iBio(IBIO) - 2025 Q4 - Annual Results

Item 2.02. Results of Operations and Financial Condition The company reported preliminary unaudited financial results, including cash and cash equivalents, which are subject to final audit and adjustments Preliminary Unaudited Financial Results iBio, Inc. reported preliminary unaudited cash, cash equivalents, and restricted cash of $8.8 million as of June 30, 2025 | Metric | Value (as of June 30, 2025) | | :--------------------------------------- | :-------------------------- | | Cash, cash equivalents and restricted cash | $8.8 million | - The preliminary financial results are unaudited estimates based on currently available information and are subject to completion of the Company's financial closing procedures and audit[6] Item 8.01. Other Events This section covers the corporate presentation, business description, preclinical pipeline, AI discovery tools, partnered programs, and updated risk factors Corporate Presentation On August 18, 2025, iBio, Inc. published an updated corporate presentation on its website for investors and analysts, detailing its pipeline for obesity and cardiometabolic diseases - iBio, Inc. posted an updated corporate presentation on its website on August 18, 2025, for use in meetings with investors, analysts, and others[7] - The presentation discusses the development of the company's obesity and cardiometabolic diseases pipeline[7] Business Description iBio, Inc. is a preclinical stage biotechnology company leveraging Artificial Intelligence (AI) and Machine Learning (ML) to develop precision antibodies for cardiometabolic and obesity diseases - iBio is a preclinical stage biotechnology company leveraging AI and ML for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space[9] - The company's strategy focuses on developing next-generation antibody therapeutics to address limitations of current approved GLP-1 treatments, aiming to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability[10] Pre-clinical Product Candidate Pipeline iBio's preclinical pipeline includes IBIO-610, a Myostatin x Activin A Bispecific Antibody, and IBIO-600, designed to address unmet needs in obesity and cardiometabolic diseases IBIO-610 IBIO-610, an Activin E inhibiting antibody, demonstrated promising preclinical results in diet-induced obese (DIO) mice, reducing body weight and fat mass - IBIO-610 is the first antibody inhibiting Activin E, identified by leveraging iBio's AI Drug Discovery Platform[14] | Study | Treatment | Body Weight Reduction | Fat Mass Reduction | Lean Mass Loss | | :------------------------------------ | :-------------------------------------------- | :-------------------- | :----------------- | :------------- | | DIO mouse model (monotherapy) | IBIO-610 (10 mg/kg biweekly for 4 weeks) | 8.9% (vs. baseline & placebo) | 26% | No measurable | | DIO mouse model (combination therapy) | IBIO-610 (biweekly) + Semaglutide (daily) | 35.3% (vs. baseline & placebo) | Greater reduction in visceral fat vs. semaglutide alone | N/A | | DIO mouse model (maintenance therapy) | IBIO-610 after semaglutide discontinuation | Regained only 28% of lost weight (vs. 71% for control) | Significantly lower fat mass | N/A | Myostatin x Activin A Bispecific Antibody This late-discovery program focuses on a bispecific antibody targeting myostatin and Activin A, showing enhanced muscle cell differentiation in vitro - The program is in late discovery, developing a bispecific antibody targeting both myostatin and Activin A, leveraging the StableHu™ platform and mammalian display[20] - Early in vitro findings suggest the bispecific candidate induces stronger differentiation of human muscle progenitor cells into mature muscle cells compared to single-target antibodies[20] IBIO-600 IBIO-600 is a long-acting anti-myostatin antibody, developed with AstralBio, showing promising preclinical results in preventing lean mass loss and promoting lean mass increase - IBIO-600 is a long-acting anti-myostatin antibody, developed in collaboration with AstralBio, optimized using the StableHu platform for affinity, binding, expression, and stability[23] - In vitro, IBIO-600 potently inhibited myostatin in human muscle progenitor cells, facilitating differentiation; in obese mice, it dose-dependently prevented lean mass loss when combined with a GLP-1 receptor agonist[24] | Metric | NHP Study Results (Single S.C. injection) | Estimated Human Half-life | | :---------------- | :---------------------------------------- | :------------------------ | | Half-life | Approximately 40-52 days | 57-147 days | | Body Composition | Promoted increase in lean mass, reduction in fat mass | N/A | - IBIO-600 is progressing towards clinical development, with CMC manufacturing and nonclinical toxicology studies underway, showing no notable safety findings to date[29] AI Discovery Tools iBio's AI Drug Discovery Platform integrates Epitope Steering, StableHu, and mammalian display-based screening to develop first-in-class and best-in-class biologics - The AI Drug Discovery Platform combines Epitope Steering (patented AI engine), StableHu (generative AI tool), and mammalian display-based multidimensional screening[31] - Key technologies include EngageTx for targeting bispecific molecules (demonstrating a 33,000-fold potency range) and ShieldTx™ masking technology to activate antibodies only in diseased tissue, aiming to broaden the therapeutic window[31] Partnered Programs In collaboration with AstralBio, iBio is developing an amylin receptor agonist engineered antibody for obesity treatment, focusing on enhanced tolerability and efficacy - iBio is collaborating with AstralBio to develop an amylin receptor antibody, a potentially promising mechanism in obesity treatment[32] - The program aims to optimize DACRA-like and selective amylin receptor agonist antibodies, avoiding calcitonin receptor engagement for improved selectivity, tolerability, and efficacy[32] Risk Factors The Company updated its risk factors, highlighting significant dependencies on third-party intellectual property licenses, potential issues with its AI/ML platform, and the lengthy nature of preclinical and clinical development Dependence on Licensed Intellectual Property iBio's most advanced product candidates, IBIO-600 and IBIO-610, rely on exclusive licenses from AstralBio, whose termination could severely harm the company's development capabilities - iBio's most advanced product candidates, IBIO-600 and IBIO-610, depend on intellectual property licensed under exclusive agreements (AstralBio Licenses) from third parties[35] - Termination of these licenses or failure to comply with obligations could result in the loss of significant rights, adversely affecting the company's business, results of operations, and financial condition[35][36] AI/ML Platform Risks The AI/ML platform faces risks from data loss, errors, reliance on third-party hosting, increasing regulation, and potential reputational harm, which could impair its effectiveness and delay product development - The AI/ML platform leverages internal and third-party data; defects, errors, or loss of access to these databases may impair the ability to discover targets and develop product candidates[37][38] - The development and use of AI/ML present privacy and security risks, subject to increasing regulation and scrutiny, which could lead to fines, require business practice changes, or limit AI/ML use[39][40] - Substantial investments in AI technologies may be more expensive than anticipated, and if the platform fails to function reliably or meets expectations, it could impair competitiveness and lead to reputational harm[41][42] Preclinical and Clinical Development Risks All product candidates are in preclinical development, facing a lengthy, expensive, and uncertain process with no guarantee of regulatory approval or successful commercialization - All product candidates are in preclinical development, and the process is lengthy, expensive, and has an uncertain outcome, with a high risk of not reaching commercialization[43] - Commencing future clinical trials is subject to regulatory approval, and authorities may disagree with trial design, requiring additional studies or imposing stricter conditions[43] Competition and Technological Obsolescence The field of precision antibodies and AI drug discovery is intensely competitive, with rapid technological progress and well-resourced competitors posing risks to iBio's market position - The manufacture of precision antibodies and use of AI is intensely competitive, with rapid technological progress that can render existing technologies obsolete or noncompetitive[44][45] - iBio competes with fully integrated pharmaceutical companies (e.g., Eli Lilly, Novo Nordisk, Amgen) and established biotechnology/tech-enabled drug discovery companies with substantially greater resources and experience[46] Risks of Foreign Clinical Studies Conducting initial clinical studies outside the United States carries risks, including non-acceptance of data by regulatory authorities and exposure to foreign regulatory and economic challenges - Conducting initial clinical studies outside the U.S. (e.g., Australia, Canada) risks non-acceptance of data by the FDA or applicable foreign authorities, potentially requiring additional studies and delaying development plans[47][48] - Additional risks of foreign clinical studies include foreign regulatory requirements, exchange fluctuations, compliance with manufacturing/customs, cultural differences in medical practice, and diminished protection of intellectual property[49][51] Item 9.01. Financial Statements and Exhibits This section lists the financial statements and exhibits, including the corporate presentation and interactive data file Exhibits The report includes Exhibit 99.1, the Corporate Presentation of iBio, Inc. dated August 2025, and Exhibit 104, the Cover Page Interactive Data File | Exhibit No. | Description | | :---------- | :-------------------------------------------------- | | 99.1 | Corporate Presentation of iBio, Inc., dated August 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | SIGNATURES This section contains the legally required signatures for the filing