IBIO 10-K & 10-Q changes, risk factors and insider trading
iBio, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1420720 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Risks Related to Intellectual Property”
New heading “Risks Related to iBio’s Operations”
New heading “The results or success of preclinical studies and early-stage clinical trials of our product candidates may not be predictive of future results or replicated in later preclinical studies or clinical trials of our product candidates in the same indications or other indications.”
New heading “Interim, initial, or preliminary results from our clinical trials that we announce or publish from time to time may change (e.g., from positive safety or efficacy results to poor or negative safety or efficacy results) as more patient data become available and are subject to additional audit, validation and verification procedures that could result in material changes in the final data.”
New heading “Delays or difficulty in the enrollment of patients in any or all of our clinical trials could increase our development costs and delay completion of our clinical trials and associated regulatory submissions.”
New heading “Our Phase 1 clinical trial of IBIO-600 is subject to significant risks that could delay or prevent further development of this product candidate.”
New heading “Conducting clinical trials in Australia exposes us to additional regulatory, operational and legal risks that could delay development of our product candidates and increase our costs.”
New heading “Our use of hazardous and biological materials could result in us being liable for damages.”
New heading “Failure to comply with health care privacy and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.”
New heading “The use of AI and ML technologies in our business operations and product offerings may expose us to risks that could harm our competitive position and have a material adverse effect on our business and results of operations.”
Removed heading “Our ability to raise additional capital, including through sales of shares of common stock under the ATM Program, may be limited if the public float of our common stock continues to be less than $75.0 million.”
Removed heading “In the past we have identified and remediated material weaknesses in our internal controls, and we cannot provide assurances additional material weaknesses will not occur in the future.”
Largest changes
“Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business. …”see in full comparison
“Failure to comply with health care privacy and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.”see in full comparison
“The development and use of AI present risks and challenges that could adversely affect our business. We may use AI and ML technologies in various aspects of our operations, including drug discovery, clinical trial design, and data analysis. The use of AI and ML in our business may implicate AI-specific data privacy and security obligations and regulations and increased scrutiny. For example, the EU AI Act establishes a risk-based regulatory framework for AI systems, including requirements for high-risk AI applications. Additionally, various U.S. …”see in full comparison
“We, our CROs, and any potential collaborators may be subject to strict and changing federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security) and policies and contractual obligations related to data privacy and security. …”see in full comparison
“In the past we have identified and remediated material weaknesses in our internal controls, and we cannot provide assurances additional material weaknesses will not occur in the future.”see in full comparison
“Furthermore, the development and use of AI/ML present various privacy and security risks that may impact our business. AI/ML are subject to privacy and data security laws, as well as increasing regulation and scrutiny. For example, several jurisdictions around the globe, including Europe and certain U.S. states, have proposed, enacted or are considering laws governing the development and use of AI/ML. We expect other jurisdictions will adopt similar laws. …”see in full comparison
Full comparison: every changed paragraph (99)
Risks Related to Intellectual Property
Risks Related to iBio’s Operations
oAny claims beyond our insurance coverage limits may result in substantial costs.
oWe may be subject to various litigation claims and legal proceedings.
Risks Related to Intellectual Property oIf we or our licensors are unable to obtain and maintain sufficient patent protection, our ability to commercialize our technology and products may be impaired.
Risks Related to iBio’s Operations oWe have previously identified and remediated material weaknesses in our internal controls, and cannot assure that additional weaknesses will not occur.
oThe loss of one or more of our executive officers or key employees could adversely affect our business.
oA failure to have an appropriately skilled and adequate workforce could adversely impact the ability of our R&D facility to operate efficiently.
oA natural disaster or other disruptions at our laboratory would adversely affect our business and results of operations.
oWe may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.
oIf we are unable to protect the confidentiality of our customers’ proprietary information, we may be subject to claims.
oWe may face integration risks and additional costs if we acquire companies, products, or technologies.
oOur failure to continue to comply with the continued listing standards of Nasdaq could result in delisting.
oProvisions in our certificate of incorporation, bylaws, and under Delaware law could discourage a takeover.
oThe issuance of preferred stock could adversely affect the rights of the holders of shares of our common stock.
oWe do not anticipate paying cash dividends for the foreseeable future.
oHolders of our warrants have no rights as common stockholders until they exercise their warrants.
oThe market price of our common stock has been and may continue to be volatile.
oReports published by securities or industry analysts could adversely affect our common stock price and trading volume.
oAs a smaller reporting company, we are subject to reduced disclosure requirements, which may make our common stock less attractive to investors.
We have a limited operating history developing vaccinesprecision andantibody therapeutics, which may limit the ability of investors to make an informed investment decision.
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, running a contract development and manufacturing organization (“CDMO”), identifying potential product candidates and undertaking, in house and through third parties, preclinical trials and clinical trials of product candidates derived from our technologies. 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.commercialization and thereafter to immune-oncology therapeutics. Our current focus is on immune-oncologyprecision therapeutics.antibodies Thefor currentobesity, vaccinescardiometabolic and therapeuticscardiopulmonary beingdiseases. developedIn June 2026, we dosed the first participant in a Phase 1 clinical trial of IBIO-600, our long-acting anti-myostatin antibody, in Australia. With the exception of IBIO-600, all of our other product candidates are allstill in preclinical development and we have not completed any clinical trials for any vaccine or therapeutic protein product candidate produced using iBio technology and there is a risk that we will be unsuccessful in developing or commercializing any product candidates. Certain vaccine candidates using iBio’s technologies have previously been evaluated by other organizations in Phase 1 clinical trials; however, all of our vaccine and therapeutic protein product candidates are still in preclinical development. Neither we nor our collaborators have completed any other clinical trials for any vaccine or therapeutic protein product candidate produced using iBio technology. As a result, weWe have not yet demonstrated our ability to successfully complete any Phase 2 or pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any conclusion you reach about our future success or viability may not be as predictive as it might be if we had a longer operating history.
Since our 2008 spinoff from Integrated BioPharma, we have incurred operating losses and negative cash flows from operations, and we expect to continue to generate operating losses for the foreseeable future. Our net loss was approximately $18.4$33.0 million and $24.9$18.4 million for the fiscal years ended June 30, 20252026 and 2024,2025, respectively. As of June 30, 2025,2026, we had an accumulated deficit of approximately $332.2$365.3 million.
To date, we have financed our operations primarily through the sale of commonCommon stock,Stock, the Woodforest Credit Agreement, preferred stock and warrants. We devote substantially all of our efforts to research and development, including the development and validation of our technologies, and the development of ahard-to-drug proprietaryprecision therapeuticantibodies productsfor againstobesity, oncology.cardiometabolic and cardiopulmonary diseases. We have not completed development of or commercialized any vaccine or therapeutic product candidates. We expect to continue to incur significant expenses and may incur operating losses for at least the next year. We anticipate that our expenses and losses will increase substantially due to the commencement of our clinical trial if we:
There can be no assurance that our collaboration with AstralBio will be successful or that we will enteredenter into agreements for the sale or out-licensing of any of our product candidates on favorable terms or that the exploration of potential options will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. If we determine to change our business strategy, our future business, prospects, financial position and operating results could be significantly different than those in historical periods or projected by our management. Because of the significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in our business strategy and future funding requirements.
All of our existing product candidates are in various early stages of development and will require extensive additional clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue. Only one product candidate is currently in human clinical trials. As a result, even if we successfully develop, achieve regulatory approval and commercialize our products, we may be unable to generate revenue for many years, if at all. We do not anticipate that we will generate revenue from product sales for at least several years, if at all. If we are unable to generate revenue from product sales, we will not become profitable, and we may be unable to continue our operations.
We expect our research and development expenses to increase significantly as our product candidates advance in clinical development, and as we add more employees. 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. Therefore, it is difficult to accurately estimate the cost of the clinical trials. Clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time consuming. We estimate that clinical trials of our product candidates will take at least several years to complete. Because of numerous risks and uncertainties involved in our business, the timing or amount of increased development expenses cannot be accurately predicted, and our expenses could increase beyond expectations if we are required by the FDA, or comparable non-U.S. regulatory authorities, to perform studies or clinical trials in addition to those we currently anticipate. We anticipate that further product development is also expected to increase expenses, including but not limited to the expectedongoing Phase 1 clinical trial of IBIO-600, continued IND-enabling studies for IBIO-610, IBIO-600, and the additional studies that will be required to support development of our other preclinical cardiometabolic and cardiopulmonary programs. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials.trials In addition, as we expand our business, we will need to retain additional employees with the necessary skills including employees for our continued expansion of drug discovery capabilities in San Diego, California.
In addition, as we expand our business, we will need to retain additional employees with the necessary skills including employees for our continued expansion of drug discovery capabilities in San Diego, California.
Despite our receipt of approximately $46.5 million in net proceeds in connection with the closing of our underwritten offering in August 2025 Offering,(the “2025 Offering”), we will need additional capital to fully implement our long-term business, operating and development plans as we do not anticipate that any of our product candidates will generate revenue in the next few years, if at all. To the extent that we initiate or continue clinical development without securing collaborator or licensee funding, our research and development expenses could increase substantially.
When we elect to raise additional funds or additional funds are required, we may raise such funds from time to time through public or private equity offerings, debt financings, corporate collaboration and licensing arrangements or other financing alternatives. Additional equity or debt financing or corporate collaboration and licensing arrangements may not be available on acceptable terms, if at all. We currently have no committed sources of funding. The At Market Issuance Sales Agreement (the “ATM Agreement”) with Chardan Capital Markets, LLC (“Chardan”) and Craig-Hallum Capital Group LLC (“Craig-Hallum”) that we entered into on February 27, 2026, with ChardanJefferies andLLC Craig-Hallum(“Jefferies”), onproviding Julyfor 3,the 2024,sale alsoof up to $100,000,000 of shares of Common Stock (the “2026 ATM Agreement”) has certain requirements that we must meet in order to sell securities pursuant to the 2026 ATM Agreement. There can be no assurance that we will meet the requirements to be able to sell securities pursuant to the 2026 ATM Agreement, of if we meet the requirements that we will be able to raise sufficient funds on favorable terms. 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.needed 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.
