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What changed in iBio, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of iBio, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+520 added−498 removedSource: 10-K (2025-09-05) vs 10-K (2024-09-20)

Top changes in iBio, Inc.'s 2025 10-K

520 paragraphs added · 498 removed · 242 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

98 edited+123 added−117 removed91 unchanged
Biggest changeAccordingly, per the amendment, on the earlier of (a) the closing of the sale of the Property, or (b) the Maturity Date, iBio CDMO would pay Woodforest a fee in the amount of $155,000. ​ On March 28, 2024, iBio CDMO and Woodforest entered into the Ninth Amendment (the “Ninth Amendment”) to the Credit Agreement, which amended the Credit Agreement to: (i) set the Maturity Date of the term loan to the earlier of (a) May 15, 2024, or (b) the acceleration of maturity of the term loan in in accordance with the Credit Agreement. ​ On May 14, 2024, iBio CDMO and Woodforest entered into the tenth amendment to the Credit Agreement, which amended the Credit Agreement to: (i) set the Maturity Date to the earlier of (a) May 31, 2024, or (b) the acceleration of maturity of the term loan in accordance with the Credit Agreement. ​ On May 31, 2024, pursuant to that certain Purchase and Sale Agreement, dated as of May 17, 2024 (the “Purchase and Sale Agreement”), by and between iBio CDMO and The Board of Regents of the Texas A&M University System (“The Board of Regents”), iBio CDMO terminated its Ground Lease Agreement with The Board of Regents, dated March 8, 2010, as amended by an Estoppel Certificate and Amendment to Ground Lease Agreement, dated as of December 22, 2015 (collectively, the “Ground Lease”), related to 21.401 acres in Brazos County, Texas (the “Land”) and completed the sale to The Board of Regents of: (i) the buildings, parking areas, improvements, and fixtures situated on the Land (the “Improvements”); (iii) all iBio CDMO’s right, title, and interest in and to furniture, personal property, machinery, apparatus, and equipment owned and currently used in the operation, repair and maintenance of the Land and Improvements and situated thereon (collectively, the “Personal Property”); (iii) all iBio CDMO’s rights under the contracts and agreements relating to the operation or maintenance of the Land, Improvements or Personal Property which extend beyond the closing date (the “Contracts”); and (iv) all iBio CDMO’s rights in intangible assets of any nature relating to any or all of the Land, the Improvements and the Personal Property (the “Intangibles”; and together with the Ground Lease, Improvements and Personal Property, collectively, the “Property”).
Biggest change(Refer to the Company’s June 30, 2024 Annual Report for more information.) On May 17, 2024, iBio CDMO entered into a purchase and sale agreement (the “2024 Purchase and Sale Agreement”) with The Board of Regents of the Texas A&M University System (“The Board of Regents”) pursuant to which iBio CDMO agreed to terminate the Ground Lease Agreement with The Board of Regents, dated March 8, 2010, as amended by an Estoppel Certificate and Amendment to Ground Lease Agreement, dated as of December 22, 2015 (together with the Ground Lease Agreement, the “Ground Lease”), related to 21.401 acres in Brazos County, Texas (the “Land”) and complete the sale to The Board of Regents of: (i) the buildings, parking areas, improvements, and fixtures situated on the Land (the “Improvements”); (ii) all iBio CDMO’s right, title, and interest in and to furniture, personal property, machinery, apparatus, and equipment owned and currently used in the operation, repair and maintenance of the Land and Improvements and situated thereon (collectively, the “Personal Property”); (iii) all iBio CDMO’s rights under the contracts and agreements relating to the operation or maintenance of the Land, Improvements or Personal Property which extend beyond the closing date (the “Contracts”); and (iv) all iBio CDMO’s rights in intangible assets of any nature relating to any or all of the Land, the Improvements and the Personal Property (the “Intangibles”; and together with the Ground Lease, Improvements and Personal Property, collectively, the “Property”).
We also acquired the approximate 30% equity interest (after conversion) in iBio CDMO LLC (“iBio CDMO”) held by the Eastern Affiliates, who became the lessee under the ground lease agreement with the Board of Regents of the Texas A&M University System (the “Ground Lease Agreement”) for the land upon which the Facility is located and terminated the Sublease iBio had entered into with the Eastern Affiliates.
We also acquired the approximate 30% equity interest (after conversion) in iBio CDMO LLC (“iBio CDMO”) held by the Eastern Affiliates, who became the lessee under the ground lease agreement with the Board of Regents of the Texas A&M University System (the “Ground Lease Agreement”) for the land upon which the Facility is located and terminated the Sublease we had entered into with the Eastern Affiliates.
Post-Approval Requirements: o Any products for which we receive FDA approvals will be subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses, known as ‘off-label’ use, limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.
Post-Approval Requirements Any products for which we receive FDA approvals will be subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses, known as ‘off-label’ use, limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.
(the “Amended RubrYc COI”), and include a preferential eight percent (8%) dividend, senior rights on liquidation, the right to elect a Series A-2 Preferred director for as long as we hold at least 1,500,000 shares of RubrYc stock, the right to vote on an as-converted basis, certain anti-dilution and other protective provisions, the right to convert the Series A-2 Preferred into shares of RubrYc common stock at our option, and mandatory conversion of the Series A-2 Preferred into shares of RubrYc common stock upon (a) the closing of a firm-commitment underwritten public offering to the public pursuant to an effective registration statement under the Securities Act of 1933, as amended, for shares of RubrYc common stock at a per share price of at least five (5) times the Series A-2 Original Issue Price (as defined in the Amended RubrYc COI) and resulting in at least $30,000,000 of gross proceeds to RubrYc or (b) such other date, time or event, specified by vote or written consent of the majority of the aggregate voting power, on an as-converted basis, of the RubrYc Series A preferred stock (“Series A Preferred” and together with the Series A-2 Preferred, the “Senior Preferred Stock”) and Series A-2 Preferred.
(the “Amended RubrYc COI”), and include a preferential eight percent (8%) dividend, senior rights on liquidation, the right to elect a Series A-2 Preferred director for as long as we held at least 1,500,000 shares of RubrYc stock, the right to vote on an as-converted basis, certain anti-dilution and other protective provisions, the right to convert the Series A-2 Preferred into shares of RubrYc common stock at our option, and mandatory conversion of the Series A-2 Preferred into shares of RubrYc common stock upon (a) the closing of a firm-commitment underwritten public offering to the public pursuant to an effective registration statement under the Securities Act of 1933, as amended, for shares of RubrYc common stock at a per share price of at least five (5) times the Series A-2 Original Issue Price (as defined in the Amended RubrYc COI) and resulting in at least $30,000,000 of gross proceeds to RubrYc or (b) such other date, time or event, specified by vote or written consent of the majority of the aggregate voting power, on an as-converted basis, of the RubrYc Series A preferred stock (“Series A Preferred” and together with the Series A-2 Preferred, the “Senior Preferred Stock”) and Series A-2 Preferred.
As a result of the reverse stock split, every twenty (20) shares of the Company's common stock either issued and outstanding or held by us in our treasury immediately prior to the effective time was, automatically and without any action on the part of the respective holders thereof, combined and converted into one (1) share of our common stock.
As a result of the reverse stock split, every twenty (20) shares of our Common Stock either issued and outstanding or held by us in our treasury immediately prior to the effective time was, automatically and without any action on the part of the respective holders thereof, combined and converted into one (1) share of our Common Stock.
Once commercialized, we could be liable to ensure full compliance with the law. Coverage, Pricing and Reimbursement o Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. This is dictated by third-party payors’ coverage and establish adequate reimbursement levels for such products.
Once commercialized, we could be liable to ensure full compliance with the law. Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. This is dictated by third-party payors’ coverage and establish adequate reimbursement levels for such products.
Other U.S. Healthcare Laws and Compliance Requirement : o In the United States, our activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare & Medicaid Services, or CMS, other divisions of the U.S.
Other U.S. Healthcare Laws and Compliance Requirement : In the United States, our activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare & Medicaid Services, or CMS, other divisions of the U.S.
By focusing on these specific regions, we believe we can overcome the limitations of traditional methods and significantly improve the efficiency and effectiveness of our antibody discovery process. iBio’s AI engine creates engineered epitopes, which are small embodiments of epitopes on the target protein.
By focusing on these specific regions, we believe we can overcome the limitations of traditional methods and significantly improve the efficiency and effectiveness of our antibody discovery process. Our AI engine creates engineered epitopes, which are small embodiments of epitopes on the target protein.
Specifically: ● we provide employee wages that are competitive and consistent with employee positions, skill levels, experience, knowledge and geographic location; ● we engage nationally recognized outside compensation and benefits consulting firms to independently evaluate the effectiveness of our executive compensation and benefit programs and to provide benchmarking against our peers within the industry; ● we align our executives’ long-term equity compensation with our shareholders’ interests by linking realizable pay with stock performance; ● annual increases and incentive compensation are based on merit, which is communicated to employees at the time of hiring and documented through our talent management process as part of our annual review procedures and upon internal transfer and/or promotion; and ● commencing January 1, 2018, we established the iBio, Inc. 401(k) Plan.
Specifically: ● we provide employee wages that are competitive and consistent with employee positions, skill levels, experience, knowledge and geographic location; ● we engage nationally recognized outside compensation and benefits consulting firms to independently evaluate the effectiveness of our executive compensation and benefit programs and to provide benchmarking against our peers within the industry; ● we align our executives’ long-term equity compensation with our shareholders’ interests by linking realizable pay with stock performance; ● annual increases and incentive compensation are based on merit, which is communicated to employees at the time of hiring and documented through our talent management process as part of our annual review procedures and upon internal transfer and/or promotion; and 32 Table of Contents ● commencing January 1, 2018, we established the iBio, Inc. 401(k) Plan.
Clinical Trails Clinical trials involve the administration of the product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control.
Clinical Trials Clinical trials involve the administration of the product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control.
The process required by the FDA before a drug or biological product may be marketed in the United States generally involves the following: ● completion of pre-clinical laboratory tests and animal studies according to good laboratory practices (“GLP”) and applicable requirements for the humane use of laboratory animals or other applicable regulations; ● submission to the FDA of an Investigational New Drug (“IND”) application which must become effective before human clinical trials may begin; ● performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices (“GCPs”) and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use; ● submission to the FDA of a New Drug Application (“NDA”) or Biologics License Application (“BLA”) for marketing approval that meets applicable requirements to ensure the continued safety, purity, and potency of the product that is the subject of the NDA or BLA based on results of pre-clinical testing and clinical trials; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the product candidates are produced, to assess compliance with cGMP, to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; ● potential FDA audit of the pre-clinical trial and clinical trial sites that generated the data in support of the NDA or BLA; and ● FDA review and approval of the NDA or licensure of the BLA.
The process required by the FDA before a drug or biological product may be marketed in the United States generally involves the following: ● completion of pre-clinical laboratory tests and animal studies according to good laboratory practices (“GLP”) and applicable requirements for the humane use of laboratory animals or other applicable regulations; ● submission to the FDA of an IND” application which must become effective before human clinical trials may begin; ● performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices (“GCPs”) and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use; ● submission to the FDA of a New Drug Application (“NDA”) or Biologics License Application (“BLA”) for marketing approval that meets applicable requirements to ensure the continued safety, purity, and potency of the product that is the subject of the NDA or BLA based on results of pre-clinical testing and clinical trials; 24 Table of Contents ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the product candidates are produced, to assess compliance with cGMP, to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; ● potential FDA audit of the pre-clinical trial and clinical trial sites that generated the data in support of the NDA or BLA; and ● FDA review and approval of the NDA or licensure of the BLA.
Pursuing specific epitopes that elicit a specific biological function allows iBio to create antibodies with complex modes of action, like agonistic or cell activating antibodies. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies.
Pursuing specific epitopes that elicit a specific biological function allows us to create antibodies with complex modes of action, like agonistic or cell activating antibodies. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies.
During the term of the RTX-003 License Agreement, RubrYc granted us an exclusive worldwide sublicensable royalty-bearing license under the patents controlled by RubrYc that cover the RTX-003 antibodies. The RTX-003 License Agreement was terminated when the Company acquired substantially all of the assets of RubrYc in September 2022, including RubrYc’s immune-oncology antibodies in its RTX-003 campaign.
During the term of the RTX-003 License Agreement, RubrYc granted us an exclusive worldwide sublicensable royalty-bearing license under the patents controlled by RubrYc that cover the RTX-003 antibodies. The RTX-003 License Agreement was terminated when we acquired substantially all of the assets of RubrYc in September 2022, including RubrYc’s immune-oncology antibodies in its RTX-003 campaign.
With the exception of any obligations that survive the termination, the Collaboration, Option and License Agreement was terminated when the Company acquired substantially all of the assets of RubrYc in September 2022. ​ 24 Table of Contents Stock Purchase Agreement: In connection with the entry into the Collaboration Agreement and RTX-003 License Agreement, iBio also entered into a Stock Purchase Agreement (“Stock Purchase Agreement”) with RubrYc whereby we purchased 1,909,563 shares of RubrYc’s Series A-2 preferred stock “Series A-2 Preferred”) for $5,000,000 and acquired an additional 954,782 shares of RubrYc’s Series A-2 Preferred.
With the exception of any obligations that survive the termination, the Collaboration, Option and License Agreement was terminated when we acquired substantially all of the assets of RubrYc in September 2022. ​ 18 Table of Contents Stock Purchase Agreement: In connection with the entry into the Collaboration Agreement and RTX-003 License Agreement, iBio also entered into a Stock Purchase Agreement (“Stock Purchase Agreement”) with RubrYc whereby we purchased 1,909,563 shares of RubrYc’s Series A-2 preferred stock “Series A-2 Preferred”) for $5,000,000 and acquired an additional 954,782 shares of RubrYc’s Series A-2 Preferred.
This platform comprises four key components, each playing a crucial role in the discovery and optimization of precision antibodies. The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy.
This platform comprises four key layers, each playing a crucial role in the discovery and optimization of precision antibodies. The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy.
Pursuant to the Voting Agreement, certain RubrYc stockholders are contractually obligated to, among other things, vote for and maintain the authorized number of directors at five members, one of which the Company has the contractual right to elect subject to the conditions set forth above. ​ Asset Purchase Agreement: On September 19, 2022, iBio purchased substantially all of the assets of RubrYc, including the AI Drug Discovery Platform, RTX-003 (IBIO-101), all Selected Compounds, three additional immune-oncology candidates, a PD-1 agonist, in addition to lab and technology equipment pursuant to an asset purchase agreement, dated September 16, 2022 (the “Asset Purchase Agreement”).
Pursuant to the Voting Agreement, certain RubrYc stockholders are contractually obligated to, among other things, vote for and maintain the authorized number of directors at five members, one of which we have the contractual right to elect subject to the conditions set forth above. ​ Asset Purchase Agreement: On September 19, 2022, we purchased substantially all of the assets of RubrYc, including the AI Drug Discovery Platform, RTX-003 (IBIO-101), all Selected Compounds, three additional immune-oncology candidates, a PD-1 agonist, in addition to lab and technology equipment pursuant to an asset purchase agreement, dated September 16, 2022 (the “Asset Purchase Agreement”).
These scaffolds are crucial for maintaining the structure of the epitope during the antibody discovery process, and their scarcity can further complicate the discovery of effective antibodies. iBio’s Epitope steering technology is designed to address these issues by guiding antibodies exclusively against the desired regions of the target protein.
These scaffolds are crucial for maintaining the structure of the epitope during the antibody discovery process, and their scarcity can further complicate the discovery of effective antibodies. Our epitope steering technology is designed to address these issues by guiding antibodies exclusively against the desired regions of the target protein.
The Asset Purchase Agreement contained representations, warranties and covenants of RubrYc and the Company. ​ 25 Table of Contents Facility Purchase from Eastern Capital Limited On November 1, 2021, we purchased the manufacturing facility (the “Facility”) previously operated under a lease from two affiliates of Eastern Capital Limited (the “Eastern Affiliates”).
The Asset Purchase Agreement contained representations, warranties and covenants of RubrYc and the Company. ​ 19 Table of Contents Facility Purchase from Eastern Capital Limited On November 1, 2021, we purchased the manufacturing facility (the “Facility”) previously operated under a lease from two affiliates of Eastern Capital Limited (the “Eastern Affiliates”).
This allows for advanced safety assessment in NHP ahead of clinical trials, providing another layer of safety assurance. ​ Figure 4: CD3-Based T-Cell Engager Panel EngageTx TM ​ ShieldTx Antibody Masking Technology The vast majority of potential drug targets are expressed in multiple tissues and cell types throughout the body, while only a few are exclusively expressed in diseased cells or tissues, such as tumors.
This allows for advanced safety assessment in NHP ahead of clinical trials, providing another layer of safety assurance. ​ CD3-Based T-Cell Engager Panel EngageTx ​ ShieldTx Antibody Masking Technology The vast majority of potential drug targets are expressed in multiple tissues and cell types throughout the body, while only a few are exclusively expressed in diseased cells or tissues, such as tumors.
We are subject to the informational requirements of the Exchange Act and file or furnish reports, proxy statements and other information with the SEC. Such reports and other information filed by the Company with the SEC are available free of charge on our website at www.ibioinc.com .
We are subject to the informational requirements of the Exchange Act and file or furnish reports, proxy statements and other information with the SEC. Such reports and other information filed by us with the SEC are available free of charge on our website at www.ibioinc.com .
The Right of First Refusal and Co-Sale Agreement gives RubrYc the right of first refusal on stock sales by key holders, generally defined as founders, and a second right of first refusal and a co-sale right to specified other investors, including certain holders of Senior Preferred Stock and the Company.
The Right of First Refusal and Co-Sale Agreement gives RubrYc the right of first refusal on stock sales by key holders, generally defined as founders, and a second right of first refusal and a co-sale right to specified other investors, including certain holders of Senior Preferred Stock and iBio.
In addition, RubrYc granted the Company an exclusive option to obtain a worldwide sublicensable commercial license with respect to each of the lead product candidates resulting from such collaboration programs (the “Selected Compounds”).
In addition, RubrYc granted us an exclusive option to obtain a worldwide sublicensable commercial license with respect to each of the lead product candidates resulting from such collaboration programs (the “Selected Compounds”).
These preclinical data must provide an adequate basis for evaluating both the safety and the scientific rationale for the initial clinical trials. In the case of vaccine 32 Table of Contents candidates, animal immunogenicity and immune protection tests must establish a sound scientific basis to believe that the product candidate may be beneficial when administered to humans.
These preclinical data must provide an adequate basis for evaluating both the safety and the scientific rationale for the initial clinical trials. In the case of vaccine candidates, animal immunogenicity and immune protection tests must establish a sound scientific basis to believe that the product candidate may be beneficial when administered to humans.
As a result, iBio CDMO and its intellectual property are now wholly owned by iBio.
As a result, iBio CDMO and its intellectual property are now wholly owned by us.
The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt 33 Table of Contents of the information. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.
The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.
The SEC also maintains a website that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. ​ ​ ​ 40 Table of Contents
The SEC also maintains a website that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. ​ 33 Table of Contents
Moreover, single-cell sorting of antibody-displaying cells allows rapid selection of desired antibodies based on multiple dimensions, such as potency, selectivity, and cross-species selectivity. 6 Table of Contents When paired with mammalian display technology, StableHu enables antibody optimization with fewer iterative optimization steps, lower immunogenicity risk, and improved developability. ​ Figure 3: StableHu TM Antibody Optimization Technology ​ EngageTx CD3-Based T-Cell Engager Panel CD3-based T-cell engagers potentially offer significant clinical benefits in cancer treatment.
Moreover, single-cell sorting of antibody-displaying cells allows rapid selection of desired antibodies based on multiple dimensions, such as potency, selectivity, and cross-species selectivity. 12 Table of Contents When paired with mammalian display technology, StableHu enables antibody optimization with fewer iterative optimization steps, lower immunogenicity risk, and improved developability. ​ StableHu Antibody Optimization Technology ​ EngageTx CD3-Based T-Cell Engager Panel CD3-based T-cell engagers potentially offer significant clinical benefits in cancer treatment.
The NDA or BLA must include results of product development, laboratory and animal studies, human trials, information on the manufacture and composition of the product, proposed labeling and other relevant information. The FDA may grant deferrals for submission of data, or full or partial waivers.
The NDA or BLA must include results of product development, laboratory and 28 Table of Contents animal studies, human trials, information on the manufacture and composition of the product, proposed labeling and other relevant information. The FDA may grant deferrals for submission of data, or full or partial waivers.
In connection with the Stock Purchase Agreement, iBio entered into the RubrYc Therapeutics, Inc. Second Amended and Restated Investors’ Rights Agreement (the “Investors’ Rights Agreement”), RubrYc Therapeutics, Inc. Second Amended and Restated Voting Agreement (the “Voting Agreement”) and the RubrYc Therapeutics, Inc.
In connection with the Stock Purchase Agreement, we entered into the RubrYc Therapeutics, Inc. Second Amended and Restated Investors’ Rights Agreement (the “Investors’ Rights Agreement”), RubrYc Therapeutics, Inc. Second Amended and Restated Voting Agreement (the “Voting Agreement”) and the RubrYc Therapeutics, Inc.
Technological developments in our field of research and development occur at a rapid rate and we expect competition to intensify as 30 Table of Contents advances in this field are made. We will be required to continue to devote substantial resources and efforts to our research and development activities.
Technological developments in our field of research and development occur at a rapid rate and we expect competition to intensify as advances in this field are made. We will be required to continue to devote substantial resources and efforts to our research and development activities.
Our most significant competitors, among others, are fully integrated pharmaceutical companies such as Eli Lilly and Company, Bristol-Myers Squibb Company, Merck & Co., Inc., Novartis AG, MedImmune, LLC (a wholly owned subsidiary of AstraZeneca plc), Johnson & Johnson, Pfizer Inc., Merck KGaA and Sanofi SA, and more established biotechnology companies such as Genentech, Inc.
Our most significant competitors, among others, are fully integrated pharmaceutical companies such as Eli Lilly and Company, Novo Nordisk A/S, Amgen Inc., Bristol-Myers Squibb Company, Merck & Co., Inc., Novartis AG, MedImmune, LLC (a wholly owned subsidiary of AstraZeneca plc), Johnson & Johnson, Pfizer Inc., Merck KGaA and Sanofi SA, and more established biotechnology companies such as Genentech, Inc.
Our compensation programs are designed to align the compensation of our employees with our performance and to provide the proper incentives to attract, retain and motivate employees to achieve superior results. The structure of our compensation programs balances incentive earnings for both short-term and long-term performance.
Competitive Pay and Benefits. Our compensation programs are designed to align the compensation of our employees with our performance and to provide the proper incentives to attract, retain and motivate employees to achieve superior results. The structure of our compensation programs balances incentive earnings for both short-term and long-term performance.
The total purchase price for the Facility, the termination of the Sublease and other agreements among the parties, and the equity described below was $28,750,000, which was paid $28,000,000 in cash and by the issuance to Bryan Capital Investors LLC, an affiliate of the Eastern Affiliates a five-year warrant to purchase 51,583 shares of our Common Stock at an exercise price of $33.25 per share. ​ In connection with the purchase of the Facility, iBio CDMO entered into a Credit Agreement, dated November 1, 2021 (the “Credit Agreement”), with Woodforest National Bank (“Woodforest”) pursuant to which Woodforest provided iBio CDMO a $22,375,000 secured term loan (the “Term Loan”) to purchase the Facility, which Term Loan was evidenced by a Term Note (the “Term Note”).
The total purchase price for the Facility, the termination of the Sublease and other agreements among the parties, and the equity described below was $28,750,000, which was paid $28,000,000 in cash and by the issuance to Bryan Capital Investors LLC, an affiliate of the Eastern Affiliates a five-year warrant to purchase 2,579 shares of our Common Stock at an exercise price of $665 per share. ​ In connection with the purchase of the Facility, iBio CDMO entered into a Credit Agreement, dated November 1, 2021 (the “Credit Agreement”), with Woodforest National Bank (“Woodforest”) pursuant to which Woodforest had provided iBio CDMO a $22,375,000 secured term loan (the “Term Loan”) to purchase the Facility, which Term Loan was evidenced by a Term Note (the “Term Note”).
The sequence diversity generated by StableHu led to an antibody panel with a wide range of potencies, which allows us to pair the panel with a wide variety of tumor-targeting antibodies. Importantly, iBio was able to retain T-cell activation and tumor cell killing capacity with significantly reduced cytokine release.
The sequence diversity generated by StableHu led to an antibody panel with a wide range of potencies, which allows us to pair the panel with a wide variety of tumor-targeting antibodies. Importantly, we were able to retain T-cell activation and tumor cell killing capacity with significantly reduced cytokine release.
The technology and products covered by our issued and pending patent applications are summarized below: Pending Product Patent Applications (U.S. and International) ● Antibodies ● Influenza vaccines ● Influenza therapeutic antibodies ● Anthrax vaccines ● Plague vaccines ● HPV vaccines ● Trypanosomiasis vaccine ● Malaria vaccines ● COVID-19 vaccines ● Antibodies against chemokine receptor 8 (CCR8) ● Antibodies against epidermal growth factor receptor variant III (EGFRvIII) ● Antibodies against MUC16 ● Antibodies against TROP2 ● Antibodies against CD3 ● High-efficiency, conditionally-activated antibodies ​ Pending Technology Patent Applications (U.S. and International) ● Activation of transgenes in plants by viral vectors ● Transient expression of proteins in plants 29 Table of Contents ● Thermostable carrier molecule ● In vivo deglycosylation of recombinant proteins in plants ● Scaffold technology ● Machine learning apparatus for engineering meso-scale peptides ● Methods of making conditionally-activated antibodies ​ Technology and Product Patents (U.S.) ● Virus-induced gene silencing in plants ● Transient expression of foreign genes in plants ● Production of foreign nucleic acids and polypeptides in sprout systems ● Production of pharmaceutically active proteins in sprouted seedlings ● Systems and method for clonal expression in plants ● Recombinant carrier molecule for expression, delivery and purification of target polypeptides ● Influenza antigens, vaccine compositions, and related methods ● Plague antigens, vaccine compositions, and related methods ● Influenza therapeutic antibodies ● Trypanosomiasis vaccine ● Anthrax antigens, vaccine compositions, and related methods ​ Competition The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.
The technology and products covered by our issued and pending patent applications are summarized below: Product Patent Applications, Technology, and Know-How (U.S. and International) ● Antibodies ● Influenza vaccines ● Influenza therapeutic antibodies ● Anthrax vaccines ● Plague vaccines ● HPV vaccines ● Trypanosomiasis vaccine ● Malaria vaccines ● COVID-19 vaccines ● Antibodies against CCR8 ● Antibodies against EGFRvIII ● Antibodies against MUC16 ● Antibodies against TROP2 ● Antibodies against CD3 ● High-efficiency, conditionally-activated antibodies 21 Table of Contents Pending Technology Patent Applications and Know-How (U.S. and International) ● Activation of transgenes in plants by viral vectors ● Transient expression of proteins in plants ● Thermostable carrier molecule ● In vivo deglycosylation of recombinant proteins in plants ● Scaffold technology ● Machine learning apparatus for engineering meso-scale peptides ● Methods of making conditionally-activated antibodies Technology, Know-How and Product Patents (U.S.) ● Virus-induced gene silencing in plants ● Transient expression of foreign genes in plants ● Production of foreign nucleic acids and polypeptides in sprout systems ● Production of pharmaceutically active proteins in sprouted seedlings ● Systems and method for clonal expression in plants ● Recombinant carrier molecule for expression, delivery and purification of target polypeptides ● Influenza antigens, vaccine compositions, and related methods ● Plague antigens, vaccine compositions, and related methods ● Influenza therapeutic antibodies ● Trypanosomiasis vaccine ● Anthrax antigens, vaccine compositions, and related methods Competition The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.
Generally, before a new drug can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. 31 Table of Contents U.S.
Generally, before a new drug can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. U.S.
This reduction is believed to lower the risk of cytokine release syndrome. Additionally, the increased humanness of the predicted antibodies, thanks to our StableHu technology, reduces the risk of immunogenicity. 7 Table of Contents Furthermore, our StableHu technology enabled the Company to engineer NHP cross-reactivity into EngageTx.
This reduction is believed to lower the risk of cytokine release syndrome. Additionally, the increased humanness of the predicted antibodies, thanks to our StableHu technology, reduces the risk of immunogenicity. 13 Table of Contents Furthermore, our StableHu technology enabled us to engineer NHP cross-reactivity into EngageTx.
Although many of the issues discussed above with respect to the United States apply similarly in the context of the European Union, the approval process varies between countries and jurisdictions and can involve 35 Table of Contents additional product testing and additional administrative review periods.
Although many of the issues discussed above with respect to the United States apply similarly in the context of the European Union and in other jurisdictions, the approval process varies between countries and jurisdictions and can involve additional product testing and additional administrative review periods.
Our current therapeutics being developed are all in preclinical development and we have not completed any clinical trials for any vaccine or therapeutic protein product candidate produced using iBio technology and there is a risk that we will be unsuccessful in developing or commercializing any product candidates.
Our current therapeutics are all in preclinical development and we have not completed any clinical trials in humans for any therapeutic protein product candidate produced using our technology and there is a risk that we will be unsuccessful in developing or commercializing any product candidates.
As the Company continues to grow, we remain committed to further investing in our digital infrastructure to support our ambitious goals. ​ Strategic Alliances, Collaborations, and Joint Ventures iBio has formed collaborations and strategic alliances to gain access to funding, capabilities, technical resources and intellectual property to further its development efforts, commercialize its technology and to generate revenues, including through the use of our patented epitope-steering AI-engine and our EngageTX platform.
As we continue to grow, we remain committed to further investing in our digital infrastructure to support our ambitious goals. ​ Strategic Alliances, Collaborations, and Joint Ventures We have formed collaborations and strategic alliances to gain access to funding, capabilities, technical resources and intellectual property to further our development efforts, commercialize our technology and to generate revenues, including through the use of our patented epitope-steering AI-engine and our EngageTx platform.
