iBio, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
IBIO$0.74+1.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-02.
0001420720-25-000025
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001420720-25-000041
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
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Tables are not compared: 23 previous and 12 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (49)
Current report
We believe the future treatment for obesity lies not just in overall weight loss—but in targeted weight loss. Current interventional therapies, such as glucagon-like peptide-1 (“GLP-1”) receptor agonists have ushered in a breakthrough era, yet challenges remain: muscle loss, fat regain after treatment cessation, and long-term tolerability. We are developing second-generation therapies to meet these unmet needs, using the power of AI-guided antibody design and advanced screening technologies.
Current report
Our obesity strategy is built on three key principles. First, we aim to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with a goal to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, we are focusing on targets with strong human validation, which we believe both helps reduce development risk and increase the likelihood of clinical success. Lastly, we are applying our integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate development-ready biologics, enabling it to move with speed and precision in a competitive and fast-evolving field. Our current therapeutics are all in preclinical development and we have not completed any clinical trials in humans for any therapeutic protein product candidate produced using our technology and there is a risk we will be unsuccessful in developing or commercializing any product candidates. With shifting our focus to IBIO-610, potentially the first antibody inhibiting Activin E, we anticipate the commencement of our first human clinical trials in early 2027.
Current report
Our discovery and development work is conducted at our San Diego research and development (“R&D”) laboratory space, where our AI and ML scientists and biopharma researchers operate side by side. This close integration of disciplines enables rapid iteration between in silico design and wet-lab validation, compressing the timeline from hypothesis to lead selection. With our robust platform, focused pre-clinical pipeline, and growing scientific and leadership team, we are building a durable and differentiated position in obesity therapeutics—one designed to outlast the first wave and define what comes next.
Current report
Our approach to the evolving needs in obesity treatment is facilitiated on a fully integrated antibody discovery platform, designed from the ground up for precision, speed and developability. At the core of our AI Drug Discovery Platform is an AI-enabled epitope steering engine enabling us to precisely direct antibodies to functional hotspots on even the most challenging targets—often considered "undruggable." When combined with our antibody optimization platform, which deeply integrates generative AI tools with mammalian display technology, we can progress from concept to development-ready antibody in as little as seven months.
Current report
The Company’s current pre-clinical product candidate pipeline is set forth below.
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IBIO-610
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In a DIO mouse model, IBIO-610 was administered biweekly at 10 mg/kg for four weeks to evaluate its effects as a monotherapy. Treated mice were observed to have a 8.9% reduction in body weight compared to baseline and placebo, with body composition analysis revealing a 26% reduction in fat mass and no measurable loss of lean mass. Outlier non-responder mice were excluded.
Current report
To test potential combination therapy with incretin treatments, IBIO-610 was dosed biweekly alongside daily semaglutide. While semaglutide alone produced a 27.8% reduction in body weight (baseline and placebo adjusted), the combination resulted in a more pronounced 35.3% weight loss, without any additive effect on food intake. The combination also led to a greater reduction in visceral fat compared to semaglutide alone, suggesting complementary mechanisms that enhance metabolic benefit.
Current report
IBIO-610 was also tested as a maintenance therapy following cessation of semaglutide treatment. In this model, DIO mice were first dosed with semaglutide for two weeks, leading to approximately 18% weight loss. Upon stopping semaglutide, control mice regained 71% of the lost weight within three weeks, with fat mass levels returning to those of untreated animals. In contrast, mice receiving IBIO-610 at the time of semaglutide discontinuation regained only 28% of the lost weight and retained significantly lower fat mass at study termination, highlighting the potential of IBIO-610 to prevent rebound weight gain.
Current report
IBIO-610 was evaluated in a pharmacokinetic (“PK”) preclinical study in obese, mature non-human primates (“NHPs”) to characterize systemic exposure and clearance following a single intravenous administration. Serum concentrations were measured at defined intervals post-dose to generate a time-concentration profile. PK analysis demonstrated IBIO-610 exhibited a terminal half-life of approximately 33.2 days in NHPs, consistent with expectations for a half-life extended antibody of this class. Using multiple allometric scaling approaches, the projected half-life in humans is estimated to fall within a range of 47 to 100 days, supporting the potential for infrequent, long-acting dosing in clinical settings. Following the completion of NHP PK study, we will initiate Chemistry, Manufacturing, and Controls (“CMC”) and nonclinical toxicology activities to support the advancement of IBIO-610 toward clinical development.
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Myostatin x Activin A Bispecific Antibody
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Following the NHP pharmacokinetic study, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-600 toward clinical development. We have now established a stable cell line, completed process and formulation development, and manufactured a Good Laboratory Practice (“GLP”) toxicology batch at 200 L scale. In parallel, we launched a nonclinical toxicology program, initiating both rat and NHP dose range-finding studies, as well as rat and NHP GLP studies. All studies are progressing as planned.
Current report
As we continue advancing IBIO-600 through IND-enabling studies, we are actively seeking a development partner to help accelerate its clinical progression in sarcopenia, muscle loss disorders, and obesity, maximizing the therapeutic and commercial potential of this unique, long-acting anti-myostatin/GDF11 antibody.
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Partnered Programs
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Amylin Receptor Agonist Engineered Antibody
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In collaboration with AstralBio, we are working to develop an amylin receptor antibody, a potentially highly promising mechanism in obesity treatment. Along with AstralBio, we are discovering and optimizing both dual amylin and calcitonin receptor (DACRA)-like engineered antibodies, and selective amylin receptor agonist antibodies while avoiding engagement of the calcitonin receptor. Improved selectivity may translate into tolerability and efficacy advantages. Leveraging the AI Drug Discovery Platform, combining soluble G protein-coupled receptor (“GPCR”) analogues with mammalian display, we have engineered agonists with tailored activity across specific amylin receptor subtypes, showcasing the ability to address complex membrane protein targets with precision.
