LONDON and PHILADELPHIA, Sept. 30, 2026 (GLOBE NEWSWIRE) -- 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(R) 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(R) 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(R), a marketed antibody drug conjugate (ADC) that targets
HER2, demonstrates that AVA6103 shows better antitumor activity
vs. Enhertu(R), 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(R) payload delivery preclinical
pharmacokinetics (PK) via AVA6103, compared with now two approved
ADCs (Enhertu(R) and Datroway(R)), presented at the Company's
Science Day, showing the clear advantages of pre|CISION(R) 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(R) dual payload technology program at AACR 2026.
-- Presented updated in vivo studies of the dual payload delivery
system AVA6207 at Science Day.
pre|CISION(R) platform and First Gen (AVA6000)
-- Reported data validating the pre|CISION(R) 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(R) 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 GBP10 million
(March 2026), and raised gross proceeds of approximately GBP9 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 GBP20.27
million (31 December 2025: GBP16.9 million million). As of August 31,
2026, cash held was GBP10.59 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(R) 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(R) platform.
"Our financing activities have raised approximately GBP19.0 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(R) (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(R) (datopotamab deruxtecan-dlnk; Dato-DXd) is a protease cleavable-linker ADC, approved for certain types of breast and lung cancer (a Daiichi Sankyo product).
For further information from Avacta, please contact:
Avacta Group plc https://avacta.com/
Christina Coughlin, Chief Executive Officer via Cohesion Bureau
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Strand Hanson Limited (Nominated Adviser) www.strandhanson.co.uk
James Harris / Chris Raggett / James Dance
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Zeus (Broker) James Hornigold / George www.zeuscapital.co.uk
Duxberry (Investment Banking) Dominic King /
Alex Bartram (Corporate Broking)
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Cohesion Bureau avacta@cohesionbureau.com
Communications / Media / Investors
Chris Maggos
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About Avacta - https://avacta.com/
Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies through its proprietary pre|CISION(R) platform. pre|CISION(R) is a payload delivery system based on a tumor-specific protease (Fibroblast Activation Protein or FAP) that is designed to concentrate highly potent payloads in the tumor microenvironment while sparing normal tissues. Avacta's innovative pre|CISION(R) 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.
Our pre|CISION(R) 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(R) 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.
About FAP-Exd (AVA6103)
AVA6103 is the second clinical candidate and is the first asset in the pipeline based on the Next Generation innovative pre|CISION(R) controlled 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.
Interim report
Strategic overview
We are making excellent progress in the development of our unique pre|CISION(R) technology platform, pioneering a novel, differentiated class of pre|CISION(R) -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(R) -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(R) across a number of modalities and in the management team's ability to secure the requisite funding to progress the pre|CISION(R) platform through multiple value driving events.
pre|CISION(R) - 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(R) platform. Avacta's innovative pre|CISION(R) 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(R) 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(R) 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(R) 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(R) medicines.
Two factors that dictate the antitumor potential of pre|CISION(R) 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(R) 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(R) 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(R) 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) 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, 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 GBP0.06 million (H1 2025: GBP0.06 million; FY 2025: GBP0.113 million).
Revenues from discontinued operations for the six months ended 30 June 2026 was GBPnil million (H1 2025: GBP6.10 million; FY 2025: GBP6.20 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(R) therapeutics programs as planned increased to GBP9.69 million (H1 2025: GBP7.20 million; FY 2025: GBP18.76 million).
Other costs and charges
Depreciation from continuing operations decreased to GBP0.56 million (H1 2025: GBP0.73 million; FY 2025: GBP1.27 million). Amortization expense remained at GBP0.01 million (H1 2025: GBP0.01 million; FY 2025: GBP0.01 million).
The share of the costs from the AffyXell joint venture was GBP0.26 million (H1 2025: GBP0.19 million; FY 2025: GBP0.45 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 GBP0.54 million (H1 2025: GBP0.74 million; FY 2025: GBP2.13 million).
Operating loss
The Group's operating loss from continuing operations decreased to GBP13.91 million (H1 2025: GBP14.18 million; FY 2025: GBP29.89 million).
Convertible bond costs
During the period, the Group made interest-only cash repayments of GBP0.66 million in accordance with the amended bond terms and settled a further GBP1.20 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 GBP3.29 million (30 June 2025: GBP0.27 million; 31 December 2025: GBP2.79 million). After taking account of the GBP0.37 million reduction arising from the early conversion, this resulted in a GBP0.87 million charge recognised in profit or loss in the period (H1 2025: GBP1.01 million credit; FY 2025: GBP1.51 million debit).