satisfaction of the amendment conditions. The amendments were assessed in accordance with IFRS 9 and were determined to be substantial, principally due to changes in the timing and contractual profile of the bond's cash flows. Accordingly, the original host debt liability was derecognised and a new host debt liability was recognised at fair value on the effective date.
The difference between the carrying amount of the original host debt liability and the fair value of the new host debt liability resulted in a gain on derecognition of financial liabilities of £2.03 million, which has been recognised in profit or loss. Following derecognition, the new host debt liability is measured at amortised cost using an effective interest rate determined at initial recognition. Finance costs recognised in the period reflect the unwinding of the discount on the new host liability together with the contractual coupon.
The embedded derivative continued to meet the definition of a derivative following the amended bond terms and remained bifurcated from the host debt liability. The derivative was remeasured at fair value on the effective date to reflect the amended contractual terms, including the revised conversion price, and is subsequently remeasured at each reporting date, with movements recognised in profit or loss.
During the year ended 31 December 2025, repayments of the Bonds were settled partly in cash and partly through the issue of ordinary shares. Settlements in shares resulted in the derecognition of the corresponding portions of the host debt and derivative liabilities, with the aggregate amounts recognised within share capital and share premium in accordance with IFRS.
At 31 December 2025, the carrying amount of the host debt liability was £13.36 million (2024:
£20.50 million) and the carrying amount of the derivative liability was £2.79 million (2024: £1.28 million). Interest expense recognised in respect of the host debt liability during the year amounted to £6.98 million (2024: £9.85 million). A loss of £1.51 million arose from remeasurement of the derivative liability during the year (2024: gain of £13.72 million).
Net finance costsFinance income decreased to £0.37 million (2024: £0.66 million) due to a lower average cash balance during the year.
Other finance costs of £0.07 million (2024: £0.24 million) relate primarily to IFRS 16 interest charges.
Losses before taxationLosses before taxation from continuing operations for the year were £36.05 million (2024: £28.98 million).
TaxationThe taxation debit decreased to £0.21 million (2024: £0.44 million). This is due to a reversal of temporary differences incurred in the prior year related to discontinued operations of (£2.27) million and the R&D expenditure credit in the current year now being classified within operational costs. The current tax asset held on the balance sheet has increased to £3.36 million (2024: £2.45 million)
Loss for the periodThe reported loss for the period from continuing operations was £36.26 million (2024: £29.43 million). The loss per ordinary share from continuing operations reduced to 9.07p (2024: 8.54p) based on a weighted average number of shares in issue during the period of 399,784,000 (2024: 344,577,451).
The reported loss for the period from discontinued operations was £2.11 million (2024: £23.41 million). Operating loss from discontinued operations decreased to £1.94 million (2024: £2.17 million), impairment charges from discontinued operations all were incurred in the prior year (2024: £22.41 million) at the point of being held for sale. The loss of the disposal of subsidiaries in the current year was £0.24 million.
Cash flowThe Group reported cash and cash equivalent balances of £16.86 million at 31 December 2025 (2023:
£12.87 million).
Net operating cash outflows from continuing operations amounted to (£23.88) million (2024: (£24.94) million). The decrease relates to a higher operating losses in the prior year due to elevated R&D expenditure and one-off costs associated with organisational realignment. Research and development tax credit cash rebates were received in relation to the year ending 31 December 2023, resulting in a cash inflow of £0.78 million from income tax received (2024: £1.17 million).
Net cash inflows from investing activities amounted to £9.90 million (2024: outflow (£1.43) million). Due to the sale of Launch Diagnostics Holdings and Coris BioConcept
There was a net cash inflow from continuing financing activities of £16.6 million (2024: £26.7 million), arising primarily from the proceeds of issue of share capital of £22.5 million (2024: £31.1 million) as well as the repayment of the convertible bond of £5.1 million (2024: £2.6 million).
Financial positionAt 31 December 2025, the Group reported net assets of £2.48 million (2024: £9.28 million), following the impact of the strategic disposal of its diagnostics business.
Total assets decreased to £29.42 million (2024: £48.27 million), primarily due to the clear down of
£22.92 million of 'assets held for sale', following the divestment process of the diagnostics division and wind down of ALS-Dx. This strategic move is expected to simplify the Group's operations and provide greater focus and capital allocation towards the therapeutic platform.
Non-current assets declined to £6.22 million (2024: £8.07 million), primarily due to depreciation. Investment in associate reduced to £3.10 million (2024: £3.45 million) due to recognised losses for the period.
Current assets decreased to £23.20 million (2024: £40.20 million), primarily due to the clear down of
£22.92 million of 'assets held for sale'. Cash and cash equivalents were £16.9 million (2024:
£12.9 million), after investing and financing activities, including the £22.5 million gross proceeds from successful share placings during the year. Current cash runway take us into the first quarter of 2027.
Total liabilities decreased to £26.9 million (2024: £39.0 million), primarily due to the clear down of
£8.69 million of 'liabilities held for sale', following the divestment process of the diagnostics division
Share capital and share premium increased by a combined £28.9 million following the equity placing and debt service. The accumulated deficit widened to £175.3 million (2024: £138.8 million), reflecting continued operating losses and non-cash finance charges.
DividendsNo dividends have been proposed for the year ended 31 December 2025 (2024: £nil).
