iBio, Inc.: Form 10-Q for the period ended Dec 31, 2025

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 December 31, 2025 (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.

Forward-Looking Statements

This Quarterly Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). For this purpose, any statements contained herein regarding our strategy, future operations, financial position, future revenues, projected costs and expenses, prospects, plans and objectives of management, other than statements of historical facts, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “may,” “plan,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements reflect our current views with respect to future events. Because these forward-looking statements involve known and unknown risks and uncertainties, actual results, performance or achievements could differ materially from those expressed or implied by these forward-looking statements for a number of important reasons, including those discussed in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report, as well as in the section titled “Risk Factors” in our Annual Report. We cannot guarantee any future results, levels of activity, performance or achievements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this Quarterly Report as anticipated, believed, estimated or expected. The forward-looking statements contained in this Quarterly Report represent our estimates as of the date of this Quarterly Report (unless another date is indicated) and should not be relied upon as representing our expectations as of any other date. While we may elect to update these forward-looking statements, we specifically disclaim any obligation to do so unless otherwise required by securities laws.

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 in the cardiometabolic and obesity space. Our core mission is to harness the potential of AI and machine learning (“ML”) to unveil novel biologics which other scientists have been unable to develop. Through our innovative AI Drug Discovery Platform, 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 targeted weight loss. Current interventional therapies, such as glucagon-like peptide-1 (“GLP-1”) receptor agonists have ushered in a breakthrough era, yet challenges remain: muscle loss, fat regain after treatment cessation, and long-term tolerability. We are developing second-generation therapies aimed 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 aim to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with a goal to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, we are focusing on targets with strong human validation, which we believe both helps reduce development risk and increase the likelihood of clinical success. Lastly, we are applying our integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate development-ready biologics, enabling it to move with speed and precision in a competitive and fast-evolving field. Our current therapeutics are all in preclinical development and we have not completed any clinical trials in humans for any therapeutic protein product candidate produced using our technology and there is a risk we will be unsuccessful in developing or commercializing any product candidates. 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.

Our discovery and development work is conducted at our San Diego research and development (“R&D”) laboratory space, where our AI and ML scientists and biopharma researchers operate side by side. This close integration of disciplines enables rapid iteration between in silico design and wet-lab validation, compressing the timeline from hypothesis to lead selection. With our AI Drug Discovery Platform, focused pre-clinical pipeline, and growing scientific and leadership team, we are building a durable and differentiated position in obesity therapeutics—one designed to outlast the first wave and define what comes next.

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.

Our strategic approach to fulfilling our mission is outlined as follows:

• Disease area strategy rests on three pillars:
• Therapeutic Focus: Develop potential therapies that either complement or follow GLP-1 treatment, or provide well-tolerated monotherapy alternatives for patients unable or unwilling to remain on GLP-1s.
• Target Selection: Prioritize targets with strong human validation – genetic or pharmacologic – to reduce development risk and increase the likelihood of achieving first- or best-in-class outcomes.
• Competitive Edge: Leverage the integration of our AI-driven discovery platform, domain expertise, experienced personnel and advancing preclinical pipeline to accelerate differentiation and unlock targets others cannot.
• Capital efficient business approach: Our strategic business approach is structured around the following pillars of value creation:
• Developing and Advancing our In-house Preclinical Programs Cost Effectively: Drug discovery and clinical advancement of our pipeline remain central to our success. We continue to advance programs in obesity and cardiometabolic diseases with the goal of becoming a clinical-stage company, while also evaluating potential partnerships around select obesity assets to maximize their value and accelerate development timelines.
• Strategic Collaborations: We continue to pursue selective strategic collaborations using our existing portfolio of obesity and immuno-oncology assets, in order to accelerate our preclinical programs efficiently.
• Out-Licensing in Diverse Therapeutic Areas: We are evaluating opportunities for out-licensing our AI Drug Discovery Platform to broaden the use of our platform technologies beyond our core focus areas of obesity and cardiometabolic disease. These opportunities include potential partnerships in therapeutic areas such as immunology, inflammation, pain, and vaccines. Through such arrangements, we aim to provide partners with access to our AI-based discovery and screening technologies while generating potential revenue streams and maintaining operational focus on our internal research and development priorities.