The third layer of the technology stack is the antibody optimizing StableHu AI technology, coupled with mammalian display technology. This combination has been shown to speed up the Lead Optimization process and potentially minimizes downstream risks, with the goal of making the overall development process more efficient and cost-effective. Next, our EngageTx platform forms the fourth layer.
The third layer of the technology stack is the antibody optimizing StableHu AI technology, coupled with mammalian display technology. This combination has been shown to speed up the Lead Optimization process and potentially minimizes downstream risks, with the goal of making the overall development process more efficient and cost-effective.
If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. 36 Table of Contents Healthcare Regulations and Healthcare Reform Healthcare regulation and pricing (included drug pricing) is complex, extensive, and dynamic around the world.
If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. Healthcare Regulations and Healthcare Reform Healthcare regulation and pricing (including drug pricing) is complex, extensive, and dynamic around the world.
Human Capital/Employees As of June 30, 2024, we had 16 employees, all of which are full time employees, and three strategic consultants. Our employees are not represented by any union and are not the subject of a collective bargaining agreement. We consider our relations with our employees to be good.
Human Capital/Employees As of June 30, 2025, we had 20 employees, all of which are full-time employees, and two strategic consultants. Our employees are not represented by any union and are not the subject of a collective bargaining agreement. We consider our relations with our employees to be good.
A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation.
A designated orphan drug may not 29 Table of Contents receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation.
However, first-generation T-cell engaging bispecific antibodies often face challenges related to safety and efficacy. They can cause severe side effects, such as cytokine release syndrome due to overactivation of the immune system. Additionally, they may lack specificity, which can lead to off-target effects and damage to healthy tissues.
However, first-generation T-cell engaging bispecific antibodies often face challenges related to safety and efficacy. They can cause severe side effects, such as cytokine release syndrome due to overactivation of the immune system. Additionally, they may lack specificity, which can lead to off-target effects and damage to healthy tissues. The lack of NHP cross-reactivity also prevents safety assessment in higher species.
The technology also holds promise in the realm of systemic secreted and cell-surface therapeutics. Here, epitope steering can be applied to the development of antibodies, circulating immune modulation factors, secreted enzymes, and transmembrane proteins. This could be particularly beneficial in treating diseases such as heart failure, infectious diseases, and rare genetic conditions.
Here, epitope steering can be applied to the development of antibodies, circulating immune modulation factors, secreted enzymes, and transmembrane proteins. This could be particularly beneficial in treating diseases such as heart failure, infectious diseases, and rare genetic conditions.
We have included our website address in this Annual Report solely as an inactive textual reference. Reverse Stock Split On October 7, 2022, we effected a reverse stock split at a ratio of one-for-twenty five (1:25) shares of our common stock.
We have included our website address in this Annual Report solely as an inactive textual reference. Reverse Stock Split On November 29, 2023, we effected a reverse stock split at a ratio of one-for-twenty (1:20) shares of our Common Stock.
On May 31, 2024, in accordance with the terms of the Settlement Agreement entered into on May 17, 2024 with Woodforest in consideration of the payment in full of all Obligations (as such term was defined under the Credit Agreement (a) iBio CDMO paid to Woodforest (i) $8,500,000, which it received from the sale of the Property under the Purchase and Sale Agreement, and (ii) approximately $915,000 from restricted cash which had previously been held by Woodforest, and (b) the Company issued a Pre-Funded Warrant to purchase 1,560,570 shares of its common stock to Woodforest.
The sale price was $8,500,000. ​ On May 17, 2024, iBio CDMO, the Company and Woodforest entered into a Settlement Agreement and Mutual Release (the “Settlement Agreement”) which provided that iBio CDMO would pay to Woodforest the proceeds of the sale of the Property under the 2024 Purchase and Sale Agreement when received and determine, in consultation with Woodforest, the remaining balance due under the Credit Agreement (the “Indebtedness Deficiency Amount”). ​ On May 31, 2024, in accordance with the terms of the Settlement Agreement in consideration of the payment in full of all Obligations (as such term is defined under the Credit Agreement) (a) iBio CDMO paid to Woodforest (i) $8,500,000, which it received from the sale of the Property under the 2024 Purchase and Sale Agreement, and (ii) approximately $915,000 from restricted cash which had previously been held by Woodforest, and (b) the Company issued a Pre-Funded Warrant to purchase 1,560,570 shares of its Common Stock to Woodforest to satisfy the Indebtedness Deficiency.
The engine is trained to match the epitope structure as closely as possible and refine the designs for greater stability and water solubility, which are critically important factors. The optimized engineered epitope is then used to identify antibodies from naïve or immunized libraries.
The engine is trained to match the epitope structure as closely as possible and refine the designs for greater stability and water solubility, which are critically important factors. The optimized engineered epitope is then used to identify antibodies from naïve or immunized libraries. The application of engineered epitopes extends to a wide array of complex and hard-to-drug protein structures.
Environmental, Health, and Safety Regulation We are subject to numerous federal, state and local environmental, health and safety (“EHS”), laws and regulations relating to, among other matters, safe working conditions, product stewardship, environmental protection, and handling or disposition of products, including those governing the generation, storage, handling, use, transportation, release, and disposal of hazardous or potentially hazardous materials, medical waste, and infectious materials that may be handled by our research laboratories.
Specifically, the Australia TG Act regulates the registration, listing, quality, safety, efficacy, promotion and sale of therapeutic goods, including pharmaceuticals, supplied in Australia. 31 Table of Contents Environmental, Health, and Safety Regulation We are subject to numerous federal, state and local environmental, health and safety (“EHS”), laws and regulations relating to, among other matters, safe working conditions, product stewardship, environmental protection, and handling or disposition of products, including those governing the generation, storage, handling, use, transportation, release, and disposal of hazardous or potentially hazardous materials, medical waste, and infectious materials that may be handled by our research laboratories.
Astral Bio On March 27, 2024, iBio entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases.
Several agreements with Astral Bio Discovery, Option and License Agreement: On March 27, 2024, we entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases.
We consider our relations with our employees to be good. Management believes that it has sufficient human capital to operate its business successfully currently and will need to attract new talent to the organization in order to achieve its plans for growth. Competitive Pay and Benefits.
We have no collective bargaining agreements with our employees and have not experienced any work stoppages. We consider our relations with our employees to be good. Management believes that it has sufficient human capital to operate its business successfully currently and will need to attract new talent to the organization in order to achieve its plans for growth.
Conditionally activated antibodies are believed to broaden the therapeutic window, potentially improving efficacy and safety of treatments and enabling the use of drug combinations that are otherwise considered too toxic, and they open the door to pursuing targets which, due to their expression in multiple tissues, would otherwise raise safety concerns. ​ 4 Table of Contents ​ Figure 1: iBio’s Technology Stack Addresses Several Current Challenges in Antibody Discovery ​ AI Epitope Steering Technology Epitopes, the small regions on large drug target proteins, play a crucial role in eliciting a desired biological function when targeted with antibodies.
These conditionally activated antibodies can broaden the therapeutic window by improving efficacy and safety, enable drug combinations that would otherwise be too toxic, and open the door to pursuing targets whose expression across multiple tissues would normally raise safety concerns. ​ ​ iBio’s Technology Stack Addresses Several Current Challenges in Antibody Discovery ​ 10 Table of Contents AI Epitope Steering Technology Epitopes, the small regions on large drug target proteins, play a crucial role in eliciting a desired biological function when targeted with antibodies.
This broad applicability not only has the potential to unlock high-value targets in the field of immuno-oncology (I/O), but it could also be transformative in various other disease areas such as cardiometabolic, immunology 5 Table of Contents and pain management. Furthermore, the potential use of this approach in vaccine development could open up new avenues for disease prevention.
This broad applicability not only has the potential to unlock high-value targets in the field of immuno-oncology (I/O), but it could also be transformative in various other disease areas such as cardiometabolic, immunology and pain management.
Identifying a fitting mask is challenging, however, iBio’s ShieldTx technology is designed to increase the probability of success. This increased success rate is due to iBio’s epitope engineering engine, which creates small embodiments of the drug target epitope to raise antibodies. These engineered epitopes, by definition, bind to the raised antibody and can be deployed as masks.
This increased success rate is due to our epitope engineering engine, which creates small embodiments of the drug target epitope to raise antibodies. These engineered epitopes, by definition, bind to the raised antibody and can be deployed as masks.
Our research and development activities take place primarily at our facilities in San Diego. iBio has leased lab and office space in San Diego for the purpose of conducting research. For the fiscal year 2024, iBio spent $5.2 million in R&D related activities.
Our research and development activities take place primarily at our facilities in San Diego. iBio has leased lab and office space in San Diego for the purpose of conducting research.
Our intention is to license the AI tech stack, extending its benefits to our partners and amplifying its biological impact and insights.
Our intention is to license the AI and screening tech stack, extending its benefits to our partners and amplifying its impact on other disease areas.
Pursuant to the Settlement Agreement, the Credit Agreement, the Guaranty dated November 1, 2021 and the other Loan Documents (as defined in the Credit Agreement) were terminated and Woodforest released the Company and iBio CDMO from any and all claims, debts, liabilities or causes of action it may have against them prior to May 31, 2024, and the Company and iBio CDMO released Woodforest and its related parties from any and all claims, debts, liabilities or causes of action it may have against them prior to May 31, 2024. ​ 28 Table of Contents Intellectual Property We currently own 69 patents.
The Pre-Funded Warrant expires upon full exercise thereof and is exercisable at a nominal exercise price equal to $0.0001 per share. ​ Pursuant to the Settlement Agreement, the Credit Agreement, the Guaranty dated November 1, 2021 and the other Loan Documents (each as defined in the Credit Agreement) were terminated and Woodforest released the Company and iBio CDMO from any and all claims, debts, liabilities or causes of action it may have against them prior to May 31, 2024, and the Company and iBio CDMO released Woodforest and its related parties from any and all claims, debts, liabilities or causes of action it may have against them prior to May 31, 2024. ​ 20 Table of Contents Intellectual Property We currently own 16 patents.
As part of the collaboration, iBio has granted an exclusive license to its AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an Investigational New Drug (IND) application. iBio has the exclusive option to license three (3) obesity and cardiometabolic targets from AstralBio and will receive the rights to develop, manufacture and commercialize those targets upon exercise.
As part of the collaboration, we granted an exclusive license to our AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an Investigational New Drug (“IND”) application.
Conditionally activated antibodies are also believed to enable the use of drug combinations that are otherwise considered too toxic, and they open the door to pursuing targets that, due to their expression in multiple tissues, would otherwise raise safety concerns. iBio’s ShieldTx technology enables the creation of conditionally activated antibodies and stands out because it is deeply integrated into iBio’s technology stack, providing multiple advantages.
Conditionally activated antibodies are also believed to enable the use of drug combinations that are otherwise considered too toxic, and they open the door to pursuing targets that, due to their expression in multiple tissues, would otherwise raise safety concerns.
Since July 1, 2023, we have primarily focused our intellectual property estate on our preclinical assets including provisional and regular patents in the U.S., including for CD25 antibodies, chemokine receptor 8 (CCR8) antibodies, epidermal growth factor receptor variant III (EGFRvIII) antibodies, anti-MUC16 antibodies, TROP2 antibodies, CD3 antibodies, and for high-efficiency, conditionally-activated antibodies.
Of the 16 patents, 11 are U.S. and 5 are international. Since July 1, 2023, we have primarily focused our intellectual property estate on our preclinical assets including provisional and regular patents in the U.S. and overseas, including for CD25 antibodies, CCR8 antibodies, EGFRvIII antibodies, anti-MUC16 antibodies, TROP-2 antibodies, CD3 antibodies, and for high-efficiency, conditionally-activated antibodies.
This approach is advantageous as antibodies that express well on the mammalian cells used in the display are more likely to express well in the production cell line.
Mammalian display is a technology that presents antibodies on the surface of mammalian cells, allowing for the direct screening and selection of antibodies in a mammalian cell environment. This approach is advantageous as antibodies that express well on the mammalian cells used in the display are more likely to express well in the production cell line.
While we believe that the potential advantages of our new technologies will enable us to compete effectively against other providers of technology for biologic product development and manufacturing, many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, clinical trials, regulatory approvals and marketing approved products than we do.
Our commercial opportunities will be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects or are less expensive than any products that we or our collaborators may develop based on the use of our technologies. 22 Table of Contents While we believe that the potential advantages of our new technologies will enable us to compete effectively against other providers of technology for biologic product development and manufacturing, many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, clinical trials, regulatory approvals and marketing approved products than we do.
Suppliers We outsource certain functions and supplies to third parties such as Lonza Sales AG, and Twist Bioscience Corporation. While we rely on our outsourcing partners to perform their contracted functions, we are continuing to build internal capabilities.
For the fiscal year 2025, iBio spent $8.3 million in R&D related activities. 23 Table of Contents Suppliers We outsource certain functions and supplies to third parties such as Lonza Sales AG, and Twist Bioscience Corporation. While we rely on our outsourcing partners to perform their contracted functions, we are continuing to build internal capabilities.
The lack of non-human primate (NHP) cross-reactivity also prevents safety assessment in higher species. To address these issues, iBio used antibodies from an epitope steering campaign as well as a first-generation T-cell engager as input and utilized our StableHu technology to identify a next-generation CD3 antibody panel.
To address these issues, we used antibodies from an epitope steering campaign as well as a first-generation T-cell engager as input and utilized our StableHu technology to identify a next-generation CD3 antibody panel.
These technologies are integral to operationalizing our strategy, accelerating our learning curve, and executing at scale. As such, the Company has made substantial investments in these areas. iBio’s aspiration is to digitize our operations to the greatest extent possible, harnessing the potential of digital technology to maximize our impact on human health.
As such, we have made substantial investments in these areas. Our aspiration is to digitize our operations to the greatest extent possible, harnessing the potential of digital technology to maximize our impact on human health.
The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. Human clinical trials involving biological products are typically conducted in three sequential phases that may overlap or be combined: ● Phase 1 .
The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed.
Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions.
Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from comparable regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in those countries.
Item 1. Business. Overview iBio, Inc. (also referred to as "we", "us", "our", "iBio", or the "Company") is a preclinical stage biotechnology company leveraging the power of Artificial Intelligence (AI) for the development of hard-to-drug precision antibodies. Our proprietary technology stack is designed to minimize downstream development risks by employing AI-guided epitope-steering and monoclonal antibody (mAb) optimization.
Item 1. Business. Overview iBio, Inc. (also referred to as "we", "us", "our", "iBio", or the "Company") is a preclinical stage biotechnology company leveraging the power of Artificial Intelligence (“AI”) for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space.
Under the terms of the Asset Purchase Agreement, upon closing of the acquisition, we made an upfront payment of approximately $1,000,000 by issuing 102,354 (post reverse split effected in October 2022) shares of our common stock, par value $.001 per share (the “Common Stock”) to RubrYc.
Under the terms of the Asset Purchase Agreement, upon closing of the acquisition, we made an upfront payment of approximately $1,000,000 by issuing 5,117 shares of our Common Stock to RubrYc.