Key performance indicatorsAt this stage of the Group's development, the non-financial key performance indicators focus on:
The progression of the preCISIONTM and Affimer® technologies into clinical stage assets within the Therapeutics Division.
These are discussed in more detail within the Operational Review on pages 15 to 22.
Principal risks and uncertaintiesThe principal risks and uncertainties facing the Group are set out on pages 26 to 28.
Cautionary statementThe Strategic Report, containing the Operational and Financial reviews of the Group, contains forward-looking statements that are subject to risk factors associated with, amongst other things, economic and business circumstances occurring from time to time within the markets in which the Group operates. The expectations expressed within these statements are believed to be reasonable but could be affected by a wide variety of variables outside of the Group's control. These variables could cause the results to differ materially from current expectations. The forward-looking statements reflect the knowledge and information available at the time of preparation.
Section 172(1) statementSection 172(1) of the Companies Act 2006 requires a Director of a company to act in the way he or she considers, in good faith, would be most likely to promote the success of the company for the benefit of its members as a whole. In doing so, s172(1) requires the Directors to have regard, amongst other matters, to the:
likely consequences of any decision in the long term;
interests of the Group's employees;
need to foster the Group's business relationships with suppliers, customers and others;
impact of the Group's operations on the community and the environment;
desirability of the Group in maintaining a reputation for high standards of business conduct; and
need to act fairly between members of the Group.
In discharging its Section 172(1) duties, the Board has regard to the factors set out above and ensures that decision-making processes are made on a consistent basis and meet the above factors.
Key decisions taken by the Board during the year include:
the strategic development and progress of the Group's lead clinical asset, AVA6000 through Phase 1 expansion cohort clinical trials;
The filing of the IND for AVA6103
the divestment strategy of the diagnostics divisions
The Board looks to promote the long-term success of the Group whilst considering the interests of all stakeholders. The Board reviews matters relating to financial and operational performance; business strategy; key risks; stakeholder-related matters; legal and regulatory compliance matters over the course of the financial year and through future financial periods. The Board members have had refresher training with their Nominated Advisor ('NOMAD') on Director responsibilities in the application of AIM rules.
The Directors work across all the Group's facilities and provide regular updates to employees, most of whom are either shareholders or holders of share options, on the progress of the Group. The updates provide details of the business objectives, strategy and business model, together with sharing of technical progress across the various teams within the Group. The Directors actively seek regular feedback from employees to ensure their interests are reflected.
Engaging with the Group's stakeholders is key to the way the Group is operated and is an important consideration for the Directors when making relevant decisions. Details of how the Directors engage with stakeholders is set out in the Corporate Governance report on pages 29 to 53, including the Group's responsibilities to health, safety and environmental issues in relation to its employees, suppliers, customers and the communities in which the Group operates.
The Directors believe strongly in maintaining the highest levels of business conduct, accountability and good corporate governance to all the Group's stakeholders. In maintaining this approach, the Group has adopted the Quoted Companies Alliance Corporate Governance Code, with further details on how it complies with the Code set out on page 37.
Principal Risks and UncertaintiesThe Board is responsible for risk management and reviewing the internal control systems. The internal control systems are designed to manage rather than eliminate the risk of failure to achieve business objectives and can only provide reasonable and not absolute assurance against material misstatement or loss.
The Group highlights potential financial and non-financial risks that may impact on the business as part of the risk management procedures in the form of a Risks and Uncertainties Register. The Board reviews these reports and monitors the position at Audit Committee and Board meetings. There are ongoing processes for identifying, evaluating and mitigating the significant risks faced by the Group, which are reviewed on a periodic basis. The review process involves a review of each area of the business to identify material risks and the controls in place to manage these risks. The process is undertaken by the Chief Financial Officer and senior managers with responsibility for specific controls. commercial, operational, development and quality teams, in addition to project teams, meet on a periodic basis to review progress of all key projects and identify key issues for discussion with Senior Management. Where any significant weakness or failing is identified, implementation of appropriate remedial action is completed following approval by the Board.
The principal risks and uncertainties that could have a significant impact on the Group are set out below:
Risk Potential impact/mitigation Reliance on third parties supporting clinical and pre-clinical programmes-Therapeutics Research and development Change )Avacta relies heavily upon other parties (including clinical research organisations) for many important stages of its therapeutic development programmes, including execution of some pre-clinical studies and later-stage development for its compounds and drug candidates, and management of its clinical trials, including medical monitoring and data management. Underperformance by any of these other parties could adversely impact the Group's ability to operate effectively.
With the Group now progressing Phase 1b expansion trials on its first clinical programme (AVA6000) relationships are established with clinical stage third parties (including the appointment of a specialist clinical CRO to support the AVA6000 trial) which has enabled the reduction of 3rd party consultants and brought a more coordinated approach. With the addition of AVA6103 currently enrolling patients in a phase 1a study activities the increase in reliance on additional outside parties requires increased monitoring to ensure completion.
The regulatory approval processes of the MHRA and FDA and other comparable regulatory authorities can be lengthy and time consuming. The Group consults, where appropriate, with regulatory advisers and regulatory-approved bodies to ensure that all regulatory requirements are met with timely approvals. With the Administration changes in the US, the Group must monitor the current state of the Food and Drug Administration (FDA) for any issues that may delay potential review of filings.
The Group uses experienced and reputable clinical research organisations and requires its clinical and manufacturing partners to comply with Good Clinical Practice and Good Manufacturing Practice.
Change )The Group's research and development activities continue to focus around the pre|CISIONTM and Affimer® technologies in the Therapeutics Division.
There is a risk, consistent with similar biotechnology companies developing new and innovative technology platforms, that the scientific results required for specific internal development programmes, product development projects, customer-related evaluations or third-party collaborations. This risk is in specific applications of the pre|CISIONTM or Affimer® technologies rather than in the individual technology platform as a whole.
Risk Potential impact/mitigationPositive progress has been made with the pre|CISIONTM platform through the AVA6000 phase I clinical trials to date and the Therapeutics team continue to progress the Affimer platform although this is still some way off entering clinical trials.
With the Group's assets (AVA6000/AVA6103) progressing through clinical trials there is a risk that the trials might not be successful and that the Group is unable to develop marketable products. There is a risk that the clinical trials could lead to unanticipated results, which require further development leading to time delays. The Group has built an experienced and reputable team of clinical advisers who are monitoring the outputs of the clinical trials to ensure appropriate decisions based on data outcomes are taken at the right time.
Funding Change
The development of the Group's pre|CISIONTM and Affimer® technologies in the Therapeutic division is resource and cash intensive.
As of 31 December 2025, the Group had cash and short-term deposits of
£16.9 million.
As with all fundraising activities in the biotech sector, there are external market, economic and political factors, such as the risk of global trade disputes leading to increased tariffs that could lead to a global recession, which may impact the timing and amount of future funding available through capital markets.
Intellectual property Change )The success of the Group's pre|CISIONTM and Affimer® technology platforms depend on its ability to obtain and maintain patent protection for its proprietary technology.
Failure to protect the pre|CISIONTM and Affimer® technology platforms, or to obtain patent protection with a scope that is sufficiently wide, could significantly impact the Group's ability to commercialise the technology.
Should the patents be challenged, there could be a considerable cost in defending the patent rights, with an uncertain outcome.
The Board regularly reviews the patent portfolio and its protection. Specialist patent attorneys are engaged to apply for and defend intellectual property rights in appropriate territories.
Key staff Change
The Group has in place experienced and motivated Senior Leadership Teams across the Therapeutics Division, together with a significant number of highly skilled senior scientists and technical specialists. Loss of key staff could lead to a delay in the Group's plans and operations.
The Group aims to provide remuneration packages, including share incentive plans, and working conditions that will attract and retain staff of the required level, informally benchmarking the level of benefits provided to its staff against comparator companies.
Cybersecurity No Change →Unexpected events such as failures of IT systems or the increasing threat of targeted cyber attacks could disrupt the Group's operations from any of its sites or lead to a loss of data.
The Group continues to place reliance on third-party cloud-hosted applications, which provide cost-effective services with significant redundancies and disaster prevention and recovery strategies.
Risk Potential impact/mitigationThe Group has in place disaster recovery plans which are periodically tested, and third-party specialists are used to assess any potential vulnerabilities in the Group's systems.
The Group ensures that all software and systems are kept up to date with current software versions and firmware updates. Its cyber security plans and security access levels are reviewed on a regular basis, to ensure comparable levels of security are in place. It also provides training to staff on dealing with potential cyber-attacks and security risks.
Loss of facilities Change )Should the Group's facilities become inaccessible through damage caused by fire, flooding or theft, the ability to carry on development programmes and meet customer deadlines may be affected depending on the severity of the incident.
The Group has purpose-built facilities in the UK with specialist equipment and working environments that potentially may not be easily repaired or replaced.
The Group has established business continuity plans in place for each location which are regularly reviewed and tested. Resilience exists between sites so that certain operations could be quickly transferred from one facility to another where appropriate. Health and safety procedures and policies exist for each site with routine checks on facilities, equipment and infrastructure. The Group also maintains adequate insurance to cover any business damage or interruption.
Governance(Section Cover)
Board of Directors 30
Directors' Report 33
Corporate Governance Report 37
Audit Committee Report 45
Remuneration Committee Report 49
Statement of Directors' Responsibilities 54
Independent Auditor's Report to the Members of Avacta Group plc 55
Board of Directors Shaun Chilton Non-executive ChairmanShaun was appointed as a Non-executive Director in June 2023. Shaun was the Chief Executive Officer of the formerly London-listed Clinigen Group plc, a global pharmaceutical and pharmaceutical services platform business, which he led through a significant growth journey. During his tenure, the company expanded through both an organic and a buy-and-build strategy which included successfully completing several transformational acquisitions. The company was eventually sold to Triton Partners for a total consideration of c.£1.3 billion in April 2022.
Shaun was also Non-executive Chairman of C7Health, a disruptive, venture capital-backed medical technology and services business which executed an acquisitive growth journey before successfully being acquired by a strategic buyer in 2022.
Shaun has held a number of senior and executive commercial positions over more than 30 years in companies in pharmaceutical and pharmaceutical services industries. These include at Pfizer, Sanofi, Wolters Kluwer Health and KnowledgePoint360 Group (now part of UDG Healthcare).
Dr Christina Coughlin Executive Director-Chief Executive OfficerChristina was appointed to the role as Chief Executive Officer in April 2024, having served as a Non-executive Director since March 2022. Christina was previously the Chief Executive Officer of Cytolmmune Therapeutics LLC, a clinical stage biotechnology company focused on development and commercialisation of novel cancer immunotherapy products designed to use the patient's own immune system to eliminate cancer cells. Christina has a broad background in biotechnology and global pharmaceuticals, with a comprehensive drug development background from pre-IND to filing experience and has a track record of building drug development teams in global companies.
Christina previously served as Chief Medical Officer to Rubius Therapeutics. Inc, where she led the clinical development, translational medicine and regulatory efforts in the allogeneic red cell therapy platform. Prior to Rubius, Christina was with Tmunity Therapeutics, Inc., where she served as Chief Medical Officer and was responsible for the development of autologous CAR-T and TCR-T cellular therapies.
Christina has held other leadership roles in the pharmaceutical and biotechnology fields in her career including Chief Medical Officer at Immunocore, where she led the development of Kimmtrak™, recently approved for the treatment of metastatic uveal melanoma. Christina was also an Oncology Asset Team Leader at Pfizer and Clinical Program Team Lead at Novartis. She received her MD and PhD from the University of Pennsylvania and completed fellowships in Haematology and Oncology at the Children's Hospital of Philadelphia and in the Translational Research Group under the direction of Carl June, MD at the University of Pennsylvania.
Dr Trevor Nicholls Non-Executive Director (resigned 30 April 2025)Trevor brings considerable experience in the commercialisation of innovative life science technologies from his previous roles as Non-executive Chairman of Oxford Nanopores Technologies, Chief Commercial Officer at Affymetrix, founder and Chief Executive Officer of UK biotech company Oxagen Ltd and Commercial Director of the Life Sciences business at Amersham International (now part of Danaher Corporation).
Prior to his retirement at the end of 2020, he was Chief Executive Officer of the Centre for Agriculture and Bioscience International, a not-for-profit intergovernmental organisation whose mission is to improve lives worldwide by providing information and applying scientific expertise to solve problems in agriculture and the environment.
Trevor is also Non-executive Chairman of Iota Sciences Limited, a spin-out company from the University of Oxford which is commercialising innovative microfluidic technology for cell biology and gene therapy, a Non-executive Director of Conidia Bioscience Limited, which develops and sells patented lateral flow tests for the detection of microbial contamination of aviation and diesel fuels, and a Non-executive Director of Wobble Genomics Ltd, a spin-out of the Roslin Institute, specialising in DNA analytics and diagnostics. Previously, Trevor has been Non-executive Chairman of Activiomics Limited, a biomarker discovery specialist, as well as a Non-executive Director of hVivo plc, a clinical research organisation.
Paul Fry Non-executive DirectorPaul was appointed as a Non-executive Director in February 2020. Paul has extensive financial experience across several industries including biotech, pharmaceutical and telecommunications. Paul is currently Chief Financial Officer of Oxford Instruments plc. Prior to this, Paul was the Chief Financial Officer of Argenta, a global CRO and CDMO specialising in animal health. Prior to this, he was Chief Financial Officer of Vectura Group Ltd, an industry-leading inhaled drug delivery specialist which up until 2021 was listed on the FTSE Main Market.
Paul was also Chief Financial Officer of Immunocore Limited, a leading biotech company focused on the development of a new class of immunotherapeutic drugs based on proprietary T-cell receptor technology. Paul has also served as Director of Global Finance Operations at Vodafone plc and spent more than 25 years at GlaxoSmithKline ('GSK'), where he held several senior roles including Head of Global Finance Services and Chief Financial Officer for GSK's Italian pharmaceutical business.
Paul holds a degree from Oxford University and is a member of the Chartered Institute of Management Accounts.
Paul is Chair of the Audit Committee and a member of the Remuneration Committee.
Dr Mark Goldberg Non-executive DirectorMark was appointed as a Non-executive Director in August 2021 and is a medical oncologist, haematologist and a biotechnology executive. Mark currently serves on the boards of GlycoMimetics, Blueprint Medicines, and Walden Biosciences.
Mark was part of the executive management team of Synageva Biopharma from 2011 until 2014. Prior to that, he served in various management capacities of increasing responsibility at Genzyme Corporation from 1996 until 2011, including as Senior Vice President of Clinical Development. Prior to joining Genzyme, he was a full-time staff physician at Dana-Farber Cancer Institute and Brigham and Women's Hospital, where he still holds an appointment. He is currently a Lecturer in Medicine (part-time) at Harvard Medical School.
Mark is also a long-time American Cancer Society (ACS) and ACS Cancer Action Network volunteer. He was a member of the American Cancer Society New England Division Board from 2010 to 2017 and has been a member of the national Board of Directors of the American Cancer Society since 2019, currently servicing as Scientific Officer of the board.
Mark received his AB from Harvard College (magna cum laude) and his MD (cum laude) from Harvard Medical School (Harvard MIT Program in Health Sciences and Technology).
Mark is Chair of the Renumeration Committee effective May 2025
Darlene Deptula-Hicks Non-executive Director (resigned 01 July 2025)Darlene was appointed as a Non-executive Director in July 2024 and has extensive financial experience in the biotech industry. Darlene currently sits on the Board of Directors of Abcuro and Aerami Therapeutics, providing strategic financial and business direction
Darlene is currently interim CFO at Normunity, and prior to that served as CFO of F-star Therapeutics (NASDAQ:FSTX), which she took public in 2020 and successfully sold in 2023. Previously, she held the role of CFO at Northern Biologics and T2 Biosystems (NASDAQ:TTOO). She also served as SVP and CFO of Pieris Pharmaceuticals (NASDAQ:PIRS) which she also took public.
Darlene received her M.B.A. from Rivier University and B.S. in Accounting from Southern New Hampshire University.
Darlene was a member of the Audit Committee
David Bryant Non-executive Director (appointed 28 May 2025)David was appointed Non-Executive director in May 2025 and is a highly experienced international pharmaceutical executive with over 35 years in the industry. He has a strong track record in commercial leadership roles at GSK and Pfizer and was one of the original management team at Clinigen Group, from its 2012 IPO on the AIM market to its sale for $1.6bn in 2022. David is currently an Advisor to Healthcare Royalty (HCRx), a US-based healthcare focused private investment business.
Richard Hughes Non-Executive director (appointed 28 May 2025)Richard was appointed Non-Executive director in May 2025 and had a long and successful career in the UK capital markets with over 30 years' corporate finance experience, including IPOs, equity capital raising and M&A for both public and private companies. He was previously a founder shareholder and a director of boohoo.com and a majority shareholder of Crawford Healthcare, a UK-based advanced wound care and dermatology company, which was acquired by Acelity in June 2018. He is a shareholder and director of numerous private companies operating across a range of sectors. Richard founded Zeus Capital, an independent financial services group, in 2003 and is a director of Zeus Group.
Directors' ReportThe Directors present their report and the audited financial statements for the year ended 31 December 2025.
Principal activityThe principal activities of the Group are the ongoing research and development activities of the therapeutics business with a unique technology platform
Avacta Therapeutics is a clinical stage oncology biotech division harnessing proprietary therapeutic platforms to develop novel, highly targeted cancer drugs.
The divestment of Launch Diagnostics was completed in March 2025.
In August 2025 the group also completed the divestment Coris Biosciences. Avacta has two proprietary platforms, pre|CISION™ and Affimer®.
The pre|CISION™ platform is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumours compared with healthy tissues. The pre|CISION™ platform harnesses this tumour specific protease to activate pre|CISION™ peptide drug conjugates and pre|CISION™ antibody/Affimer® drug conjugates in the tumour microenvironment, reducing systemic exposure and toxicity, allowing dosing to be optimised to deliver the best outcomes for patients.
The lead pre|CISION™ programme AVA6000, a peptide drug conjugate form of doxorubicin, is in Phase 1b expansion studies. It has shown a dramatic improvement in safety and tolerability in clinical trials to date compared with standard doxorubicin and preliminary signs of clinical activity in multiple patients.
The second clinical candadite, AVA6103 is based on the innovative pre|CISION® sustained release mechanism that provides for prolonged release of payload directly in the tumor, minimizing systemic exposure. AVA6103 is being evaluated in the FOCUS-01 Phase 1 trial (FAP-Exd in Oncologic Cancers with Unmet needS). Preclinical data suggest this approach has optimized payload delivery with a high intratumoral concentration and prolonged exposure of released payload in the tumor, coupled with limited systemic exposure to the released payload.
Business review and future developmentsA review of the Group's operations and future developments is covered in the Strategic Report on pages 9 to 28. This report includes sections on strategy and markets and considers key risks and key performance indicators.
Financial resultsDetails of the Group's financial results, including events after the end of the reporting period, are set out in the Consolidated Statement of Profit or Loss and other financial statements on pages 65 to 116.
The Directors have reviewed the results for the years ended 31 December 2025 and 31 December 2024, including the Annual Report & Accounts and preliminary results statement. In reviewing the statements and determining whether they are fair, balanced and understandable, the Directors considered the work and recommendations of management.
DividendsThe Directors do not recommend the payment of a dividend (2024: £nil).
Going concernThe Financial Statements have been prepared on a going concern basis. The Company's going concern assessment has been performed as part of the Group's going concern assessment.
During the year ended 31 December 2025, the Group reported a loss from continuing operations of
£36.3 million and incurred net cash used in operating activities of £26.8 million.
As at 31 December 2025, the Group's accumulated losses were £175.3 million, and cash and cash equivalents were £16.9 million. The Group has external borrowings in the form of a convertible bond, with a principal amount outstanding of £20.4 million as at 31 December 2025.
As disclosed in Note 17, the gross proceeds of £22.5 million were received, net of costs of £1.2 million, through a placing of ordinary shares. As disclosed in Note 28 of the financial statements for the year ended 31 December 2025, the Group completed the disposal of Launch Diagnostics Holdings Limited and its subsidiaries ("Launch Diagnostics") in March 2025 and the disposal of Coris BioConcept in August 2025. The combined net proceeds from these disposals totalled £10.0 million.
The Group continues to advance its clinical trials and generate successful data and expects to report further findings in late 2026 and early 2027. Following the data, the Group will evaluate partnering and out-licensing opportunities.
The Group faces significant risks associated with successful execution of its strategy. These risks include, but are not limited to technology and product development, introduction and market acceptance of new products and services, changes in the marketplace, liquidity, competition from existing and new competitors which may enter the marketplace and retention of key personnel. As a clinical stage oncology business, the Directors anticipate operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, growth plans and further development of our technology.
The Directors have considered detailed cash flow forecasts that extended to 31 December 2027, which is at least twelve months from the date of approval of these financial statements ("the going concern period"). The forecasts indicate that we currently have enough cash to fund our planned operations into the first quarter of 2027. The forecasts consider current and future economic conditions that are expected to prevail over the period. These forecasts include assumptions regarding the timing and quantum of investment in the therapeutic development programs together with various scenarios which reflect growth plans, opportunities, risks and mitigating actions. The Board is focused on both the short-term and long-term financing strategy to achieve the company goals including obtaining additional funding through the capital markets.
The forecast therefore shows the Group and the Parent Company are dependent on raising funds to advance their key projects and investments to remain cash positive during the going concern period. There are currently no agreements in place and there is no certainty that funds will be raised within the appropriate timeframe. This indicates that a material uncertainty exists that may cast significant doubt on the Group and the Parent Company's ability to continue as a going concern, and therefore they may be unable to realise their assets and discharge their liabilities in the normal course of business.
However, the directors have a reasonable expectation that the required funding will be forthcoming. As a result, the directors believe that the Group and the Company will continue as a going concern for a period of at least 12 months from the date of approval of these financial statements and have therefore prepared the financial statements on a going concern basis.
DirectorsThe Directors who were in office during the year and up to the date of signing the Report and Accounts, unless otherwise stated were:
Shaun Chilton
Dr Trevor Nicholls Resigned 30 April 2025 Paul Fry
Dr Mark Goldberg
Darlene Deptula-Hicks Resigned 01 July 2025 Dr Christina Coughlin
David Bryant Appointed 28 May 2025
Richard Hughes Appointed 28 May 2025
Under Under the Articles of Association of the Company, one third of the Directors are required to retire at the forthcoming 2026 AGM, notice of which accompanies this Report and Accounts. Notwithstanding this requirement, and in accordance with good corporate governance practice, all six Directors will stand for re-election at the forthcoming 2026 AGM. The Directors offering themselves for re-election are Shaun
Chilton, Chris Coughlin, Mark Goldberg, Paul Fry, David Bryant and Richard Hughes. All Directors, being eligible, offer themselves for re-election. In relation to the re-election of each Director, the Board is satisfied that all six Directors continue to be effective and demonstrate commitment to the Company. Details of the Directors offering themselves for re-election at the 2026 AGM can be found on pages 34 and 35.
The Directors benefited from qualifying third-party indemnity provisions in place during the financial year and at the date of this report.
Substantial shareholdersThe Company is informed that, at 27 May 2026, there are no shareholders with more than 3%.
Directors' shareholdingsThe beneficial interests of the Directors in the share capital of the Company at 31 December 2025 and at 27 May 2026 were as follows:
31 December 2025 number of shares | 27 May 2026 number of shares | ||
Non-executive Directors Trevor Nicholls (resigned 30 April 2025) . . . . . . . . . . . . . . . . . . . . . . . . . . . | 107,455 | 107,455 | |
Paul Fry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mark Goldberg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Shaun Chilton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Darlene Deptula-Hicks (resigned 01 July 2025) . . . . . . . . . . . . . . . . . . . . . . | - - 40,000 - | - - 40,000 - | |
Executive Directors Christina Coughlin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . | 50,000 | 50,000 | |
David Bryant (appointed 29 May 2025) . . . . . . . . . . . . . . . . . . . . . . . . . . . . | - | 79,365 | |
Richard Hughes (appointed 29 May 2025) . . . . . . . . . . . . . . . . . . . . . . . . . . | - | 793,651 |
In addition, Alastair Smith has a joint interest in 1,640,000 shares and Tony Gardiner has a joint interest in 150,000 shares in the share capital of the Company. Such shares are jointly held by themselves individually and Avacta Group Trustee Limited in its capacity as trustee of The Avacta Employees' Share Trust. The precise nature of the joint interest is described within Joint Share Ownership Agreements between Alastair Smith (dated 9 January 2012 and 15 February 2016) or Tony Gardiner (dated 15 February 2016) and Avacta Group Trustee Limited and Avacta Group plc in both cases.
None of the Directors have any interest in the share capital of any subsidiary company. Further details of options held by the Directors are set out in the Remuneration Committee Report on page 49.
The middle market price of the Company's ordinary shares on 31 December 2025 was 58.0p and the range during the period was 27.5p to 82.5p with an average price of 49.1p.
Information on Directors' remuneration and share option rights is given in the Remuneration Committee Report on pages 49 to 52.
Post balance-sheet eventsOn 27 March 2026, the Group announced the successful completion of an oversubscribed placing and subscription to raise gross proceeds of £10.0 million. A total of 15,000,000 new ordinary shares of 10p each were issued pursuant to the placing, together with a further 873,016 new ordinary shares issued under a director subscription, at an issue price of 63 pence per share.
On 13 May 2026, 1,604,063 new ordinary shares of 10p each were issued in settlement of a £1.20 million conversion in respect of the unsecured convertible bond.
Research and developmentDuring the year, the Group expensed through the income statement £18.76 million (2024: £14.27 million) in relation to research costs which relate to the costs associated with the pre-clinical Affimer® and pre|CISION™ therapeutic programmes and the early-stage costs of the diagnostic programmes.
Derivatives and financial instrumentsThe Group's policy and exposure to derivatives and financial instruments, along with the Group's management of capital, liquidity credit, interest rate and foreign currency risk, is set out at Note 19.
Employment and environmentThe Group's policies on health and safety, the environment, and employee-related matters are disclosed in the Corporate Governance Report under the corporate social responsibility section on pages 37 to 44.
Political and charitable donationsThere were no charitable or political donations in the year ended 31 December 2025 (2024: £nil).
Supplier payment policy and practiceThe Group does not operate a standard code in respect of payments to suppliers. The Group agrees terms of payment with suppliers at the start of business and then makes payments in accordance with contractual and other legal obligations.
Disclosure of information to auditorThe Directors who held office at the date of approval of this Directors' Report confirm that, so far as they are aware, there is no relevant audit information of which the Company's auditor is unaware and each Director has taken all the steps that he or she ought to have taken to make himself or herself aware of any relevant audit information and to establish that the Company's auditor is aware of that information.
Re-appointment of auditorA resolution for the re-appointment as auditor of BDO LLP will be put to the forthcoming Annual General Meeting.
Annual General MeetingThe Annual General Meeting of the Company will be held at 9 Montague CI, London SE1 9DD, on Monday 22 June 2026 at 09.00 a.m. Full details of the business to be transacted at the Annual General Meeting can be found in the Notice of Annual General Meeting on pages 118 to 120 of this report.
This Director's Report and the Strategic Report on pages 9 to 36, were approved by the Board on 27 May 2026 and signed on its behalf.
By order of the Board
Christina Coughlin Chief Executive Officer 27 May 2026Avacta Group plc (Registered number-04748597)
Brian Hahn
Brian Hahn Chief Financial Officer & Company Secretary27 May 2026
Corporate Governance Report Chairman's statement on corporate governanceAll members of the Board believe strongly in the value and importance of good corporate governance and in our accountability to all the Company's stakeholders, including shareholders, staff, customers and suppliers. In the statement below, we explain our approach to governance, and how the Board and its committees operate.
The corporate governance framework which the Company operates, including Board leadership and effectiveness, Board remuneration, and internal control, is based upon practices which the Board believes are proportional to the size, risks, complexity and operations of the business and is reflective of the Group's values. The Board adopts the Quoted Companies Alliance's ('QCA') Corporate Governance Code for small and mid-size quoted companies.
The QCA Code is constructed around ten broad principles and a set of disclosures. The QCA has stated what it considers to be appropriate arrangements for growing companies and asks companies to provide an explanation about how they are meeting the principles through the prescribed disclosures.
Delivering growth1-Establishing a strategy and business model which promote long-term value for shareholders 2-Seek to understand and meet shareholder needs and expectations
3-Consider wider stakeholder and social responsibilities and their implications for long-term success
4-Embed effective risk management, considering both opportunities and threats, throughout the organisation
Maintain a dynamic management framework 5-Maintain the Board as a well-functioning, balanced team led by the Chairman6-Ensure that between them the Directors have the necessary up-to-date experience, skills and capabilities
7-Evaluate Board performance based on clear and relevant objectives, seeking continuous improvement
8-Promote a corporate culture that is based on ethical values and behaviours
9-Maintain governance structures and processes that are fit for purpose and support good decision-making by the Board
Build trust10-Communicate how the Company is governed and is performing by maintaining a dialogue with shareholders and other relevant stakeholders
See Business Overview on page 15.
See this section and the 'Corporate Governance' section of our website https://www.avacta.com
See this section and the 'Corporate Governance' section of our website.
See this section and the 'Principal Risks and Uncertainties' on pages 26 to 28.
See this section and the 'Corporate Governance' section of our website.
See this section and the 'Board of Directors' section on pages 30 to 32.
See this section.
See this section and the 'Corporate Governance' section of our website.
See this section and the 'Corporate Governance' section of our website.
See this section and the 'Corporate Governance' section of our website.
The Board considers that it does not depart from any of the principles of the QCA Code.
Establishing a strategy and business model which promotes long-term value for shareholders Our MissionOur Mission is to improve patients' lives and grow shareholder value by developing novel cancer therapies to create a portfolio of product candidates using our proprietary Affimer® and pre|CISION™ platforms.
Investment opportunityAvacta Group is strategically transitioning into a pure-play oncology therapeutics company by the ongoing divestment of its diagnostics division. This move allows the company to concentrate resources on its proprietary pre|CISION® platform, aiming to revolutionize cancer treatment through targeted peptide drug conjugates (PDCs)
In March 2025, Avacta sold its UK-based diagnostics unit, Launch Diagnostics Holdings Limited, for
£12.9 million (net £9.5 million) in cash to Duomed Belgium NV. In August 2025, Avacta sold its UK-based diagnostics unit, Coris Holdings SRL, for £2.2 million (net £0.5 million) in cash to 3B BlackBio Dx Ltd. This is a significant step toward Avacta's goal of becoming a dedicated biotechnology company.
Technology platformsAvacta has two proprietary platform technologies-the Affimer® and pre|CISION™ platforms-which are being used to deliver a robust portfolio of products that address multi-billion-dollar markets.
The pre|CISION™ platform is a highly specific substrate for fibroblast activation protein (FAP) which is highly upregulated in most solid tumours compared with healthy tissues. The pre|CISION platform harnesses this tumour-specific protease to activate pre|CISION peptide drug conjugates and pre|CISION antibody drug conjugates in the tumour microenvironment, reducing systemic exposure and toxicity, allowing dosing to be optimised to deliver the best outcomes for patients.
Affimer® molecules are engineered alternatives to antibodies that have significant competitive advantages including size, stability, versatility, rapid development and ease of production.
