REG - Avacta Group PLC - Year-end trading update

AvactaAnnouncement

Today 07:02

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260120:nRST5121Pa&default-theme=true

RNS Number : 5121P  Avacta Group PLC  20 January 2026

Avacta Group plc

("Avacta", the "Group" or the "Company")

 

Year-end trading update

 

LONDON and PHILADELPHIA - January 20, 2026 - Avacta Therapeutics (AIM: AVCT),
a clinical stage biopharmaceutical company developing pre|CISION(®), a
tumor-activated oncology delivery platform, has published a trading update for
the year ended December 31, 2025.

 

The Company made excellent progress during 2025, developing its unique
industry-leading technology platform, pre|CISION(®), with two programs
anticipated to be in clinical development in 2026. The Company raised £22.5m
in equity during 2025 to support the investment in its programs.

 

Highlights

Research and Development

·    Faridoxorubicin (AVA6000) program

o  In December 2025 Avacta reported highly encouraging efficacy and safety
data from the cohort of patients enrolled with salivary gland cancer where a
disease control rate of 90% is maintained in the full cohort (link
(https://polaris.brighterir.com/public/avacta/news/rns/story/xzl65pr) )

o  Program continued to enroll patients in the Phase 1b expansion cohorts, to
assess the efficacy of faridoxorubicin in more homogenous, defined patient
populations to better predict the magnitude of efficacy anticipated in larger
Phase 2/3 trials.

·    FAP-Exd (AVA6103) program

o  In December 2025 Avacta reported new pharmacology data in support of the
IND process and the design of the Phase 1 trial was published in parallel
(link (https://avacta.com/research-development-spotlight-series-episode-13/) )

o  Clinical testing expected to initiate in Q1 2026, subject to clearance by
regulators. Multiple U.S. specialty oncology centers are expected to open with
key investigators of different specialties to enroll the four selected tumor
types: pancreatic cancer, gastric cancer, small cell lung cancer and cervical
cancer.

·    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:

o  the sustained release mechanism of payload delivery, piloted in the
AVA6103 program, which is anticipated to begin clinical testing in Q1 2026;

o  and the dual payload mechanism of delivery allowing the precise delivery
of two payloads to the tumor with all of the benefits of the pre|CISION(®)
technology.

Financial

·    The Company successfully raised £22.5m 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
(https://polaris.brighterir.com/public/avacta/news/rns/story/r7q49gw) )

·    Unaudited cash and cash equivalents as of December 31, 2025: £16.9m
providing a runway into Q3 2026 supporting the planned spend on the Group's
two clinical stage programs and preclinical pipeline to key value inflection
points.

 

Outlook for 2026

·    Faridoxorubicin (AVA6000) program. Multiple data updates in both
patient groups, with salivary gland cancers and with triple negative breast
cancer updates expected in H1 2026.

·    Beginning of the FAP-Exd (AVA6103) clinical testing expected in Q1
2026. A group of U.S. clinical trial specialty centers are expected to open
imminently with key investigators of different specialties to enroll the four
selected tumor types: pancreatic cancer, gastric cancer, small cell lung
cancer and cervical cancer. Preliminary data from this trial is anticipated in
the second half of 2026.

·    Continued active interaction with potential partners regarding both
faridoxorubicin (AVA6000) and FAP-Exd (AVA6103). The survival data in the SGC
indication continues to mature, allowing planning of the next stage of
development with potential partners (link
(https://polaris.brighterir.com/public/avacta/news/rns/story/xe8ng2x) ). The
initiation of the FAP-Exd clinical trial continues to be of interest in the
market.

 

Christina Coughlin MD, PhD, CEO of Avacta, commented:

 

"We gained real traction with our R&D programs, based on our unique
industry leading technology, pre|CISION(®), during 2025. 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 sustained release mechanism piloted in the FAP-Exd (AVA6103) program is
anticipated to begin clinical testing this quarter, a significant milestone
achievement, just 24 months after the beginning of the program. This program
continues to garner significant interest from global pharmaceutical companies;
however, the Company's strategy remains to retain 100% of AVA6103 until we
begin to see readouts from the Phase 1a clinical trial. Importantly, the trial
has been designed to rapidly deliver clinical data in this program.

 

"We are developing further IP around the pre|CISION(®) platform. Drug
development isn't just about science, it is about strategy and protecting our
innovation. Our IP estate is the most valuable asset we have. To further this
IP estate, we also raised over £22m to support our research and development
programs, which gives us a runway into Q3 2026. These funds allow the Company
to initiate the AVA6103 clinical trial and we anticipate the initial data in
the AVA6103 program in the second half of 2026.

"The unique nature of the dual payload program is also generating interest and
we are exploring opportunities with multiple potential partners with a view to
investigating the wide utility of this novel technology.

"We continue to have multiple conversations with global pharmaceutical
companies regarding our full pipeline. We are incredibly excited for the year
ahead, which the board believes will be a transformative period for the
Company, patients and our shareholders."

 

Operational update

Faridoxorubicin (AVA6000)

·    Highly encouraging data were presented last month describing the
efficacy observed in the patients treated in the Phase 1b expansion cohort,
which appears highly similar to the data observed in the Phase 1a patient
population (link
(https://polaris.brighterir.com/public/avacta/news/rns/story/xzl65pr) ).

-    The larger numbers of patients treated in this cohort are important to
inform the design and size of a subsequent trial in this indication.
Importantly, the prolonged PFS observed in the Phase 1a cohort of patients
indicates a prolonged PFS in the Phase 1b cohort.

-    Although these data can take time to collect, the Company is
encouraged by the extended survival observations in the trial. Attention to
this stage of development is designed to derisk later stages of clinical
trials.

·    The data in the Phase 1a portion of the trial were updated at ESMO
(link (https://avacta.com/wp-content/uploads/2025/10/ESMO-2025_vfinal.pdf) ),
where the PFS was reported as highly encouraging when compared with benchmark
data in this indication. As the data in the Phase 1b expansion cohort are
preliminary, the Company continues to collect the data. The estimates of the
PFS and overall survival (OS) will be used to design the randomized study in
this indication.

·    In addition, the Company expects to release data in the TNBC cohort
in H1 2026.  Further development of faridoxorubicin will be undertaken
subject to a partner being secured.  The Company continues to engage with
multiple partners as the data matures.

 

 

FAP-Exd (AVA6103)

Recent pharmacology data (link
(https://polaris.brighterir.com/public/avacta/news/rns/story/xojeq9r) ) have
been released demonstrating several key aspects of the FAP-Exd (AVA6103)
program, including:

·    Robust efficacy in a broad range of patient-derived cancer models
with deep complete responses observed with only three doses of FAP-Exd, even
in settings of low FAP expression. In an encouraging parallel, the durability
of the responses in the preclinical setting with FAP-Exd match those observed
among patients with salivary gland cancers, treated with faridoxorubicin even
in the setting of low FAP expression (link
(https://avacta.com/wp-content/uploads/2025/10/ESMO-2025_vfinal.pdf) ).

·    Tumor and plasma exposure studies have demonstrated that FAP-Exd
rapidly penetrates the tumor microenvironment (TME), is held intact for over
five days in the tumor and releases exatecan, with an observed high maximal
concentration (C(max)) in the tumor within minutes and very low exposure in
the bloodstream which is undetectable within two hours.

 

The FAP-Exd Phase 1 trial design has been released (link
(https://avacta.com/research-development-spotlight-series-episode-13/) ) and
includes the following aspects to optimize the execution of this study:

·    The trial will enroll patients with a selected set of four cancer
indications predicted by AI (in our strategic collaboration with Tempus AI) to
be the most sensitive among solid tumor indications. These include pancreatic
cancer, small cell lung cancer, gastric cancer and cervical cancer.
Importantly, each of these four disease settings has a favorable regulatory
path forward and the group includes both large tumor types as well as
potential orphan indications.

·    Clinical trial sites in the U.S. and the trial investigators have
been selected based on their deep experience with these indications. The
Company has enjoyed strong interest among clinical trial sites and
investigators in the study.

