1.    Nature of Business

iBio, Inc. (the “Company” or “iBio”) is a preclinical stage biotechnology company leveraging the power of Artificial Intelligence (“AI”) for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space. The Company’s 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 has been able to identify differentiated molecules aimed to address unmet needs by current GLP-1 receptor agonists.

The Company believes the future of obesity care lies not just in weight loss—but in quality weight loss. Current interventional therapies such as 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 second-generation therapies to meet these unmet needs, using the power of AI-guided antibody design and advanced screening technologies. iBio’s obesity strategy is built on three key principles. First, the Company is aiming to develop next-generation antibody therapeutics addressing limitations of current approved treatments, offering options with a goal to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, the Company is focusing on targets with strong human validation, which it believes both helps reduce development risk and increase the likelihood of clinical success. Lastly, the Company is applying its integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate development-ready biologics, enabling it to move with speed and precision in a competitive and fast-evolving field. The Company’s current therapeutics are all in preclinical development and it has not completed any clinical trials in humans for any therapeutic protein product candidate produced using its technology and there is a risk that the Company will be unsuccessful in developing or commercializing any product candidates. The Company anticipates the commencement of its first human clinical trials in late fiscal 2026 or early fiscal 2027. As the Company continues to leverage its technology stack and develop its existing immune-oncology pre-clinical pipeline, it is also seeking strategic partners with the capabilities to more rapidly advance these programs towards the clinic.

The Company’s current pre-clinical 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. The Company’s proprietary technology stack is designed to minimize downstream development risks by employing AI-guided epitope-steering and monoclonal antibody (“mAb”) optimization.

​

The Company’s proprietary technology stack combines Epitope Steering, its patented AI engine that directs antibody binding to precisely defined regions of target proteins, increasing selectivity and therapeutic impact; StableHu, a generative AI tool that rapidly optimizes antibodies for expression, stability, and manufacturability; and mammalian display-based multidimensional screening, enabling simultaneous optimization of affinity, specificity, and half-life in a single selection step. Together, these tools power a fully integrated platform that allows the Company to go from concept to in vivo proof-of-concept within weeks, accelerating the development of first-in-class and best-in-class biologics. The Company’s EngageTx technology enables it to target bi-specific molecules. Data from a number of in vitro tumor cell-killing assays suggests that the Company’s most advanced MUC16 clone, when combined with eight distinct CD3 binders using our EngageTx technology, revealed a potency range of approximately 33,000-fold. With the ability to navigate sequence diversity and promote Human-Cyno cross reactivity while mitigating cytokine release, the goal is to enhance agility and bolster preclinical safety assessments. Another key technology of the Company’s technology stack is its ShieldTx masking technology, which keeps antibodies inactive until they reach diseased tissue. At that point, the masks are removed and the antibodies become active, all with the goal of broadening the therapeutic window and potentially improving both efficacy and safety.

iBio’s discovery and development work is conducted at the Company’s San Diego research and development laboratory space, where its AI and machine learning (ML) scientists and biopharma researchers operate side by side. This close integration of disciplines enables rapid iteration between in silico design and wet-lab validation, compressing the timeline from hypothesis to lead selection. With the Company’s robust platform, focused pre-clinical pipeline, and growing scientific and leadership team, it is building a durable and differentiated position in obesity therapeutics—one designed to outlast the first wave and define what comes next.

Digital Infrastructure

iBio is a firm believer in the transformative power of digital technologies, including robotics, automation, AI, ML, and cloud computing. These technologies are integral to operationalizing the Company’s strategy, accelerating its learning curve, and executing at scale. As such, the Company has made substantial investments in these areas. iBio’s aspiration is to digitize its operations to the greatest extent possible, harnessing the potential of digital technology to maximize its impact on human health. As the Company continues to grow, it remains committed to further investing in its digital infrastructure to support its ambitious goals.

​

Strategic Alliances, Collaborations, and Joint Ventures

The Company has formed collaborations and strategic alliances to gain access to funding, capabilities, technical resources and intellectual property to further its development efforts, commercialize its technology and to generate revenues, including through the use of its patented epitope-steering AI-engine and our EngageTx platform.