ATH-063

Media Los Angeles, CA – March 9, 2026 – Athos Therapeutics, Inc. (“Athos”), an AI software and clinical stage biotechnology company pioneering the development of precision small molecule therapeutics for patients with immune-mediated diseases, today spotlighted the promising profile of its lead candidate ATH-063, a novel, first-in-class oral G9A methyltransferase inhibitor for the treatment of Inflammatory Bowel Disease (IBD), including ulcerative colitis. The discussion, featured in a recent DocWire News article based on insights from Allan Pantuck, MD, Co-Founder, Chairman, and Chief Medical Officer of Athos Therapeutics, underscores the transformative role of the company’s proprietary AthosOmics.AI platform in identifying and developing groundbreaking therapies. ATH-063, now in a Phase 2 clinical trial, is the Company’s drug candidate for the treatment of IBD. The compound was discovered and designed through Athos’ innovative AI-driven drug discovery and development platform, AthosOmics.AI, which begins with multi-omic analysis of thousands of patient samples (including genomics, transcriptomics, epigenomics, and microbiome data) to construct comprehensive disease networks. Rather than relying on predefined targets, the platform allows patient-derived data to “educate” the system, identifying key hubs such as G9A—a novel epigenomic enzyme not previously a focus for the treatment of IBD. AthosOmics.AI then models the 3D protein structure, computationally designs small molecule inhibitors, predicts mechanisms of action, evaluates ADME and safety profiles, and guides precision patient selection for clinical trials. “ATH-063 represents a true first-in-class advancement, with mechanisms of action that were predicted by our AthosOmics.AI platform years before entering clinical trials,” said Dimitrios Iliopoulos, PhD, MBA, Founder, President & CEO of Athos Therapeutics. “By integrating raw multi-omic and longitudinal human clinical data with autonomous AI and machine learning, we identified G9A as a critical target, designed ATH-063, and accurately predicted its dual mechanisms – suppressing inflammation through expansion and activation of potent FoxP3+ regulatory T cells while directly promoting mucosal healing via upregulation of tight junction proteins – long before validation in human studies.” Recent Phase 1 topline data, presented at the 2026 Crohn’s and Colitis Congress, demonstrated ATH-063’s favorable safety, tolerability, and pharmacokinetics in healthy volunteers across multiple dose levels, with no serious adverse events, dose-limiting toxicities, or treatment-related discontinuations. Pharmacodynamic markers confirmed target engagement, including dose-dependent G9A inhibition, increased functional regulatory T cells (with upregulated FoxP3), and reductions in key inflammatory markers such as calprotectin and oncostatin M, even in healthy subjects, providing early proof-of-principle for its anti-inflammatory, T cell, and direct healing effects. The Annual Crohn’s & Colitis Congress (https://lnkd.in/dKbTFWa) featured abstracts spanning breakthrough science, new technologies, and advancing approaches to IBD care. Athos received recognition to be chosen as only 1 of 3 abstracts to be awarded honorable distinction at the Congress (https://lnkd.in/gcFHgzHd). Athos is now advancing ATH-063 into an international multicenter Phase 2 trial in patients with moderately to severely active, biologic-refractory ulcerative colitis. The study will evaluate efficacy and safety while leveraging AthosOmics.AI for additional multi-omic analyses to further validate mechanism of action, biomarkers, and future Phase 3 clinical trial design. ATH-063 offers potential advantages as an oral therapy with a differentiated profile, addressing unmet needs in refractory patients and potentially extending to broader IBD populations. “We are excited by the recognition of ATH-063’s potential as a first-in-class, AI-generated therapy that could provide meaningful benefits, particularly for those who have progressed beyond anti-TNF agents, while offering fewer long-term risks than existing biologics,” added Dr. Pantuck. “This milestone validates the power of our AthosOmics.AI platform to accelerate the discovery and development of precision therapeutics that directly target disease biology for improved patient outcomes.” AthosOmics.AI, a no-code, agentic AI platform, automates the analysis of raw omics data and longitudinal human clinical data to deliver actionable insights rapidly and cost-effectively. Validated internally through the successful prediction and advancement of ATH-063, the platform is now available across industries for applications in drug discovery and development, agriculture, forensics, food and beverage, and more. Athos Therapeutics is an AI software and clinical stage biotechnology company pioneering precision small molecule therapeutics for immune-mediated and autoimmune diseases, including IBD. Powered by the AthosOmics.AI platform, Athos integrates multi-omic patient data, systems biology, and advanced machine learning to identify novel targets, design first-in-class drugs, and enable precision medicine approaches that accelerate development and improve outcomes for patients with high unmet needs. For more information about ATH-063, the ongoing Phase 2 trial, or AthosOmics.AI, visit https://athostx.com/ and https://athosomics.ai/. DocWire news article https://www.docwirenews.com/post/potential-of-an-ai-generated-first-in-class-agent-for-ibd. Contact: Keith Hoffman, PhD, CBO of AthosOmics.AI and Athos Therapeutics Inc. khoffman@athostx.com © Athos Therapeutics 2026.