·    The trial design has two key features to optimize the rapid
collection of data:

-    Two independent arms investigating two schedules with every two weeks
dosing (Q2W) and every three weeks dosing (Q3W) are anticipated to enroll in
parallel, and;

-    The trial will use the Bayesian Optimal Interval (BOIN) design, a
modern statistical method for oncology Phase 1 trials. BOIN combines the
simplicity of the traditional 3+3 enrollment method, where small groups of
patients are treated at increasing doses, with efficient dose exploration and
flexible enrollment into cohorts to optimize data collection over the course
of the trial. This approach has been shown to enable the trial to handle
complex findings and rapidly identify the optimal dose range.

 

 

Dual Payload Technology (AVA6207)

·    The work in the AVA6103 program to better define the self-immolative
linker technology led to the invention of the dual payload technology (link
(https://polaris.brighterir.com/public/avacta/news/rns/story/x20vg6r) ). The
dual payload platform is enabled by the insertion of two payload attachment
points in the linker, ensuring the independent release of both payloads with a
single FAP cleavage event.

·    The release of two payloads in one pre|CISION(®) medicine has three
key advantages:

-    Combination therapy is the mainstay of how patients are treated in
oncology. The challenge is the toxicities with each individual drug. With a
single pre|CISION(®) medicine, a simple monotherapy trial is needed and both
payloads have the benefits of the pre|CISION(®) technology: concentration in
the TME and minimal exposure in normal tissues.

-    The release of dual payloads is accomplished without the need for a
biologic arm (e.g. an antibody, Fc region or Affimer) which greatly simplifies
the manufacturing of these medicines. Indeed, all pre|CISION(®) medicines are
small molecules, meaning short and chemical-based manufacturing that is more
cost-efficient than biologics.

-    Because the size of the molecule is small, rapid and efficient tumor
penetration of two payloads is anticipated based on the data presented with
FAP-Exd, where tumor cells will see both payloads in parallel. The design of
the first program combines a topoisomerase I inhibitor with a second payload
that can overcome a key resistance mechanism, namely the DNA Damage Repair
pathway (DDR). Preclinical data presented at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics (October, 2025)
demonstrates preliminary synergy of this combination (link
(https://avacta.com/wp-content/uploads/2025/10/AACR-NCI-EORTC-2025-Avacta-Dual-Payload-Poster.pdf)
).

·    The Company has committed to the selection of the payloads for the
AVA6207 program in 2026.

 

 

Financial update

The Company raised £22.5m in equity (gross) to support its investment
programs during the year and also realized just over £15m from the disposal
of the non-core diagnostics businesses.

 

The Company renegotiated the terms of the convertible bond with the Quarterly
Convertible Bond repayments and interest in January 2026 and April 2026
payment dates deferred until October 2027. In addition, the bondholder has the
right to accelerate the satisfaction of the deferred repayments based on
agreed conditions and the conversion price of the convertible bond is reset at
75.0p. All conditions of the bond renegotiation are reported here (link
(https://polaris.brighterir.com/public/avacta/news/rns/story/r7q49gw) ).

 

Unaudited cash and cash equivalents at as December 31, 2025, were £16.9m,
providing the Company with a runway into Q3 2026 to support its research and
development activities.

 

-Ends-

 

 

For further information from Avacta, please contact:

 

 Avacta Group plc                                           https://avacta.com/ (https://avacta.com/)

 Christina Coughlin, Chief Executive Officer                via ICR Healthcare

 Strand Hanson Limited (Nominated Adviser)                  www.strandhanson.co.uk (https://www.strandhanson.co.uk/)

 James Harris / Chris Raggett / James Dance

 Zeus (Broker)                                              www.zeuscapital.co.uk (http://www.zeuscapital.co.uk)

 James Hornigold / George Duxberry / Dominic King

 ICR Healthcare                                              avacta@consilium-comms.com (mailto:avacta@consilium-comms.com)

 Mary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert

 Investor Contact                                           renee@thrustsc.com (mailto:renee@thrustsc.com)

 Renee Leck

 THRUST Strategic Communications

 Media Contact                                              carly@thrustsc.com (mailto:carly@thrustsc.com)

 Carly Scaduto

 THRUST Strategic Communications

 

 

About Avacta - www.avacta.com (https://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 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.

 

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.

 

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.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  TSTEAFFNFLEKEAA



            Copyright 2019 Regulatory News Service, all rights reserved