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.

Our current pre-clinical product candidate pipeline is set forth below.

IBIO-610

By leveraging our AI Drug Discovery Platform, we believe we have successfully identified the first long-acting antibody inhibiting Activin E. Preclinical data from multiple in vitro cell-based assays, including one on a human adipocyte cell line, demonstrated robust blockade of Activin E-mediated signaling. The antibody 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 a 8.9% reduction in body weight compared to baseline and placebo, with body composition analysis revealing a 26% reduction in fat mass and no measurable loss of lean mass. Outlier non-responder mice were excluded.

To test potential combination therapy with incretin treatments, IBIO-610 was dosed biweekly alongside daily semaglutide. While semaglutide alone produced a 27.8% reduction in body weight (baseline and placebo adjusted), the combination resulted in a more pronounced 35.3% weight loss, without any additive effect on food intake. The combination also led to a greater reduction in visceral fat compared to semaglutide alone, suggesting complementary mechanisms that enhance metabolic benefit.

IBIO-610 was also tested as a maintenance therapy following cessation of semaglutide treatment. In this model, DIO mice were first dosed with semaglutide for two weeks, leading to approximately 18% weight loss. Upon stopping semaglutide, control mice regained 71% of the lost weight within three weeks, with fat mass levels returning to those of untreated animals. In contrast, mice receiving IBIO-610 at the time of semaglutide discontinuation regained only 28% of the lost weight and retained significantly lower fat mass at study termination, highlighting the potential of IBIO-610 to prevent rebound weight gain.

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.

Myostatin x Activin A Bispecific Antibody

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.

IBIO-600

In April 2024, as result of the collaboration with AstralBio, we initiated a program to discover and develop a long-acting anti-myostatin antibody. Using our StableHu platform coupled with mammalian display, we optimized hit antibodies across multiple parameters, including affinity for myostatin, binding to the FcRn receptor, expression levels in mammalian cells, and resistance to poly-reactivity and aggregation. The final candidate, IBIO-600, was also observed to have a beneficial profile between thermostability and resistance to stress conditions during initial testing.

In vitro, IBIO-600 was evaluated in human muscle progenitor cells, where it potently inhibited myostatin. This inhibition facilitated the differentiation of progenitor cells into mature human muscle cells. In interim data from a preclinical study in obese mice, we observed that IBIO-600 dose-dependently prevented lean mass loss when administered in combination with a GLP-1 receptor agonist.

In November 2024, we initiated a study in obese and elderly NHP for IBIO-600. The primary goal of the study was to assess the PK profile of IBIO-600. The study consisted of two dose levels, a low dose of 5 mg/kg and a high dose of 50 mg/kg, with a single subcutaneous injection in each case. In addition to monitoring PK in serum, the study analyzed body composition changes over time by employing DEXA scans, measuring lean and fat mass.

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 52.4 days. By using multiple allometric scaling approaches, we estimated the half-life in humans of IBIO-600 as falling with a range of 74-147 days.

Following the NHP pharmacokinetic study, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-600 toward clinical development. We have completed manufacturing and fill/finish of a GMP batch of IBIO-600, with long term stability testing ongoing. To continue development of IBIO-600 after the completion 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 launched a nonclinical toxicology program, initiating both rat and NHP dose range-finding studies, as well as rat and NHP GLP studies. All studies are progressing as planned.

As we continue developing IBIO-600, we are actively seeking a development partner to help accelerate its clinical progression in sarcopenia, muscle loss disorders, and obesity, maximizing the therapeutic and commercial potential of this unique, long-acting anti-myostatin/GDF11 antibody.

Partnered Programs

Amylin Receptor Agonist Engineered Antibody

In collaboration with AstralBio, we are working to develop an amylin receptor antibody, a potentially highly promising mechanism in obesity treatment. Along with AstralBio, we are discovering and optimizing both dual amylin and calcitonin receptor (DACRA)-like engineered antibodies, and selective amylin receptor agonist antibodies while avoiding engagement of the calcitonin receptor. Improved selectivity may translate into tolerability and efficacy advantages. Leveraging the AI Drug Discovery Platform, combining soluble G protein-coupled receptor (“GPCR”) analogues with mammalian display, we have engineered agonists with tailored activity across specific amylin receptor subtypes, showcasing the ability to address complex membrane protein targets with precision.

Early preclinical results to date show the promise of the approach. In a proof-of-concept study in DIO mice, an early DACRA-like agonist antibody delivered approximately a ~60% reduction in acute food intake (p<0.05), nearly matching the 67% reduction seen with a benchmark DACRA peptide. These data affirm that antibody-based approaches targeting amylin receptor are promising and can access the parts of the brain containing amylin receptor. As the third obesity program from our AstralBio partnership, this achievement marks a significant validation of our integrated AI Drug Discovery Platform and sets the stage for advancing this differentiated modality into the next stages of development.

AI Drug Discovery Platform

Overview

Our technology stack is a multi-layered, AI-powered system designed to significantly enhance the probability of success in discovering and developing antibodies against hard-to-drug, pathophysiologically relevant proteins. The platform comprises four integrated layers, each contributing a distinct capability to the discovery, engineering, and optimization of precision antibodies. By seamlessly combining advanced computational design with cutting-edge biological technologies, iBio’s AI-driven discovery platform enables the rapid generation of antibody therapeutics characterized by high specificity, optimized developability, and accelerated progression from concept to clinic.

The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy. Pursuing specific epitopes that elicit a specific biological function allows us to create antibodies with complex modes of action, like agonistic or cell activating antibodies. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies. The third layer of the technology stack is the antibody optimizing StableHu AI technology, coupled with mammalian display technology. This combination has been shown to speed up the Lead Optimization process and potentially minimizes downstream risks, with the goal of making the overall development process more efficient and cost-effective.

Building on this foundation, the fourth layer is our EngageTx™ and ShieldTx™ technologies expanding the platform’s reach into multi-specific and conditionally active antibody formats. EngageTx delivers an optimized, next-generation CD3 T-cell engager antibody panel with a wide range of potencies, NHP cross-reactivity, enhanced humanness, and strong tumor-killing activity with reduced cytokine release. In parallel, ShieldTx provides an antibody masking technology that enables the creation of conditionally activated antibodies. These conditionally activated antibodies can broaden the therapeutic window by improving efficacy and safety, enable drug combinations that would otherwise be too toxic, and open the door to pursuing targets whose expression across multiple tissues would normally raise safety concerns.

AI Epitope Steering Technology

Epitopes—the small regions on large target proteins—are critical to eliciting desired biological effects when targeted with antibodies. Traditional epitope-specific discovery methods often struggle with dominant-epitope antibodies that lack efficacy yet overwhelm screening, obscuring antibodies against more therapeutically valuable sites. These approaches also tend to yield few or no hits against complex, hard-to-drug epitopes due to structural challenges and the limited availability of stable scaffolds needed to maintain epitope integrity during discovery.

Our Epitope Steering technology directly addresses these limitations by guiding antibody generation toward predefined regions of a target protein. Using AI, we design *engineered epitopes—*precisely modeled and optimized fragments of the target—to improve structural fidelity, solubility, and stability. These engineered epitopes enable efficient antibody selection from naïve or immunized libraries, significantly increasing discovery success, especially for agonistic or functionally active antibodies.