The actual amount of funds we will need to operate our business is subject to many factors, some of which are beyond our control therefore we are unable to determine this amount with certainty. These factors include the following:
Our ability to raise additional capital, including through sales of shares of common stock under the ATM Program, may be limited if the public float of our common stock continues to be less than $75.0 million.
Under current SEC regulations, if the aggregate market value of our common stock held by non-affiliates, or public float, is less than $75.0 million at the time we file this Annual Report or earlier in some cases, and for so long as our public float remains less than $75.0 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements, including sales under this prospectus supplement, will be limited to an aggregate of one-third of our public float. As of September 3, 2025, our public float was approximately $20.0 million. If our public float decreases, the amount of securities we may sell under Form S-3 may also decrease.
We arerecently became a pre-clinical-stageclinical stage biopharmaceutical company that recently began to focus on leveraging the power of Artificial Intelligence (AI) for the development of precision antibodies.antibodies for obesity, cardiometabolic and cardiopulmonary diseases. Prior to August 23, 2021, when we entered into a series of agreements with RubrYc, we were focused on our CDMO business. We have never generated any product revenue from the development of precision antibodies, do not expect to generate revenue in the near future and do not have any products approved for sale. Our operations to date have been primarily focused on developing our product candidates. WeIn June 2026, we dosed the first participant in a Phase 1 clinical trial of IBIO-600 in Australia; however, we have not yet successfully conductedcompleted any clinical trials of any antibodies we have developed.trials. 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.
We have a limited number of product candidates, with IBIO-600 in a Phase 1 clinical trial and our other candidates in preclinical development, focused primarily on obesity, cardiometabolic and cardiopulmonary diseases. During fiscal year 2026, we completed a strategic pivot away from immune-oncology, fully impairing our IBIO-101 asset and ceasing active marketing of our oncology programs. As a result, our pipeline is now concentrated in a single therapeutic area, which increases our exposure to setbacks in that area. It is possible that we may never be able to develop a marketable product candidate.
We are currently in preclinical development of multiple product candidates as potential treatments across multiple therapeutic areas. It is possible that we may never be able to develop a marketable product candidate.
All but one of our product candidates are still in preclinical development. Our ability to generate product sales revenues for our own products, which we do not expect will occur for many years, will depend heavily on the successful development and eventual commercialization of our product candidates. The success of our product candidates will depend on several factors, including the following:
The risks associated with our product candidates not proceeding through clinical development is high. We expect it will be many years before we commercialize any product candidate, if ever. The product candidates we are developing are unproven, which makes it difficult to accurately predict the challenges we may face with respect to our product candidates as they proceed through development. It is also impossible to predict whether our clinical trials will proceed through registrational trials and when or if any of our product candidates will receive regulatory approval. To obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate through extensive preclinical studies and lengthy, complex and expensive clinical trials that our product candidates are safe and effective in humans. We anticipate the commencement ofcommenced our first human clinical trialstrial in lateJune fiscal 2026 or early fiscal 2027.2026. Clinical testing can take many years to complete, and its outcome is inherently uncertain. Commencing any future clinical trials is subject to finalizing the trial design and submitting an application to the FDA or a comparable foreign regulatory authority. Even after we make our submission, the FDA or comparable foreign regulatory authority could disagree that we have satisfied their requirements to commence our clinical trials or disagree with our trial design, which may require us to complete additional studies or trials, amend our protocols or impose stricter conditions on the commencement of clinical trials.
In addition, we, IRBs/ECsECs, the FDA, the Australian TGA or theother FDAregulatory or foreign equivalentauthorities may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if IRBs/ECsECs, the FDA, the Australian TGA or theother FDAregulatory oragencies foreign equivalent findsfind deficiencies in our submissions or conduct of our trials.
Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and by similar regulatory authorities outside the United States. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. WeIn haveApril not2026, we received Clinical Trial Notification acknowledgement from Australia’s TGA and ethics approval tofrom engagea inHREC, anyenabling clinical trials for anyinitiation of ourthe productIBIO-600 candidatesPhase and1 trial; however, there is no assurance that we will conduct successful clinical trials or obtain approval to market any of our product candidates from regulatory authorities in any jurisdiction. We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third parties to assist us in this process. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. If any of our product candidates receives marketing approval, the accompanying label may limit the approved use in such a restrictive manner that it is not possible to obtain commercial viability for such product.
Although the FDA and other regulatory authorities have approved plant-based therapeutics in the past, consistent with the oversight of all products, the FDA is monitoring whether these plant-based therapeutics pose any health and human safety risks. While they have not issued any regulation to date that is averse to plant-based vaccines or therapeutics, it is possible that the FDA and other regulatory authorities could issue regulations in the future that could adversely affect our product candidates.
For our obesity and cardiometabolic disease, not only will we compete with fully integrated pharmaceutical companies, but we will also compete with various companies that have developed or are trying to develop weight-loss treatments or cardiovascular therapies. Certain of our competitors have substantially greater capital resources, large customer bases, broader product lines, sales forces, greater marketing and management resources, larger research and development staffs with extensive facilities and equipment than we do and have more established reputations as well as global distribution channels. Our most significant competitors, among others, are fully integrated pharmaceutical companies such as Eli Lilly and Company, Novo Nordisk A/S, Amgen Inc., Bristol-Myers Squibb Company, Merck & Co., Inc., Novartis AG, MedImmune, LLC (a wholly owned subsidiary of AstraZeneca plcAstraZeneca PLC), Johnson & Johnson, Pfizer Inc., Merck KGaA and Sanofi SA, and more established biotechnology companies such as Genentech, Inc. (a member of the Roche Group), Gilead Sciences, Inc. and its subsidiary Kite Pharma, Inc, and Regeneron Pharmaceuticals.Pharmaceuticals, Inc.. We also compete with additional companies who are more advanced in the obesity and cardiometabolic space, such as Keros Therapeutics, Inc., Scholar Rock,Rock Inc.,Holding Corporation, Biohaven, Ltd., Basecure Therapeutics Inc., Structure Therapeutics, Inc., Viking Therapeutics, Inc., Veru Inc., Zealand Pharma A/S, Metsera, Inc., Terns Pharmaceuticals, Inc., Skye Bioscience, Inc., SixPeaks Bio AG, Laekna, Inc., Wave Life Sciences Ltd., Arrowhead Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., and Helicore Biopharma Inc., as well as tech enabled drug discovery companies such as Recursion,Recursion Pharmaceuticals, Inc., AbCellera Biologics, Inc., Cellarity, Inc., BenevolentAI, Nabla Technologies, Inc., and others, some of which have substantially greater financial, technical, sales, marketing, and human resources than we do.
The results or success of preclinical studies and early-stage clinical trials of our product candidates may not be predictive of future results or replicated in later preclinical studies or clinical trials of our product candidates in the same indications or other indications.
The results or success of preclinical studies and early-stage clinical trials of our product candidates may not be predictive of future results or replicated in later preclinical studies or later-stage clinical trials. Preclinical studies and early-stage clinical trials are primarily designed to study PK and PD, understand the side effects of product candidates, and evaluate various doses and dosing schedules. Our current or future product candidates may demonstrate different chemical, biological and pharmacological properties in patients than they do in laboratory studies or may interact with human biological systems in unforeseen or harmful ways. Product candidates in later-stages of clinical trials may fail to show desired pharmacological properties or produce positive safety and efficacy results despite having progressed through preclinical studies and early-stage clinical trials. Additionally, product candidates evaluated in one disease indication may interact in unforeseen or harmful ways in a patient population with a different disease indication than was previously studied. We cannot assure you that the current Phase 1 clinical trial of IBIO-600 or any future clinical trials of our product candidates will show positive results or demonstrate the same or similar results of our preclinical trials. There can be no assurance that any of our current or planned clinical trials will ultimately be successful or support further clinical development or registration of any of our product candidates.
Interim, initial, or preliminary results from our clinical trials that we announce or publish from time to time may change (e.g., from positive safety or efficacy results to poor or negative safety or efficacy results) as more patient data become available and are subject to additional audit, validation and verification procedures that could result in material changes in the final data.
Any interim, initial or preliminary data or results from clinical trials, including interim top-line results and other results published from our clinical trials may materially change as more patient data become available. Preliminary, initial, interim or top-line results also remain subject to audit, validation and verification procedures that may result in the final data being materially different from the data we previously published. As a result, interim, initial or preliminary data may not be predictive of final results and should be viewed with caution until the final data are available. We may also arrive at different conclusions, or considerations may qualify such results, once we have received and fully evaluated additional data. Differences between preliminary, initial or interim data and final data could adversely affect our business.
There is a high failure rate for drugs and biologics proceeding through clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical development even after achieving promising results in earlier studies, and we cannot be certain that we will not face similar setbacks. Many drugs have failed to replicate efficacy and safety results in larger or more complex later stage trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain regulatory approval. If we fail to produce positive results in our ongoing and planned preclinical studies and clinical trials with IBIO-600, IBIO-610 or any of our other product candidates, or if a regulatory authority interprets and analyzes the results as not positive, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, may be materially adversely affected.
Delays or difficulty in the enrollment of patients in any or all of our clinical trials could increase our development costs and delay completion of our clinical trials and associated regulatory submissions.
We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including:
For example, we may not be able to continue our Phase 1 clinical trial of IBIO-600 if we are unable to locate and enroll a sufficient number of eligible overweight or obese adults in Australia to participate in the trial as required by the Australian TGA. As of the date of the filing of this Annual Report, 31 of the 32 planned participants have been enrolled in the SAD portion of the Phase 1 clinical trial of IBIO-600. Our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site.
Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our current Phase 1 clinical trial of IBIO-600 or future clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates. Even if we are able to enroll a sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development costs for our product candidates may increase, and the completion of our trials may be delayed or our trials could become too expensive to complete.
Our Phase 1 clinical trial of IBIO-600 is subject to significant risks that could delay or prevent further development of this product candidate.