It provides an optimized next-generation CD3 T-cell engager antibody panel characterized by a wide range of potencies, Non-Human Primate (NHP) cross-reactivity, increased humanness of the antibodies, and retained tumor cell killing capacity with reduced cytokine release. Lastly, iBio’s ShieldTx antibody masking technology enables the creation of conditionally activated antibodies.
The fourth layer of our technology stack is comprised of our EngageTx and ShieldTx technologies. EngageTx delivers an optimized, next-generation CD3 T-cell engager antibody panel with a wide range of potencies, NHP cross-reactivity, enhanced humanness, and strong tumor-killing activity with reduced cytokine release. In parallel, ShieldTx provides an antibody masking technology that enables the creation of conditionally activated antibodies.
Hiring for such personnel is competitive, and there can be no assurance that we will be able to retain our key employees or attract, assimilate or retain the qualified personnel necessary for the development of our business. 38 Table of Contents We have no collective bargaining agreements with our employees and have not experienced any work stoppages.
We anticipate that we will need to identify, attract, train and retain other highly skilled personnel to pursue our development program. Hiring for such personnel is competitive, and there can be no assurance that we will be able to retain our key employees or attract, assimilate or retain the qualified personnel necessary for the development of our business.
Such reforms could have an adverse effect on anticipated revenues from product candidates and may affect our overall financial condition and ability to develop product candidates. 37 Table of Contents We anticipate that current and future U.S. legislative healthcare reforms may result in additional downward pressure on the price that we receive for any approved product, if covered, and could seriously harm our business.
We anticipate that current and future U.S. legislative healthcare reforms may result in additional downward pressure on the price that we receive for any approved product, if covered, and could seriously harm our business. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors. 30 Table of Contents U.S.
Included in the 69 patents are 30 U.S. and foreign applications that we acquired from RubrYc for novel antibodies, scaffold technology, and a machine learning apparatus for engineering meso-scale peptides, including 1 allowed application.
Included in the 88 patents and patent applications are U.S. and foreign patents and applications that we acquired from RubrYc for novel antibodies, scaffold technology, and a machine learning apparatus for engineering meso-scale peptides. Our success will depend in part on our ability to obtain and maintain patent protection for our technologies and preclinical assets.
This strategic approach enables us to capitalize on the value of our meticulously curated data while empowering collaborations and innovations, while at the same time allowing iBio to focus on both the platform and our core therapeutic areas, metabolic diseases and oncology. ● Focused Investment in advancing the platform: iBio maintains a focused commitment to invest in our platform, continually unlocking the potential of biology through AI and machine learning.
This strategic approach enables us to capitalize on the value of our meticulously curated data while empowering collaborations and innovations, while at the same time allowing us to focus on our core therapeutic areas, obesity and cardiometabolic diseases.
As a biopharmaceutical company with a focus on cancer therapeutics, we compete with a broad range of companies. At the highest level, our therapeutics can be seen as both a complement and a potential competitor to any oncology therapy, most notably chemotherapy, radiotherapy, biologics and small molecule drugs.
As a biopharmaceutical company developing next generation obesity therapeutics, we compete with a broad range of companies. At the highest level, our therapeutics can be seen as both a complement and a potential competitor to any obesity therapeutic, most incretin peptides, biologics, other peptide therapies, siRNAs, surgical interventions, and small molecules.
This process includes humanization, which alters non-human antibodies to mimic human antibodies, thereby reducing the risk of immune reactions when used in therapy. The proprietary StableHu technology is instrumental in this optimization process. StableHu is an AI-powered tool designed to predict a library of antibodies with fully human CDR variants based on an input antibody.
It refines an antibody's properties to enhance its efficacy, safety, and manufacturability. This process includes humanization, which alters non-human antibodies to mimic human antibodies, thereby reducing the risk of immune reactions when used in therapy. Our proprietary StableHu technology is instrumental in this optimization process.
The biological product is initially introduced into a small number of closely monitored healthy human volunteers and tested for safety.
Human clinical trials involving biological products are typically conducted in three sequential phases that may overlap or be combined: ● Phase 1 . The biological product is initially introduced into a small number of closely monitored healthy human volunteers and tested for safety.
As we continue to develop our existing immune-oncology pre-clinical pipeline, we are also seeking strategic partners with the capabilities to more rapidly advance these programs towards the clinic.
As we continue to leverage our technology stack and develop our existing immune-oncology pre-clinical pipeline, we are also seeking strategic partners with the capabilities to more rapidly advance these programs towards the clinic. ​ Our discovery and development work is conducted at our San Diego research and development (“R&D”) laboratory space, where our AI and ML scientists and biopharma researchers operate side by side.
By tapping into our, infrastructure, and expertise, partners have the potential to streamline timelines, reduce costs tied to biologic drug discovery applications and cell line process development, and expedite preclinical programs with efficiency. o Developing and advancing our in-house programs cost effectively : Clinical advancement is crucial for drug discovery.
By tapping into our infrastructure, and expertise, partners have the potential to streamline timelines, reduce costs tied to biologic drug discovery applications and cell line process development, and expedite preclinical programs with efficiency. o Out-Licensing in Diverse Therapeutic Areas: In pursuit of adding value, we are exploring partnerships in diverse therapeutic domains such as immunology and inflammation, pain or vaccines.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf our product candidates do not receive regulatory approval our business may be harmed. • We may fail to capitalize on particular technology or product candidates that we expend our limited resources on. • There can be no guarantee that we will be able to successfully develop and commercialize product candidates. • We may not be successful in our efforts to use iBio technologies to build a pipeline of product candidates. • Clinical trials are very expensive, time-consuming and difficult to design and implement. • We, our clients, collaborators and potential licensees are dependent upon successful preclinical studies and demonstration of safety and efficacy in clinical trials to be able to commercialize product candidates. • If we, or our clients and collaborators, are not able to obtain required regulatory approvals, we, or our clients and collaborators, will not be able to commercialize our, or third-party, product candidates. • Alternative technologies may supersede our technologies or make them noncompetitive, which may harm our business. • Our clinical product candidates may exhibit undesirable side effects. • Product liability lawsuits could cause us to incur substantial liabilities and to limit product commercialization. ​ Risks Related to Dependence on Third Parties • For any clinical product candidates we may develop, any manufacturing problems experienced by our third-party contract manufacturers could result in a delay or interruption in the supply of our clinical product candidate. • If we are unable to establish new collaborations and maintain both new and existing collaborations, or if these collaborations are not successful, our business could be adversely affected. • If third parties on whom we or our licensees will rely for the conduct of preclinical and clinical studies do not perform as required, we may not be able to obtain regulatory approval for or commercialize our product candidates. • Our inability to obtain raw materials or supplies may adversely impact our business and results of operations. • Any claims beyond our insurance coverage limits may result in substantial costs. • We may be subject to various litigation claims and legal proceedings. ​ Risks Related to Intellectual Property • If we or our licensors are unable to obtain and maintain sufficient patent protection for our technology and products, our ability to successfully commercialize our technology and products may be impaired. • We may become involved in lawsuits related to our patents or other intellectual property, which could be costly. • Patent terms may be inadequate to protect our competitive position for an adequate amount of time. 41 Table of Contents • If we are unable to protect our trade secrets, our business and competitive position would be harmed . • We may be subject to claims challenging the inventorship of our patent filings and other intellectual property. • Intellectual property rights do not necessarily address all potential threats to our competitive advantage. • We may not be able to protect our intellectual property rights throughout the world. • If we should fail to comply with various patents laws, our patent protection could be reduced or eliminated. • Changes in patent law could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. ​ Risks Related to iBio’s Operations • We recently identified and remediated material weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will not occur in the future. • The loss of one or more of our executive officers or key employees could adversely affect our business. • A failure to have an appropriately skilled and adequate workforce could adversely impact the ability of our R&D facility to operate efficiently. • A natural disaster or other disruptions at our laboratory would adversely affect our business and results of operations. • We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy. • If we are unable to protect the confidentiality of our customers’ proprietary information, we may be subject to claims. • We may face integration risks and additional costs if we acquire companies, products or technologies. • Our business and operations would suffer in the event of computer system failures. • We rely extensively on our information technology systems and are vulnerable to damage and interruption, including cybersecurity and data leakage risks. • Any failure to maintain the security of information relating to our patients, customers, employees and suppliers, could expose us to litigation, government enforcement actions and costly response measures. ​ Risks Related to Our Common Stock • Our stockholders will experience dilution from the issuance of the development milestone payments if paid in equity. • Our failure to continue to comply with the continued listing standards of NYSE American could result in our delisting from the NYSE American. • Provisions in our certificate of incorporation, bylaws and under Delaware law could discourage a takeover. • Our bylaws provide that the Delaware Court of Chancery is the exclusive forum for certain disputes. • The issuance of preferred stock could adversely affect the rights of the holders of shares of our common stock. • We do not anticipate paying cash dividends for the foreseeable future. • Changes in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business and operating results. • Holders of our warrants have no rights as common stockholders until they exercise their warrants. • The market price of our common stock has been and may continue to be volatile. • Reports published by securities or industry analysts could adversely affect our common stock price and trading volume. • As a smaller reporting company, we are subject to reduced disclosure requirements, which may make our common stock less attractive to investors. ​ ​ 42 Table of Contents Detailed Risk Factors Our business faces many risks.
Biggest changeRisks Related to Intellectual Property o If we or our licensors are unable to obtain and maintain sufficient patent protection, our ability to commercialize our technology and products may be impaired. o We may become involved in lawsuits related to our patents or other intellectual property, which could be costly. o Patent terms may be inadequate to protect our competitive position for an adequate amount of time. o If we are unable to protect our trade secrets, our business and competitive position would be harmed. o We may be subject to claims challenging the inventorship of our patent filings and other intellectual property. o Intellectual property rights do not necessarily address all potential threats to our competitive advantage. o We may not be able to protect our intellectual property rights throughout the world. o If we should fail to comply with various patent laws our patent protection could be reduced or eliminated. o Changes in patent law could increase the uncertainties and costs surrounding the prosecution and enforcement of our patents. 35 Table of Contents Risks Related to iBio’s Operations o We have previously identified and remediated material weaknesses in our internal controls, and cannot assure that additional weaknesses will not occur. o The loss of one or more of our executive officers or key employees could adversely affect our business. o A failure to have an appropriately skilled and adequate workforce could adversely impact the ability of our R&D facility to operate efficiently. o A natural disaster or other disruptions at our laboratory would adversely affect our business and results of operations. o We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy. o If we are unable to protect the confidentiality of our customers’ proprietary information, we may be subject to claims. o We may face integration risks and additional costs if we acquire companies, products, or technologies. o Our business and operations would suffer in the event of computer system failures, including cybersecurity and data leakage risks. o We rely extensively on our information technology systems and are vulnerable to damage and interruption, including cybersecurity and data leakage risks. o Any failure to maintain the security of information relating to our patients, customers, employees, and suppliers could expose us to litigation, government enforcement actions, and costly response measures. o Changes in general economic conditions, geopolitical conditions, trade policies, and other factors beyond our control may adversely impact our business and operating results. o Global climate change and related regulations could negatively affect our business.
Notwithstanding our large investment to date and anticipated future expenditures in these technologies, we have not yet developed, and may never successfully develop, any marketed products using these technologies.
Notwithstanding our large investment to date and anticipated future expenditures in these technologies, we have not yet developed, and may never successfully develop, any marketed products using these technologies.
As a result, we may fail to address or develop product candidates based on other scientific approaches that may offer greater commercial potential or for which there is a greater likelihood of success. We also may not be successful in our efforts to identify or discover additional product candidates using our technologies.
As a result, we may fail to address or develop product candidates based on other scientific approaches that may offer greater commercial potential or for which there is a greater likelihood of success. We also may not be successful in our efforts to identify or discover additional product candidates using our technologies.
Research programs to identify new product candidates require substantial technical, financial, and human resources. These research programs may initially show promise in identifying potential product candidates yet fail to yield product candidates for clinical development.
Research programs to identify new product candidates require substantial technical, financial, and human resources. These research programs may initially show promise in identifying potential product candidates yet fail to yield product candidates for clinical development.
Our realization of these revenues and payments including dependence on existing collaborations, and any future collaborations we enter into, is subject to a number of risks, including the following: ● collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations; ● collaborators may not perform their obligations as expected; ● collaborators may not pursue development and, if successful, commercialization of product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, which divert resources or create competing priorities; ● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours, which may cause collaborators to cease to devote resources to the commercialization of our product candidates; ● collaborators with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products; or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; 57 Table of Contents ● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; ● collaborations may be terminated for the convenience of the collaborator and, if terminated, we would potentially lose the right to pursue further development or commercialization of the applicable product candidates; ● collaborators may learn about our technology and use this knowledge to compete with us in the future; ● results of collaborators’ preclinical or clinical studies could produce results that harm or impair other products using our technology; ● there may be conflicts between different collaborators that could negatively affect those collaborations and others; and ● the number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers.
Our realization of these revenues and payments including dependence on existing collaborations, and any future collaborations we enter into, is subject to a number of risks, including the following: ● collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations; ● collaborators may not perform their obligations as expected; ● collaborators may not pursue development and, if successful, commercialization of product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, which divert resources or create competing priorities; ● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours, which may cause collaborators to cease to devote resources to the commercialization of our product candidates; ● collaborators with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products; or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; ● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; 53 Table of Contents ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; ● collaborations may be terminated for the convenience of the collaborator and, if terminated, we would potentially lose the right to pursue further development or commercialization of the applicable product candidates; ● collaborators may learn about our technology and use this knowledge to compete with us in the future; ● results of collaborators’ preclinical or clinical studies could produce results that harm or impair other products using our technology; ● there may be conflicts between different collaborators that could negatively affect those collaborations and others; and ● the number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers.
The market price of our common stock could fluctuate significantly in response to various factors and events, including: ● investor reaction to our business strategy; ● the success of competitive products or technologies; ● our continued compliance with the listing standards of the NYSE American; ● results of our preclinical and clinical trials; ● actions taken by regulatory agencies with respect to our products, clinical studies, manufacturing process or sales and marketing terms; ● variations in our financial results or those of companies that are perceived to be similar to us; ● developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products; ● our ability or inability to raise additional capital and the terms on which we raise it; ● declines in the market prices of stocks generally; 71 Table of Contents ● trading volume of our common stock; ● sales of our common stock by us or our stockholders; ● announcements of licensing or other business development initiatives; ● general economic, industry and market conditions; and ● other events or factors, including those resulting from such events, or the prospect of such events, including war, terrorism and other international conflicts, public health issues including health epidemics or pandemics, and natural disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather and climate conditions, whether occurring in the United States or elsewhere, could disrupt our operations, disrupt the operations of our suppliers or result in political or economic instability.
The market price of our common stock could fluctuate significantly in response to various factors and events, including: ● investor reaction to our business strategy; ● the success of competitive products or technologies; ● our continued compliance with the listing standards of the NYSE American; ● results of our preclinical and clinical trials; ● actions taken by regulatory agencies with respect to our products, clinical studies, manufacturing process or sales and marketing terms; ● variations in our financial results or those of companies that are perceived to be similar to us; ● developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products; ● our ability or inability to raise additional capital and the terms on which we raise it; ● declines in the market prices of stocks generally; ● trading volume of our common stock; 68 Table of Contents ● sales of our common stock by us or our stockholders; ● announcements of licensing or other business development initiatives; ● general economic, industry and market conditions; and ● other events or factors, including those resulting from such events, or the prospect of such events, including war, terrorism and other international conflicts, public health issues including health epidemics or pandemics, and natural disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather and climate conditions, whether occurring in the United States or elsewhere, could disrupt our operations, disrupt the operations of our suppliers or result in political or economic instability.
