iBio (IBIO) risk factors, FY2024 10-K

Risks Related to Dependence on Third Parties

1. 01For 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
2. 23approval 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
3. 24If 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
4. 25If 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
5. 26If 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
6. 27We 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
7. 28Any 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
8. 29We may be subject to various litigation claims and legal proceedings

Risks Related to iBio’s Operations

1. 02We rely extensively on our information technology systems and are vulnerable to damage and interruption, including cybersecurity and data leakage risks
2. 38In 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
3. 39The 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
4. 40A 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
5. 41Use 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
6. 42We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy
7. 43If we are unable to protect the confidentiality of our partners’ or collaborators’ proprietary information, we may be subject to claims
8. 44If 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
9. 45Our business and operations would suffer in the event of computer system failures

Risks Related to Our Financial Position and Need for Additional Capital

1. 03We have a limited operating history developing vaccines and therapeutics, which may limit the ability of investors to make an informed investment decision
2. 04We are reviewing potential options to extend our cash runway. This review could impact our future operations and financial position
3. 05We 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
4. 06We 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
5. 07We anticipate that our expenses will increase in the future
6. 08In 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
7. 09The actual amount of funds we will need to operate is subject to many risk factors, some of which are beyond our control
8. 10Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates

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

1. 11We 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
2. 12All 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
3. 13We 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
4. 14We, 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
5. 15We may not be successful in our efforts to use iBio technologies to build a pipeline of product candidates and develop marketable products
6. 16Clinical trials are very expensive, time-consuming, and difficult to design and implement
7. 17Neither 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
8. 18immune 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
9. 19If 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
10. 20Alternative technologies may supersede our technologies or make them noncompetitive, which would harm our ability to generate future revenue
11. 21Our 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
12. 22Product 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 Intellectual Property

1. 30We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and ultimately unsuccessful
2. 31Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
3. 32If we are unable to protect our trade secrets, our business and competitive position would be harmed
4. 33We may be subject to claims challenging the inventorship of our patent filings and other intellectual property
5. 34Intellectual property rights do not necessarily address all potential threats to our competitive advantage
6. 35We may not be able to protect our intellectual property rights throughout the world
7. 36If we should fail to comply with various patent laws our patent protection could be reduced or eliminated
8. 37Changes 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

1. 46Our 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
2. 47Our failure to continue to comply with the continued listing standards of the NYSE American could result in delisting from the NYSE American
3. 48Provisions in our certificate of incorporation, bylaws and under Delaware law could discourage a takeover that stockholders may consider favorable
4. 49Our 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
5. 50The issuance of preferred stock could adversely affect the rights of the holders of shares of our common stock
6. 51Changes 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
7. 52Holders of our warrants issued in our offerings have no rights as common stockholders until they exercise their warrants and acquire our common stock
8. 53The market price of our common stock has been and may continue to be volatile and adversely affected by various factors
9. 54Reports 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
10. 55We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors