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What changed in iBio, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of iBio, Inc.'s 2023 and 2024 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 2024 report.

+404 added−419 removedSource: 10-K (2024-09-20) vs 10-K (2023-09-27)

Top changes in iBio, Inc.'s 2024 10-K

404 paragraphs added · 419 removed · 270 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

97 edited+65 added−36 removed144 unchanged
Biggest changeCentral time on November 13, 2023; and (iii) the delivery at closing by the title company of a title policy to Majestic Realty in the amount of the Purchase Price. ​ On September 18, 2023, iBio CDMO and Woodforest entered into a sixth amendment to the Credit Agreement (the “Sixth Amendment”), to amend the Credit Agreement to: (i) set the maturity date of the term loan to the earlier of (a) December 31, 2023, or (b) the acceleration of maturity of the term loan in accordance with the Credit Agreement, (ii) provided that iBio CDMO will, immediately upon receipt of the proceeds of the sale of the Property, apply the net proceeds to satisfy all outstanding obligations under the term loan, and to the extent such net proceeds are sufficient, to pay off the term loan, and (iii) change the annual filing requirement solely for the fiscal year ending June 30, 2023, such that the filing is 29 Table of Contents acceptable with or without a “going concern” designation; provided that (y) iBio CDMO shall deliver an executed copy of the Purchase and Sale Agreement for the sale of the Facility within one business day after entry into the Sixth Amendment, and (z) if the Facility is not sold on or before December 1, 2023, iBio CDMO will pay a fee in the amount of $20,000 upon the earlier of the date of the closing or the maturity date. ​ The Facility is a life science building located on land owned by the Board of Regents of the Texas A&M University System (“Texas A&M”) and is designed and equipped for the manufacture of plant-made biopharmaceuticals.
Biggest changeThe Company also agreed to pay Woodforest a fee in the amount of (x) $75,000 if the Facility was sold on or before June 30, 2023, (y) $100,000 if the Facility was sold after June 2023, but on or before September 30, 2023, or (x) $125,000, if the Facility was sold after September 30, 2023, or not sold prior to the Maturity Date. ​ On September 18, 2023, iBio CDMO and Woodforest entered into a sixth amendment to the Credit Agreement (the “Sixth Amendment”), which amended the Credit Agreement to: (i) set the Maturity Date to the earlier of (a) December 31, 2023, or (b) the acceleration of maturity of the term loan in accordance with the Credit Agreement, (ii) provided that iBio CDMO would, immediately upon receipt of the proceeds of the sale of the Facility, apply the net proceeds to satisfy all outstanding obligations under the term loan, and to the extent such net proceeds were sufficient, to pay off the term loan, and (iii) change the annual filing requirement solely for the fiscal year ending June 30, 2023; provided that (y) iBio CDMO deliver an executed copy of the Purchase and Sale Agreement for the sale of the Facility within one business day after entry into the Sixth Amendment, and (z) if the Facility was not sold on or before December 1, 2023, iBio CDMO would pay a fee in the amount of $20,000 upon the earlier of the date of the closing or the Maturity Date. ​ On October 4, 2023, iBio CDMO and Woodforest entered into the seventh amendment to the Credit Agreement (the “Seventh Amendment”), which amendment among other things, permitted the Company, in each case, so long as no Potential Default or Default (as such terms were defined in the Credit Agreement) to make the following withdrawals from the Reserve Funds Deposit Account (as defined in the Credit Agreement): (i) up to $1,000,000 on October 4, 2023 so long as iBio CDMO maintained a minimum balance of $2,000,000 until October 16, 2023, (ii) up to an additional $750,000 after October 16, 2023 so long as iBio CDMO maintained a minimum balance of $1,250,000 until November 13, 2023, and (iii) up to an additional $250,000 after November 13, 2023 so long as iBio CDMO maintained a minimum balance of $1,000,000 until Payment in Full (as defined in the Credit Agreement).
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 iBio’s 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.
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 iBio’s innovative platform, we champion a culture of innovation by swiftly identifying novel targets, forging strategic collaborations with the goal of enhancing efficiency, diversifying pipelines, and accelerating preclinical processes.
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 is 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 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”).
Tumor cells can evade immune attack by shedding or glycosylating MUC16, making it difficult for traditional antibody therapies to effectively target and destroy the cancer cells. ​ 15 Table of Contents Figure 14: MUC16 structure and mechanisms to evade anti-cancer therapy ​ Using the Company’s patented epitope steering AI platform, iBio's innovative approach to this challenge allows its new mAbs to bind to a specific region of MUC16 that is not shed or glycosylated, circumventing both tumor evasion mechanisms and potentially providing a powerful tool in the fight against cancer. ​ ​ Figure 15: iBio’s epitope steering approach and immunization strategy to target the non-shed MUC16 region During its immunization and screening campaign, iBio identified several hits that specifically bound to the non-shed region of MUC16 while no binding to the shed fragment of MUC16 was observed. ​ ​ 16 Table of Contents Figure 16: iBio’s hit molecules bind to the non-shed but not the shed region of MUC16 Establishing antibodies with the ability to bind to a recombinant version of their target protein represents a vital initial step in the validation process.
Tumor cells can evade immune attack by shedding or glycosylating MUC16, making it difficult for traditional antibody therapies to effectively target and destroy the cancer cells. ​ 16 Table of Contents Figure 15: MUC16 structure and mechanisms to evade anti-cancer therapy ​ Using the Company’s patented epitope steering AI platform, iBio's innovative approach to this challenge allows its new mAbs to bind to a specific region of MUC16 that is not shed or glycosylated, circumventing both tumor evasion mechanisms and potentially providing a powerful tool in the fight against cancer. ​ ​ Figure 16: iBio’s epitope steering approach and immunization strategy to target the non-shed MUC16 region During its immunization and screening campaign, iBio identified several hits that specifically bound to the non-shed region of MUC16 while no binding to the shed fragment of MUC16 was observed. ​ ​ 17 Table of Contents Figure 17: iBio’s hit molecules bind to the non-shed but not the shed region of MUC16 Establishing antibodies with the ability to bind to a recombinant version of their target protein represents a vital initial step in the validation process.
We aim is 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.
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.
On September 19, 2022, in connection with the closing of the acquisition, the Company entered into a termination agreement (the “Termination Agreement”) with RubrYc in order terminate the RTX-003 License Agreement and the Collaboration Agreement, which terminated any and all future milestone payments or royalty obligations we had under those agreements.
On September 19, 2022, in connection with the closing of the acquisition, we entered into a termination agreement (the “Termination Agreement”) with RubrYc in order terminate the RTX-003 License Agreement and the Collaboration Agreement, which terminated any and all future milestone payments or royalty obligations we had under those agreements.
Figure 12: iBio’s TROP-2 x CD3 lead antibody shows reduced cytokine release while retaining tumor cell killing potential When tested in a humanized mouse model of squamous cell carcinoma, iBio’s lead TROP-2 x CD3 bi-specific antibody demonstrated a significant 36 percent reduction in tumor size within just 14 days after tumor implantation, and after only a single dose. 14 Table of Contents Figure 13: iBio’s lead TROP-2 x CD3 molecule showed a 36% reduction in tumor size in an animal model engrafted with human peripheral blood mononuclear immune cells (PBMC) and human tumor cells MUC16 MUC16 is a well-known cancer target often overexpressed in several types of solid tumors, including ovarian, lung, and pancreas cancers.
Figure 13: iBio’s TROP-2 x CD3 lead antibody shows reduced cytokine release while retaining tumor cell killing potential When tested in a humanized mouse model of squamous cell carcinoma, iBio’s lead TROP-2 x CD3 bi-specific antibody demonstrated a significant 36 percent reduction in tumor size within just 14 days after tumor implantation, and after only a single dose. 15 Table of Contents Figure 14: iBio’s lead TROP-2 x CD3 molecule showed a 36% reduction in tumor size in an animal model engrafted with human peripheral blood mononuclear immune cells (PBMC) and human tumor cells MUC16 MUC16 is a well-known cancer target often overexpressed in several types of solid tumors, including ovarian, lung, and pancreas cancers.
RubrYc is also eligible to receive up to $5,000,000 in development milestone over the period of five years from the date of the Purchase Agreement, which can be paid in shares of our Common Stock or cash, at our sole discretion.
RubrYc is also eligible to receive up to $5,000,000 in development milestone over the period of five years from the date of the Asset Purchase Agreement, which can be paid in shares of our Common Stock or cash, at our sole discretion.
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 or 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; 33 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.
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.
Additionally, these molecules have effectively eliminated tumor cells, while sparing healthy ones, in in vitro cell killing tests. ​ ​ Figure 20: In vitro characterization of iBio’s hit molecules demonstrates selective binding to EGFRvIII leading to tumor-specific cell killing while sparing healthy cells 19 Table of Contents iBio’s lead anti-EGFRvIII antibody was specially engineered to enhance its ability to attack cancer cells and has proven effective in a mouse model for head and neck cancer.
Additionally, these molecules have effectively eliminated tumor cells, while sparing healthy ones, in in vitro cell killing tests. ​ ​ Figure 21: In vitro characterization of iBio’s hit molecules demonstrates selective binding to EGFRvIII leading to tumor-specific cell killing while sparing healthy cells 20 Table of Contents iBio’s lead anti-EGFRvIII antibody was specially engineered to enhance its ability to attack cancer cells and has proven effective in a mouse model for head and neck cancer.
Through this precision approach, iBio has designed tumor-specific molecules aimed at selectively targeting cancer cells while preserving healthy ones, potentially offering patients a more focused and safer therapeutic solution. ​ 18 Table of Contents ​ Figure 19: Tumor epitope specific antibodies target tumor cells while sparing healthy cells ​ iBio's hit molecules have demonstrated strong binding to the tumor-specific EGFRvIII protein without targeting the wildtype EGFR.
Through this precision approach, iBio has designed tumor-specific molecules aimed at selectively targeting cancer cells while preserving healthy ones, potentially offering patients a more focused and safer therapeutic solution. ​ 19 Table of Contents ​ Figure 20: Tumor epitope specific antibodies target tumor cells while sparing healthy cells ​ iBio's hit molecules have demonstrated strong binding to the tumor-specific EGFRvIII protein without targeting the wildtype EGFR.
In preclinical studies, iBio’s anti-EGFRvIII antibody demonstrated a 43 percent reduction in tumor growth compared to untreated animals. Figure 21: iBio’s lead molecule demonstrates efficacy in a mouse model for head and neck cancer CCR8 GPCRs are one of the most successful therapeutic target classes, with approximately one-third of all approved drugs targeting these proteins.
In preclinical studies, iBio’s anti-EGFRvIII antibody demonstrated a 43 percent reduction in tumor growth compared to untreated animals. Figure 22: iBio’s lead molecule demonstrates efficacy in a mouse model for head and neck cancer CCR8 GPCRs are one of the most successful therapeutic target classes, with approximately one-third of all approved drugs targeting these proteins.
In addition, on February 9, 2023, the Company, as guarantor, entered into a second amendment to the Guaranty, which as amended, among other things, allowed the Company to account for the Fraunhofer Settlement Funds in determining whether the Company is in compliance with the Liquidity Covenant until a specified period dependent upon the occurrence of a specific milestone in the Credit Agreement.
In addition, on February 9, 2023, the Company, as guarantor, entered into a second amendment to the Guaranty, which as amended, among other things, allowed the Company to account for the Fraunhofer Settlement Funds in determining whether the Company was in compliance with the Liquidity Covenant until a specified period dependent upon the occurrence of a specific milestone in the Credit Agreement.
IBIO-101 is a second-generation anti-CD25 mAb that has demonstrated in preclinical models of disease the ability to bind and deplete immunosuppressive regulatory T [Treg] cells to inhibit the growth of solid tumors. ​ Targeting depletion of Treg cells to control tumors emerged as an area of interest in oncology over the past several years.
IBIO-101 IBIO-101 is our second-generation anti-CD25 mAb that has demonstrated in preclinical models of disease the ability to bind and deplete immunosuppressive regulatory T [Treg] cells to inhibit the growth of solid tumors. ​ Targeting depletion of Treg cells to control tumors emerged as an area of interest in oncology over the past several years.
