Avacta Group PLC (AIM:AVCT) Preliminary Full Year 2024 Results

Preliminary Results for the Year Ended December 31, 2024

LONDON and PHILADELPHIA – June 6, 2025 – Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, has published its unaudited preliminary results for the 12 months ended December 31, 2024 (“FY24”).

Highlights

 Christina Coughlin, MD, PhD, CEO of Avacta, said, 

“Over the past year, we have transformed the business into a dedicated therapeutics company focused on our unique pre|CISION^® platform. We are pioneering a novel, differentiated class of medicines, which has the potential to revolutionize drug delivery.

“This unique platform has the potential to treat up to 90% of solid tumors by repurposing a range of effective oncology drugs to significantly reduce toxicity and side effects. This represents a potential breakthrough for patients and a major opportunity for Avacta.

“With our first program in the clinic, we expect to release the initial data in salivary gland cancer for FAP-Dox (AVA6000) towards the end of 2025 and in triple negative breast cancer in H1 2026 with potential for Phase 2 trials in H1 2026.

“FAP-EXd (AVA6103) has advanced into IND-enabling work this year and we plan to initiate the Phase 1 trial in early 2026. In parallel, we are actively pursuing a number of commercial opportunities.

“Overall, 2025 and 2026 are set to be a transformative for Avacta, driven by a number of catalysts to drive shareholder value.”

-Ends-

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About Avacta – www.avacta.com

Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION^® platform. pre|CISION^® is a proprietary warhead delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent warheads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION^® peptide drug conjugates (PDC) or Affimer^® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates.

About the pre|CISION^® Platform

The pre|CISION^® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION^® platform harnesses this tumor specific protease to cleave pre|CISION^® peptide drug conjugates and pre|CISION^® antibody/Affimer^® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients.

Chairman’s statement  

The Group has undergone significant transformation in the past year, driven by Dr. Christina Coughlin following her appointment as CEO, positioning Avacta as a dedicated therapeutics company with its unique pre|CISION^® technology platform.

This novel platform demonstrates significant potential in addressing one of the primary challenges of effective treatment of diseases, specifically the balance between efficacy and safety.

There has never been any doubt in my mind about the potential of, and the opportunities for, Avacta’s pre|CISION^® platform. Avacta is pioneering a novel, differentiated class of pre|CISION^®-based medicines to revolutionize drug delivery, which have the potential to demonstrate multiple advantages over conventional therapeutics.

Despite the challenging environment, we have achieved a number of significant markers of strategic and operational progress, including the repositioning of the business into a pure-play therapeutics business with a unique technology platform; the divestment of the non-core diagnostics business; and the build-out of a leading management team, particularly the appointments of Michelle Morrow as Chief Scientific Officer and Brian Hahn as Chief Financial Officer.

FAP-Dox (AVA6000), the lead asset in the pre|CISION^® platform, continues to make good clinical progress. Avacta is continuing to develop an exciting and innovative pipeline of differentiated assets as the business builds its IP portfolio and builds a profile in the sector with corporates and investors.

Now that Avacta is positioned as a clinical stage biopharmaceutical company, the more immediate challenges are less about clinical and operational execution – since Chris and her team continue to demonstrate their expertise and capabilities here – and are more about ensuring Avacta can establish a sustainable, long-term financing strategy to realize the pipeline’s potential.

Avacta has a clear value proposition and world-class scientific capabilities and is supported by robust data and an innovative platform and there are good opportunities to attract long-term investors. The Avacta management team continues to build knowledge and trust with a broad range of specialist and other investors in the US and closer to home.

At this stage in the Company’s development, with substantially all resources dedicated to research and development and generating key data that will be key to the Company’s long-term value, the Board’s primary focus in relation to cash management is on funding critical pipeline progression.

The macroeconomic backdrop to the global biotechnology sector remains volatile, driven by both economic and political uncertainties resulting in a more subdued market backdrop and competitive funding environment.

The Board understands that the Heights Capital Bond (“HCB”) liability remains a source of frustration for shareholders and is a significant factor in shaping shareholder sentiment. We continue to explore a number of possible alternatives.

The Board is committed to both the Company’s near-term as well as the long-term financing requirements and is resolutely focused on executing its strategic goals and furthering the pre|CISION^® platform, which it believes will be the springboard to deliver a longer-term solution to the Company’s needs including its capital structure and driving shareholder value.

Throughout the year, we have been actively engaging with interested industry parties who align with our strategic vision and have the potential to bring complementary expertise and resources to the table. These discussions have focused on identifying collaborative opportunities to accelerate the development and commercialization of our pre|CISION^® platform assets.

Establishing the right partnerships is critical for expanding our reach and ensuring the long-term success of our pipeline as well as potentially reducing the Group’s internal financing requirement. Alongside finding a solution to the HCB, progressing these discussions remains a top priority for the Board.

Avacta is updating its Board to reflect the evolution in its strategy and its needs. We have recently brought on two new Non-Executive Directors, David Bryant and Richard Hughes. David brings extensive commercial industry knowledge and networks and Richard a track record in UK capital markets. Their respective experience and perspective will strengthen the Board’s oversight and governance. As previously announced, Dr. Trevor Nicholls has retired from the Board as a Non-Executive Director.

