PART I [Item 1. Business](index=4&type=section&id=Item%201.%20Business) iBio is a preclinical biotechnology company using an AI platform to develop precision antibodies for cardiometabolic and obesity diseases [Overview](index=4&type=section&id=Overview) The company leverages AI to develop novel biologics targeting unmet needs in the cardiometabolic and obesity space - iBio is a preclinical stage biotechnology company leveraging AI for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space[14](index=14&type=chunk) - The company's mission is to use AI and machine learning to discover novel biologics, specifically differentiated molecules to address unmet needs by current GLP-1 receptor agonists[14](index=14&type=chunk) - The obesity strategy focuses on developing next-generation antibody therapeutics to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability, using AI-guided antibody design and advanced screening technologies[15](index=15&type=chunk) - First human clinical trials are anticipated in **late fiscal 2026 or early fiscal 2027**[15](index=15&type=chunk) [Key Achievements in Fiscal Year 2025](index=4&type=section&id=Key%20Achievements%20in%20Fiscal%20Year%202025) The company advanced its preclinical pipeline, expanded a key collaboration, and secured significant capital through financing activities - Completed target selection for the multi-target discovery collaboration with AstralBio, focusing on genetically validated pathways in obesity and cardiometabolic disease[17](index=17&type=chunk) - Advanced IBIO-610, an Activin E antibody, to development candidate selection based on strong preclinical data in fat-specific weight loss, combination potential with GLP-1 therapies, and weight maintenance[17](index=17&type=chunk) - Advanced IBIO-600, a long-acting anti-myostatin antibody, into IND-enabling studies[17](index=17&type=chunk) - Received net proceeds of approximately **$46.5 million** from an underwritten public offering in August 2025, with potential for up to **$50 million** more from warrant exercises[18](index=18&type=chunk) - Received aggregate gross proceeds of approximately **$6.2 million** from a warrant inducement transaction in April 2025, involving the exercise of existing warrants and sale of inducement warrants[19](index=19&type=chunk) - Expanded discovery collaboration with AstralBio to include an additional (fifth) target and secured full development and commercialization rights to IBIO-600 and IBIO-610 through in-licensing from AstralBio[20](index=20&type=chunk) [Strategy](index=8&type=section&id=Strategy) The company's strategy centers on developing next-generation antibody medicines for obesity using an AI-enabled platform - The company's strategy is to develop next-generation antibody medicines for obesity and cardiometabolic complications, complementing or following GLP-1 treatment, or offering well-tolerated monotherapy alternatives[24](index=24&type=chunk)[28](index=28&type=chunk) - The strategy focuses on pursuing targets with strong human validation (genetic or pharmacologic) to reduce development risk and increase the likelihood of clinical success[28](index=28&type=chunk) - The core of the platform is an AI-enabled epitope steering engine combined with an antibody optimization platform, integrating generative AI tools with mammalian display technology, to rapidly generate development-ready biologics[25](index=25&type=chunk) [Current Pre-Clinical Product Candidate Pipeline](index=9&type=section&id=Current%20Pre-Clinical%20Product%20Candidate%20Pipeline) The company's pipeline consists of several preclinical antibody candidates targeting obesity and muscle-loss disorders Pre-Clinical Product Candidate Pipeline | Program | Potential Indications | Early Discovery | Late Discovery | Lead Optimization | IND-Enabling | Anticipated Near-Term Catalysts | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | IBIO-610 Activin-E | Obesity, PH-HFpEF | | | | | IND equivalent filing expected in 2026; Phase I expected to be initiated in 1H 2027; Pre-clinical data expected in 2026 | | Myostatin x Activin A | Obesity | | | | | IND equivalent filing expected in 2027 | | IBIO-600 Long-Acting Anti-Myostatin | Sarcopenia, Other muscle-loss disorders, Obesity | | | | | IND equivalent filing expected in 2026 | | Amylin Receptor | Obesity | | | | | Partnered with AstralBio | | Target 4 | Obesity | | | | | | - All current therapeutics are in preclinical development, with no completed human clinical trials for any therapeutic protein product candidate produced using the company's technology[29](index=29&type=chunk) [IBIO-610](index=9&type=section&id=IBIO-610) IBIO-610 is an Activin E antibody showing promise in preclinical models for weight loss and fat mass reduction - IBIO-610 is an Activin E antibody, identified using the AI Drug Discovery Platform, implicated in energy homeostasis and metabolic health, with human genetic studies supporting Activin E as a therapeutic target[31](index=31&type=chunk)[33](index=33&type=chunk) - Preclinical data in a diet-induced obesity (DIO) mouse model showed IBIO-610 monotherapy resulted in an **8.9% body weight reduction** and a **26% reduction in fat mass** with no measurable lean mass loss[34](index=34&type=chunk) - In combination with semaglutide, IBIO-610 led to a more pronounced **35.3% weight loss** (compared to 27.8% for semaglutide alone) and a greater reduction in visceral fat, suggesting complementary mechanisms[35](index=35&type=chunk) - IBIO-610 demonstrated potential as a maintenance therapy, **preventing 71% of lost weight regain** (vs 28% with IBIO-610) after semaglutide cessation in DIO mice[38](index=38&type=chunk) [Myostatin x Activin A Bispecific Antibody](index=12&type=section&id=Myostatin%20x%20Activin%20A%20Bispecific%20Antibody) This program is developing a bispecific antibody targeting myostatin and Activin A to promote muscle cell differentiation - This program is developing a bispecific antibody targeting both myostatin and Activin A, leveraging the StableHu™ platform and mammalian display for optimization[42](index=42&type=chunk) - Early in vitro findings in human muscle progenitor cells suggest the bispecific candidate induces stronger differentiation into mature muscle cells compared to targeting myostatin or Activin A alone[42](index=42&type=chunk) [IBIO-600](index=13&type=section&id=IBIO-600) IBIO-600 is a long-acting anti-myostatin antibody designed to prevent muscle loss and is advancing toward clinical development - IBIO-600 is a long-acting anti-myostatin antibody, discovered and developed in collaboration with AstralBio, optimized for affinity, FcRn binding, expression, and resistance to poly-reactivity and aggregation[44](index=44&type=chunk) - In vitro, IBIO-600 potently inhibited myostatin in human muscle progenitor cells, facilitating differentiation into mature muscle cells[45](index=45&type=chunk) - Interim preclinical data in obese mice showed IBIO-600 dose-dependently prevented lean mass loss when combined with a GLP-1 receptor agonist[45](index=45&type=chunk) - A study in obese and elderly non-human primates (NHPs) for IBIO-600 showed a **half-life of approximately 40 to 52 days**, with an estimated human half-life of 57-147 days, and promoted an increase in lean mass and reduction in fat mass[47](index=47&type=chunk)[48](index=48&type=chunk) - Chemistry, Manufacturing, and Controls (CMC) manufacturing and nonclinical toxicology activities have been initiated for IBIO-600, with no notable safety findings observed to date, supporting advancement towards clinical development for sarcopenia, muscle loss disorders, and obesity[51](index=51&type=chunk) [AI Discovery Tools](index=16&type=section&id=AI%20Discovery%20Tools) The company's proprietary AI platform integrates multiple technologies to accelerate and de-risk antibody discovery and optimization - The proprietary AI Drug Discovery Platform aims to minimize downstream development risks through AI-guided epitope-steering and monoclonal antibody (mAb) optimization[52](index=52&type=chunk) - The technology stack includes Epitope Steering (patented AI engine for precise antibody binding), StableHu (generative AI for antibody optimization), and mammalian display-based multidimensional screening[53](index=53&type=chunk) - EngageTx™ technology enables targeting bispecific molecules, demonstrating a potency range of approximately **33,000-fold** with an advanced MUC16 clone and CD3 binders[53](index=53&type=chunk) - ShieldTx™ masking technology keeps antibodies inactive until they reach diseased tissue, aiming to broaden the therapeutic window and improve efficacy and safety[53](index=53&type=chunk) [Partnered Programs](index=16&type=section&id=Partnered%20Programs) The company collaborates with AstralBio on an amylin receptor antibody program, showing promising early preclinical results - In collaboration with AstralBio, the company is developing an amylin receptor antibody, engineering agonists with tailored activity across specific amylin receptor subtypes[54](index=54&type=chunk) - Early preclinical results in DIO mice showed an early DACRA-like agonist antibody **reduced acute food intake by approximately 60%**, validating the antibody-based approach for amylin receptor targeting[55](index=55&type=chunk) [AI-Technology Platform](index=17&type=section&id=AI-Technology%20Platform) The AI platform comprises several proprietary technologies for precise epitope steering, antibody optimization, and targeted activation [AI Epitope Steering Technology](index=19&type=section&id=AI%20Epitope%20Steering%20Technology) This technology uses an AI engine to guide antibodies to specific protein regions, overcoming traditional discovery limitations - Epitope steering technology guides antibodies exclusively against desired regions of target proteins, overcoming limitations of traditional methods like dominant-epitope antibodies and low discovery rates for high-value epitopes[59](index=59&type=chunk)[60](index=60&type=chunk) - The AI engine creates engineered epitopes, optimizing designs for greater stability and water solubility, which are then used to identify antibodies from naïve or immunized libraries[60](index=60&type=chunk) - This technology has broad applicability across immuno-oncology, cardiometabolic, immunology, pain management, and vaccine development, particularly for complex and hard-to-drug protein structures[61](index=61&type=chunk) [Naïve Human Antibody