On September 29, 2026 Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a life sciences company developing innovative, targeted oncology drugs, reported its unaudited interim results for the six months ended June 30, 2026 ("H1 26").
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H1 highlights and post period
Research & development
Next Generation pre|CISION pipeline
AVA6103 (FAP-Exd)
Preliminary preclinical and clinical data with AVA6103 have been presented recently. Data reported in the Phase 1a trial in patients with select solid tumors demonstrate proof of mechanism with two key findings:
AVA6103 pre|CISION controlled-release exatecan demonstrates a clean safety profile through the first three dose levels, including a payload dose level 50% higher than the maximum tolerated dose (MTD) of conventional exatecan at dose level 3, and
The comparison of the preclinical modeled pharmacokinetic (PK) data and clinical trial PK data demonstrates an exceptional alignment through the first 3 dose levels with controlled release of exatecan evident in patients for days after dosing
The first head-to-head preclinical comparison of AVA6103 and Enhertu, a marketed antibody drug conjugate (ADC) that targets HER2, demonstrates that AVA6103 shows better antitumor activity vs. Enhertu, with deep and durable responses delivered by our dose dense regimen that has been applied in the FOCUS-01 trial.
Updated preclinical pharmacology and exposure data analyses, highlighting the favorable delivery profile, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.
Comparative analyses of pre|CISION payload delivery preclinical pharmacokinetics (PK) via AVA6103, compared with now two approved ADCs (Enhertu and Datroway), presented at the Company’s Science Day, showing the clear advantages of pre|CISION over traditional ADCs.
U.S. Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application for AVA6103 in January, 2026 and the first patient was treated in the trial in March, 2026.
AVA6207 (Dual Payload)
Presented first in vivo efficacy and exposure pharmacology for the pre|CISION dual payload technology program at AACR (Free AACR Whitepaper) 2026.
Presented updated in vivo studies of the dual payload delivery system AVA6207 at Science Day.
pre|CISION platform and First Gen (AVA6000)
Reported data validating the pre|CISION PDC platform, with AVA6000 in patients with salivary gland cancer, where robust tumor responses are observed with low expression of fibroblast activation protein (FAP) and the persistence of FAP expression despite tumor response.
Published new data demonstrating the favorable delivery profile and advantages of pre|CISION compared to a marketed antibody drug conjugate (ADC)
AVA6000 (Faridoxorubicin, pending partnering)
Presented updated Phase 1a/1b data showing encouraging early efficacy signals for AVA6000 in salivary gland cancers at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
At the end of Phase 1 meeting, certain pivotal trial elements and the regulatory path forward with Phase 1b data were agreed with the U.S. Food and Drug Administration (FDA) for potential full regulatory approval.
Agreed updates with the FDA to the ongoing Phase 1 trial protocol including the removal of the maximum dosing limit and to allow flexibility in dosing levels to identify the dose for further development.
Financial
Strengthened financial position to support R&D programs:
Completed oversubscribed placing and subscription, raising £10 million (March 2026), and raised gross proceeds of approximately £9 million in an equity fundraise (June 2026), from institutional investors and existing shareholders.
Today, separately announcing a proposed capital raise to further strengthen the balance sheet
Cash and short-term deposit balances at June 30, 2026, of £20.27 million (31 December 2025: £16.9 million million). As of August 31, 2026, cash held was £10.59 million.
Corporate
Strengthened leadership and corporate governance via Board appointments:
Richard Hughes as non-executive Chairman (June 2026)
Patrick Vink as Deputy Chairman (in July 2026)
Mats Blom as Chair of the Audit Committee (in September 2026)
Outlook 2026 and beyond
The design of the FOCUS-1 trial of AVA6013 and preclinical updates were presented in Trials in Progress presentations at both the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Conference on Pancreatic Cancer, being held on September 25-28, 2026, and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held on October 23-27, 2026.
First efficacy data from the FOCUS-01 trial with AVA6103 is anticipated to be presented in H1 2027 – including data from clinical tumor biopsies which are anticipated to confirm AVA6103 is being retained in a ‘drug reservoir’ in the tumor, based on the preliminary Phase 1 data.
The selection of the payloads and data to support clinical candidate selection for the Dual Payload Next Gen Program (AVA6207) will be presented in Q4 2026.