Current report
Early preclinical results to date show the promise of the approach. In a proof-of-concept study in DIO mice, an early DACRA-like agonist antibody delivered approximately a ~60% reduction in acute food intake (p<0.05), nearly matching the 67% reduction seen with a benchmark DACRA peptide. These data affirm that antibody-based approaches targeting amylin receptor are promising and can access the parts of the brain containing amylin receptor. As the third obesity program from our AstralBio partnership, this achievement marks a significant validation of our integrated AI Drug Discovery Platform and sets the stage for advancing this differentiated modality into the next stages of development.
Current report
Our technology stack is a multi-layered, AI-powered system designed to significantly enhance the probability of success in discovering and developing antibodies against hard-to-drug, pathophysiologically relevant proteins. The platform comprises four integrated layers, each contributing a distinct capability to the discovery, engineering, and optimization of precision antibodies. By seamlessly combining advanced computational design with cutting-edge biological technologies, iBio’s AI-driven discovery platform enables the rapid generation of antibody therapeutics characterized by high specificity, optimized developability, and accelerated progression from concept to clinic.
Current report
Building on this foundation, the fourth layer is our EngageTx™ and ShieldTx™ technologies expanding the platform’s reach into multi-specific and conditionally active antibody formats. EngageTx delivers an optimized, next-generation CD3 T-cell engager antibody panel with a wide range of potencies, NHP cross-reactivity, enhanced humanness, and strong tumor-killing activity with reduced cytokine release. In parallel, ShieldTx provides an antibody masking technology that enables the creation of conditionally activated antibodies. These conditionally activated antibodies can broaden the therapeutic window by improving efficacy and safety, enable drug
Current report
combinations that would otherwise be too toxic, and open the door to pursuing targets whose expression across multiple tissues would normally raise safety concerns.
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AI Epitope Steering Technology
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Epitopes—the small regions on large target proteins—are critical to eliciting desired biological effects when targeted with antibodies. Traditional epitope-specific discovery methods often struggle with dominant-epitope antibodies that lack efficacy yet overwhelm screening, obscuring antibodies against more therapeutically valuable sites. These approaches also tend to yield few or no hits against complex, hard-to-drug epitopes due to structural challenges and the limited availability of stable scaffolds needed to maintain epitope integrity during discovery.
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Our Epitope Steering technology directly addresses these limitations by guiding antibody generation toward predefined regions of a target protein. Using AI, we designengineered epitopes—precisely modeled and optimized fragments of the target—to improve structural fidelity, solubility, and stability. These engineered epitopes enable efficient antibody selection from naïve or immunized libraries, significantly increasing discovery success, especially for agonistic or functionally active antibodies.
Current report
This approach is broadly applicable across complex protein classes and holds promise in unlocking new targets in cardiometabolic disease, immuno-oncology, immunology, and pain. Moreover, it has potential applications in vaccine design, offering new opportunities for disease prevention.
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Naïve Human Antibody Library
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StableHu AI Antibody-Optimizing Technology
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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. This process includes humanization, which alters non-human antibodies to mimic human antibodies, thereby reducing the risk of immune reactions when used in therapy.
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EngageTx CD3-Based T-Cell Engager Panel
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CD3-based T-cell engagers can drive powerful anti-tumor responses by recruiting and activating the body’s own T cells. However, first-generation bispecifics have faced major challenges—namely, cytokine release syndrome, limited specificity, and poor non-human primate (NHP) cross-reactivity, which complicates safety testing.
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To address these limitations, we applied StableHu technology to antibodies derived from an epitope steering campaign and a first-generation T-cell engager. This approach generated a diverse CD3 antibody panel with a wide potency range, enabling flexible pairing with various tumor-targeting antibodies. The resulting molecules retained potent tumor-killing activity while significantly reducing cytokine release, potentially lowering the risk of cytokine release syndrome.
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StableHu also increased antibody humanness, reducing immunogenicity risk, and introduced NHP cross-reactivity—allowing for robust preclinical safety assessments ahead of clinical trials.
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ShieldTx Antibody Masking Technology
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Many potential drug targets are expressed across both healthy and diseased tissues, making selective targeting a major safety challenge. Antibodies that kill target-expressing cells can damage healthy tissues if the target is not disease-restricted.
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Antibody masking offers a solution. Masked, orconditionally activated, antibodies remain inactive in circulation through a temporary “mask” linked to the binding site. Once the antibody reaches diseased tissue, disease-specific enzymes cleave the linker, removing the mask and activating the antibody precisely where it is needed. This targeted activation broadens the therapeutic window, improves safety, and enables the pursuit of targets and drug combinations otherwise considered too toxic.
Current report
Our ShieldTx platform integrates antibody masking directly into the antibody discovery process, increasing the probability of success. Using our epitope engineering engine, we design small, accurate replicas of target epitopes to raise antibodies; these same engineered epitopes can then serve as optimized masks—making mask design an inherent part of discovery.
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Through StableHu multi-dimensional optimization, we simultaneously refine the antibody, mask, and linker components—reducing development time compared to traditional sequential approaches. The result is a faster, more integrated path to conditionally active antibodies with enhanced efficacy and safety potential.
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Programs Available for Partnering Outside the Cardiometabolic Area
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There have been notable advances in the field of oncology in recent years, and arguably none more important than the advent of immunotherapies. We have a pipeline of pre-clinical programs with differentiated profiles and high potential impact, including IBIO-101, our second-generation anti-CD25 monoclonal antibody, a TROP-2 x CD3 bispecific antibody, an antibody that binds to a non-shed, non-glycosylated region of MUC16, an antibody that binds to an epitope on EGFRvIII without binding wildtype EGFR, and an anti-CCR8 antibody. With our therapeutic focus shifting to precision antibodies in the cardiometabolic and obesity space, we are exploring the best path forward for our immune-oncology programs, with a focus on identifying partners who bring complementary capabilities and a shared vision for patient impact.