When paired with an anti-PD-1 checkpoint inhibitor in the same model, the combined treatment of IBIO-101 and anti-PD-1 exhibited superior tumor inhibition compared to either anti-PD-1 or IBIO-101 used independently. ​ 10 Table of Contents ​ Figure 8: IBIO-101 monotherapy in a humanized mouse model leads to increased Treg/Teff ratio, resulting in the suppression of tumor growth ​ ​ ​ Figure 9: Combination Therapy of IBIO-101 and anti-PD-1 exhibited superior tumor inhibition compared to anti-PD-1 or IBIO-101 alone iBio has progressed IBIO-101 to the IND-enabling phase and entrusted its Chemistry, Manufacturing, and Controls (CMC) development to a reputable Contract Research Organization (CRO).
When paired with an anti-PD-1 checkpoint inhibitor in the same model, the combined treatment of IBIO-101 and anti-PD-1 exhibited superior tumor inhibition compared to either anti-PD-1 or IBIO-101 used independently. ​ ​ Figure 9: IBIO-101 monotherapy in a humanized mouse model leads to increased Treg/Teff ratio, resulting in the suppression of tumor growth ​ ​ 12 Table of Contents ​ Figure 10: Combination Therapy of IBIO-101 and anti-PD-1 exhibited superior tumor inhibition compared to anti-PD-1 or IBIO-101 alone iBio has progressed IBIO-101 to the IND-enabling phase and entrusted its Chemistry, Manufacturing, and Controls (CMC) development to a Contract Research Organization (CRO).
In addition, the Company agreed that each time it consummates an at-the-market issuance of Equity Interests (as defined within the Credit Agreement), no later than five (5) days following such issuance of Equity Interests, it will (i) pay to Woodforest in immediately available cash funds, without setoff or counterclaim of any kind, forty percent (40%) of the Net Proceeds (as defined within the Credit Agreement) received by the Company for such issuance of Equity Interests; provided, any such payment would cease upon payment obligations in full and (ii) provide Woodforest with a detailed accounting of each such issuance of Equity Interests.
In addition, the Company agreed that each time it consummated an at-the-market issuance of Equity Interests (as defined within the Credit Agreement), no later than five (5) days following such issuance of Equity Interests, it would (i) pay to Woodforest in immediately available cash funds, without setoff or counterclaim of any kind, forty percent (40%) of the Net Proceeds (as defined within the Credit Agreement) received by the Company for such issuance of Equity Interests; provided, any such payment would cease upon payment obligations in full and (ii) provide Woodforest with a detailed accounting of each such issuance of Equity Interests.
Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others. 35 Table of Contents ● NDA/BLA: o Once clinical trials of a product candidate are completed, FDA approval of an NDA or BLA must be obtained before commercial marketing of the product.
Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others. 34 Table of Contents ● NDA/BLA: o Once clinical trials of a product candidate are completed, FDA approval of an NDA or BLA must be obtained before commercial marketing of the product.
During pre-clinical studies, iBio’s MUC16 molecule has demonstrated binding to MUC16 on OVCAR-3 ovarian cancer cells as shown below. ​ ​ Figure 17: iBio’s MUC16 molecule shows binding to MUC16 on human ovarian cancer cells ​ 17 Table of Contents Another critical step in antibody optimization is the humanization of molecules originally raised in mice or other species.
During pre-clinical studies, iBio’s MUC16 molecule has demonstrated binding to MUC16 on OVCAR-3 ovarian cancer cells as shown below. ​ ​ Figure 18: iBio’s MUC16 molecule shows binding to MUC16 on human ovarian cancer cells ​ 18 Table of Contents Another critical step in antibody optimization is the humanization of molecules originally raised in mice or other species.
Figure 18: iBio’s humanized MUC16 molecule retains binding to the engineered epitope and human tumor cell lines EGFRvIII EGFRvIII is a specific variant of the EGFR protein, unique to tumor cells. Unlike the more common EGFR, EGFRvIII is not found in healthy cells, making it an attractive target for therapeutic interventions.
Figure 19: iBio’s humanized MUC16 molecule retains binding to the engineered epitope and human tumor cell lines EGFRvIII EGFRvIII is a specific variant of the EGFR protein, unique to tumor cells. Unlike the more common EGFR, EGFRvIII is not found in healthy cells, making it an attractive target for therapeutic interventions.
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. 37 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. 36 Table of Contents Healthcare Regulations and Healthcare Reform Healthcare regulation and pricing (included drug pricing) is complex, extensive, and dynamic around the world.
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. ​ 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 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.
The technology and products covered by our issued and pending patent applications are summarized below: 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 30 Table of Contents ● 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 ● Use of endostatin peptides for the treatment of fibrosis ​ Pending Technology Patent Applications (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 ​ 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 ​ 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: 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.
This is because CCR4 is found in many immune cells, and accidentally targeting it could potentially lead to unwanted side effects. 20 Table of Contents Figure 22: Proposed mechanism of action for selective anti-CCR8 antibodies Using its unique AI-driven technology, iBio successfully identified molecules targeting CCR8, addressing some of the hurdles often faced when creating therapies that target GPCR with antibodies. iBio's specialized anti-CCR8 antibody has shown strong attachment to cells expressing CCR8 and effectively disrupted the CCR8 signaling process, resulting in the efficient elimination of Tregs derived from primary human immune cells.
This is because CCR4 is found in many immune cells, and accidentally targeting it could potentially lead to unwanted side effects. 21 Table of Contents Figure 23: Proposed mechanism of action for selective anti-CCR8 antibodies Using its unique AI-driven technology, iBio successfully identified molecules targeting CCR8, addressing some of the hurdles often faced when creating therapies that target GPCR with antibodies. iBio's specialized anti-CCR8 antibody has shown strong attachment to cells expressing CCR8 and effectively disrupted the CCR8 signaling process, resulting in the efficient elimination of Tregs derived from primary human immune cells.
In essence, we believe that 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. ​ 3 Table of Contents AI-Technology Platform Overview iBio's technology stack is a multi-layered, AI-powered system designed to significantly enhance the probability of success to discover and develop antibodies against hard-to-drug pathophysiologically relevant proteins.
In essence, we believe that 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 iBio's technology stack is a multi-layered, AI-powered system designed to significantly enhance the probability of success to discover and develop antibodies against hard-to-drug pathophysiologically relevant proteins.
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 36 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, the approval process varies between countries and jurisdictions and can involve 35 Table of Contents additional product testing and additional administrative review periods.
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, 31 Table of Contents regulatory approvals and marketing approved products than we do.
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.
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.
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.
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 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.
Under the terms of the Purchase Agreement, upon closing of the acquisition, the Company 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 102,354 (post reverse split effected in October 2022) shares of our common stock, par value $.001 per share (the “Common Stock”) to RubrYc.
On May 10, 2023, iBio CDMO and Woodforest entered into a fifth amendment to the Credit Agreement (the “Fifth Amendment”), pursuant to which Woodforest agreed to: (i) waive our obligation to deliver to Woodforest an executed copy of a Purchase Agreement for the sale of the Facility no later than April 14, 2023 and, (ii) release $500,000 of the $3.0 million being held in a Company account at Woodforest when the outstanding principal amount is reduced to $10.0 million and for each additional $2.5 million reduction of the outstanding principal amount, an additional $750,00 will be released from the Company account at Woodforest.
On May 10, 2023, iBio CDMO and Woodforest entered into a fifth amendment to the Credit Agreement (the “Fifth Amendment”), pursuant to which Woodforest agreed to: (i) waive the obligation to deliver to Woodforest an executed copy of a Woodforest Purchase Agreement for the sale of the Facility no later than April 14, 2023 and, (ii) release $500,000 of the $3.0 million being held in a Company account at Woodforest when the outstanding principal amount was reduced to $10.0 million and for each additional $2.5 million reduction of the outstanding principal amount, an additional $750,000 was to be released from the Company account at Woodforest.
On March 24, 2023, iBio CDMO and Woodforest entered into a fourth amendment to the Credit Agreement (the “Fourth Amendment”), which within the Fourth Amendment Woodforest agreed to (i) reduce the percentage of any payment to Woodforest the Company is required to make from the proceeds of sales of its common stock under its at-the-market facility from 40% to 20%, (ii) reduce the percentage of any payment to Woodforest the Company is required to make from 28 Table of Contents the proceeds of sales of its equipment from 40% to 20%, and (iii) allowed the Company to retain $2,000,000 million of the $5,100,000 million that the Company received from the Fraunhofer Settlement Funds, with the remaining $3,000,000 million being held in a Company account at Woodforest.
On March 24, 2023, iBio CDMO and Woodforest entered into a fourth amendment to the Credit Agreement (the “Fourth Amendment”), which within the Fourth Amendment Woodforest agreed to (i) reduce the percentage of any payment to Woodforest the Company was required to make from the proceeds of sales of its common stock under its at-the-market facility from 40% to 20%, (ii) reduce the percentage of any payment to Woodforest the Company was required to make from the proceeds of sales of its equipment from 40% to 20%, and (iii) allowed the Company to retain $2,000,000 million of the $5,100,000 million that the Company received from the Fraunhofer Settlement Funds, with the remaining $3,000,000 million being held in a Company account at Woodforest.
As a result, on February 9, 2023, iBio CDMO and Woodforest entered into a second amendment to the Credit Agreement (the “Second Amendment”), which as amended, among other things, added a milestone that had to be met by a specified date, the failure of which would be an event of default.
On February 9, 2023, iBio CDMO and Woodforest entered into a second amendment to the Credit Agreement (the “Second Amendment”), which amendment, among other things, added a milestone that had to be met by a specified date, the failure of which would be an event of default.
In the case of some products for severe or life-threatening diseases, especially 34 Table of Contents when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients with the targeted disease. ● Phase 2 .
In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients with the targeted disease. ● Phase 2 .
Figure 11: Proposed mechanism of action of iBio’s TROP-2 x CD3 bispecific antibodies ​ 13 Table of Contents Using EngageTx, iBio’s lead TROP-2 x CD3 bispecific antibody was engineered to potently kill tumor cells while limiting the release of cytokines, like Interferon Gamma (IFNg), Interleukin 2 (IL-2) and Tumor Necrosis Factor Alpha (TNFa), all of which have the potential to cause cytokine release syndrome.
Figure 12: Proposed mechanism of action of iBio’s TROP-2 x CD3 bispecific antibodies ​ 14 Table of Contents Using EngageTx, iBio’s lead TROP-2 x CD3 bispecific antibody was engineered to potently kill tumor cells while limiting the release of cytokines, like Interferon Gamma (IFNg), Interleukin 2 (IL-2) and Tumor Necrosis Factor Alpha (TNFa), all of which have the potential to cause cytokine release syndrome.
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 area, 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 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.
The Term Loan is secured by a lien on all of the assets of iBio CDMO and we guaranteed payments of the obligations owed under the Term Loan. ​ The Credit Agreement contains customary events of default (which are in some cases subject to certain exceptions, thresholds, notice requirements and grace periods), including, but not limited to, nonpayment of principal or interest, failure to perform or observe covenants, breaches of representations and warranties, cross-defaults with certain other indebtedness, certain bankruptcy-related events or proceedings, final monetary judgments or orders and certain change of control events.
The Term Loan was secured by a lien on all of the assets of iBio CDMO and we guaranteed payments of the obligations owed under the Term Loan. ​ The Credit Agreement contained customary events of default (which were in some cases subject to certain exceptions, thresholds, notice requirements and grace periods), including, but not limited to, nonpayment of principal or interest, failure to perform or observe covenants, breaches of representations and warranties, cross-defaults with certain other indebtedness, certain bankruptcy-related events or proceedings, final monetary judgments or orders and certain change of control events.
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.
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.
(“Fraunhofer”) as part of our legal settlement with them (the “Fraunhofer Settlement Funds”) (see Note 19 – Fraunhofer Settlement for more information), (iii) include principal payments of $250,000 per month in debt amortization for a six-month period commencing the date of the amendment through March 2023, (iv) include an amendment fee of $22,375 and all costs and expenses, (v) require delivery of a report detailing cash flow expenditures every two (2) weeks for the period prior to the delivery of the last report and a monthly 12-month forecast, (vi) reduce the liquidity covenant in the Guaranty (as defined in the Credit Agreement) from $10 million to $7.5 million with the ability to lower the liquidity covenant to $5.0 million upon the occurrence of a specific milestone in the Credit Agreement, and (vii) change the annual filing requirement solely for the fiscal year ended June 30, 2022, such that the filing is acceptable with or without a “going concern” designation.
