IBIO — what changed in the latest 10-K

Text added vs the prior filing · source: 10-K · 2026-08-28

• We believe 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: …

• Our strategy is built on multiple key principles. First, we aim 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…

• Obesity is associated with a broad range of cardiometabolic and cardiopulmonary complications, therefore, we are also evaluating selected adjacent indications where our AI Drug Discovery Platform and target biology may offer differentiated therapeutic opportunities. IBIO-600 is currently in clinical…

• Following Clinical Trial Notification (“CTN”) acknowledgement from Australia’s Therapeutic Goods Administration (“TGA”) and ethics approval from a Human Research Ethics Committee (“HREC”), we initiated a Phase 1 clinical trial of IBIO-600 in Australia and dosed the first participant in June 2026, ma…

• Our discovery and development work is conducted at our San Diego research and development (“R&D”) laboratory space, where our AI and ML scientists and biopharma researchers operate side by side. This close integration of disciplines enables rapid iteration between AI-enabled design and translational…

Text removed vs the prior filing · source: 10-K · 2025-09-05

• We believe 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. We…

• Our discovery and development work is conducted at our San Diego research and development (“R&D”) laboratory space, where our AI and ML scientists and biopharma researchers operate side by side. This close integration of disciplines enables rapid iteration between in silico design and wet-lab valida…

• Progress on Obesity and Cardiometabolic Pre-Clinical Pipeline

• ●Identified all four targets for the AstralBio collaboration: Completed target selection for our multi-target discovery collaboration we entered into with AstralBio, Inc. (“AstralBio”) in April 2024, focused on genetically validated pathways in obesity and cardiometabolic disease.

• ●Advanced IBIO-610, an Activin E antibody, to development candidate selection: Achieved development candidate nomination based on strong preclinical data in fat-specific weight loss, combination potential with GLP-1 therapies and weight maintenance.

Text added vs the prior filing · source: 10-K · 2026-08-28

• oWe have a limited operating history developing precision antibody and therapeutics.

• oWe have a history of significant losses; may never achieve profitability.

• oThe results of preclinical studies and early-stage clinical trials may not be predictive of future results.

• oFinal data for our clinical trials may materially differ from preliminary results that we announce or publish.

• oDelays or difficulty in the enrollment of patients in any or all of our clinical trials could increase our development costs and delay completion of our clinical trials and associated regulatory submissions.

Text removed vs the prior filing · source: 10-K · 2025-09-05

• oWe have a limited operating history developing vaccines and therapeutics, which may limit investors’ ability to make informed decisions.

• oWe have incurred and expect to continue to incur significant losses and may never achieve or maintain profitability.

• oOur ability to raise additional capital, including through sales of shares of common stock under the ATM Program, may be limited if the public float of our common stock continues to be less than $75.0 million.

• oWe may conduct initial clinical studies outside the United States, and the FDA or other regulators may not accept data from such studies, causing delays.

• oOur clinical product candidates may exhibit undesirable side effects.

Text added vs the prior filing · source: 10-K · 2026-08-28

• We are developing next-generation antibody medicines for obesity and its cardiometabolic and cardiopulmonary complications. One of the most important advances in modern obesity treatment has been the emergence of GLP-1 receptor agonists and other incretin-based therapies. These drugs have transforme…

• Our approach to the evolving needs in obesity treatment is facilitated by our fully integrated antibody discovery platform, designed from the ground up for precision, speed and developability. At the core of our AI Drug Discovery Platform is an AI-enabled epitope steering engine enabling us to preci…

• In essence, we believe we are sculpting a future where cutting-edge AI-driven biotechnology propels the discovery of intricate biologics, fostering partnerships, accelerating innovation, and propelling the advancement of science.

• By leveraging our AI Drug Discovery Platform, we believe we have successfully identified the first antibody inhibiting Activin E. Preclinical data from multiple in vitro cell-based assays, including one on a human adipocyte cell line, demonstrated robust blockade of Activin E-mediated signaling. The…

• studies in a model of DIO in mice, both alone with bi-weekly dosing and in combination with semaglutide dosed daily. These results suggest IBIO-610 may induce fat-selective weight loss.

Text removed vs the prior filing · source: 10-K · 2025-09-05

• We are a preclinical stage biotechnology company leveraging the power of AI for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space. Our core mission is to harness the potential of AI and ML to unveil novel biologics which other scientists have been unable t…

• We believe 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. We are developing second-generation therapies to meet these unmet needs, using the power of AI-guided antibody design and advanced screening technologies. Our obesity strategy is built on three key principles. First, we are aiming to deve…

• Our current therapeutics are all in preclinical development and we have not completed any clinical trials in humans for any therapeutic protein product candidate produced using our technology and there is a risk that we will be unsuccessful in developing or commercializing any product candidates. Th…

• Activin E, like myostatin, is part of the TGF-β superfamily and has been implicated in the regulation of energy homeostasis and overall metabolic health. Human genetic studies provide compelling support for Activin E as a therapeutic target, as individuals carrying loss-of-function variants of the I…