Our Phase 1 clinical trial of IBIO-600 is subject to significant risks and uncertainties, including the risk that the trial may be delayed, suspended, or terminated due to adverse events, regulatory actions, or other unforeseen circumstances. Clinical trials are inherently risky, and the results of early-stage trials may not be predictive of results in later-stage trials. Even if our Phase 1 trial generates positive safety and pharmacokinetic data, there can be no assurance that IBIO-600 will demonstrate sufficient efficacy in subsequent trials to support regulatory approval. Additionally, the Phase 1 trial is being conducted in Australia under a Clinical Trial Notification scheme rather than an FDA-approved IND, and there can be no assurance that the FDA will accept data from this study to support a future U.S. IND application or marketing approval. We have engaged a CRO to manage the trial, and we are dependent on their performance to recruit participants, conduct the study in compliance with applicable regulations, and deliver reliable data. Any failure or delay by our CRO could materially impact our clinical development timeline and increase our costs. Furthermore, as a company that has only recently transitioned to clinical stage, we have limited experience managing clinical trials and may encounter unexpected challenges in trial execution, data management, regulatory interactions, or manufacturing clinical supply.
We are conducting clinical studies for IBIO-600 outside of the United States, and may conduct our initial clinical studies for IBIO-610 and our other product candidates outside of the United States. However, theThe FDA and other foreign equivalents may not accept data from such studies, in which case our development plans will be delayed, which could materially harm our business.
We mayare conductconducting our Phase 1 clinical studies for IBIO-610IBIO-600 in Australia, and may conduct other productclinical candidatestrials in Australia, Canada or other foreign countries. The acceptance of study data from clinical studies conducted outside the United States or another jurisdiction by the FDA or applicable foreign authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical studies are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the studies were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where the studies are conducted. There can be no assurance that the FDA or any applicable foreign authority will accept data from studies conducted outside of the United States or the applicable jurisdiction. If the FDA or any applicable foreign authority does not accept such data, it would result in the need for additional studies, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.
Conducting clinical trials in Australia exposes us to additional regulatory, operational and legal risks that could delay development of our product candidates and increase our costs.
We conduct, and may continue to conduct, certain clinical trials and clinical development activities in Australia. As a result, we are subject to Australian laws, regulations and regulatory authorities, including the Australian TGA, HREC and other governmental and institutional bodies that oversee clinical research. Compliance with these requirements may be complex, time-consuming and costly and may differ significantly from the regulatory requirements applicable in the United States and other jurisdictions in which we may seek marketing approval.
Clinical trials conducted in Australia are subject to risks that may be outside of our control, including delays in obtaining regulatory and ethics committee approvals, changes in applicable laws, regulations or regulatory interpretations, difficulties in patient enrollment and retention, shortages of qualified investigators or clinical trial sites, and challenges associated with managing trial activities across multiple jurisdictions. In addition, Australian regulatory authorities may suspend, terminate, delay or require modifications to a clinical trial if safety concerns arise or if regulatory requirements are not satisfied. Any such actions could delay the development of our product candidates, increase our development costs and adversely affect our ability to obtain regulatory approval on a timely basis or at all.
Furthermore, data generated from clinical trials conducted in Australia may be subject to additional review by the FDA and other foreign regulatory authorities. There can be no assurance that data obtained from Australian clinical trials will be accepted by the FDA or other regulators without additional studies or analyses. If regulatory authorities determine that additional clinical trials are required, or if they question the adequacy, integrity or applicability of data generated in Australia, our development timelines could be significantly extended, our costs could increase substantially, and commercialization of our product candidates could be delayed or prevented.
In addition, conducting operations internationally exposes us to risks relating to currency fluctuations, cross-border data privacy requirements, supply chain disruptions, geopolitical events, changes in tax laws, employment matters and other legal and operational uncertainties. The occurrence of any of these events could adversely affect our clinical development programs, financial condition, results of operations and prospects.
Management's Discussion & Analysis (MD&A)
New heading “2026 ATM Agreement”
New heading “2026 Private Placement”
New heading “Impairment of Indefinite-Lived Intangible Asset”
New heading “Income Tax Expense”
Removed heading “AstralBio Activin E License Agreement”
Removed heading “Inducement of Existing Warrants”
Removed heading “Net Loss from Continuing Operations”
Removed heading “Net Loss from Discontinued Operations”
Largest changes
“In an effort to mitigate the substantial doubt about continuing as a going concern and increasing cash reserves, we have raised funds from time to time through equity offerings or other financing alternatives, entered into a collaboration agreement to discover and develop novel antibodies for obesity and other cardiometabolic diseases and sold certain intellectual property rights. …”see in full comparison
“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 in the past raised substantial doubt about our ability to continue as a going concern. In August 2025, we closed on an underwritten public offering raising gross proceeds of approximately $50 million and in January 2026, we raised gross proceeds of approximately $26 million in a private placement. …”see in full comparison
“The history of significant losses, the negative cash flow from operations, the limited cash resources on hand and the dependence by us on our ability to obtain additional financing to fund our operations after the current cash resources are exhausted raised substantial doubt about our ability to continue as a going concern. …”see in full comparison
“Based on management’s plans described above, our cash and cash equivalents are anticipated to be sufficient to support operations beyond twelve (12) months from the date of the filing of this Annual Report, which amounted to approximately $52.1 million. Accordingly, we concluded we have substantially mitigated the substantial doubt about our ability to continue as a going concern.”see in full comparison
“Our approach to the evolving needs in obesity treatment is facilitated by our 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. …”see in full comparison
Full comparison: every changed paragraph (87)
We are developing next-generation antibody medicines for obesity and its cardiometabolic and cardiopulmonary complications. One of the most important advances in modern obesity treatment has been the emergence of GLP-1 receptor agonists and other incretin-based therapies. These drugs have transformed the field by enabling weight loss that, in some cases, rivals the effects of invasive bariatric surgery. But as physicians and patients gain real-world experience, it’s becoming increasingly clear first-generation therapies, while groundbreaking, leave important gaps.
Our approach to the evolving needs in obesity treatment is facilitated by our 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.
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.
The current product candidate pipeline is set forth below.
We are a preclinical stage biotechnology company leveraging the power of AI for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space. Our core mission is to harness the potential of AI and ML to unveil novel biologics which other scientists have been unable to develop. Through our innovative AI Drug Discovery Platform, we have been able to identify differentiated molecules aimed to address unmet needs by current GLP-1 receptor agonists.
We believe the future of obesity care lies not just in weight loss—but in quality weight loss. Current interventional therapies such as GLP-1 receptor agonists have ushered in a breakthrough era, yet challenges remain: muscle loss, fat 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. Our obesity strategy is built on three key principles. First, we are aiming to develop next-generation antibody therapeutics addressing limitations of current approved treatments, offering options with a goal to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, we are focusing on targets with strong human validation, which we believe both helps reduce development risk and increase the likelihood of clinical success. Lastly, we are applying our integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate development-ready biologics, enabling us to move with speed and precision in a competitive and fast-evolving field. We anticipate the commencement of our first human clinical trials in late fiscal 2026 or early fiscal 2027. As we continue to leverage our technology stack and develop our existing immune-oncology pre-clinical pipeline, we are also seeking strategic partners with the capabilities to more rapidly advance these programs towards the clinic.
Our current therapeutics are all in preclinical development and we have not completed any clinical trials in humans for any therapeutic protein product candidate produced using our technology and there is a risk that we will be unsuccessful in developing or commercializing any product candidates. The current pre-clinical product candidate pipeline is set forth below.
Activin E, like myostatin, is part of the TGF-β superfamily and has been implicated in the regulation of energy homeostasis and overall metabolic health. Human genetic studies provide compelling support for Activin E as a therapeutic target, as individuals carrying loss-of-function variants of the INHBE gene exhibit reduced visceral fat, improved lipid profiles, and lower risk of cardiometabolic diseases.
IBIO-610 was evaluated in a preclinical PK and a body composition study in obese, mature NHPs designed to characterize systemic exposure and assess early signs of activity on fat and body composition. In previously disclosed results from this study, IBIO-610 demonstrated a terminal half-life of approximately 33.2 days in obese NHPs following administration, and based on allometric scaling approaches, we estimated a projected human half-life of up to 100 days, which may support infrequent dosing. In addition, in a small study that was not statistically powered, following two once-every-eight-week doses, treatment with IBIO-610 was associated with 6.7% lower visceral fat and 5.2% lower total fat mass compared with vehicle-treated obese NHPs, with a slight increase in lean mass. These findings are consistent with the fat-selective profile we observed in prior rodent studies. Additionally, obese NHPs treated with a single IV dose of IBIO-610 showed up to a 98% reduction in serum levels of active Activin E.
In July 2026, we announced new preclinical data from our obese NHP study evaluating IBIO-610. Following a single dose of IBIO-610, active Activin E levels in the blood were reduced in all treated NHPs and remained suppressed through eight weeks. At both weeks 4 and 8, active Activin E levels were reduced to levels below the limits of the assay. Overall, active Activin E was reduced by 98% at week 4 and 97% at week 8 compared with baseline. We believe that these findings support IBIO-610's potential for best-in-class pathway inhibition and further support the potential for an infrequently dosed, long-acting antibody approach. The data also demonstrated IBIO-610's potential to promote fat-selective weight loss while preserving lean mass. In obese NHPs, when combined with semaglutide, IBIO-610 drove greater visceral and total fat loss while reducing lean mass loss by 73% versus semaglutide alone, further supporting its potential as both a stand-alone therapy and a complementary approach to GLP-1-based treatments.
Following these studies, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-610 toward clinical development and we anticipate commencing first-in-human clinical trials in the first half of calendar year 2027.
IBIO-800: Myostatin x Activin A Bispecific Antibody
We are developing a bispecific antibody program targeting myostatin, growth differentiation factor 11 (“GDF11”) and Activin A, that we now refer to as IBIO-800. We are evaluating IBIO-800 for potential use in obesity and cardiopulmonary disease, including PH-HFpEF. Leveraging our innovative AI Drug Discovery Platform, IBIO-800 is in late discovery, where multiple parameters, including potency, selectivity, expression, stability and manufacturability, are being optimized. We nominated a development candidate in June 2026 and initiated CMC and nonclinical testing to enable continued progression of this program.
IBIO-800 is designed to selectively neutralize what we believe are key pathological ligands across multiple aspects of disease biology. Based on our preclinical work, Activin A may contribute to cardiac fibrosis and vascular remodeling, while myostatin and GDF11 may contribute to skeletal muscle dysfunction and reduced functional capacity. In combination, IBIO-800 is designed to reduce cardiac fibrosis, reverse pulmonary vascular remodeling, and improve whole body functional capacity, while avoiding some of the safety considerations associated with broader TGF-β ligand blockade.
