iBio (IBIO) FY2025 10-K Risk Factors: 18 New, 10 Dropped

What the changes say

iBio faces severe going concern risks with an accumulated deficit of $332.2 million as of June 30, 2025.
Raising capital is constrained because its public float dropped to approximately $20.0 million, well below the $75.0 million threshold.
All product candidates remain in preclinical development, focusing primarily on cardiometabolic and obesity fields.

What changed since the prior 10-K

New

NewRisks Related to Our Business, Financial Position and Capital Requirements
o The actual amount of funds we will need to operate is subject to many risk factors, some of which are beyond our control
Our ability to raise additional capital via the ATM Program may be restricted if our public float remains below $75.0 million.
NewRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
o Clinical trials are very expensive, time-consuming, and difficult to design and implement
We depend on preclinical and clinical success, regulatory approvals, and avoiding product liability lawsuits or undesirable side effects.
NewRisks Related to Dependence on Third Parties
o Our most advanced product candidates depend on intellectual property licensed from third parties and termination of any of these or future licenses could result in the loss of significant rights, which could adversely affect our business, results of operations and financial condition
We rely on third-party licenses for intellectual property, third-party databases for our AI/ML platform, and third-party contract manufacturers.
NewRisks Related to Dependence on Third Parties
o If we are unable to establish new collaborations and maintain both new and existing collaborations, or if these collaborations are not successful, our business could be adversely affected
Our business depends on establishing and maintaining successful collaborations, raw material supplies, and adequate insurance coverage.
NewRisks Related to iBio’s Operations
o We rely extensively on our information technology systems and are vulnerable to damage and interruption, including cybersecurity and data leakage risks
We are vulnerable to IT system interruptions, cybersecurity breaches, and global climate change regulations.
NewRisks Related to Our Business, Financial Position and Capital Requirements
of the significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in our business strategy and future funding requirements
We may be unable to generate product revenue for many years, threatening our survival as a going concern.
NewRisks Related to Our Business, Financial Position and Capital Requirements
clinical development without securing collaborator or licensee funding, our research and development expenses could increase substantially
We have no committed funding sources and must meet specific requirements to sell securities under our ATM Agreement with Chardan and Craig-Hallum.
NewRisks Related to Our Business, Financial Position and Capital Requirements
Our ability to raise additional capital, including through sales of shares of common stock under the ATM Program, may be limited if the public float of our common stock continues to be less than $75.0 million
Our public float of approximately $20.0 million limits primary public offerings on Form S-3 to one-third of our public float under SEC regulations.
NewRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
We are currently in preclinical development of multiple product candidates as potential treatments across multiple therapeutic areas. It is possible that we may never be able to develop a marketable product candidate
Our efforts are heavily focused on cardiometabolic and obesity product candidates, and we have never submitted an NDA or BLA to the FDA.
NewRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
extensive, lengthy, expensive, and inherently uncertain process, and the FDA may delay, limit or deny approval of its product for many reasons
Our limited resources force us to prioritize certain product candidates, risking missed opportunities in other scientific approaches.
NewRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements on terms less favorable to us than possible
Inaccurate evaluation of commercial potential could lead us to relinquish valuable rights to product candidates on unfavorable collaboration terms.
NewRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
If we or our collaborators do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully develop and commercialize our product candidates, which would materially harm our business
We do not anticipate commencing our first human clinical trials until late fiscal 2026 or early fiscal 2027.
NewRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
We may conduct our initial clinical studies for IBIO-610 and our other product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such studies, in which case our development plans will be delayed, which could materially harm our business
NewRisks Related to Dependence on Third Parties
Our most advanced product candidates depend on intellectual property licensed from third parties and termination of any of these or future licenses could result in the loss of significant rights, which could adversely affect our business, results of operations and financial condition
NewRisks Related to Dependence on Third Parties
Our AI/ML platform leverages internal data as well as data from third parties. Defects in, or loss of access to, our databases or those of third parties may impair our ability to discover additional targets and develop our product candidates
NewRisks Related to iBio’s Operations
Global climate change and related regulations could negatively affect our business
NewRisks Related to Our Common Stock
Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock. Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if our common stock is delisted
NewRisks Related to Our Common Stock
We do not intend to pay dividends in the foreseeable future

Dropped

DroppedRisks Related to Dependence on Third Parties
For any clinical product candidates we may develop, any manufacturing problems experienced by our third-party contract manufacturers could result in a delay or interruption in the supply of our clinical product candidate
Manufacturing problems by third-party contractors could delay supply of clinical candidates.
DroppedRisks Related to Our Financial Position and Need for Additional Capital
We are reviewing potential options to extend our cash runway. This review could impact our future operations and financial position
DroppedRisks Related to Our Financial Position and Need for Additional Capital
We have incurred net losses and used significant cash in operating activities since inception, and we expect to continue to generate operating losses for the foreseeable future. As of June 30, 2024, we have an accumulated deficit of $313.8 million
DroppedRisks Related to Our Financial Position and Need for Additional Capital
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
We are reviewing options to extend cash runway, including selling our facility and reducing workforce.
DroppedRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
We, our clients and collaborators, are very early in our development efforts. If we or our clients and collaborators are unable to successfully develop and commercialize product candidates or experience significant delays in doing so, our business will be materially harmed
Doubt on going concern beyond first quarter of fiscal 2026 with $14.4 million in cash.
DroppedRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
We may not be successful in our efforts to use iBio technologies to build a pipeline of product candidates and develop marketable products
DroppedRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
immune response generated by a product candidate is too low or occurs in too few treated individuals, then the product candidate will have no commercial value
DroppedRisks Related to Dependence on Third Parties
approval of a product candidate, we will be required to demonstrate comparability between the product manufactured by the old manufacturer and the product manufactured by the new manufacturer. If we are unable to do so we may need to conduct additional clinical trials with product manufactured by the new manufacturer
DroppedRisks Related to Our Common Stock
Our stockholders will experience substantial dilution from the issuance of the development milestone payments if paid in equity and may not realize a benefit from the acquisition of substantially all of the assets RubrYc commensurate with the ownership dilution they will experience in connection therewith
DroppedRisks Related to Our Common Stock
Our failure to continue to comply with the continued listing standards of the NYSE American could result in delisting from the NYSE American
Raising capital may cause dilution or require relinquishing technology rights.

Reworded

98% rewrittenRisks Related to iBio’s Operations
Changes in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business and operating results
Updated macroeconomic risk to focus on U.S. healthcare reform, energy costs, credit availability, and potential recession.
96% rewrittenRisks Related to iBio’s Operations
We rely extensively on our information technology systems and are vulnerable to damage and interruption, including cybersecurity and data leakage risks
Expanded IT risk to explicitly mention cloud providers and supplier systems vulnerability to cyber intrusions.
90% rewrittenRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
All of our existing product candidates are in early stages of development and will require extensive additional clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue
Removed specific mention of devoting efforts to immune-oncology field.
Was: All of our existing product candidates are in very early stages of development and will require extensive additional clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue
82% rewrittenRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
Neither we nor our clients, collaborators or potential licensees will be able to commercialize product candidates based on our technologies and services if preclinical studies do not produce successful results or clinical trials do not demonstrate safety and efficacy in humans
Adjusted headings to emphasize reliance on preclinical and clinical safety and efficacy.
69% rewrittenRisks Related to iBio’s Operations
Our business and operations would suffer in the event of computer system failures
Retained computer system failure risks without material wording changes.
67% rewrittenRisks Related to Our Business, Financial Position and Capital Requirements
In addition, as we expand our business, we will need to retain additional employees with the necessary skills including employees for our continued expansion of drug discovery capabilities in San Diego, California
Added specific need to retain employees for drug discovery expansion in San Diego, California.
56% rewrittenRisks Related to Our Business, Financial Position and Capital Requirements
We have incurred significant losses since our inception. We expect to incur losses during our next fiscal year, we do not anticipate generating significant revenue for several years and may never achieve or maintain profitability
Updated net loss figure to $18.4 million for fiscal 2025 and accumulated deficit to $332.2 million.
49% rewrittenRisks Related to the Development and Commercialization of Our Technologies and Product Candidates
Alternative technologies may supersede our technologies or make them noncompetitive, which would harm our ability to generate future revenue
Retained alternative technology risks without material wording changes.
43% rewrittenRisks Related to iBio’s Operations
In the past we have identified and remediated material weaknesses in our internal controls, and we cannot provide assurances additional material weaknesses will not occur in the future
27% rewrittenRisks Related to Our Common Stock
The issuance of preferred stock could adversely affect the rights of the holders of shares of our common stock

All 63 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business, Financial Position and Capital Requirements

01o The actual amount of funds we will need to operate is subject to many risk factors, some of which are beyond our controlNew
06We have a limited operating history developing vaccines and therapeutics, which may limit the ability of investors to make an informed investment decision
07We have incurred significant losses since our inception. We expect to incur losses during our next fiscal year, we do not anticipate generating significant revenue for several years and may never achieve or maintain profitability56% rewritten
08of the significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in our business strategy and future funding requirementsNew
09We anticipate that our expenses will increase in the future
10In addition, as we expand our business, we will need to retain additional employees with the necessary skills including employees for our continued expansion of drug discovery capabilities in San Diego, California67% rewritten
11clinical development without securing collaborator or licensee funding, our research and development expenses could increase substantiallyNew
12The actual amount of funds we will need to operate is subject to many risk factors, some of which are beyond our control
13Our ability to raise additional capital, including through sales of shares of common stock under the ATM Program, may be limited if the public float of our common stock continues to be less than $75.0 millionNew

Risks Related to the Development and Commercialization of Our Technologies and Product Candidates

02o Clinical trials are very expensive, time-consuming, and difficult to design and implementNew
14We currently have a limited operating history developing precision antibodies, no products approved for commercial sale, have no significant source of revenue and may never generate significant revenue
15All of our existing product candidates are in early stages of development and will require extensive additional clinical evaluation, regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue90% rewritten
16We are currently in preclinical development of multiple product candidates as potential treatments across multiple therapeutic areas. It is possible that we may never be able to develop a marketable product candidateNew
17extensive, lengthy, expensive, and inherently uncertain process, and the FDA may delay, limit or deny approval of its product for many reasonsNew
18We may expend our limited resources to pursue a particular technology or product candidate and fail to capitalize on technologies or product candidates that may be more profitable or for which there is a greater likelihood of success
19If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements on terms less favorable to us than possibleNew
20If we or our collaborators do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully develop and commercialize our product candidates, which would materially harm our businessNew
21Clinical trials are very expensive, time-consuming, and difficult to design and implement
22Neither we nor our clients, collaborators or potential licensees will be able to commercialize product candidates based on our technologies and services if preclinical studies do not produce successful results or clinical trials do not demonstrate safety and efficacy in humans82% rewritten
23If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenues will be materially impaired
24Alternative technologies may supersede our technologies or make them noncompetitive, which would harm our ability to generate future revenue49% rewritten
25We may conduct our initial clinical studies for IBIO-610 and our other product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such studies, in which case our development plans will be delayed, which could materially harm our businessNew
26Our product candidates may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical products, which may delay or preclude its development or regulatory approval or limit its use if ever approved
27Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop

Risks Related to Dependence on Third Parties

03o Our most advanced product candidates depend on intellectual property licensed from third parties and termination of any of these or future licenses could result in the loss of significant rights, which could adversely affect our business, results of operations and financial conditionNew
04o If we are unable to establish new collaborations and maintain both new and existing collaborations, or if these collaborations are not successful, our business could be adversely affectedNew
28Our most advanced product candidates depend on intellectual property licensed from third parties and termination of any of these or future licenses could result in the loss of significant rights, which could adversely affect our business, results of operations and financial conditionNew
29Our AI/ML platform leverages internal data as well as data from third parties. Defects in, or loss of access to, our databases or those of third parties may impair our ability to discover additional targets and develop our product candidatesNew
30If we encounter any of these problems or are otherwise delayed, or if the cost of manufacturing is not economically feasible or we cannot find another third-party manufacturer, we may not be able to produce our clinical product candidate in a sufficient quantity to meet future demand
31If we are unable to establish new collaborations and maintain both new and existing collaborations, or if these collaborations are not successful, our business could be adversely affected
32If third parties on whom we or our licensees will rely for the conduct of preclinical studies and clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business may suffer
33We rely on third parties to supply the raw materials needed to operate our research and development activities and do not have any long-term commitments from such suppliers
34Any claims beyond our insurance coverage limits, or that are otherwise not covered by our insurance, may result in substantial costs and a reduction in our available capital resources
35We may be subject to various litigation claims and legal proceedings

Risks Related to iBio’s Operations

05o We rely extensively on our information technology systems and are vulnerable to damage and interruption, including cybersecurity and data leakage risksNew
44In the past we have identified and remediated material weaknesses in our internal controls, and we cannot provide assurances additional material weaknesses will not occur in the future43% rewritten
45The loss of one or more of our executive officers or key employees or an inability to attract and retain highly skilled employees could adversely affect our business
46A failure by iBio to hire and retain an appropriately skilled and adequate workforce could adversely impact the ability to operate our R&D facility efficiently
47Use of our laboratory space in San Diego is critical to our success. A natural disaster or other disruptions at our laboratory would adversely affect our business, financial condition, and results of operations
48We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy
49If we are unable to protect the confidentiality of our partners’ or collaborators’ proprietary information, we may be subject to claims
50If we acquire companies, products or technologies, we may face integration risks and costs associated with those acquisitions that could negatively impact our business, results from operations and financial condition
51Our business and operations would suffer in the event of computer system failures69% rewritten
52We rely extensively on our information technology systems and are vulnerable to damage and interruption, including cybersecurity and data leakage risks96% rewritten
53Changes in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business and operating results98% rewritten
54Global climate change and related regulations could negatively affect our businessNew

Risks Related to Intellectual Property

36We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and ultimately unsuccessful
37Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
38If we are unable to protect our trade secrets, our business and competitive position would be harmed
39We may be subject to claims challenging the inventorship of our patent filings and other intellectual property
40Intellectual property rights do not necessarily address all potential threats to our competitive advantage
41We may not be able to protect our intellectual property rights throughout the world
42If we should fail to comply with various patent laws our patent protection could be reduced or eliminated
43Changes in patent law, including recent patent reform legislation, could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents

Risks Related to Our Common Stock

55Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock. Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if our common stock is delistedNew
56Provisions in our certificate of incorporation, bylaws and under Delaware law could discourage a takeover that stockholders may consider favorable
57Our Second Amended and Restated Bylaws provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees
58The issuance of preferred stock could adversely affect the rights of the holders of shares of our common stock27% rewritten
59We do not intend to pay dividends in the foreseeable futureNew
60Holders of our warrants issued in our offerings have no rights as common stockholders until they exercise their warrants and acquire our common stock
61The market price of our common stock has been and may continue to be volatile and adversely affected by various factors
62Reports published by securities or industry analysts, including projections in those reports that exceed our actual results, could adversely affect our common stock price and trading volume
63We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors

Other iBio 10-Ks

FY2026 10-K risk factors
70 risks18 new11 dropped14 reworded
IBIO-600 is now in a Phase 1 Australian trial, adding country-specific regulatory, enrollment, CRO and FDA-data-acceptance exposure.
Filed Aug 28, 2026
FY2024 10-K risk factors
55 risks
The risk profile is dominated by severe liquidity concerns, ongoing operating losses, and a looming going concern doubt. The company faces high dependence on third-party manufacturers, unproven artificial intelligence drug discovery technologies, and early-stage preclinical assets. Operations are threatened by the need for additional capital raising, which risks significant dilution for existing stockholders.
Filed Sep 20, 2024

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.