e-therapeutics De-risks Clinical Path for GalOmic Candidate ETX-312 with Positive Non-clinical Data

ETX-312 well tolerated at exaggerated dose levels in GLP-compliant toxicology studies

GMP manufacturing of clinical trial batch successfully completed

On track for CTA submission in Q4 2025

London, UK, 10 July 2025 – e-therapeutics plc, a company integrating computational power and biological data to discover life-transforming RNAi medicines, today announced significant progress on its lead candidate, ETX-312, a GalOmic siRNA therapy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The Company has successfully de-risked the path to clinical entry for ETX-312 and remains on track to submit a clinical trial application (CTA) in Q4 2025.

ETX-312 was repeatedly administered at doses far exceeding anticipated clinical exposure in GLP-compliant toxicology and toxicokinetic studies. The candidate was well tolerated across all dose levels, with no toxicity or adverse findings observed. These non-clinical results support a broad therapeutic window for ETX-312 and strengthen confidence in the program and the GalOmic platform as it advances toward first-in-human trials.

In parallel, e-therapeutics has successfully completed GMP manufacturing of the clinical batch of ETX-312, supporting the Company’s operational readiness to progress to first-in-human dosing. Productive interactions with regulatory authorities have provided further support for our clinical strategy and plans.

“Recent results and progress on ETX-312 represent a pivotal step towards the clinical development of our first GalOmic therapeutic, designed to silence a novel target identified in-house” said Ali Mortazavi, CEO of e-therapeutics. “The tolerability profile of ETX-312 provides key de-risking for our program, supporting a Q4 2025 CTA filing. We look forward to advancing ETX-312 to first-in-human studies over the coming months and continuing to execute efficiently to offer a differentiated treatment option to MASH patients.”

About ETX-312

ETX312 is a GalOmic GalNAc-conjugated small-interfering RNA (GalNAc-siRNA) therapeutic candidate in development as a safe and effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) with potential for a quarterly subcutaneous dosing regimen. In preclinical studies using the Gubra-Amylin NASH diet-induced obese (GANDIO) mouse model, administration of ETX-312 led to dramatic reductions in NAFLD Activity Score (NAS), decreased hepatic inflammation, and slowed fibrosis progression, both as monotherapy and in synergistic combination with approved and emerging therapies. ETX-312 is currently progressing through IND-enabling studies, with a regulatory submission planned by the end of 2025.