iBio Inc
For the period ended Mar 31, 2025. Filed May 2, 2025.
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.
Mar 31, 2025 · Filed May 2, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-12-31; filed 2025-02-10.
0001420720-25-000012
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-02.
0001420720-25-000025
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of 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 144 previous paragraphs and 151 current paragraphs.
92 unchanged; 42 reworded; 14 added; 4 removed; 6 previous and 3 current paragraphs rearranged.
Tables are not compared: 23 previous and 23 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 (14)
Current report
The study consisted of six NHPs, sorted randomly into the low and high dose groups. The results indicate IBIO-600 promoted a dose-dependent increase in lean mass and a reduction in fat mass from baseline values. The effect peaked after 8 weeks, when the NHPs receiving the low-dose had a 3.1% (163g) increase in lean mass and a 5.1% (270g) increase in the NHPs receiving the high-dose. Standard PK calculations indicated the half-life of IBIO-600 in NHPs was approximately 40 to 52 days. By using multiple allometric scaling approaches, we estimated the half-life in humans of IBIO-600 as falling with a range of 57-130 days.
Current report
In the DIO mouse study, after only two weeks of dosing, monotherapy of Activin E antibody alone resulted in fat-selective weight loss of approximately 4%, with an approximately 18% reduction in total body fat compared to placebo. Notably, when combined with semaglutide, our Activin E antibody demonstrated a strong synergistic effect, enhancing total weight loss by an additional 9% beyond semaglutide therapy alone, leading to an overall weight reduction of 34%. This combination also resulted in a 72% reduction in body fat over the treatment period, as measured by DEXA scans.
Current report
Although we initially progressed IBIO-101 to the IND-enabling phase and identified an optimal cell lines for master cell bank creation, after evaluating whether IBIO-101 could be utilized in certain orphan diseases and in order to focus our resources on obesity and cardiometabolic diseases, we have decided to terminate our relationship with a Contract Research Organization (CRO) who was assisting us with the Chemistry, Manufacturing, and Controls (CMC) development of IBIO-101. Unless we receive funding to do so, we plan to pause any additional development on IBIO-101 and pursue partnering and/or licensing opportunities.
Current report
In consideration of the rights and licenses granted by AstralBio to us in the License Agreement, we agreed to pay AstralBio an upfront license fee in the amount of $750,000. In lieu of paying such upfront fee in cash, on January 28, 2025, we issued to AstralBio 246,087
Current report
Transfer of Listing
Current report
On February 19, 2025, the Company, acting pursuant to authorization from its Board, determined to voluntarily withdraw the listing of its Common Stock, par value $0.001 per share, from NYSE American and to transfer such listing to The Nasdaq Capital Market (“Nasdaq”). The Company informed NYSE American on February 19, 2025, of its intent to transfer the listing of its Common Stock to Nasdaq. The listing and trading of the Company’s Common Stock on NYSE American ended at market close on March 3, 2025, and began on the Nasdaq at market open on March 4, 2025. The Company’s Common Stock continues to trade under the ticker symbol “IBIO.”
Current report
AstralBio Activin E License Agreement
Current report
On April 21, 2025, we entered into the Activin E License Agreement with AstralBio, pursuant to which AstralBio has licensed to us, on an worldwide exclusive basis and with the right to grant sublicenses, the AstralBio Licensed Patents (as defined in the Activin E License Agreement) and AstralBio Licensed Know-How (as defined in the Activin E License Agreement) to develop, manufacture and commercialize and otherwise exploit any product directed to Activin E that contains the Activin E Licensed Product.
Current report
Inducedment of Existing Warrants
Current report
On April 29, 2025, we entered into a warrant inducement agreement ( the “Inducement Agreement”) with holders (the “Holders”) of certain existing warrants (the “Existing Warrants”) to purchase shares of our common stock, par value $0.001 per share (“Common Stock”). Pursuant to the Inducement Agreement, the Holders agreed to exercise for cash on April 29, 2025 Existing Warrants to purchase an aggregate of 5,626,685 shares of Common Stock at a reduced exercise price of $0.86 per share, which was the Minimum Price, as defined in the rules of the Nasdaq Capital Market, as of the close of trading on April 28, 2025. In consideration of the Holders’ agreement to exercise the Existing Warrants in accordance with the Inducement Agreement, we agreed to issue Inducement Warrants to purchase up to 11,253,370 shares of Inducement Warrant Shares, for consideration of $0.125 per Inducement Warrant. We received aggregate gross proceeds of approximately $6.2 million from the exercise of the Existing Warrants and the sale of the Inducement Warrants, before deducting financial advisory fees and other expenses payable by the Company. We agreed in the Inducement Agreement to file a resale registration statement within 45 days of the date of the Inducement Agreement providing for the resale of the Inducement Warrant Shares by the holders of the Inducement Warrant Shares.
Current report
The Inducement Warrants will have an exercise price of $0.86 per share, will be exercisable upon issuance and will expire on the five-year anniversary of the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Inducement Warrant are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock. In addition, in certain circumstances, upon a fundamental transaction (as defined in the Inducement Warrants), a holder of Inducement Warrants will be entitled to receive, upon exercise of the Inducement Warrants, the kind and amount of securities, cash or other property that such holder would have received had they exercised the Inducement Warrants immediately prior to the fundamental transaction.
Current report
We engaged Chardan to act as our financial advisor in connection with the transactions summarized above and paid Chardan an aggregate fee equal to approximately $217,000 in connection with the transactions contemplated by the Inducement Agreement. The Company expects to use the net proceeds from these transactions for working capital and other general corporate purposes.
Current report
On April 29, 2025, we entered into an Inducement Agreement with Holders, wherein the Holders agreed to exercise certain Existing Warrants to purchase up 5,626,685 shares of Common Stock at a reduced exercise price of $0.86 per share. In consideration for the exercise of the Existing Warrants for cash, the Holders received Inducement Warrants to purchase up to an aggregate of 11,253,370 shares of Common Stock for consideration of $0.125 per Inducement Warrant. We received aggregate gross proceeds of approximately $6.2 million from the exercise of the Existing Warrants and the sale of the Inducement Warrants, before deducting offering fees and other expenses payable by us. The Inducement Warrants will be registered after the transaction closes, in accordance with the terms of the agreement and are exercisable at an exercise price of $0.86 per common share and will expire five years from the issuance date.
Current report
G&A expenses for the three months ended March 31, 2025 and 2024 were approximately $3.0 million and $2.7 million, respectively, an increase of $0.3 million. The increase is primarily attributable to increased IT related costs, consulting fees and franchise taxes. The increases were partially offset by lower accounting and legal fees.
Removed paragraphs (4)
Previous report
We have progressed IBIO-101 to the IND-enabling phase and entrusted its Chemistry, Manufacturing, and Controls (CMC) development to a Contract Research Organization (CRO). In the initial stages of this process, IBIO-101 has exhibited promising attributes for CMC progression. Notably, we've pinpointed optimal cell lines for master cell bank creation and have set in place a CMC methodology to produce IBIO-101 in compliance with current Good Manufacturing Practice, or cGMP, standards.
Previous report
An anti-CD25 antibody, such as IBIO-101, could be applicable in a number of indications including solid tumors, leukemia, and potentially additional orphan diseases. The Company continues to review the IL-2 sparing anti-CD25 antibody program, IBIO-101, including evaluating whether it can be utilized in certain orphan diseases. If such evaluation is promising, the Company will determine whether to initiate discussions with FDA before the end of calendar year 2025 to outline a potential clinical pathway for the program.
Previous report
Board Appointments
Previous report
On November 25, 2024, we announced the appointment of biotech industry veterans David Arkowitz and António Parada to our Board of Directors.
Reworded paragraphs (42)
Previous wording
The following information should be read together with the consolidated financial statements and the notes thereto and other information included elsewhere in this Quarterly Report on Form 10-Q (this “Report”) and in our Annual Report on Form 10-K for the year ended June 30, 2024, as filed with the SEC on September 20, 2024, as amended on September 24, 2024 (the “Annual Report”). Unless the context requires otherwise, references in this Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc.
Current wording
The following information should be read together with the consolidated financial statements and the notes thereto and other information included elsewhere in this Quarterly Report on Form 10-Q (this “Report”) and in our Annual Report on Form 10-K for the year ended June 30, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on September 20, 2024, as amended on September 24, 2024 (the “Annual Report”). Unless the context requires otherwise, references in this Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc.
Previous wording
Our epitope steering technology is designed to address these issues by guiding antibodies exclusively against the desired regions of the target protein. By focusing on these specific regions, we can overcome the limitations of traditional methods and significantly improve the efficiency and effectiveness of our antibody discovery process. Our AI engine creates engineered epitopes, which are small embodiments of epitopes on the target protein. The engine is trained to match the epitope structure as closely as possible and refine the designs for greater stability and water solubility, which are critically important factors. The optimized engineered epitope is then used to identify antibodies from naïve or immunized libraries.
Current wording
Our epitope steering technology is designed to address challenges related to antibody specificity and efficacy by guiding discovery efforts exclusively against the desired regions of the target protein. By focusing on these specific regions, we can overcome the limitations of traditional methods and significantly improve the efficiency and effectiveness of our antibody discovery process. Our AI engine creates engineered epitopes, which are small embodiments of epitopes on the target protein. The engine is trained to match the epitope structure as closely as possible and refine the designs for greater stability and water solubility, which are critically important factors. The optimized engineered epitope is then used to identify antibodies from naïve or immunized libraries.
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 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
Previous wording
to an antibody panel with a wide range of potencies, which allows us to pair the panel with a wide variety of tumor-targeting antibodies. Importantly, we were able to retain T-cell activation and tumor cell killing capacity with significantly reduced cytokine release. This reduction is believed to lower the risk of cytokine release syndrome. Additionally, the increased humanness of the predicted antibodies, thanks to our StableHu technology, has the ability to reduce the risk of immunogenicity.
Current wording
We have used antibodies from an epitope steering campaign as well as a first-generation T-cell engager as input and utilized our StableHu technology to identify a next-generation CD3 antibody panel. The sequence diversity generated by StableHu led to an antibody panel with a wide range of potencies, which allows us to pair the panel with a wide variety of tumor-targeting antibodies. Importantly, we were able to retain T-cell activation and tumor cell killing capacity with significantly reduced cytokine release. This reduction is believed to lower the risk of cytokine release syndrome. Additionally, the increased humanness of the predicted antibodies, thanks to our StableHu technology, has the ability to reduce the risk of immunogenicity.
Previous wording
We have enhanced our proprietary technology with the introduction of ShieldTx, patent-pending innovative antibody masking technique. ShieldTx leverages our engineered epitope technology, which is utilized not only for the identification of antibodies against complex drug targets but also for concealing the antibodies' active sites. A significant hurdle in therapeutic antibody development is the expression of drug target on both healthy and diseased tissues, leading to adverse effects on non-targeted tissues. ShieldTx is designed to address this challenge by rendering antibodies inactive until they reach a specific environment unique to diseased tissues. Upon contact with this environment, the masking element is detached, activating the antibody. In the tumor microenvironment this is achieved by a highly expressed matrix metalloproteinase. This strategy aims to minimize or eliminate unintended effects on healthy tissues, thereby improving the safety profile and reducing the immunogenicity risks associated with bispecific antibodies.
Current wording
We have enhanced our proprietary technology with the introduction of ShieldTx, a patent-pending innovative antibody masking technique. ShieldTx leverages our engineered epitope technology, which is utilized not only for the identification of antibodies against complex drug targets but also for concealing the antibodies' active sites. A significant hurdle in therapeutic antibody development is the expression of drug target on both healthy and diseased tissues, leading to adverse effects on non-targeted tissues. ShieldTx is designed to address this challenge by rendering antibodies inactive until they reach a specific environment unique to diseased tissues. Upon contact with this environment, the masking element is detached, activating the antibody. In the tumor microenvironment this is achieved by a highly expressed matrix metalloproteinase. This strategy aims to minimize or eliminate unintended effects on healthy tissues, thereby improving the safety profile and reducing the immunogenicity risks associated with bispecific antibodies.
Previous wording
In March 2024, we entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases. As part of the collaboration, we granted an exclusive license to AstralBio of our AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an Investigational New Drug (IND) application. We have the exclusive option to license three (3) obesity and cardiometabolic targets from AstralBio and as a result, we will receive the rights 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 Investigational New Drug (IND) application. We have the exclusive option to license three (3) obesity and cardiometabolic targets from AstralBio and as a result, we will receive the right to develop, manufacture and commercialize those targets upon exercise. Upon mutual consent with AstralBio, we may also expand the collaboration to include additional targets in other fields.
Previous wording
sublicenses, under the AstralBio Licensed Patents (as defined in the License Agreement) and AstralBio Licensed Know-How (as defined in the 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
Current wording
As a result of this collaboration with AstralBio, we exercised our first option and entered into an exclusive agreement (the “Myostatin License Agreement”) with AstralBio, pursuant to which AstralBio licensed to us, on an worldwide exclusive basis and with the right to grant sublicenses, under the AstralBio Licensed Patents (as defined in the Myostatin License Agreement) and AstralBio Licensed Know-How (as defined in the Myostatin License Agreement) to develop, manufacture and commercialize and otherwise exploit IBIO-600 for research, diagnosis, treatment, prevention, or management of any disease or medical condition. We are solely responsible for all decisions related to the launch, sales and marketing and promotion of IBIO-600 in our discretion, subject to the terms of the License Agreement, and for all costs for all activities related to the development, manufacture and commercialization of IBIO-600 worldwide. IBIO-600 was identified by AstralBio using our proprietary technology stack and was designed for subcutaneous administration with the potential for an extended half-life. In parallel, we initiated a bispecific antibody program targeting myostatin/activin A to treat obesity and cardiometabolic disorders, leveraging our proprietary technology stack as well as the technology of IBIO-600.
Previous wording
In April 2024, as as result of the collaboration with AstralBio, we initiated a program to discover and develop a long-acting anti-myostatin antibody. Using our StableHu platform coupled with mammalian display, we optimized hit antibodies across multiple parameters, including affinity for myostatin, binding to the FcRn receptor, expression levels in mammalian cells, and resistance to poly-reactivity and aggregation. The final candidate, IBIO-600, also demonstrated a beneficial profile between thermostability and resistance to stress conditions during initial testing.
Current wording
In April 2024, as result of the collaboration with AstralBio, we initiated a program to discover and develop a long-acting anti-myostatin antibody. Using our StableHu platform coupled with mammalian display, we optimized hit antibodies across multiple parameters, including affinity for myostatin, binding to the FcRn receptor, expression levels in mammalian cells, and resistance to poly-reactivity and aggregation. The final candidate, IBIO-600, also demonstrated a beneficial profile between thermostability and resistance to stress conditions during initial testing.