In preclinical in vitro studies, early findings in human muscle progenitor or muscle stem cells suggest our bispecific candidates induced greater differentiation and fusion into mature muscle cells than antibodies targeting myostatin or Activin A alone. In addition, in human cardiac fibroblast studies, growth differentiation factor 8 (“GDF8”), GDF11 and Activin A promoted fibrotic activation and pro-inflammatory or pro-fibrotic gene expression, supporting the biological rationale for combined blockade in cardiopulmonary disease. We are also evaluating the program in vivo in a mouse model designed to assess stress-induced right ventricular remodeling in the setting of obesity and hemodynamic stress. In June 2026, we nominated a development candidate and are initiating CMC and nonclinical testing to enable continued progression of the program.
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 observed in garetosmab, an Activin A antagonist antibody that exhibited promising outcomes in early clinical trials and in published NHP data.
Building on these insights, we initiated a program to develop a bispecific antibody targeting both myostatin and Activin A. 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. Early in vitro findings in human muscle progenitor cells suggest that the bispecific candidate induces a stronger differentiation of progenitor cells into mature muscle cells compared to antibodies targeting only myostatin or Activin A alone. Increased muscle fusion index in human muscle stem cells, as shown in the chart below, is a surrogate of muscle growth.
Myostatin, also known as GDF8, is a member of the 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.
In April 2024, as result of ourthe 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.
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 5252.4 days. By using multiple allometric scaling approaches, we estimated the half-life in humans of IBIO-600 as falling with a range of 57-14774-147 days. IBIO-600 also demonstrated durable body composition effects, including lean mass gains of up to 5.1% with accompanying reductions in fat mass.
Following the NHP PK study, we initiated CMC manufacturing and nonclinical toxicology activities to support advancement of IBIO-600 toward clinical development. We have completed GMP manufacturing of an initial batch of drug product being used in our clinical study. Additionally, we have completed 1-month GLP toxicology studies in both rats and NHPs.
In June 2026, we announced the dosing of the first participant in a randomized, double-blind, placebo-controlled, first-in-human, phase 1 SAD clinical trial. This study is intended to test the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight or obese adults, as well as exploratory effects on body composition, with four SAD cohorts currently planned. To date, we have enrolled 31 participants in the first four cohorts of the Phase 1 clinical trial of IBIO-600 in Australia and each will be monitored for approximately nine months following administration, with study completion expected in second half of 2027. Data from the study will help inform potential future development of IBIO-600. This trial is designed to establish the initial human profile of IBIO-600 and begin generating evidence of its effects on body composition, helping to inform potential future studies in combination with GLP-1-based therapies. We are now preparing to advance IBIO-600 into the MAD portion of the study. Further, we intend to continue progressing the development of IBIO-600 in obesity, sarcopenia, and other muscle loss disorders.
Amylin Receptor Agonist Engineered Antibody
In collaboration with AstralBio, we initiated the development of an antibody agonists targeting the amylin receptor, a potentially highly promising mechanism in obesity treatment. Amylin receptors are closely related, multi-component GPCR complexes, making it challenging to discover antibodies with precisely controlled receptor subtype selectivity and functional activity. To address this challenge, we combined engineered GPCR antigens designed to mimic distinct amylin and calcitonin receptor configurations with our mammalian display-based discovery platform. This approach enables multidimensional antibody selection across properties including receptor subtype specificity, cross-species binding, functional activity and developability. Using these capabilities, we have generated both DACRA antibodies and selective amylin receptor agonist SARA antibodies designed to activate specific amylin receptor subtypes while avoiding activation of the calcitonin receptor.
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), compared with a 67% reduction observed with a benchmark DACRA peptide. Building on these results, we generated and characterized AMY1-selective, AMY3-selective and dual AMY1/AMY3 agonist antibodies, referred to as SARA antibodies, with distinct in vitro potency and selectivity profiles.
These data support the feasibility of using engineered antibodies to achieve differentiated amylin receptor pharmacology and demonstrate the application of our integrated discovery platform to a complex GPCR target class. The program provides an additional demonstration of our ability to combine engineered antigens with multidimensional mammalian display-based selection to generate functionally differentiated antibody candidates against challenging membrane-protein targets.
Following the NHP pharmacokinetic study, we initiated Chemistry, Manufacturing, and Controls manufacturing and nonclinical toxicology activities to support advancement of IBIO-600 toward clinical development. We have established a stable cell line, completed process and formulation development, and manufactured a GLP toxicology batch at 200L scale. In parallel, we launched a nonclinical toxicology program, initiating both rat and NHP dose range finding studies as well as a rat GLP tox study, with plans underway for an NHP GLP tox study. All studies are progressing as planned, with no notable safety findings observed to date. We intend to continue progressing the development of IBIO-600 through IND in sarcopenia, other muscle loss disorders and obesity.
2026 ATM Agreement
On February 27, 2026, we entered into the 2026 ATM Agreement with Jefferies providing for the sale by us of our shares of our Common Stock, from time to time, through or to Jefferies in an at-the-market offering program as set forth in the 2026 ATM Agreement. Offers and sales of shares of Common Stock by us, if any, under the 2026 ATM Agreement, will be made pursuant to our shelf registration statement on Form S-3 (File No. 333-293864), filed with the SEC on February 27, 2026 under the Securities Act, which was declared effective on March 6, 2026, and the prospectus included therein related to the offer and sale of up to $100,000,000 of shares of Common Stock. We have agreed to pay Jefferies a commission for its services in acting as agent of up to 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the 2026 ATM Agreement. The offering of shares of Common Stock pursuant to the 2026 ATM Agreement will terminate upon the earlier of (i) the sale of all shares of Common Stock subject to the 2026 ATM Agreement, or (ii) termination of the 2026 ATM Agreement as permitted therein by us or Jefferies. No shares have been sold under the 2026 ATM Agreement as of June 30, 2026.
2026 Private Placement
On January 13, 2026, pursuant to the terms of the securities purchase agreement that we entered into on January 8, 2026 with the 2026 Investors, we issued and sold to the 2026 Investors in the 2026 Private Placement an aggregate of 1,408,481 shares of Common Stock and, in lieu of shares, 2026 Pre-Funded Warrants to purchase up to an aggregate of 9,653,257 shares of Common Stock. The purchase price per share was $2.35. The purchase price per pre-funded warrant was $2.349, which is equal to the purchase price per share, minus the exercise price of $0.001 for each pre-funded warrant. We received aggregate gross proceeds from the 2026 Private Placement of approximately $26 million, before deducting the placement agent commissions and offering expenses payable by us which totaled approximately $1.7 million.
On August 19, 2025, we entered into an Underwriting Agreement with Leerink Partners LLC (“Leerink”),Leerink, as representative of the underwriters named in Schedule A thereto, relating to the offering, issuance and sale of 2025 Pre-Funded Warrants to purchase an aggregate of 71,540,000 shares of Common Stock and accompanying Series G Warrants to purchase (i) an aggregate of up to 35,770,000 shares of Common Stock (or, for those investors who so choose, pre-funded warrants to purchase up to 35,770,000 shares of Common Stock in lieu thereof) and (ii) Series H Warrants to purchase an aggregate of up to 35,770,000 shares of Common Stock (or, for those investors who so choose, pre-funded warrants to purchase up to 35,770,000 shares of Common Stock in lieu thereof) (the 2025 Offering). The combined public offering price per 2025 Pre-Funded Warrant and accompanying Series G Warrant was $0.699. The closing of the 2025 Offering took place on August 22, 2025. We received net proceeds from the 2025 Offering of approximately $46.5 million after deducting underwriting discounts and commissions and offering expenses payable by us in connection with the 2025 Offering. We may also receive up to an aggregate of $50 million of additional gross proceeds if the Series G Warrants and Series H Warrants are exercised in full for cash.
Each 2025 Pre-Funded Warrant and the pre-funded warrants issuable upon exercise of the Series G Warrants or Series H Warrants will have an exercise price per share of Common Stock equal to $0.001 and will bewere immediately exercisable from their date of issuance for one share of Common Stock, subject to certain beneficial ownership and other limitations. The Series G Warrants and Series H Warrants willwere each be exercisable from their date of issuance and will have an exercise price equal to $0.70 per whole share of Common Stock (or $0.699 per pre-funded warrant) and in the case of the Series G Warrants, the accompanying Series H Warrant. The Series G Warrants will expire on the date that is the earlier of (i)expired 30 trading days following our public announcement of a Trial Initiation Milestone and (ii) five years from the date of issuance.Milestone. In addition, to the extent the proportion of the unexercised portion of the Series G Warrant relative to the originally issued Series G Warrant is greater than the proportion of the unexercised portion of the originally issued 2025 Pre-Funded Warrant relative to the originally issued 2025 Pre-Funded Warrant, each Series G Warrant will immediately expireexpired in proportion to the extent that the corresponding 2025 Pre-Funded Warrant held by a holder is exercised prior to the occurrence of the Trial Initiation Milestone. When issued upon exercise of the Series G Warrants, the Series H Warrants will expire on the four-year anniversary of the closing date of the 2025 Offering.
On April 8, 2026, we issued a Public Announcement that we received CTN acknowledgement from Australia’s Therapeutic Goods Administration and ethics approval from a Human Research Ethics Committee, enabling the initiation of a first-in-human clinical trial of IBIO-600 in Australia. All Series G Warrants were exercised prior to their expiration at 5:00 p.m. (New York City time) on May 20, 2026.
During fiscal year 2026, 2025 Pre-Funded Warrants to purchase an aggregate of 9,250,394 shares of Common Stock were exercised for proceeds of approximately $9,250.
During fiscal year 2026, Series G Warrants to purchase 35,770,000 shares of Common Stock were exercised whereby the holders elected to receive pre-funded warrants to purchase up to 21,610,000 shares of Common Stock in lieu of shares of Common Stock and 14,160,000 shares of Common Stock, together with Series H Warrants to purchase up to 35,770,000 shares of Common Stock, for gross proceeds of approximately $25 million. The pre-funded warrants issued upon this election have an exercise price of $0.001 and are immediately exercisable.