(“Fraunhofer”) as part of our legal settlement with them (the “Fraunhofer Settlement Funds”) (see Note 19 – Fraunhofer Settlement for more information), (iii) include principal payments of $250,000 per month in debt amortization for a six-month period commencing the date of the amendment through March 2023, (iv) include an amendment fee of $22,375 and all costs and expenses, (v) require delivery of a report detailing cash flow expenditures every two (2) weeks for the period prior to the delivery of the last report and a monthly 12-month forecast, (vi) reduce the liquidity covenant in the Guaranty (as defined in the Credit Agreement) from $10 million to $7.5 million with the ability to lower the liquidity covenant to $5.0 million upon the occurrence of a specific milestone in the Credit Agreement, and (vii) change the annual filing requirement solely for the fiscal year ended June 30, 2022.
In addition, starting on the effective date of the Fifth Amendment, the interest on the Term Loan increased to 5.25%, and the Term Loan shall further accrue interest, payable in kind and added to the balance of the outstanding principal amount at a fixed rate per annum equal to (a) 1.00%, if the Facility is sold on or before June 30, 2023, (b) 2.00% if the Facility is sold after June 2023, but on or before September 30, 2023, or (c) 3:00%, if the Facility is sold after September 30, 2023, or not sold prior to the Maturity Date.
In addition, starting on the effective date of the Fifth Amendment, the interest on the Term Loan was increased to 5.25%, and the Term Loan further accrued interest, payable in kind and added to the balance of the outstanding principal amount at a fixed rate per annum equal to (a) 1.00%, if the Facility was sold on or before June 30, 2023, (b) 2.00% if the Facility was sold after June 2023, but on or before September 30, 2023, or (c) 3:00%, if the Facility was sold after September 30, 2023, or not sold prior to the Maturity Date.
The result was a failure of first-gen anti-CD25 mAbs as cancer immunotherapies, since their favorable anti-Treg effects were negated by their unfavorable impact on Teff cells. 9 Table of Contents ​ Figure 6: Mechanism of action of first and 2 nd generation Treg depleting antibodies ​ In vitro characterization of IBIO-101 demonstrated potent binding to recombinant CD25 while preserving IL-2 signaling.
The result was a failure of first-gen anti-CD25 mAbs as cancer immunotherapies, since their favorable anti-Treg effects were negated by their unfavorable impact on Teff cells. ​ ​ Figure 7: Mechanism of action of first and 2 nd generation Treg depleting antibodies ​ In vitro characterization of IBIO-101 demonstrated potent binding to recombinant CD25 while preserving IL-2 signaling.
Figure 23: Selective binding to CCR8 and inhibition of the CCR8 signaling pathway by iBio’s lead molecule leads to potent killing of Tregs derived from primary human immune cells 21 Table of Contents iBio’s CCR8 antibody has proven effective in a mouse model for colon cancer.
Figure 24: Selective binding to CCR8 and inhibition of the CCR8 signaling pathway by iBio’s lead molecule leads to potent killing of Tregs derived from primary human immune cells 22 Table of Contents iBio’s CCR8 antibody has proven effective in a mouse model for colon cancer.
Item 1. Business. Overview iBio, Inc. (also referred to as "we", "us", "our", "iBio", or the "Company") is a preclinical stage biotechnology company that leverages the power of Artificial Intelligence (AI) for the development of 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. Our proprietary technology stack is designed to minimize downstream development risks by employing AI-guided epitope-steering and monoclonal antibody (mAb) optimization.
(a member of the Roche Group), Amgen Inc., Gilead Sciences, Inc. and its subsidiary Kite Pharma, Inc., and competing cancer immunotherapy companies such as, Bluebird Bio, Inc., Transgene SA, Bausch Health Companies, Lumos Pharma, Agenus Inc., Aduro Biotech, Inc., Advaxis, Inc., ImmunoCellular Therapeutics, Ltd., IMV Inc., Oxford BioMedica plc, Bavarian Nordic A/S, Celldex Therapeutics, Inc., as well as tech enabled drug discovery companies such as Recursion, Abcellera Biologics, Inc., Cellarity, BenevolentAI, and others, some of which have substantially greater financial, technical, sales, marketing, and human resources than we do.
(a member of the Roche Group), Amgen Inc., Gilead Sciences, Inc. and its subsidiary Kite Pharma, Inc., more advanced obesity and cardiometabolic companies such as Keros Therapeutics, Inc., Scholar Rock, Inc., and Biohaven, Ltd., and competing cancer immunotherapy companies such as, Bluebird Bio, Inc., Transgene SA, Bausch Health Companies, Lumos Pharma, Agenus Inc., Aduro Biotech, Inc., Advaxis, Inc., ImmunoCellular Therapeutics, Ltd., IMV Inc., Oxford BioMedica plc, Bavarian Nordic A/S, Celldex Therapeutics, Inc., as well as tech enabled drug discovery companies such as Recursion, Abcellera Biologics, Inc., Cellarity, BenevolentAI, and others, some of which have substantially greater financial, technical, sales, marketing, and human resources than we do.
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.
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.
Further assessment of IBIO-101 showed selective Treg depletion and sparing of Teffs. ​ ​ Figure 7: In vitro characterization of IBIO-101 ​ In a humanized mouse disease model, IBIO-101, when used as a monotherapy, effectively demonstrated its mechanism of action by significantly enhancing the Treg/Teff ratio, resulting in the suppression of tumor growth.
Further assessment of IBIO-101 showed selective Treg depletion and sparing of Teffs. ​ 11 Table of Contents ​ Figure 8: In vitro characterization of IBIO-101 ​ In a humanized mouse disease model, IBIO-101, when used as a monotherapy, effectively demonstrated its mechanism of action by significantly enhancing the Treg/Teff ratio, resulting in the suppression of tumor growth.
In addition, the Guaranty was amended to allow the Company until February 28, 2023, to account for the Fraunhofer Settlement Funds in determining whether the Company was in compliance with the Liquidity Covenant without being dependent upon a specified milestone.
In addition, the Guaranty was amended to allow the Company until February 28, 2023, to account for the Fraunhofer Settlement Funds in determining whether the Company was in compliance with the Liquidity Covenant without being 26 Table of Contents dependent upon a specified milestone.
In addition to patents and patent applications that we own, our plant focused patent estate relies on trade secrets and know-how, which we are currently seeking a partner to out-license such proprietary technology and processes. Our success will depend in part on our ability to obtain and maintain patent protection for our technologies and preclinical assets.
In addition to patents and patent applications that we own, our plant-focused patent estate relies on trade secrets and know-how, which we have been seeking a partner to out-license including proprietary technology and processes. Our success will depend in part on our ability to obtain and maintain patent protection for our technologies and preclinical assets.
Drug Approval Process All of the vaccine and therapeutic products developed from our technologies will require regulatory approval by governmental agencies prior to commercialization. In particular, pharmaceutical drugs and vaccines are subject to rigorous preclinical testing and clinical trials and other pre-marketing approval requirements by the FDA and regulatory authorities in other countries.
Drug Approval Process All of the vaccine and therapeutic products developed from our technologies will require regulatory approval by governmental agencies prior to commercialization. In particular, pharmaceutical drugs and vaccines are subject to rigorous preclinical testing and clinical trials and other pre-marketing approval requirements by the U.S. Food and Drug Administration (the “FDA”) and regulatory authorities in other countries.
We consider our relations with our employees to be good. We believe that our success depends upon our ability to attract, develop, retain and motivate key personnel. Our management and scientific teams possess considerable experience in drug discovery, research and development, manufacturing, clinical and regulatory affairs, and iBio directly benefits from this experience and industry knowledge.
We believe that our success depends upon our ability to attract, develop, retain and motivate key personnel. Our management and scientific teams possess considerable experience in drug discovery, research and development, manufacturing, clinical and regulatory affairs, and iBio directly benefits from this experience and industry knowledge.
Subsequently, iBio has meticulously eliminated a range of sequence liabilities. Such careful curation process could potentially significantly reduce the development risk for antibodies identified from our library. StableHu TM AI Antibody-Optimizing Technology Antibody optimization is a pivotal step in the development of therapeutic antibodies. It refines an antibody's properties to enhance its efficacy, safety, and manufacturability.
Such careful curation process could potentially significantly reduce the development risk for antibodies identified from our library. StableHu TM AI Antibody-Optimizing Technology Antibody optimization is a pivotal step in the development of therapeutic antibodies. It refines an antibody's properties to enhance its efficacy, safety, and manufacturability.
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. ​ 26 Table of Contents Purchase Agreement: On September 16, 2022, iBio entered into an asset purchase agreement (the “Purchase Agreement”) with RubrYc in order to acquire substantially all of its assets, 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 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”).
The assets acquired include the patented AI drug discovery platform, all rights with no future milestone payments or royalty obligations, to IBIO-101 (RTX-003), in addition to CCR8, EGFRvIII, MUC16, CD3 and one additional immuno-oncology candidate plus a PD-1 agonist. The Purchase Agreement contained representations, warranties and covenants of RubrYc and the Company.
The assets acquired include the patented AI drug discovery platform, all rights with no future milestone payments or royalty obligations, to IBIO-101 (RTX-003), in addition to CCR8, EGFRvIII, MUC16, CD3 and one additional immuno-oncology candidate plus a PD-1 agonist.
In addition, the Company was obligated to (y) deliver to Woodforest an executed copy of a purchase agreement (the “Purchase Agreement”) for the sale of the Facility, no later than April 14, 2023, and (z) pay to Woodforest a fee in the amount of $75,000 on the earlier of the date of the closing of the Purchase Agreement, or the Maturity Date (as defined in the Credit Agreement).
In addition, the Company was obligated to (y) deliver to Woodforest an executed copy of a purchase agreement (the “Woodforest Purchase Agreement”) for the sale of the Facility, no later than April 14, 2023, and (z) pay to Woodforest a fee in the amount of $75,000 on the earlier of the date of the closing of the Woodforest Purchase Agreement, or the maturity date of the term loan (the “Maturity Date”).
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.
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.
Figure 5: iBio’s Preclinical Therapeutics Pipeline Therapeutics Immuno-Oncology There have been notable advances in the field of oncology in recent years, and arguably none more important than the advent of immunotherapies. The Company has established its own AI drug discovery and drug development capabilities in San Diego, California, has built a pipeline of nine immuno-oncology programs.
Immuno-Oncology There have been notable advances in the field of oncology in recent years, and arguably none more important than the advent of immunotherapies. The Company has established its own AI drug discovery and drug development capabilities in San Diego, California, and has built a pre-clinical pipeline of six immuno-oncology programs.
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.
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.
Since July 1, 2022, we have primarily focused our intellectual property estate on our preclinical assets filing 10 provisional patents in the U.S. and foreign countries, including for chemokine receptor 8 (CCR8) antibodies, epidermal growth factor receptor variant III (EGFRvIII) antibodies, anti-MUC16 antibodies, TROP2 antibodies, CD3 antibodies, and recently filed a provisional patent for our high-efficiency, conditionally-activated antibodies.
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.
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.
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.
Management believes that it has sufficient human capital to operate 38 Table of Contents 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 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.
The 8 patents expiring in 2023 in the U.S. and overseas are related to virus-induced gene silencing in plants. Included in the 95 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 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.
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 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.
This multidisciplinary expertise allows us to quickly translate scientific discoveries into potential therapeutic applications. Artificial Intelligence in Antibody Discovery and Development The potential of AI in antibody discovery is immense and is being increasingly recognized in the biopharmaceutical industry. The mAbs market has seen impressive growth in recent years, with mAbs increasingly the top-selling drugs in the United States.
This multidisciplinary expertise allows us to quickly translate scientific discoveries into potential therapeutic applications. Artificial Intelligence in Antibody Discovery and Development The potential of AI in antibody discovery is immense and is being increasingly recognized in the biopharmaceutical industry.
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. ​ 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”).
In addition, the Credit Agreement originally provided that the Company must maintain unrestricted cash of no less than $10,000,000 (the “Liquidity Covenant”), which amount has been amended to $1,000,000. ​ On October 11, 2022, iBio CDMO and Woodforest amended the Credit Agreement (the “First Amendment”) to: (i) include a payment of $5,500,000 of the outstanding principal balance owed under the Credit Agreement on the date of the First Amendment, (ii) include a payment of $5,100,000 of the outstanding principal balance owed under the Credit Agreement within two (2) business days upon our receipt of such amount owed to us by Fraunhofer USA, Inc.
