AI-driven analysis of Phase 2 survival and progression data aims to identify high-benefit patient subgroups and optimize future registrational trial strategy

SACRAMENTO, Calif., Feb. 9, 2026 /PRNewswire/ -- Lunai Bioworks (NASDAQ:LNAI), an AI-powered drug discovery and biodefense company, today announced the launch of a new oncology collaboration with a clinical-stage partner to analyze data from a randomized Phase 2 metastatic colorectal cancer trial.

The objective is to define biologically meaningful patient subgroups that may benefit most from the investigational therapy. Under the pilot agreement, Lunai will deploy its proprietary Augusta AI platform to evaluate de-identified patient-level clinical, imaging, and longitudinal outcomes data, with a focus on overall survival and disease progression endpoints.

By integrating traditional clinical variables with AI-derived imaging features and temporal response patterns, Lunai aims to generate data-driven enrichment strategies designed aid in the FDA trial design, including optimized inclusion criteria, endpoint strategy, and its statistical powering.

"This collaboration reflects how AI can unlock hidden value in existing oncology datasets," said David Weinstein, Chief Executive Officer of Lunai Bioworks. "Our platform is built to identify which patients derive the greatest survival benefit from a drug candidate, enabling smarter development decisions and potentially accelerating the path toward approval."

The collaboration begins as a defined pilot project, with the potential to expand into a broader commercial multi-study program as supported by the data. If successful, the parties anticipate exploring additional applications across multiple tumor types, earlier-line treatment settings, and adaptive trial designs such as basket or umbrella studies.

As pharmaceutical companies increasingly seek AI-enabled patient stratification to reduce late-stage development risk, Lunai's approach positions the company at the intersection of machine learning, precision oncology, and clinical trial optimization.

Patient stratification divides trial participants into subgroups based on key characteristics like biomarkers, genetics, or disease severity. This improves trial power by reducing variability within groups, minimizing bias, and enabling detection of treatment effects in specific patient subsets who benefit most. There will be more details about this press release in the shareholder letter being sent out today.

About Lunai Bioworks

Lunai Bioworks (NASDAQ:LNAI) is an AI-powered drug discovery and biodefense company pioneering safe and responsible generative biotechnology. Leveraging advanced machine learning and proprietary phenotypic and neurotoxicity datasets, Lunai is redefining how artificial intelligence can accelerate therapeutic innovation while safeguarding society from emerging threats. For more information, visit https://lunaibioworks.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding potential clinical impact, therapeutic benefit, development timelines, partnering strategy, and commercial value. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Lunai Bioworks undertakes no obligation to update forward-looking statements, except as required by law.

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SOURCE Lunai Bioworks Inc.

Lunai Bioworks (NASDAQ: LNAI) Launches AI Oncology Pilot with Clinical-Stage Partner to Analyze Randomized Phase 2 Metastatic Colorectal Cancer Survival Trial Data