During fiscal year 2026, Series H Warrants to purchase 4,250,000 shares of Common Stock were exercised whereby the holders elected to receive pre-funded warrants to purchase up to 4,250,000 shares of Common Stock in lieu of shares of Common Stock for gross proceeds of approximately $3 million. The pre-funded warrants issued upon this election have an exercise price of $0.001 and are immediately exercisable.
During fiscal year 2026, pre-funded warrants issued upon the exercise of Series G Warrants to purchase an aggregate of 1,970,000 shares of Common Stock, were exercised for proceeds of approximately $1,970.
In conjunction with 2025 Underwriting Agreement, we agreed to pay the underwriter a fee equal to six percent (6%) of the cash exercise fee received by us for all cash exercises of warrants for a period of thirty (30) months following the close of the transaction. The fee is due no later than five (5) business days following each calendar quarter. We incurred fees on these proceeds totaling approximately $1,680,000 during fiscal year 2026, of which approximately $1,173,000 is included in accrued expenses on the consolidated balance sheets at June 30, 2026.
AstralBio Activin E License Agreement
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.
Inducement of Existing Warrants
On April 29, 2025, we entered into a warrant inducement agreement (the “Inducement Agreement”) with holders (the “Holders”) of certain existing warrants (the “Existing Warrants”) to purchase shares of our Common Stock. Pursuant to the Inducement Agreement, the Holders agreed to exercise for cash on April 29, 2025 Existing Warrants to purchase an aggregate of 5,626,685 shares of Common Stock at a reduced exercise price of $0.86 per share, which was the Minimum Price, as defined in the rules of the Nasdaq Capital Market, as of the close of trading on April 28, 2025. In consideration of the Holders’ agreement to exercise the Existing Warrants in accordance with the Inducement Agreement, we agreed to issue warrants (the “Inducement Warrants”) to purchase up to 11,253,370 shares of Common Stock (the “Inducement Warrant Shares”), for consideration of $0.125 per Inducement Warrant. We received aggregate gross proceeds of approximately $6.2 million from the exercise of the Existing Warrants and the sale of the Inducement Warrants, before deducting financial advisory fees and other expenses payable by us. We agreed in the Inducement Agreement to file a resale registration statement within 45 days of the date of the Inducement Agreement providing for the resale of the Inducement Warrant Shares by the Holders of the Inducement Warrant Shares. The registration statement was filed with the SEC on June 13, 2025 and declared effective by the SEC on June 23, 2025.
The Inducement Warrants have an exercise price of $0.86 per share, are exercisable upon issuance and will expire on the five-year anniversary of the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Inducement Warrant are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock. In addition, in certain circumstances, upon a fundamental transaction (as defined in the Inducement Warrants), a holder of Inducement Warrants will be entitled to receive, upon exercise of the Inducement Warrants, the kind and amount of securities, cash or other property that such holder would have received had they exercised the Inducement Warrants immediately prior to the fundamental transaction.
We engaged Chardan to act as our financial advisor in connection with the transactions summarized above and paid Chardan an aggregate fee equal to approximately $217,000 in connection with the transactions contemplated by the Inducement Agreement. In addition, we incurred approximately $150,000 of transaction related costs. We expect to use the net proceeds from these transactions for working capital and other general corporate purposes.
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 year ended June 30, 2026. Revenue in the amount of $0.4 million was recognized for services provided to a collaborative partner during the year ended June 30, 2025. 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.
R&D expenses for the fiscal yearyears ended June 30, 20252026 and 20242025 were approximately $8.3$19.6 million and $5.2$8.3 million, respectively, an increase of approximately $3.1$11.3 million or approximately 60%.136%. The increase in R&D expenses wereis primarily due to increased spending onof approximately $8.4 million for consultants and outside services ofsupporting $2.7our millionR&D efforts, including NHP studies and consumableCMC suppliesactivities, offor $0.4 million as a result of advancing research activities to support the Company’s IBIO-600,our IBIO-610 and IBIO-600 programs and other preclinical pipeline assets.assets, and a $2.5 million development milestone.
On a program-by-program basis, consultants and outside services reported in R&D expenses for the fiscal year ended June 30, 2026, included $6.0 million for IBIO-610, $4.3 million for IBIO-600, and $0.6 million for all other pipeline programs. On a program-by-program basis, consultants and outside services reported in R&D expenses for the fiscal year ended June 30, 2025, included $2.5 million for IBIO-600, $0.5 million for IBIO-610, and $0.2 million for all other pipeline programs.
Consultant and outside services accounted for approximately 55% and 38% of total R&D expenses for the fiscal years ended June 30, 2026 and 2025, respectively.
G&A expenses for the fiscal yearyears ended June 30, 20252026 and 20242025 were approximately $10.7$10.6 million and $11.7$10.7 million, respectively, a decrease of $1.0approximately $0.1 million or 8%.1.0%. The slight decrease iswas primarily attributable to a reduction in personnel-related costs of $0.7 million, lower insurance premiums due to negotiated rates $0.3 million, a decrease in depreciation of $0.2 million, a reduction in legal fees of $0.1 million. The decreases were partially offsetdriven by increasedIT franchisecost taxes of $0.2 million and travel expenses of $0.1 million.reductions.
Impairment of Indefinite-Lived Intangible Asset
In the fiscal year ended June 30, 2026, an impairment charge of $5.0 million was recorded for our IBIO-101 indefinite-lived intangible asset. No impairments of indefinite-lived intangible assets were recorded in the fiscal year ended June 30, 2025.
Other income for the fiscal years ended June 30, 20252026 and 20242025 were $0.2$2.1 million and $1.2$0.2 million, respectively, aan decreaseincrease of approximately $1.0$1.9 million. The decreaseincrease is mainly attributable to interest earned on the saleproceeds offrom anour intangiblecapital assetraises inand fiscalwarrant year 2024 that did not recur in fiscal year 2025.exercises.
Income Tax Expense
There was no provision for current federal or state taxes for the fiscal years ended June 30, 2026 and June 30, 2025 as a result of taxable losses incurred.
Net Loss from Continuing Operations
Net loss from continuing operations for the fiscal year ended June 30, 2025 was $18.4 million, or $1.75 per share, compared to approximately $15.4 million, or $4.03 per share, in 2024. The increase is mainly attributable to increased research and development activities.
Net Loss from Discontinued Operations
On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO) in order to complete our transformation into an AI-driven, precision antibody drug discovery and development company. In conjunction with the divestment, we completed a workforce reduction and discontinued the CDMO operations. CDMO operations were classified as discontinued operations on our financial statements through the fiscal year ended June 30, 2024. The loss from Discontinued Operations for the year ended June 30, 2024 was approximately $9.5 million.
Our net loss for the fiscal year ended June 30, 20252026 was approximately $18.4$33.0 million, or $1.75$0.32 per share,share of Common Stock, compared to our net loss of approximately $24.9$18.4 million, or $6.50$1.75 per share,share of Common Stock, in the fiscal year ended June 30, 2024, which included the results of both continued and discontinued operations.2025.
What changed in the latest 10-Q
Risk Factors
New heading “Our stockholders will experience substantial dilution from the issuance of shares of Common Stock upon the exercise of outstanding warrants issued in our public and private offerings. Raising additional capital may also cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. Further, our stockholders will experience substantial dilution from the issuance of certain development milestone payments if paid in equity.”
Largest changes
“Our stockholders will experience substantial dilution from the issuance of shares of Common Stock upon the exercise of outstanding warrants issued in our public and private offerings. Raising additional capital may also cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. Further, our stockholders will experience substantial dilution from the issuance of certain development milestone payments if paid in equity.”see in full comparison
“If we raise additional funds by issuing equity securities, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences, which are not favorable to us or our stockholders. …”see in full comparison
“The current partial shutdown, or a recurring shutdown, of the U.S. federal government may adversely affect our business operations and regulatory compliance. Since February 14, 2026, the U.S. federal government has been operating under a partial shutdown resulting from a lapse in appropriations for the Department of Homeland Security (“DHS”), while other federal agencies remain funded. …”see in full comparison
“Until such time as we can generate substantial development, manufacturing, license or product revenues, we expect to finance our cash needs through a combination of equity offerings, collaborations, strategic alliances, service contracts, manufacturing contracts, licensing and other arrangements. Sources of funds may not be available or, if available, may not be available on terms satisfactory to us.”see in full comparison
“To the extent that we raise additional capital through a public or private offering and sale of equity securities, stockholders’ ownership interest will be diluted, and the terms of the securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Sales of our Common Stock offered through current or future equity offerings may result in substantial dilution to our stockholders. …”see in full comparison
“We have the option to pay the contingent development milestone consideration owed to the RubrYc shareholders in shares of our Common Stock. Our stockholders will experience substantial dilution from the issuance of shares of Common Stock to pay the contingent development milestone consideration, should we elect to pay such development milestones in shares of Common Stock in lieu of cash and may not realize a benefit from the acquisition of substantially all of the assets RubrYc commensurate with the ownership dilution they will experience in connection therewith.”see in full comparison
Full comparison: every changed paragraph (13)
Since our 2008 spinoff from Integrated BioPharma, we have incurred operating losses and negative cash flows from operations. Our net loss was approximately $9.0$22.4 million and $4.4$13.2 million for the threenine months ended DecemberMarch 31, 20252026 and 2024,2025, respectively. As of DecemberMarch 31, 2025,2026, we had an accumulated deficit of approximately $346.9$354.7 million. Based on the total cash and cash equivalents, and investments in debt securities of approximately $52.7$74.8 million at DecemberMarch 31, 2025,2026, we believe that our current cash position is sufficient to fund our operations for at least 12 months from the date of filing this Quarterly Report. 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 January 2026, we closed on the 2026 Private Placement raising gross proceeds of approximately $26 million. Our ability to generate future revenue is dependent on the successful development, regulatory approval, and commercialization of our product candidates, which are subject to significant risks and uncertainties, including clinical trial outcomes, FDA review timelines, and market acceptance.
