iBio, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 10, 2026
IBIO$0.78-1.9%Stored close · as of Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001104659-26-059416
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001420720-26-000036
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 134 previous paragraphs and 119 current paragraphs.
60 unchanged; 31 reworded; 26 added; 38 removed; 5 previous and 2 current paragraphs rearranged.
Tables are not compared: 12 previous and 13 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (26)
Current report
Additional NHP data demonstrated sustained inhibition of active Activin E following a single intravenous dose of IBIO-610, with reductions in circulating active Activin E levels of 98% at week 4 and 97% at week 8 compared with baseline. In an eight-week NHP study evaluating IBIO-610 in combination with semaglutide, the combination resulted in greater visceral and total fat loss and a 73% reduction in lean mass loss compared with semaglutide alone. Further analysis of this study demonstrated that at week eight, fat accounted for 93% of the weight lost in NHPs receiving IBIO-610 in combination with semaglutide, compared with 77% in NHPs receiving semaglutide alone and lean mass accounted for 6% and 22% of weight lost, respectively. These preclinical findings further support the potential of IBIO-610 to improve body composition, both as a standalone therapy and in combination with GLP-1 receptor agonists.
Current report
IBIO-800
Current report
We are developing IBIO-800, a bispecific antibody designed to selectively neutralize Activin A, myostatin (GDF8), and growth differentiation factor 11 (“GDF11”), with an initial focus on cardiopulmonary disease, particularly pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”). PH-HFpEF is a complex condition involving cardiac and pulmonary vascular dysfunction, often accompanied by skeletal muscle impairment and reduced exercise capacity. IBIO-800 is designed to address multiple aspects of this disease biology through selective inhibition of these ligands.
Current report
In preclinical studies using human cardiac fibroblasts, GDF8, GDF11, and Activin A induced markers of fibrotic activation and pro-fibrotic signaling, supporting the biological rationale for targeting these ligands in cardiopulmonary disease. Additional studies using human muscle progenitor cells demonstrated that bispecific antibodies from this program promoted greater differentiation and fusion into mature muscle cells compared with antibodies targeting myostatin or Activin A alone. We are also evaluating the effects of IBIO-800 in preclinical models of cardiopulmonary disease.
Current report
In June 2026, we nominated IBIO-800 as a development candidate and have since advanced the program into investigational new drug (“IND”)-enabling development. These activities include the initiation of CMC development and GLP toxicology studies. We currently anticipate an IND-equivalent filing in the first half of calendar year 2027.
Current report
The Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight and obese adult participants. We have successfully completed dosing across all four planned single ascending dose (SAD) cohorts, with no dose-limiting safety findings observed to date. Clinical evaluation remains ongoing, including assessment of safety, pharmacokinetics, and pharmacodynamics. A multiple ascending dose (MAD) study for IBIO-600 is expected to initiate in first quarter of calendar year 2027.
Current report
Early preclinical results demonstrate the potential of this approach. In a proof-of-concept study in diet-induced obesity (“DIO”) mice, an early DACRA-like agonist antibody reduced acute food intake by approximately 60% (p<0.05), compared with a 67% reduction observed with a benchmark DACRA peptide. Building on these results, we have generated and characterized a portfolio of selective amylin receptor agonist (“SARA”) antibodies, including AMY1-selective, AMY3-selective, and dual AMY1/AMY3 agonists with distinct in vitro potency and selectivity profiles. Together, these findings support the further study of the potential of antibody-based amylin receptor agonism and demonstrate our ability to engineer antibodies with differentiated receptor pharmacology. As the third obesity program from our AstralBio collaboration, this work further demonstrates the application of our AI Drug Discovery Platform to challenging GPCR targets.
Current report
cytokine release. This technology provides a versatile foundation for developing bispecific T-cell engagers with tailored activity profiles for optimization of therapeutic efficacy and safety.
Current report
Mammalian Display StableHu AI Antibody-Optimization Technology
Current report
Antibody optimization is a critical step in the development of therapeutic antibodies, enabling the refinement of properties influencing efficacy, safety, and manufacturability. Traditional approaches often optimize individual antibody characteristics sequentially, requiring multiple rounds of engineering and screening to achieve the desired combination of properties. In contrast, technologies enabling simultaneous selection across multiple dimensions can accelerate the identification of antibodies with favorable therapeutic and developability profiles.
