PresentationGood morning, and welcome to the Avacta Group Plc investor presentation. [Operator Instructions] Before we begin, we'd like to submit the following poll. I'd now like to hand you over to Christina Coughlin, CEO. Good morning.Christina CoughlinCEO & Executive Director Thanks, Paul. Good morning, and thank you, everyone, for joining us for the data release for faridoxorubicin in Phase Ib in patients with salivary gland cancers. I'm joined today by 2 team members, our Chief Medical Officer, David L ...

Preliminary Phase 1b data is in line with Phase 1a data reported at the European Society of Medical Oncology in September 2025 Combined disease control rate of 90% across both Phase 1a and Phase 1b patients with confirmed partial and minor responses observed LONDON and PHILADELPHIA, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a clinical stage biopharmaceutical company developing pre|CISION®, a tumor-activated oncology delivery platform, today announced compelling new data in patients ...

Core Insights - Avacta Therapeutics has presented preclinical data on its first-in-class dual payload peptide drug conjugate, AVA6207, which aims to enhance tumor control and overcome resistance mechanisms in cancer therapy [1][2]. Company Overview - Avacta is a clinical stage biopharmaceutical company focused on developing the pre|CISION platform, which enables targeted delivery of oncology drugs through peptide drug conjugates (PDCs) [13]. Technology and Innovation - The dual payload technology allows for the simultaneous delivery of two distinct therapeutic agents to the tumor microenvironment via a single fibroblast activation protein (FAP)-mediated cleavage event, addressing critical challenges in cancer treatment [2][3]. - The pre|CISION platform has demonstrated a tumor-to-plasma payload concentration of 100:1 with reduced off-target toxicities, even at doses up to approximately four times that of conventional doxorubicin [5]. Preclinical Findings - The dual payload technology showed robust FAP-selective delivery and potent anti-tumor activity, with IC50 values ranging from 2-9 nM in the presence of FAP, indicating excellent tumor selectivity [6]. - The technology confirmed dual mechanism biomarker modulation, with specific biomarkers being affected only in the presence of FAP, validating the effectiveness of the dual payload approach [6][7]. - Enhanced synergistic activity was observed, with FAP-dependent tumor cell killing being 4-5 times greater compared to exatecan alone, effectively addressing known resistance pathways [7]. Market Potential - The pre|CISION platform targets a large addressable market, potentially impacting 90% of solid tumors, and offers advantages over traditional antibody drug conjugates (ADCs) such as better tumor penetration and reduced toxicity [7].

Core Insights - Avacta Therapeutics has reported promising results from its Phase 1a clinical trial of faridoxorubicin (FAP-Dox, AVA6000), indicating a significant improvement in progression-free survival (PFS) for patients with salivary gland cancer, with a disease control rate of 91% [1][10] - The treatment demonstrated favorable safety and tolerability, with no severe cardiac toxicity observed even at cumulative doses up to 550 mg/m², which is approximately four times the conventional doxorubicin dose [2][12] Clinical Trial Results - Median PFS has not been reached in the cohort of patients with salivary gland cancers, suggesting a durable response, with follow-up data indicating a duration of PFS more than double that of benchmark data [3][10] - In the Phase 1a study, faridoxorubicin was well-tolerated across both every-three-week and every-two-week dosing regimens, with no maximum tolerated dose reached despite dosing up to 385 mg/m² [8][9] - The trial included 11 patients with salivary gland cancers, showing multiple confirmed partial and minor responses, and a median PFS follow-up of approximately 41 weeks [10] Safety Profile - Cardiac safety data revealed no severe cardiac events reported during treatment or follow-up, even at maximum cumulative exposure [12] - The study demonstrated that faridoxorubicin has a markedly improved safety profile over conventional doxorubicin, with only two patients showing echocardiogram changes consistent with adverse findings [12][9] Mechanism of Action - Faridoxorubicin is designed to reduce systemic side effects by concentrating the active drug in the tumor microenvironment, leveraging the pre|CISION platform [7][19] - The platform allows for the release of the drug specifically within the tumor, resulting in higher concentrations at the tumor site and lower levels in the bloodstream and healthy tissues [21] Future Developments - Avacta continues to enroll patients in the Phase 1b expansion cohorts, with further data in salivary gland cancer expected by the end of 2025 [15] - The company plans to present additional findings at the upcoming Investor Meet conference on October 21, 2025 [16]

Core Insights - Avacta Therapeutics has developed the first dual-payload peptide drug conjugate (PDC) platform, enhancing its position in oncology combination therapy innovation [1][5][6] - The upcoming presentation at the 2025 AACR-NCI-EORTC International Conference will showcase in vitro proof of mechanism data for this novel platform [2][7] Company Overview - Avacta is a clinical stage biopharmaceutical company focused on developing the pre|CISION platform, which aims to improve drug delivery in oncology by concentrating drugs directly in tumors [11][12] - The pre|CISION technology utilizes a cleavable peptide that releases the active drug only within the tumor environment, minimizing systemic toxicity [12] Technology Development - The dual-payload PDC platform allows for the simultaneous delivery of two complementary drugs targeting cancer, representing a significant advancement in the pre|CISION technology [2][4] - This innovation builds on the existing FAP-EXd (AVA6103) program, which successfully implemented a sustained release delivery mechanism [6] Clinical Implications - The dual payload approach aims to enhance treatment efficacy by targeting both the tumor and known resistance mechanisms in a single therapeutic agent [6][12] - The technology is designed to address highly-resistant cancers, potentially expanding treatment options for patients [6][12]

Core Insights - Avacta Therapeutics will present updated data from the Phase 1a trial of FAP-Dox (AVA6000) at the 2025 ESMO Congress in Berlin from October 17-21, 2025 [1][2] - FAP-Dox is a peptide drug conjugate designed to target FAP-positive solid tumors, utilizing a mechanism that cleaves doxorubicin specifically in the tumor microenvironment [1][5] Company Overview - Avacta Therapeutics is a clinical-stage life sciences company focused on developing targeted oncology drugs through its proprietary pre|CISION platform [5][6] - The pre|CISION platform aims to deliver highly potent cancer therapies by concentrating drug payloads in the tumor microenvironment while minimizing exposure to normal tissues [5][6] Clinical Trial Details - The Phase 1a trial of FAP-Dox has completed the enrollment dose escalation phase, with ongoing patient enrollment in multiple dose expansion cohorts for a Phase 1b study [2] - The presentation at ESMO will include data from patients with FAP-positive solid tumors, highlighting the drug's targeted approach [2][3]