To date, we have financed our operations primarily through the sale of commonCommon stock,Stock, preferred stock and warrants and the exercise of warrants. We are devoting substantially all of our efforts to research and development, including the development and validation of our technologies, and the development of proprietary therapeutic products against oncology.obesity, cardiometabolic and cardiopulmonary diseases. We have not completed development of or commercialized any vaccine or therapeutic product candidates. We expect to continue to incur significant expenses and may incur operating losses for at least the next year. We anticipate that our expenses and losses will increase substantially if we:
Despite our receipt of net proceeds approximately $46.4 million in connection with theour 2025underwritten Offeringoffering andconsummated $24.4in August 2025, $24.3 million in connection with the 2026 Private Placement, and $13.6 million upon the exercise of warrants during the nine month ended March 31, 2026, we will need additional capital to fully implement our long-term business, operating and development plans as we expect to commence clinical trials in the nextsecond fewquarter monthsof calendar year 2026 and do not anticipate that any of our product candidates will generate revenue in the next few years, if at all. To the extent that we initiate or continue clinical development without securing collaborator or licensee funding, our research and development expenses could increase substantially.
When we elect to raise additional funds or additional funds are required, we may raise such funds from time to time through public or private equity offerings, debt financings, corporate collaboration and licensing arrangements or other financing alternatives. Additional equity or debt financing or corporate collaboration and licensing arrangements may not be available on acceptable terms, if at all. We currently have no committed sources of funding. The 2026 ATM Agreement with Chardan Capital Markets, LLC (“Chardan”) and Craig-Hallum Capital Group LLC (“Craig-Hallum”) that we entered into with Chardan and Craig-HallumJefferies on JulyFebruary 3,27, 2024,2026, also has certain requirements that we must meet in order to sell securities pursuant to the 2026 ATM Agreement. There can be no assurance that we will meet the requirements to be able to sell securities pursuant to the 2026 ATM Agreement, of if we meet the requirements that we will be able to raise sufficient funds on favorable terms. There can be no assurances that we will be able to raise the funds needed. Although we are no longer limited in our ability to sell securities registered on our registration statement on Form S-3 because the market value of our voting securities held by non-affiliates exceeded $75 million, we could in the future be subject to such limitations if the price of our stock should drop at certain measurement times. 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.
Our stockholders will experience substantial dilution from the issuance of shares of Common Stock upon the exercise of outstanding warrants issued in our public and private offerings. Raising additional capital may also cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. Further, our stockholders will experience substantial dilution from the issuance of certain development milestone payments if paid in equity.
As of March 31, 2026, up to 89,042,863 shares of Common Stock are issuable upon the exercise of pre-funded warrants, with an exercise price of $0.001, and up to 38,555,185 shares of Common Stock are issuable upon the exercise of outstanding warrants, the issuance of which will result in substantial dilution to the existing holders of our Common Stock and will increase the number of shares eligible for resale in the public market.
Until such time as we can generate substantial development, manufacturing, license or product revenues, we expect to finance our cash needs through a combination of equity offerings, collaborations, strategic alliances, service contracts, manufacturing contracts, licensing and other arrangements. Sources of funds may not be available or, if available, may not be available on terms satisfactory to us.
If we raise additional funds by issuing equity securities, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences, which are not favorable to us or our stockholders. 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. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, our business, operating results, financial condition and prospects could be materially and adversely affected, and we may be unable to continue our operations.
To the extent that we raise additional capital through a public or private offering and sale of equity securities, stockholders’ ownership interest will be diluted, and the terms of the securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Sales of our Common Stock offered through current or future equity offerings may result in substantial dilution to our stockholders. The sale of a substantial number of shares of our Common Stock to investors, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
We have the option to pay the contingent development milestone consideration owed to the RubrYc shareholders in shares of our Common Stock. Our stockholders will experience substantial dilution from the issuance of shares of Common Stock to pay the contingent development milestone consideration, should we elect to pay such development milestones in shares of Common Stock in lieu of cash and may not realize a benefit from the acquisition of substantially all of the assets RubrYc commensurate with the ownership dilution they will experience in connection therewith.
The current partial shutdown, or a recurring shutdown, of the U.S. federal government may adversely affect our business operations and regulatory compliance. Since February 14, 2026, the U.S. federal government has been operating under a partial shutdown resulting from a lapse in appropriations for the Department of Homeland Security (“DHS”), while other federal agencies remain funded. As a result, certain DHS-related services and activities have been disrupted or delayed, including staffing and operations at agencies such as the Transportation Security Administration and the Federal Emergency Management Agency, and related third-party functions on which we may indirectly rely. More broadly, the shutdown has contributed to market volatility, operational inefficiencies and economic uncertainty, including disruptions to travel and commerce. If the shutdown continues or expands, or if future funding lapses occur, additional federal agency operations or regulatory activities could be suspended or delayed, which could adversely affect our operations, access to capital, business plans and the market price and liquidity of our securities. The duration and ultimate impact of the current shutdown are uncertain and beyond our control.
A recurring shutdown of the U.S. federal government may adversely affect our business operations and regulatory compliance. During such shutdowns, while the SEC’s EDGAR system remains operational, the unavailability of SEC staff to review filings, issue comments, or declare registration statements effective may delay our ability to complete public offerings, respond to comment letters, or obtain timely regulatory approvals. These delays could impact access to capital markets, hinder strategic transactions, and create uncertainty around our disclosure obligations. Additionally, the lack of interpretive guidance or exemptive relief during a shutdown may increase legal and compliance risks. Failure to adapt to or comply with evolving regulatory requirements or investor or stakeholder expectations and standards could negatively impact our reputation, ability to do business with certain partners, access to capital and our stock price.
We have previously applied for government grants to support some of our research and development activities for our product candidates. A lapse in appropriations resulting in a government shutdown could materially disrupt the timing and availability of these funds. During such shutdowns, federal agencies may suspend the processing of new grant applications, delay reimbursements, or pause disbursements for existing awards. These interruptions could adversely affect our ability to complete our planned research and development activities. If federal funding continues to be delayed, reduced or canceled, we may need to seek alternative sources of financing, scale back research efforts, or defer planned initiatives, any of which could have a material adverse effect on our financial condition and results of operations. If we resume applying for government grants and do not obtain the grants we apply forfor, we may not have sufficient funds to develop certain of our product candidates. Even if we obtain grant funding, the terms of the grant funding may be restrictive. Often government grants include provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to potentially require repayment of all or a portion of the grant award proceeds, in certain cases with interest, in the event we violate certain covenants pertaining to various matters.
Management's Discussion & Analysis (MD&A)
New heading “2026 ATM Agreement”
New heading “Series G Warrants”
Largest changes
“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. …”see in full comparison
“The 2026 Purchase Agreement prohibits us, with certain limited exceptions, from issuing any shares of Common Stock or Common Stock Equivalents (as defined in the 2026 Purchase Agreement), effecting a reverse stock split, recapitalization, share consolidation reclassification or similar transaction, or filing any registration statement (other than the 2026 Resale Registration Statement (defined below) as required pursuant to the Registration Rights Agreement, discussed below, or a registration statement on Form S-8), until the earlier of: (i) 60 days after the Closing Date; …”see in full comparison
“During the third quarter of fiscal year 2026, we ceased our marketing efforts of the IBIO-101 asset and with our focus on the development of hard-to-drug precision antibodies for obesity, cardiometabolic, and cardiopulmonary diseases, we fully impaired the remaining $2.5 million value of the IBIO-101 asset. Also, during the third quarter of fiscal year 2026, we performed our annual impairment testing of the remaining indefinite-lived intangible assets, with the assistance of a third party, which had a carrying amount of $1.5 million on March 31, 2026 and concluded that they were not impaired.”see in full comparison
“Obesity is associated with a broad range of cardiometabolic and cardiopulmonary complications, therefore, we are also evaluating selected adjacent indications where our AI Drug Discovery Platform and target biology may offer differentiated therapeutic opportunities. 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. There is a risk that we will be unsuccessful in developing or commercializing any product candidates.”see in full comparison
Full comparison: every changed paragraph (59)
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 DecemberMarch 31, 20252026 (this “Quarterly Report”) and in our annual report on Form 10-K for the year ended June 30, 2025 (the “Annual Report”), 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.
Overview 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 infor theobesity, cardiometabolic and obesitycardiopulmonary space.diseases. 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, we have been able to identify differentiated molecules aimed to address unmet needs by current approved interverional therapies.
We believe the future treatment for obesity lies not just in overall weight loss—but in targetedthe quality, durability, and tolerability of 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-generationnext-generation therapies aimeddesigned to meet these unmet needs, usingby the power ofleveraging AI-guided antibody design anddesign, advanced screening technologies.technologies and deep expertise in biologics development.
Our obesity strategy is built on threemultiple key principles. First, we aim to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with athe goalpotential to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, we are focusingprioritizing on targets with strong human genetic and clinical validation, which we believe both helps reduce developmenttranslational risk and increase the likelihood of clinical success. Third, we are evaluating opportunities in adjacent obesity-related indications, including cardiometabolic and cardiopulmonary conditions such as PH-HFpEF. Lastly, we are applying our integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate and advance development-ready biologics, enabling itus 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. We anticipate IBIO-600 will enter Phase 1a clinical trials in the first half of calendar 2026, marking a pivotal milestone for us as the first molecule generated from our technology platform to advance into clinical development. In parallel, with shifting our focus to IBIO-610, potentially the first long-acting antibody inhibiting Activin E, we have accelerated the development of IBIO-610 and anticipate the commencement of first human clinical trials in early calendar 2027.
Obesity is associated with a broad range of cardiometabolic and cardiopulmonary complications, therefore, we are also evaluating selected adjacent indications where our AI Drug Discovery Platform and target biology may offer differentiated therapeutic opportunities. 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. There is a risk that we will be unsuccessful in developing or commercializing any product candidates.
After receiving Clinical Trial Notification acknowledgement from Australia’s Therapeutic Goods Administration and ethics approval from a Human Research Ethics Committee, we anticipate IBIO-600 will enter Phase 1a clinical trials in Australia in the second quarter of calendar 2026, marking a pivotal milestone for us as the first molecule generated from our technology platform to advance into clinical development. In parallel, with shifting our focus to IBIO-610, potentially the first long-acting antibody inhibiting Activin E, we have accelerated the development of IBIO-610 and anticipate the commencement of first human clinical trials in the first half of calendar 2027. We are also advancing additional preclinical programs, including a bispecific antibody program for cardiopulmonary disease, which we are evaluating for potential use in PH-HFpEF.
Our approach to the evolving needs in obesity treatment is facilitated by our 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.
