LONDON and PHILADELPHIA – September 30, 2026 – Avacta Therapeutics (AIM: AVCT, “the Company”, “Avacta”), a life sciences company developing innovative, targeted oncology drugs, today publishes its unaudited interim results for the six months ended June 30, 2026 (“H1 26”).
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:
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- 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) 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.
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- AVA6207 (Dual Payload)
- Presented first in vivo efficacy and exposure pharmacology for the pre|CISION® dual payload technology program at AACR 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) 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) Conference on Pancreatic Cancer, being held on September 25-28, 2026, and the European Society for Medical Oncology (ESMO) 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 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).
- Download the full Interim Results report here.