Current report
of IBIO-600.
Current report
Underwritten Public Offering
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Removed paragraphs (79)
Previous report
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. Another key feature of our technology stack is our ShieldTx™ masking technology, which keeps antibodies inactive until they reach diseased tissue. At that point, the masks are removed and the antibodies become active, all with the goal of broadening the therapeutic window and potentially improving both efficacy and safety.
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Although bispecific antibodies and antibody-drug conjugates have proven to be highly efficacious, they have also raised safety concerns. Our ShieldTx technology is an integrated part of the discovery process, designed to allow antibodies to be masked and rendered inactive until they reach the intended tissue (e.g., a tumor), where the mask is removed and the antibody is activated. ShieldTx is believed to have the capability of reducing or eliminating adverse effects stemming from on-target, off tumor effects, increase the probability of success in identifying a suitable mask for an antibody, and reduce development time.
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Our AI Drug Discovery Platform comprises of five key components, each playing a crucial role in the discovery and optimization of precision antibodies.
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Our epitope steering technology is designed to address challenges related to antibody specificity and efficacy by guiding discovery efforts exclusively against the desired regions of the target protein. By focusing on these specific regions, we can overcome the limitations of traditional methods and significantly improve the efficiency and effectiveness of our antibody discovery process. Our AI engine creates engineered epitopes, which are small embodiments of epitopes on the target protein. The engine is trained to match the epitope structure as closely as possible and refine the designs for greater stability and water solubility, which are critically important factors. The optimized engineered epitope is then used to identify antibodies from naïve or immunized libraries.
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We have used antibodies from an epitope steering campaign as well as a first-generation T-cell engager as input and utilized our StableHu technology to identify a next-generation CD3 antibody panel. The sequence diversity generated by StableHu led to an antibody panel with a wide range of potencies, which allows us to pair the panel with a wide variety of tumor-targeting antibodies. Importantly, we were able to retain T-cell activation and tumor cell killing capacity with significantly reduced cytokine release. This reduction is believed to lower the risk of cytokine release syndrome. Additionally, the increased humanness of the predicted antibodies, thanks to our StableHu technology, has the ability to reduce the risk of immunogenicity.
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Furthermore, our StableHu technology enabled us to engineer NHP cross-reactivity into EngageTx. This allows for advanced safety assessment in NHP ahead of clinical trials, providing another layer of safety assurance.
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From our screening process, we identified CD3 binders with a T-cell binding range spanning more than 1,000-fold and a T-cell activation range over 800-fold. We selected the most promising candidates and evaluated the level of cytokine release they induced. These top clones showed a broad range of potency and efficacy, all performing well compared to SP34, a widely used and clinically tested CD3 binder.
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We have enhanced our proprietary technology with the introduction of ShieldTx, a patent-pending innovative antibody masking technique. ShieldTx leverages our engineered epitope technology, which is utilized not only for the identification of antibodies against complex drug targets but also for concealing the antibodies' active sites. A significant hurdle in therapeutic antibody development is the expression of drug target on both healthy and diseased tissues, leading to adverse effects on non-targeted tissues. ShieldTx is designed to address this challenge by rendering antibodies inactive until they reach a specific environment unique to diseased tissues. Upon contact with this environment, the masking element is detached, activating the antibody. In the tumor microenvironment this is achieved by a highly expressed matrix metalloproteinase. This strategy aims to minimize or eliminate unintended effects on healthy tissues, thereby improving the safety profile and reducing the immunogenicity risks associated with bispecific antibodies.
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Modalities
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Epitope steering, an innovative AI-based technology we are pioneering, has the potential to positively impact various areas of medicine. Foremost in immuno-oncology, this technology is instrumental in creating targeted antibodies against specific cancer antigens, potentially enhancing the efficacy of treatments like checkpoint inhibitors and CAR-T therapies.
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Similarly, in the battle against obesity and cardiometabolic disorders, epitope steering enables the discovery of therapeutics aimed at systemic secreted and cell-surface agents—key factors in these prevalent health issues. Its application could potentially lead to emerging treatments in cardiovascular diseases by targeting specific damaged tissues.
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Beyond these areas, epitope steering may contribute to advancements in treating immune system diseases, neurological conditions, infectious diseases, and rare genetic disorders. In the specialized field of intratumoral immuno-oncology, there is potential for epitope steering to modify the tumor microenvironment, which could improve the outcomes of immune-stimulatory protein therapies. Additionally, the precision offered by epitope steering could play a role in the next generation of cancer vaccines, aiming to enhance T cell responses.
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While the prospects are broad, epitope steering remains a hopeful strategy in the development of novel treatments, extending through pain management, and potentially even vaccine development for complex protein structures that have been difficult to target.
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Therapeutics
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Obesity/Cardiometabolic Diseases
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Obesity Strategy
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Our obesity strategy is built on three key principles. First, we aim to develop molecules that can be used in combination with, as a follow-up to, or as alternatives to incretin drugs. Second, we prioritize targets with strong genetic or pharmacological validation to ensure a high probability of success. Lastly, we leverage our proprietary technology platform and the unique expertise of our scientific team to design and execute a strategy that is uniquely suited to us, setting us apart from competitors.
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Obesity Preclinical Pipeline
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Myostatin, also known as growth differentiation factor 8 (GDF8), is a member of the transforming growth factor-β (TGF-β) family that regulates and limits skeletal muscle growth. A loss of function in the myostatin gene eliminates this inhibitory effect, leading to increased muscle mass and strength. This genetic alteration results in significant muscle hypertrophy (increased size) and hyperplasia (increased number of muscle fibers). While these effects can enhance muscle development, they may also have implications for overall metabolism and cardiovascular health.
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Anti-Myostatin Antibody X Activin A
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Activin A is another member of the TGF-β family and is known to modulate muscle growth among its various biological functions. The therapeutic potential of targeting Activin A has been demonstrated by garetosmab, an Activin A antagonist antibody that exhibited promising outcomes in early clinical trials and in published non-human primate data.
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Activin E
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Activin E, like myostatin and Activin A, is part of the TGF-β superfamily and has been implicated in the regulation of energy homeostasis and overall metabolic health. Human genetic studies provide compelling support for Activin E as a therapeutic target, as individuals carrying protective loss-of-function variants of the INHBE gene exhibit reduced visceral fat, improved lipid profiles, and lower risk of cardiometabolic diseases.
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In the DIO mouse study, after only two weeks of dosing, monotherapy of Activin E antibody alone resulted in fat-selective weight loss of approximately 4%, with an approximately 18% reduction in total body fat compared to placebo. Notably, when combined with semaglutide, our Activin E antibody demonstrated a strong synergistic effect, enhancing total weight loss by an additional 9% beyond semaglutide therapy alone, leading to an overall weight reduction of 34%. This combination also resulted in a 72% reduction in body fat over the treatment period, as measured by DEXA scans.
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Immuno-Oncology
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Immuno-Oncology Pipeline
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IBIO-101
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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. Since Treg cells express interleukin-2 Rα (“IL-2Rα” or “CD25”), it was envisioned mAbs could be developed that bind CD25 and thereby trigger depletion by Natural Killer cells, resulting in stimulation of anti-tumor immunity.
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Unfortunately, while first-generation mAbs successfully bound CD25+ cells, they also interfered with interleukin-2 (“IL-2”) signaling to T effector (“Teff”) cells to activate their cancer cell killing effects. 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.
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In vitro characterization of IBIO-101 demonstrated potent binding to recombinant CD25 while preserving IL-2 signaling. Further assessment of IBIO-101 showed selective Treg depletion and sparing of Teffs.
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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. 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.
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Although we initially progressed IBIO-101 to the IND-enabling phase and identified an optimal cell lines for master cell bank creation, after evaluating whether IBIO-101 could be utilized in certain orphan diseases and in order to focus our resources on obesity and cardiometabolic diseases, we have decided to terminate our relationship with a Contract Research Organization (CRO) who was assisting us with the Chemistry, Manufacturing, and Controls (CMC) development of IBIO-101. Unless we receive funding to do so, we plan to pause any additional development on IBIO-101 and pursue partnering and/or licensing opportunities.
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TROP-2 x CD3 Bispecific
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We have identified highly potent, fully human TROP-2 (Trophoblast Cell Surface Antigen 2) monoclonal antibodies, which have been formatted into bispecific TROP-2 x CD3 molecules using our T-cell engager antibody panel, EngageTx. TROP-2 is highly expressed in multiple solid tumors, including breast, lung, colorectal, and pancreatic cancers and is closely linked to metastasis and tumor growth. TROP-2 antibody drug conjugates have been developed to deliver toxic payloads to these cancer cells but could risk harming healthy cells and cause adverse effects. Our bispecific approach has the potential to increase the therapeutic window, while promoting a robust and long-lasting anti-tumor response. Combining the bispecific TROP-2 approach with immunotherapies like checkpoint inhibitors can potentially lead to improved clinical outcomes.
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Using EngageTx, our 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. When compared to a bispecific molecule engineered with our TROP-2 binding arm and a first generation CD3 engager, SP34, our lead TROP-2 x CD3 bispecific antibody showed a markedly reduced cytokine release profile, potentially indicating a decreased risk for cytokine release syndrome.
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When tested in a humanized mouse model of squamous cell carcinoma, our 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.
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MUC16 x CD3 Bispecific
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MUC16 is a widely recognized cancer antigen overexpressed in several solid tumors, notably ovarian, lung, and pancreatic cancers. In ovarian malignancies more than 80% of tumors appear as a large extracellular protein that tumor cells can shed or glycosylate, potentially diminishing the effectiveness of traditional antibody-based therapies. By contrast, our patented epitope steering AI platform focuses on a region of MUC16 that remains unaltered by shedding or glycosylation, allowing for more consistent tumor targeting and potentially offering a substantial therapeutic advantage.
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By using our patented epitope steering AI platform, we identified multiple monoclonal antibodies binding specifically to the non-shed region of MUC16, with no detectable binding to the shed fragment. Our lead molecule demonstrated binding to MUC16 in OVCAR-3 ovarian cancer cells, reinforcing its potential as a viable therapeutic candidate. Subsequent humanization, a critical step for reducing immunogenicity, preserved the molecule’s potent affinity for both the engineered epitope and the native form of MUC16 in OVCAR-3 cells.
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Building on this progress, we employed our EngageTx T-Cell Engager platform to combine our most advanced MUC16 clone with eight distinct CD3 binders. Evaluation of these bispecific constructs in in vitro tumor cell-killing assays revealed a potency range of approximately 60,000-fold, underscoring the platform’s versatility. Furthermore, T-cell activation and cytokine release data demonstrated a diverse spectrum of potencies. This enables us to select an optimal candidate that balances robust tumor cell killing with a reduced risk of excessive cytokine release.
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Previous wording
The following information should be read together with the consolidated financial statements and the notes thereto and other information included elsewhere in this Quarterly Report on Form 10-Q (this “Report”) and in our Annual Report on Form 10-K for the year ended June 30, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on September 20, 2024, as amended on September 24, 2024 (the “Annual Report”). Unless the context requires otherwise, references in this Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc.
Current wording
The following information should be read together with the consolidated financial statements and the notes thereto and other information included elsewhere in this Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 (this “Quarterly Report”) and in our Annual Report on Form 10-K for the year ended June 30, 2025, as filed with the Securities and Exchange Commission (the “SEC”) on September 5, 2025. Unless the context requires otherwise, references in this Quarterly Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc.
Previous wording
This Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). For this purpose, any statements contained herein regarding our strategy, future operations, financial position, future revenues, projected costs and expenses, prospects, plans and objectives of management, other than statements of historical facts, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “may,” “plan,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements reflect our current views with respect to future events. Because these forward-looking statements involve known and unknown risks and uncertainties, actual results, performance or achievements could differ materially from those expressed or implied by these forward-looking statements for a number of important reasons, including those discussed in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Report, as well as in the section titled “Risk Factors” in our Annual Report. We cannot guarantee any future results, levels of activity, performance or achievements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this Report as anticipated, believed, estimated or expected. The forward-looking statements contained in this Report represent our estimates as of the date of this Report (unless another date is indicated) and should not be relied upon as representing our expectations as of any other date. While we may elect to update these forward-looking statements, we specifically disclaim any obligation to do so unless otherwise required by securities laws.
Current wording
This Quarterly Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). For this purpose, any statements contained herein regarding our strategy, future operations, financial position, future revenues, projected costs and expenses, prospects, plans and objectives of management, other than statements of historical facts, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “may,” “plan,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements reflect our current views with respect to future events. Because these forward-looking statements involve known and unknown risks and uncertainties, actual results, performance or achievements could differ materially from those expressed or implied by these forward-looking statements for a number of important reasons, including those discussed in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report, as well as in the section titled “Risk Factors” in our Annual Report. We cannot guarantee any future results, levels of activity, performance or achievements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this Quarterly Report as anticipated, believed, estimated or expected. The forward-looking statements contained in this Quarterly Report represent our estimates as of the date of this Quarterly Report (unless another date is indicated) and should not be relied upon as representing our expectations as of any other date. While we may elect to update these forward-looking statements, we specifically disclaim any obligation to do so unless otherwise required by securities laws.
Previous wording
iBio, Inc. (“iBio,” “we,” “us,” or “our”) is a preclinical stage biotechnology company leveraging the power of Artificial Intelligence (AI) for the development of hard-to-drug precision antibodies. Our core mission is to harness the potential of AI and machine learning (ML) to unveil elusive biologics that stand out and have evaded other scientists. Through our innovative AI Drug Discovery 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 proprietary technology stack is designed to minimize downstream development risks by employing AI-guided epitope-steering and monoclonal antibody (mAb) optimization.
Current wording
iBio, Inc. (the “Company” or “iBio”) is a preclinical stage biotechnology company leveraging the power of Artificial Intelligence (“AI”) for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space. Our core mission is to harness the potential of AI and machine learning (“ML”) to unveil novel biologics which other scientists have been unable to develop. Through our innovative AI Drug Discovery Platform, it has been able to identify differentiated molecules aimed to address unmet needs by current approved interverional therapies.
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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.
Current wording
In essence, we believe 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.
Previous wording
By leveraging our AI Drug Discovery Platform, we believe we have successfully identified the first antibody inhibiting Activin E. Preclinical data from multiple in vitro cell-based assays, including one on a human adipocyte cell line, demonstrated robust blockade of Activin E-mediated signaling. The antibody is being evaluated in an exploratory pre-clinical study in a model of diet-induced obesity (DIO) in mice, both as a monotherapy with bi-weekly dosing and in combination with semaglutide dosed daily.
Current wording
By leveraging our AI Drug Discovery Platform, we believe we have successfully identified the first long-acting antibody inhibiting Activin E. Preclinical data from multiplein vitro cell-based assays, including one on a human adipocyte cell line, demonstrated robust blockade of Activin E-mediated signaling. The antibody has been evaluated in multiple pre-clinical studies in a model of diet-induced obesity (DIO) in mice, both alone with biweekly dosing and in combination with semaglutide dosed daily. These results suggest IBIO-610 may induce fat-selective weight loss.
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our StableHu platform and mammalian display, this program is in late discovery, where multiple parameters—such as binding affinity, expression levels, and stability—are being optimized. Early in vitro findings in human muscle progenitor cells reveal that the bispecific candidate induces a stronger differentiation of progenitor cells into mature muscle cells compared to antibodies targeting only myostatin or Activin A alone.
Current wording
We initiated a program to develop a bispecific antibody targeting both myostatin and Activin A. Leveraging our StableHu™ platform and mammalian display, this program is in late discovery, where multiple parameters, such as binding affinity, expression levels, and stability, are being optimized. Earlyin vitro findings in human muscle progenitor cells suggest that the bispecific candidate induces a stronger differentiation of progenitor cells into mature muscle cells compared to antibodies targeting only myostatin or Activin A alone.
Previous wording
In April 2024, as result of the collaboration with AstralBio, we initiated a program to discover and develop a long-acting anti-myostatin antibody. Using our StableHu platform coupled with mammalian display, we optimized hit antibodies across multiple parameters, including affinity for myostatin, binding to the FcRn receptor, expression levels in mammalian cells, and resistance to poly-reactivity and aggregation. The final candidate, IBIO-600, also demonstrated a beneficial profile between thermostability and resistance to stress conditions during initial testing.