The following examples are illustrative: ● others may be able to make products that are similar to our product candidates but that are not covered by the claims of the patents that we license; ● our licensors or collaborators might not have been the first to make the inventions covered by an issued patent or pending patent application; ● our licensors or collaborators might not have been the first to file patent applications covering an invention; ● others may independently develop similar or alternative technologies or duplicate any of our or our licensors’ technologies without infringing our intellectual property rights; ● pending patent applications may not lead to issued patents; 63 Table of Contents ● issued patents may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we may not develop or in-license additional proprietary technologies that are patentable; ● the patents of others may have an adverse effect on our business; and ● we may choose not to file a patent application for certain trade secrets or know-how, and a third party may subsequently obtain a patent covering such intellectual property.
The following examples are illustrative: ● others may be able to make products that are similar to our product candidates but that are not covered by the claims of the patents that we license; ● our licensors or collaborators might not have been the first to make the inventions covered by an issued patent or pending patent application; ● our licensors or collaborators might not have been the first to file patent applications covering an invention; ● others may independently develop similar or alternative technologies or duplicate any of our or our licensors’ technologies without infringing our intellectual property rights; ● pending patent applications may not lead to issued patents; ● issued patents may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; 59 Table of Contents ● we may not develop or in-license additional proprietary technologies that are patentable; ● the patents of others may have an adverse effect on our business; and ● we may choose not to file a patent application for certain trade secrets or know-how, and a third party may subsequently obtain a patent covering such intellectual property.
We need additional funding to fully execute our business plan, which funding may not be available on commercially acceptable terms or at all. If we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate the commercialization of our development and manufacturing services and efforts for our product development programs.
We will need additional funding to fully execute our business plan, which funding may not be available on commercially acceptable terms or at all. If we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate the commercialization of our development and manufacturing services and efforts for our product development programs.
Our ability to generate revenue depends on a number of factors, including our ability to: ● set an acceptable price for our products and obtain coverage and adequate reimbursement from third-party payors; ● establish sales, marketing, manufacturing and distribution systems; add operational, financial and management information systems and personnel, including personnel to support our clinical, manufacturing and planned future clinical development and commercialization efforts and operations as a public company; ● manufacture commercial quantities of product candidates at acceptable cost levels; ● achieve broad market acceptance of our product candidates in the medical community and with third-party payors and consumers; ● attract and retain an experienced management and advisory team; ● launch commercial sales of our products, whether alone or in collaboration with others; and 43 Table of Contents ● maintain, expand and protect our intellectual property portfolio.
Our ability to generate revenue depends on a number of factors, including our ability to: ● set an acceptable price for our products and obtain coverage and adequate reimbursement from third-party payors; ● establish sales, marketing, manufacturing and distribution systems; add operational, financial and management information systems and personnel, including personnel to support our clinical, manufacturing and planned future clinical development and commercialization efforts and operations as a public company; ● manufacture commercial quantities of product candidates at acceptable cost levels; 37 Table of Contents ● achieve broad market acceptance of our product candidates in the medical community and with third-party payors and consumers; ● attract and retain an experienced management and advisory team; ● launch commercial sales of our products, whether alone or in collaboration with others; and ● maintain, expand and protect our intellectual property portfolio.
Reliance on third-party manufacturers and suppliers entails risks to which we would not be subject if we manufacture our clinical product candidate ourselves, including: ● reliance on the third parties for regulatory compliance and quality assurance; 56 Table of Contents ● the possible breach of the manufacturing agreements by the third parties because of factors beyond our control or the insolvency of any of these third parties or other financial difficulties, labor unrest, natural disasters or other factors adversely affecting their ability to conduct their business; and ● possibility of termination or non-renewal of the agreements by the third parties, at a time that is costly or inconvenient for us, because of our breach of the manufacturing agreement or based on their own business priorities.
Reliance on third-party manufacturers and suppliers entails risks to which we would not be subject if we manufacture our clinical product candidate ourselves, including: ● reliance on the third parties for regulatory compliance and quality assurance; ● the possible breach of the manufacturing agreements by the third parties because of factors beyond our control or the insolvency of any of these third parties or other financial difficulties, labor unrest, natural disasters or other factors adversely affecting their ability to conduct their business; and 52 Table of Contents ● possibility of termination or non-renewal of the agreements by the third parties, at a time that is costly or inconvenient for us, because of our breach of the manufacturing agreement or based on their own business priorities.
All of our existing product candidates are in very early stages of development and will require extensive additional clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue.
All of our existing product candidates are in early stages of development and will require extensive additional clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue.
Furthermore, if any of our products are approved and then cause serious or unexpected side effects, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw their approval of the clinical product candidate or impose restrictions on its distribution or other risk management measures; ● regulatory authorities may require the addition of labeling statements, such as warnings or contraindications; 54 Table of Contents ● we may be required to conduct additional clinical trials; ● we could be sued and held liable for injuries sustained by patients; ● we could elect to discontinue the sale of the clinical product candidate; and ● our reputation may suffer.
Furthermore, if any of our products are approved and then cause serious or unexpected side effects, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw their approval of the clinical product candidate or impose restrictions on its distribution or other risk management measures; ● regulatory authorities may require the addition of labeling statements, such as warnings or contraindications; ● we may be required to conduct additional clinical trials; ● we could be sued and held liable for injuries sustained by patients; ● we could elect to discontinue the sale of the clinical product candidate; and ● our reputation may suffer.
If we are unable to raise funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies; b) seek collaborators for our technology and product candidates on terms that are less favorable 46 Table of Contents than might otherwise be available; c) relinquish or otherwise dispose of rights to technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or d) possibly liquidate assets or cease operations.
If we are unable to raise funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies; b) seek collaborators for our technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or otherwise dispose of rights to technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or d) possibly liquidate assets or cease operations.
We cannot predict whether investors will find our common stock less attractive if we rely on such exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and the market price of our common stock may be more volatile. 72 Table of Contents Item 1B.
We cannot predict whether investors will find our common stock less attractive if we rely on such exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and the market price of our common stock may be more volatile. 69 Table of Contents Item 1B.
While we make significant efforts to protect our partners’ proprietary and confidential information, including requiring our employees to enter into agreements protecting such information, if any of our employees breaches the non-disclosure provisions in such agreements, or if our partners make claims that their proprietary information has been disclosed, our reputation may suffer 66 Table of Contents damage and we may become subject to legal proceedings that could require us to incur significant expenses and divert our management’s time, attention and resources.
While we make significant efforts to protect our partners’ proprietary and confidential information, including requiring our employees to enter into agreements protecting such information, if any of our employees breaches the non-disclosure provisions in such agreements, or if our partners make claims that their proprietary information has been disclosed, our reputation may suffer damage and we may become subject to legal proceedings that could require us to incur significant expenses and divert our management’s time, attention and resources.
After March 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
After March 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, enacted in 60 Table of Contents September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
These requirements include submissions of safety, efficacy and other post-marketing information and reports, establishment registration and drug listing requirements, continued compliance with cGMP, requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping and current GCP requirements for any clinical trials that we conduct post-approval.
These requirements include submissions of safety, 46 Table of Contents efficacy and other post-marketing information and reports, establishment registration and drug listing requirements, continued compliance with cGMP, requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping and current GCP requirements for any clinical trials that we conduct post-approval.
Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. 60 Table of Contents The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad.
Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad.
As part of the regulatory 45 Table of Contents process, we must conduct clinical trials for each product candidate to demonstrate safety and efficacy to the satisfaction of the FDA and other regulatory authorities. The number and design of the clinical trials that will be required varies depending upon product candidate, the condition being evaluated, and the trial results themselves.
As part of the regulatory process, we must conduct clinical trials for each product candidate to demonstrate safety and efficacy to the satisfaction of the FDA and other regulatory authorities. The number and design of the clinical trials that will be required varies depending upon product candidate, the condition being evaluated, and the trial results themselves.
Obtaining approval of an NDA or BLA is an extensive, lengthy, expensive, and inherently uncertain process, and the FDA may delay, limit or deny approval of its product for many reasons. Because we have limited financial and managerial resources, our focus is limited to the development of multiple product candidates.
Obtaining approval of an NDA or BLA is an 41 Table of Contents extensive, lengthy, expensive, and inherently uncertain process, and the FDA may delay, limit or deny approval of its product for many reasons. Because we have limited financial and managerial resources, our focus is limited to the development of multiple product candidates.
Furthermore, we may have to incur debt or issue equity securities to pay for any additional future acquisitions or investments, the issuance of which could be dilutive to our existing stockholders. Our business and operations would suffer in the event of computer system failures.
Furthermore, we may have to incur debt or issue equity securities to pay for any additional future acquisitions or investments, the issuance of which could be dilutive to our existing stockholders. 62 Table of Contents Our business and operations would suffer in the event of computer system failures.
If we are unable to do so we may need to conduct additional clinical trials with product manufactured by the new manufacturer. If we or any outsourced manufacturer of our products are not able to manufacture sufficient quantities of our clinical product candidate, our development activities would be impaired.
If we are unable to do so we may need to conduct additional clinical trials with product manufactured by the new manufacturer. 51 Table of Contents If we or any outsourced manufacturer of our products are not able to manufacture sufficient quantities of our clinical product candidate, our development activities would be impaired.
If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us.
If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate 58 Table of Contents it, from using that technology or information to compete with us.
We have not yet contracted with any third parties to conduct clinical trials of product candidates we develop independently of collaborators. We will depend on licensees or on independent clinical investigators, contract research organizations and other third-party service providers to conduct the clinical trials of our 58 Table of Contents product candidates.
We have not yet contracted with any third parties to conduct clinical trials of product candidates we develop independently of collaborators. We will depend on licensees or on independent clinical investigators, contract research organizations and other third-party service providers to conduct the clinical trials of our product candidates.
We, as well as certain of our directors and officers, may be subject to claims or lawsuits during the ordinary course of business. Regardless of the outcome, these lawsuits may result in significant legal fees and expenses and could divert management’s time and other resources.
We may be subject to various litigation claims and legal proceedings. We, as well as certain of our directors and officers, may be subject to claims or lawsuits during the ordinary course of business. Regardless of the outcome, these lawsuits may result in significant legal fees and expenses and could divert management’s time and other resources.
The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of product candidates are and will remain subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries that each have differing 48 Table of Contents regulations.
The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of product candidates are and will remain subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries that each have differing regulations.
In addition, if we change manufacturers at any point once we commence clinical trials or after 55 Table of Contents approval of a product candidate, we will be required to demonstrate comparability between the product manufactured by the old manufacturer and the product manufactured by the new manufacturer.
In addition, if we change manufacturers at any point once we commence clinical trials or after approval of a product candidate, we will be required to demonstrate comparability between the product manufactured by the old manufacturer and the product manufactured by the new manufacturer.
If the 51 Table of Contents immune response generated by a product candidate is too low or occurs in too few treated individuals, then the product candidate will have no commercial value. ● Enrollment in any clinical trials that we or our licensee’s conduct may be slower than projected, resulting in significant delays.
If the immune response generated by a product candidate is too low or occurs in too few treated individuals, then the product candidate will have no commercial value. ● Enrollment in any clinical trials that we or our licensee’s conduct may be slower than projected, resulting in significant delays.
Statements about plans, predictions or expectations should not be construed to be assurances of performance or promises to take a given course of action. Risks Related to Our Financial Position and Need for Additional Capital We have a limited operating history developing vaccines and therapeutics, which may limit the ability of investors to make an informed investment decision.
Statements about plans, predictions or expectations should not be construed to be assurances of performance or promises to take a given course of action. Risks Related to Our Business, Financial Position and Capital Requirements We have a limited operating history developing vaccines and therapeutics, which may limit the ability of investors to make an informed investment decision.
For example, clinical trials require adequate supplies of clinical trial material and sufficient patient enrollment to power the trial. Delays in patient enrollment can result in increased costs and longer development times.
For example, 45 Table of Contents clinical trials require adequate supplies of clinical trial material and sufficient patient enrollment to power the trial. Delays in patient enrollment can result in increased costs and longer development times.
We expect to incur losses during our next fiscal year, we do not anticipate generating significant revenue for several years and may never achieve or maintain profitability. Since our 2008 spinoff from Integrated BioPharma, we have incurred operating losses and negative cash flows from operations.
We expect to incur losses during our next fiscal year, we do not anticipate generating significant revenue for several years and may never achieve or maintain profitability. Since our 2008 spinoff from Integrated BioPharma, we have incurred operating losses and negative cash flows from operations, and we expect to continue to generate operating losses for the foreseeable future.
Specifically, if in the due exercise of its fiduciary obligations, the Board of Directors were to determine that a takeover proposal was not in our best interest, shares could be issued by our Board of Directors without stockholder approval in one or more transactions that might prevent or render more difficult or costly the completion of the takeover by: ● diluting the voting or other rights of the proposed acquirer or insurgent stockholder group, 68 Table of Contents ● putting a substantial voting bloc in institutional or other hands that might undertake to support the incumbent Board of Directors, or ● effecting an acquisition that might complicate or preclude the takeover.
Specifically, if in the due exercise of its fiduciary obligations, the Board of Directors were to determine that a takeover proposal was not in our best interest, shares could be issued by our Board of Directors without stockholder approval in one or more transactions that might prevent or render more difficult or costly the completion of the takeover by: ● diluting the voting or other rights of the proposed acquirer or insurgent stockholder group, ● putting a substantial voting bloc in institutional or other hands that might undertake to support the incumbent Board of Directors, or ● effecting an acquisition that might complicate or preclude the takeover. 66 Table of Contents Our certificate of incorporation also allows our Board of Directors to fix the number of directors in the by-laws.
Our future profitability and cash flow in large part depends on the advancement of our research and development programs, including our AI platform, and our ability to successfully develop, partner or commercialize our product candidates and to a lesser extent, which is not anticipated for several years.
Our future profitability and cash flow in large part depends on the advancement of our research and development programs, including our AI Drug Discovery Platform, and our ability to successfully develop, partner or commercialize our product candidates, which is not anticipated for several years.
Our most significant competitors, among others, are fully integrated pharmaceutical companies such as Eli Lilly and Company, Bristol-Myers Squibb Company, Merck & Co., Inc., Novartis AG, MedImmune, LLC (a wholly owned subsidiary of AstraZeneca plc), Johnson & Johnson, Pfizer Inc., MerckKGaA and Sanofi SA, and more established biotechnology companies such as Genentech, Inc.
Our most significant competitors, among others, are fully integrated pharmaceutical companies such as Eli Lilly and Company, Novo Nordisk A/S, Amgen Inc., Bristol-Myers Squibb Company, Merck & Co., Inc., Novartis AG, MedImmune, LLC (a wholly owned subsidiary of AstraZeneca plc), Johnson & Johnson, Pfizer Inc., Merck KGaA and Sanofi SA, and more established biotechnology companies such as Genentech, Inc.
