In8bio (INAB) risk factors, FY2024 10-K

Other

1. 01Summary of Selected Risk Factors Associated with Our Business
2. 02The report of our independent registered public accounting firm for the years ended December 31, 2024 and 2023 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern
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 monotherapy
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 procure cells for manufacturing and to administer gamma-delta T cells to patients, and our business could be harmed if these third parties administer these processes and/or cells incorrectly
8. 08If we fail to satisfy all applicable requirements of Nasdaq and it determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease

Risks Related to Our Financial Position and Capital Needs

1. 09the extent to which we acquire or in-license other product candidates and technologies
2. 10Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates
3. 11A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline
4. 12Our outstanding Series A, Series B and Series C warrants may not be exercised and we may not receive any cash proceeds from any exercise of warrants
5. 13We 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
6. 14incur 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. 15changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval
2. 16Additionally, 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. 17We 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. 18Clinical 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. 19need to conduct additional clinical trials or abandon product development programs
6. 20inability of clinical sites to enroll patients as health care capacities are required to cope with natural disasters, epidemics or other health system emergencies
7. 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
8. 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
9. 23a product candidate may not be accepted as safe and effective by physicians, patients, the medical community or third-party payors
10. 24Public opinion and scrutiny of our competitors, cell-based immunotherapy 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
11. 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 process is 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. 27product. If we are not able to meet market demand for any approved product, it would negatively impact our ability to generate revenue, harm our reputation, and could have an adverse effect on our business and financial condition
3. 28carrier disruptions or increased costs that are beyond our control
4. 29INB-200 and INB-400. Any damage or loss to the ability of our suppliers to deliver supplies in a timely manner could cause delays in manufacturing, and our clinical trials and our business could suffer
5. 30We 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 incorrectly
6. 31We 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
7. 32We 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
8. 33Our 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
9. 34undergo changes in priorities or become financially distressed
10. 35manufacturing or clinical data from these investigator-sponsored trials. If so, regulatory authorities may require us to obtain and submit additional preclinical, manufacturing or clinical data before we may initiate further clinical trials and/or obtain any regulatory approvals
11. 36Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading

Risks Related to Our Intellectual Property

1. 37Obtaining 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. 38Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
3. 39Third 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. 40We 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. 41We 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. 42Changes 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. 43We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business
8. 44Reliance 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. 45If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
10. 46Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business
11. 47Intellectual property rights do not necessarily address all potential threats to our business

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

1. 48Our workforce reduction undertaken to optimize our cost structure may not achieve our intended outcome
2. 49We plan to expand our organization in the future, and we may experience difficulties in managing this growth, which could disrupt our operations
3. 50We 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
4. 51termination or expiration of the arrangement, which would delay the development and may increase the cost of developing our product candidates
5. 52Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations
6. 53There 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
7. 54the inability to commercialize any products we develop

Risks Related to Commercialization and Regulatory Compliance

1. 55Even if we obtain regulatory approvals for our product candidates, they will remain subject to ongoing regulatory oversight
2. 56Even 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
3. 57any restrictions on the use of the product candidate together with other medications
4. 58If 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
5. 59Even 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
6. 60If we commercialize our product candidates outside the United States, a variety of risks associated with international operations could harm our business
7. 61business interruptions resulting from geopolitical actions, including war and terrorism such as the Israel-Hamas war and the Russia-Ukraine war, natural disasters including earthquakes, typhoons, floods and fires, and public health emergencies
8. 62of our operations. If the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government-funded healthcare programs
9. 63Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell profitably, if approved
10. 64Healthcare legislative reform measures may have a negative impact on our business and results of operations
11. 65judicial and Congressional challenges and amendments to the ACA. It is unclear how any such challenges, and the healthcare reform measures of the Trump administration will impact the ACA and our business
12. 66The 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 concerns
13. 67In 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 business

Risks Related to the Ownership of Our Common Stock

1. 68An active trading market for our common stock may not continue to be developed or sustained, and you may not be able to sell your shares quickly or at the market price
2. 69The market price of our common stock is volatile and may fluctuate substantially, and you could lose all or part of your investment
3. 70investors’ general perception of us and our business
4. 71Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions
5. 72Provisions 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
6. 73require 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
7. 74any action or proceeding asserting a claim against us or any of our directors, officers, employees or agents that is governed by the internal-affairs doctrine
8. 75Unstable market and economic conditions, including as a result of inflation expectations, bank closures, public health crises or geopolitical tensions such as the Russia-Ukraine and/or the Israel-Hamas wars, may have serious adverse consequences on our business, financial condition and share price
9. 76If 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
10. 77We 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
11. 78Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud