iBio, Inc.
For the period ended Dec 31, 2025. Filed Feb 10, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Dec 31, 2025 · Filed Feb 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001420720-25-000041
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-12-31; filed 2026-02-10.
0001420720-26-000004
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 115 previous paragraphs and 129 current paragraphs.
78 unchanged; 28 reworded; 17 added; 7 removed; 2 previous and 6 current paragraphs rearranged.
Tables are not compared: 12 previous and 12 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (17)
Current report
Private Placement
Current report
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.
Current report
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.
Current report
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.
Current report
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).
Current report
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 75 th 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
Current report
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.
Current report
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.
Current report
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.
Current report
Revenue
Current report
R&D
Current report
G&A
Current report
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.
Current report
Total Operating Expenses
Current report
Net Loss
Current report
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.
Current 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 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.
Removed paragraphs (7)
Previous report
of IBIO-600.
Previous report
Underwritten Public Offering
Previous report
On August 19, 2025, we entered into an Underwriting Agreement with Leerink, as representative of the underwriters, relating to the offering, issuance and sale of 2025 Pre-Funded Warrants to purchase an aggregate of 71,540,000 shares of Common Stock and accompanying Series G Warrants to purchase (i) an aggregate of up to 35,770,000 shares of Common Stock (or, for those investors who so choose, pre-funded warrants to purchase up to 35,770,000 shares of Common Stock in lieu thereof) and (ii) Series H Warrants to purchase an aggregate of up to 35,770,000 shares of Common Stock (or, for those investors who so choose, pre-funded warrants to purchase up to 35,770,000 shares of Common Stock in lieu thereof) (the “2025 Offering”). The combined public offering price per 2025 Pre-Funded Warrant and accompanying Series G Warrant was $0.699. The closing of the 2025 Offering took place on August 22, 2025. We received net proceeds from the 2025 Offering of approximately $46.5 million after deducting underwriting discounts and commissions and offering expenses payable by us in connection with the 2025 Offering. We may also receive up to an aggregate of $50 million of additional gross proceeds if the Series G Warrants and Series H Warrants are exercised in full for cash.
Previous report
Each 2025 Pre-Funded Warrant and the pre-funded warrants issuable upon exercise of the Series G Warrants or Series H Warrants have an exercise price per share of Common Stock equal to $0.001 and are immediately exercisable from their date of issuance for one share of Common Stock, subject to certain beneficial ownership and other limitations. The Series G Warrants and Series H Warrants will each be exercisable from their date of issuance and will have an exercise price equal to $0.70 per whole share of Common Stock (or $0.699 per pre-funded warrant) and in the case of the Series G Warrants, the accompanying Series H Warrant. The Series G Warrants will expire on the date that is the earlier of (i) 30 trading days following our public announcement of a Trial Initiation Milestone and (ii) five years from the date of issuance. In addition, to the extent the proportion of the unexercised portion of the Series G Warrant relative to the originally issued Series G Warrant is greater than the proportion of the unexercised portion of the originally issued 2025 Pre-Funded Warrant relative to the originally issued 2025 Pre-Funded Warrant, each Series G Warrant will immediately expire in proportion to the extent that the corresponding 2025 Pre-Funded Warrant held by a holder is exercised prior to the occurrence of the Trial Initiation Milestone. When issued upon exercise of the Series G Warrants, the Series H Warrants will expire on the four-year anniversary of the closing date of the 2025 Offering.
Previous report
G&A expenses for the three months ended September 30, 2025 and 2024 were approximately $2.5 million and $2.8 million, respectively, a decrease of approximately $0.3 million. The decrease is primarily attributable to a reduction in accounting fees, consulting fees and IT related expenses and legal fees.
Previous report
Our net loss for the three months ended September 30, 2025 was $5.7 million, or $0.11 per share, compared to our net loss of approximately $4.0 million, or $0.46 per share for the three months ended September 30, 2024.
Previous report
obligations, term promissory note and equipment financing loan. Net cash used in financing activities was approximately $0.2 million for the three months ended September 30, 2024.
Reworded paragraphs (28)
Previous wording
The following information should be read together with the consolidated financial statements and the notes thereto and other information included elsewhere in this Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 (this “Quarterly Report”) and in our Annual Report on Form 10-K for the year ended June 30, 2025, as filed with the Securities and Exchange Commission (the “SEC”) on September 5, 2025. Unless the context requires otherwise, references in this Quarterly Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc.