We anticipate that our expenses will increase in the future. Although we have recently reduced expenses, we expect our research and development expenses to increase significantly as our product candidates advance in clinical development, and as we add more employees.
We anticipate that our expenses will increase in the future. We expect our research and development expenses to increase significantly as our product candidates advance in clinical development, and as we add more employees.
These factors include the following: ● the progress of our research activities; ● the number and scope of our research programs; ● the progress of our preclinical and clinical development activities; ● the progress of the development efforts of parties with whom we have entered into research and development agreements and amount of funding received from partners and collaborators; ● our ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements; ● our ability to achieve our milestones under licensing arrangements; ● the costs associated with manufacturing related services to produce materials for use in our clinical trials; ● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; ● the costs incurred to screen and enroll patients; and ● the costs and timing of regulatory approvals.
These factors include the following: ● the progress of our research activities; ● the number and scope of our research programs; ● the progress of our preclinical and clinical development activities; ● the progress of the development efforts of parties with whom we have entered into research and development agreements and amount of funding received from partners and collaborators; ● our ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements; ● our ability to achieve our milestones under licensing arrangements; ● the costs associated with manufacturing related services to produce materials for use in our clinical trials; ● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; ● the costs incurred to screen and enroll patients; and ● the costs and timing of regulatory approvals. 40 Table of Contents We have based our estimate on assumptions that may prove to be wrong.
Use of our laboratory space in San Diego is critical to our success. A natural disaster or other disruptions at our laboratory would adversely affect our business, financial condition, and results of operations . We currently conduct all of our pre-clinical research at our laboratory in San Diego using specialized equipment that we have purchased.
A natural disaster or other disruptions at our laboratory would adversely affect our business, financial condition, and results of operations . We currently conduct all of our pre-clinical research at our laboratory in San Diego using specialized equipment that we have purchased.
To make such renewing investment we will need to obtain additional financing and/or collaborations. If we are unable to secure such financing, we will not have sufficient resources to continue 53 Table of Contents such investment.
To make such renewing investment we will need to obtain additional financing and/or collaborations. If we are unable to secure such financing, we will not have sufficient resources to continue such investment.
Past experience may not be indicative of future performance, and as noted elsewhere in this Annual Report, we have included forward-looking statements about our business, plans and prospects that are subject to change.
Detailed Risk Factors Our business faces many risks. Past experience may not be indicative of future performance, and as noted elsewhere in this Annual Report, we have included forward-looking statements about our business, plans and prospects that are subject to change.
To the extent that we initiate or continue clinical development without securing collaborator or licensee funding, our research and development expenses could increase substantially.
To the extent that we initiate or continue 39 Table of Contents clinical development without securing collaborator or licensee funding, our research and development expenses could increase substantially.
Any or all of the foregoing could harm our reputation and adversely affect our results of operations and our business reputation. 67 Table of Contents Any failure to maintain the security of information relating to our patients, customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm our reputation.
Any failure to maintain the security of information relating to our patients, customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm our reputation.
Our comprehensive net loss was approximately ($24.9) million and ($64.8) million for the years ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of approximately ($313.8) million. To date, we have financed our operations primarily through the sale of common stock, the Woodforest Credit Agreement, preferred stock and warrants.
Our net loss was approximately $18.4 million and $24.9 million for the years ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of approximately $332.2 million. To date, we have financed our operations primarily through the sale of common stock, the Woodforest Credit Agreement, preferred stock and warrants.
We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to our product candidates in the immune-oncology field.
We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to our product candidates in the cardiometabolic and obesity fields.
The At Market Issuance Sales Agreement (the “ATM Agreement”) with Chardan Capital Markets, LLC and Craig-Hallum Capital Group LLC that we entered into with Chardan Capital Markets, LLC and Craig-Hallum Capital Group LLC on July 3, 2024, also has certain requirements that we must meet in order to sell securities pursuant to the ATM Agreement.
We currently have no committed sources of funding. The At Market Issuance Sales Agreement (the “ATM Agreement”) with Chardan Capital Markets, LLC (“Chardan”) and Craig-Hallum Capital Group LLC (“Craig-Hallum”) that we entered into with Chardan and Craig-Hallum on July 3, 2024, also has certain requirements that we must meet in order to sell securities pursuant to the ATM Agreement.
Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology.
Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects. 57 Table of Contents Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology.
If we or our collaborators do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully develop and commercialize our product candidates, which would materially harm our business.
If we or our collaborators do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully develop and commercialize our product candidates, which would materially harm our business. The risks associated with our product candidates not proceeding through clinical development is high.
We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, 62 Table of Contents consultants, advisors and other third parties.
We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also seek to enter into confidentiality and invention or patent assignment agreements with our employees and consultants.
If we and our collaborators do not successfully develop and commercialize product candidates based upon our technologies, we will not obtain product or collaboration revenues in future periods, which likely would result in significant harm to our financial position and adversely affect our stock price.
If we and our collaborators do not successfully develop and commercialize product candidates based upon our technologies, we will not obtain product or collaboration revenues in future periods, which likely would result in significant harm to our financial position and adversely affect our stock price. Clinical trials are very expensive, time-consuming, and difficult to design and implement.
Because of the numerous risks and uncertainties associated with development and manufacturing product candidates, we are unable to predict if we will generate significant revenue. If we cannot successfully execute on any of the factors listed above, our business may not succeed, and we may never generate significant revenue. We are reviewing potential options to extend our cash runway.
Because of the numerous risks and uncertainties associated with development and manufacturing product candidates, we are unable to predict if we will generate significant revenue. If we cannot successfully execute on any of the factors listed above, our business may not succeed, and we may never generate significant revenue. We have incurred significant losses since our inception.
We will rely on these vendors and individuals to perform many facets of the clinical development process on our behalf, including conducting preclinical studies and will rely on them for the recruitment of sites and subjects for participation in our clinical trials, maintenance of good relations with the clinical sites, and ensuring that these sites are conducting our trials in compliance with the trial protocol and applicable regulations.
We will rely on these vendors and individuals to perform many facets of the clinical development process on our behalf, including conducting preclinical studies and will rely on them for the recruitment of sites and subjects for participation in our clinical trials, maintenance of good relations with the clinical sites, and ensuring that these sites are conducting our trials in compliance with the trial protocol and applicable regulations. 54 Table of Contents We will rely heavily on these parties for successful execution of our clinical trials but will not control many aspects of their activities.
If the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages and be required to alter or cease certain of our business practices. Any of these outcomes could cause our business, financial performance and cash position to be negatively impacted.
If the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages and be required to alter or cease certain of our business practices.
The sale of a substantial number of shares of our common stock to investors, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
The sale of a substantial number of shares of our common stock to investors, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales. 65 Table of Contents We have the option to pay the contingent development milestone consideration owed to the RubrYc shareholders in shares of our common stock.
Risks Related to Intellectual Property If we or our licensors are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
Any of these outcomes could cause our business, financial performance and cash position to be negatively impacted. 55 Table of Contents Risks Related to Intellectual Property If we or our licensors are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
Any manufacturing problems experienced by us could result in a delay or interruption in the supply of our clinical product candidate until the problem is cured or until we locate and qualify an alternative source of manufacturing and supply.
For any clinical product candidates we may develop we will rely on third-party contract manufacturers. Any manufacturing problems experienced by us could result in a delay or interruption in the supply of our clinical product candidate until the problem is cured or until we locate and qualify an alternative source of manufacturing and supply.
We need additional capital to fully implement our near term and long-term business, operating and development plans as we do not anticipate that any of our product candidates will generate revenue in the next few years, if at all.
Despite our receipt of approximately $46.5 million in net proceeds in connection with the 2025 Offering, we will need additional capital to fully implement our long-term business, operating and development plans as we do not anticipate that any of our product candidates will generate revenue in the next few years, if at all.
Risks Related to the Development and Commercialization of Our Technologies and Product Candidates We currently have a limited operating history developing precision antibodies, no products approved for commercial sale, have no significant source of revenue and may never generate significant revenue.
If our public float decreases, the amount of securities we may sell under Form S-3 may also decrease. ​ Risks Related to the Development and Commercialization of Our Technologies and Product Candidates We currently have a limited operating history developing precision antibodies, no products approved for commercial sale, have no significant source of revenue and may never generate significant revenue.
We may never succeed in these activities. We may never generate revenues that are significant or large enough to achieve profitability. All of our existing product candidates are in various stages of development and will require extensive additional clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue.
All of our existing product candidates are in various stages of development and will require extensive additional clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue.
By way of example, on January 19, 2024, the price of our common stock closed at $1.06 per share while on March 28, 2024, our stock price closed at $4.06 per share. We may incur rapid and substantial decreases in our stock price in the foreseeable future that are unrelated to our operating performance or prospects.
By way of example, on August 11, 2025, the price of our common stock closed at $0.59 per share while on March 3, 2025, our stock price closed at $6.41 per share. We may incur rapid and substantial decreases in our stock price in the foreseeable future that are unrelated to our operating performance or prospects.
In addition, the ability of our Board of Directors to designate and issue shares of preferred stock without any further action on the part of our stockholders may impede a takeover of our company and may prevent a transaction that is favorable to our stockholders. 69 Table of Contents We do not anticipate paying cash dividends for the foreseeable future, and therefore investors should not buy our stock if they wish to receive cash dividends.
In addition, the ability of our Board of Directors to designate and issue shares of preferred stock without any further action on the part of our stockholders may impede a takeover of our company and may prevent a transaction that is favorable to our stockholders. We do not intend to pay dividends in the foreseeable future.
We are currently in preclinical development of multiple product candidates as potential treatments across multiple therapeutic areas; however, we announced we are evaluating potential options to extend our cash runway and may change the focus of our resources. It is possible that we may never be able to develop a marketable product candidate.
We are currently in preclinical development of multiple product candidates as potential treatments across multiple therapeutic areas. It is possible that we may never be able to develop a marketable product candidate.
We anticipate that further product development is also expected to increase expenses, including but not limited to the expected continued IND-enabling studies IBIO-101, reviewing whether IBIO-101 can be utilized in certain orphan diseases, and the additional studies that will be required to support development of our immuno-oncology and cardiometabolic programs.
We anticipate that further product development is also expected to increase expenses, including but not limited to the expected continued IND-enabling studies IBIO-610, IBIO-600, and the additional studies that will be required to support development of our other preclinical cardiometabolic programs.
We estimate that clinical trials for our product candidates would take at least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials.
Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements on terms less favorable to us than possible. 49 Table of Contents We, our clients and collaborators, are very early in our development efforts.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements on terms less favorable to us than possible. 42 Table of Contents Preclinical and clinical development involves a lengthy and expensive process, with an uncertain outcome.
If we are unable to generate revenue from product sales, we will not become profitable, and we may be unable to continue our operations. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
If we are unable to generate revenue from product sales, we will not become profitable, and we may be unable to continue our operations. We may not be able to generate revenue or achieve profitability in the future.
There can be no assurance that we will be able to retain key personnel, or to attract and retain additional qualified employees especially in light of our cash position. Our inability to attract and retain key personnel as we grow in two locations may have a material adverse effect on our business.
There can be no assurance that we will be able to retain key personnel, or to attract and retain additional qualified employees especially in light of our cash position.
Risks Related to Our Common Stock ​ Our stockholders will experience substantial dilution from the issuance of the development milestone payments if paid in equity and may not realize a benefit from the acquisition of substantially all of the assets RubrYc commensurate with the ownership dilution they will experience in connection therewith.
Our stockholders will experience substantial dilution from the issuance of shares of common stock to pay the contingent development milestone consideration, should we elect to pay such development milestones in shares of common stock in lieu of cash and may not realize a benefit from the acquisition of substantially all of the assets RubrYc commensurate with the ownership dilution they will experience in connection therewith.
Our current cash, cash equivalents and restricted cash as of June 30, 2024, is anticipated to be sufficient to support operations into the first quarter of fiscal year 2026. ​ There can be no assurance that our collaboration with AstralBio will be successful or will entered into agreements for the sale or out-licensing of any of our product candidates on favorable terms or that the exploration of potential options will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms.
There can be no assurance that our collaboration with AstralBio will be successful or will entered into agreements for the sale or out-licensing of any of our product candidates on favorable terms or that the exploration of potential options will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms.
Additionally, we may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. We do not have any committed sources of financing at this time, and it is uncertain whether additional funding will be available when we need it on terms that will be acceptable to us, or at all.
We do not have any committed sources of financing at this time, and it is uncertain whether additional funding will be available when we need it on terms that will be acceptable to us, or at all.
We may observe adverse or serious adverse events or drug-drug interactions in preclinical studies or clinical trials of our clinical product candidate, which could result in the delay or termination of its development, prevent regulatory approval, or limit its market acceptance if it is ultimately approved.
We may observe adverse or serious adverse events or drug-drug interactions in preclinical studies or clinical trials of our clinical product candidate, which could result in the delay or termination of its development, prevent regulatory approval, or limit its market acceptance if it is ultimately approved. 48 Table of Contents Adverse events caused by any of our product candidates or generally by plant-based therapeutics could cause reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval.
Because of the significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in our business strategy and future funding requirements. ​ Our historical operating results indicate substantial doubt exists related to our ability to operate as a going concern.
Because 38 Table of Contents of the significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in our business strategy and future funding requirements.
However, we will be responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Third parties may not complete activities on schedule or may not conduct our clinical trials in accordance with regulatory requirements or our stated protocols.
For example, the investigators participating in our clinical trials will not be our employees. However, we will be responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial.
We also seek to enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Our trade secrets may also be obtained by third parties by other means, such as breaches of our physical or computer security systems.
Although the material weakness has been remediated, there can be no assurance that the internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations.
Although a previously identified material weakness in our internal controls has been remediated since June 2023, there can be no assurance that the internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future.
Clinical trials are very expensive, time-consuming, and difficult to design and implement. 50 Table of Contents Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time-consuming.
Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time-consuming. We estimate that clinical trials for our product candidates would take at least several years to complete.
We have never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
We have never paid cash dividends on our common stock. We currently intend to retain our future earnings, if any, to finance the operation and growth of our business and currently do not plan to pay any cash dividends in the foreseeable future.
Our Board of Directors is divided into three classes, each of which serves for a staggered term of three years. This division of our Board of Directors could have the effect of impeding an attempt to take over our company or change or remove management, since only one class will be elected annually.
This division of our Board of Directors could have the effect of impeding an attempt to take over our company or change or remove management, since only one class will be elected annually. Thus, only approximately one-third of the existing Board of Directors could be replaced at any election of directors.
The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates.
Third parties may not complete activities on schedule or may not conduct our clinical trials in accordance with regulatory requirements or our stated protocols. The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates.
Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, our business, operating results, financial condition and prospects could be materially and adversely affected, and we may be unable to continue our operations. 47 Table of Contents To the extent that we raise additional capital through a public or private offering and sale of equity securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder.
To the extent that we raise additional capital through a public or private offering and sale of equity securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder.