Library](index=20&type=section&id=Na%C3%AFve%20Human%20Antibody%20Library) The company utilizes a curated, fully human antibody library built on clinically validated frameworks to reduce development risk - The fully human antibody library is built upon clinically validated human antibody frameworks, with diverse Complementarity-Determining Region (CDR) sequences extracted from public databases[63](index=63&type=chunk) - A meticulous curation process eliminates sequence liabilities, potentially reducing development risk for antibodies identified from the library[63](index=63&type=chunk) [StableHu AI Antibody-Optimizing Technology](index=20&type=section&id=StableHu%20AI%20Antibody-Optimizing%20Technology) StableHu is an AI-powered tool that predicts and optimizes fully human antibody variants to improve developability - StableHu is an AI-powered tool designed to predict a library of antibodies with fully human CDR variants, trained on over **1 billion human antibodies**[65](index=65&type=chunk) - It overcomes the limitations of traditional phage display (developability risks) and mammalian display (reduced diversity) by generating focused library diversity within mammalian display capacity[66](index=66&type=chunk) - Paired with mammalian display, StableHu enables antibody optimization with fewer iterative steps, lower immunogenicity risk, and improved developability[69](index=69&type=chunk) [EngageTx CD3-Based T-Cell Engager Panel](index=21&type=section&id=EngageTx%20CD3-Based%20T-Cell%20Engager%20Panel) EngageTx technology develops next-generation T-cell engagers with a wide potency range and reduced cytokine release - EngageTx addresses challenges of first-generation T-cell engagers by identifying a next-generation CD3 antibody panel with a wide range of potencies, retained T-cell activation, and significantly reduced cytokine release[70](index=70&type=chunk)[71](index=71&type=chunk) - The technology enhances humanness of predicted antibodies, reducing immunogenicity risk, and enables NHP cross-reactivity for advanced safety assessment prior to clinical trials[71](index=71&type=chunk)[73](index=73&type=chunk) [ShieldTx Antibody Masking Technology](index=22&type=section&id=ShieldTx%20Antibody%20Masking%20Technology) ShieldTx technology creates conditionally activated antibodies that are triggered only in diseased tissue to improve safety and efficacy - ShieldTx enables the creation of conditionally activated antibodies that remain inactive until reaching diseased tissue, where a mask is cleaved off, activating the antibody[75](index=75&type=chunk) - This technology aims to broaden the therapeutic window, improve efficacy and safety, enable drug combinations, and allow targeting of proteins expressed in multiple tissues without off-target effects[76](index=76&type=chunk) - The mask design process is integrated into antibody discovery via the epitope engineering engine, and multi-dimensional optimization with StableHu allows simultaneous optimization of antibody, mask, and linker[77](index=77&type=chunk)[79](index=79&type=chunk) [Programs Available for Partnering Outside the Cardiometabolic Area](index=23&type=section&id=Programs%20Available%20for%20Partnering%20Outside%20the%20Cardiometabolic%20Area) iBio offers several immuno-oncology programs for partnership, each demonstrating promising preclinical anti-tumor activity [IBIO-101](index=23&type=section&id=IBIO-101) IBIO-101 is a second-generation anti-CD25 antibody designed to selectively deplete regulatory T cells and enhance anti-tumor immunity - IBIO-101 is a second-generation anti-CD25 monoclonal antibody designed to selectively deplete immunosuppressive regulatory T cells (Tregs) while preserving interleukin-2 signaling in effector T cells (Teffs)[81](index=81&type=chunk) - Preclinical studies demonstrated selective Treg depletion, enhanced anti-tumor immune responses, tumor growth suppression as monotherapy, and synergistic benefit with anti-PD-1 checkpoint inhibition[81](index=81&type=chunk) [TROP-2 x CD3 Bispecific](index=23&type=section&id=TROP-2%20x%20CD3%20Bispecific) This bispecific antibody targets TROP-2-expressing tumors with potent killing activity and a reduced cytokine release profile - The lead TROP-2 x CD3 bispecific antibody, developed with the EngageTx platform, is designed to harness T cells to selectively kill TROP-2–expressing tumors while minimizing cytokine release[82](index=82&type=chunk) - Preclinical studies showed potent tumor cell killing with a reduced cytokine release profile and a **36% reduction in tumor size** after a single dose in a humanized mouse model of squamous cell carcinoma[82](index=82&type=chunk) [MUC16](index=25&type=section&id=MUC16) The company has generated antibodies targeting a non-shed region of MUC16 to potentially overcome tumor immune evasion - Using the patented epitope steering AI platform, antibodies were generated that bind a non-shed, non-glycosylated region of MUC16, potentially avoiding tumor immune evasion mechanisms[84](index=84&type=chunk) - Preclinical studies demonstrated selective binding to the engineered epitope and MUC16 on OVCAR-3 ovarian cancer cells, with the lead antibody retaining binding after humanization[84](index=84&type=chunk) [EGFRvIII](index=25&type=section&id=EGFRvIII) The AI platform has produced antibodies that selectively target the tumor-specific EGFRvIII variant, showing preclinical efficacy - The AI-enabled epitope steering platform generated antibodies that selectively recognize a unique epitope on EGFRvIII, a tumor-specific variant, without binding wildtype EGFR[85](index=85&type=chunk) - Preclinical studies showed strong binding to EGFRvIII, selective tumor cell killing in vitro, and a **43% reduction in tumor growth** in a mouse model of head and neck cancer[85](index=85&type=chunk) [CCR8](index=25&type=section&id=CCR8) Anti-CCR8 antibodies generated by the AI platform show potent and specific depletion of Tregs and preclinical anti-tumor activity - The AI-enabled discovery platform generated anti-CCR8 antibodies with high specificity, strong binding to CCR8-expressing cells, and potent depletion of primary human Tregs while sparing CCR4[86](index=86&type=chunk) - Preclinical studies demonstrated inhibition of tumor growth and a **22% reduction in tumor size** in a colon cancer mouse model, supporting its potential as a differentiated Treg-targeting immunotherapy[86](index=86&type=chunk) [Modalities](index=25&type=section&id=Modalities) The company's epitope steering technology has broad potential applications across multiple therapeutic areas and modalities - Epitope steering technology has potential applications across various medical areas, including immuno-oncology (targeting cancer antigens), systemic secreted and cell-surface therapeutics (heart failure, infectious diseases, rare genetic conditions), and localized regenerative therapeutics (cardiovascular diseases)[87](index=87&type=chunk)[88](index=88&type=chunk) - The technology can also impact intratumoral immuno-oncology (altering tumor microenvironment) and cancer vaccine development (increasing T-cell activity)[88](index=88&type=chunk) [Digital Infrastructure](index=27&type=section&id=Digital%20Infrastructure) iBio has invested heavily in digital technologies like AI and automation to accelerate its research and development strategy - iBio has made substantial investments in digital technologies, including robotics, automation, AI, ML, and cloud computing, to operationalize its strategy, accelerate learning, and execute at scale[89](index=89&type=chunk) - The company aims to digitize its operations to maximize its impact on human health and is committed to further investing in its digital infrastructure[89](index=89&type=chunk) [Strategic Alliances, Collaborations, and Joint Ventures](index=27&type=section&id=Strategic%20Alliances%2C%20Collaborations%2C%20and%20Joint%20Ventures) The company has engaged in key collaborations, acquisitions, and facility transactions to build its technology platform and pipeline [Several agreements with Astral Bio](index=27&type=section&id=Several%20agreements%20with%20Astral%20Bio) iBio has multiple agreements with AstralBio for antibody discovery and has in-licensed key product candidates IBIO-600 and IBIO-610 - In March 2024, iBio entered a collaboration with AstralBio to discover and develop novel antibodies for obesity and cardiometabolic diseases, granting an exclusive license to its AI-powered technology for four targets[91](index=91&type=chunk) - The collaboration was amended in April 2025 to add a fifth target, with AstralBio providing a **$750,000 credit** applied towards the option fee for the Activin E license[91](index=91&type=chunk) - In December 2024, iBio exercised its option for IBIO-600 (anti-myostatin antibody) from AstralBio, agreeing to an upfront license fee of **$750,000** (paid with 246,087 shares of common stock) and up to **$28 million** in milestone payments[92](index=92&type=chunk)[93](index=93&type=chunk) - In April 2025, iBio entered an exclusive license agreement for IBIO-610 (Activin E antibody) from AstralBio, with an upfront fee of **$750,000** (paid via credit) and up to **$28 million** in milestone payments[95](index=95&type=chunk)[96](index=96&type=chunk) [Several agreements with RubrYc Therapeutics, Inc.](index=29&type=section&id=Several%20agreements%20with%20RubrYc%20Therapeutics%2C%20Inc.) iBio acquired RubrYc's assets, including its AI Drug Discovery Platform and immuno-oncology candidates, after an initial investment - iBio entered into a collaboration and license agreement for RTX-003 immune-oncology antibodies and a collaboration, option, and license agreement for RubrYc's AI discovery platform in August 2021, both of which were terminated upon iBio's acquisition of RubrYc's assets[97](index=97&type=chunk)[98](index=98&type=chunk) - In August 2021, iBio purchased 2,864,345 shares of RubrYc's Series A-2 preferred stock for **$7,500,000**[99](index=99&type=chunk) - In September 2022, iBio acquired substantially all of RubrYc's assets, including the AI Drug Discovery Platform, IBIO-101 (RTX-003), and other immuno-oncology candidates, for an upfront payment of approximately **$1,000,000** (5,117 shares of common stock) and up to **$5,000,000** in development milestones[103](index=103&type=chunk) [Facility Purchase from Eastern Capital Limited](index=32&type=section&id=Facility%20Purchase%20from%20Eastern%20Capital%20Limited) iBio