The Credit Agreement also contained negative covenants. ​ On October 11, 2022, iBio CDMO and Woodforest amended the Credit Agreement (the “First Amendment”) to: (i) include a payment of $5,500,000 of the outstanding principal balance owed under the Credit Agreement on the date of the First Amendment, (ii) include a payment of $5,100,000 of the outstanding principal balance owed under the Credit Agreement within two (2) business days upon our receipt of such amount owed to us by Fraunhofer USA, Inc.
This is particularly relevant for complex and hard-to-drug protein structures. Pre-Clinical Pipeline iBio is currently in the process of building and advancing its preclinical pipeline. The focus of this pipeline is primarily on immuno-oncology, with one program also dedicated to the immunology space. By leveraging iBio’s technology stack, the pipeline is geared towards hard-to-drug targets and molecules offering differentiation.
This is particularly relevant for complex and hard-to-drug protein structures. Pre-Clinical Pipeline iBio is currently in the process of building and advancing its preclinical pipeline by leveraging its technology stack focused on hard-to-drug targets and molecules offering differentiation in both in obesity and cardiometabolic disease space, as well as immune-oncology.
This advanced technology allows us to target specific regions of proteins with precision enabling the creation of antibodies highly specific to therapeutically relevant regions within large target proteins, potentially improving their efficacy and safety profile. Another integral part of iBio’s technology stack is the machine learning (ML) based antibody-optimizing StableHu™ technology.
One of the key features of iBio’s technology stack is the patented epitope-steering AI-engine. This advanced technology allows us to target specific regions of proteins with precision enabling the creation of antibodies highly specific to therapeutically relevant regions within large target proteins, potentially improving their efficacy and safety profile.
The Term Loan was advanced in full on the closing date. The Term Loan originally bared an interest at a rate of 3.25%, with higher interest rates upon an event of default, which interest is payable monthly beginning November 5, 2021.
The Term Loan originally bore an interest at a rate of 3.25%, with higher interest rates upon an event of default, which interest was payable monthly beginning November 5, 2021. Principal on the Term Loan was originally payable on November 1, 2023, subject to early termination upon events of default.
Such reports and other information filed by the Company with the SEC are available free of charge on our website at www.ibioinc.com . Information contained on, or that can be accessed through, our website is not incorporated by reference into this Annual Report, and you should not consider information on our website to be part of this Annual Report.
Information contained on, or that can be accessed through, our website is not incorporated by reference into this Annual Report, and you should not consider information on our website to be part of this Annual Report.
Furthermore, the potential use of this approach in vaccine development could open up new avenues for disease prevention. Figure 2: iBio’s patented epitope steering technology Naïve Human Antibody Library The fully human antibody library is built upon clinically validated, entirely human antibody frameworks. By leveraging public databases, iBio has extracted a diverse array of Complementarity-Determining Region (CDR) sequences.
Figure 2: iBio’s patented epitope steering technology Naïve Human Antibody Library The fully human antibody library is built upon clinically validated, entirely human antibody frameworks. By leveraging public databases, iBio has extracted a diverse array of Complementarity-Determining Region (CDR) sequences. Subsequently, iBio has meticulously eliminated a range of sequence liabilities.
National Institute of Allergy and Infectious Diseases On June 12, 2023, iBio entered into a research collaboration with the National Institute of Allergy and Infectious Diseases (“NIAID”), a component of the National Institutes of Health (“NIH”), to investigate the potential of the patented AI-driven epitope steering platform for the development of a vaccine for Lassa fever, which currently there is no vaccine available.
National Institute of Allergy and Infectious Diseases On June 12, 2023, iBio entered into a research collaboration with NIAID, a component of the NIH, to investigate the potential of iBio’s patented AI-driven epitope steering platform for the development of a vaccine for Lassa fever, a sometimes fatal viral disease endemic to parts of West Africa.
All share and per share amounts of common stock presented in this Annual Report have been retroactively adjusted to reflect the one-for-twenty five reverse stock split. 39 Table of Contents Available Information Our website address is www.ibioinc.com.
All share and per share amounts of common stock presented in this Annual Report have been retroactively adjusted to reflect the one-for-twenty reverse stock split. Available Information Our website address is www.ibioinc.com. We file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements and other materials with the SEC.
We continue to mitigate the risks through inventory management, relationship management and evaluation of alternative sources when possible. Refer to Item 1A, “Risk Factors,” for a description of risks associated with our reliance on suppliers and outsourcing partners.
Refer to Item 1A, “Risk Factors,” for a description of risks associated with our reliance on suppliers and outsourcing partners.
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 October 7, 2022, we effected a reverse stock split at a ratio of one-for-twenty five (1:25) shares of our common stock.
The Company also agreed to pay Woodforest a fee in the amount of (x) $75,000 if the Facility is sold on or before June 30, 2023, (y) $100,000 if the Facility is sold after June 2023, but on or before September 30, 2023, or (x) $125,000, if the Facility is sold after September 30, 2023, or not sold prior to the Maturity Date. ​ On September 15, 2023, iBio CDMO entered into a purchase and sale agreement, dated as of September 15, 2023 (the “Purchase and Sale Agreement”) with Majestic Realty Co., a California corporation (“Majestic Realty”), pursuant to which iBio CDMO agreed to sell to Majestic Realty for a purchase price of $17,250,000 its Facility located in Bryan, TX consisting of: (i) the ground leasehold estate and interest held under the Ground Lease Agreement, dated March 8, 2010, as amended by an Estoppel Certificate and Amendment to Ground Lease Agreement, dated as of December 22, 2015, between iBio CDMO (as assignee from College Station Investors LLC) and The Board of Regents of the Texas A&M University System (together, the “Ground Lease”), related to 21.401 acres in Brazos County, Texas land (the “Land”); (ii) 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”).
Accordingly, 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”).
We now have 18 U.S., 2 Patent Cooperation Treaty, and 32 international applications pending. International patents and applications include numerous foreign countries including Australia, Brazil, Canada, China, Hong Kong, India, Japan, Korea, and several countries in Europe. In the U.S. our patents expire between 2023 and 2036. Outside the U.S. these patents expire between 2023 and 2036.
We now have 13 U.S., 5 Patent Cooperation Treaty, and 40 international applications pending. International patents and applications include numerous foreign countries including Australia, Brazil, Canada, China, Hong Kong, India, Japan, Korea, and several countries in Europe. All of our patents will expire between 2024 and 2040 with 15 patents, all part of the de-prioritized plant portfolio, expiring in 2024.
This combination speeds up the Lead Optimization process and potentially minimizes downstream risks, with the goal of making the overall development process more efficient and cost-effective. Finally, 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. Next, our EngageTx platform forms the fourth layer.
The application of engineered epitopes extends to a wide array of complex and hard-to-drug protein structures (as depicted in Figure 2). 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 immunology and pain 5 Table of Contents management.
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.
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.
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.
Our principal executive offices are located at 8800 Health Science Center Parkway, Bryan, Texas and our telephone number is (979) 446-0027. Our website address is www.ibioinc.com. The information contained on, or accessible through, our website does not constitute part of this Annual Report. We have included our website address in this Annual Report solely as an inactive textual reference.
Our principal executive offices are located at 11750 Sorrento Valley Road, Suite 200, San Diego, California 92121 and our telephone number is (979) 446-0027. Our website address is www.ibioinc.com. The information contained on, or accessible through, our website does not constitute part of this Annual Report.
Human Capital/Employees As of June 30, 2023, we had 23 employees in iBio and 3 employees in iBio CDMO that are maintaining the Facility until it is sold, all of which are full time employees. Our employees are not represented by any union and are not the subject of a collective bargaining agreement.
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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

101 edited+29 added−44 removed271 unchanged
Biggest changeA more detailed description of our risk factors is set forth below under the caption “Detailed Risk Factors.” Risks Related to Our Financial Position and Need for Additional Capital • We have a limited operating history developing vaccines and therapeutics. • We are evaluating potential options to extend our cash runway that could impact our future operations and financial position. • Substantial doubt exists related to our ability to operate as a going concern. • We have incurred and expect to continue to incur significant losses. • We anticipate that our expenses will increase in the future. • We need additional funding to fully execute our business plan. • The actual amount of funds we will need to operate is subject to many risk factors. • Raising additional capital may cause dilution to our existing stockholders and/or restrict our operations or rights. • There can be no assurance that the sale of the Property will be completed in a timely manner or at all. • Failure to complete the sale of the Property is expected to negatively impact our stock price and our future business and financial results. • If the sale of the Property is not complete, we will have incurred substantial expenses without realizing the expected benefits of the sale. • The unaudited pro forma financial information included as an exhibit to our Current Report on Form 8-K filed with the SEC on September 21, 2023 is for illustrative purposes and although we do not expect actual results to differ materially from the preliminary estimates, our actual financial position or result of operations after the anticipated sale may differ from the estimates. • A default under the terms of the Credit Agreement could result in action against our pledged assets. • The Credit Agreement requires that we pay a significant amount of cash to the lender. • Covenant restrictions in the Credit Agreement may limit our ability to operate our business. • Potential use of government funding for R&D programs may impose conditions limiting our ability to take certain actions. ​ Risks Related to the Development and Commercialization of Our Technologies and Product Candidates • We have a limited operating history developing precision antibodies and have no significant source of revenue. • We are reliant on a limited number of product candidates that involve significant clinical testing before seeking regulatory approval. • 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 or our clients, collaborators or licensees are dependent upon successful preclinical and clinical studies. • 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. • Our clinical product candidates may exhibit undesirable side effects. • Our failure to receive or maintain regulatory approval for product candidates could negatively impact our revenue and profitability. • Product liability lawsuits could cause us to incur substantial liabilities and to limit product commercialization. • Any manufacturing problems experienced by our only third-party contract manufacturer could result in a delay or interruption in the supply of our clinical product candidate. ​ Risks Related to Dependence on Third Parties 41 Table of Contents • 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 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 to protect or enforce our patents or other intellectual property. • Patent terms may be inadequate to protect our competitive position for an adequate amount of time. • 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. • A natural disaster, unfavorable weather conditions or other disruptions at 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. ​ Risks Related to Our Common Stock • Our stockholders will experience dilution from the issuance of the development milestone payments if paid in equity. • We are subject to compliance under the NYSE American continued listing standards of the NYSE American Company Guide, the failure of which can 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. • We do not anticipate paying cash dividends for the foreseeable future. • The issuance of preferred stock could adversely affect the rights of the holders of shares of our common stock. • 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. • We rely extensively on our information technology systems and are vulnerable to damage and interruptions. • 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. • We are subject to reduced disclosure requirements applicable to smaller reporting companies . ​ ​ 42 Table of Contents Detailed Risk Factors Our business faces many risks.
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.
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 59 Table of Contents 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; ● 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; 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.
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; 73 Table of Contents ● 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; ● 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; 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.
In order to maintain its listing with NYSE American, we must remain in compliance with the continued listing standards as set forth in the NYSE American Company Guide (the “Company Guide”), including the listing standard set forth in Section 1003 of the Guide, which applies if a listed company has stockholders’ equity below certain threshold amounts and has sustained losses from continuing operations and/or net losses in its five most recent fiscal years.
In order to maintain our listing with NYSE American, we must remain in compliance with the continued listing standards as set forth in the NYSE American Company Guide (the “Company Guide”), including the listing standard set forth in Section 1003 of the Guide, which applies if a listed company has stockholders’ equity below certain threshold amounts and has sustained losses from continuing operations and/or net losses in its five most recent fiscal years.
To continue to develop our pipeline and execute our strategy, we also must attract and retain highly skilled personnel in our industry. ​ A failure by iBio to hire and retain an appropriately skilled and adequate workforce could adversely impact the ability to operate and function efficiently. iBio’s operations will depend, in part, on our ability to attract and retain an appropriately skilled and sufficient workforce to operate our R&D facility.
To continue to develop our pipeline and execute our strategy, we also must attract and retain highly skilled personnel in our industry. ​ A failure by iBio to hire and retain an appropriately skilled and adequate workforce could adversely impact the ability to operate our R&D facility efficiently. iBio’s operations will depend, in part, on our ability to attract and retain an appropriately skilled and sufficient workforce to operate our R&D facility.
