Q1 2026 Business Update

Avacta Group PLC

09 April 2026

 

Q1 2026 Business Update

LONDON and PHILADELPHIA - April 9, 2026 - Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre|CISION^®, a tumor-activated oncology delivery platform, today provides a business update through the first quarter of 2026.

Q1 2026 Highlights  

Gen Two (AVA6103)

·    The Investigational New Drug (IND) application for Avacta's first Gen Two program, AVA6103 (FAP-Exd, pre|CISION^®-enabled exatecan), was cleared in January. Three specialist oncology centers are now open for enrollment in the U.S. On 31 March 2026 Avacta announced the first patient was treated as planned in the FOCUS-01 Phase 1 clinical trial.

·    In February 2026 highly favorable data from a preclinical study were presented, comparing the pre|CISION^® sustained release payload delivery of AVA6103 with a highly successful antibody drug conjugate, Enhertu^®. The study used a synthetic comparator arm and demonstrated the optimized pre|CISION^® payload delivery with rapid tumor penetration, one log higher maximal tumor concentration, and 3x tumor selectivity index (TSI) of the exposure (AUC) in tumor versus plasma.

Gen One (AVA6000)

·    Positive health authority interactions were reported in the Gen One program, AVA6000 (Faridoxorubicin, pre|CISION®-enabled doxorubicin), resulting in the lifting of the lifetime maximum dose due to highly favorable cardiac safety and an agreement on the dose selection for subsequent trials.

Financial

·    Completed a successful financing with an oversubscribed placing and subscription raising £10 million, as announced on 27 March 2026, extending the cash runway into early Q1 2027 and allowing the Company to retain 100% ownership of all assets in the pipeline.

·    Christina Coughlin, CEO and Brian Hahn, CFO participated in the 46^th Annual TD Cowen Health Care Conference in Boston on March 4, 2026

Company Outlook for 2026

·    Updated preclinical and translational data on the Gen Two AVA6103 program will be presented at the American Association of Cancer Research (AACR) Annual Congress in San Diego on 21 April 2026.  Initial clinical data in the AVA6103 program are anticipated in late H2 2026.

·    A clinical data update on Gen One AVA6000 clinical data from the Phase 1a and 1b cohorts is expected at a medical conference in H1 2026. This would include updated efficacy data in expansion cohorts, including the lead indication of salivary gland cancer, as well as the cardiac safety data which resulted in the removal of the lifetime maximum dose limit, as announced on 03 February 2026.

·    Payload selection and clinical candidate selection in the Gen Three pre|CISION^® Dual Payload program (AVA6207) are expected in H2 2026.  Updated in vitro and in vivo preclinical data will also be presented at the AACR Annual Congress on 21 April 2026.

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

"Avacta continued to build momentum, having reached a number of important milestones in the first quarter of 2026, with treatment of the first patient in the FOCUS-01 trial of AVA6103 being a critical step forward in the development of our pre|CISION^® platform.  The sustained release mechanism allows the modulation of the kinetics of payload release, and also opens up the platform to many therapeutic modalities over the Gen One approach.

Furthermore, our AVA6000 (faridoxorubicin) program is especially well positioned following the updates from health authorities which allow the lifting of the lifetime maximum dosing and dose selection. 

Our first, second and third generation assets are all attracting substantial interest from multiple parties for potential partnering. With our recent financing completed, we now have funding in place beyond multiple value inflection points through the rest of 2026 and we are excited about this potentially transformative period for the Company, delivering benefit for our patients and our shareholders alike."

-Ends-

For further information from Avacta, please contact:

Avacta Group plc Christina Coughlin, Chief Executive Officer	https://avacta.com/ via Cohesion Bureau
Strand Hanson Limited (Nominated Adviser) James Harris / Chris Raggett / James Dance	www.strandhanson.co.uk
Zeus (Broker) James Hornigold / George Duxberry / Dominic King	www.zeuscapital.co.uk
Cohesion Bureau Communications / Media / Investors Richard Jarvis	[e-mail]

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^® platform. pre|CISION^® 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^® 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^® PDCs leverage this tumor-specific release mechanism to provide unique benefits over traditional antibody drug conjugates, 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 faridoxorubicin (AVA6000), a Gen One FAP-enabled pre|CISION^® version of doxorubicin that delivers the payload directly in the tumor with limited peripheral blood exposure and has demonstrated preliminary activity in tumor types sensitive to doxorubicin including salivary gland cancer and soft tissue sarcoma. 

About FAP-Exd (AVA6103)

AVA6103 is the second clinical candidate and is the first asset in the pipeline based on the Gen Two innovative pre|CISION^® sustained 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. 

 

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