Previous wording
In November 2024, we manufactured a non-cGMP batch of IBIO-600 for a non-human primate (NHP) study. The primary goal of the study was to assess the pharmacokinetic (PK) profile of IBIO-600. Additionally, imaging endpoints were included to measure body composition and detect potential early signs of efficacy, although the study was not powered to detect small changes in lean and fat mass. Dosing for the NHP study commenced in November 2024, with preliminary readouts anticipated in early 2025.
Current wording
In November 2024, we manufactured a non-cGMP batch of IBIO-600 for a non-human primate (NHP) study in obese and elderly NHPs. The primary goal of the study was to assess the pharmacokinetic (PK) profile of IBIO-600. The study consisted of two dose levels, a low dose of 5 mg/kg and a high dose of 50 mg/kg, with a single subcutaneous injection in each case. In addition to monitoring PK in serum, the study analyzed body composition changes over time by employing DEXA scans, measuring lean and fat mass.
Previous wording
Building on these insights, we initiated a program to develop a bispecific antibody targeting both myostatin and Activin A. Leveraging our StableHu platform and mammalian display, this program is in late discovery, where multiple parameters—such as binding affinity, expression levels, and stability—are being optimized. Early in vitro findings in human muscle progenitor cells reveal that the bispecific candidate induces a stronger differentiation of progenitor cells into mature muscle cells compared to antibodies targeting only myostatin or Activin A alone.
Current wording
our StableHu platform and mammalian display, this program is in late discovery, where multiple parameters—such as binding affinity, expression levels, and stability—are being optimized. Early in vitro findings in human muscle progenitor cells reveal that the bispecific candidate induces a stronger differentiation of progenitor cells into mature muscle cells compared to antibodies targeting only myostatin or Activin A alone.
Previous wording
By leveraging our AI Drug Discovery Platform, we believe we have successfully identified the first antibody that inhibits Activin E. Preclinical data from multiple in vitro cell-based assays, including one on a human adipocyte cell line, demonstrated robust blockade of Activin E-mediated signaling. We are now advancing the characterization of this candidate while concurrently identifying additional Activin E antibodies, with the goal of expanding our pipeline of innovative therapies for cardiometabolic disorders.
Current wording
By leveraging our AI Drug Discovery Platform, we believe we have successfully identified the first antibody inhibiting Activin E. Preclinical data from multiple in vitro cell-based assays, including one on a human adipocyte cell line, demonstrated robust blockade of Activin E-mediated signaling. The antibody is being evaluated in an exploratory pre-clinical study in a model of diet-induced obesity (DIO) in mice, both as a monotherapy with bi-weekly dosing and in combination with semaglutide dosed daily.
Previous wording
emerged as an area of interest in oncology over the past several years. Since Treg cells express interleukin-2 Rα (“IL-2Rα” or “CD25”), it was envisioned mAbs could be developed that bind CD25 and thereby trigger depletion by Natural Killer cells, resulting in stimulation of anti-tumor immunity.
Current wording
IBIO-101 is a second-generation anti-CD25 mAb that has demonstrated in preclinical models of disease the ability to bind and deplete immunosuppressive regulatory T (“Treg”) cells to inhibit the growth of solid tumors. Targeting depletion of Treg cells to control tumors emerged as an area of interest in oncology over the past several years. Since Treg cells express interleukin-2 Rα (“IL-2Rα” or “CD25”), it was envisioned mAbs could be developed that bind CD25 and thereby trigger depletion by Natural Killer cells, resulting in stimulation of anti-tumor immunity.
Previous wording
MUC16 is a widely recognized cancer antigen overexpressed in several solid tumors, notably ovarian, lung, and pancreatic cancers. In ovarian malignancies, it appears on more than 80% of tumors as a large extracellular protein that tumor cells can shed or glycosylate, potentially diminishing the effectiveness of traditional antibody-based therapies. By contrast, our patented epitope steering AI platform focuses on a region of MUC16 that remains unaltered by shedding or glycosylation, allowing for more consistent tumor targeting and potentially offering a substantial therapeutic advantage.
Current wording
MUC16 is a widely recognized cancer antigen overexpressed in several solid tumors, notably ovarian, lung, and pancreatic cancers. In ovarian malignancies more than 80% of tumors appear as a large extracellular protein that tumor cells can shed or glycosylate, potentially diminishing the effectiveness of traditional antibody-based therapies. By contrast, our patented epitope steering AI platform focuses on a region of MUC16 that remains unaltered by shedding or glycosylation, allowing for more consistent tumor targeting and potentially offering a substantial therapeutic advantage.
Previous wording
Leveraging our patented AI-enabled epitope steering engine, we've specifically directed antibodies to target a unique epitope found exclusively on EGFRvIII, and not on the wildtype receptor, EGFR. Through this precision approach, we have designed tumor-specific molecules aimed at selectively targeting cancer cells while preserving healthy ones, potentially offering patients a more focused and safer therapeutic solution.