acquired full ownership of its manufacturing facility, later sold it, and settled the associated debt - In November 2021, iBio purchased its manufacturing facility and 30% equity interest in iBio CDMO LLC from Eastern Capital Limited affiliates for **$28,750,000**, making iBio CDMO wholly owned[104](index=104&type=chunk) - In May 2024, iBio CDMO sold the facility and terminated the ground lease with The Board of Regents of the Texas A&M University System for **$8,500,000**[105](index=105&type=chunk) - A settlement agreement with Woodforest National Bank in May 2024 involved paying **$8,500,000** from the facility sale proceeds and approximately **$915,000** from restricted cash, and issuing a pre-funded warrant for 1,560,570 shares of common stock to satisfy the remaining debt of approximately **$4.5 million**[106](index=106&type=chunk)[107](index=107&type=chunk) [Intellectual Property](index=34&type=section&id=Intellectual%20Property) The company's intellectual property estate includes numerous owned and pending patents covering its preclinical assets and technologies - iBio currently owns **16 patents** (11 US, 5 international) and has 23 US, 2 Patent Cooperation Treaty, and 47 international applications pending, with patents expiring between 2025 and 2040[110](index=110&type=chunk) - The intellectual property estate primarily focuses on preclinical assets, including antibodies for CD25, CCR8, EGFRvIII, MUC16, TROP-2, CD3, and high-efficiency, conditionally-activated antibodies[110](index=110&type=chunk)[113](index=113&type=chunk) - Acquired patents and patent applications from RubrYc include novel antibodies, scaffold technology, and a machine learning apparatus for engineering meso-scale peptides[111](index=111&type=chunk) [Competition](index=36&type=section&id=Competition) iBio faces intense competition from large pharmaceutical companies and other biotech firms with greater resources and more advanced pipelines - The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products[116](index=116&type=chunk) - iBio faces competition from commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and research institutions, many of which have significantly greater financial resources and expertise[117](index=117&type=chunk)[119](index=119&type=chunk) - In the obesity and cardiometabolic space, iBio competes with fully integrated pharmaceutical companies (eg, Eli Lilly, Novo Nordisk, Amgen) and more advanced biotechnology companies (eg, Keros Therapeutics, Scholar Rock), as well as tech-enabled drug discovery companies[122](index=122&type=chunk) [Research and Development](index=37&type=section&id=Research%20and%20Development) The company's R&D activities are focused on creating new products and are primarily conducted at its San Diego laboratory - iBio's research and development activities are focused on creating new products and enhancing existing offerings, primarily conducted at its San Diego R&D laboratory space[123](index=123&type=chunk) Research and Development Expenses | Fiscal Year | R&D Expenses | | :---------- | :------------- | | 2025 | $8.3 million | [Suppliers](index=38&type=section&id=Suppliers) iBio relies on third-party suppliers for certain functions and materials, facing risks related to long lead times and supply chain disruptions - iBio outsources certain functions and supplies to third parties like Lonza Sales AG and Twist Bioscience Corporation, while also building internal capabilities[124](index=124&type=chunk) - The company faces risks from long lead time items, exacerbated by increased demand in the current macro environment, and mitigates these through inventory management, relationship management, and evaluating alternative sources[124](index=124&type=chunk) [Government Regulation and Product Approval](index=38&type=section&id=Government%20Regulation%20and%20Product%20Approval) The company's products are subject to extensive and rigorous government regulation, including a multi-stage approval process [U.S. Drug Approval Process](index=38&type=section&id=U.S.%20Drug%20Approval%20Process) Product approval in the US requires rigorous preclinical testing and multi-phase clinical trials under FDA oversight - All vaccine and therapeutic products require regulatory approval by governmental agencies, including the US Food and Drug Administration (FDA), involving rigorous preclinical testing and clinical trials[125](index=125&type=chunk)[126](index=126&type=chunk) - The process includes preclinical laboratory tests and animal studies (GLP), submission of an Investigational New Drug (IND) application, human clinical trials (GCP), FDA inspection of manufacturing facilities (cGMP), and submission of a New Drug Application (NDA) or Biologics License Application (BLA)[127](index=127&type=chunk)[128](index=128&type=chunk)[131](index=131&type=chunk) [Preclinical Tests](index=40&type=section&id=Preclinical%20Tests) Preclinical testing involves laboratory evaluation of product candidate safety and efficacy to support an IND application - Preclinical testing involves in vitro and in vivo laboratory evaluation of product candidate safety and efficacy, conducted according to Good Laboratory Practices (GLP)[128](index=128&type=chunk) - Results from preclinical tests are submitted to the FDA as part of an IND application to provide a basis for evaluating safety and scientific rationale for initial human clinical trials[128](index=128&type=chunk) [IND](index=40&type=section&id=IND) An Investigational New Drug application must become effective before human clinical trials can begin and is subject to FDA holds - An IND application automatically becomes effective 30 days after FDA receipt unless concerns are raised, which must be resolved before clinical trials can proceed[129](index=129&type=chunk) - The FDA may impose clinical holds at any time during trials due to safety concerns or non-compliance, requiring authorization to recommence[129](index=129&type=chunk) [Clinical Trials](index=40&type=section&id=Clinical%20Trials) Clinical trials are conducted in three phases to evaluate the safety and efficacy of product candidates in humans - Clinical trials involve administering product candidates to volunteers or patients under qualified investigators, following Good Clinical Practices (GCPs) and approved protocols[130](index=130&type=chunk) - Trials typically proceed through three phases: Phase 1 (safety in small healthy/patient population), Phase 2 (adverse effects, preliminary efficacy, dosage in limited patients), and Phase 3 (efficacy, safety in expanded population, risk-benefit ratio)[133](index=133&type=chunk) - Regulatory agencies require extensive monitoring, auditing, and prompt reporting of adverse events; trials can be suspended or terminated by the FDA, sponsor, or IRB due to health risks or non-compliance[133](index=133&type=chunk) [Data Privacy](index=42&type=section&id=Data%20Privacy) The company is subject to numerous US and international data privacy laws, with non-compliance carrying significant financial penalties - The company's data processing activities are subject to numerous data privacy and security obligations, including federal, state, and local laws in the US (eg, HIPAA, CCPA, MHMD) and international regulations (eg, EU GDPR, UK GDPR)[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) - Non-compliance can lead to significant consequences, including statutory fines (up to **$7,500 per CCPA violation**, up to **20 million Euros or 4% of global revenue under GDPR**), private litigation, and operational disruptions[139](index=139&type=chunk)[141](index=141&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) - Cross-border data transfer laws, particularly from the EEA and UK to the US, pose challenges, with mechanisms like standard contractual clauses subject to legal challenges and increased regulatory scrutiny[143](index=143&type=chunk)[144](index=144&type=chunk)[145](index=145&type=chunk) [NDA/BLA](index=46&type=section&id=NDA%2FBLA) FDA approval of a New Drug Application or Biologics License Application is required for commercial marketing in the US - After clinical trials, FDA approval of an NDA or BLA is required for commercial marketing, involving submission of extensive product development, laboratory, animal, and human trial data, manufacturing information, and proposed labeling[151](index=151&type=chunk)[152](index=152&type=chunk) - The approval process is expensive, lengthy, and uncertain; the FDA has discretion to delay, limit, or deny approval, or impose restrictions on approved uses[152](index=152&type=chunk)[226](index=226&type=chunk)[248](index=248&type=chunk) [Post-Approval Requirements](index=48&type=section&id=Post-Approval%20Requirements) Approved products are subject to ongoing FDA regulation, including reporting, distribution, and advertising compliance - Approved products are subject to ongoing FDA regulation, including record-keeping, adverse event reporting, updated safety/efficacy information, product sampling/distribution, and compliance with promotion and advertising requirements[153](index=153&type=chunk) [Other U.S. Healthcare Laws and Compliance Requirement](index=48&type=section&id=Other%20U.S.