All organizations are dependent upon their people, and we are very fortunate to have some of the leading international scientists in biotech, who are providing the intellectual backbone to the Company. They are developing the IP which makes our business so exciting and on behalf of the Board, I would like to thank them for their commitment and hard work.

With the strategy and operational focus solely now on the pre|CISION^® platform and the strong development of the pipeline, along with the strength of the management team, we are now a much better proposition for both investors and potential international industry partners.

The future continues to be exciting for Avacta and the Board is resolutely focused on driving this exciting program of assets forward and delivering long-term shareholder value.

Shaun Chilton,

Chairman

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Chief Executive Office’s statement 

Overview

Avacta’s proprietary pre|CISION^® platform enables the repurposing of a range of oncology

drugs to significantly reduce toxicity and side effects for patients by concentrating the payload in the tumor, offering the potential to improve efficacy and patient tolerability.

Many anticancer drugs have demonstrated positive activity in the clinic but failed in clinical testing due to either severe toxicity that limits dosing or inferior drug half-life. Our pre|CISION^® technology can address both these limitations.

Over the last year or so, we have rapidly developed a range of early-stage technologies using pre|CISION^®.  Avacta has multiple programs running designed to improve the therapeutic index (quantitative measurement of the relative safety and efficacy of a drug) and the exposure (the released drug kinetics or half-life). 

These advances have led to new and increasingly valuable intellectual property being developed around our foundational pre|CISION^® technology. Advances in chemistry are opening multiple opportunities for the development of pre|CISION^® enabled drugs.  

We see very significant market prospects as some 90% of solid tumors are potentially treatable by our pre|CISION^® platform as demonstrated by multiple indications across all solid tumors. The versatility of the platform is one of its key advantages and USPs. 

pre|CISION^® is a highly innovative and unique platform that is set to deliver clinical results across our two lead programs in late 2025 and 2026.

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.

The key aspect of pre|CISION^® peptide drug conjugates (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 active payload is released.  The release of the payload from the pre|CISION^® product 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 is capable of delivering 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. 

Programs

We are generating a portfolio of product candidates that combine our pre|CISION^® peptide with various anticancer drugs to enable the treatment of a broad spectrum of solid tumors.  This will require execution of both a near term and long-term financing strategy to achieve the Company’s goals.

FAP-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 for three reasons:

AVA6000 has been well-tolerated in the Phase 1a dose escalation trial in patients, with solid tumors and promising antitumor activity has been observed. FAP-Dox dosing in Phase 1 has escalated to doses nearly four-fold higher than those safely achieved with conventional doxorubicin in routine clinical use. 

Despite these high doses delivered and high lifetime exposure to released doxorubicin, there has been no serious cardiac toxicity observed in the trial.

Importantly, tumor biopsy data from this trial demonstrated that intratumoral levels of doxorubicin were a median 100-fold higher than plasma levels in most of the patients tested, validating the ability of pre|CISION^® to limit systemic exposure to the active cytotoxic (tissue damaging) drug.

The Phase 1b portion of the trial is underway, with the expansion cohorts currently enrolling at the recommended dose for expansion (RDE) determined in the Phase 1a dose escalation part of the trial. 

Exatecan (EXd) (AVA6103) is our second product candidate that uses the pre|CISION peptide drug conjugate technology to deliver exatecan, a potent topoisomerase I inhibitor directly to tumors, while limiting the exposure of the released exatecan in normal tissues.

Exatecan has demonstrated clinical activity in cancers such as breast, gastric, lung and pancreatic cancers. However, dose-limiting toxicities and a short half-life in patients led to discontinuation of its development.

We believe that exatecan represents a good candidate for our pre|CISION^® technology for three reasons:

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 associated with poor tolerability

Our research pipeline has now extended to our new biologic drug conjugate platform, where the pre|CISION^® peptide is used as the linker element to attach the payload to a biologic agent such as an antibody or an Affimer (another form of protein). 

The advantage of this technology is the tumor-specificity of the release mechanism. It also enables half-life extension (e.g. optimizing the exposure) and further targeting with the biologic aspect of the drug.  We anticipate moving a candidate forward in late 2025 from this research program

Our strategic collaboration with Tempus, a technology company leading the adoption of artificial intelligence to advance precision medicine and patient care, has delivered results in terms of a better understanding of the addressable patient population for the full suite of pre|CISION^® medicines. 

It has also a deeper understanding of the indications for the FAP-EXd program where we would anticipate the optimal efficacy, based on the wider use of the topoisomerase I inhibitor mechanism (direct to tumor drugs) of action in oncology.

Outlook

2025 and into 2026 are set to be a transformative time for Avacta with multiple catalysts. 

For FAP-Dox (AVA6000), we anticipate releasing the initial data in salivary gland cancer in late 2025 and in triple negative breast cancer in H1 2026 from these cohorts. Phase 2 trials in these indications are also planned for H1 2026.

The second asset, FAP-EXd (AVA6103) will advance into clinical testing with the IND filing in late 2025 and initiation of the Phase 1 trial in 2026, with initial data available in late 2026.

Our team continues to explore a number of commercial opportunities.  We continue to seek a partner for our lead asset FAP-Dox that is poised to enter Phase 2 in 1H 2026. 

Christina Coughlin,

Chief Executive Officer