Indaptus Therapeutics (INDP) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Capital Requirements

1. 01We are a clinical-stage company with a limited operating history. We are not currently profitable, do not expect to become profitable in the near future and may never become profitable
2. 02We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern
3. 03Since we will be unable to generate sufficient, if any, cash flow to fund our operations for the foreseeable future, we will need to seek additional equity or debt financing to provide the capital required to maintain or expand our operations
4. 04Raising additional capital would cause dilution to our shareholders and may restrict our operations or require us to relinquish rights to our technologies or product candidates

Risks Related to the Discovery and Development of Our Product Candidates

1. 05We are dependent on the success of one or more of our current product candidates, and we cannot be certain that any of them will receive regulatory approval or be commercialized
2. 06We expect to continue to incur significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability
3. 07We may expend our limited resources to pursue a limited number of research programs, product candidates and specific indications and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
4. 08We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
5. 09Interim, “topline” and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
6. 10Our efforts to discover product candidates beyond our current product candidates may not succeed, and any product candidates we recommend for clinical development may not actually begin clinical trials
7. 11The regulatory approval processes of the FDA, the EMA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed
8. 12Even if we obtain FDA approval for any of our product candidates in the United States, we may never obtain approval for or commercialize such candidates in any other jurisdiction, which would limit our ability to realize their full market potential
9. 13Even if we receive regulatory approval for any product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expenses
10. 14The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
11. 15The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses

Risks Related to Our Dependence on Third Parties

1. 16The commercial success of our product candidates depends upon their market acceptance among physicians, patients, healthcare payors and the medical community
2. 17Any clinical supply or collaboration arrangement that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our current and potential future product candidates
3. 18The success of our clinical supply and collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations
4. 19If we are unable to develop our own commercial organization or enter into agreements with third parties to sell and market our product candidates, we may be unable to generate significant revenues

Risks Related to Commercialization

1. 20Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize Decoy20 and any future product candidates and may affect the prices we may set
2. 21Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop
3. 22We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit the supply of our product candidates

Risks Related to Competition, Retaining Key Employees and Managing Growth

1. 23If our competitors have product candidates that are approved faster, marketed more effectively, are better tolerated, have a more favorable safety profile or are demonstrated to be more effective than our product candidates, our commercial opportunity may be adversely affected
2. 24Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated
3. 25Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
4. 26We will need to increase the size of our organization and may not successfully manage our growth

Risks Related to Our Intellectual Property

1. 27We may not be able to adequately protect our proprietary or licensed technology in the marketplace
2. 28We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses
3. 29If we are unable to successfully obtain required third-party intellectual property rights or maintain our existing intellectual property rights, we may need to abandon development of the related program and our business, financial condition and results of operations could be materially and adversely affected
4. 30Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
5. 31Any claims or lawsuits relating to infringement of intellectual property rights brought by or against us will be costly and time consuming and may adversely affect our business, financial condition and results of operations
6. 32Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
7. 33We may not be able to protect our intellectual property rights throughout the world
8. 34We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
9. 35We may be subject to claims challenging the inventorship of our patents, any future patents we may own, and other intellectual property

Risks Related to Healthcare Laws and Other Legal Compliance Matters

1. 36We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our results of operations and financial condition
2. 37Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition
3. 38Violations of or liabilities under environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material adverse effect on the success of our business
4. 39Our business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity
5. 40We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management

Risks Related to Our Common Stock

1. 41If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
2. 42The market price of our common stock is volatile and you may sustain a complete loss of your investment
3. 43These factors and any corresponding price fluctuations may materially and adversely affect the market price of our common stock, which would result in substantial losses by our investors
4. 44An active trading market for our common stock may not be sustained
5. 45If securities or industry analysts do not publish or cease publishing research or reports, or publish unfavorable reports about us, our business or our market, our share price and trading volume could be negatively impacted
6. 46Sales of a substantial number of our shares in the public market by our existing shareholders could cause our share price to decline
7. 47We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
8. 48Maintaining and improving our financial controls and the requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members
9. 49Failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our share price
10. 50If the Domestication Merger (defined below), taken together with the Merger (defined below), fails to qualify as a Section 351(a) Exchange, former U.S. holders of Intec Pharma (“Intec Israel”) ordinary shares may recognize taxable gain as a result of the Domestication Merger
11. 51Notwithstanding that the Domestication Merger and the Merger together are intended to qualify as a Section 351(a) Exchange, the Domestication Merger could be a taxable event for certain former U.S. Holders of Intec Israel ordinary shares
12. 52Unfavorable global economic or geopolitical conditions could adversely affect our business, financial condition or results of operations
13. 53Changes in tax law and regulations could adversely affect our business, financial condition and results of operations