By leveraging our AI Drug Discovery Platform, we believe we have successfully identified the first long-acting antibody inhibiting Activin E.E, a potentially first-in-class Activin E antibody candidate. Preclinical data from multiple in vitro cell-based assays, including one on a human adipocyte cell line, demonstrated robust blockade of Activin E-mediated signaling. The antibody has been evaluated in multiple pre-clinical studies in a model of 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.
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 aan 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.
IBIO-610 was evaluated in a preclinical pharmacokinetic (“PK”) and body composition study in obese, mature non-human primates (“NHPs”) designed to characterize systemic exposure and assess early signs of activity on fat and body composition. In previously disclosed results from this study, IBIO-610 demonstrated a terminal half-life of approximately 33.2 days in obese NHPs following administration, and based on allometric scaling approaches, we estimated a projected human half-life of up to 100 days, which may support infrequent dosing. In addition, in a small study that was not statistically powered, following two once-every-eight-week doses, IBIO-610 reduced visceral fat by 6.7% and total fat mass by 5.2% in obese NHPs compared to vehicle-treated obese NHPs, with a slight increase in lean mass following treatment. These findings are consistent with the fat-selective profile we observed in prior rodent studies. Following these studies, we initiated chemistry, manufacturing and controls (“CMC”) and nonclinical toxicology activities to support the advancement of IBIO-610 toward clinical development.
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 up to 100 days, supporting the potential for infrequent, long-acting dosing in clinical settings. Following the NHP pharmacokinetic study, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-610 toward clinical development. Stable cell line development is ongoing, with process development proceeding in parallel. Dose range finding toxicology studies have been initiated in parallel in relevant species.
We are developing a bispecific antibody program targeting myostatin, GDF11 and Activin A. We are evaluating this program for potential use in obesity and cardiopulmonary disease, including PH-HFpEF. Leveraging our innovative AI Drug Discovery Platform, this program is in late discovery, where multiple parameters, including potency, selectivity, expression, stability and manufacturability, are being optimized.
Our bispecific antibody is designed to selectively neutralize what we believe are key pathological ligands across multiple aspects of disease biology. Based on our preclinical work, Activin A may contribute to cardiac fibrosis and vascular remodeling, while myostatin and GDF11 may contribute to skeletal muscle dysfunction and reduced functional capacity. In combination, our bispecific antibody is designed to reduce cardiac fibrosis, reverse pulmonary vascual remodeling, and improve whole body functional capacity, while avoiding some of the safety considerations associated with broader TGF-β ligand blockade.
In preclinical in vitro studies, early findings in human muscle progenitor or muscle stem cells suggest our bispecific candidates induced greater differentiation and fusion into mature muscle cells than antibodies targeting myostatin or Activin A alone. In addition, in human cardiac fibroblast studies, GDF8, GDF11 and Activin A promoted fibrotic activation and pro-inflammatory or pro-fibrotic gene expression, supporting the biological rationale for combined blockade in cardiopulmonary disease. We are also evaluating the program in vivo in a mouse model designed to assess stress-induced right ventricular remodeling in the setting of obesity and hemodynamic stress. We currently expect to nominate an optimized development candidate, validated for potency, selectivity, manufacturability and in vivo efficacy, in the third quarter of calendar 2026, before entering IND-enabling activities.
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. Early in vitro findings in human muscle progenitor cells suggest that the bispecific candidate induces a stronger differentiation of progenitor cells into mature muscle cells compared to antibodies targeting only myostatin or Activin A alone.
Following completion of the NHP pharmacokineticPK study, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-600 towardinto clinical development. We have completed manufacturingmanufacture and fill/finishfill-finish of a GMP batch of IBIO-600, withand long termlong-term stability testing is ongoing. ToWe continuehave developmentengaged ofa IBIO-600contract afterresearch organization to support the completioninitiation of CMC and nonclinical toxicology testing, we have contracted with a CRO to advance IBIO-600 into first-in-human clinical testing. In parallel, we launchedinitiated a nonclinical toxicology program, initiating bothincluding rat and NHP dosedose-range range-findingfinding studies,studies as well as rat and NHP GLP toxicology studies. AllWe studiesreceived Clinical Trial Notification (“CTN”) acknowledgement from Australia’s Therapeutic Goods Administration (“TGA”) and ethics approval from a Human Research Ethics Committee (“HREC”) in Australia, enabling initiation of the first-in-human Phase 1 clinical trial for IBIO-600 in Australia. The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight and obese adult participants. First participants are progressingexpected asto planned.be dosed in the second quarter of calendar 2026.
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.
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.
As a result of this collaboration with AstralBio, we exercised our first option and entered into 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 obesityobesity, cardiometabolic, and cardiometaboliccardiopulmonary disorders, leveraging our proprietary technology stack as well as the technology of IBIO-600.
In April 2025, we exercised our second option and entered into 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,to the development, manufacture and commercialization of IBIO-610 worldwide.
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.
2026 ATM Agreement
On February 27, 2026, we entered into an Open Market Sale AgreementSM (the “2026 ATM Agreement”) with Jefferies LLC (“Jefferies”) providing for the sale by us of our shares of our common stock, par value $0.001 per share (the “Common Stock”), from time to time, through or to Jefferies in an at-the-market offering program as set forth in the 2026 ATM Agreement. Offers and sales of shares of Common Stock by us, if any, under the 2026 ATM Agreement, will be made pursuant to our shelf registration statement on Form S-3 (File No. 333-293864), filed with the SEC on February 27, 2026 under the Securities Act, which was declared effective on March 6, 2026, and the prospectus included therein related to the offer and sale of up to $100,000,000 of shares of Common Stock. We have agreed to pay Jefferies a commission for its services in acting as agent of up to 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the 2026 ATM Agreement. The offering of shares of Common Stock pursuant to the 2026 ATM Agreement will terminate upon the earlier of (i) the sale of all shares of Common Stock subject to the 2026 ATM Agreement, or (ii) termination of the 2026 ATM Agreement as permitted therein by us or Jefferies. No shares have been sold under the 2026 ATM Agreement as of March 31, 2026.
2026 Private Placement
On January 13, 2026 (the “Closing Date”), pursuant to the terms of the securities purchase agreement (the “2026 Purchase Agreement”) that we entered into on January 8, 2026 with certain investors (the “2026 Investors”), we issued and sold to the 2026 Investors in a private placement (the “2026 Private Placement”) an aggregate of 1,408,481 shares of our common stock, par value $0.001 per share (the “Common Stock”) and, in lieu of shares, pre-funded warrants (the “2026 Pre-Funded Warrants”) to purchase up to an aggregate of 9,653,257 shares of Common Stock (the “2026 Pre-Funded Warrant Shares”).Stock. The purchase price per share was $2.35. The purchase price per pre-funded warrant was $2.349, which is equal to the purchase price per share, minus the exercise price of $0.001 for each pre-funded warrant. We received aggregate gross proceeds from the 2026 Private Placement of approximately $26 million, before deducting the placement agent commissions and offering expenses payable by us which totaled approximately $1.7 million.
Series G Warrants
During the fourth quarter ended June 30, 2026 to date, Series G Warrants to purchase 13,790,000 shares of Common Stock were exercised whereby the holders elected to receive pre-funded warrants to purchase up to 13,790,000 shares of Common Stock in lieu of shares of Common Stock, together with Series H Warrants to purchase up to 13,790,000 shares of Common Stock, for gross proceeds of approximately $9.6 million. The pre-funded warrants issued upon this election have an exercise price of $0.001 and are immediately exercisable.
During the fourth quarter ended June 30, 2026 to date, Series G Warrants to purchase 10,580,000 shares of Common Stock were exercised whereby the holders elected to receive 10,580,000 shares of Common Stock, together with Series H Warrants to purchase up to 10,580,000 shares of Common Stock, for gross proceeds of approximately $7.4 million.
We received aggregate gross proceeds from the 2026 Private Placement of approximately $26 million, before deducting the placement agent commissions and estimated offering expenses payable by us.
The 2026 Pre-Funded Warrants have an exercise price equal to $0.001 per share, are exercisable at any time after their date of issuance and will not expire until exercised in full. The 2026 Pre-Funded Warrants provide that a holder of the 2026 Pre-Funded Warrants will not have the right to exercise any portion of its 2026 Pre-Funded Warrants if such holder, together with its affiliates, and any other party whose holdings would be aggregated with those of the holder for purposes of Section 13(d) of the Exchange Act, would beneficially own in excess of 4.99%, or, at the option of each 2026 Investor, 9.99%, of the number of shares of Common Stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that the holder may increase or decrease the Beneficial Ownership Limitation by giving notice to us, with any such increase not taking effect until the sixty-first day after such notice is delivered to us but not to any percentage in excess of 9.99%. The 2026 Pre-Funded Warrants may be exercised on a cashless basis if, at the time of exercise, there is no effective registration statement or the prospectus contained therein is not available for the issuance of the 2026 Pre-Funded Warrant Shares. The exercise price and number of 2026 Pre-Funded Warrant Shares are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events.
The 2026 Purchase Agreement prohibits us, with certain limited exceptions, from issuing any shares of Common Stock or Common Stock Equivalents (as defined in the 2026 Purchase Agreement), effecting a reverse stock split, recapitalization, share consolidation reclassification or similar transaction, or filing any registration statement (other than the 2026 Resale Registration Statement (defined below) as required pursuant to the Registration Rights Agreement, discussed below, or a registration statement on Form S-8), until the earlier of: (i) 60 days after the Closing Date; and (ii) the business day immediately following the effective date of the 2026 Resale Registration Statement (defined below).