Resulting changes in U.S. trade policy could trigger retaliatory actions by Russia, its allies and other affected countries, including China, resulting in a “trade war.” ​ The above factors, including a number of other economic and geopolitical factors both in the U.S. and abroad, could ultimately have material adverse effects on our business, financial condition, results of operations or cash flows, including the following: ​ ● effects of significant changes in economic, monetary and fiscal policies in the U.S. and abroad including currency fluctuations, inflationary pressures and significant income tax changes; ● supply chain disruptions; ● a global or regional economic slowdown in any of our market segments; ● changes in government policies and regulations affecting the Company or its significant customers; ● industrial policies in various countries that favor domestic industries over multinationals or that restrict foreign companies altogether; ● new or stricter trade policies and tariffs enacted by countries, such as China, in response to changes in U.S. trade policies and tariffs; ● postponement of spending, in response to tighter credit, financial market volatility and other factors; ● rapid material escalation of the cost of regulatory compliance and litigation; ● difficulties protecting intellectual property; ● longer payment cycles; ● credit risks and other challenges in collecting accounts receivable; and ● the impact of each of the foregoing on outsourcing and procurement arrangements.
Resulting changes in U.S. trade policy could trigger retaliatory actions by Russia, its allies and other affected countries, including China, resulting in a “trade war.” ​ The above factors, including a number of other economic and geopolitical factors both in the U.S. and abroad, could ultimately have material adverse effects on our business, financial condition, results of operations or cash flows, including the following: ​ ● effects of significant changes in economic, monetary and fiscal policies in the U.S. and abroad including currency fluctuations, inflationary pressures and significant income tax changes; ● supply chain disruptions; ● a global or regional economic slowdown in any of our market segments; ● changes in government policies and regulations affecting the Company or its significant customers; ● industrial policies in various countries that favor domestic industries over multinationals or that restrict foreign companies altogether; ● new or stricter trade policies and tariffs enacted by countries, such as China, in response to changes in U.S. trade policies and tariffs; ● postponement of spending, in response to tighter credit, financial market volatility and other factors; ● rapid material escalation of the cost of regulatory compliance and litigation; ● difficulties protecting intellectual property; ● longer payment cycles; 70 Table of Contents ● credit risks and other challenges in collecting accounts receivable; and ● the impact of each of the foregoing on outsourcing and procurement arrangements.
We commenced independent operations in 2008, and our operations to date have included organizing and staffing our company, business planning, raising capital, acquiring and developing our proprietary technologies, identifying potential product candidates and undertaking, through third parties, preclinical trials and clinical trials of product candidates derived from our technologies.
We commenced independent operations in 2008, and our operations to date have included organizing and staffing our company, business planning, raising capital, acquiring and developing our proprietary technologies, identifying potential product candidates and undertaking, in house and through third parties, preclinical trials and clinical trials of product candidates derived from our technologies.
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; ● 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; 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.
If we or our clients and collaborators are unable to successfully develop and commercialize product candidates or experience significant delays in doing so, our business will be materially harmed. All of our vaccine and therapeutic protein product candidates are still in preclinical development.
If we or our clients and collaborators are unable to successfully develop and commercialize product candidates or experience significant delays in doing so, our business will be materially harmed. All of our therapeutic protein product candidates are still in preclinical development.
We also may encounter problems with the following: ● achieving adequate or clinical-grade materials that meet FDA or other comparable regulatory agency standards or specifications with consistent and acceptable production yield and costs; ● failing to develop an acceptable formulation to support late-stage clinical trials for, or the commercialization of, our clinical product candidate; ● being unable to increase the scale of or the capacity for, or reformulate the form of our clinical product candidate, which may cause us to experience a shortage in supply or cause the cost to manufacture our clinical product candidate to increase; ● we cannot assure you that we will be able to manufacture our clinical product candidate at a suitable commercial scale, or that we will be able to find alternative manufacturers acceptable to us that can do so; ● our facility closing as a result of regulatory sanctions, pandemic or a natural disaster; ● shortages of qualified personnel, raw materials or key contractors; ● failing to obtain FDA approval for commercial scale manufacturing; and 58 Table of Contents ● ongoing compliance with cGMP regulations and other requirements of the FDA or other comparable regulatory agencies.
We also may encounter problems with the following: ● achieving adequate or clinical-grade materials that meet FDA or other comparable regulatory agency standards or specifications with consistent and acceptable production yield and costs; ● failing to develop an acceptable formulation to support late-stage clinical trials for, or the commercialization of, our clinical product candidate; ● being unable to increase the scale of or the capacity for, or reformulate the form of our clinical product candidate, which may cause us to experience a shortage in supply or cause the cost to manufacture our clinical product candidate to increase; ● we cannot assure you that we will be able to manufacture our clinical product candidate at a suitable commercial scale, or that we will be able to find alternative manufacturers acceptable to us that can do so; ● our facility closing as a result of regulatory sanctions, pandemic or a natural disaster; ● shortages of qualified personnel, raw materials or key contractors; ● failing to obtain FDA approval for commercial scale manufacturing; and ● ongoing compliance with cGMP regulations and other requirements of the FDA or other comparable regulatory agencies.
We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors. We are a "smaller reporting company" as defined in Rule 12b-2 promulgated under the Exchange Act.
We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors. We are a “smaller reporting company” as defined in Rule 12b-2 promulgated under the Exchange Act.
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 ● 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; 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.
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.
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.
However, there can be no assurance that we will be successful in implementing any of the options that we are evaluating. ​ Our consolidated audited financial statements as of and for the year ended June 30, 2023 have been prepared under the assumption that we will continue as a going concern for the next 12 months.
However, there can be no assurance that we will be successful in implementing any of the options that we are evaluating. ​ Our consolidated audited financial statements as of and for the year ended June 30, 2024 have been prepared under the assumption that we will continue as a going concern for the next 12 months.
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.
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.
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.
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.
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.
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.
Regardless of merit or eventual outcome, liability claims may result in: ● decreased demand for any product candidates or products that we may develop; ● injury to our reputation and significant negative media attention; ● withdrawal of clinical trial participants; ● significant costs to defend the related litigation; ● substantial monetary awards to trial participants or patients; ● loss of revenue; ● reduced resources of our management to pursue our business strategy; and 57 Table of Contents ● the inability to commercialize any products that we may develop.
Regardless of merit or eventual outcome, liability claims may result in: ● decreased demand for any product candidates or products that we may develop; ● injury to our reputation and significant negative media attention; ● withdrawal of clinical trial participants; ● significant costs to defend the related litigation; ● substantial monetary awards to trial participants or patients; ● loss of revenue; ● reduced resources of our management to pursue our business strategy; and ● the inability to commercialize any products that we may develop.
We and our third-party contract manufacturers, contract research organizations, and any clinical sites that may conduct our clinical trials in the future may also face disruptions in procuring items that are essential to our research and development activities, including, for example, medical and laboratory supplies used in our clinical trials or preclinical studies, in each case, that are sourced from abroad or for 71 Table of Contents which there are shortages because of ongoing efforts to address the outbreak.
We and our third-party contract manufacturers, contract research organizations, and any clinical sites that may conduct our clinical trials in the future may also face disruptions in procuring items that are essential to our research and development activities, including, for example, medical and laboratory supplies used in our clinical trials or preclinical studies, in each case, that are sourced from abroad or for which there are shortages because of ongoing efforts to address the outbreak.
Potential options being considered to increase liquidity include focusing product development on a select number of product candidates, the sale of the CDMO Facility, the sale or out-licensing of certain product candidates or parts of the business, raising money from capital markets, grant revenue or collaborations, or a combination thereof.
Potential options being considered to increase liquidity include focusing product development on a select number of product candidates, the sale or out-licensing of certain product candidates or parts of the business, raising money from capital markets, grant revenue or collaborations, or a combination thereof.
We devoting substantially all of our efforts to research and development, including the development and validation of our technologies, and the development of a proprietary therapeutic products against oncology. We have not completed development of or commercialized any vaccine or therapeutic product candidates.
We devote substantially all of our efforts to research and development, including the development and validation of our technologies, and the development of a proprietary therapeutic products against oncology. We have not completed development of or commercialized any vaccine or therapeutic product candidates.
If we fail to reach agreements 60 Table of Contents with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development or the development of one or more of our other product candidates, or increase our expenditures and undertake additional development or commercialization activities at our own expense.
If we fail to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development or the development of one or more of our other product candidates, or increase our expenditures and undertake additional development or commercialization activities at our own expense.
Our resource allocation decisions may cause us to fail to capitalize on viable 51 Table of Contents commercial products or profitable market opportunities. Our spending and the spending of our clients and collaborators may not yield any commercially viable products. We have based our research and development efforts largely on our technologies and product candidates derived from such technologies.
Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending and the spending of our clients and collaborators may not yield any commercially viable products. We have based our research and development efforts largely on our technologies and product candidates derived from such technologies.
As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued 62 Table of Contents which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products.
As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products.
Our auditors also included an explanatory paragraph in its report on our financial statements as of and for the year ended June 30, 2023 with respect to this uncertainty.
Our auditors also included an explanatory paragraph in its report on our financial statements as of and for the year ended June 30, 2024 with respect to this uncertainty.
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.
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.
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.
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.
We anticipate that our expenses and losses will increase substantially if we: ● initiate clinical trials of our product candidates; ● continue the research and development of our product candidates; ● seek to discover or license in additional product candidates; and ● add operational, financial and management information systems and personnel, including personnel to support our product development and manufacturing efforts.
We anticipate that our expenses and losses will increase substantially if we: ● initiate clinical trials of our product candidates; ● continue the research and development of our product candidates; ● seek to discover or license in additional product candidates; and ● add operational, and administrative information systems and personnel, including personnel to support our product development and manufacturing efforts.
Our future profitability and cash flow in large part depends on 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 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.
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 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 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.
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.
Even if any of our product candidates demonstrate adequate biologic activity and clear clinical benefit, any 56 Table of Contents unacceptable side effects or adverse events, when administered alone or in the presence of other pharmaceutical products, may outweigh these potential benefits.
Even if any of our product candidates demonstrate adequate biologic activity and clear clinical benefit, any unacceptable side effects or adverse events, when administered alone or in the presence of other pharmaceutical products, may outweigh these potential benefits.
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. 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. 49 Table of Contents We, our clients and collaborators, are very early in our development efforts.
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.
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.
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.
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.
Although we believe we have sufficient supply of our other raw materials at this time, due to supply chain shortages, we may not be able to obtain such materials 61 Table of Contents in the future is our current suppliers should be unable to satisfy our needs.
Although we believe we have sufficient supply of our other raw materials at this time, due to supply chain shortages, we may not be able to obtain such materials in the future is our current suppliers should be unable to satisfy our needs.
We rely extensively on our information technology systems and are vulnerable to damage and interruption We rely on our information technology systems and infrastructure to process transactions, summarize results and manage our business, including maintaining client and supplier information. Additionally, we utilize third parties, including cloud providers, to store, transfer and process data.
We rely extensively on our information technology systems and are vulnerable to damage and interruption, including cybersecurity and data leakage risks. We rely on our information technology systems and infrastructure to process transactions, summarize results and manage our business, including maintaining client and supplier information. Additionally, we utilize third parties, including cloud providers, to store, transfer and process data.
If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, 65 Table of Contents or right to use, intellectual property that is important to our product candidates.
If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our product candidates.
In the past, we have received notification of noncompliance with the continued listing requirements, which to date have been remediated There can be no assurance that we will continue to meet all of the Exchange’s continued listing standards, or exemptions therefrom, in the future.
In the past, we have received notification of noncompliance with the continued listing requirements, which to date have been remediated. There can be no assurance that we will continue to meet all of the continued listing standards of NYSE American, or exemptions therefrom, in the future.
In addition, any manufacturing facility where any of our clinical product candidates are manufactured will be subject to ongoing, periodic inspection by the FDA or other comparable regulatory agencies to ensure compliance with current Good Manufacturing Practice, or cGMP.
In addition, any manufacturing facility where any of our clinical product candidates are manufactured will be subject to ongoing, periodic inspection by the FDA or other comparable regulatory agencies to ensure compliance with cGMP.
A cyber-attack or other significant disruption involving our information technology systems, or those of our vendors, suppliers and other partners, could also result in disruptions in critical 72 Table of Contents systems, corruption or loss of data and theft of data, funds or intellectual property.
A cyber-attack or other significant disruption involving our information technology systems, or those of our vendors, suppliers and other partners, could also result in disruptions in critical systems, corruption or loss of data and theft of data, funds or intellectual property.
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.
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.
Although we 68 Table of Contents do believe that we could find alternative space in the case of a natural disaster, there can be no assurance that we will find suitable space near the location of our employees or that our equipment will survive a natural disaster.
Although we do believe that we could find alternative space in the case of a natural disaster, there can be no assurance that we will find suitable space near the location of our employees or that our equipment will survive a natural disaster.