%20Healthcare%20Laws%20and%20Compliance%20Requirement) The company is subject to various federal and state healthcare laws beyond FDA regulations, covering fraud and transparency - Activities are subject to regulation by various federal, state, and local authorities beyond the FDA, including CMS, OIG, DOJ, and state governments, covering anti-fraud, false claims, physician payment transparency, and HIPAA[154](index=154&type=chunk) [Coverage, Pricing and Reimbursement](index=48&type=section&id=Coverage%2C%20Pricing%20and%20Reimbursement) Marketability of products depends on uncertain coverage and reimbursement levels from third-party payors - Significant uncertainty exists regarding coverage and reimbursement status of product candidates by third-party payors, which can impact marketability if adequate levels are not established[155](index=155&type=chunk) [Orphan Drug Act](index=48&type=section&id=Orphan%20Drug%20Act) The Orphan Drug Act provides incentives, including market exclusivity, for developing drugs for rare diseases - The Orphan Drug Act allows FDA to grant designation for drugs treating rare diseases (<200,000 US individuals), offering benefits like PDUFA fee waivers, enhanced FDA access, and potential waiver of pediatric research requirements[156](index=156&type=chunk) - Orphan product exclusivity grants **seven years of market exclusivity** if the product receives the first FDA approval for the designated disease, with limited exceptions[157](index=157&type=chunk) [Accelerated Approval](index=50&type=section&id=Accelerated%20Approval) The FDA's accelerated approval program allows for early approval of drugs for serious conditions based on surrogate endpoints - The FDA's accelerated approval program allows early approval for drugs treating serious conditions with unmet medical needs, based on surrogate or intermediate clinical endpoints that predict clinical benefit[159](index=159&type=chunk)[160](index=160&type=chunk) - Drugs receiving accelerated approval require post-approval confirmatory trials (Phase 4) to confirm clinical benefit; failure to do so can lead to market withdrawal[161](index=161&type=chunk) [Healthcare Regulations and Healthcare Reform](index=50&type=section&id=Healthcare%20Regulations%20and%20Healthcare%20Reform) Ongoing healthcare reforms and regulatory changes create pressure on drug pricing, potentially impacting future revenues - Healthcare regulation and pricing are complex, extensive, and dynamic globally, with ongoing legislative and regulatory changes aimed at broadening healthcare availability, improving quality, and containing costs[162](index=162&type=chunk) - Future reforms are likely to increase pressure on drug pricing, potentially adversely affecting anticipated revenues and the company's financial condition and ability to develop product candidates[163](index=163&type=chunk)[164](index=164&type=chunk) [U.S. Patent-Term Extension](index=51&type=section&id=U.S.%20Patent-Term%20Extension) The Hatch-Waxman Act allows for limited patent term extensions to compensate for time lost during FDA regulatory review - The Hatch-Waxman Act permits a limited patent term extension of up to five years to compensate for patent term lost during the FDA regulatory review process, not exceeding 14 years from the product's approval date[165](index=165&type=chunk) - Only one patent applicable to an approved drug is eligible for extension, covering the approved drug, its method of use, or manufacturing method[165](index=165&type=chunk) [Rest of World Government Regulation](index=51&type=section&id=Rest%20of%20World%20Government%20Regulation) The company is subject to varying international regulations, where approval in one jurisdiction does not guarantee approval elsewhere - Beyond the US, the company is subject to varying regulations in other jurisdictions for clinical trials and commercial sales, with approval processes differing in time and requirements[166](index=166&type=chunk) - Regulatory approval in one country does not guarantee approval in another, and delays or failures in one jurisdiction can negatively impact processes in others[166](index=166&type=chunk) [Australia](index=51&type=section&id=Australia) The pharmaceutical industry in Australia is highly regulated by the Therapeutic Goods Administration (TGA) - The pharmaceutical industry in Australia is highly regulated by the Australian Therapeutic Goods Administration (TGA), which requires notification of all clinical trials via an electronic submission of a Clinical Trial Notification[169](index=169&type=chunk) [Environmental, Health, and Safety Regulation](index=53&type=section&id=Environmental%2C%20Health%2C%20and%20Safety%20Regulation) iBio is subject to numerous EHS laws, and non-compliance could result in substantial fines or operational limitations - iBio is subject to numerous federal, state, and local environmental, health, and safety (EHS) laws and regulations concerning safe working conditions, product stewardship, and handling/disposal of hazardous materials[171](index=171&type=chunk) - Compliance requires obtaining licenses or permits, and failure to comply could result in substantial fines, permit revocation, or operational limitations, though current compliance costs have not been material[171](index=171&type=chunk) [Human Capital/Employees](index=53&type=section&id=Human%20Capital%2FEmployees) The company's success depends on attracting and retaining key personnel, with competitive compensation programs in place - As of June 30, 2025, iBio had **20 full-time employees** and two strategic consultants, with no union representation or collective bargaining agreements[172](index=172&type=chunk) - The company's success relies on attracting, developing, retaining, and motivating key personnel with experience in drug discovery, R&D, manufacturing, clinical, and regulatory affairs[173](index=173&type=chunk)[174](index=174&type=chunk) - Compensation programs are designed to be competitive, align with performance, and include a 401(k) Plan with a **100% matching contribution up to 5%** of eligible employee compensation[176](index=176&type=chunk)[177](index=177&type=chunk) [Corporate Information](index=55&type=section&id=Corporate%20Information) iBio, Inc was incorporated in Delaware in 2008 and its principal executive offices are located in San Diego, California - iBio, Inc was incorporated in Delaware on April 17, 2008, and changed its name to iBio, Inc on August 10, 2009[178](index=178&type=chunk) - The principal executive offices are located at 11750 Sorrento Valley Road, Suite 200, San Diego, California 92121[179](index=179&type=chunk) [Reverse Stock Split](index=55&type=section&id=Reverse%20Stock%20Split) The company effected a one-for-twenty reverse stock split in November 2023, retroactively adjusting all share data - On November 29, 2023, iBio effected a **one-for-twenty (1:20) reverse stock split** of its Common Stock, which retroactively adjusted all share and per share amounts in the Annual Report[180](index=180&type=chunk) [Available Information](index=55&type=section&id=Available%20Information) The company's SEC filings are available free of charge on its corporate website and the SEC's website - iBio files Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other materials with the SEC, available free of charge on its website (www.ibioinc.com) and the SEC's website (www.sec.gov)[181](index=181&type=chunk)[182](index=182&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) iBio faces significant risks related to its financial position, preclinical product development, and reliance on third parties [Summary Risk Factors](index=56&type=section&id=Summary%20Risk%20Factors) Key risks include a limited operating history, ongoing losses, need for funding, and reliance on preclinical product candidates - Key risks include a limited operating history, significant and expected ongoing losses, the need for additional funding, and reliance on a limited number of preclinical product candidates[186](index=186&type=chunk)[196](index=196&type=chunk)[201](index=201&type=chunk)[213](index=213&type=chunk)[223](index=223&type=chunk) - Development and commercialization risks involve the lengthy, expensive, and uncertain nature of clinical trials, potential for undesirable side effects, and the need for regulatory approvals[186](index=186&type=chunk)[234](index=234&type=chunk)[261](index=261&type=chunk) - Dependence on third parties for intellectual property licenses, manufacturing, and clinical studies, as well as cybersecurity threats, are significant risks[188](index=188&type=chunk)[189](index=189&type=chunk)[270](index=270&type=chunk)[279](index=279&type=chunk)[338](index=338&type=chunk)[339](index=339&type=chunk) - Risks related to common stock include dilution from warrant exercises and future offerings, potential delisting from Nasdaq, and stock price volatility[193](index=193&type=chunk)[351](index=351&type=chunk)[357](index=357&type=chunk)[372](index=372&type=chunk) [Detailed Risk Factors](index=62&type=section&id=Detailed%20Risk%20Factors) The company faces detailed risks across its business, product development, third-party dependencies, IP, and operations [Risks Related to Our Business, Financial Position and Capital Requirements](index=62&type=section&id=Risks%20Related%20to%20Our%20Business%2C%20Financial%20Position%20and%20Capital%20Requirements) The company has a limited operating history, a history of significant losses, and requires additional funding to execute its plan - iBio has a limited operating history since commencing independent operations in 2008, with a recent shift in focus from CDMO services to developing vaccines and therapeutics, all of which are currently in preclinical development[196](index=196&type=chunk) - The company has incurred significant operating losses and negative cash flows since inception, with a **net loss of approximately $18.4 million in FY2025** and an **accumulated deficit of $332.2 million**, and expects to continue incurring losses[201](index=201&type=chunk) - Expenses are anticipated to increase significantly due to advancing product candidates in clinical development and expanding the workforce, with clinical trials being very expensive and time-consuming[210](index=210&type=chunk)[211](index=211&type=chunk) - Additional funding is required to fully execute the business plan, and the ability to raise capital may be limited if the public float of common stock remains below **$75.0 million**, potentially forcing delays or reductions in development programs[213](index=213&type=chunk)[216](index=216&type=chunk)[220](index=220&type=chunk) [Risks Related to the Development and Commercialization of Our Technologies and Product Candidates](index=70&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization%20of%20Our%20Technologies%20and%20Product%20Candidates) All product candidates are in early preclinical stages, facing a lengthy, expensive, and uncertain development and approval process - iBio has no products approved for commercial sale and no significant revenue from precision antibody development, with all existing product candidates in early preclinical stages requiring extensive clinical evaluation and regulatory approval[221](index=221&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk)[234](index=234&type=chunk) - The preclinical and clinical development process is lengthy, expensive, and uncertain, with high risks of delays or failures due to negative or inconclusive results, slow patient enrollment, or unforeseen safety issues[234](index=234&type=chunk)[236](index=236&type=chunk)[240](index=240&type=chunk)[243](index=243&type=chunk) - Failure to obtain required regulatory approvals or delays in the process will materially impair the ability to commercialize product candidates and generate revenue, as the process is extensive, lengthy, expensive, and inherently uncertain[248](index=248&type=chunk)[249](index=249&type=chunk)[251](index=251&type=chunk) - Alternative technologies developed by competitors, who often have greater resources, could supersede iBio's technologies or make them noncompetitive, harming future revenue generation[255](index=255&type=chunk)[256](index=256&type=chunk)[257](index=257&type=chunk) - Conducting initial clinical studies outside the United States (eg, Australia, Canada) carries risks that the FDA or other foreign regulators may not accept the data, leading to delays and additional costs[259](index=259&type=chunk)[260](index=260&type=chunk) - Product candidates may exhibit undesirable side effects, alone or in combination with other drugs, potentially delaying or precluding development, regulatory approval, or limiting market acceptance, and could lead to product liability lawsuits[261](index=261&type=chunk)[263](index=263&type=chunk)[264](index=264&type=chunk)[266](index=266&type=chunk) [Risks Related to Dependence on Third Parties](index=86&type=section&id=Risks%20Related%20to%20Dependence%20on%20Third%20Parties) The company relies on third parties for IP licenses, manufacturing, and clinical studies, posing risks of termination or non-performance - iBio's most advanced product candidates (IBIO-600, IBIO-610) depend on intellectual property licensed from third parties (AstralBio), and termination of these licenses could result in the loss of significant rights and harm the business[270](index=270&type=chunk) - The AI/ML platform leverages internal and third-party data; defects or loss of access to these databases, or increasing regulation of AI/ML, could impair target discovery and product development[272](index=272&type=chunk)[276](index=276&type=chunk) - Reliance on third-party contract manufacturers for clinical product candidates poses risks of manufacturing problems, supply delays or interruptions, and challenges in meeting regulatory compliance (cGMP)[279](index=279&type=chunk)[280](index=280&type=chunk)[283](index=283&type=chunk) - The business plan relies on establishing and maintaining collaborations, but these may not be successful, and collaborators may not perform as expected, leading to delays in funding or development[286](index=286&type=chunk)[287](index=287&type=chunk)[288](index=288&type=chunk) - Reliance on third parties for preclinical and clinical studies means iBio does not control many aspects of these activities, and their failure to perform could delay or prevent regulatory approval and commercialization[290](index=290&type=chunk)[293](index=293&type=chunk) - Reliance on third parties for raw materials and supplies, without long-term commitments, exposes the company to risks of shortages, increased costs, and disruptions from natural disasters or pandemics[295](index=295&type=chunk) [Risks Related to Intellectual Property](index=97&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Success depends on obtaining and maintaining patent protection, which is an expensive, uncertain, and time-consuming process - Success depends on obtaining and maintaining patent and other intellectual property protection, but the patent prosecution process is expensive, time-consuming, and uncertain, with **no guarantee of meaningful protection**[299](index=299&type=chunk)[301](index=301&type=chunk)[302](index=302&type=chunk)[304](index=304&type=chunk) - iBio may become involved in costly and time-consuming lawsuits to protect or enforce its patents, or face claims of infringing third-party intellectual property, which could lead to substantial liabilities or force cessation of commercialization[307](index=307&type=chunk)[310](index=310&type=chunk) - Patent terms may be inadequate to protect competitive position for a sufficient time, as patents might expire before or shortly after product commercialization[315](index=315&type=chunk) - Inability to protect trade secrets, through breaches of non-disclosure agreements or independent development by competitors, would harm the business and competitive position[316](index=316&type=chunk)[318](index=318&type=chunk) - Claims challenging inventorship of patent filings or other intellectual property, potentially from former employees or collaborators, could lead to litigation, loss of valuable rights, and distraction of management[319](index=319&type=chunk) - Intellectual property rights have limitations and may not address all threats to competitive advantage, such as competitors developing similar non-infringing products or conducting R&D in countries without patent protection[320](index=320&type=chunk) - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may offer less protection, and enforcement proceedings can be costly and divert resources[322](index=322&type=chunk) - Failure to comply with various patent laws (eg, maintenance fees) could lead to abandonment or lapse of patent rights, allowing competitors to enter the market[323](index=323&type=chunk) - Changes in patent law, such as the America Invents Act, could increase uncertainties and costs in patent prosecution and enforcement, potentially diminishing the value of existing patents[324](index=324&type=chunk)[326](index=326&type=chunk) [Risks Related to iBio's Operations](index=107&type=section&id=Risks%20Related%20to%20iBio's%20Operations) Operational risks include potential internal control weaknesses, reliance on key personnel, and cybersecurity threats - Despite past remediation, there is no assurance that additional material weaknesses in internal controls over financial reporting will not occur, potentially affecting financial reporting accuracy and investor confidence[327](index=327&type=chunk)[328](index=328&type=chunk) - The loss of executive officers or key employees, or an inability to attract and retain highly skilled personnel, particularly in the competitive San Diego biotechnology hub, could adversely affect business operations and R&D efficiency[329](index=329&type=chunk)[330](index=330&type=chunk)[331](index=331&type=chunk) - Disruptions at the San Diego laboratory due to natural disasters or other unforeseen circumstances would adversely affect business, financial condition, and R&D operations, as all preclinical research is conducted there[332](index=332&type=chunk) - Inability to effectively manage future growth, including scaling manufacturing, customer service, and administrative functions, could strain infrastructure and hinder business strategy execution[333](index=333&type=chunk)[334](index=334&type=chunk) - Failure to protect the confidentiality of partners' or collaborators' proprietary information could damage reputation and lead to legal proceedings and significant expenses[335](index=335&type=chunk) - Acquiring companies, products, or technologies may introduce integration risks and costs, diverting management attention and potentially leading to impairment charges[336](index=336&type=chunk)[337](index=337&type=chunk) - Computer system failures, including cyber-attacks, malware, and data breaches, pose significant risks to operations, data integrity, and confidential information, potentially leading to legal claims, reputational damage, and delays in product development[338](index=338&type=chunk)[339](index=339&type=chunk)[340](index=340&type=chunk) - Changes in general economic conditions, geopolitical conditions, trade policies, and inflation rates can adversely impact business and operating results, creating uncertainty and potentially increasing operating costs[342](index=342&type=chunk)[343](index=343&type=chunk)[344](index=344&type=chunk)[346](index=346&type=chunk)[347](index=347&type=chunk) - Global climate change and related regulations could negatively affect the business through increased supply chain volatility, raw material costs, and disruptions to clinical trials, potentially requiring additional investments[348](index=348&type=chunk)[349](index=349&type=chunk)[350](index=350&type=chunk) [Risks Related to Our Common Stock](index=115&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Common stock risks include substantial dilution from warrant exercises, potential delisting from Nasdaq, and price volatility - Stockholders will experience **substantial dilution** from the issuance of up to 143,080,000 shares of common stock upon the exercise of warrants from the recent underwritten public offering, and from future equity offerings or development milestone payments made in equity[351](index=351&type=chunk)[352](index=352&type=chunk)[354](index=354&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk) - Failure to comply with Nasdaq's continued listing standards, such as the Minimum Bid Price Requirement, could result in **delisting**, adversely affecting trading ability, liquidity, and the value of common stock[357](index=357&type=chunk)[358](index=358&type=chunk)[359](index=359&type=chunk) - Provisions in the certificate of incorporation, bylaws, and Delaware law could discourage takeovers that stockholders might consider favorable, by diluting voting rights or staggering board terms[360](index=360&type=chunk)[362](index=362&type=chunk)[363](index=363&type=chunk) - The Second Amended and Restated Bylaws designate the Court of Chancery of Delaware as the exclusive forum for certain disputes, potentially limiting stockholders' ability to choose a favorable judicial forum[364](index=364&type=chunk)[365](index=365&type=chunk) - The Board of Directors' authority to issue preferred stock without stockholder approval could adversely affect common stockholders' rights by granting preferred rights to assets, dividends, or redemption[366](index=366&type=chunk) - The company **does not anticipate paying cash dividends** in the foreseeable future, meaning returns to stockholders will depend solely on stock price appreciation[367](index=367&type=chunk) - Holders of warrants have no rights as common stockholders until exercise, and the value of warrants depends on market conditions and common stock price, which cannot be predicted[369](index=369&type=chunk)[370](index=370&type=chunk) - The market price of common stock has been and may continue to be **volatile**, influenced by factors like business strategy, competitive products, regulatory actions, financial results, and general economic conditions[372](index=372&type=chunk)[373](index=373&type=chunk) - Reports by securities or industry analysts, especially if projections are not met or coverage ceases, could adversely affect common stock price and trading volume[374](index=374&type=chunk) - As a 'smaller reporting company,' iBio is subject to reduced disclosure requirements, which may make its common stock less attractive to some investors and potentially lead to a less active trading market[375](index=375&type=chunk) [Item 1B. Unresolved Staff Comments](index=124&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments to report - No unresolved staff comments were reported[378](index=378&type=chunk) [Item 1C. Cybersecurity](index=124&type=section&id=Item%201C.%20Cybersecurity) iBio maintains a cyber risk management protocol aligned with the NIST Cybersecurity Framework, with oversight from the Audit Committee - iBio maintains a cyber risk management protocol designed to identify, assess, manage, mitigate, and respond to cybersecurity threats, incorporating recognized best practices and standards like the NIST Cybersecurity Framework (CSF)[379](index=379&type=chunk) - Management is responsible for oversight and administration of the protocol, with the Audit Committee providing oversight of cybersecurity risks and receiving annual briefings on vulnerabilities, program effectiveness, and emerging threats[381](index=381&type=chunk)[382](index=382&type=chunk) - The company acknowledges the prevalent risk of cyber incidents and proactively seeks to detect and investigate unauthorized attempts, but potential vulnerabilities remain, and increasing regulation could lead to additional liability and reputational harm[383](index=383&type=chunk) - To date, **iBio has not experienced a cybersecurity incident**[383](index=383&type=chunk) [Item 2. Properties](index=124&type=section&id=Item%202.%20Properties) iBio leases an 11,383 square foot R&D facility in San Diego, California, which is considered adequate for current operations - iBio leases approximately **11,383 square feet** of lab and office space at 11750 Sorrento Valley Road in San Diego, CA, with the lease commencing in September 2022 for a term of seven years and four months[384](index=384&type=chunk) - The facility is primarily used for R&D associated with its AI Drug Discovery Platform and biologic product portfolio, and the company believes it is adequate for current operations[386](index=386&type=chunk) [Item 3. Legal Proceedings](index=126&type=section&id=Item%203.%20Legal%20Proceedings) iBio is not currently involved in any material legal proceedings, though any future litigation could be costly - iBio is **not currently subject to any material legal proceedings**[387](index=387&type=chunk) - Litigation, regardless of outcome, could adversely impact the company due to defense and settlement costs, and diversion of management resources[387](index=387&type=chunk) [Item 4. Mine Safety Disclosures](index=126&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to iBio - Mine Safety Disclosures are not applicable to iBio[388](index=388&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=127&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) iBio's common stock trades on Nasdaq under "IBIO," and the company has never paid cash dividends - iBio's common stock is traded on The Nasdaq Stock Market LLC under the trading symbol "IBIO"[390](index=390&type=chunk) - As of August 20, 2025, there were **21 stockholders of record** of the company's common stock[390](index=390&type=chunk) - The company has **never declared or paid any cash dividends** on its common stock and does not plan to pay any in the foreseeable future[391](index=391&type=chunk)[367](index=367&type=chunk) - iBio did not purchase any of its equity securities during the fiscal year ended June 30, 2025[393](index=393&type=chunk) [Item 6. [Reserved]](index=127&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information - Item 6 is reserved and contains no information[393](index=393&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=127&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes iBio's financial condition and operational results, highlighting its preclinical pipeline and recent capital raises [Overview](index=127&type=section&id=Overview) iBio is a preclinical biotech using AI to develop antibodies for obesity, with its pipeline advancing toward clinical trials - iBio is a preclinical stage biotechnology company utilizing AI for precision antibody development in cardiometabolic and obesity, aiming to address limitations of current GLP-1 receptor agonists[394](index=394&type=chunk)[395](index=395&type=chunk)[396](index=396&type=chunk) - The company's pipeline includes IBIO-610 (Activin E antibody), Myostatin x Activin A Bispecific Antibody, and IBIO-600 (long-acting anti-myostatin antibody), all in preclinical development with anticipated human clinical trials in **late fiscal 2026 or early fiscal 2027**[397](index=397&type=chunk)[398](index=398&type=chunk) - Preclinical data for IBIO-610 showed fat-selective weight loss (**8.9% body weight reduction, 26% fat mass reduction**) and enhanced weight loss (**35.3%**) in combination with semaglutide in DIO mice, also preventing rebound weight gain[400](index=400&type=chunk)[401](index=401&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk) - IBIO-600 demonstrated potent myostatin inhibition in human muscle progenitor cells and prevented lean mass loss in obese mice; NHP studies showed a **half-life of 40-52 days** and increased lean mass with reduced fat mass[409](index=409&type=chunk)[410](index=410&type=chunk)[411](index=411&type=chunk)[413](index=413&type=chunk) [Recent Financial Developments](index=133&type=section&id=Recent%20Financial%20Developments) The company recently secured significant capital through an underwritten public offering, a warrant inducement, and an ATM agreement - In August 2025, iBio completed an underwritten public offering of pre-funded warrants and Series G/H warrants, receiving approximately **$46.5 million in net proceeds**, with potential for an additional **$50 million** from warrant exercises[415](index=415&type=chunk)[439](index=439&type=chunk) - In April 2025, the company entered a warrant inducement agreement, generating approximately **$6.2 million in gross proceeds** from the exercise of existing warrants at a reduced price and the sale of inducement warrants[419](index=419&type=chunk)[438](index=438&type=chunk) - Under an At Market Issuance Sales Agreement (ATM) entered in July 2024, iBio sold 3,184,899 shares in FY2025 for approximately **$2.617 million in net proceeds**, with additional sales in July 2025[436](index=436&type=chunk) - In January 2025, a private placement with officers and directors generated approximately **$655,000 in gross proceeds** from the sale of 240,807 shares of common stock[437](index=437&type=chunk) [Results of Operations](index=135&type=section&id=Results%20of%20Operations) The company's net loss improved in FY2025, driven by the absence of discontinued operations losses, despite higher R&D expenses Key Financial Results (FY2025 vs FY2024) | Metric | FY2025 (in thousands) | FY2024 (in thousands) | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue | $400 | $225 | +$175 | | Research and Development Expenses | $8,312 | $5,185 | +$3,127 | | General and Administrative Expenses | $10,690 | $11,674 | -$984 | | Total Operating Expenses | $19,002 | $16,859 | +$2,143 | | Operating Loss | $(18,602) | $(16,634) | -$(1,968) | | Other Income | $225 | $1,191 | -$966 | | Net Loss from Continuing Operations | $(18,377) | $(15,443) | -$(2,934) | | Loss from Discontinued Operations | $0 | $(9,464) | +$9,464 | | Net Loss | $(18,377) | $(24,907) | +$6,530 | | Loss per common share - basic and diluted - total | $(1.75) | $(6.50) | +$4.75 | - The **60% increase in R&D expenses** was primarily due to increased spending on consultants, outside services, and consumable supplies to advance IBIO-600, IBIO-610, and other preclinical pipeline assets[423](index=423&type=chunk) - The **8% decrease in G&A expenses** was mainly attributable to reductions in personnel-related costs, insurance premiums, depreciation, and legal fees, partially offset by increased franchise taxes and travel expenses[424](index=424&type=chunk) [Liquidity and Capital Resources](index=137&type=section&id=Liquidity%20and%20Capital%20Resources) Recent financing activities have provided sufficient capital to support operations for more than twelve months, mitigating going concern doubts - iBio incurred a **net loss of approximately $18.4 million** and **negative cash flows from operations of approximately $15.3 million** in fiscal year 2025[431](index=431&type=chunk)[442](index=442&type=chunk) Liquidity and Capital Resources (FY2025 vs FY2024) | Metric | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Total Current Assets | $9,721 | $15,672 | | Cash and Cash Equivalents | $8,582 | $14,210 | | Operating Capital Deficit | $15,300 | $18,600 | | Net Cash Used in Operating Activities | $(15,304) | $(18,554) | | Net Cash Provided by Investing Activities | $742 | $906 | | Net Cash Provided by Financing Activities | $8,929 | $24,494 | - The company's cash and cash equivalents, amounting to approximately **$52.1 million** after recent financing, are anticipated to be sufficient to support operations beyond twelve months, mitigating substantial doubt about its ability to continue as a going concern[440](index=440&type=chunk)[441](index=441&type=chunk) - Future funding plans include cash on hand, commercialization of technologies, asset sales/out-licensing, grant revenue, collaborations, and additional equity or securities sales[446](index=446&type=chunk) [Off-Balance Sheet Arrangements](index=141&type=section&id=Off-Balance%20Sheet%20Arrangements) The company does not participate in off-balance sheet arrangements or transactions with unconsolidated entities - As of June 30, 2025, iBio does not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as structured finance or special purpose entities, and was not involved in any SPE transactions[447](index=447&type=chunk) [Critical Accounting Estimates](index=141&type=section&id=Critical%20Accounting%20Estimates) Critical accounting estimates include liquidity assertions, asset valuations, and share-based compensation, involving significant judgment - Critical accounting estimates involve significant judgment and estimation uncertainty, with potential material impact on financial condition or results, including liquidity assertions, valuation of intellectual property and fixed assets, incremental borrowing rates for leases, legal contingencies, and share-based compensation[448](index=448&type=chunk)[450](index=450&type=chunk)[451](index=451&type=chunk)[576](index=576&type=chunk) - The annual impairment test for indefinite-lived intangible assets, such as the IBIO-101 therapeutic technology (carrying amount **$5 million** at June 30, 2025), uses the Multi-Period Excess Earnings Method (MPEEM) to estimate fair value[452](index=452&type=chunk)[454](index=454&type=chunk) - As of June 30, 2

[Item 2.02. Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition) The company reported preliminary unaudited financial results, including cash and cash equivalents, which are subject to final audit and adjustments [Preliminary Unaudited Financial Results](index=2&type=section&id=Preliminary%20Unaudited%20Financial%20Results) 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](index=6&type=chunk) [Item 8.01. Other Events](index=2&type=section&id=Item%208.01.%20Other%20Events) This section covers the corporate presentation, business description, preclinical pipeline, AI discovery tools, partnered programs, and updated risk factors [Corporate Presentation](index=2&type=section&id=Corporate%20Presentation) 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](index=7&type=chunk) - The presentation discusses the development of the company's obesity and cardiometabolic diseases pipeline[7](index=7&type=chunk) [Business Description](index=2&type=section&id=Business%20Description) 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](index=9&type=chunk) - 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](index=10&type=chunk) [Pre-clinical Product Candidate Pipeline](index=3&type=section&id=Pre-clinical%20Product%20Candidate%20Pipeline) 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](index=3&type=section&id=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](index=14&type=chunk) | 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](index=4&type=section&id=Myostatin%20x%20Activin%20A%20Bispecific%20Antibody) 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](index=20&type=chunk) - 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](index=20&type=chunk) [IBIO-600](index=4&type=section&id=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](index=23&type=chunk) - 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](index=24&type=chunk) | 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](index=29&type=chunk) [AI Discovery Tools](index=6&type=section&id=AI%20Discovery%20Tools) 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](index=31&type=chunk) - 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](index=31&type=chunk) [Partnered Programs](index=6&type=section&id=Partnered%20Programs) 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](index=32&type=chunk) - The program aims to optimize DACRA-like and selective amylin receptor agonist antibodies, avoiding calcitonin receptor engagement for improved selectivity, tolerability, and efficacy[32](index=32&type=chunk) [Risk Factors](index=7&type=section&id=Risk%20Factors) 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](index=7&type=section&id=Dependence%20on%20Licensed%20Intellectual%20Property) 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](index=35&type=chunk) - 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](index=35&type=chunk)[36](index=36&type=chunk) [AI/ML Platform Risks](index=7&type=section&id=AI%2FML%20Platform%20Risks) 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](index=37&type=chunk)[38](index=38&type=chunk) - 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](index=39&type=chunk)[40](index=40&type=chunk) - 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](index=41&type=chunk)[42](index=42&type=chunk) [Preclinical and Clinical Development Risks](index=9&type=section&id=Preclinical%20and%20Clinical%20Development%20Risks) 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](index=43&type=chunk) - Commencing future clinical trials is subject to regulatory approval, and authorities may disagree with trial design, requiring additional studies or imposing stricter conditions[43](index=43&type=chunk) [Competition and Technological Obsolescence](index=9&type=section&id=Competition%20and%20Technological%20Obsolescence) 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](index=44&type=chunk)[45](index=45&type=chunk) - 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](index=46&type=chunk) [Risks of Foreign Clinical Studies](index=10&type=section&id=Risks%20of%20Foreign%20Clinical%20Studies) 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](index=47&type=chunk)[48](index=48&type=chunk) - 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](index=49&type=chunk)[51](index=51&type=chunk) [Item 9.01. Financial Statements and Exhibits](index=11&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits) This section lists the financial statements and exhibits, including the corporate presentation and interactive data file [Exhibits](index=11&type=section&id=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](index=12&type=section&id=SIGNATURES) This section contains the legally required signatures for the filing

Core Insights - iBio, Inc. has reported transformative progress in its fiscal year 2025, focusing on advancing its pipeline in cardiometabolic diseases and obesity, with significant developments in antibody therapies [2][3] Financial Results - Revenues for the fiscal year ended June 30, 2025, were approximately $0.4 million, an increase of $0.2 million compared to fiscal year 2024 [8] - Research and Development (R&D) expenses increased to $8.3 million from $5.2 million in the previous year, primarily due to higher spending on consultants and outside services [9] - General and Administrative expenses decreased to approximately $10.7 million from $11.7 million, attributed to reduced personnel-related costs and lower insurance premiums [10] - The company reported a net loss of $18.4 million for the fiscal year, compared to a net loss of $24.9 million in the previous year [16] Pipeline Developments - iBio has developed a differentiated preclinical portfolio, including IBIO-610, which demonstrated a 26% reduction in fat mass without loss of lean mass in a study involving diet-induced obese mice [5] - The company is advancing IBIO-600, a long-acting anti-myostatin antibody, through pharmacokinetics studies showing extended half-life and dose-dependent muscle growth [5] - A bispecific antibody targeting myostatin and activin A is being developed to promote weight loss and muscle preservation [5] Corporate Developments - iBio began trading on the Nasdaq Stock Market under the ticker symbol "IBIO," enhancing visibility and trading liquidity [4] - The company raised $6.2 million through a warrant inducement transaction and completed a $50 million public offering, with potential total gross proceeds of up to $100 million [13] - The Board was expanded with industry veterans to strengthen leadership in capital markets and antibody development [13] Strategic Focus - The company is committed to leveraging AI and advanced computational biology to develop next-generation biopharmaceuticals for unmet medical needs in cardiometabolic diseases, obesity, and cancer [12]

Core Viewpoint - iBio, Inc. has successfully closed a public offering, raising approximately $50 million initially, with the potential for total gross proceeds of $100 million if all associated warrants are exercised for cash [1][5]. Group 1: Offering Details - The public offering was led by Balyasny Asset Management, with participation from several notable investment firms including Cormorant Asset Management and Adage Capital Partners LP [2]. - iBio issued pre-funded warrants to purchase 71,540,000 shares of common stock, along with Series G and Series H warrants, each representing the right to purchase 35,770,000 shares of common stock [3]. - The combined public offering price for one pre-funded warrant and one Series G warrant was set at $0.699 [3]. Group 2: Warrant Characteristics - The pre-funded warrants are immediately exercisable and will remain so until fully exercised, while the Series G and Series H warrants are also immediately exercisable with an exercise price of $0.70 per share [4]. - The Series G warrants will expire either 30 trading days after a significant trial initiation announcement or five years from the issuance date, whichever comes first [4]. Group 3: Use of Proceeds - iBio plans to utilize the net proceeds from the offering to advance its preclinical cardiometabolic programs, including IBIO-610 and IBIO-600, and to support other preclinical pipeline assets [5]. Group 4: Company Overview - iBio, Inc. is a biotech company focused on developing next-generation biopharmaceuticals for various diseases, leveraging AI and advanced computational biology [8].

Core Viewpoint - iBio, Inc. has announced a public offering of pre-funded warrants and accompanying Series G and Series H warrants, aiming to raise approximately $50 million to advance its preclinical programs and support working capital needs [1][3][4]. Offering Details - The offering includes pre-funded warrants for 71,540,000 shares and Series G warrants for 35,770,000 shares, with a combined public offering price of $0.699 per unit [1][3]. - The estimated gross proceeds from the offering are expected to be around $50 million before deducting underwriting discounts and commissions [3]. - The offering is expected to close on or about August 22, 2025, subject to customary closing conditions [1]. Warrant Specifications - Pre-funded warrants are immediately exercisable until fully exercised, while Series G and Series H warrants will have an exercise price of $0.70 per share [2]. - Series G warrants will expire either 30 trading days after a significant trial initiation announcement or five years from issuance [2]. Use of Proceeds - iBio plans to use the net proceeds to advance its preclinical cardiometabolic programs, including IBIO-610 and IBIO-600, and to fund working capital and other corporate purposes [4]. Underwriters - Leerink Partners is the lead bookrunner for the offering, with LifeSci Capital and Oppenheimer & Co. as bookrunning managers [5].

