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IBIO • CIK 0001420720
1. Nature of Business iBio, Inc. (the “Company” or “iBio”) is a clinical-staged biotechnology company leveraging the power of Artificial Intelligence (“AI”) for the development of hard-to-drug precision antibodies for obesity, cardiometabolic and cardiopulmonary diseases. The core mission is to harness the potential of AI and machine learning (“ML”) to unveil novel biologics which other scientists have been unable to develop. Through the Company’s innovative AI Drug Discovery Platform, it have been able to identify differentiated molecules aimed at addressing unmet needs by current approved therapies. The Company believes the future treatment for obesity lies not just in overall weight loss, but in the quality, durability, and tolerability of weight loss. Current interventional therapies, such as glucagon-like peptide-1 (“GLP-1”) receptor agonists have ushered in a breakthrough era, yet challenges remain: muscle loss, fat regain after treatment cessation, and long-term tolerability. The Company is developing next-generation therapies being designed with the goal of meeting these unmet needs, by leveraging AI-guided antibody design, advanced screening technologies and deep expertise in biologics development. The Company’s strategy is built on multiple key principles. First, the Company aims to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with the potential to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, the Company is prioritizing targets with strong human genetic and clinical validation, which it believes both reduces translational risk and increases the likelihood of clinical success. Third, the Company is evaluating opportunities in adjacent obesity-related indications, including cardiometabolic and cardiopulmonary conditions such as pulmonary hypertension due to heart failure with preserved ejection fraction (“PH-HFpEF”). Lastly, the Company is applying its integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate and advance development-ready biologics, enabling us to move with speed and precision in a competitive and fast-evolving field. Obesity is associated with a broad range of cardiometabolic and cardiopulmonary complications, therefore, the Company is also evaluating selected adjacent indications where its AI Drug Discovery Platform and target biology may offer differentiated therapeutic opportunities. IBIO-600 is currently in clinical development, while the Company’s other product candidates are in preclinical development. The Company has not completed any clinical trials in humans for any therapeutic protein product candidate produced using our technology, and there is a risk that the Company will be unsuccessful in developing or commercializing any product candidates. Following Clinical Trial Notification (“CTN”) acknowledgement from Australia’s Therapeutic Goods Administration (“TGA”) and ethics approval from a Human Research Ethics Committee (“HREC”), the Company initiated a Phase 1 clinical trial of IBIO-600 in Australia and dosed the first participant in June 2026, marking the Company’s transition to a clinical-stage company and represented the first molecule generated using the Company’s AI Drug Discovery Platform to advance into clinical development. To date, the Phase 1 clinical trial of IBIO-600 in Australia has enrolled 31 participants in the first four cohorts. In parallel, the Company has accelerated the development of IBIO-610, a potentially first-in-class, long-acting antibody designed to inhibit Activin E, and the Company anticipates commencing first-in-human clinical trials in the first half of calendar year 2027. The Company is also advancing additional preclinical programs, including IBIO-800, a myostatin × Activin A bispecific antibody being evaluated for potential use in PH-HFpEF. The Company’s current product candidate pipeline is set forth below. Through the Company’s innovative AI Drug Discovery Platform, it champions a culture of innovation by identifying novel targets, forging strategic collaborations to enhance efficiency, diversify pipelines, with the goal of accelerating preclinical processes.…