Avacta Provides Business Update for the First Quarter of 2025 Outlining Progress Against Strategic Objectives

AVA6000 Phase 1b expansion cohorts enrolling with data targeted for later in 2025

AVA6103 IND-enabling studies underway with a Phase 1 trial anticipated to begin in the first quarter of 2026

Multiple presentations at the AACR Annual Meeting highlight the promise of the pre|CISION^® platform

Transformation into a pure-play therapeutics company prioritizes proprietary pre|CISION^® platform and extends cash runway into Q1 2026

LONDON AND PHILADELPHIA - March 31, 2025 Avacta Therapeutics (AIM: AVCT, 'the Company'), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today provides a business update on progress for the first three months of 2025 and a review of upcoming milestones.  

Christina Coughlin, M.D., Ph.D., Chief Executive Officer of Avacta, said: "We made a strong start to 2025, continuing to make excellent progress against all of our strategic objectives. We are very encouraged by the Phase 1 data from FAP-Dox (AVA60000) so far, which continue to show an excellent tolerability profile and increasingly durable responses in salivary gland cancers. We are now enrolling in multiple dose expansion cohorts, including triple negative breast cancer with preliminary data targeted for later in 2025.

"Our pre|CISION^®-enabled exatecan program (FAP-EXd, AVA6103) also continues to progress toward a Phase 1 trial initiation early next year, underscoring our deep commitment to pioneering a novel, differentiated class of medicines to revolutionize drug delivery mechanisms. We are enthusiastic about the promise of a potent topoisomerase I inhibitor delivered in this mechanism."

pre|CISION^® Medicine Pipeline

FAP-Dox (AVA6000), a pre|CISION^®-enabled form of doxorubicin chemotherapy, advances to Phase 1b dose expansion.  During the first quarter, Avacta completed the Phase 1a dose escalation portion of the trial, demonstrating promising early efficacy and a favorable safety profile. As of the most recent data cut-off, AVA6000 continues to show improved tolerability compared to conventional dose doxorubicin, with no observed events of severe cardiac toxicity. Encouraging progression-free survival (PFS) data has also been observed in patients with salivary gland cancers. The Company has begun enrolling patients in the Phase 1b expansion cohorts, including salivary gland cancer, triple negative breast cancer and high-grade soft tissue sarcoma and plans to report updates from these trials later in 2025. For more details see announcement from 07 March 2025 here.   

·    AVA6103, a pre|CISION^®-enabled PDC comprised of the pre|CISION peptide linked to the potent topo I inhibitor exatecan, continues preclinical development. AVA6103 is currently in investigational new drug (IND)-enabling studies with a Phase 1 trial anticipated to begin in the first quarter of 2026.

·    Upcoming Data Presentations at AACR. Avacta is presenting three posters at the American Association for Cancer Research (AACR) Annual Meeting from April 25-30, 2025 in Chicago, IL. The presentations will feature data from the Company's proprietary pre|CISION^® platform and pipeline of next generation peptide drug conjugates (PDCs), including clinical data on AVA6000 and preclinical pharmacology highlights for AVA6103. For more details see announcement from 26 March 2025 here.

·    Novel data from our strategic collaboration with Tempus AI continues to be reported, including at the AACR Annual Meeting in Chicago.

Executive Leadership Team Addition

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·    Strengthened management team. In January Avacta strengthened the management team with the appointment of Brian Hahn as Chief Financial Officer ("CFO"). Brian is a seasoned CFO with over 25 years' biopharma financial and operational experience. He spent 15 years as CFO and Senior Vice President of GlycoMimetics, Inc., where he led the company's 2014 initial public offering ("IPO") on Nasdaq.

Notice of 2024 Preliminary Results

Avacta expects to report its Preliminary Results for the 12 months ended 31 December 2024 during May 2025. 

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For further information from Avacta, please contact:

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 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.

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.