Core Viewpoint - iBio, Inc. has initiated an underwritten public offering of pre-funded warrants and Series G and H warrants to raise capital for advancing its preclinical cardiometabolic programs and other pipeline assets [1][2]. Group 1: Offering Details - The offering includes pre-funded warrants to purchase shares of iBio's common stock and accompanying Series G and H warrants [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. - Leerink Partners is the lead bookrunning manager, with LifeSci Capital and Oppenheimer & Co. as bookrunning managers [3]. Group 2: Use of Proceeds - iBio plans to use the net proceeds from the offering to advance its preclinical cardiometabolic programs, including IBIO-610 and IBIO-600, through key development milestones [2]. - Additional proceeds will be allocated to fund working capital requirements and other general corporate purposes [2]. Group 3: Regulatory Information - The offering is made under a shelf registration statement filed with the SEC, which became effective on August 6, 2024 [4]. - A preliminary prospectus supplement and accompanying base prospectus will be filed with the SEC and made available on their website [4].

Core Viewpoint - Impact Biomedical Inc. has received a new patent for a composition and method aimed at controlling infectious diseases, showcasing its commitment to innovative healthcare solutions [1][2][3]. Company Summary - The newly issued U.S. patent No. 12,357,584 B2 is titled "Composition and Method of Controlling Infectious Diseases with Functional Fragrances" and is part of the company's 3F™ technology platform [1][2]. - This patent expands the company's existing patent estate, which includes insect repellent and antimicrobial applications, indicating a strategic focus on addressing unmet healthcare needs [3]. - The CEO of Impact Biomedical emphasized the success of their business model in delivering proprietary technology aimed at improving human healthcare [8]. Product and Technology Summary - The patented compositions consist of plant-derived constituents and fragrances, which have demonstrated unique antimicrobial and antiviral properties [2][4]. - Potential applications of these compositions include their use as disinfectants and treatments for various infectious diseases, targeting pathogens such as E. coli, MRSA, influenza, rhinovirus, and M. tuberculosis [5][6]. - The global infectious disease market is projected to grow significantly, from $21.7 billion in 2024 to $34 billion in 2033, reflecting a compound annual growth rate (CAGR) of 5.77% [7].

Summary of iBio (IBIO) Conference Call - June 24, 2025 Company Overview - **Company**: iBio (IBIO) - **Focus**: Development of next-generation antibody medicines targeting obesity and its cardiometabolic complications [2][28] Industry Context - **Current Treatments**: First-generation GLP-1 receptor agonists and incretin-based therapies have transformed obesity treatment but have limitations, including gastrointestinal side effects and weight regain after discontinuation [3][4][6] - **Market Need**: There is a growing demand for new therapies that can provide durable weight loss, preserve muscle mass, and have better tolerability profiles [6][28] Core Programs and Developments 1. **iBio 600**: - **Type**: Long-acting anti-myostatin inhibitor - **Current Status**: In IND-enabling studies, with GLP toxicology studies about to begin [10][12] - **Mechanism**: Targets myostatin and GDF11, aiming to increase muscle mass and reduce fat mass [13][15] - **Preclinical Results**: In nonhuman primates, a single dose led to an 8% increase in muscle mass and a 12-15% reduction in fat mass [15] - **Projected Half-Life**: 74 to 130 days in humans, allowing for potential biannual dosing [14] 2. **iBio 610**: - **Type**: First-in-class Actin E antibody - **Current Status**: Development candidate selected, testing in nonhuman primates expected to yield data by Q3 2025 [11][19] - **Mechanism**: Promotes fat-specific weight loss without affecting muscle [19][21] - **Preclinical Results**: In obese rodents, led to a 9% reduction in total body weight, with a 26% reduction in fat mass [21] 3. **Amylin Receptor Program**: - **Current Status**: Advanced from early to late discovery, in vivo testing of multiple candidate molecules [23][24] - **Mechanism**: Targets amylin receptors to promote satiety and slow gastric emptying, potentially addressing obesity and cardiometabolic diseases [24][26] - **Unique Approach**: Utilizes AI-driven antibody discovery to create selective agonists for amylin receptor subtypes, avoiding calcitonin receptor activation [26][27] Competitive Advantages - **Integrated AI Platform**: iBio's discovery platform allows for rapid development of antibodies with high specificity and manufacturability [7][29] - **Focus on Developability**: The design process incorporates manufacturability and stability from the outset, ensuring that developed antibodies are ready for clinical use [8][29] - **Strategic Pipeline**: The company has a clear strategy to complement existing therapies and address unmet needs in obesity treatment [9][28] Market Positioning and Future Outlook - **Regulatory Goals**: iBio 600 aims for IND filing in Q1 2026 and patient dosing in Q2 2026 [12][13] - **Potential for Combination Therapies**: iBio's programs are designed to work alongside existing treatments, enhancing efficacy and addressing muscle preservation during weight loss [16][18][22] - **Long-Term Vision**: iBio is positioned to lead in the next wave of obesity therapeutics, focusing on genetically validated targets and innovative treatment strategies [29] Key Takeaways - iBio is addressing significant gaps in current obesity treatments with innovative antibody therapies - The company is leveraging advanced technology and a strategic approach to develop differentiated products - There is a strong emphasis on preclinical data supporting the efficacy and safety of their lead programs, with promising results in animal models [15][21][22]

iBio's Technology Platform - iBio utilizes an AI-driven technology platform for antibody discovery, enabling rapid development from idea to development candidate in approximately 7 months[7, 59] - The platform includes patented Epitope Steering technology and StableHu antibody optimization, facilitating the generation of novel IP against hard-to-drug targets[7] - iBio's StableHu antibody optimization and mammalian display screening accelerate antibody development in a cost-effective manner[9] Pipeline and Programs - iBio is developing IBIO-600, a long-acting anti-myostatin antibody, with an anticipated IND filing in Q1 2026 and Phase 1 trial initiation in Q2 2026[14, 59] - IBIO-610, a first-in-class anti-Activin E antibody, is also in development, with an anticipated IND filing by the end of 2026[14, 59] - iBio is also working on an Amylin Receptor Agonist program[14] IBIO-600 (Anti-Myostatin Antibody) - IBIO-600 is designed to preserve and increase muscle mass, complementing current weight loss treatments that can lead to muscle atrophy[17, 18, 19] - Preclinical data suggests IBIO-600 has a half-life of 52.4 days in obese NHPs at a dose of 5 mg/kg, I.V[24, 26] - Allometric scaling predicts a human half-life of 74-130 days for IBIO-600[32] - In aged, obese non-human primates, a single 5 mg/kg dose of IBIO-600 resulted in increased lean mass and decreased fat mass[33, 34, 35] IBIO-610 (Anti-Activin E Antibody) - IBIO-610 targets Activin E to drive targeted fat loss and maintain weight reduction after GLP-1 discontinuation[37] - In diet-induced obese mice, IBIO-610 induced an 8.9% body weight loss and a 26% fat loss, with no lean mass loss[43] - IBIO-610 synergizes with GLP-1 agonists, resulting in a 35.3% body weight change compared to 27.8% with Semaglutide alone in DIO mice[45]

Core Insights - iBio, Inc. announced preclinical data showing that an engineered amylin receptor agonist antibody reduced acute food intake in a mouse model of obesity by 60%, comparable to a leading amylin peptide agonist which achieved a 67% reduction [1] - The findings support the potential of antibody-based agonists to meet the increasing demand for safer, longer-acting treatments for obesity and cardiometabolic diseases [1][3] - The collaboration between iBio and AstralBio has resulted in multiple novel engineered antibody agonists targeting the amylin receptor, a promising therapeutic target for obesity [2] Company Developments - The engineered antibody's selective activation of the amylin receptor may match or exceed the efficacy of dual agonism seen with DACRA, while improving tolerability [3] - iBio's proprietary Drug Discovery Platform and advanced AI capabilities enable the discovery of innovative antibodies with exceptional selectivity and potency, targeting specific amylin receptor subtypes [3] - The company aims to develop next-generation therapies to address the limitations of current obesity treatments, leveraging its advanced technology [3] Market Context - Other amylin analogs in clinical development have shown weight loss results of up to 22.7% when combined with semaglutide and 11.8% as monotherapy, indicating a competitive landscape for obesity treatments [4] - iBio's approach may enhance weight-loss efficacy compared to GLP-1 receptor agonists and provide options for patients who are intolerant or unresponsive to existing GLP-1-based therapies [4]