We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and ultimately unsuccessful. Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties.
Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries. Competitors may infringe our issued patents or other intellectual property.
Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property.
To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe lease is triple net with Base Rent starting at $4.50 per month per square foot escalating approximately 3.0 percent per year during the lease term. iBio will use the facility primarily for R&D associated with its AI Drug Discovery Platform and our biologic product portfolio.
Biggest changeThe lease is triple net with base rent starting at $4.50 per month per square foot escalating approximately 3.0% per year during the lease term. We will use the facility primarily for R&D associated 70 Table of Contents with its AI Drug Discovery Platform and our biologic product portfolio.
Biopharmaceutical R&D Facility On September 11, 2021, iBio entered into a lease with SAN DIEGO INSPIRE 4, LLC for approximately 11,383 square feet of lab and office space at 11750 Sorrento Valley Road in San Diego, CA. The lease commenced in September 2022. The lease is for seven years and four months.
Item 2. Properties. Biopharmaceutical R&D Facility On September 11, 2021, iBio entered into a lease with SAN DIEGO INSPIRE 4, LLC for approximately 11,383 square feet of lab and office space at 11750 Sorrento Valley Road in San Diego, CA. The lease commenced in September 2022. The lease is for seven years and four months.
Removed
Facility On November 1, 2021, the Company and its subsidiary, iBio CDMO LLC (“iBio CDMO”, and collectively with the Company, the “Purchaser”) entered into a series of agreements (the “Transaction”) with College Station Investors LLC (“College Station”), and Bryan Capital Investors LLC (“Bryan Capital” and, collectively with College Station, “Seller”), each affiliates of Eastern Capital Limited (“Eastern,” a former significant stockholder of the Company) described in more detail below whereby in exchange for a certain cash payment and a warrant the Company: 73 Table of Contents (i) acquired both the Facility where iBio CDMO at that time conducted business and also the rights as the tenant in the Facility’s ground lease; (ii) acquired all of the equity owned by one of the affiliates of Eastern in the Company and iBio CDMO; and (iii) otherwise terminated all agreements between the Company and the affiliates of Eastern.
Added
We believe that the facility is adequate for our current operations and needs.
Removed
On May 17, 2024, iBio CDMO entered into the 2024 Purchase and Sale Agreement with The Board of Regents pursuant to which iBio CDMO agreed to terminate the Ground Lease Agreement, related to the Land and to sell to The Board of Regents the Property.
Removed
The 2024 Purchase and Sale Agreement provided that the Property will be sold to The Board of Regents for the Purchase Price. The closing of the sale of the Property occurred on May 31, 2024.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeLitigation, regardless of the outcome, could have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. ​ Item 4. Mine Safety Disclosures. Not applicable. ​ 74 Table of Contents PART II
Biggest changeLitigation, regardless of the outcome, could have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. ​ Item 4. Mine Safety Disclosures. Not applicable. ​ 71 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRecent Sales of Unregistered Securities There were no sales of unregistered securities other than as set forth in documents previously filed by the Company with the SEC. Issuer Purchases of Equity Securities We did not purchase any of our equity securities during the fiscal year ended June 30, 2024.
Biggest changeRecent Sales of Unregistered Securities There were no sales of unregistered securities during the quarter ended June 30, 2025 other than as set forth in documents previously filed by the Company with the SEC. Issuer Purchases of Equity Securities We did not purchase any of our equity securities during the fiscal year ended June 30, 2025.
Market Information Our common stock is traded on the NYSE American under the trading symbol “IBIO.” Holders On September 6, 2024, there were 14 stockholders of record of our common stock, one of which was Cede & Co., a nominee for Depository Trust Company, or DTC.
Market Information Our common stock is traded on the Nasdaq Stock Market LLC under the trading symbol “IBIO.” Holders On August 20, 2025, there were 21 stockholders of record of our common stock, one of which was Cede & Co., a nominee for Depository Trust Company, or DTC.
Removed
Reverse Stock Split As discussed above, the Company effected a reverse stock split at a ratio of one-for-twenty five (1:25) shares of the Company's common stock on October 7, 2022. All share and per share amounts of common stock presented have been retroactively adjusted to reflect the one-for-twenty-five reverse stock split.
Added
For information regarding our equity compensation plans, see PART III ITEM 12, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.” Item 6. [Reserved]
Removed
Further, as discussed above, the Company effected a reverse stock split at a ratio of one-for-twenty (1:20) shares of the Company's common stock on November 29, 2023. All share and per share amounts of common stock presented have been retroactively adjusted to reflect the one-for-twenty-five reverse stock split.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

33 edited+64 added−90 removed11 unchanged
Biggest changeThe decrease in net cash was primarily used to support our ongoing operations. ​ Net Cash Provided by Investing Activities In 2024, net cash provided by investing activities was $0.9 million, which primarily consisted of proceeds from the sale of intellectual property rights to Otsuka of $1 million and proceeds from the sale of fixed assets of $0.1 million, offset by the purchase of fixed assets of $0.2 million.
Biggest changeIn fiscal year 2024, net cash provided by investing activities was $0.9 million, which primarily consisted of proceeds from the sale of intellectual property rights to Otsuka of $1 million and proceeds from the sale of fixed assets of $0.1 million, offset by the purchase of fixed assets of $0.2 million. ​ Net Cash Provided by Financing Activities Net cash provided by financing activities in fiscal year 2025 was approximately $8.9 million and was attributable to the proceeds from the inducement of Existing Warrants and the sale of securities partially offset by payments towards debt, including the finance lease obligations, term promissory note and equipment financing loan.
Off-Balance Sheet Arrangements As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (SPEs), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes.
Off-Balance Sheet Arrangements As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (“SPE”s), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes.
During the fourth quarter of fiscal year 2024, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million at June 30, 2024.
During the fourth quarter of fiscal year 2025, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million at June 30, 2025.
The sum of the discounted excess earnings and the present value of the tax benefit related to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was $5.9 million as of the June 30, 2024, valuation date.
The sum of the discounted excess earnings and the present value of the tax benefit related to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was $5.9 million as of the June 30, 2025 valuation date.
The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 16% discount rate, which was based on iBio’s weighted average cost of capital.
The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 15% discount rate, which was based on iBio’s weighted average cost of capital.
Given that the carrying amount of the asset was $5 million at June 30, 2024, it was concluded that no impairment existed. We will continue to monitor the value of the IP as part of our annual accounting policy for impairment of long-live assets.
Given that the carrying amount of the asset was $5 million at June 30, 2025, it was concluded that no impairment existed. We will continue to monitor the value of the IP as part of our annual accounting policy for impairment of long-lived assets.
As of June 30, 2024, we were not involved in any SPE transactions.
As of June 30, 2025, we were not involved in any SPE transactions.
Potential options being considered to further increase liquidity, focusing product development on a select number of product candidates, the sale or out-licensing of certain product candidates, raising money from the capital markets, grant revenue or collaborations, or a combination thereof.
Potential options being considered to further increase liquidity include focusing product 77 Table of Contents development on a select number of product candidates, the sale or out-licensing of certain product candidates, raising money from the capital markets, collaborations, or a combination thereof.
Historical information is modified as appropriate based on current business factors and various assumptions that we believe are necessary to form a basis for making judgments about the carrying value of assets and liabilities. We evaluate our estimates on an ongoing basis and make changes when necessary. Actual results could differ from our estimates.
We base our estimates, to the extent possible, on historical experience. Historical information is modified as appropriate based on current business factors and various assumptions that we believe are necessary to form a basis for making judgments about the carrying value of assets and liabilities. We evaluate our estimates on an ongoing basis and make changes when necessary.
Liquidity and Capital Resources The history of significant losses, the negative cash flow from operations, the limited cash resources on hand and the dependence by the Company on its ability to obtain additional financing to fund its operations after the current cash resources are exhausted raise substantial doubt about the Company's ability to continue as a going concern.
The history of significant losses, the negative cash flow from operations, the limited cash resources on hand and the dependence by us on our ability to obtain additional financing to fund our operations after the current cash resources are exhausted raised substantial doubt about our ability to continue as a going concern.
See Note 4 – Summary of Significant Accounting Policies - for a complete discussion of our significant accounting policies and estimates.
Actual results could differ from our estimates. See Note 4 – Summary of Significant Accounting Policies - for a complete discussion of our significant accounting policies and estimates.
Accordingly, we may have to adjust our cash flow projections and valuation assumptions in the near future to account for market trends and any changes to our research and development plans.
Accordingly, we may have to adjust our cash flow projections and valuation assumptions in the near future to account for market trends and any changes to our research and development plans. Any such future adjustments may lead to material future impairments in the IP and other related assets.
General and Administrative Expenses (“G&A”) G&A expenses for fiscal year ended June 30, 2024 and 2023 were approximately $11.7 million and $19.0 million, respectively, a decrease of ($7.3) million or (39)%.
General and Administrative Expenses (“G&A”) G&A expenses for the fiscal year ended June 30, 2025 and 2024 were approximately $10.7 million and $11.7 million, respectively, a decrease of $1.0 million or 8%.
Critical Accounting Estimates A critical accounting policy is one that is both important to the portrayal of a company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.
Critical Accounting Estimates A critical accounting policy is one that is both important to the portrayal of a company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. 79 Table of Contents Our consolidated financial statements are presented in accordance with accounting principles generally accepted in the United States of America (“U.S.
Other Income (Expense) Other income for the fiscal years ended June 30, 2024 and 2023 were $1.2 million and $0.03 million, an increase of approximately $1.2 million.
Other Income Other income for the fiscal years ended June 30, 2025 and 2024 were $0.2 million and $1.2 million, respectively, a decrease of approximately $1.0 million.
As of June 30, 2024, our accumulated deficit was approximately ($313.8) million, and we used approximately $6.8 million of net cash in fiscal year 2024. 84 Table of Contents We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of our technologies, through potential proceeds from the sale or out-licensing of assets, and through proceeds from the sale of additional equity or other securities.
We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of our technologies, through potential proceeds from the sale or out-licensing of assets, grant revenue or collaborations, and through proceeds from the sale of additional equity or other securities.
The preparation of consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. Some of those estimates are subjective and complex, and, consequently, actual results could differ from those estimates. We base our estimates, to the extent possible, on historical experience.
Some of those estimates are subjective and complex, and, consequently, actual results could differ from those estimates. We base our estimates, to the extent possible, on historical experience.
Unless the context requires otherwise, references in this Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc. Overview We are a pioneering biotechnology company at the intersection of AI and biologics, committed to reshaping the landscape of discovery.
Unless the context requires otherwise, references in this Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc. Overview We are a preclinical stage biotechnology company leveraging the power of AI for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space.
Total Operating Expenses Total operating expenses, consisting primarily of R&D and G&A expenses, for fiscal year ended June 30, 2024 were approximately $16.9 million, compared to approximately $29.3 million for fiscal year ended June 30, 2023.
The decreases were partially offset by increased franchise taxes of $0.2 million and travel expenses of $0.1 million. 76 Table of Contents Total Operating Expenses Total operating expenses, consisting primarily of R&D and G&A expenses, for fiscal year ended June 30, 2025 were approximately $19.0 million, compared to approximately $16.9 million for fiscal year ended June 30, 2024.
Funding Requirements We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008.
Funding Requirements We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of June 30, 2025, our accumulated deficit was approximately $332.2 million, and we used approximately $5.6 million of net cash in fiscal year 2025.
Stockholders Net loss available to iBio, Inc. stockholders from both continuing and discontinued operations for fiscal year ended June 30, 2024 was approximately ($24.9) million, or ($6.50) per share, compared to approximately ($65.0) million, or ($106.19) per share, in fiscal year ended June 30, 2023.
The loss from Discontinued Operations for the year ended June 30, 2024 was approximately $9.5 million. ​ Net Loss Our net loss for the fiscal year ended June 30, 2025 was approximately $18.4 million, or $1.75 per share, compared to our net loss of approximately $24.9 million, or $6.50 per share, in the fiscal year ended June 30, 2024, which included the results of both continued and discontinued operations.
In addition to the aforementioned critical accounting estimates, the following accounting policies and estimates have been highlighted as significant because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial statements: ● revenue recognition; ● legal and contractual contingencies; ● research and development expenses; ● fair value of equity issuance related to debt extinguishment; and ● share-based compensation expenses. ​ We base our estimates, to the extent possible, on historical experience.
Our remaining critical accounting estimates remain consistent with the information disclosed in the same section in our last annual report on Form 10-K for the year ended June 30, 2024. 80 Table of Contents In addition to the aforementioned critical accounting estimates, the following accounting policies and estimates have been highlighted as significant because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial statements: ● revenue recognition; ● legal and contractual contingencies; ● research and development expenses; and ● share-based compensation expenses.
Net cash generated from financing activities in 2024 primarily related to proceeds from sales of common stock offset by payments made to settle all obligations related to the term note payable while the net cash spent in 2023 related to proceeds from sales of common stock offset by payments made towards term note payable.
Net cash provided by financing activities in fiscal year 2024 was approximately $24.5 million and primarily related to proceeds from sales of Common Stock offset by payments made to settle all obligations related to the term note payable. The decrease of $15.6 million was primarily due to a decrease in proceeds from the sale of Common Stock and pre-funded warrants.
(See Note 3 – Discontinued Operation and Note 5 – Financial Instruments for further information.) Impairment of Indefinite-Lived Intangible Assets ​ For indefinite life intangible assets, we perform an impairment test annually and whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable.
The following accounting estimate had a material impact on the results of operations of the Company for the year ended June 30, 2025. Impairment of Indefinite-Lived Intangible Assets ​ For indefinite life intangible assets, we perform an impairment test annually and whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable.
During the year ended June 30, 2024, we reported revenue in the amount of $0.2 million related to research activities performed and license fees. During the year ended June 30, 2023 we reported no revenue.
During the year ended June 30, 2024, we reported revenue in the amount of $0.2 million related to research activities performed and license fees. Research and Development Expenses (“R&D”) R&D expenses for the fiscal year ended June 30, 2025 and 2024 were approximately $8.3 million and $5.2 million, respectively, an increase of approximately $3.1 million or approximately 60%.
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the AI-driven discovery platform in the future.
We expect to use the net proceeds from these transactions for working capital and other general corporate purposes. ​ Results of Operations Revenue Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on advancing our AI-driven discovery platform to develop molecules against hard to drug targets.
The increase is mainly attributable to the sale of an intangible asset and an increase in interest income, partially offset by interest expenses. ​ Net Loss from Continuing Operations Net loss from continuing operations for fiscal year ended June 30, 2024 was ($15.4) million, or ($4.03) per share, compared to approximately ($29.3) million, or ($47.88) per share, in 2023. 80 Table of Contents Net Loss from Discontinued Operations ​ On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO) in order to complete our transformation into an AI-driven, precision antibody drug discovery and development company.
The increase is mainly attributable to increased research and development activities. Net Loss from Discontinued Operations ​ On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO) in order to complete our transformation into an AI-driven, precision antibody drug discovery and development company.
As we continue to leverage our technology stack and develop our existing immune-oncology pre-clinical pipeline, we are also seeking strategic partners with the capabilities to more rapidly advance these programs towards the clinic.