This approach is broadly applicable across complex protein classes and holds promise in unlocking new targets in cardiometabolic disease, immuno-oncology, immunology, and pain. Moreover, it has potential applications in vaccine design, offering new opportunities for disease prevention.

Naïve Human Antibody Library

The fully human antibody library is built upon clinically validated, entirely human antibody frameworks. By leveraging public databases, we have extracted a diverse array of Complementarity-Determining Region (CDR) sequences. Subsequently, we have meticulously eliminated a range of sequence liabilities. Such careful curation process could potentially significantly reduce the development risk for antibodies identified from our library.

StableHu AI Antibody-Optimizing Technology

Antibody optimization is a pivotal step in the development of therapeutic antibodies. It refines an antibody's properties to enhance its efficacy, safety, and manufacturability. This process includes humanization, which alters non-human antibodies to mimic human antibodies, thereby reducing the risk of immune reactions when used in therapy.

Our proprietary StableHu technology is instrumental in this optimization process. StableHu is an AI-powered tool designed to predict a library of antibodies with fully human CDR variants based on an input antibody. This input can range from an early, unoptimized molecule to an approved drug. The model has been trained utilizing a set of over 1 billion human antibodies, progressively masking known amino acids within CDRs until the algorithm could predict the correct human sequence.

While phage display libraries are often used in antibody optimization due to their vast diversity, they can increase developability risks such as low expression, instability, or aggregation of antibodies. Mammalian display libraries, on the other hand, offer significantly improved developability but reduced diversity due to the smaller library size they can handle. StableHu overcomes this limitation by utilizing a machine learning algorithm generating focused library diversity within the capacity of mammalian display.

Mammalian display is a technology that presents antibodies on the surface of mammalian cells, allowing for the direct screening and selection of antibodies in a mammalian cell environment. This approach is advantageous as antibodies that express well on the mammalian cells used in the display are more likely to express well in the production cell line. Moreover, single-cell sorting of antibody-displaying cells allows rapid selection of desired antibodies based on multiple dimensions, such as potency, selectivity, and cross-species selectivity.

When paired with mammalian display technology, StableHu enables antibody optimization with fewer iterative optimization steps, lower immunogenicity risk, and improved developability.

EngageTx CD3-Based T-Cell Engager Panel

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.

To address these limitations, we applied StableHu technology to antibodies derived from an epitope steering campaign and a first-generation T-cell engager. This approach generated a diverse CD3 antibody panel with a wide potency range, enabling flexible pairing with various tumor-targeting antibodies. The resulting molecules retained potent tumor-killing activity while significantly reducing cytokine release, potentially lowering the risk of cytokine release syndrome.

StableHu also increased antibody humanness, reducing immunogenicity risk, and introduced NHP cross-reactivity—allowing for robust preclinical safety assessments ahead of clinical trials.

ShieldTx Antibody Masking Technology

Many potential drug targets are expressed across both healthy and diseased tissues, making selective targeting a major safety challenge. Antibodies that kill target-expressing cells can damage healthy tissues if the target is not disease-restricted.

Antibody masking offers a solution. Masked, or conditionally activated, antibodies remain inactive in circulation through a temporary “mask” linked to the binding site. Once the antibody reaches diseased tissue, disease-specific enzymes cleave the linker, removing the mask and activating the antibody precisely where it is needed. This targeted activation broadens the therapeutic window, improves safety, and enables the pursuit of targets and drug combinations otherwise considered too toxic.

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.

Through StableHu multi-dimensional optimization, we simultaneously refine the antibody, mask, and linker components—reducing development time compared to traditional sequential approaches. The result is a faster, more integrated path to conditionally active antibodies with enhanced efficacy and safety potential.

