LNAI News & Events

Lunai Bioworks announced the issuance of a U.S. patent titled "Methods, Systems, and Frameworks for Debiasing Data in Drug Discovery Predictions." The newly issued patent protects the foundational first step of Lunai's proprietary closed-loop disease reverse engineering platform, multimodal data standardization and structural bias removal prior to predictive modeling. Lunai's patented architecture systematically detects, standardizes, and removes structural bias across multimodal inputs before downstream artificial intelligence modeling begins. By protecting this core data layer, Lunai aims to strengthen its ability to accurately identify biologically coherent patient subtypes and trace those subtypes to the gene networks most strongly associated with each disease type.

In a letter to shareholders, CEO David Weinstein said, in part, "We have completed our AI platform in the last 12 months and now it is commercial. Negotiations are moving forward with several pharmaceutical and drug discovery companies. Partnerships and collaborations are imminent. Why? -because Lunai Bioworks operates a closed loop AI system that is truly disruptive to current discovery platforms and that turns complex biology into real-world action in several ways with less cash burn and new revenue streams. Our Augusta platform starts with real biological signals from patients - genetic, molecular, and clinical data - and uses artificial intelligence to reverse-engineer diseases into biologically defined subgroups. Instead of asking, "What drug hits this target?" Lunai asks, "What biology is actually driving this subgroup of patients?" Then comes the part most AI companies can't do. Lunai rapidly tests its predictions in living systems using high-throughput in vivo models. That means its drug ideas aren't just computer outputs - they're biologically validated early, before hundreds of millions of dollars are spent. Our approach is designed to shorten pharmaceutical companies' current drug discovery programs from over 2 years to under a year, same them substantial money, and increase the probability of success...Over the coming period, our focus is to: Advance late-stage commercial discussions across clinical data analytics, precision trial design, and biology-driven discoveries. Finalizing biodefense funding conversations and defining the roadmap for Sentinel, Pathfinder, and CounterAct. Complete a big new pharma Royalty partnership program on in-house immunotherapy technologies. We know many of you have read several Lunai announcements recently. The message we want to leave you with is simple: Lunai has established three immediately scalable revenue generating engines; AI powered drug discovery for CNS diseases and cancer and AI Bio Defense discoveries and tools, each designed for real-world impact, and each capable of creating long-term value and partnerships when implemented and executed with discipline; - our high level focus is driven by one thing only - creating value for our Shareholders. We are trying to fix one of the most expensive problems in medicine using a model that aligns perfectly with how drug development is evolving. When it executes, the gap between what it is today and what it could become is exactly how shareholder value is created."

Lunai Bioworks 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.

Lunai Bioworks completed a key commercial milestone under its NIH STTR-supported initiative, generating high-resolution, multidimensional behavioral signatures of ethanol exposure and alcohol withdrawal. Using high-throughput vertebrate screening, the company identified distinct, reproducible neurobehavioral phenotypes that are only partially addressed by currently approved therapies, highlighting previously underexplored biological mechanisms with strong translational potential. Based on these results, the company has initiated a new commercial drug discovery program targeting Alcohol Use Disorder, a condition affecting approximately 30 million individuals in the U.S. alone, with over 95% receiving no effective pharmacologic treatment. Lunai's AUD program is designed to advance differentiated, mechanism-informed therapeutic candidates toward clinical translation, while remaining strategically positioned for partnerships, licensing, and non-dilutive funding opportunities. With scalable screening infrastructure now operational, the company believes the program can rapidly progress toward candidate nomination and downstream development. The program is supported by a Small Business Technology Transfer grant from the National Institutes of Health and is being conducted in collaboration with Dr. Calum MacRae, Vice Chair, Scientific Innovation at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School.