Current wording
The following information should be read together with the consolidated financial statements and the notes thereto and other information included elsewhere in this Quarterly Report on Form 10-Q for the quarterly period ended 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.
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 in the cardiometabolic and obesity space. Our core mission is to harness the potential of AI and machine learning (“ML”) to unveil novel biologics which other scientists have been unable to develop. Through our innovative AI Drug Discovery Platform, it has been able to identify differentiated molecules aimed to address unmet needs by current approved interverional therapies.
Current wording
iBio, Inc. (the “Company” or “iBio”) is a preclinical stage biotechnology company leveraging the power of Artificial Intelligence (“AI”) for the development of hard-to-drug precision antibodies in the cardiometabolic and obesity space. Our core mission is to harness the potential of AI and machine learning (“ML”) to unveil novel biologics which other scientists have been unable to develop. Through our innovative AI Drug Discovery Platform, we have been able to identify differentiated molecules aimed to address unmet needs by current approved interverional therapies.
Previous wording
We believe the future treatment for obesity lies not just in overall weight loss—but in targeted weight loss. Current interventional therapies, such as glucagon-like peptide-1 (“GLP-1”) receptor agonists have ushered in a breakthrough era, yet challenges remain: muscle loss, fat regain after treatment cessation, and long-term tolerability. We are developing second-generation therapies to meet these unmet needs, using the power of AI-guided antibody design and advanced screening technologies.
Current wording
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.
Previous wording
Our obesity strategy is built on three key principles. First, we aim to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with a goal to preserve muscle mass, target fat selectively, and provide durable weight loss with improved tolerability. Second, we are focusing on targets with strong human validation, which we believe both helps reduce development risk and increase the likelihood of clinical success. Lastly, we are applying our integrated AI Drug Discovery Platform and deep scientific expertise to rapidly generate development-ready biologics, enabling it to move with speed and precision in a competitive and fast-evolving field. Our current therapeutics are all in preclinical development and we have not completed any clinical trials in humans for any therapeutic protein product candidate produced using our technology and there is a risk we will be unsuccessful in developing or commercializing any product candidates. With shifting our focus to IBIO-610, potentially the first antibody inhibiting Activin E, we anticipate the commencement of our first human clinical trials in early 2027.
Current wording
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.
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 robust platform, focused pre-clinical pipeline, and growing scientific and leadership team, we are building a durable and differentiated position in obesity therapeutics—one designed to outlast the first wave and define what comes next.
Current 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.
Previous wording
Our approach to the evolving needs in obesity treatment is facilitiated on a fully integrated antibody discovery platform, designed from the ground up for precision, speed and developability. At the core of our AI Drug Discovery Platform is an AI-enabled epitope steering engine enabling us to precisely direct antibodies to functional hotspots on even the most challenging targets—often considered "undruggable." When combined with our antibody optimization platform, which deeply integrates generative AI tools with mammalian display technology, we can progress from concept to development-ready antibody in as little as seven months.
Current wording
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.
Previous wording
The Company’s current pre-clinical product candidate pipeline is set forth below.
Current wording
Our current pre-clinical product candidate pipeline is set forth below.
Previous wording
IBIO-610 was evaluated in a pharmacokinetic (“PK”) preclinical study in obese, mature non-human primates (“NHPs”) to characterize systemic exposure and clearance following a single intravenous administration. Serum concentrations were measured at defined intervals post-dose to generate a time-concentration profile. PK analysis demonstrated IBIO-610 exhibited a terminal half-life of approximately 33.2 days in NHPs, consistent with expectations for a half-life extended antibody of this class. Using multiple allometric scaling approaches, the projected half-life in humans is estimated to fall within a range of 47 to 100 days, supporting the potential for infrequent, long-acting dosing in clinical settings. Following the completion of NHP PK study, we will initiate Chemistry, Manufacturing, and Controls (“CMC”) and nonclinical toxicology activities to support the advancement of IBIO-610 toward clinical development.
Current wording
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.
Previous wording
The study consisted of six NHPs, sorted randomly into the low and high dose groups. IBIO-600 promoted an increase in lean mass and a reduction in fat mass from baseline values. Standard PK calculations indicated the half-life of IBIO-600 in NHPs was approximately 40 to 52 days. By using multiple allometric scaling approaches, we estimated the half-life in humans of IBIO-600 as falling with a range of 57-147 days.
Current wording
The study consisted of six NHPs, sorted randomly into the low and high dose groups. IBIO-600 promoted an increase in lean mass and a reduction in fat mass from baseline values. Standard PK calculations indicated the half-life of IBIO-600 in NHPs was approximately 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.
Previous wording
Following the NHP pharmacokinetic study, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-600 toward clinical development. We have now established a stable cell line, completed process and formulation development, and manufactured a Good Laboratory Practice (“GLP”) toxicology batch at 200 L scale. In parallel, we launched a nonclinical toxicology program, initiating both rat and NHP dose range-finding studies, as well as rat and NHP GLP studies. All studies are progressing as planned.
Current wording
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.
Previous wording
As we continue advancing IBIO-600 through IND-enabling studies, we are actively seeking a development partner to help accelerate its clinical progression in sarcopenia, muscle loss disorders, and obesity, maximizing the therapeutic and commercial potential of this unique, long-acting anti-myostatin/GDF11 antibody.
Current wording
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 wording
As a result of this collaboration with AstralBio, we exercised our first option and entered into an exclusive agreement related to myostatin (the “Myostatin License Agreement”) with AstralBio, pursuant to which AstralBio licensed to us, on an worldwide exclusive basis and with the right to grant sublicenses, under the AstralBio Licensed Patents (as defined in the Myostatin License Agreement) and AstralBio Licensed Know-How (as defined in the Myostatin License Agreement) to develop, manufacture and commercialize and otherwise exploit IBIO-600 for research, diagnosis, treatment, prevention, or management of any disease or medical condition. We are solely responsible for all decisions related to the launch, sales and marketing and promotion of IBIO-600 in our discretion, subject to the terms of the License Agreement, and for all costs for all activities related to the development, manufacture and commercialization of IBIO-600 worldwide. IBIO-600 was identified by AstralBio using our proprietary technology stack and was designed for subcutaneous administration with the potential for an extended half-life. In parallel, we initiated a bispecific antibody program targeting myostatin/activin A to treat obesity and cardiometabolic disorders, leveraging our proprietary technology stack as well as the technology
Current wording
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.
Previous wording
In April 2025, we exercised our second option and entered into an exclusive agreement related to Activin E (the “Activin E License Agreement”) with AstralBio, pursuant to which AstralBio licensed to us, on an worldwide exclusive basis and with the right to grant sublicenses, under the AstralBio Licensed Patents (as defined in the Activin E License Agreement) and AstralBio Licensed Know-How (as defined in the Activin E License Agreement) to develop, manufacture and commercialize and otherwise exploit IBIO-610 for research, diagnosis, treatment, prevention, or management of any disease or medical condition. We are solely responsible for all decisions related to the launch, sales and marketing and promotion of IBIO-610 in our discretion, subject to the terms of the Activin E License Agreement, and for all costs for all activities related to, the development, manufacture and commercialization of IBIO-610 worldwide.
Current wording
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.
Previous wording
We have incurred net losses and generated negative cash flows from operations for many years. For the three months ended September 30, 2025, we incurred a net loss of approximately $5.7 million and had negative cash flows from operations of approximately $5.7 million. Historically, our liquidity needs have been met by the sale and issuances of common shares including the issuances of common shares through the exercise of warrants. As of September 30, 2025, we had total current assets of approximately $50.8 million, of which approximately $28.1 million was cash and cash equivalents and approximately $21.5 million was investments in debt securities. For the three months ended September 30, 2025, we had an operating capital deficit of $5.7 million which compares to the $3.7 million operating capital deficit it maintained for the three months ended September 30, 2024.
Current wording
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.
Previous wording
Based on the total cash and cash equivalents, and investments in debt securities of approximately $49.6 million at September 30, 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.
Current wording
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.
Previous wording
August 2025, we closed on an underwritten public offering raising gross proceeds of approximately $50 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.
Current wording
Despite this liquidity position, the history of significant losses, the negative cash flow from operations, and the dependence by us on our ability to obtain additional financing to fund our operations raised substantial doubt about our ability to continue as a going concern. In 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.
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 three months ended September 30, 2025. No revenue was recognized for the three months ended September 30, 2024.
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. 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.
Previous wording
R&D expenses for the three months ended September 30, 2025 and 2024 were $3.6 million and $1.3 million, respectively, an increase of approximately $2.3 million. The increase in R&D expenses is mainly due to increased spending on consultants and outside services and an increase in people costs as a result of advancing research activities to support our IBIO-600 and IBIO-610 programs and other preclinical pipeline assets.
Current wording
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.
Previous wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the three months ended September 30, 2025 were approximately $6.1 million, compared to approximately $4.1 million in the same period of fiscal year 2025.
Current wording
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.
Previous wording
Net cash used in operating activities was approximately $5.7 million for the three months ended September 30, 2025, compared to net cash used in operating activities of $3.7 million for the three months ended September 30, 2024. The use of cash was primarily attributable to funding our net loss for the period.
Current wording
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.
Previous wording
Net cash used in investing activities of approximately $21.5 million for the three months ended September 30, 2025 was due to the purchase of debt securities and the purchase of fixed assets. Net cash provided by investing activities was approximately $0.7 million for the three months ended September 30, 2024.
Current wording
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.
Previous wording
Net cash provided by financing activities during the three months ended September 30, 2025, was approximately $46.7 million and was attributable to the net proceeds from the sale of securities partially offset by payments towards debt, including the finance lease
Current wording
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.
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 September 30, 2025, our accumulated deficit was approximately $337.9 million and we used approximately $5.7 million of cash for operating activities during the three months ended September 30, 2025. As of September 30, 2024, our accumulated deficit was approximately $317.8 million and we used approximately $3.7 million of cash for operating activities during the three months ended September 30, 2024. Our current cash, cash equivalents and investments in debt securities of approximately $49.6 million as of September 30, 2025, is anticipated to be sufficient to support operations into the fourth quarter of fiscal year 2027.
Current wording
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.
Previous wording
We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of our technologies, through potential proceeds from the sale or out-licensing of assets, collaborations, and through proceeds from the sale of additional equity or other securities. However, there can be no assurance that we will be successful in implementing these plans, many of which will take several years before we realize proceeds. We cannot be certain that such funding will be available on favorable terms or available at all. If we are unable to raise funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies; b) seek collaborators for our technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or otherwise dispose of rights to technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or d) possibly cease operations.
Current wording
We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of our technologies, through potential proceeds from the sale or out-licensing of assets, collaborations, and through proceeds from the sale of additional equity or other securities 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.
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 months ended September 30, 2025.
Current wording
Critical accounting estimates are those estimates made in accordance with U.S. GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations. The following accounting estimate had a material impact on our results of operations for the three and six months ended December 31, 2025.
Previous wording
During the fourth quarter of the fiscal year ended June 30, 2025, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million on June 30, 2025. We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the
Current wording
During the fourth quarter of the fiscal year ended June 30, 2025, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million on June 30, 2025. We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the 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 wording
No triggering events were identified during the three months ended September 30, 2025. We will continue to monitor the value of the IP as part of our annual accounting policy for impairment of long-lived assets. The primary impairment indicators that may arise in the near future are (1) any sustained decline in our common stock market price and (2) FDA decisions on similar competing technologies that are applying for Phase 1 approval.
Current wording
We will continue to monitor the value of the IP as part of our annual accounting policy for impairment of long-lived assets. The primary impairment indicators that may arise in the near future are (1) any sustained decline in our common stock market price and (2) FDA decisions on similar competing technologies that are applying for Phase 1 approval.
Previous wording
We continue to operate in a highly competitive environment, rising interest rates (and 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.
Current wording
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.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
Results of Operations – Comparison of the six months ended December 31, 2025 and 2024
Current report — wording carried from 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. 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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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
Current report — wording carried from elsewhere
No triggering events were identified during the three months ended September 30, 2025.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Despite this liquidity position, the history of significant losses, the negative cash flow from operations, and the dependence by us on our ability to obtain additional financing to fund our operations raised substantial doubt about our ability to continue as a going concern. In
Previous report — wording carried elsewhere
asset. Since IBIO-101 is currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the cash flows related to the subject asset.