If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, future 47 Table of Contents revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
Consequently, predictions about our 50 Table of Contents future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing product candidates.
Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing product candidates.
If we are unable to raise capital in sufficient amounts when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or 46 Table of Contents commercialization efforts and our ability to generate revenues and achieve or sustain profitability will be substantially harmed.
If we are unable to raise capital in sufficient amounts when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or commercialization efforts and our ability to generate revenues and achieve or sustain profitability will be substantially harmed.
There can be no assurances that we will be able to raise the funds needed, especially in light of the fact that our ability to sell securities registered on our registration statement on Form S-3 after we regain eligibility to use a registration statement on Form S-3 will be limited until such time the market value of our voting securities held by non-affiliates is $75 million or more.
There can be no assurances that we will be able to raise the funds needed, especially in light of the fact that our ability to sell securities registered on our registration statement on Form S-3 will be limited until such time the market value of our voting securities held by non-affiliates is $75 million or more.
For example, 54 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.
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.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference or derivation proceedings before the U.S. PTO 63 Table of Contents and similar bodies in other countries.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference or derivation proceedings before the U.S. PTO and similar bodies in other countries.
These requirements include submissions of safety, 55 Table of Contents efficacy and other post-marketing information and reports, establishment registration and drug listing requirements, continued compliance with current Good Manufacturing Practice, or 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, 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.
Based on current trends and activities, there is significant doubt that we can continue as a going concern beyond the second quarter of Fiscal 2024. We are currently evaluating a number of potential options to expand our cash runway, the implementation of which will impact our liquidity.
Based on current trends and activities, there is significant doubt that we can continue as a going concern beyond the first quarter of fiscal year 2026. We are currently evaluating a number of potential options to expand our cash runway, the implementation of which will impact our liquidity.
Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made 66 Table of Contents using our inventions in and into the United States or other jurisdictions.
Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
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 ● maintain, expand and protect our intellectual property portfolio. 43 Table of Contents 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.
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.
(a member of the Roche Group), Amgen Inc., Gilead Sciences, Inc. and its subsidiary Kite Pharma, Inc., and competing cancer immunotherapy companies such as, Bluebird Bio, Inc., Transgene SA, Bausch Health Companies, Lumos Pharma, Agenus Inc., Aduro Biotech, Inc., Advaxis, Inc., ImmunoCellular Therapeutics, Ltd., IMV Inc., Oxford BioMedica plc, Bavarian Nordic A/S, Celldex Therapeutics, Inc., as well as tech enabled drug discovery companies such as Recursion, Abcellera Biologics, Inc., Cellarity, and BenevolentAI.
(a member of the Roche Group), Amgen Inc., Gilead Sciences, Inc. and its subsidiary Kite Pharma, Inc., more advanced obesity and cardiometabolic companies such as Keros Therapeutics, Inc., Scholar Rock, Inc., and Biohaven, Ltd., and competing cancer immunotherapy companies such as, Bluebird Bio, Inc., Transgene SA, Bausch Health Companies, Lumos Pharma, Agenus Inc., Aduro Biotech, Inc., Advaxis, Inc., ImmunoCellular Therapeutics, Ltd., IMV Inc., Oxford BioMedica plc, Bavarian Nordic A/S, Celldex Therapeutics, Inc., as well as tech enabled drug discovery companies such as Recursion, Abcellera Biologics, Inc., Cellarity, and BenevolentAI.
Commencement and completion of clinical trials may be delayed by several factors, including: ● obtaining an IND application with the FDA or foreign equivalent to commence clinical trials; ● identification of, and acceptable arrangements with, one or more clinical sites; ● obtaining IRB or EC approval to commence clinical trials; ● obtaining IBC approval for use of a genetically modified organism; ● unforeseen safety issues; ● determination of dosing; ● lack of effectiveness during clinical trials; ● slower than expected rates of patient recruitment; ● inability to monitor patients adequately during or after treatment; ● lower than expected rates of patient completion of clinical trials; ● inability to obtain supply of our drug candidate in a timely manner; ● inability or unwillingness of medical investigators to follow our clinical protocols; and ● unwillingness of the FDA or foreign equivalent, IRBs/ECs, or IBCs to permit the clinical trials to be initiated.
Commencement and completion of clinical trials may be delayed by several factors, including: ● obtaining an IND application with the FDA or foreign equivalent to commence clinical trials; ● identification of, and acceptable arrangements with, one or more clinical sites; ● obtaining IRB or Ethics Committee (“EC”) approval to commence clinical trials; ● unforeseen safety issues; ● determination of dosing; ● lack of effectiveness during clinical trials; ● slower than expected rates of patient recruitment; ● inability to monitor patients adequately during or after treatment; ● lower than expected rates of patient completion of clinical trials; ● inability to obtain supply of our drug candidate in a timely manner; ● inability or unwillingness of medical investigators to follow our clinical protocols; and ● unwillingness of the FDA or foreign equivalent, or IRBs/ECs to permit the clinical trials to be initiated.
There can be no assurance that we will meet the requirements to be able to sell securities pursuant to the Purchase Agreement or the Sales Agreement, of if we meet the requirements that we will be able to raise sufficient funds on favorable terms.
There can be no assurance that we will meet the requirements to be able to sell securities pursuant to the ATM Agreement, of if we meet the requirements that we will be able to raise sufficient funds on favorable terms.
Even if we are able to consummate the sale of the Facility, we will 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.
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.
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.
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.
If we obtain such coverage, we may in the future be unable to maintain such coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Risks Related to Dependence on Third Parties For our clinical product candidates, we currently rely on one third-party contract manufacturer.
If we obtain such coverage, we may in the future be unable to maintain such coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Risks Related to Dependence on Third Parties For any clinical product candidates we may develop we will rely on third-party contract manufacturers.
The success of our product candidates will depend on several factors, including the following: ● completion of preclinical studies and clinical trials with positive results; ● receipt of marketing approvals from applicable regulatory authorities; ● obtaining and maintaining patent and trade secret protection and regulatory exclusivity, which may exceed patent exclusivity, for our product candidates; ● making arrangements with third-party manufacturers for commercial manufacturing capabilities; ● launching commercial sales of our products, if and when approved, whether alone or in collaboration with others; ● successfully maintaining existing collaborations and entering into new ones throughout the development process as appropriate, from preclinical studies through to commercialization; ● acceptance of the products, if and when approved, by patients, the medical community and third-party payors; ● effectively competing with other products; ● obtaining and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for any products we successfully develop; ● protecting our rights in our intellectual property portfolio; and ● maintaining a continued acceptable safety profile of the products following approval. 52 Table of Contents 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 success of our product candidates will depend on several factors, including the following: ● completion of preclinical studies and clinical trials with positive results; ● receipt of marketing approvals from applicable regulatory authorities; ● obtaining and maintaining patent and trade secret protection and regulatory exclusivity, which may exceed patent exclusivity, for our product candidates; ● making arrangements with third-party manufacturers for commercial manufacturing capabilities; ● launching commercial sales of our products, if and when approved, whether alone or in collaboration with others; ● successfully maintaining existing collaborations and entering into new ones throughout the development process as appropriate, from preclinical studies through to commercialization; ● acceptance of the products, if and when approved, by patients, the medical community and third-party payors; ● effectively competing with other products; ● obtaining and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for any products we successfully develop; ● protecting our rights in our intellectual property portfolio; and ● maintaining a continued acceptable safety profile of the products following approval.
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 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.
Our comprehensive net loss was approximately ($64.8) million and ($50.5) million for the years ended June 30, 2023 and 2022, respectively. As of June 30, 2023, we had an accumulated deficit of approximately ($288.9) million. To date, we have financed our operations primarily through the sale of common stock, preferred stock and warrants.
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.
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.
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.
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.
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.
However, we anticipate that our expenses will increase as we continue our research and development activities and conduct clinical trials. ​ Our cash, cash equivalents and restricted cash of $7.6 million as of June 30, 2023, is not anticipated to be sufficient to support our operations for at least 12 months from the date of the filing of this Annual Report unless we reduce our burn rate further, sell the CDMO Facility for amounts above its term note payable, or raise additional capital.
However, we anticipate that our expenses will increase as we continue our research and development activities and conduct clinical trials. ​ Our cash, cash equivalents and restricted cash of $14.4 million as of June 30, 2024, is not anticipated to be sufficient to support our operations for at least 12 months from the date of the filing of this Annual Report unless we reduce our burn rate further, or raise additional capital.
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. 64 Table of Contents In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
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.
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 in light of the acquisition of the assets of RubrYc as our product candidates advance in clinical development, and as we 45 Table of Contents add more employees.
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 have incurred net losses and used significant cash in operating activities since inception, and we expect to continue to generate operating losses for the foreseeable future. As of June 30, 2023, we have an accumulated deficit of $288.9 million. ​ We held cash, cash equivalents and restricted cash of $7.6 million as of June 30, 2023.
We have incurred net losses and used significant cash in operating activities since inception, and we expect to continue to generate operating losses for the foreseeable future. As of June 30, 2024, we have an accumulated deficit of $313.8 million. ​ We held cash, cash equivalents and restricted cash of $14.4 million as of June 30, 2024.
By way of example, on September 11, 2023, the price of our common stock closed at $0.28 per share while on April 19, 2023, our stock price closed at $1.30 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 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.
We anticipate that further product development is also expected to increase expenses, including but not limited to the expected initiation of IND-enabling studies IBIO-101 and the additional studies that will be required to support development of our immuno-oncology 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-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.
Thus, only approximately one-third of the existing Board of Directors could be replaced at any election of directors. 70 Table of Contents The effect of these provisions may be to delay or prevent a tender offer or takeover attempt that a stockholder may determine to be in his, her or its best interest, including attempts that might result in a premium over the market price for the shares held by the stockholders.
The effect of these provisions may be to delay or prevent a tender offer or takeover attempt that a stockholder may determine to be in his, her or its best interest, including attempts that might result in a premium over the market price for the shares held by the stockholders.
During the past year, we shifted our focus away from generating revenue as a CDMO service provider to the development of vaccines and therapeutics for commercialization. Our current focus is on immune-oncology therapeutics. The current vaccines and therapeutics being developed are all in preclinical development.
Prior to the end of calendar year 2022, we shifted our focus away from generating revenue as a CDMO service provider to the development of vaccines and therapeutics for commercialization. Our current focus is on immune-oncology therapeutics.
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 are reviewing potential options to extend our cash runway.
As of June 30, 2023, management believes that significant progress has been made in enhancing internal controls and has concluded that the enhanced controls are operating effectively. Therefore, as of June 30, 2023, the material weakness described in Item 4 Controls and Procedures in our Quarterly Report on Form 10-Q for quarter ended March 31, 2023 has been fully remediated.
Therefore, as of June 30, 2023, the material weakness described in Item 4 Controls and Procedures in our Quarterly Report on Form 10-Q for quarter ended March 31, 2023 has been fully remediated and management believes it does not have any weaknesses in internal controls.
These provisions include: ● an exemption from compliance with the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, on the design and effectiveness of our internal controls over financial reporting; and ● scaled reporting and disclosure requirements including about our executive compensation arrangements. 74 Table of Contents We cannot predict whether investors will find our common stock less attractive if we rely on such exemptions.
These provisions include: ● an exemption from compliance with the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, on the design and effectiveness of our internal controls over financial reporting; and ● scaled reporting and disclosure requirements including about our executive compensation arrangements.
Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials.
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.
Provisions in our certificate of incorporation, bylaws and under Delaware law could discourage a takeover that stockholders may consider favorable. Provisions of our certificate of incorporation, bylaws and provisions of applicable Delaware law may discourage, delay or prevent a merger or other change in control that a stockholder may consider favorable.
Provisions of our certificate of incorporation, bylaws and provisions of applicable Delaware law may discourage, delay or prevent a merger or other change in control that a stockholder may consider favorable. Pursuant to our certificate of incorporation, our Board of Directors may issue additional shares of common stock or preferred stock.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeCentral time on November 13, 2023; and (iii) the delivery at closing by the title company of a title policy to Majestic Realty in the amount of the Purchase Price. ​ 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.
Biggest changeBiopharmaceutical 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.
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: (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.
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.
On September 15, 2023, iBio CDMO entered into a Purchase and Sale Agreement with Majestic Realty, pursuant to which iBio CDMO agreed to sell the Property to Majestic Realty for a purchase price of $17,250,000.
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 closing of the sale of the Property is to occur, with time being of the essence, on December 1, 2023 or such other date as mutually agreed. Pursuant to the terms of the Purchase and Sale Agreement, Majestic Realty deposited with a title company $200,000 as an earnest money deposit.
Added
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.
Removed
Majestic Realty will also be afforded access to the Property to conduct a due diligence review of its condition. The closing is subject to certain closing conditions, including: (i) Majestic Realty’s delivery to iBio CDMO and the Escrow Agent of written notice of its approval of the condition of the Property on or before 5:00 p.m.
Removed
Central time on October 16, 2023; (ii) Majestic Realty obtaining the approval of The Board of Regents of the Texas A&M University System of Majestic Realty’s purchase from it of the fee interest in the Land on or before 5:00 p.m.
Removed
The lease recently commenced in September 2022. The lease is for seven years and four months.

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. 75 Table of Contents Item 4. Mine Safety Disclosures. Not applicable. ​ 76 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. ​ 74 Table of Contents PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 76 ​ ​ ​ PART II ​ ​ ​ Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 77 Item 6. [Reserved] 77 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 78 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 90
Biggest changeItem 4. Mine Safety Disclosures 74 ​ ​ ​ PART II ​ ​ ​ Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 75 Item 6. [Reserved] 75 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 76 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 87

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. Reverse Stock Split As discussed above, the Company completed a reverse stock split at a ratio of one-for-twenty five (1:25) shares of the Company's common stock.
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.
Market Information Our common stock is traded on the NYSE American under the trading symbol “IBIO.” Holders On September 12, 2023, there were 27 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 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.
The effective date of the reverse stock split was 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.
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
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

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Biggest changeRecent Developments On September 15, 2023, iBio CDMO entered into the Purchase and Sale Agreement with Majestic Realty Co., pursuant to which iBio CDMO agreed to sell to Majestic Realty for a purchase price of $17,250,000 its Facility located in Bryan, TX consisting of: (i) the ground leasehold estate and interest held under the Ground Lease Agreement, dated March 8, 2010, as amended by an Estoppel Certificate and Amendment to Ground Lease Agreement, dated as of December 22, 2015, between iBio CDMO (as assignee from College Station Investors LLC) and The Board of Regents of the Texas A&M University System (together, the “Ground Lease”), related to 21.401 acres in Brazos County, Texas land (the “Land”); (ii) 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 80 Table of Contents 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 changeRecent Developments 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”), we terminated 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 (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 of our 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 of our 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 of our 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”).
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.
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.
By tapping into our platform, 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 Developing and advancing our in-house programs cost effectively : Clinical advancement is crucial for drug discovery.
The offering closed on December 9, 2022. ​ Wainwright acted as the sole book-running manager for the Offering. We paid Wainwright an underwriting discount equal to 7.0% of the gross proceeds of the offering, and reimbursed Wainwright for the legal fees and certain expenses of the underwriter.
The offering closed on December 9, 2022. ​ Wainwright acted as the sole book-running manager for the Offering. We paid Wainwright an underwriting discount equal to 7.0% of the gross proceeds of the offering, and reimbursed Wainwright for the legal fees and certain expenses.
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 four key components, each playing a crucial role in the discovery and optimization of precision antibodies.
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.
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 raises substantial doubt about the Company's ability to continue as a going concern.
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 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. 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.
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.
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, 2023, have been taken into consideration in preparing the consolidated financial statements.
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.
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 are leveraging our platform and pipeline by forming strategic partnerships.
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.
("Cantor Fitzgerald") to sell shares of Common Stock, from time to time, through an “at the market offering” program having an aggregate offering price of up to $100,000,000 through which Cantor Fitzgerald would act as sales agent.
(“Cantor Fitzgerald”) to sell shares of Common Stock, from time to time, through an “at the market offering” program having an aggregate offering price of up to $100,000,000 through which Cantor Fitzgerald would act as sales agent.
Our auditors also included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended June 30, 2023 with respect to this uncertainty.
Our auditors also included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended June 30, 2024 with respect to this uncertainty.
The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 13% 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 16% discount rate, which was based on iBio’s weighted average cost of capital.
The following accounting estimate had a material impact on the results of operations of the Company for the year ended June 30, 2023. Impairment of Fixed Assets ​ We monitor fixed assets for impairment indicators throughout the year.
The following accounting estimate had a material impact on the results of operations of the Company for the year ended June 30, 2024. Impairment of Fixed Assets ​ We monitor fixed assets for impairment indicators throughout the year.
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 79 Table of Contents 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.
Our aim is 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, a rich array of fast follower molecules within our pre-clinical pipeline holds the potential to drive substantial partnerships, opening doors to innovative projects.
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.
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 identifying novel targets, forging strategic collaborations to enhance efficiency, diversify pipelines, and with the goal of accelerating preclinical processes.
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.
The pinnacle of being on the forefront of machine learning advancing algorithms, and models in order to improve its predictive power and reduce the time it takes to find a viable molecule.
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.
In the first quarter of Fiscal 2024, we entered into an agreement for the sale of the Facility for $17.25 million, and an additional impairment of $0.3 million was recorded in Fiscal 2023 to reflect the agreed upon sales price less estimated costs to sell.
In the first quarter of fiscal year 2024, we entered into an agreement for the sale of the Facility for $17.25 million, and an additional impairment of $0.3 million was recorded in fiscal year 2023 to reflect the agreed upon sales price less estimated costs to sell. The CDMO Equipment was sold during fiscal year 2023.
Wainwright elected to purchase 504,807 Series A Warrants and 504,807 Series B Warrants. ​ We also agreed to issue to Wainwright, as the representative of the underwriters, warrants (the “Representative’s Warrants”) to purchase a number of shares of Common Stock equal to 6.0% of the aggregate number of shares of Common Stock and Pre-Funded Warrants being offered in the offering.
Wainwright elected to purchase 25,240 Series A Warrants and 25,240 Series B Warrants. ​ We also agreed to issue to Wainwright, as the representative of the underwriters, warrants (the “Representative’s Warrants”) to purchase a number of shares of Common Stock equal to 6.0% of the aggregate number of shares of Common Stock and 2022 Pre-Funded Warrants being offered in the offering.
As of June 30, 2023, we were not involved in any SPE transactions.
As of June 30, 2024, we were not involved in any SPE transactions.
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. ​ We base our estimates, to the extent possible, on historical experience.
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.
Regardless of whether we are able to reduce our burn rate or sell or out-license certain assets or parts of the business, we will need to raise additional capital in order to fully execute our longer-term business plan.
Regardless of whether we are able to reduce our burn rate or sell or out-license certain assets or parts of the business, we will need to raise additional capital through either non-dilutive partnership deals or through the capital markets in order to fully execute our longer-term business plan.
The decrease in net cash was primarily used to support our ongoing operations. ​ Net Cash Provided by (Used in) Investing Activities In fiscal year 2023, net cash provided by investing activities was $7.0 million, which primarily consisted of redemption and sales of debt securities of $10.8 million and the sale of fixed asset of $2.6 million, partially offset by the purchase of ($5.7) million of fixed assets and ($0.7) million for certain assets acquired from RubrYc.
In 2023, our net cash used in investing activities was $7.0 million, which primarily consisted of redemption and sales of debt securities of $10.8 million and the sale of fixed asset of $2.6 million, partially offset by the purchase of ($5.7) million of fixed assets and ($0.7) million for certain assets acquired from RubrYc. ​ Net Cash Provided by Financing Activities In 2024, net cash provided by financing activities was $24.5 million, compared to net cash used in financing activities of $2.3 million in 2023.
As of June 30, 2023, our accumulated deficit was approximately ($288.9) million, and we used approximately ($21.1) million of net cash in fiscal year 2023. 87 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 proceeds from the sale of the CDMO Facility, through potential proceeds from the sale or out-licensing of assets, and through proceeds from the sale of additional equity or other securities.
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 recorded an impairment charge of $6.3 million for the facility and $11.3 million for the machinery and equipment in the quarter ended December 31, 2022. The key assumption in the valuation analysis is the expected sale price of $21.1 million for the Facility and the associated machinery and equipment less approximate costs to sell of $2.7 million.
We recorded an impairment charge of $6.3 million for the facility and $11.3 million for the machinery and equipment in the second quarter of fiscal year 2023. The key assumption in the valuation analysis was the expected sale price of $21.1 million for the Facility and the associated machinery and equipment less approximate costs to sell of $2.7 million.
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 area, oncology. 78 Table of Contents ● Unwavering Investment in advancing the platform: We maintain an unwavering 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 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.
Net cash generated from financing activities in 2023 primarily related to proceeds from sales of common stock offset by payments made towards term note payable while the net cash spent in 2022 mainly related to the purchase of the Facility.
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.
Additionally, our groundbreaking EngageTx technology enables us to target bi-specific molecules. 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.
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.
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 $7.1 million as of the April 1, 2023, 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, 2024, valuation date.
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.
(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.
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.
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.
Pursuant to the Underwriting Agreement, we granted Wainwright a 30-day option to purchase up to an additional 504,807 shares of Common Stock and/or Common Warrants to purchase up to an additional 1,009,614 shares of Common Stock at the public offering price, less the underwriting discounts and commissions, solely to cover over-allotments.
Pursuant 82 Table of Contents to the Underwriting Agreement, we granted Wainwright a 30-day option to purchase up to an additional 25,240 shares of Common Stock and/or Common Warrants to purchase up to an additional 50,480 shares of Common Stock at the public offering price, less the underwriting discounts and commissions, solely to cover over-allotments.
Stockholders Net loss available to iBio, Inc. stockholders from both continuing and discontinued operations for Fiscal year ended June 30, 2023 was approximately ($65.0) million, or ($5.31) per share, compared to approximately ($50.4) million, or ($5.78) per share, in Fiscal year ended June 30, 2022.
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.
Lincoln Park Stock Purchase Agreement On August 4, 2023, iBio entered into a purchase agreement, dated as of August 4, 2023 (the “Purchase Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which, under the terms and subject to the satisfaction of specified conditions set forth therein, we may sell to Lincoln Park up to $10.0 million (subject to certain limitations) of Common Stock, from time to time during the term of the Purchase Agreement.
Wainwright received warrants to purchase up to 10,094 shares of Common Stock. ​ We received net proceeds of approximately $2,864,000 after deducting underwriting discounts, commissions and other issuance costs. ​ Lincoln Park Stock Purchase Agreement On August 4, 2023, iBio entered into a purchase agreement, dated as of August 4, 2023 (the “Purchase Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which, under the terms and subject to the satisfaction of specified conditions set forth therein, we may sell to Lincoln Park up to $10.0 million (subject to certain limitations) of Common Stock, from time to time during the term of the Purchase Agreement.
Our management concluded that our recurring losses from operations and the fact that we have not generated significant revenue or positive cash flows from operations raise substantial doubt about our ability to continue as a going concern for the next 12 months after issuance of our financial statements.
Our management concluded that our recurring losses from operations and the fact that we have not generated significant revenue or positive cash flows from operations raise substantial doubt about our ability to continue as a going concern for the next 12 months from the date of filing this Annual Report for the year ended June 30, 2024.
General and Administrative Expenses (“G&A”) G&A expenses for Fiscal year ended June 30 2023 and Fiscal year ended June 30 2022 were approximately $19.0 million and $21.8 million, respectively, a decrease of ($2.8) million or (13)%.
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)%.
It is our goal to implement one or more potential options described herein to allow us to have a cash runway for at least 12 months from the date of the filing of this Annual Report. However, there can be no assurance that we will be successful in implementing any of the options that we are evaluating.
It is our goal to implement one or more potential options described herein to allow us to have a cash runway for at least 12 months from the date of the filing of this Annual Report.
The third layer of the technology stack is the antibody optimizing StableHu AI technology, coupled with mammalian display technology. Finally, 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. Next, our EngageTx platform forms the fourth layer. Lastly, our ShieldTx antibody masking technology enables the creation of conditionally activated antibodies.
During the fourth quarter of Fiscal 2023, 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, 2023. We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation.
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.
We utilized a market approach in the second quarter of Fiscal 2023, using independent third-party appraisals, including comparable assets, in addition to bids received from prospective buyers, to estimate the fair value of the Facility, the machinery and equipment.
The decision to divest triggered a quantitative impairment analysis of our CDMO fixed assets of the Facility totaling $22.65 million and machinery and equipment totaling $13.4 million. 85 Table of Contents We utilized a market approach in the second quarter of fiscal year 2023, using independent third-party appraisals, including comparable assets, in addition to bids received from prospective buyers, to estimate the fair value of the Facility, the machinery and equipment.