Current wording
Leveraging our patented AI-enabled epitope steering engine, we have specifically directed antibodies to target a unique epitope found exclusively on EGFRvIII, and not on the wildtype receptor, EGFR. Through this precision approach, we have designed tumor-specific molecules aimed at selectively targeting cancer cells while preserving healthy ones, potentially offering patients a more focused and safer therapeutic solution.
Previous wording
The chemokine receptor CCR8 is a GPCR which is predominantly expressed on Tregs, which play a role in suppressing immune responses. In the context of cancer, Tregs can inhibit the body's natural immune response against tumor cells, promoting cancer progression. Anti-CCR8 antibodies are being explored as a therapeutic strategy to deplete these Tregs in the tumor environment. By targeting and reducing Tregs using anti-CCR8 antibodies, the hope is to enhance the body's immune response against cancer cells, offering a promising avenue for cancer treatment.
Current wording
The chemokine receptor CCR8 is a GPCR which is predominantly expressed on Tregs, which plays a role in suppressing immune responses. In the context of cancer, Tregs can inhibit the body's natural immune response against tumor cells, promoting cancer progression. Anti-CCR8 antibodies are being explored as a therapeutic strategy to deplete these Tregs in the tumor environment. By targeting and reducing Tregs using anti-CCR8 antibodies, the hope is to enhance the body's immune response against cancer cells, offering a promising avenue for cancer treatment.
Previous wording
In consideration for the rights and licenses granted by AstralBio to the Company in the License Agreement, paid AstralBio an upfront license fee in the amount of $750,000. The fixed upfront fee was settled with the issuance of 246,087 shares of our Common Stock based on the volume weighted average price of our Common Stock as reported by Bloomberg, LP over the five day period ending at 4:00 PM on the day prior to issuance, January 28, 2025.
Current wording
shares of our Common Stock, which amount was calculated based on the volume weighted average price of our Common Stock as reported by Bloomberg, LP over the five day period ending at 4:00 PM on the day prior to issuance.
Previous wording
The history of significant losses, the negative cash flow from operations, the limited cash resources on hand and the dependence by the Company on its ability to obtain additional financing to fund its operations after the current cash resources are exhausted raises substantial doubt about the Company’s ability to continue as a going concern. Our management concluded that our recurring losses from operations and the fact that we have not generated significant revenue or positive cash flows from operations raise substantial doubt about our ability to continue as a going concern for the next 12 months from the date of filing this Report for the quarterly period ended December 31, 2024. Our auditors also included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended June 30, 2024 with respect to this uncertainty.
Current wording
The history of significant losses, the negative cash flow from operations, the limited cash resources on hand and the dependence by the Company on its ability to obtain additional financing to fund its operations after the current cash resources are exhausted raises substantial doubt about the Company’s ability to continue as a going concern. Our management concluded that our recurring losses from operations and the fact that we have not generated significant revenue or positive cash flows from operations raise substantial doubt about our ability to continue as a going concern for the next 12 months from the date of filing this Report for the quarterly period ended March 31, 2025. Our auditors also included an explanatory paragraph in their report on our consolidated financial statements as of and for the year ended June 30, 2024 with respect to this uncertainty.
Previous wording
In an effort to mitigate the substantial doubt about continuing as a going concern and increase cash reserves, we have raised funds from time to time through equity offerings or other financing alternatives, reduced our workforce, entered into a collaboration agreement to discover and develop novel antibodies for obesity and other cardiometabolic diseases and sold certain intellectual property rights. Potential options being considered to further increase liquidity, focusing product development on a select number of product candidates, the sale or out-licensing of certain product candidates, raising money from the capital markets, grant revenue or collaborations, or a combination thereof. There can be no assuance that we will be successful in these financing activities. However, we anticipate that our expenses will increase as it continues its research and development activities and conducts clinical trials.
Current wording
In an effort to mitigate the substantial doubt about continuing as a going concern and increase cash reserves, we have raised funds from time to time through equity offerings or other financing alternatives, reduced our workforce, entered into a collaboration agreement to discover and develop novel antibodies for obesity and other cardiometabolic diseases and sold certain intellectual property rights. Potential options being considered to further increase liquidity, focusing product development on a select number of product candidates,
Previous wording
On July 3, 2024, we entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with Chardan Capital Markets, LLC and Craig-Hallum Capital Group LLC (the “Sales Agents”) providing for the sale us of our common stock, par value $0.001 per share (the “Common Stock”), from time to time, through the Sales Agents, with certain limitations on the amount of Common Stock that may be offered and sold by us as set forth in the ATM Agreement (the “ATM”). Offers and sales of shares of Common Stock by us, if any, under the ATM Agreement, is subject to the effectiveness of our shelf registration statement on Form S-3, filed with the SEC on July 3, 2024 which became effective on August 6, 2024. The aggregate market value of the shares of Common Stock eligible for sale under the ATM prospectus supplement included in the Registration Statement is currently $7,350,000, which is based on the limitations of General Instruction I.B.6 of Form S-3. No Common Stock was sold under this agreement as of December 31, 2024. In January 2025, our Sales Agents sold 32,167 shares and we received net proceeds of approximately $102,000.
Current wording
On July 3, 2024, we entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with Chardan Capital Markets, LLC and Craig-Hallum Capital Group LLC (the “Sales Agents”) providing for the sale us of our Common Stock, from time to time, through the Sales Agents, with certain limitations on the amount of Common Stock that may be offered and sold by us as set forth in the ATM Agreement (the “ATM”). Offers and sales of shares of Common Stock by us, if any, under the ATM Agreement, are subject to the effectiveness of our shelf registration statement on Form S-3, filed with the SEC on July 3, 2024, which became effective on August 6, 2024. The aggregate market value of the shares of Common Stock eligible for sale under the ATM prospectus supplement included in the Registration Statement was initially $7,350,000 and currently is $7,188,000, which was based on the limitations of General Instruction I.B.6 of Form S-3 and takes into account sales already made pursuant to the ATM Agreement discussed in the next two sentences. As of March 31, 2025, our Sales Agents sold 32,167 shares of Common Stock under this agreement and we received net proceeds of approximately $102,000. In April 2025, our Sales Agents sold 22,812 shares of Common Stock and we received net proceeds of approximately $60,000.
Previous wording
Our cash, cash equivalents and restricted cash of approximately $7.2 million as of December 31, 2024, is anticipated to be sufficient to support operations into the first quarter of fiscal year 2026, unless we reduce our burn rate further or raise additional capital. Regardless of whether we are able to reduce our burn rate or sell or out-license certain assets or parts of the business, we will need to raise additional capital in order to fully execute our longer-term business plans. It is our goal to implement one or more potential options described above to allow us to have a cash runway for at least 12 months from the date of the filing of this Report. However, there can be no assurance that we will be successful in implementing any of the options that we are evaluating.
Current wording
Our cash, cash equivalents and restricted cash was approximately $5.2 million as of March 31, 2025. Our cash, cash equivalents and restricted cash on May 1, 2025, which included the proceeds from the exercised of the Existing Warrants and the sale of the Inducement Warrants, was approximately $10.5 million and is anticipated to be sufficient to support operations through the end of the first quarter of fiscal year 2026, unless we reduce our burn rate further or raise additional capital. Regardless of whether we are able to reduce our burn rate or sell or out-license certain assets or parts of the business, we will need to raise additional capital in order to fully execute our longer-term business plans. It is our goal to implement one or more potential options described above to allow us to have a cash runway for at least 12 months from the date of the filing of this Report. However, there can be no assurance that we will be successful in implementing any of the options that we are evaluating. If we do not raise sufficient capital, 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
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the AI-driven discovery platform in the future. Revenue in the amount of $0.2 million was recognized for services provided to a collaborative partner during the three months ended December 31, 2024. No revenue was recognized for the three months ended December 31, 2023.
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 our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the AI-driven discovery platform in the future. No revenue was recognized for the three months ended March 31, 2025 and 2024.
Previous wording
R&D expenses for the three months ended December 31, 2024 and 2023 were $1.9 million and $1.5 million, respectively, an increase of approximately $0.4 million. The increase in R&D expenses is mainly due to increased spend on consumable supplies, consultants and outside services as a result of increased research activities. This increase was partially offset by a reduction in personnel related costs.
Current wording
R&D expenses for the three months ended March 31, 2025 and 2024 were $1.9 million and $0.9 million, respectively, an increase of approximately $1.0 million. The increase in R&D expenses is mainly due to increased spending on consultants and outside services, consumable supplies, and personnel-related costs as a result of increased research activities.
Previous wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the three months ended December 31, 2024 were approximately $4.6 million, compared to approximately $4.5 million in the same period of fiscal year 2023.
Current wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the three months ended March 31, 2025 were approximately $4.9 million, compared to approximately $3.6 million in the same period of fiscal year 2024.
Previous wording
On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO, LLC) in order to complete our transformation into an AI-driven precision antibody discovery and development company. In conjunction with the divestment, we completed a workforce reduction and discontinued the CDMO operations. CDMO operations were classified as discontinued operations on our financial statements through the fiscal year ended June 30, 2024. The loss from Discontinued Operations for the six months ended December 31, 2023 was approximately ($4.4) million which primarily consisted of a ($3.1) million impairment of fixed assets, approximately ($0.7) million of interest related to the term note payable on the former iBio CDMO facility sold on May 31, 2024, and approximately ($0.6) million of costs to maintain the former facility prior to its sale.
Current wording
On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO, LLC) in order to complete our transformation into an AI-driven precision antibody discovery and development company. In conjunction with the divestment, we completed a workforce reduction and discontinued the CDMO operations. CDMO operations were classified as discontinued operations on our financial statements through the fiscal year ended June 30, 2024. The loss from Discontinued Operations for the three months ended March 31, 2024 was approximately ($0.5) million which primarily consisted of an approximately ($0.3) million of interest related to the term note payable on the former iBio CDMO facility sold on May 31, 2024, and approximately ($0.2) million of costs to maintain the former facility prior to its sale.
Previous wording
Net loss from continuing operations for the three months ended December 31, 2024 was ($4.4) million, or ($0.48) per share. Net loss from continuing operations for the three months ended December 31, 2023 was approximately ($4.5) million, or ($2.42) per share.
Current wording
Net loss from continuing operations for the three months ended March 31, 2025 was ($4.9) million, or ($0.49) per share. Net loss from continuing operations for the three months ended March 31, 2024 was approximately ($2.6) million, or ($0.71) per share.
Previous wording
Results of Operations – Comparison of the six months ended December 31, 2024 and 2023
Current wording
Results of Operations – Comparison of the nine months ended March 31, 2025 and 2024
Previous wording
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the AI-driven discovery platform in the future. Revenue in the amount of $0.2 million was recognized for services provided to a collaborative partner during the six months ended December 31, 2024. Revenue for the six months ended December 31, 2023 in the amount of $0.05 million was related to a research licensing agreement utilizing our AI-driven discovery platform.
Current wording
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the AI-driven discovery platform in the future. Revenue in the amount of $0.2 million was recognized for services provided to a collaborative partner during the nine months ended March 31, 2025. Revenue for the nine months ended March 31, 2024 in the amount of $0.05 million was related to a research licensing agreement utilizing our AI-driven discovery platform.
Previous wording
R&D expense for the six months ended December 31, 2024 and 2023 were approximately $3.2 million and $3.1 million, respectively. The slight increase in R&D expense was primarily due to increased spend on consumable supplies, consultants and outside services as a result of increased research activities and offset by a reduction in personnel related costs when compared to the six months ended December 31, 2023.
Current wording
R&D expenses for the nine months ended March 31, 2025 and 2024 were approximately $5.1 million and $4.0 million, respectively, an increase of $1.1 million. The increase in R&D expense was primarily due to increased spending on consultants and outside services, consumable supplies, and lab maintenance as a result of increased research activities. The increases were partially offset by a reduction in equity award expense when compared to the nine months ended March 31, 2024.
Previous wording
G&A expenses for the six months ended December 31, 2024 and 2023 were approximately $5.5 million and $6.5 million, respectively, a decrease of ($1.0) million. The decrease in expenses is primarily attributable to the reduction of personnel related costs, consulting fees and outside services and lower negotiated insurance premiums. The decreases were partially offset by an increase in travel expenses.
Current wording
G&A expenses for the nine months ended March 31, 2025 and 2024 were approximately $8.5 million and $9.2 million, respectively, a decrease of ($0.7) million. The decrease in expenses is primarily attributable to the reduction of personnel-related costs, insurance premiums, legal fees, depreciation, accounting and consulting fees. The decreases were partially offset by increased IT-related costs, travel expenses and franchise taxes.
Previous wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the six months ended December 31, 2024 were approximately $8.7 million, compared to approximately $9.6 million in the same period of fiscal year 2023.
Current wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the nine months ended March 31, 2025 were approximately $13.6 million, compared to approximately $13.3 million in the same period of fiscal year 2024.
Previous wording
On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO, LLC) in order to complete our transformation into an AI-driven precision antibody discovery and development company. In conjunction with the divestment, we completed a workforce reduction and discontinued the CDMO operations. CDMO operations were classified as discontinued operations on our financial statements through the fiscal year ended June 30, 2024. The loss from Discontinued Operations for the three months ended December 31, 2023 was approximately ($3.7) million which primarily consisted of a ($3.1) million impairment of fixed assets, approximately ($0.3) million of interest related to the term note payable on the former iBio CDMO facility sold on May 31, 2024, and approximately ($0.3) million of costs to maintain the former facility prior to its sale.
Current wording
On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO, LLC) in order to complete our transformation into an AI-driven precision antibody discovery and development company. In conjunction with the divestment, we completed a workforce reduction and discontinued the CDMO operations. CDMO operations were classified as discontinued operations on our financial statements through the fiscal year ended June 30, 2024. The loss from Discontinued Operations for the nine months ended March 31, 2024 was approximately ($4.9) million which primarily consisted of a ($3.1) million impairment of fixed assets, approximately ($0.9) million of interest related to the term note payable on the former iBio CDMO facility sold on May 31, 2024, and approximately ($0.9) million of costs to maintain the former facility prior to its sale.
Previous wording
Net loss from continuing operations for the six months ended December 31, 2024 was ($8.4) million, or ($0.94) per share. Net loss from continuing operations for the six months ended December 31, 2023 was approximately ($9.6) million, or ($6.27) per share.
Current wording
Net loss from continuing operations for the nine months ended March 31, 2025 was ($13.2) million, or ($1.44) per share. Net loss from continuing operations for the nine months ended March 31, 2024 was approximately ($12.2) million, or ($5.43) per share.
Previous wording
Net cash used in operating activities was approximately ($7.6) million for the six months ended December 31, 2024, compared to net cash used in operating activities of ($10.0) million for the six months ended December 31, 2023. 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 ($10.7) million for the nine months ended March 31, 2025, compared to net cash used in operating activities of ($13.7) million for the nine months ended March 31, 2024. The use of cash was primarily attributable to funding our net loss for the period.
Previous wording
Net cash provided by investing activities of approximately $0.7 million for the six months ended December 31, 2024 was due to the payment received for interest and principal on the promissory note receivable. Net cash provided by investing activities was approximately $0.1 million for the six months ended December 31, 2023.
Current wording
Net cash provided by investing activities of approximately $0.7 million for the nine months ended March 31, 2025 was due to the payment received for interest and principal on the promissory note receivable. Net cash provided by investing activities was approximately $1.1 million for the nine months ended March 31, 2024.
Previous wording
Net Cash (Used in) Provided by Financing Activities
Current wording
Net Cash Provided by Financing Activities
Previous wording
Net cash used in financing activities during the six months ended December 31, 2024, was approximately ($0.3) million and was attributable to payments towards debt, including the finance lease obligations, term promissory note and equipment financing loan. Net cash provided by financing activities was approximately $6.5 million for the six months ended December 31, 2023.
Current wording
Net cash provided by financing activities during the nine months ended March 31, 2025, was approximately $0.7 million and was attributable to the proceeds from the sale of securities partially offset by payments towards debt, including the finance lease obligations, term promissory note and equipment financing loan. Net cash provided by financing activities was approximately $11.5 million for the nine months ended March 31, 2024.
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 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. As of December 31, 2023, our accumulated
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 March 31, 2025, our accumulated deficit was approximately ($327.1) million and we used approximately ($10.7) million of cash for operating activities during the nine months ended March 31, 2025. As of March 31, 2024, our accumulated deficit was approximately ($306.1) million and we used approximately ($13.7) million of cash for operating activities during the nine months ended March 31, 2024.
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 six months ended December 31, 2024.
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 nine months ended March 31, 2025.
Previous wording
Evaluating for impairment requires judgment, including the estimation of future cash flows, future growth rates and profitability and the expected life over which cash flows will occur. Changes in our business strategy or adverse changes in market conditions could impact impairment analyses and require the recognition of an impairment charge. Although we base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, actual results could differ from these estimates.
Current wording
Evaluating impairment requires judgment, including the estimation of future cash flows, future growth rates and profitability and the expected life over which cash flows will occur. Changes in our business strategy or adverse changes in market conditions could impact impairment analyses and require the recognition of an impairment charge. Although we base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, actual results could differ from these estimates.
Previous wording
During the fourth quarter of the fiscal year ended June 30, 2024, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million at June 30, 2024. We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the asset. Since IBIO-101 is currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the cash flows related to the subject asset.
Current wording
During the fourth quarter of the fiscal year ended June 30, 2024, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million on June 30, 2024. We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the asset. Since IBIO-101 is currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the cash flows related to the subject asset.
Showing the first 40 of 42 pairs. Open the source sections for the rest.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
this limitation by utilizing a machine learning algorithm generating focused library diversity within the capacity of mammalian display.
Current report — wording carried from elsewhere
Building on these insights, we initiated a program to develop a bispecific antibody targeting both myostatin and Activin A. Leveraging
Current report — wording carried from elsewhere
the sale or out-licensing of certain product candidates, raising money from the capital markets, grant revenue or collaborations, or a combination thereof. There can be no assurance that we will be successful in these financing activities. However, we anticipate that our expenses will increase as we continue our research and development activities and conduct clinical trials and therefore our cash needs will increase.
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
We have used antibodies from an epitope steering campaign as well as a first-generation T-cell engager as input and utilized our StableHu technology to identify a next-generation CD3 antibody panel. The sequence diversity generated by StableHu led
Previous report — wording carried elsewhere
As a result of this collaboration with AstralBio, we exercised our first option and entered into an exclusive agreement (the “License Agreement”) with AstralBio, pursuant to which AstralBio licensed to us, on an worldwide exclusive basis and with the right to grant
Previous report — wording carried elsewhere
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 report — wording carried elsewhere
IBIO-101 is a second-generation anti-CD25 mAb that has demonstrated in preclinical models of disease the ability to bind and deplete immunosuppressive regulatory T (“Treg”) cells to inhibit the growth of solid tumors. Targeting depletion of Treg cells to control tumors
Previous report — wording carried elsewhere
G&A expenses for the three months ended December 31, 2024 and 2023 were approximately $2.7 million and $3.0 million, respectively, a decrease of ($0.3) million. The decrease in expenses is primarily attributable to the reduction of consulting fees and outside services. The decreases were partially offset by an increase in travel expenses.
Previous report — wording carried elsewhere
deficit was approximately ($313.8) million and we used approximately ($10.0) million of cash for operating activities during the six months ended December 31, 2023.