Current report
StableHu is a proprietary AI-powered technology designed to generate focused libraries of antibodies with fully human complementarity-determining region (CDR) variants based on an input antibody. This input can range from an early, unoptimized molecule to an approved drug. StableHu uses ML to predict human-like CDR sequences while preserving key characteristics of the input antibody. By intelligently exploring sequence diversity, StableHu enables the generation of antibody libraries enriched for variants with desirable properties, reducing the need to screen large numbers of randomly generated sequences. This targeted approach allows us to explore antibody sequence space more efficiently while maintaining library sizes compatible with high-throughput mammalian display screening.
Current report
When paired with mammalian display technology, StableHu enables multidimensional antibody engineering through the integration of AI-guided library design and high-throughput experimental selection. This approach has the potential to reduce iterative optimization steps while improving antibody expression, binding selectivity, cross-species reactivity, and overall developability.
Current report
In August 2026, we exercised our third option and entered into the Amylin License Agreement with AstralBio, pursuant to which AstralBio licensed to us, on a worldwide exclusive basis and with the right to grant sublicenses, under the AstralBio Licensed Patents (as defined in the Amylin License Agreement) and AstralBio Licensed Know-How (as defined in the Amylin License Agreement) to develop, manufacture and commercialize and otherwise exploit any product directed to Amylin that contains the licensed antibody targeting Amylin, 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 Amylin Licensed Product in our discretion,
Current report
subject to the terms of the Amylin License Agreement, and for all costs for all activities related to, the development, manufacture and commercialization of the Amylin Licensed Product worldwide.
Current report
2025 Pre-Funded Warrants
Current report
During the three months ended September 30, 2026 and subsequent through November 10, 2026, 2025 Pre-Funded Warrants to purchase an aggregate of 14,692,248 shares of Common Stock were exercised for proceeds of approximately $14,692.
Current report
Series H Warrants
Current report
Carr Separation Agreement
Current report
Effective October 30, 2026, Chief Medical Officer Dr. Molly Carr is no longer employed by the Company. We are conducting a search for Dr. Carr’s replacement. We expect to complete a separation and release agreement with Dr. Carr, the details of which have not yet been finalized.
Current report
On a program-by-program basis, consultants and outside services reported in R&D expenses for the three months ended September 30, 2026, included $2.6 million for IBIO-600, $0.8 million for IBIO-610, $1.0 million for IBIO-800, and $0.3 million for all other pipeline programs. On a program-by-program basis, consultants and outside services reported in R&D expenses for the three months ended September 30, 2025, included $1.5 million for IBIO-600, $0.4 million for IBIO-610, and $0.2 million for all other pipeline programs.
Current report
Consultant and outside services accounted for approximately 70% and 57% of total R&D expenses for the three months ended September 30, 2026 and 2025, respectively.
Current report
G&A expenses for the three months ended September 30, 2026 and 2025 were approximately $2.8 million and $2.5 million, respectively, an increase of approximately $0.3 million or approximately 10%. The increase is primarily attributable to an increase in personnel costs and legal fees.
Current report
Other Income (Expense)
Current report
Total other income for the three months ended September 30, 2026 was approximately $0.8 million, compared to approximately $0.2 million for the three months ended September 30, 2025, an increase of approximately $0.6 million. Interest income increased by approximately $0.5 million, or approximately 195%, primarily due to higher average balances of cash equivalents and investments in debt securities following our financing transactions, and interest expense decreased to $0 from approximately $34,000 as a result of the repayment of our debt and finance lease obligations.
Current report
Net cash used in financing activities during the three months ended September 30, 2026, was approximately $1.1 million and was primarily attributable to the payment of underwriter fees related to warrants exercised in the fourth quarter of fiscal year 2026. Net cash provided by financing activities during the three months ended September 30, 2025, was approximately $46.7 million and was
Current report
A critical accounting policy is one that is both important to the portrayal of a company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.
Removed paragraphs (38)
Previous report
Myostatin x Activin A Bispecific Antibody
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
Partnered Programs
Previous report
Early preclinical results to date show the promise of the approach. In a proof-of-concept study in DIO mice, an early DACRA-like agonist antibody delivered approximately a ~60% reduction in acute food intake (p<0.05), nearly matching the 67% reduction seen with a benchmark DACRA peptide. These data affirm that antibody-based approaches targeting amylin receptor are promising and can access the parts of the brain containing amylin receptor. As the third obesity program from our AstralBio partnership, this achievement marks a significant validation of our integrated AI Drug Discovery Platform and sets the stage for advancing this differentiated modality into the next stages of development.
Previous report
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.
Previous report
StableHu AI Antibody-Optimizing Technology
Previous report
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.
Previous report
Our proprietary StableHu technology is instrumental in this optimization process. StableHu is an AI-powered tool designed to predict a library of antibodies with fully human CDR variants based on an input antibody. This input can range from an early, unoptimized molecule to an approved drug. The model has been trained utilizing a set of over 1 billion human antibodies, progressively masking known amino acids within CDRs until the algorithm could predict the correct human sequence.
Previous report
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.
Previous report
When paired with mammalian display technology, StableHu enables antibody optimization with fewer iterative optimization steps, lower immunogenicity risk, and improved developability.
Previous report
ShieldTx Antibody Masking Technology
Previous report
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.
Previous report
Antibody masking offers a solution. Masked, orconditionally activated, antibodies remain inactive in circulation through a temporary “mask” linked to the binding site. Once the antibody reaches diseased tissue, disease-specific enzymes cleave the linker, removing the mask and activating the antibody precisely where it is needed. This targeted activation broadens the therapeutic window, improves safety, and enables the pursuit of targets and drug combinations otherwise considered too toxic.
Previous report
Our ShieldTx platform integrates antibody masking directly into the antibody discovery process, increasing the probability of success. Using our epitope engineering engine, we design small, accurate replicas of target epitopes to raise antibodies; these same engineered epitopes can then serve as optimized masks - making mask design an inherent part of discovery.
Previous report
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.
Previous report
2026 ATM Agreement
Previous report
On February 27, 2026, we entered into an Open Market Sale Agreement SM (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.
Previous report
2026 Private Placement
Previous report
On January 13, 2026 (the “Closing Date”), pursuant to the terms of the securities 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 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 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.
Previous report
Series G Warrants
Previous report
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.
Previous report
nine months ended March 31, 2026, we had an operating capital deficit of $17 million which compares to the $10.7 million operating capital deficit we maintained for the nine months ended March 31, 2025.
Previous report
G&A expenses for the three months ended March 31, 2026 and 2025 were approximately $5.1 million and $3.0 million, respectively, an increase of approximately $2.1 million. The increase is primarily attributable to the impairment of the Company’s indefinite-lived intangible asset IBIO-101 of $2.5 million offset by lower IT related costs and franchise taxes.
Previous report
Revenue
Previous report
R&D
Previous report
G&A
Previous report
G&A expenses for the nine months ended March 31, 2026 and 2025 were approximately $12.8 million and $8.5 million, respectively, an increase of approximately $4.3 million. The increase is primarily attributable to the impairment of our indefinite-lived intangible asset, IBIO-101, of $5 million offset by a reduction in IT costs, consulting expenses, accounting fees and franchise taxes.
Previous report
Total Operating Expenses
Previous report
Total operating expenses, consisting of R&D expenses and G&A expenses, for the nine months ended March 31, 2026 were approximately $23.9 million, compared to approximately $13.6 million in the same period of fiscal year 2025.
Previous report
Net Loss
Previous report
Our net loss for the nine months ended March 31, 2026 was $22.4 million, or $0.25 per share of Common Stock, compared to our net loss of approximately $13.2 million, or $1.44 per share of Common Stock, for the nine months ended March 31, 2025.
Previous report
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.
Previous report
The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 15% discount rate, which was based on iBio’s weighted average cost of capital. The sum of the discounted excess earnings and the present value of the tax benefit related to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was $5.9 million as of the June 30, 2025 valuation date. Given that the carrying amount of the asset was $5 million on June 30, 2025, it was concluded that no impairment existed.
Previous report
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
Previous report
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.
Previous report
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.
Reworded paragraphs (31)
Previous wording
iBio, Inc. (the “Company” or “iBio”) is a preclinical stage biotechnology company leveraging the power of Artificial Intelligence (“AI”) for the development of hard-to-drug precision antibodies for obesity, cardiometabolic and cardiopulmonary 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.
Current wording
We are a clinical-stage biotechnology company leveraging the power of Artificial Intelligence (“AI”) for the development of precision antibodies against hard-to-drug targets in cardiometabolic and cardiopulmonary diseases. The 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 at addressing unmet needs by current approved therapies.
Previous wording
We believe the future treatment for obesity lies not just in overall weight loss—but in the 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 next-generation therapies designed to meet these unmet needs, by leveraging AI-guided antibody design, advanced screening technologies and deep expertise in biologics development.
Current wording
We believe the future treatment for obesity lies not just in overall weight loss, but in the 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 next-generation therapies with the goal of meeting these unmet needs, by leveraging AI-guided antibody design, advanced screening technologies and deep expertise in biologics development.
Previous wording
Our strategy is built on multiple key principles. First, we aim to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with the potential to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, we are prioritizing on targets with strong human genetic and clinical validation, which we believe both reduce translational 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 us to move with speed and precision in a competitive and fast-evolving field.
Current wording
Our strategy is built on multiple key principles. First, we aim to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with the potential to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, we are prioritizing targets with strong human genetic and clinical validation, which we believe both reduces translational risk and increases the likelihood of clinical success. Third, we are evaluating opportunities in adjacent obesity-related indications, including cardiometabolic and cardiopulmonary conditions such as pulmonary hypertension due to heart failure with preserved ejection fraction (“PH-HFpEF”). Lastly, we are applying our integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate and advance development-ready biologics, with the goal of enabling us to move with speed and precision in a competitive and fast-evolving field.
Previous wording
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.
Current wording
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. IBIO-600 is currently in clinical development, while our other product candidates are in preclinical development. 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.
Previous wording
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.
Current wording
Following Clinical Trial Notification (“CTN”) acknowledgement from Australia’s Therapeutic Goods Administration (“TGA”) and ethics approval from a Human Research Ethics Committee (“HREC”), we initiated a Phase 1 clinical trial of IBIO-600 in Australia and dosed the first participant in June 2026, marking our transition to a clinical-stage company and represented the first molecule generated using our AI Drug Discovery Platform to advance into clinical development. To date, we have completed dosing across all four planned single ascending dose (SAD) cohorts of the Phase 1 clinical trial of IBIO-600 in Australia. In parallel, we have accelerated the development of IBIO-610, a potentially first-in-class, long-acting antibody designed to inhibit Activin E, and anticipate commencing first-in-human clinical trials in the first half of calendar year 2027. We are also advancing additional preclinical programs, including IBIO-800, a myostatin × Activin A bispecific antibody being evaluated for potential use in PH-HFpEF.
Previous wording
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.
Current wording
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 AI-enabled design and translational validation, compressing the timeline from hypothesis to clinic. With our robust platform, focused clinical and preclinical 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.
Previous wording
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.
Current wording
IBIO-610 was evaluated in preclinical pharmacokinetic (“PK”) and body composition studies in obese, mature non-human primates (“NHPs”) designed to characterize systemic exposure, target engagement, and effects on body composition. IBIO-610 demonstrated a terminal half-life of approximately 33.2 days in obese NHPs, and based on allometric scaling approaches, we estimated a projected human half-life of up to 100 days, which may support infrequent dosing. In a small study that was not statistically powered, following two doses administered eight weeks apart, IBIO-610 reduced visceral fat by 6.7% and total fat mass by 5.2% compared with vehicle-treated obese NHPs, with a slight increase in lean mass. These findings are consistent with the fat-selective profile observed in prior rodent studies.
Previous wording
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.
Current wording
Based on our preclinical work, we believe Activin A may contribute to cardiac fibrosis and pulmonary vascular remodeling, while myostatin and GDF11 may contribute to skeletal muscle dysfunction and reduced functional capacity. By targeting these pathways simultaneously, IBIO-800 is being designed to reduce cardiac fibrosis and pulmonary vascular remodeling while improving skeletal muscle function and exercise capacity. The antibody is also designed to avoid broader inhibition of related TGF-β family ligands, with the goal of mitigating certain safety risks associated with less selective approaches.
Previous wording
In April 2024, as result of the collaboration with AstralBio, we initiated a program to discover and develop a long-acting anti-myostatin antibody. Using our StableHu platform coupled with mammalian display, we optimized hit antibodies across multiple parameters, including affinity for myostatin, binding to the FcRn receptor, expression levels in mammalian cells, and resistance to poly-reactivity and aggregation. The final candidate, IBIO-600, was also observed to have a beneficial profile between thermostability and resistance to stress conditions during initial testing.
Current wording
In April 2024, as result of the collaboration with AstralBio, Inc. (“AstralBio”), we initiated a program to discover and develop a long-acting anti-myostatin antibody. Using our StableHu platform coupled with mammalian display, we optimized hit antibodies across multiple parameters, including affinity for myostatin, binding to the FcRn receptor, expression levels in mammalian cells, and resistance to poly-reactivity and aggregation. The final candidate, IBIO-600, was also observed to have a beneficial profile between thermostability and resistance to stress conditions during initial testing.
Previous wording
Following completion of the NHP PK study, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-600 into clinical development. We have completed manufacture and fill-finish of a GMP batch of IBIO-600, and long-term stability testing is ongoing. We have engaged a contract research organization to support the initiation of first-in-human clinical testing. In parallel, we initiated a nonclinical toxicology program, including rat and NHP dose-range finding studies as well as rat and NHP GLP toxicology studies. We received 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 expected to be dosed in the second quarter of calendar 2026.
Current wording
Following completion of the NHP PK study, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-600 into clinical development. We have completed manufacture and fill-finish of a GMP batch of IBIO-600, and long-term stability testing is ongoing. We also initiated a nonclinical toxicology program, including rat and NHP dose-range finding studies and GLP toxicology studies. We received 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.
Previous wording
Our technology stack is a multi-layered, AI-powered system designed to significantly enhance the probability of success in discovering and developing antibodies against hard-to-drug, pathophysiologically relevant proteins. The platform comprises four integrated layers, each contributing a distinct capability to the discovery, engineering, and optimization of precision antibodies. By seamlessly combining advanced computational design with cutting-edge biological technologies, iBio’s AI-driven discovery platform enables the rapid generation of antibody therapeutics characterized by high specificity, optimized developability, and accelerated progression from concept to clinic.
Current wording
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 three 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, our AI-driven discovery platform enables the rapid generation of antibody therapeutics characterized by high specificity, optimized developability, and accelerated progression from concept to clinic.
Previous wording
The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy. 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.
Current wording
The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy. Pursuing specific epitopes that elicit a specific biological function allows us to create antibodies with complex modes of action, like agonistic or cell activating antibodies. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies. The third layer of the technology stack is our mammalian display technology coupled to StableHu AI for antibody optimization. This combination has been shown to speed up the Lead Optimization process and potentially minimize downstream risks, with the goal of making the overall development process more efficient and cost-effective.
Previous wording
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
Current wording
Building on this foundation, EngageTx™ is our next-generation CD3 T-cell engager technology designed to enable the development of potent and selective T-cell-engaging therapeutics. EngageTx comprises of an optimized panel of CD3-binding antibodies spanning a broad range of potencies, with NHP cross-reactivity, enhanced humanness, and strong tumor-killing activity accompanied by reduced
Previous wording
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.
Current wording
Epitopes - the regions of a target protein recognized by antibodies - 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.
Previous wording
While phage display libraries are often used in antibody optimization due to their vast diversity, they can increase developability risks such as low expression, instability, or aggregation of antibodies. Mammalian display libraries, on the other hand, offer significantly improved developability but reduced diversity due to the smaller library size they can handle. StableHu overcomes this limitation by utilizing a machine learning algorithm generating focused library diversity within the capacity of mammalian display.
Current wording
While phage display libraries are often used in antibody engineering 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 improved developability characteristics but reduced diversity due to the smaller library sizes they can accommodate. StableHu addresses this limitation by using ML to generate focused library diversity within the capacity of mammalian display.
Previous wording
In March 2024, we entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases. As part of the collaboration, we granted an exclusive license to AstralBio of our AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an IND application. We have the exclusive option to license three (3) obesity and cardiometabolic targets from AstralBio and as a result, we will receive the right to develop, manufacture and commercialize those targets upon exercise. Upon mutual consent with AstralBio, we may also expand the collaboration to include additional targets in other fields.
Current wording
In March 2024, we entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases. As part of the collaboration, we granted an exclusive license to AstralBio of our AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an IND application. We have the exclusive option to license four (4) obesity and cardiometabolic targets from AstralBio and as a result, we will receive the right to develop, manufacture and commercialize those targets upon exercise. Upon mutual consent with AstralBio, we may also expand the collaboration to include additional targets in other fields.
Previous wording
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.
Current wording
During the three months ended September 30, 2026, Series H Warrants to purchase 65,000 shares of Common Stock were exercised whereby the holder elected to receive 65,000 shares of Common Stock for gross proceeds of approximately $46,000.
Previous wording
We have incurred net losses and generated negative cash flows from operations for many years. For the nine months ended March 31, 2026, we incurred a net loss of approximately $22.4 million and had negative cash flows from operations of approximately $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 March 31, 2026, we had total current assets of approximately $77.3 million, of which approximately $47.6 million was cash and cash equivalents and approximately $27.2 million was investments in debt securities. For the
Current wording
We have incurred net losses and generated negative cash flows from operations for many years. For the three months ended September 30, 2026, we incurred a net loss of approximately $7.6 million and had negative cash flows from operations of approximately $9.4 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 September 30, 2026, we had total current assets of approximately $81.2 million, of which approximately $45.4 million was cash and cash equivalents and approximately $31.2 million was investments in debt securities. For the three months ended September 30, 2026, we used net cash in operating activities of $9.4 million compared to $5.7 million for the three months ended September 30, 2025.
Previous wording
Based on the total cash and cash equivalents, and investments in debt securities of approximately $74.8 million at March 31, 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.
Current wording
Based on the total cash and cash equivalents, and investments in debt securities of approximately $76.7 million at September 30, 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.
Previous wording
Despite this liquidity position, the history of significant losses, the negative cash flow from operations, and the dependence by us on our ability to obtain additional financing to fund our operations raised substantial doubt about our ability to continue as a going concern. In 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.
Current wording
Despite this liquidity position, the history of significant losses, the negative cash flow from operations, and the dependence by us on our ability to obtain additional financing to fund our operations raised substantial doubt about our ability to continue as a going concern. However, based on our current liquidity we concluded the substantial doubt has been alleviated. We received gross proceeds of approximately $54,000 from the exercise of warrants during the three months ended September 30, 2026. 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.
Previous wording
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on 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 nine months ended March 31, 2026. Revenue in the amount of $0.2 million was recognized for services provided to a collaborative partner during the nine months ended March 31, 2025.
Current wording
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on advancing our AI-driven discovery platform to develop molecules against hard to drug targets. To date this platform has not generated any material revenue, though we may realize revenue from it in the future. Revenue in the amount of $1.1 million was recognized for services provided to a collaborative partner during the three months ended September 30, 2026. Revenue in the amount of $0.1 million was recognized for services provided to a collaborative partner during the three months ended September 30, 2025.
Previous wording
R&D expenses for the three months ended March 31, 2026 and 2025 were $3.3 million and $1.9 million, respectively, an increase of approximately $1.4 million. The increase in R&D expenses is primarily due to increased spending for consultants and outside services supporting our R&D efforts, including NHP studies and CMC activities, and an increase in personnel costs as a result of advancing research activities for our IBIO-600 and IBIO-610 programs and other preclinical pipeline assets.
Current wording
R&D expenses for the three months ended September 30, 2026 and 2025 were $6.7 million and $3.6 million, respectively, an increase of approximately $3.1 million or approximately 87%. The increase in R&D expenses is primarily due to increased spending of approximately $2.6 million for consultants and outside services supporting our R&D efforts, including the IBIO-600 Phase 1 human clinical trial, NHP studies and CMC activities, and an increase of approximately $0.3 million in personnel costs as a result of advancing research activities for our IBIO-600, IBIO-610, and IBIO-800 programs and other preclinical pipeline assets.
Previous wording
Total operating expenses, consisting primarily of G&A expenses and R&D expenses, for the three months ended March 31, 2026 were approximately $8.4 million, compared to approximately $4.9 million in the same period of fiscal year 2025.
Current wording
Total operating expenses, consisting primarily of G&A expenses and R&D expenses, for the three months ended September 30, 2026 were approximately $9.4 million, compared to approximately $6.1 million in the same period of fiscal year 2026.
Previous wording
Our net loss for the three months ended March 31, 2026 was $7.7 million, or $0.06 per share of Common Stock, compared to our net loss of approximately $4.9 million, or $0.49 per share of Common Stock, for the three months ended March 31, 2025.
Current wording
Our net loss for the three months ended September 30, 2026 was $7.6 million, or $0.05 per share of Common Stock, compared to our net loss of approximately $5.7 million, or $0.11 per share of Common Stock, for the three months ended September 30, 2025.
Previous wording
Net cash used in operating activities was approximately $17.0 million for the nine months ended March 31, 2026, compared to $10.7 million for the nine months ended March 31, 2025. The use of cash was primarily attributable to funding our net loss for the period.
Current wording
Net cash used in operating activities was approximately $9.4 million for the three months ended September 30, 2026, compared to $5.7 million for the three months ended September 30, 2025. The use of cash was primarily attributable to funding our net loss for the period.
Previous wording
Net cash used in investing activities of approximately $27.6 million for the nine months ended March 31, 2026 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 nine months ended March 31, 2025 and was primarily due to the receipt of $0.7 million principal on a promissory note receivable.
Current wording
Net cash used in investing activities of approximately $0.5 million for the three months ended September 30, 2026 was related to the purchase of investments in debt securities, acquisition of the Amylin license, and purchase of fixed assets, offset by the redemption of investments in debt securities. Net cash used in investing activities was approximately $21.5 million for the three months ended September 30, 2025 and was primarily due to the purchase of investments in debt securities and the purchase of fixed assets.
Previous wording
Net Cash (Used in) Provided by Investing Activities
Current wording
Net Cash (Used in) Provided by Financing Activities
Previous wording
Net cash provided by financing activities during the nine months ended March 31, 2026, was approximately $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, the 2026 Private Placement, pursuant to which we received net proceeds of approximately $24.3 million, net warrant exercise proceeds of approximately $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 provided by financing activities was approximately $0.8 million for the nine months ended March 31, 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.
Current wording
attributable to the net proceeds from the sale of securities partially offset by payments towards debt, including the finance lease obligations, term promissory note and equipment financing loan.
Previous wording
We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of March 31, 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 $327.1 million, and we used approximately $10.7 million for operating activities during the nine months ended March 31, 2025. Our current cash, cash equivalents and investments in debt securities of approximately $74.8 million as of March 31, 2026, in addition to the gross proceeds of approximately $17 million from warrant exercises through the date of the filing of this Quarterly Report, is anticipated to be sufficient to support operations into the fourth quarter of fiscal year 2028.
Current wording
We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of September 30, 2026, our accumulated deficit was approximately $372.8 million, and we used approximately $9.4 million for operating activities during the three months ended September 30, 2026. As of September 30, 2025, our accumulated deficit was approximately $337.9 million, and we used approximately $5.7 million for operating activities during the three months ended September 30, 2025. Our current cash, cash equivalents and investments in debt securities of approximately $76.7 million as of September 30, 2026, is anticipated to be sufficient to support operations into the fourth quarter of fiscal year 2028.
Previous wording
Critical accounting estimates are those estimates made in accordance with U.S. GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations. The following accounting estimate had a material impact on our results of operations for the three and nine months ended March 31, 2026.
Current wording
Critical accounting estimates are those estimates made in accordance with U.S. GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations. The following accounting estimate had a material impact on our results of operations for the three months ended September 30, 2026.
Previous wording
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:
Current wording
Our remaining critical accounting estimates remain consistent with the information disclosed in the same section in our last annual report on Form 10-K for the year ended June 30, 2026. 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 condensed consolidated financial statements:
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
We have advanced IBIO-610 into IND-enabling development, including chemistry, manufacturing and controls (“CMC”) activities and good laboratory practice (“GLP”) toxicology studies in rats and NHPs. We have completed manufacture and fill-finish of a GMP batch of IBIO-610, and long-term stability testing is ongoing. We have engaged a contract research organization to support the initiation of first-in-human clinical testing and anticipate initiating first-in-human clinical trials in the first half of calendar year 2027.
Current report — wording carried from elsewhere
Net Cash (Used in) Investing Activities
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on 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 March 31, 2026 and 2025.
Previous report — wording carried elsewhere
Results of Operations – Comparison of the nine months ended March 31, 2026 and 2025
Previous report — wording carried elsewhere
R&D expenses for the nine months ended March 31, 2026 and 2025 were $11.1 million and $5.1 million, respectively, an increase of approximately $6 million. The increase in R&D expenses is primarily due to increased spending for consultants and outside services supporting our R&D efforts, including NHP studies and CMC activities, for our IBIO-600 and IBIO-610 programs and other preclinical pipeline assets.
Previous report — wording carried elsewhere
Net Cash Provided by Financing Activities
Previous report — wording carried elsewhere
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.