
PART I Item 1. Business iBio is a preclinical biotechnology company using an AI platform to develop precision antibodies for cardiometabolic and obesity diseases 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 space14 - 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 agonists14 - 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 technologies15 - First human clinical trials are anticipated in late fiscal 2026 or early fiscal 202715 Key Achievements in Fiscal Year 2025 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 disease17 - 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 maintenance17 - Advanced IBIO-600, a long-acting anti-myostatin antibody, into IND-enabling studies17 - 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 exercises18 - 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 warrants19 - 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 AstralBio20 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 alternatives2428 - The strategy focuses on pursuing targets with strong human validation (genetic or pharmacologic) to reduce development risk and increase the likelihood of clinical success28 - 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 biologics25 Current Pre-Clinical Product Candidate Pipeline 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 technology29 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 target3133 - 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 loss34 - 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 mechanisms35 - IBIO-610 demonstrated potential as a maintenance therapy, preventing 71% of lost weight regain (vs 28% with IBIO-610) after semaglutide cessation in DIO mice38 Myostatin x Activin A Bispecific Antibody 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 optimization42 - 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 alone42 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 aggregation44 - In vitro, IBIO-600 potently inhibited myostatin in human muscle progenitor cells, facilitating differentiation into mature muscle cells45 - Interim preclinical data in obese mice showed IBIO-600 dose-dependently prevented lean mass loss when combined with a GLP-1 receptor agonist45 - 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 mass4748 - 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 obesity51 AI Discovery Tools 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) optimization52 - The technology stack includes Epitope Steering (patented AI engine for precise antibody binding), StableHu (generative AI for antibody optimization), and mammalian display-based multidimensional screening53 - EngageTx™ technology enables targeting bispecific molecules, demonstrating a potency range of approximately 33,000-fold with an advanced MUC16 clone and CD3 binders53 - ShieldTx™ masking technology keeps antibodies inactive until they reach diseased tissue, aiming to broaden the therapeutic window and improve efficacy and safety53 Partnered Programs 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 subtypes54 - 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 targeting55 AI-Technology Platform The AI platform comprises several proprietary technologies for precise epitope steering, antibody optimization, and targeted activation AI Epitope Steering Technology 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 epitopes5960 - 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 libraries60 - This technology has broad applicability across immuno-oncology, cardiometabolic, immunology, pain management, and vaccine development, particularly for complex and hard-to-drug protein structures61 Naïve Human Antibody Library 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 databases63 - A meticulous curation process eliminates sequence liabilities, potentially reducing development risk for antibodies identified from the library63 StableHu AI Antibody-Optimizing Technology 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 antibodies65 - It overcomes the limitations of traditional phage display (developability risks) and mammalian display (reduced diversity) by generating focused library diversity within mammalian display capacity66 - Paired with mammalian display, StableHu enables antibody optimization with fewer iterative steps, lower immunogenicity risk, and improved developability69 EngageTx CD3-Based T-Cell Engager Panel 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 release7071 - The technology enhances humanness of predicted antibodies, reducing immunogenicity risk, and enables NHP cross-reactivity for advanced safety assessment prior to clinical trials7173 ShieldTx Antibody Masking Technology 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 antibody75 - 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 effects76 - 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 linker7779 Programs Available for Partnering Outside the Cardiometabolic Area iBio offers several immuno-oncology programs for partnership, each demonstrating promising preclinical anti-tumor activity 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 - Preclinical studies demonstrated selective Treg depletion, enhanced anti-tumor immune responses, tumor growth suppression as monotherapy, and synergistic benefit with anti-PD-1 checkpoint inhibition81 TROP-2 x CD3 Bispecific 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 release82 - 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 carcinoma82 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 mechanisms84 - Preclinical studies demonstrated selective binding to the engineered epitope and MUC16 on OVCAR-3 ovarian cancer cells, with the lead antibody retaining binding after humanization84 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 EGFR85 - 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 cancer85 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 CCR486 - 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 immunotherapy86 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)8788 - The technology can also impact intratumoral immuno-oncology (altering tumor microenvironment) and cancer vaccine development (increasing T-cell activity)88 Digital Infrastructure 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 scale89 - The company aims to digitize its operations to maximize its impact on human health and is committed to further investing in its digital infrastructure89 Strategic Alliances, Collaborations, and Joint Ventures The company has engaged in key collaborations, acquisitions, and facility transactions to build its technology platform and pipeline Several agreements with Astral Bio 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 targets91 - 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 license91 - 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 payments9293 - 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 payments9596 Several agreements with RubrYc Therapeutics, Inc. 