Clinical data from the First Gen faridoxorubicin (AVA6000) program will also be presented in Q4 2026 at the ESMO (Free ESMO Whitepaper) Congress, Oct 23-27, 2026.
Christina Coughlin, CEO of Avacta, commented:
"This has been a transformative first half for Avacta, with compelling clinical validation of our pre|CISION platform delivering robust and durable tumor responses and demonstrating the clear advantages of our approach over conventional ADCs. The controlled-release mechanism of our Next Gen pipeline with AVA6103 as the lead asset is now working in patients, exactly as modelled, and we are moving towards initial efficacy data in 2027.
"This progress is underpinned by a strong and complementary leadership team. We have further reinforced the expertise and governance at Avacta with several senior appointments in 2026 to management and our Board, who bring the benefit of their scientific, industry, markets and financial acumen to the Company as we advance our proprietary pipeline and explore partnering opportunities to maximize the potential of our pre|CISION platform.
"Our financing activities have raised approximately £19.0 million in 2026 to date, which together with the anticipated proceeds of our planned capital raise being launched today, will ensure funding is in place to execute on multiple value inflection milestones, including the efficacy data on AVA6103 in H1 2027, as well as payload selection for our dual-payload program AVA6207 later this year."
Enhertu (trastuzumab deruxtecan; T-DXd) is a protease cleavable-linker ADC, approved for both breast cancer and gastric cancer indications (an AstraZeneca/Daiichi Sankyo product). Datroway (datopotamab deruxtecan-dlnk; Dato-DXd) is a protease cleavable-linker ADC, approved for certain types of breast and lung cancer (a Daiichi Sankyo product).
Interim report
Strategic overview
We are making excellent progress in the development of our unique pre|CISION technology platform, pioneering a novel, differentiated class of pre|CISION-based medicines to revolutionize drug delivery.
Our platform technology demonstrates multiple advantages over conventional therapeutics by addressing one of the primary challenges of effective treatment of diseases, specifically the balance between efficacy and safety. pre|CISION-based medicines are specifically designed to be silent (inert) in the bloodstream and in the tissues, and to only activate once in the tumor.
We are confident in Avacta’s ability to partner preCISION across a number of modalities and in the management team’s ability to secure the requisite funding to progress the pre|CISION platform through multiple value driving events.
pre|CISION – our proprietary technology
The challenge in oncology is that the most effective therapies cause the most toxicity in normal tissues. The ability to deliver the active drug directly to the tumor is the promise of our proprietary pre|CISION platform. Avacta’s innovative pre|CISION peptide drug conjugates (PDC) are a novel entry to the XDC drug class, leveraging the success of antibody drug conjugates with alternative methods of delivery beyond antibodies.
The key aspect of pre|CISION peptide drug conjugate (PDC) technology is that the conjugated drug (the combination of the oncology drug and our peptide) is inert. It is incapable of entering cells and killing until the peptide is specifically released when it comes into contact with common tumor-associated protein, known as fibroblast activation protein or FAP, in the tumor.
When a pre|CISION PDC encounters FAP in the tumor, the peptide is cleaved and the active payload is released. The release of the payload from the pre|CISION compound in the tumor 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. Importantly, the increased toxicities (payload) at the tumor are directly associated with the pre|CISION medicines.
Two factors that dictate the antitumor potential of pre|CISION medicines are (1) the expression of FAP in the tumor to cleave the peptide (the amount of the FAP protein that exists in the tumor) and (2) the inherent susceptibility of the associated tumors to the chemotherapy (chemicals in the drug) that is released.
We believe that pre|CISION can deliver higher drug levels within tumors which will lead to improved antitumor activity while reducing systemic toxicities. This will dramatically impact the therapeutic index and efficacy of a given anticancer drug. We have observed this with our first clinical program, faridoxorubicin. This program has demonstrated a dramatic reduction in the toxicities associated with conventional doxorubicin and is delivering exciting preliminary efficacy data.
To further extend the pipeline, Avacta has invented the Next Generation Controlled Release pre|CISION technology that adds a chemical capping group and linker with two key advantages: (1) greater control over the release of the payload in the tumor, allowing optimized pharmacokinetic delivery even with payloads that have challenging PK properties, and (2) implementing the linker technology opens a large number of payloads that can be delivered with Next Gen pre|CISION, permitting a full exploration of the landscape opportunity of pre|CISION with ~90% FAP expression among solid tumors.
Programs
Our pre|CISION PDCs leverage this tumor-specific release mechanism in a small molecule format to provide unique benefits over traditional antibody drug conjugates (ADC), releasing active payload in the tumor and reducing systemic exposure and toxicity which enables dosing to be optimized to deliver the best outcomes for patients. The lead clinical program is AVA6103, a Next Generation FAP-enabled controlled release pre|CISION version of exatecan that delivers the payload directly in the tumor with limited peripheral blood exposure and is currently in clinical development as a treatment for tumor types sensitive to exatecan including cervical cancer, HR+ breast cancer, small cell lung cancer, gastric cancer, colorectal cancer and pancreatic cancer.
Our first generation asset, Faridoxorubicin (AVA6000) continues in Phase 1b. We anticipate presenting data in October, 2026, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting from the cohort of patients with salivary gland cancer. This program is intended to go forward within a partnership and discussions are ongoing regarding such an arrangement.
AVA6207 is our Next Gen Dual Payload program which is on track for the goals, in 2H 2026, of naming of the two payloads that will be included in the molecule and clinical candidate selection. Clinical candidate selection is based on the preclinical pharmacology, chemical properties of the molecule with initial assessment of manufacturing for use in the clinic. These data will be presented in the fourth quarter of 2026.
Outlook
Avacta continues to build our value proposition and our unique world-class scientific and clinical capabilities. Our data are robust and building and industry interest in our innovative platform continues to increase. We are very excited about the next stages of Avacta’s journey with the recent clinical data demonstrating proof of mechanism for AVA6103 in the clinic demonstrating the potential in the Next Gen pre|CISION platform. Our upcoming data catalysts demonstrate the progress made in the programs, including the presentation of the FOCUS-01 trial and updated preclinical work with AVA6103, our updated Farodoxorubicin data being presented in October at ESMO (Free ESMO Whitepaper), and the payloads and clinical candidate selection in the Next Gen pre|CISION Dual Payload program in the fourth quarter of 2026.
Financial Review
Revenue
Revenues from continuing operations for the six months ended 30 June 2026 were £0.06 million (H1 2025: £0.06 million; FY 2025: £0.113 million).
Revenues from discontinued operations for the six months ended 30 June 2026 was £nil million (H1 2025: £6.10 million; FY 2025: £6.20 million).
Research costs and selling, general and administrative costs
Research costs relate predominantly to the clinical and pre-clinical development work of the pre|CISION therapeutics programs as planned increased to £9.69 million (H1 2025: £7.20 million; FY 2025: £18.76 million).
Other costs and charges
Depreciation from continuing operations decreased to £0.56 million (H1 2025: £0.73 million; FY 2025: £1.27 million). Amortization expense remained at £0.01 million (H1 2025: £0.01 million; FY 2025: £0.01 million).
The share of the costs from the AffyXell joint venture was £0.26 million (H1 2025: £0.19 million; FY 2025: £0.45 million). The share of losses reflects the Group’s 21% ownership share of the losses accumulated in the year. The Group investment remained at 21%.
Share-based payment charges were £0.54 million (H1 2025: £0.74 million; FY 2025: £2.13 million).
Operating loss
The Group’s operating loss from continuing operations decreased to £13.91 million (H1 2025: £14.18 million; FY 2025: £29.89 million).
Convertible bond costs
During the period, the Group made interest-only cash repayments of £0.66 million in accordance with the amended bond terms and settled a further £1.20 million of the debt component through an early equity conversion.
The Board continues to consider each settlement event as it arises, taking into account a range of factors including the Company’s cash runway, shareholder dilution and broader business prospects.
The bond agreement contains embedded derivatives in conjunction with an ordinary host debt liability. Accordingly, the convertible bonds are presented in the Consolidated Statement of Financial Position as two separate components: ‘Convertible bond – debt’ and ‘Convertible bond – derivative’. The derivative element is measured at fair value using a Monte Carlo option pricing model.
The derivative element was revalued as at 30 June 2026 to £3.29 million (30 June 2025: £0.27 million; 31 December 2025: £2.79 million). After taking account of the £0.37 million reduction arising from the early conversion, this resulted in a £0.87 million charge recognised in profit or loss in the period (H1 2025: £1.01 million credit; FY 2025: £1.51 million debit).
The debt element of the bond increased to £15.77 million (H1 2025: £18.17 million; 31 December 2025: £13.36 million). The movement primarily reflects a non-cash interest expense of £3.46 million and a £0.82 million loss arising from revisions to expected future cash flows, partially offset by £0.66 million of interest-only cash repayments and an early conversion of £1.20 million. As of 30 September, the outstanding loan balance is £12.00 million.
Loss for the period
The reported loss from continuing operations after taxation was £19.02 million (H1 2025: £16.13 million; FY 2025: £36.26 million).
The basic loss per share from continuing operations was 4.23p (H1 2025: 4.23p; FY 2025: 9.07p).
The basic loss per share from discontinued operations was nil (H1 2025: 3.82p; FY 2025: 0.59p).
Cash flow
The Group reported cash and cash-equivalent balances of £20.27 million (30 June 2025: £12.65 million; 31 December 2025: £16.86 million). Cash and cash-equivalents were £10.59 million as of 31 August 2026.
There was a cash outflow from operations and working capital movements of £15.69 million (H1 2025: £12.33 million; FY 2025: £24.93 million) and cash outflow from investing activities was £0.02 million (H1 2025: inflow of £8.77 million; FY 2025: inflow of £9.90 million, reflecting the proceeds of the sale of Launch and Coris).
Cash inflow from financing activities, being net proceeds from the issue of share capital and share options, net of the principal elements of lease payments amounted to £17.76 million (H1 2025: inflow of £0.67 million; FY 2025: inflow of £15.64 million). The cash inflows for H1 2026 and FY 2025 related to equity fundraising.
Financial position
Net assets as at 30 June 2026 were £3.77 million (30 June 2025: £0.14 million; 31 December 2025: £2.48 million) of which cash and cash equivalents amounted to £20.27 million (30 June 2025: £12.65 million; 31 December 2025: £16.86 million).
Right-of-use assets amounting to £0.63 million (30 June 2025: £1.77 million; 31 December 2025: £1.32 million) are recognized in relation to the Group’s leasehold properties, together with a corresponding lease liability of £0.80 million (30 June 2025: £1.97 million; 31 December 2025: £1.55 million).
Intangible assets decreased to £1.55 million (30 June 2025: £1.83 million; 31 December 2025: £1.55 million) due to amortization of intangible assets.
Liabilities in relation to the unsecured senior convertible bonds issued in October 2022 result in a fair value of the derivative element of £3.29 million (30 June 2025: £0.27 million; 31 December 2025: £2.79 million). The convertible bond debt element at 30 June 2026 was £15.77 million (30 June 2025: £18.17 million; 31 December 2025: £13.36 million).
With current committed expenses, current cash runway takes the Group into early first quarter of 2027.
Events after the reporting period
In July 2026 the Company received an accelerated payment notice from the convertible bond holder in respect of the January 2026 quarterly deferred convertible bond repayment, as referenced most recently in the financing announced on 5 June 2026, which the Company has elected to settle in cash. Accordingly, the Company has settled the accelerated quarterly amortization payment of £3.67 million representing principal of £2.4 million together with the associated interest and fees payable in the deferment.
In September 2026 the Company received an accelerated payment notice from the convertible bond holder in respect of the April 2026 quarterly deferred convertible bond repayment, which the Company elected to settle in cash. Accordingly, the Company has settled the accelerated quarterly amortization payment of £2.613 million, representing principal of £2.4 million together with the associated interest and fees payable in the deferment. Following the cash settlement of the April 2026 quarterly deferred convertible bond repayment, both deferred payments have now been satisfied.
As announced on 1 September 2026, the Board of Directors granted share options under the Company’s Equity Share Option Scheme incentive plan ("ESOS") to all members of the Management Team (the "Options"). The Options are exercisable at an exercise price of 69 pence per share, being the mid-market closing price of the Company’s Ordinary Shares on 27 August 2026, the last trading date before the Options were granted.
As announced on 14 September 2026, Mats Blom, an experienced biotechnology finance executive and Board member with a strong track record as Chief Financial Officer in several life sciences companies, was appointed as a member of its Board of Directors and Chair of the Audit Committee.
(Press release, Avacta Life Sciences, SEP 29, 2026, View Source [SID1234671157])