The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the asset.
We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the asset.
G&A expenses relating to CDMO operations are captured separately under discontinued operations. 81 Table of Contents Total Operating Expenses Total operating expenses, consisting primarily of R&D and G&A expenses, for Fiscal year ended June 30, 2023 were approximately $29.3 million, compared to approximately $31.6 million for Fiscal ended June 30, 2022.
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.
Pre-Clinical Pipeline We are currently in the process of building and advancing our preclinical pipeline. The focus of our pipeline is primarily on immuno-oncology, with one program also dedicated to the immunology space. By leveraging our technology stack, the pipeline is geared towards hard-to-drug targets and molecules offering differentiation.
Pre-Clinical Pipeline We are currently in the process of building and advancing our preclinical pipeline by leveraging our technology stack focused on hard-to-drug targets and molecules offering differentiation in both in obesity and cardiometabolic disease space, as well as immune-oncology.
Given that the carrying amount of the asset was $5 million at June 30, 2023, it was concluded that no impairment existed. 89 Table of Contents We will continue to monitor the value of the IP, since we believe it is at risk for impairment.
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.
Pursuant to the Underwriting Agreement, we agreed to sell to Wainwright, in a firm commitment underwritten offering (the “Offering”) (i) 1,530,769 shares of the Company’s Common Stock, (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 1,834,616 shares of Common Stock, (iii) Series A Common Stock purchase warrants (the “Series A Warrants”) to purchase up to 3,365,385 shares of Common Stock and (iv) Series B Common Stock purchase warrants (the “Series B Warrants” and together with the Series A Warrants, the “Common Warrants”) to purchase up to 3,365,385 shares of Common Stock.
Wainwright & Co., LLC (“Wainwright”), pursuant to which we agreed to sell to Wainwright, in a firm commitment underwritten offering (the “Offering”) (i) 76,538 shares of Common Stock, (ii) pre-funded warrants (the “2022 Pre-Funded Warrants”) to purchase up to 91,730 shares of Common Stock, (iii) Series A Common Stock purchase warrants (the “Series A Warrants”) to purchase up to 168,267 shares of Common Stock and (iv) Series B Common Stock purchase warrants (the “Series B Warrants” and together with the Series A Warrants, the “2022 Warrants”) to purchase up to 168,267 shares of Common Stock.
Other Income (Expense) Other income (expense) for Fiscal year ended June 30, 2023 and Fiscal year ended June 30, 2022 was approximately $0.03 million and $0.2 million, a decrease of approximately ($0.2) million.
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.
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, 2022.
Any such future adjustments may lead to material future impairments in the IP and other related assets. 86 Table of Contents 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, 2023.
Research and Development Expenses (“R&D”) R&D expenses for Fiscal year ended June 30, 2023 and Fiscal year ended June 30, 2022 were approximately $10.3 million and $9.8 million, respectively, an increase of approximately $0.5 million or 5%.
Research and Development Expenses (“R&D”) R&D expenses for 2024 and 2023 were approximately $5.2 million and $10.3 million, respectively, a decrease of approximately ($5.1) million or approximately (50)%.
This increase in expense was offset by the decrease of Facility related expenses of ($4.5) million, personnel costs of ($3.6) million, consultant/outside services of ($1.5) million, the gain on sale of fixed assets of ($0.8) million and the ($0.6) million forgiveness of the PPP loan in Fiscal year 2022, which did not reoccur in Fiscal year 2023. ​ Total Net Loss Available to iBio, Inc.
This decrease was offset by the $4.8 million loss on sale of the Facility, an approximate $0.8 million gain on sale of equipment that did not reoccur in fiscal year 2024, approximately $0.3 million of revenue that did not reoccur in fiscal year 2024 and an increase of approximately $0.2 million of interest expense. ​ Net Loss Available to iBio, Inc.
We received net proceeds of approximately $6.4 million during the Fiscal year 2023 and hold a subscription receivable for $204,000 at June 30, 2023 for proceeds received on July 6, 2023. ​ In Fiscal year 2022, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 175,973 shares of Common Stock. We received net proceeds of approximately $1.2 million.
In the fiscal year ended June 30, 2024, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 170,989 shares of Common Stock. We received net proceeds of approximately $1.7 million. ​ In the fiscal year ended June 30, 2023, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 289,144 shares of Common Stock.
Through the process of seeking to divest its contract development and manufacturing organization, we have entered into a Purchase 88 Table of Contents and Sale Agreement for the Facility. The decision to divest triggered a quantitative impairment analysis of our CDMO fixed assets of the Facility totaling $22.65 million and machinery and equipment totaling $13.4 million.
Through the process of seeking to divest our contract development and manufacturing organization, we entered into a Purchase and Sale Agreement for the Facility.
Our cash, cash equivalents and restricted cash of approximately $7.6 million as of June 30, 2023, is not anticipated to be sufficient to support operations through the second quarter of Fiscal 2024, unless we further reduce our burn rate, consummate the sale of the Facility for amounts above the debt on the Facility, or increase our capital as described above.
We received net proceeds of approximately $14.1 million from the Private Placement, after deducting estimated offering expenses payable by us, including placement agent fees and expenses. ​ Our cash, cash equivalents and restricted cash of $14.4 million as of June 30, 2024, is not anticipated to be sufficient to support operations through the first quarter of fiscal year 2026, unless we reduce our burn rate further, or increase our capital as described above.
This increase was primarily due to the impairment of fixed assets ($17.9) million, impairment of consumable inventory of ($4.9) million, and ($3.1) million of personnel restructuring related charges including severance, benefits and the acceleration of stock compensation awards.
This decrease was primarily due to ($14.8) million less impairments of fixed assets, lower personnel related charges of ($7.6) million including severance, benefits and the acceleration of stock compensation awards, a ($4.9) million impairment of consumables inventory that did not reoccur in fiscal year 2024, and approximately ($4.3) million lower site related costs.
CDMO operations are reported as discontinued operations on our financial statements. Losses for Discontinued Operations for 2023 and 2022 were approximately ($35.7) million and ($20.8) million, respectively, an increase of ($14.9) million, or 72%.
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%.
Also, during the fourth quarter of Fiscal 2023, we completed at-the-market offerings and sold 4,230,992 shares of Common Stock of which we received approximately $3.3 million and holds a subscription receivable for $204,000 at June 30, 2023 for proceeds received on July 6, 2023.
We received net proceeds of approximately $6.4 million during the fiscal year ended June 30, 2023 and held a subscription receivable for $204,000 at June 30, 2023 for proceeds received on July 6, 2023. ​ Wainwright Underwriting ​ On December 6, 2022, we entered into an underwriting agreement with H.C.
We cannot be certain that such funding will be available on favorable terms or available at all.
However, there can be no assurance that we will be successful in implementing these plans, many of which will take several years before we realize proceeds. We cannot be certain that such funding will be available on favorable terms or available at all.
We are actively looking for opportunities to progress our internal pre-clinical programs, with a focal point on oncology, steadily reinforcing our pre-clinical pipeline. 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.
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.
Discontinued Operations ​ On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO, LLC) in order to complete our transformation into an AI-driven, precision antibody drug discovery and development company. In conjunction with the restructuring, we completed a workforce reduction of approximately 60% and discontinued the CDMO operations.
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.
In fiscal year 2022, our net cash used in investing activities was ($5.1) million, which primarily consisted of the purchase of RubrYc equity and acquisition of intangible assets related to our license of IBIO-101, and purchases of fixed assets, offset by the net redemption of debt securities. ​ Net Cash Provided by (Used in) Financing Activities In fiscal year 2023, net cash provided by financing activities was $2.3 million, compared to net cash used in financing activities of ($6.1) million in 2022.
The 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.
During the year ended June 30, 2023, we reported no revenue. Revenue for the year ended June 30, 2022 was mainly related to a licensing agreement.
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.
This increase was partially offset by a reduction of approximately $1.8 million in spend on consultants and contracted services. iBio anticipates R&D expenses in Fiscal year ended June 30, 2024 will be close to those of Fiscal year ended June 30, 2023. R&D expenses relating to CDMO operations are captured separately under discontinued operations.
This decrease was partially offset by an increase of depreciation of ($0.2) million due to the San Diego assets being in service for a full year. R&D expenses relating to CDMO operations are captured separately under discontinued operations.
The decrease is primarily attributable to a reduction in intangible asset impairment charges and related amortization of ($1.5) million, a reduction of legal fees expense of ($0.8) million, a reduction in profession/consulting fees and outside services of ($0.8) million, and reduced travel of ($0.2) million.
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 Company received net proceeds of approximately $1.2 million during the first quarter of Fiscal 2024. ​ Net Cash Used in Operating Activities In fiscal year 2023, net cash used in operating activities was ($30.4) million, compared to net cash used in operating activities of ($37.5) million in 2022.
However, there can be no assurance that we will be successful in implementing any of the options that we are evaluating. ​ Net Cash Used in Operating Activities In fiscal year 2024, net cash used in operating activities was ($18.6) million, compared to net cash used in operating activities of ($30.4) million in 2023.
Removed
To mitigate target risk and capitalize on the learnings of competitors, our programs are primarily adopting a fast follower strategy. This approach allows us to focus on targets that have to some extent been validated and learn from the advancements of those ahead in the field.
Added
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.
Removed
The closing of the sale of the Property is to occur, with time being of the essence, on December 1, 2023 or such other date as mutually agreed. Pursuant to the terms of the Purchase and Sale Agreement, Majestic Realty deposited with a title company (the “Escrow Agent”) $200,000 as an earnest money deposit.
Added
ShieldTx Antibody Masking Technology Our ShieldTx technology enables the creation of conditionally activated antibodies and stands out because it is deeply integrated into our technology stack, providing multiple advantages. Identifying a fitting mask is challenging, however, ShieldTx is designed to increase the probability of success.
Removed
Majestic Realty will also be afforded access to the Property to conduct a due diligence review of its condition. The closing is subject to certain closing conditions, including: (i) Majestic Realty’s delivery to iBio CDMO and the Escrow Agent of written notice of its approval of the condition of the Property on or before 5:00 p.m.
Added
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. Thus, the mask design process is inherently built into the antibody discovery process.
Removed
Central time on October 16, 2023; (ii) Majestic Realty obtaining the approval of The Board of Regents of the Texas A&M University System of Majestic Realty’s purchase from it of the fee interest in the Land on or before 5:00 p.m.
Added
Additionally, multi-dimensional optimization with our StableHu antibody optimization technology allows for the simultaneous optimization of the three components of conditionally activated antibodies: the antibody, mask, and linker. This approach, we believe, will significantly reduce development time compared to the typically sequential optimization of the individual components.
Removed
Central time on November 13, 2023; and (iii) the delivery at closing by the title company of a title policy to Majestic Realty in the amount of the Purchase Price. ​ Results of Operations Revenue Revenue from the CDMO operations is now included in discontinued operations and not broken out separately on the financial statements.
Added
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.
Removed
The increase primarily related to the increase in activities related to our internal pipeline including IBIO-101, CCR8, and EGFRvIII, and the expansion of our AI-driven discovery platform to include an increased spend of approximately $1.7 million on lab supplies, lab equipment/maintenance, and facility rent for the San Diego facility and an increase of approximately $0.6 million in R&D personnel at the San Diego center.
Added
Finally, we continue to assess the the optional time whether to trigger our options rights to license three of the four assets under the AstralBio collaboration to add obesity and cardiometabolic programs into our 78 Table of Contents pre-clinical pipeline.
Removed
G&A expenses principally include officer and employee salaries and benefits, depreciation and amortization, professional fees, consulting services, operational costs and other costs associated with being a publicly traded company.
Added
Under this strategic collaboration with AstraBio, it affords us the opportunity to expand our pipeline and build a presence in the cardiometabolic disease space.
Removed
The decrease was partially offset by an increase of ($0.5) million for IT security and related costs. iBio expects G&A expenses to continue to decrease in Fiscal year ended June 30, 2024.
Added
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 is defined under the Credit Agreement (a) we 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) we issued a Pre-Funded Warrant to purchase 1,560,570 shares of its common stock to Woodforest.
Removed
The minimal increase in interest income was offset by interest expenses and loss on sale of debt securities for a total other income (expense) of approximately $0.03 million. ​ Net Loss Available to iBio, Inc.

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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-44 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-54 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