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 assets9798 - In August 2021, iBio purchased 2,864,345 shares of RubrYc's Series A-2 preferred stock for $7,500,00099 - 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 milestones103 Facility Purchase from Eastern Capital Limited 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 owned104 - 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 $8,500,000105 - 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 million106107 Intellectual Property 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 2040110 - The intellectual property estate primarily focuses on preclinical assets, including antibodies for CD25, CCR8, EGFRvIII, MUC16, TROP-2, CD3, and high-efficiency, conditionally-activated antibodies110113 - Acquired patents and patent applications from RubrYc include novel antibodies, scaffold technology, and a machine learning apparatus for engineering meso-scale peptides111 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 products116 - 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 expertise117119 - 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 companies122 Research and Development 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 space123 Research and Development Expenses | Fiscal Year | R&D Expenses | | :---------- | :------------- | | 2025 | $8.3 million | 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 capabilities124 - 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 sources124 Government Regulation and Product Approval The company's products are subject to extensive and rigorous government regulation, including a multi-stage approval process U.S. Drug Approval Process 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 trials125126 - 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)127128131 Preclinical Tests 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 - 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 trials128 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 proceed129 - The FDA may impose clinical holds at any time during trials due to safety concerns or non-compliance, requiring authorization to recommence129 Clinical Trials 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 protocols130 - 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 - 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-compliance133 Data Privacy 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)138139140141 - 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 disruptions139141148149 - 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 scrutiny143144145 NDA/BLA 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 labeling151152 - The approval process is expensive, lengthy, and uncertain; the FDA has discretion to delay, limit, or deny approval, or impose restrictions on approved uses152226248 Post-Approval Requirements 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 requirements153 Other U.S. Healthcare Laws and Compliance Requirement 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 HIPAA154 Coverage, Pricing and Reimbursement 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 established155 Orphan Drug Act 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 requirements156 - Orphan product exclusivity grants seven years of market exclusivity if the product receives the first FDA approval for the designated disease, with limited exceptions157 Accelerated Approval 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 benefit159160 - Drugs receiving accelerated approval require post-approval confirmatory trials (Phase 4) to confirm clinical benefit; failure to do so can lead to market withdrawal161 Healthcare Regulations and Healthcare Reform 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 costs162 - 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 candidates163164 U.S. Patent-Term Extension 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 date165 - Only one patent applicable to an approved drug is eligible for extension, covering the approved drug, its method of use, or manufacturing method165 Rest of World Government Regulation 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 requirements166 - Regulatory approval in one country does not guarantee approval in another, and delays or failures in one jurisdiction can negatively impact processes in others166 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 Notification169 Environmental, Health, and Safety Regulation 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 materials171 - 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 material171 Human Capital/Employees 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 agreements172 - The company's success relies on attracting, developing, retaining, and motivating key personnel with experience in drug discovery, R&D, manufacturing, clinical, and regulatory affairs173174 - 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 compensation176177 Corporate Information 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, 2009178 - The principal executive offices are located at 11750 Sorrento Valley Road, Suite 200, San Diego, California 92121179 Reverse Stock Split 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 Report180 Available Information 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 Item 1A. Risk Factors iBio faces significant risks related to its financial position, preclinical product development, and reliance on third parties Summary Risk Factors 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 candidates186196201213223 - Development and commercialization risks involve the lengthy, expensive, and uncertain nature of clinical trials, potential for undesirable side effects, and the need for regulatory approvals186234261 - Dependence on third parties for intellectual property licenses, manufacturing, and clinical studies, as well as cybersecurity threats, are significant risks188189270279338339 - Risks related to common stock include dilution from warrant exercises and future offerings, potential delisting from Nasdaq, and stock price volatility193351357372 Detailed Risk Factors 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 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 development196 - 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 losses201 - 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-consuming210211 - 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 programs213216220 Risks Related to the Development and Commercialization of Our Technologies and Product Candidates 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 approval221222223234 - 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 issues234236240243 - 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 uncertain248249251 - Alternative technologies developed by competitors, who often have greater resources, could supersede iBio's technologies or make them noncompetitive, harming future revenue generation255256257 - 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 costs259260 - 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 lawsuits261263264266 Risks Related to Dependence on Third Parties 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 business270 - 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 development272276 - 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)279280283 - 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 development286287288 - 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 commercialization290293 - 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 pandemics295 Risks Related to Intellectual Property 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 protection299301302304 - 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 commercialization307310 - Patent terms may be inadequate to protect competitive position for a sufficient time, as patents might expire before or shortly after product commercialization315 - Inability to protect trade secrets, through breaches of non-disclosure agreements or independent development by competitors, would harm the business and competitive position316318 - 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 management319 - 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 protection320 - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may offer less protection, and enforcement proceedings can be costly and divert resources322 - Failure to comply with various patent laws (eg, maintenance fees) could lead to abandonment or lapse of patent rights, allowing competitors to enter the market323 - 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 patents324326 Risks Related to iBio's Operations 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 confidence327328 - 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 efficiency329330331 - 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 there332 - Inability to effectively manage future growth, including scaling manufacturing, customer service, and administrative functions, could strain infrastructure and hinder business strategy execution333334 - Failure to protect the confidentiality of partners' or collaborators' proprietary information could damage reputation and lead to legal proceedings and significant expenses335 - Acquiring companies, products, or technologies may introduce integration risks and costs, diverting management attention and potentially leading to impairment charges336337 - 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 development338339340 - 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 costs342343344346347 - 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 investments348349350 Risks Related to Our Common Stock 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 equity351352354355356 - 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 stock357358359 - 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 terms360362363 - 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 forum364365 - 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 redemption366 - The company does not anticipate paying cash dividends in the foreseeable future, meaning returns to stockholders will depend solely on stock price appreciation367 - 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 predicted369370 - 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 conditions372373 - Reports by securities or industry analysts, especially if projections are not met or coverage ceases, could adversely affect common stock price and trading volume374 - 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 market375 Item 1B. Unresolved Staff Comments There are no unresolved staff comments to report - No unresolved staff comments were reported378 Item 1C. Cybersecurity 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 - 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 threats381382 - 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 harm383 - To date, iBio has not experienced a cybersecurity incident383 Item 2. Properties 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 months384 - 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 operations386 Item 3. Legal Proceedings 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 proceedings387 - Litigation, regardless of outcome, could adversely impact the company due to defense and settlement costs, and diversion of management resources387 Item 4. Mine Safety Disclosures This item is not applicable to iBio - Mine Safety Disclosures are not applicable to iBio388 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 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 - As of August 20, 2025, there were 21 stockholders of record of the company's common stock390 - The company has never declared or paid any cash dividends on its common stock and does not plan to pay any in the foreseeable future391367 - iBio did not purchase any of its equity securities during the fiscal year ended June 30, 2025393 Item 6. [Reserved] This item is reserved and contains no information - Item 6 is reserved and contains no information393 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations This section analyzes iBio's financial condition and operational results, highlighting its preclinical pipeline and recent capital raises 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 agonists394395396 - 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 2027397398 - 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 gain400401403404 - 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 mass409410411413 Recent Financial Developments 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 exercises415439 - 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 warrants419438 - 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 2025436 - 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 stock437 Results of Operations 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 assets423 - 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 expenses424 Liquidity and Capital Resources 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 2025431442 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 concern440441 - Future funding plans include cash on hand, commercialization of technologies, asset sales/out-licensing, grant revenue, collaborations, and additional equity or securities sales446 Off-Balance Sheet Arrangements 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 transactions447 Critical Accounting Estimates 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 compensation448450451576 - 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 value452454 - As of June 30, 2