In connection with the 2026 Private Placement, we entered into a registration rights agreement (the “Registration Rights Agreement”) with the 2026 Investors, dated January 8, 2026, pursuant to which we agreed to register for resale the shares of Common Stock issued in the 2026 Private Placement and the Pre-Funded Warrant Shares held by the 2026 Investors (the “Registrable Securities”). Under the Registration Rights Agreement, we agreed to file a registration statement (the “2026 Resale Registration Statement”) covering the resale of the Registrable Securities as promptly as reasonably practicable and in any event no later than 60 days after the Closing Date. We agreed to use commercially reasonable efforts to cause the 2026 Resale Registration Statement to become effective at the earliest possible date but no later than the earlier of: (a) the 75th calendar day following the initial filing date of the 2026 Resale Registration Statement if the SEC notifies us that it will “review” the 2026 Resale Registration Statement and (b) the fifth business say after the date we are notified (orally or in writing, whichever is earlier) by the SEC that the 2026 Resale Registration Statement will not be “reviewed” or will not be subject to further review. We agreed to use reasonable best efforts to keep the 2026 Resale Registration Statement continuously effective pursuant to Rule 415 promulgated under the Securities Act, and available for the resale by the 2026 Investors of all of the Registrable Securities covered thereby at all times until the earliest to occur of the following events: (i) the date on which the 2026 Investors have resold all the Registrable Securities covered thereby; and (ii) the date on which the Registrable Securities may be resold by the 2026 Investors pursuant to Rule 144 without restriction. We agreed to be responsible for all fees and expenses incurred in connection with the registration of the Registrable Securities. We filed the 2026 Resale Registration Statement with the SEC on January 30, 2026 and declared effective by the SEC on February 9, 2026.
We have incurred net losses and generated negative cash flows from operations for many years. For the sixnine months ended DecemberMarch 31, 2025,2026, we incurred a net loss of approximately $14.7$22.4 million and had negative cash flows from operations of approximately $10.9$17 million. Historically, our liquidity needs have been met by the sale and issuances of securities and the issuances of shares of Common Stock through the exercise of warrants. As of DecemberMarch 31, 2025,2026, we had total current assets of approximately $53.4$77.3 million, of which approximately $28.7$47.6 million was cash and cash equivalents and approximately $24.0$27.2 million was investments in debt securities. For the sixnine months ended DecemberMarch 31, 2025,2026, we had an operating capital deficit of $10.9$17 million which compares to the $7.6$10.7 million operating capital deficit we maintained for the sixnine months ended DecemberMarch 31, 2024.2025.
Based on the total cash and cash equivalents, and investments in debt securities of approximately $52.7$74.8 million at DecemberMarch 31, 2025,2026, we believe that our current cash position is sufficient to fund our operations for at least 12 months from the date of filing this Quarterly Report.
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 August 2025, we closed on an underwritten public offering raising gross proceeds of approximately $50 million and in January 2026, we closed on the 2026 Private Placement raising gross proceeds of approximately $26 million. Additionally, we received gross proceeds of approximately $13.8 million from the exercise of warrants during the nine months ended March 31, 2026. Furthermore, in the fourth quarter of fiscal year 2026, we received gross proceeds of approximately $17 million from warrant exercises. Our ability to generate future revenue is dependent on the successful development, regulatory approval, and commercialization of our product candidates, which are subject to significant risks and uncertainties, including clinical trial outcomes, review timelines of the U.S. Food and Drug Administration (the “FDA”), and market acceptance.
Results of Operations – Comparison of the three months ended DecemberMarch 31, 20252026 and 20242025
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. No revenue was recognized during the three months ended DecemberMarch 31, 2026 and 2025. Revenue in the amount of $0.2 million was recognized for services provided to a collaborative partner during the three months ended December 31, 2024.
R&D expenses for the three months ended DecemberMarch 31, 20252026 and 20242025 were $4.3$3.3 million and $1.9 million, respectively, an increase of approximately $2.4$1.4 million. The increase in R&D expenses is mainlyprimarily due to increased spending onfor consultants and outside services supporting the Company’sour R&D efforts, including NHP studies and CMC activities, and an increase in peoplepersonnel costs as a result of advancing research activities for our IBIO-600 and IBIO-610 programs and other preclinical pipeline assets. The increased spend was partially offset by decreased spending on consumable supplies.
G&A expenses for the three months ended DecemberMarch 31, 20252026 and 20242025 were approximately $5.2$5.1 million and $2.7$3.0 million, respectively, an increase of approximately $2.5$2.1 million. The increase is primarily attributable to the impairment of the Company’s indefinite livedindefinite-lived intangible asset IBIO-101.IBIO-101 of $2.5 million offset by lower IT related costs and franchise taxes.
Total operating expenses, consisting primarily of G&A expenses and R&D expenses, for the three months ended DecemberMarch 31, 20252026 were approximately $9.4$8.4 million, compared to approximately $4.6$4.9 million in the same period of fiscal year 2025.
Our net loss for the three months ended DecemberMarch 31, 20252026 was $9.0$7.7 million, or $0.09$0.06 per share of Common Stock, compared to our net loss of approximately $4.4$4.9 million, or $0.48$0.49 per share of Common StockStock, for the three months ended DecemberMarch 31, 2024.2025.
Results of Operations – Comparison of the sixnine months ended DecemberMarch 31, 20252026 and 20242025
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 sixnine months ended DecemberMarch 31, 2025.2026. Revenue in the amount of $0.2 million was recognized for services provided to a collaborative partner during the sixnine months ended DecemberMarch 31, 2024.2025.
R&D expenses for the sixnine months ended DecemberMarch 31, 20252026 and 20242025 were $7.8$11.1 million and $3.2$5.1 million, respectively, an increase of approximately $4.6$6 million. The increase in R&D expenses is mainlyprimarily due to increased spending onfor consultants and outside services supporting the Company’sour R&D efforts, including NHP studies and CMC activities, for our IBIO-600 and IBIO-610 programs and other preclinical pipeline assets.
G&A expenses for the sixnine months ended DecemberMarch 31, 20252026 and 20242025 were approximately $7.7$12.8 million and $5.5$8.5 million, respectively, an increase of approximately $2.2$4.3 million. The increase is primarily attributable to the impairment of theour Company’s indefinite livedindefinite-lived intangible asset, IBIO-101, of $5 million offset by a reduction in IT costs, consulting expenseexpenses, accounting fees and accountingfranchise fees.taxes.
Total operating expenses, consisting of R&D expenses and G&A expenses, for the sixnine months ended DecemberMarch 31, 20252026 were approximately $15.5$23.9 million, compared to approximately $8.7$13.6 million in the same period of fiscal year 2025.
Our net loss for the sixnine months ended DecemberMarch 31, 20252026 was $14.7$22.4 million, or $0.19$0.25 per share of Common Stock, compared to our net loss of approximately $8.4$13.2 million, or $0.94$1.44 per share of Common StockStock, for the sixnine months ended DecemberMarch 31, 2024.2025.
Net cash used in operating activities was approximately $10.9$17.0 million for the sixnine months ended DecemberMarch 31, 2025,2026, compared to $7.6$10.7 million for the sixnine months ended DecemberMarch 31, 2024.2025. The use of cash was primarily attributable to funding our net loss for the period.
Net cash used in investing activities of approximately $24.5$27.6 million for the sixnine months ended DecemberMarch 31, 20252026 was primarily due to the purchase of investments in debt securities and the purchase of fixed assets. Net cash provided by investing activities was approximately $0.7 million for the sixnine months ended DecemberMarch 31, 2024.2025 and was primarily due to the receipt of $0.7 million principal on a promissory note receivable.
Net Cash Provided by (Used in) Financing Activities
Net cash provided by financing activities during the sixnine months ended DecemberMarch 31, 2025,2026, was approximately $55.5$83.6 million and was primarily attributable to the net proceeds from the sale of securities primarily from the underwritten public offering that we consummated in August 2025, pursuant to which we received net proceeds of approximately $46.4 million, andthe 2026 Private Placement, pursuant to which we received net proceeds of approximately $24.3 million, net warrant exercise proceeds of approximately $9.5$13.6 million, partially offset by approximately $0.8 million of payments towards debt, including the term promissory note, equipment financing loan, and finance lease obligations. Net cash usedprovided inby financing activities was approximately $0.3$0.8 million for the sixnine months ended DecemberMarch 31, 2024.2025 and consisted of proceeds of $1.3 million for the sale of Common Stock and the exercise of stock options offset by payments totaling $0.5 million for various debt.
We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of DecemberMarch 31, 2026, our accumulated deficit was approximately $354.7 million, and we used approximately $17.0 million for operating activities during the nine months ended March 31, 2026. As of March 31, 2025, our accumulated deficit was approximately $346.9$327.1 millionmillion, and we used approximately $10.9$10.7 million of cash for operating activities during the sixnine months ended DecemberMarch 31, 2025. As of December 31, 2024, our accumulated deficit was approximately $322.2 million and we used approximately $7.6 million of cash for operating activities during the six months ended December 31, 2024. Our current cash, cash equivalents and investments in debt securities of approximately $52.7$74.8 million as of DecemberMarch 31, 20252026, in addition to the netgross proceeds of approximately $24.4$17 million from warrant exercises through the 2026date Privateof Placement,the filing of this Quarterly Report, is anticipated to be sufficient to support operations into the thirdfourth quarter of fiscal year 2028.
As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (“SPE”s), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes. As of DecemberMarch 31, 2025,2026, we were not involved in any SPE transactions.
Our condensed consolidated financial statements are presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of DecemberMarch 31, 2025,2026, have been taken into consideration in preparing the condensed consolidated financial statements. The preparation of condensed consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. Some of those estimates are subjective and complex, and, consequently, actual results could differ from those estimates. We base our estimates, to the extent possible, on historical experience. 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.
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 sixnine months ended DecemberMarch 31, 2025.2026.
For indefinite lifeindefinite-lived 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.
No triggering events were identified during the three months ended September 30, 2025.
During the third quarter of fiscal year 2026, we ceased our marketing efforts of the IBIO-101 asset and with our focus on the development of hard-to-drug precision antibodies for obesity, cardiometabolic, and cardiopulmonary diseases, we fully impaired the remaining $2.5 million value of the IBIO-101 asset. Also, during the third quarter of fiscal year 2026, we performed our annual impairment testing of the remaining indefinite-lived intangible assets, with the assistance of a third party, which had a carrying amount of $1.5 million on March 31, 2026 and concluded that they were not impaired.
We will continue to monitor the value of theour 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 commonCommon stockStock market price and (2) FDA decisions on similar competing technologies that are applying for Phase 1 approval.
IBIO insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding IBIO (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 1,651,473 | $2.9M | 0.0% | Added 7% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 1,384,029 | $2.4M | 0.0% | Added 45% |
| Two Sigma Investments | 2026-06-30 | 400,667 | $701.2K | 0.0% | Reduced 2% |
| Renaissance Technologies | 2026-06-30 | 202,847 | $355.0K | 0.0% | New position |