Current wording
In April 2024, as result of the collaboration with AstralBio, we initiated a program to discover and develop a long-acting anti-myostatin antibody. Using our StableHu platform coupled with mammalian display, we optimized hit antibodies across multiple parameters, including affinity for myostatin, binding to the FcRn receptor, expression levels in mammalian cells, and resistance to poly-reactivity and aggregation. The final candidate, IBIO-600, was also observed to have a beneficial profile between thermostability and resistance to stress conditions during initial testing.
Previous wording
In vitro, IBIO-600 was evaluated in human muscle progenitor cells, where it potently inhibited myostatin. This inhibition facilitated the differentiation of progenitor cells into mature human muscle cells. Interim data from a preclinical study in obese mice showed IBIO-600 dose-dependently prevented lean mass loss when administered in combination with a GLP-1 receptor agonist.
Current wording
In vitro, IBIO-600 was evaluated in human muscle progenitor cells, where it potently inhibited myostatin. This inhibition facilitated the differentiation of progenitor cells into mature human muscle cells. In interim data from a preclinical study in obese mice, we observed that IBIO-600 dose-dependently prevented lean mass loss when administered in combination with a GLP-1 receptor agonist.
Previous wording
In November 2024, we manufactured a non-cGMP batch of IBIO-600 for a non-human primate (NHP) study in obese and elderly NHPs. The primary goal of the study was to assess the pharmacokinetic (PK) profile of IBIO-600. The study consisted of two dose levels, a low dose of 5 mg/kg and a high dose of 50 mg/kg, with a single subcutaneous injection in each case. In addition to monitoring PK in serum, the study analyzed body composition changes over time by employing DEXA scans, measuring lean and fat mass.
Current wording
In November 2024, we initiated a study in obese and elderly NHP for IBIO-600. The primary goal of the study was to assess the PK profile of IBIO-600. The study consisted of two dose levels, a low dose of 5 mg/kg and a high dose of 50 mg/kg, with a single subcutaneous injection in each case. In addition to monitoring PK in serum, the study analyzed body composition changes over time by employing DEXA scans, measuring lean and fat mass.
Previous wording
The study consisted of six NHPs, sorted randomly into the low and high dose groups. The results indicate IBIO-600 promoted a dose-dependent increase in lean mass and a reduction in fat mass from baseline values. The effect peaked after 8 weeks, when the NHPs receiving the low-dose had a 3.1% (163g) increase in lean mass and a 5.1% (270g) increase in the NHPs receiving the high-dose. Standard PK calculations indicated the half-life of IBIO-600 in NHPs was approximately 40 to 52 days. By using multiple allometric scaling approaches, we estimated the half-life in humans of IBIO-600 as falling with a range of 57-130 days.
Current wording
The study consisted of six NHPs, sorted randomly into the low and high dose groups. IBIO-600 promoted an increase in lean mass and a reduction in fat mass from baseline values. Standard PK calculations indicated the half-life of IBIO-600 in NHPs was approximately 40 to 52 days. By using multiple allometric scaling approaches, we estimated the half-life in humans of IBIO-600 as falling with a range of 57-147 days.
Previous wording
The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies. The third layer of the technology stack is the antibody optimizing StableHu AI technology, coupled with mammalian display technology. Next, we use our EngageTx T-cell engager platform to create bispecific antibodies. And last, antibodies are transformed into conditionally activated antibodies by ShieldTx, our antibody masking technology. Each layer of the tech stack is designed to work synergistically, enabling us to rapidly advance antibodies from concept to in vivo proof-of-concept (POC).
Current wording
The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy. Pursuing specific epitopes that elicit a specific biological function allows us to create antibodies with complex modes of action, like agonistic or cell activating antibodies. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies. 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.
Previous wording
Our proprietary StableHu technology is instrumental in the optimization process. StableHu is an AI-powered tool designed to predict a library of antibodies with fully human CDR variants based on an input antibody. This input can range from an early, unoptimized molecule to an approved drug. 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.
Current wording
Our proprietary StableHu technology is instrumental in this optimization process. StableHu is an AI-powered tool designed to predict a library of antibodies with fully human CDR variants based on an input antibody. This input can range from an early, unoptimized molecule to an approved drug. 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.
Previous wording
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. Mammalian display libraries, on the other hand, offer significantly improved developability but reduced diversity due to the smaller library size they can handle. StableHu overcomes
Current wording
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. Mammalian display libraries, on the other hand, offer significantly improved developability but reduced diversity due to the smaller library size they can handle. StableHu overcomes this limitation by utilizing a machine learning algorithm generating focused library diversity within the capacity of mammalian display.
Previous wording
In March 2024, we entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases. As part of the collaboration, we granted an exclusive license to AstralBio of our AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an Investigational New Drug (IND) application. We have the exclusive option to license three (3) obesity and cardiometabolic targets from AstralBio and as a result, we will receive the right to develop, manufacture and commercialize those targets upon exercise. Upon mutual consent with AstralBio, we may also expand the collaboration to include additional targets in other fields.
Current wording
In March 2024, we entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases. As part of the collaboration, we granted an exclusive license to AstralBio of our AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an IND application. We have the exclusive option to license three (3) obesity and cardiometabolic targets from AstralBio and as a result, we will receive the right to develop, manufacture and commercialize those targets upon exercise. Upon mutual consent with AstralBio, we may also expand the collaboration to include additional targets in other fields.
Previous wording
As a result of this collaboration with AstralBio, we exercised our first option and entered into an exclusive agreement (the “Myostatin License Agreement”) with AstralBio, pursuant to which AstralBio licensed to us, on an worldwide exclusive basis and with the right to grant sublicenses, under the AstralBio Licensed Patents (as defined in the Myostatin License Agreement) and AstralBio Licensed Know-How (as defined in the Myostatin License Agreement) to develop, manufacture and commercialize and otherwise exploit IBIO-600 for research, diagnosis, treatment, prevention, or management of any disease or medical condition. We are solely responsible for all decisions related to the launch, sales and marketing and promotion of IBIO-600 in our discretion, subject to the terms of the License Agreement, and for all costs for all activities related to the development, manufacture and commercialization of IBIO-600 worldwide. IBIO-600 was identified by AstralBio using our proprietary technology stack and was designed for subcutaneous administration with the potential for an extended half-life. In parallel, we initiated a bispecific antibody program targeting myostatin/activin A to treat obesity and cardiometabolic disorders, leveraging our proprietary technology stack as well as the technology of IBIO-600.
Current wording
As a result of this collaboration with AstralBio, we exercised our first option and entered into an exclusive agreement related to myostatin (the “Myostatin License Agreement”) with AstralBio, pursuant to which AstralBio licensed to us, on an worldwide exclusive basis and with the right to grant sublicenses, under the AstralBio Licensed Patents (as defined in the Myostatin License Agreement) and AstralBio Licensed Know-How (as defined in the Myostatin License Agreement) to develop, manufacture and commercialize and otherwise exploit IBIO-600 for research, diagnosis, treatment, prevention, or management of any disease or medical condition. We are solely responsible for all decisions related to the launch, sales and marketing and promotion of IBIO-600 in our discretion, subject to the terms of the License Agreement, and for all costs for all activities related to the development, manufacture and commercialization of IBIO-600 worldwide. IBIO-600 was identified by AstralBio using our proprietary technology stack and was designed for subcutaneous administration with the potential for an extended half-life. In parallel, we initiated a bispecific antibody program targeting myostatin/activin A to treat obesity and cardiometabolic disorders, leveraging our proprietary technology stack as well as the technology
Previous wording
On April 21, 2025, we entered into the Activin E License Agreement with AstralBio, pursuant to which AstralBio has licensed to us, on an worldwide exclusive basis and with the right to grant sublicenses, the AstralBio Licensed Patents (as defined in the Activin E License Agreement) and AstralBio Licensed Know-How (as defined in the Activin E License Agreement) to develop, manufacture and commercialize and otherwise exploit any product directed to Activin E that contains the Activin E Licensed Product.
Current wording
In April 2025, we exercised our second option and entered into an exclusive agreement related to Activin E (the “Activin E License Agreement”) with AstralBio, pursuant to which AstralBio licensed to us, on an worldwide exclusive basis and with the right to grant sublicenses, under the AstralBio Licensed Patents (as defined in the Activin E License Agreement) and AstralBio Licensed Know-How (as defined in the Activin E License Agreement) to develop, manufacture and commercialize and otherwise exploit IBIO-610 for research, diagnosis, treatment, prevention, or management of any disease or medical condition. We are solely responsible for all decisions related to the launch, sales and marketing and promotion of IBIO-610 in our discretion, subject to the terms of the Activin E License Agreement, and for all costs for all activities related to, the development, manufacture and commercialization of IBIO-610 worldwide.
Previous wording
We continue to seek out opportunities for future collaborations using our AI Drug Discovery Platform.
Current wording
We continue to seek to advance of our preclinical immune-oncology candidates with potential as standalone or combination therapies while seeking partnerships for IBIO-600 in the most competitive areas that will likely require combination therapy. Further, we continue to seek out opportunities for future collaborations using our AI Drug Discovery Platform.
Previous wording
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. 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 Report for the quarterly period ended March 31, 2025. Our auditors also included an explanatory paragraph in their report on our consolidated financial statements as of and for the year ended June 30, 2024 with respect to this uncertainty.
Current wording
Despite this liquidity position, the history of significant losses, the negative cash flow from operations, and the dependence by us on our ability to obtain additional financing to fund our operations raised substantial doubt about our ability to continue as a going concern. In
Previous wording
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the AI-driven discovery platform in the future. Revenue in the amount of $0.2 million was recognized for services provided to a collaborative partner during the nine months ended March 31, 2025. Revenue for the nine months ended March 31, 2024 in the amount of $0.05 million was related to a research licensing agreement utilizing our AI-driven discovery platform.
Current wording
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on advancing our AI-driven discovery platform to develop molecules against hard to drug targets. To date this platform has not generated any material revenue, though we may realize revenue from it in the future. Revenue in the amount of $0.1 million was recognized for services provided to a collaborative partner during the three months ended September 30, 2025. No revenue was recognized for the three months ended September 30, 2024.
Previous wording
R&D expenses for the three months ended March 31, 2025 and 2024 were $1.9 million and $0.9 million, respectively, an increase of approximately $1.0 million. The increase in R&D expenses is mainly due to increased spending on consultants and outside services, consumable supplies, and personnel-related costs as a result of increased research activities.
Current wording
R&D expenses for the three months ended September 30, 2025 and 2024 were $3.6 million and $1.3 million, respectively, an increase of approximately $2.3 million. The increase in R&D expenses is mainly due to increased spending on consultants and outside services and an increase in people costs as a result of advancing research activities to support our IBIO-600 and IBIO-610 programs and other preclinical pipeline assets.
Previous wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the three months ended March 31, 2025 were approximately $4.9 million, compared to approximately $3.6 million in the same period of fiscal year 2024.
Current wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the three months ended September 30, 2025 were approximately $6.1 million, compared to approximately $4.1 million in the same period of fiscal year 2025.
Previous wording
Net cash used in operating activities was approximately ($10.7) million for the nine months ended March 31, 2025, compared to net cash used in operating activities of ($13.7) million for the nine months ended March 31, 2024. The use of cash was primarily attributable to funding our net loss for the period.
Current wording
Net cash used in operating activities was approximately $5.7 million for the three months ended September 30, 2025, compared to net cash used in operating activities of $3.7 million for the three months ended September 30, 2024. The use of cash was primarily attributable to funding our net loss for the period.
Previous wording
Net Cash Provided by Investing Activities
Current wording
Net Cash (Used in) Provided by Investing Activities
Previous wording
Net cash provided by investing activities of approximately $0.7 million for the nine months ended March 31, 2025 was due to the payment received for interest and principal on the promissory note receivable. Net cash provided by investing activities was approximately $1.1 million for the nine months ended March 31, 2024.
Current wording
Net cash used in investing activities of approximately $21.5 million for the three months ended September 30, 2025 was due to the purchase of debt securities and the purchase of fixed assets. Net cash provided by investing activities was approximately $0.7 million for the three months ended September 30, 2024.
Previous wording
Net cash provided by financing activities during the nine months ended March 31, 2025, was approximately $0.7 million and was attributable to the proceeds from the sale of securities partially offset by payments towards debt, including the finance lease obligations, term promissory note and equipment financing loan. Net cash provided by financing activities was approximately $11.5 million for the nine months ended March 31, 2024.
Current wording
Net cash provided by financing activities during the three months ended September 30, 2025, was approximately $46.7 million and was attributable to the net proceeds from the sale of securities partially offset by payments towards debt, including the finance lease
Previous wording
We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of March 31, 2025, our accumulated deficit was approximately ($327.1) million and we used approximately ($10.7) million of cash for operating activities during the nine months ended March 31, 2025. As of March 31, 2024, our accumulated deficit was approximately ($306.1) million and we used approximately ($13.7) million of cash for operating activities during the nine months ended March 31, 2024.
Current wording
We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of September 30, 2025, our accumulated deficit was approximately $337.9 million and we used approximately $5.7 million of cash for operating activities during the three months ended September 30, 2025. As of September 30, 2024, our accumulated deficit was approximately $317.8 million and we used approximately $3.7 million of cash for operating activities during the three months ended September 30, 2024. Our current cash, cash equivalents and investments in debt securities of approximately $49.6 million as of September 30, 2025, is anticipated to be sufficient to support operations into the fourth quarter of fiscal year 2027.
Previous wording
We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of our technologies, through potential proceeds from the sale or out-licensing of assets, grant revenue or collaborations, and through proceeds from the sale of additional equity or other securities. 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. 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 cease operations.
Current wording
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, collaborations, and through proceeds from the sale of additional equity or other securities. 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. 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 cease operations.
Previous wording
Critical accounting estimates are those estimates made in accordance with U.S. GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations. The following accounting estimate had a material impact on our results of operations for the three and nine months ended March 31, 2025.
Current wording
Critical accounting estimates are those estimates made in accordance with U.S. GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations. The following accounting estimate had a material impact on our results of operations for the three months ended September 30, 2025.
Previous wording
During the fourth quarter of the fiscal year ended June 30, 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 on June 30, 2024. 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. Since IBIO-101 is currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the cash flows related to the subject asset.
Current wording
During the fourth quarter of the fiscal year ended June 30, 2025, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million on June 30, 2025. 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
Previous wording
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 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. Given that the carrying amount of the asset was $5 million on June 30, 2024, it was concluded that no impairment existed.
Current wording
The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 15% discount rate, which was based on iBio’s weighted average cost of capital. The sum of the discounted excess earnings and the present value of the tax benefit related to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was $5.9 million as of the June 30, 2025 valuation date. Given that the carrying amount of the asset was $5 million on June 30, 2025, it was concluded that no impairment existed.
Previous wording
No triggering events were identified during the nine months ended March 31, 2025. We will continue to monitor the value of the IP as part of our annual accounting policy for impairment of long-lived assets. The primary impairment indicators that may arise in the near future are (1) any sustained decline in our common stock market price and (2) FDA decisions on similar competing technologies that are applying for Phase 1 approval.
Current wording
No triggering events were identified during the three months ended September 30, 2025. We will continue to monitor the value of the IP as part of our annual accounting policy for impairment of long-lived assets. The primary impairment indicators that may arise in the near future are (1) any sustained decline in our common stock market price and (2) FDA decisions on similar competing technologies that are applying for Phase 1 approval.
Previous wording
Our remaining critical accounting estimates remain consistent with the information disclosed in the same section in our last annual report on Form 10-K/A for the year ended June 30, 2024.
Current wording
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, 2025.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
obligations, term promissory note and equipment financing loan. Net cash used in financing activities was approximately $0.2 million for the three months ended September 30, 2024.
Current report — wording carried from elsewhere
asset. Since IBIO-101 is currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the cash flows related to the subject asset.
Rearranged previous paragraphs (8)
Previous report — wording carried elsewhere
this limitation by utilizing a machine learning algorithm generating focused library diversity within the capacity of mammalian display.
Previous report — wording carried elsewhere
Building on these insights, we initiated a program to develop a bispecific antibody targeting both myostatin and Activin A. Leveraging
Previous report — wording carried elsewhere
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the AI-driven discovery platform in the future. No revenue was recognized for the three months ended March 31, 2025 and 2024.
Previous report — wording carried elsewhere
Results of Operations – Comparison of the nine months ended March 31, 2025 and 2024
Previous report — wording carried elsewhere
Research and Development Expenses (“R&D”)
Previous report — wording carried elsewhere
General and Administrative Expenses (“G&A”)
Previous report — wording carried elsewhere
Total operating expenses, consisting primarily of R&D and G&A expenses, for the nine months ended March 31, 2025 were approximately $13.6 million, compared to approximately $13.3 million in the same period of fiscal year 2024.
Previous report — wording carried elsewhere
Net Cash Provided by Financing Activities