In8bio (INAB) risk factors, FY2025 10-K

Other

1. 01Summary of Selected Risk Factors Associated with Our Business
2. 02Our outstanding warrants may not be exercised and we may not receive any cash proceeds from any exercise of warrants100% rewritten
3. 03We have a limited operating history and have no products approved for commercial sale, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability
4. 04The clinical and commercial utility of our DeltEx platform is uncertain and may never be realized. Additionally, certain aspects of the function and production of gamma-delta T cells are poorly understood or currently unknown and may only become known through further preclinical and clinical testing
5. 05Development of a product candidate intended for use in combination with an already approved therapy may present increased complexity and more or different challenges than development of a product candidate for use as a single agent or monotherapy22% rewritten
6. 06We may rely on third-party contractors or contract development manufacturing organization for the manufacturing of our product candidates, and failure by those parties to adequately perform their obligations could harm our business
7. 07We rely on third-party healthcare professionals to administer gamma-delta T cells to patients, and our business could be harmed if these third parties administer these cells incorrectly100% rewritten

Risks Related to Our Financial Position and Capital Needs

1. 08the extent to which we acquire or in-license other product candidates and technologies27% rewritten
2. 09Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates22% rewritten
3. 10A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline59% rewritten
4. 11We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability
5. 12incur additional legal, accounting or other expenses in operating our business, including the additional costs associated with operating as a public company

Risks Related to the Development of Our Product Candidates

1. 13changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval
2. 14Additionally, any delay in, or termination of, our clinical trials will delay the submission of a BLA to the FDA or other similar applications with other relevant foreign regulatory authorities and, ultimately, our ability to commercialize our product candidates, if approved, and generate product revenue
3. 15We must be able to overcome these challenges in order for us to successfully develop, commercialize and manufacture our product candidates utilizing our novel approaches to gamma-delta T cell therapies
4. 16Clinical product candidate development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and encounter substantial delays or difficulties in our clinical trials
5. 17need to conduct additional clinical trials or abandon product development programs82% rewritten
6. 18conditions. Regulatory action or private litigation could result in expenses, delays or other impediments to our research programs or the commercialization of resulting productsNew
7. 19inability of clinical sites to enroll patients as health care capacities are required to cope with natural disasters, epidemics or other health system emergencies44% rewritten
8. 20targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claimsNew
9. 21We may not be able to file IND applications to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed
10. 22We may not be able to identify or discover other product candidates and may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success
11. 23a product candidate may not be accepted as safe and effective by physicians, patients, the medical community or third-party payors
12. 24Public opinion and scrutiny of our competitors, cell-based immunotherapy, T cell engagers, and genetic modification approaches may impact public perception of our company and product candidates, or may adversely affect our ability to raise capital, conduct our business and our business plans
13. 25We expect the product candidates we develop will be regulated as biologics, and therefore they may be subject to competition sooner than anticipated

Risks Related to Manufacturing and Our Dependence on Third Parties

1. 26Our manufacturing processes are complex, and we may encounter difficulties in production, which would delay or prevent our ability to provide a sufficient supply of our product candidates for future clinical trials or commercialization, if approved
2. 27carrier disruptions or increased costs that are beyond our control53% rewritten
3. 28We believe we may require an updated and validated protocol for commercial-scale expansion and manufacturing of gamma-delta T cells for conducting pivotal trials and for commercialization of our product candidates, if approved
4. 29We have not yet developed commercial-scale infrastructure for freezing and thawing large quantities of gamma-delta T cells, which we believe will be required for the storage and distribution of our gamma-delta T cell product candidates at commercial scale
5. 30Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict or interrupt our business
6. 31undergo changes in priorities or become financially distressed49% rewritten
7. 32Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading27% rewritten

Risks Related to Our Intellectual Property

1. 33Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements
2. 34Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
3. 35Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights and/or trademark, the outcome of which would be uncertain and could have a negative impact on the success of our business
4. 36We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property
5. 37We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful
6. 38Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates
7. 39We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business
8. 40Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed
9. 41If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
10. 42Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business
11. 43Intellectual property rights do not necessarily address all potential threats to our business

Risks Related to Our Business Operations, Employee Matters and Managing Growth

1. 44We plan to expand our organization in the future, and we may experience difficulties in managing this growth, which could disrupt our operations
2. 45We may explore strategic collaborations that may not have the intended benefits or never materialize, or we may be required to relinquish important rights to and control over the development and commercialization of our product candidates to any future collaborators
3. 46termination or expiration of the arrangement, which would delay the development and may increase the cost of developing our product candidates21% rewritten
4. 47Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations
5. 48There are risks inherent in our business that may subject us to potential product liability suits and other claims, which may require us to engage in expensive and time-consuming litigation or pay substantial damages and may harm our reputation and reduce the demand for our product
6. 49the inability to commercialize any products we develop

Risks Related to Commercialization and Regulatory Compliance

1. 50Even if we obtain regulatory approvals for our product candidates, they will remain subject to ongoing regulatory oversight84% rewritten
2. 51for surveillance to monitor the quality, safety and efficacy of the product candidate. Such regulatory requirements may differ from country to country depending on where we have received regulatory approvalNew
3. 52Even if any product candidate receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success
4. 53any restrictions on the use of the product candidate together with other medications
5. 54If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be successful in commercializing them, if and when they are approved
6. 55Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval outside the United States, which would limit our market opportunities
7. 56If we commercialize our product candidates outside the United States, a variety of risks associated with international operations could harm our business
8. 57business interruptions resulting from geopolitical actions, including wars and terrorism, natural disasters including earthquakes, typhoons, floods and fires, and public health emergencies33% rewritten
9. 58Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell profitably, if approved
10. 59Healthcare legislative reform measures may have a negative impact on our business and results of operations47% rewritten
11. 60Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect until 2032 unless additional Congressional action is takenNew
12. 61The FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels, ability to hire and retain key personnel, statutory, regulatory and policy changes and global health concerns36% rewritten
13. 62In addition, certain countries outside Europe have also passed or are considering laws requiring local data residency or otherwise impeding the transfer of personal data across borders, which increases the cost and complexity of doing business38% rewritten

Risks Related to the Ownership of Our Common Stock

1. 63An active trading market for our common stock may not be sustained, and you may not be able to sell your shares quickly or at the market price88% rewritten
2. 64The market price of our common stock is volatile and may fluctuate substantially, and you could lose all or part of your investment
3. 65investors’ general perception of us and our business
4. 66Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
5. 67require the approval of the holders of at least 66 2∕3% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws
6. 68any action or proceeding asserting a claim against us or any of our directors, officers, employees or agents that is governed by the internal-affairs doctrine67% rewritten
7. 69If research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline
8. 70We will continue to incur increased costs as a result of operating as a public company, and our management will continue to be required to devote substantial time to new compliance initiatives
9. 71Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud