Risks Related to COVID-19
• We may continue to be impacted by the COVID-19 pandemic.
Risks Related to Our Financial Position and Need for Additional Capital
• We have incurred and expect to continue to incur significant losses.
• We anticipate that our expenses will increase in the future.
• We need additional funding to fully execute our business plan, which funding may not be available on commercially acceptable terms or at all.
• Raising additional capital may cause dilution to our existing stockholders and/or restrict our operations or rights.
• We have a limited operations as a CDMO and biopharmaceutical.
• Potential use of government funding for our R&D programs may impose requirements that limit our ability to take certain actions
• We may not have an adequate number of shares of common stock authorized to enable us to complete future equity financing transactions or strategic transactions, which may adversely affect our ability to grow and develop and may require us to rely on debt to fund our business plans.
Risks Related to the Development and Commercialization of Our Technologies and Product Candidates
• We currently have only four product candidates in early stages of pre-clinical development and are dependent on the success of these product candidates, which requires significant clinical testing before seeking regulatory approval.
• Our business could be significantly impacted if the products we manufacture do not gain market acceptance.
• There can be no guarantee that we will be able to successfully develop and commercialize product candidates.
• We may not be successful in our efforts to use iBio technologies to build a pipeline of product candidates.
• We or our clients, collaborators or licensees are dependent upon successful preclinical and clinical studies.
• If we, or our clients and collaborators, are not able to obtain required regulatory approvals, we, or our clients and collaborators, will not be able to commercialize our, or third-party, product candidates.
• Alternative technologies may supersede our technologies or make them noncompetitive.
• Our clinical product candidate may exhibit undesirable side effects, which may delay or preclude its development or regulatory approval, or limits use if ever approved.
• Our failure to receive or maintain regulatory approval for product candidates developed at our facility could negatively impact our revenue and profitability.
• Product liability lawsuits could cause us to incur substantial liabilities and to limit product commercialization.
• Any manufacturing problems at our facility could result in a delay or interruption in the supply of our clinical product.
Risks Related to Dependence on Third Parties
• 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.
• If third parties on whom we or our licensees will rely for the conduct of preclinical and clinical studies do not perform as required, we may not be able to obtain regulatory approval for or commercialize our product candidates.
• If revenue is concentrated on a few clients, we may be adversely impacted by the dependence upon those clients.
• Our inability to obtain such raw materials or supplies may adversely impact our business and results of operations.
• Any claims beyond our insurance coverage limits may result in substantial costs.
• We may be subject to various litigation claims and legal proceedings.
Risks Related to Intellectual Property
• If we or our licensors are unable to obtain and maintain sufficient patent protection for our technology and products, our ability to successfully commercialize our technology and products may be impaired.
• We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and ultimately unsuccessful.