Therapeutics Division
Avacta Therapeutics' strategy is to develop and ultimately commercialize a broad portfolio of product candidates based on the ability of our pre|CISION® technology to deliver potent warheads to tumors. In principle, if applied to all patients whose tumors overexpress FAP, our approach could lead to treatments for hundreds of thousands of patients. Our strategy to achieve this goal is as follows:
Continue to develop AVA6000 for the treatment of breast cancer, head and neck cancers and other tumors sensitive to doxorubicin. Interim data from our ongoing Phase 1 trial indicates that AVA6000 delivers high concentrations of released doxorubicin directly to tumors in human subjects resulting in fewer toxicities than reported in the literature for conventional doxorubicin administration. We have observed clinically meaningful antitumor activity in the Phase 1a portion of this trial. To confirm this activity, we opened the indication-specific dose expansion cohorts to screening in December 2024 and began dosing patients early in 2025.
Advance AVA6103 into and through clinical development. We have demonstrated the ability of our pre|CISION® technology to be applied to other warheads through the creation of AVA6103, an exatecan derivative. We selected a product candidate and filed the IND just before year end 2025. We have initiated a Phase 1 trial of AVA6103 in the first quarter of 2026.
Advance AVA7100 into and through clinical development. We believe AVA7100, utilizing our Affimer® proteins, will have the potential to impart tumor-antigen-specific targeting of pre|CISION® drug conjugates with improved pharmacokinetics that will optimize targeting of tumor types that have lower expression of FAP.
Establish product-based partnerships on pre|CISION® product candidates. We believe that the broad applicability of our pre|CISION® technology can drive the creation of a number of product candidates. We may seek to accelerate the development of some of these product candidates with corporate partners with clinical expertise in certain therapeutic areas or geographies.
Explore additional technology-based collaborations surrounding our pre|CISION® and Affimer® platforms. We believe that the broad potential of these technology platforms may serve as the basis for
future partnerships outside of our core area of focus. For example, we have previously licensed our pre|CISION® technology to POINT Biopharma Inc., or POINT, for the development of radiopharmaceutical product candidates; and we have partnerships with both Pharmaceutical Co. Ltd., or Daewoong, and LG Chem Life Sciences, or LG Chem, focused on generation of therapeutics based on our Affimer® technology.
Diagnostics DivisionThe Group's strategy is to focus its cash resources on growing the Therapeutics Division which the Board believes is now the main value driver of the Group. Whilst the Diagnostics Division is expected to be cash generative in the near future, it is strategically important for the Group to simplify its structure in order to attract specialist healthcare investors with the ability to support the growing pre-clinical and clinical pipeline of pre|CISIONTM and Affimer® therapeutics and it will do so in a manner which maximises value for its shareholders.
The Board believes it has a balanced business and capital allocation model, and a high-value oncology pipeline which seeks to create long-term shareholder value alongside patient benefit. While the Board has prepared the financial statements on a going concern basis, it acknowledges that a material uncertainty exists which may cast significant doubt on the Group's ability to continue as a going concern.
Board structure, skills and competenciesThe Board has a collective responsibility and legal obligation to promote the interests of the Company and to define the corporate governance arrangements. At 31 December 2025, the Board comprised five Non-executive Directors and one Executive Directors. The profiles of the Directors are set out on page 40.
The division of responsibilities between the Chairman and the Chief Executive Officer is clearly defined. The Chairman's primary responsibility is ensuring the effectiveness of the Board and setting its agenda. The Chairman is not involved in the day-to-day business of the Group. The Chief Executive has direct charge of the Group on a day-to-day basis and is accountable to the Board for the financial and operational performance of the Group.
The Chairman, Shaun Chilton, was appointed as a Non-Executive director in June 2023 and appointed as Chairman in June 2024. Prior to his appointment to the Board, he was not involved with any part of the Avacta Group and has been considered independent since his appointment. Shaun has held a number of senior and executive commercial positions over more than 30 years in companies in pharmaceutical and pharmaceutical services industries. Shaun's time commitment is one to two days per month.
The Chief Executive Officer, Dr Christina Coughlin was appointed as a Non-executive Director in March 2022. Prior to her appointment to the Board, she was not involved with any part of the Avacta Group and was considered independent up to July 2023. In late July 2023 Christina undertook an additional consulting role to assist the Therapeutics Division with the clinical trials of its lead asset, AVA6000. This consulting role continued through to the end of January 2024, at which point Christina joined Avacta full time to become an Executive Director and Head of Research and Development. In late April 2024 Chirstina was named Chief Executive Officer. Christina has an extensive background in the pharmaceutical and biotechnology fields, with a broad background of drug development from pre-IND to filing experience in global companies. Christina's time commitment from February 2024 is full time.
Paul Fry was appointed as a Non-executive Director in February 2020. Prior to his appointment to the Board, he was not involved with any part of the Avacta Group and has been considered independent since his appointment. Paul has an extensive financial background within the life sciences sector and has been Chairman of the Audit Committee since his appointment to the Board. Paul's time commitment is one to two days per month.
Dr Mark Goldberg was appointed as a Non-executive Director in August 2021. Prior to his appointment to the Board, he was not involved with any part of the Avacta Group and has been considered independent since his appointment. Mark has an extensive background as an Executive and Non-executive Director within the US biotechnology sector and is also a medical oncologist. Mark's time commitment is one to two days per month.
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Avacta Group plc published this content on May 29, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 29, 2026 at 15:29 UTC.
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