As we continue to leverage our technology stack and develop our existing immune-oncology pre-clinical pipeline, we are also seeking strategic partners with the capabilities to more rapidly advance these programs towards the clinic. ​ Our current therapeutics are all in preclinical development and we have not completed any clinical trials in humans for any therapeutic protein product candidate produced using our technology and there is a risk that we will be unsuccessful in developing or commercializing any product candidates.
However, we anticipate that our expenses will increase as we continue our research and development activities and conduct clinical trials. ​ Facility Purchase from Eastern Capital Limited On November 1, 2021, we purchased the Facility previously operated under a lease from two affiliates of Eastern Affiliates.
However, we anticipate that our expenses will increase as we continue our research and development activities and conduct clinical trials.
In an effort to mitigate the substantial doubt about continuing as a going concern and increase cash reserves, we consummated the sale of our Facility, reduced our work force, signed a collaboration with AstralBio with to discover and develop novel antibodies for obesity and other cardiometabolic diseases, entered into a securities purchase agreement for a PIPE financing resulting in gross proceeds of approximately $15.0 million.
In an effort to mitigate the substantial doubt about continuing as a going concern and increasing cash reserves, we have raised funds from time to time through equity offerings or other financing alternatives, entered into a collaboration agreement to discover and develop novel antibodies for obesity and other cardiometabolic diseases and sold certain intellectual property rights.
Our consolidated financial statements are presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All applicable U.S. GAAP accounting standards effective as of June 30, 2024, have been taken into consideration in preparing the consolidated financial statements.
GAAP”). All applicable U.S. GAAP accounting standards effective as of June 30, 2025, have been taken into consideration in preparing the consolidated financial statements. The preparation of consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures.
In conjunction with the restructuring, we completed a workforce reduction of approximately 60% and discontinued the CDMO operations. CDMO operations are reported as discontinued operations on our financial statements. Losses for Discontinued Operations for 2024 and 2023 were approximately ($9.5) million and ($35.7) million, respectively, a decrease of ($26.2) million, or 73%.
In conjunction with the divestment, we completed a workforce reduction and discontinued the CDMO operations. CDMO operations were classified as discontinued operations on our financial statements through the fiscal year ended June 30, 2024.
The decrease is primarily attributable to a reduction in personnel costs of ($5.2) million due to the transformation of the Company into an antibody discovery and development company announced in November 2022, profession/consulting fees and outside services of ($1.0) million, an in tangible asset impairment charge that did not reoccur in fiscal year 2024 ($0.6) million, lower insurance premiums due to negotiated rates ($0.5) million and lower IT related spend ($0.2) million.
The decrease is primarily attributable to a reduction in personnel-related costs of $0.7 million, lower insurance premiums due to negotiated rates $0.3 million, a decrease in depreciation of $0.2 million, a reduction in legal fees of $0.1 million.
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Our core mission is to harness the potential of AI and machine learning to unveil elusive biologics that stand out and have evaded other scientists. Through our innovative platform, we champion a culture of innovation by swiftly identifying novel targets, forging strategic collaborations with the goal of to enhancing efficiency, diversifying pipelines, and accelerating preclinical processes.
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Our core mission is to harness the potential of AI and ML to unveil novel biologics which other scientists have been unable to develop. Through our innovative AI Drug Discovery Platform, we have been able to identify differentiated molecules aimed to address unmet needs by current GLP-1 receptor agonists.
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Additionally, our groundbreaking EngageTx technology enables us to target bi-specific molecules, while ShieldTx is designed to reduce or eliminate adverse effects stemming from off-target tissue effects. With the ability to navigate sequence diversity and promote Human-Cyno cross reactivity while mitigating cytokine release, our goal is to enhance agility and bolster preclinical safety assessments.
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We believe the future of obesity care lies not just in weight loss—but in quality weight loss. Current interventional therapies such as GLP-1 receptor agonists have ushered in a breakthrough era, yet challenges remain: muscle loss, fat 72 Table of Contents regain after treatment cessation, and long-term tolerability.
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Our strategic approach to fulfilling our mission is outlined as follows: ● Elevate Epitope Discovery: We believe we lead the field with our patented AI-engine uncovering "hard to develop" molecules. Our unparalleled epitope engine stands out by allowing the ability to target select regions of a protein, potentially removing the lengthy trial and error out of mAb discovery.
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We are developing second-generation therapies to meet these unmet needs, using the power of AI-guided antibody design and advanced screening technologies. Our obesity strategy is built on three key principles.
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This capability is expected to improve probability of success while at the same time, reduces costs commonly caused by having an iterative process.
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First, we are aiming to develop next-generation antibody therapeutics addressing limitations of current approved treatments, offering options with a goal to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, we are focusing on targets with strong human validation, which we believe both helps reduce development risk and increase the likelihood of clinical success.
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Our epitope engine is engineered to match its target, refined for stability and optimized for water solubility; allowing us to identify new drug candidates that have failed or have been abandoned due to their complexity. ● Capital efficient business approach: Our strategic business approach is structured around the following pillars of value creation: o Strategic Collaborations : We have leveraged our platform and pipeline by forming strategic partnerships.
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Lastly, we are applying our integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate development-ready biologics, enabling us to move with speed and precision in a competitive and fast-evolving field. We anticipate the commencement of our first human clinical trials in late fiscal 2026 or early fiscal 2027.
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We aim to become the preferred partner for major pharmaceutical and biotechnology companies seeking rapid and cost-effective integration of complex molecules into their portfolios, de-risking their early-stage pre-clinical work. Additionally, rich array of fast follower molecules within the Company’s pre-clinical pipeline holds the potential to drive substantial partnerships, opening doors to innovative projects.
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The current pre-clinical product candidate pipeline is set forth below. ​ ​ IBIO-610 Activin E, like myostatin, is part of the TGF-β superfamily and has been implicated in the regulation of energy homeostasis and overall metabolic health.
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By tapping into our, infrastructure, and expertise, partners have the potential to streamline timelines, reduce costs tied to biologic drug discovery applications and cell line process development, and expedite preclinical programs with efficiency. o Developing and advancing our in-house programs cost effectively : Clinical advancement is crucial for drug discovery.
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Human genetic studies provide compelling support for Activin E as a therapeutic target, as individuals carrying loss-of-function variants of the INHBE gene exhibit reduced visceral fat, improved lipid profiles, and lower risk of cardiometabolic diseases. By leveraging our AI Drug Discovery Platform, we believe we have successfully identified the first antibody inhibiting Activin E.
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As we continue to develop our existing immune-oncology pre-clinical pipeline, we are also seeking strategic partners with the capabilities to more rapidly advance these programs towards the clinic.
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Preclinical data from multiple in vitro cell-based assays, including one on a human adipocyte cell line, demonstrated robust blockade of Activin E-mediated signaling. The antibody has been evaluated in multiple pre-clinical studies in a model of DIO in mice, both alone with bi-weekly dosing and in combination with semaglutide dosed daily.
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We also continue to assess our option rights to license three of the four assets under the collaboration with AstralBio to expand our pre-clinical pipeline into obesity and cardiometabolic programs and with the goal to become a clinical stage company. 76 Table of Contents o Tech Licensing in Diverse Therapeutic Areas: In pursuit of adding value, we are exploring partnerships in diverse therapeutic domains such as CNS or vaccines.
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These results suggest IBIO-610 may induce fat-selective weight loss. ​ In a DIO mouse model, IBIO-610 was administered biweekly at 10 mg/kg for four weeks to evaluate its effects as a monotherapy.
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Our intention is to license the AI tech stack, extending its benefits to our partners and amplifying its biological impact and insights.
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Treated mice were observed to have a 8.9% reduction in body weight compared to baseline and placebo, with body composition analysis revealing a 26% reduction in fat mass and no measurable loss of lean mass. Outlier non-responder mice were excluded. 73 Table of Contents To test potential combination therapy with incretin treatments, IBIO-610 was dosed biweekly alongside daily semaglutide.
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This strategic approach enables us to capitalize on the value of our meticulously curated data while empowering collaborations and innovations, while at the same time allowing us to focus on both the platform and our core therapeutic areas, metabolic diseases and oncology. ● Unwavering Investment in advancing the platform: We maintain a focused commitment to invest in our platform, continually unlocking the potential of biology through AI and ML.
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While semaglutide alone produced a 27.8% reduction in body weight (baseline and placebo adjusted), the combination resulted in a more pronounced 35.3% weight loss, without any additive effect on food intake. The combination also led to a greater reduction in visceral fat compared to semaglutide alone, suggesting complementary mechanisms that enhance metabolic benefit.
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The pinnacle of being on the forefront of ML advancing algorithms, and models in order to improve its predictive power and reduce the time it takes to find a viable molecule.
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IBIO-610 was also tested as a maintenance therapy following cessation of semaglutide treatment. In this model, DIO mice were first dosed with semaglutide for two weeks, leading to approximately 18% weight loss. Upon stopping semaglutide, control mice regained 71% of the lost weight within three weeks, with fat mass levels returning to those of untreated animals.
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In essence, we are sculpting a future where cutting-edge AI-driven biotechnology propels the discovery of intricate biologics, fostering partnerships, accelerating innovation, and propelling the advancement of science. ​ AI-Technology Platform Overview Our platform comprises five key components, each playing a crucial role in the discovery and optimization of precision antibodies.
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In contrast, mice receiving IBIO-610 at the time of semaglutide discontinuation regained only 28% of the lost weight and retained significantly lower fat mass at study termination, highlighting the potential of IBIO-610 to prevent rebound weight gain. ​ Myostatin x Activin A Bispecific Antibody Activin A is another member of the TGF-β family and is known to modulate muscle growth among its various biological functions.
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The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies.
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The therapeutic potential of targeting Activin A has been observed in garetosmab, an Activin A antagonist antibody that exhibited promising outcomes in early clinical trials and in published NHP data. Building on these insights, we initiated a program to develop a bispecific antibody targeting both myostatin and Activin A.
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The third layer of the technology stack is the antibody optimizing StableHu AI technology, coupled with mammalian display technology. Next, our EngageTx platform forms the fourth layer. Lastly, our ShieldTx antibody masking technology enables the creation of conditionally activated antibodies.
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Leveraging our StableHu platform and mammalian display, this program is in late discovery, where multiple parameters, such as binding affinity, expression levels, and stability, are being optimized.
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Each layer of the tech stack is designed to work synergistically, enabling us to rapidly advance antibodies from concept to in vivo proof-of-concept (POC). ​ AI Epitope Steering Technology Our epitope steering technology is designed to address these issues by guiding antibodies exclusively against the desired regions of the target protein.
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Early in vitro findings in human muscle progenitor cells suggest that the bispecific candidate induces a stronger differentiation of progenitor cells into mature muscle cells compared to antibodies targeting only myostatin or Activin A alone.
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By focusing on these specific regions, we can overcome the limitations of traditional methods and significantly improve the efficiency and effectiveness of our antibody discovery process. Our AI engine creates engineered epitopes, which are small embodiments of epitopes on the target protein.
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Increased muscle fusion index in human muscle stem cells, as shown in the chart below, is a surrogate of muscle growth. ​ IBIO-600 Myostatin, also known as GDF8, is a member of the TGF-β family that regulates and limits skeletal muscle growth.
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The engine is trained to match the epitope structure as closely as possible and refine the designs for greater stability and water solubility, which are critically important factors. The optimized engineered epitope is then used to identify antibodies from naïve or immunized libraries.
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A loss of function in the myostatin gene eliminates this inhibitory effect, leading to increased muscle mass and strength. This genetic alteration results in significant muscle hypertrophy (increased size) and hyperplasia (increased number of muscle fibers). While these effects can enhance muscle development, they may also have implications for overall metabolism and cardiovascular health.
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Naïve Human Antibody Library The fully human antibody library is built upon clinically validated, entirely human antibody frameworks. By leveraging public databases, we have extracted a diverse array of Complementarity-Determining Region (CDR) sequences. Subsequently, we have meticulously eliminated a range of sequence liabilities. Such careful curation process could potentially significantly reduce the development risk for antibodies identified from our library.
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In April 2024, as result of our collaboration with AstralBio, we initiated a program to discover and develop a long-acting anti-myostatin antibody. Using our StableHu platform coupled with mammalian display, we optimized hit antibodies across multiple parameters, including affinity for myostatin, binding to the FcRn receptor, expression levels in mammalian cells, and resistance to poly-reactivity and aggregation.
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StableHu TM AI Antibody-Optimizing Technology Our proprietary StableHu technology is instrumental in the optimization process. StableHu is an AI-powered tool designed to predict a library of antibodies with fully human CDR variants based on an input antibody. This input can range from an early, unoptimized molecule to an approved drug.
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The final candidate, IBIO-600, was also observed to have a beneficial profile between thermostability and resistance to stress conditions during initial testing. In vitro , IBIO-600 was evaluated in human muscle progenitor cells, where it potently inhibited myostatin. This inhibition facilitated the differentiation of progenitor cells into mature human muscle cells.
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The model has been trained utilizing a set of over 1 billion human antibodies, progressively masking known amino acids within CDRs until the algorithm could predict the correct human sequence. 77 Table of Contents While phage display libraries are often used in antibody optimization due to their vast diversity, they can increase developability risks such as low expression, instability, or aggregation of antibodies.
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In interim data from a preclinical study in obese mice, we observed that IBIO-600 dose-dependently prevented lean mass loss when administered in combination with a GLP-1 receptor agonist. In November 2024, we initiated a study in obese and elderly NHPs for IBIO-600. The primary goal of the study was to assess the PK profile of IBIO-600.
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Mammalian display libraries, on the other hand, offer significantly improved developability but reduced diversity due to the smaller library size they can handle. StableHu overcomes this limitation by utilizing a machine learning algorithm generating focused library diversity within the capacity of mammalian display.
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The study consisted of two dose levels, a low dose of 5 mg/kg and a high dose of 50 mg/kg, with a single subcutaneous injection in each case.
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Mammalian display is a technology that presents antibodies on the surface of mammalian cells, allowing for the direct screening and selection of antibodies in a mammalian cell environment. This approach is advantageous as antibodies that express well on the mammalian cells used in the display are more likely to express well in the production cell line.
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In addition to monitoring PK in serum, the study analyzed body composition changes over time by employing DEXA scans, measuring lean and fat mass. ​ The study consisted of six NHPs, sorted randomly into the low and high dose groups. IBIO-600 promoted an increase in lean mass and a reduction in fat mass from baseline values.
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Moreover, single-cell sorting of antibody-displaying cells allows rapid selection of desired antibodies based on multiple dimensions, such as potency, selectivity, and cross-species selectivity. When paired with mammalian display technology, StableHu enables antibody optimization with fewer iterative optimization steps, lower immunogenicity risk, and improved developability.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk. The information under this Item is not required to be provided by smaller reporting companies. Item 8. Financial Statements and Supplementary Data. Financial statements and notes thereto appear on pages F-1 to F-54 of this Annual Report. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk. The information under this Item is not required to be provided by smaller reporting companies. Item 8. Financial Statements and Supplementary Data. Financial statements and notes thereto appear on pages F-1 to F-48 of this Annual Report. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.

Other IBIO 10-K year-over-year comparisons