Programs Available for Partnering Outside the Cardiometabolic Area

There have been notable advances in the field of oncology in recent years, and arguably none more important than the advent of immunotherapies. We have a pipeline of pre-clinical programs with differentiated profiles and high potential impact, including IBIO-101, our second-generation anti-CD25 monoclonal antibody, a TROP-2 x CD3 bispecific antibody, an antibody that binds to a non-shed, non-glycosylated region of MUC16, an antibody that binds to an epitope on EGFRvIII without binding wildtype EGFR, and an anti-CCR8 antibody. With our therapeutic focus shifting to precision antibodies in the cardiometabolic and obesity space, we are exploring the best path forward for our immune-oncology programs, with a focus on identifying partners who bring complementary capabilities and a shared vision for patient impact.

Collaborations and Partnerships

As noted above, one of the three pillars of value creation that structures of our strategic business approach are strategic collaborations and partnerships. At the center of such pillar is our AI Drug Discovery Platform.

In March 2024, we entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases. As part of the collaboration, we granted an exclusive license to AstralBio of our AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an IND application. We have the exclusive option to license three (3) obesity and cardiometabolic targets from AstralBio and as a result, we will receive the right to develop, manufacture and commercialize those targets upon exercise. Upon mutual consent with AstralBio, we may also expand the collaboration to include additional targets in other fields.

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 obesity and cardiometabolic 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, 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.

Recent Developments

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”). 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 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.

Liquidity and Capital Resources

We have incurred net losses and generated negative cash flows from operations for many years. For the six months ended December 31, 2025, we incurred a net loss of approximately $14.7 million and had negative cash flows from operations of approximately $10.9 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 December 31, 2025, we had total current assets of approximately $53.4 million, of which approximately $28.7 million was cash and cash equivalents and approximately $24.0 million was investments in debt securities. For the six months ended December 31, 2025, we had an operating capital deficit of $10.9 million which compares to the $7.6 million operating capital deficit we maintained for the six months ended December 31, 2024.

Based on the total cash and cash equivalents, and investments in debt securities of approximately $52.7 million at December 31, 2025, 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 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, review timelines of the U.S. Food and Drug Administration (the “FDA”), and market acceptance.

Results of Operations – Comparison of the three months ended December 31, 2025 and 2024

Revenue

Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on advancing our AI-driven discovery platform to develop molecules against hard to drug targets. 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 December 31, 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.

Research and Development Expenses (“R&D”)

R&D expenses for the three months ended December 31, 2025 and 2024 were $4.3 million and $1.9 million, respectively, an increase of approximately $2.4 million. The increase in R&D expenses is mainly due to increased spending on consultants and outside services supporting the Company’s R&D efforts, including NHP studies and CMC activities, and an increase in people 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.

General and Administrative Expenses (“G&A”)

G&A expenses for the three months ended December 31, 2025 and 2024 were approximately $5.2 million and $2.7 million, respectively, an increase of approximately $2.5 million. The increase is primarily attributable to the impairment of the Company’s indefinite lived intangible asset IBIO-101.

Total Operating Expenses

Total operating expenses, consisting primarily of G&A expenses and R&D expenses, for the three months ended December 31, 2025 were approximately $9.4 million, compared to approximately $4.6 million in the same period of fiscal year 2025.

Net Loss

Our net loss for the three months ended December 31, 2025 was $9.0 million, or $0.09 per share of Common Stock, compared to our net loss of approximately $4.4 million, or $0.48 per share of Common Stock for the three months ended December 31, 2024.

Results of Operations – Comparison of the six months ended December 31, 2025 and 2024

Revenue

Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on advancing our AI-driven discovery platform to develop molecules against hard to drug targets. 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 six months ended December 31, 2025. Revenue in the amount of $0.2 million was recognized for services provided to a collaborative partner during the six months ended December 31, 2024.

R&D

R&D expenses for the six months ended December 31, 2025 and 2024 were $7.8 million and $3.2 million, respectively, an increase of approximately $4.6 million. The increase in R&D expenses is mainly due to increased spending on consultants and outside services supporting the Company’s R&D efforts, including NHP studies and CMC activities, for our IBIO-600 and IBIO-610 programs and other preclinical pipeline assets.

G&A

G&A expenses for the six months ended December 31, 2025 and 2024 were approximately $7.7 million and $5.5 million, respectively, an increase of approximately $2.2 million. The increase is primarily attributable to the impairment of the Company’s indefinite lived intangible asset, IBIO-101, offset by a reduction in consulting expense and accounting fees.

Total Operating Expenses

Total operating expenses, consisting of R&D expenses and G&A expenses, for the six months ended December 31, 2025 were approximately $15.5 million, compared to approximately $8.7 million in the same period of fiscal year 2025.

Net Loss

Our net loss for the six months ended December 31, 2025 was $14.7 million, or $0.19 per share of Common Stock, compared to our net loss of approximately $8.4 million, or $0.94 per share of Common Stock for the six months ended December 31, 2024.

Uses of Cash and Funding Requirements

Net Cash Used in Operating Activities

Net cash used in operating activities was approximately $10.9 million for the six months ended December 31, 2025, compared to $7.6 million for the six months ended December 31, 2024. The use of cash was primarily attributable to funding our net loss for the period.

Net Cash (Used in) Provided by Investing Activities

Net cash used in investing activities of approximately $24.5 million for the six months ended December 31, 2025 was due to the purchase of debt securities and the purchase of fixed assets. Net cash provided by investing activities was approximately $0.7 million for the six months ended December 31, 2024.

Net Cash Provided by (Used in) Financing Activities

Net cash provided by financing activities during the six months ended December 31, 2025, was approximately $55.5 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, and warrant exercise proceeds of approximately $9.5 million, partially offset by payments towards debt, including the term promissory note, equipment financing loan, and finance lease obligations. Net cash used in financing activities was approximately $0.3 million for the six months ended December 31, 2024.

Funding Requirements

We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of December 31, 2025, our accumulated deficit was approximately $346.9 million and we used approximately $10.9 million of cash for operating activities during the six months ended December 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 million as of December 31, 2025 in addition to the net proceeds of approximately $24.4 million from the 2026 Private Placement, is anticipated to be sufficient to support operations into the third quarter of fiscal year 2028.

We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of our technologies, through potential proceeds from the sale or out-licensing of assets, collaborations, and through proceeds from the sale of additional equity or other securities and exercise of outstanding warrants. However, there can be no assurance that we will be successful in implementing these plans, many of which will take several years before we realize proceeds. We cannot be certain that such funding will be available on favorable terms or available at all. If we are unable to raise funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies; b) seek collaborators for our technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or otherwise dispose of rights to technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or d) possibly cease operations.

Off-Balance Sheet Arrangements

As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (“SPE”s), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes. As of December 31, 2025, we were not involved in any SPE transactions.

Critical Accounting Estimates

Our condensed consolidated financial statements are presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of December 31, 2025, 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 six months ended December 31, 2025.

Impairment of Indefinite-Lived Intangible Assets

For indefinite life intangible assets, we perform an impairment test annually and whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable.

Evaluating impairment requires judgment, including the estimation of future cash flows, future growth rates and profitability and the expected life over which cash flows will occur. Changes in our business strategy or adverse changes in market conditions could impact impairment analyses and require the recognition of an impairment charge. Although we base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, actual results could differ from these estimates.

During the fourth quarter of the fiscal year ended June 30, 2025, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million on June 30, 2025. We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the asset. Since IBIO-101 is currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the cash flows related to the subject asset.

The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 15% discount rate, which was based on iBio’s weighted average cost of capital. The sum of the discounted excess earnings and the present value of the tax benefit related to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was $5.9 million as of the June 30, 2025 valuation date. Given that the carrying amount of the asset was $5 million on June 30, 2025, it was concluded that no impairment existed.

No triggering events were identified during the three months ended September 30, 2025.

During the second quarter of fiscal year 2026, we retained a global advisory firm to market and actively identify partners for IBIO-101 and the other oncology programs we acquired from RubrYc due to our therapeutic focus shift to precision antibodies in the cardiometabolic and obesity space. The market data collected indicated the full carrying value of IBIO-101 may not be recoverable. We engaged a third party to perform a valuation of IBIO-101, utilizing the MPEEM under the income approach to value the indefinite-lived asset. The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 16% discount rate, which was based on iBio’s weighted average cost of capital. The sum of the discounted excess earnings and the present value of the tax benefit related to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was approximately $2.5 million as of the December 31, 2025 valuation date. The carrying amount of the asset was $5 million at the time of the valuation, it was concluded that a $2.5 million impairment existed. We recorded an impairment charge in general and administrative expenses of approximately $2.5 million for the three and six months ended December 31, 2025.

We will continue to monitor the value of the IP as part of our annual accounting policy for impairment of long-lived assets. The primary impairment indicators that may arise in the near future are (1) any sustained decline in our common stock market price and (2) FDA decisions on similar competing technologies that are applying for Phase 1 approval.

We continue to operate in a highly competitive environment, rising cost of capital and experience liquidity challenges. Accordingly, we may have to adjust our cash flow projections and valuation assumptions in the near future to account for market trends and any changes to our research and development plans. Any such future adjustments may lead to material future impairments in the IP and other related assets.

Our remaining critical accounting estimates remain consistent with the information disclosed in the same section in our last annual report on Form 10-K for the year ended June 30, 2025.

In addition to the aforementioned critical accounting estimates, the following accounting policies and estimates have been highlighted as significant because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial statements:

• revenue recognition;
• legal and contractual contingencies;
• research and development expenses; and
• share-based compensation expenses.

We base our estimates, to the extent possible, on historical experience. 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. See Note 3 – Summary of Significant Accounting Policies - for a complete discussion of our significant accounting policies and estimates.

Evaluation of Disclosure Controls and Procedures

Our management, under the direction of our Chief Executive Officer (our Principal Executive Officer) and Chief Financial Officer (our Principal Financial Officer) have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of December 31, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Based on our evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2025.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the quarter ended December 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. The following information updates, and should be read in conjunction with, the information disclosed in Part I, Item 1A, “Risk Factors,” contained in the Annual Report. Except as described below, our risk factors as of the date of this Quarterly Report have not changed materially from those described in “Part I, Item 1A. Risk Factors” of our Annual Report.

We have incurred significant losses since our inception. We expect to incur losses during our next Fiscal year, we do not anticipate generating significant revenue for several years and may never achieve or maintain profitability.

Since our 2008 spinoff from Integrated BioPharma, we have incurred operating losses and negative cash flows from operations. Our net loss was approximately $9.0 million and $4.4 million for the three months ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of approximately $346.9 million. Based on the total cash and cash equivalents, and investments in debt securities of approximately $52.7 million at December 31, 2025, 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 common 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. 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:

• initiate clinical trials of our product candidates which we plan to commence in the first half of calendar year 2026;
• continue the research and development of our product candidates;
• seek to discover or license in additional candidates; and
• add operational, financial and management information systems and personnel, including personnel to support our product development and manufacturing efforts.

Our future profitability and cash flow in large part depends on our research and development programs, including our AI platform, and our ability to successfully develop, partner or commercialize our product candidates and to a lesser extent, which is not anticipated for several years. Our cash position is expected to limit the number of product candidates that we seek to develop. This will require us, alone or with our licensees and collaborators, to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our product candidates, obtaining regulatory approval for these product candidates and manufacturing, marketing and selling those products for which regulatory approval is obtained or establishing collaborations with parties willing and able to provide necessary capital or other value. We may never succeed in these activities. We may never generate revenues that are significant or large enough to achieve profitability.

There can be no assurance that our collaboration with AstralBio will be successful or we will be able to enter 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 research and development, clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue. As a result, even if we successfully develop, achieve regulatory approval and commercialize our products, we will 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 may not be able to generate revenue or achieve profitability in the future. Our failure to achieve or maintain profitability would likely negatively impact the value of our securities and could prevent us from continuing as a going concern. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would diminish the value of our company and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

We will need additional funding to fully execute our business plan, which funding may not be available on commercially acceptable terms or at all. If we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate the commercialization of our development and manufacturing services and efforts for our product development programs.

Despite our receipt of net proceeds approximately $46.4 million in connection with the 2025 Offering and $24.4 million in connection with the 2026 Private Placement, 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 next few months 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 ATM Agreement with Chardan Capital Markets, LLC (“Chardan”) and Craig-Hallum Capital Group LLC (“Craig-Hallum”) that we entered into with Chardan and Craig-Hallum on July 3, 2024, also has certain requirements that we must meet in order to sell securities pursuant to the ATM Agreement. There can be no assurance that we will meet the requirements to be able to sell securities pursuant to the ATM Agreement, of if we meet the requirements that we will be able to raise sufficient funds on favorable terms. 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.

If we are unable to raise funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies; b) seek collaborators for our technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or otherwise dispose of rights to technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or d) possibly liquidate assets or cease operations.

A future shutdown of the U.S. federal government may adversely affect our business.

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.

Changes or disruptions at the FDA and other government agencies caused by funding cuts, government shutdowns, personnel reductions, substantial changes in leadership and policy, or other changes or disruptions to these agencies’ operations could prevent these agencies from performing functions on which the operation of our business relies, including the timely review of filings, and any such disruptions and changes could negatively impact our business.

The ability of the FDA and foreign regulatory authorities to review and or approve new products can be affected by a variety of factors, including government budget and funding levels, staffing levels, and statutory, regulatory, and policy changes, the FDA’s and foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA and foreign regulatory authorities have fluctuated in recent years as a result. Disruptions at the FDA and other agencies, including substantial leadership, personnel, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in the first several months of 2025, the U.S. government, among other measures, issued executive orders and undertaken reductions in force that could adversely impact FDA staffing and resources. Such changes could significantly impact the ability of the FDA to timely review and take action on our regulatory submissions, which could have a material adverse effect on our business.

Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ staffing and operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The current U.S. administration is focused on reducing costs of the federal government generally, including significantly reducing the number of government employees. Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S. market could be impacted. The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely is subject to the political process, which is inherently fluid and unpredictable.

Our business depends on timely interactions with the FDA, including the review of regulatory submissions, scheduling of formal meetings, and oversight of clinical trials. Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, policy changes and those related to the federal government shutdown, may result in reduced staffing or suspension of non-essential FDA operations, which could delay or cancel meetings with the FDA, hinder regulatory guidance, delay the implementation or enforcement of regulatory requirements in a timely fashion or at all, and postpone the review of IND applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). These disruptions may also affect the initiation, conduct, and monitoring of clinical trials, particularly those requiring FDA authorization or ongoing regulatory engagement. Interruptions in FDA activities could materially delay our development timelines, increase operational costs, and adversely impact our ability to complete our ongoing and planned clinical trials and to advance product candidates toward approval and commercialization. Any such delays or uncertainties may have a significant negative effect on our business, financial condition, and results of operations.

If the FDA, National Institutes of Health (“NIH”), SEC or the United States Patent and Trademark Office (“USPTO”) experiences significant decreases in funding or personnel, it could significantly impact the ability of the FDA to issue licenses needed for conduct of our clinical trials, the NIH to conduct research or provide grants, and the abilities of the FDA and the USPTO to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

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 for 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.

There is substantial uncertainty as to whether and how the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval. Additionally, the new administration could also issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates. Complying with any new legislation and regulatory requirements could be time-intensive and expensive.