Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 10

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 10
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 supply shortages and problems, increased costs and quality or compliance issues, any of which could harm our business. |
| ● | We may not be able to replace our current manufacturing capabilities in a timely manner.                                                                                                                                               |

| ● | Our business plan is dependent upon third-party service providers. If such third-party service providers fail to maintain a high quality of service, the utility of our products could be impaired, which could adversely affect the penetration of our products, our business, operating results and reputation in the future. |

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| ● | Our business plan relies on certain assumptions about the market for our product, however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we have estimated, we may not be able to capture additional market share. |
| ● | We depend on third parties to manage our clinical studies and trials, perform related data collection and analysis, and to enroll patients for our clinical trials, and, as a result, we may face costs and delays that are beyond our control.                                                                                                            |

| ● | We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under our indebtedness, which may not be successful. |

| ● | Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk.                     |
| ● | We are highly dependent on key members of our executive management team. Our inability to retain these individuals could impede our business plan and growth strategies, which could have a negative impact on our business and the value of your investment. |
| ● | Exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel and inflation may negatively affect our results of operations, and we may not be able to hedge our currency exchange risks successfully.                                        |
| ● | The outcome of any future claims and litigation could have a material adverse impact on our business, financial condition and results of operations.                                                                                                          |
| ● | Certain of our directors, director nominees and/or officers may have interests that compete with ours and our shareholders.                                                                                                                                   |
| ● | Our management team has limited experience managing a public company.                                                                                                                                                                                         |

Risks Related to Our Reliance on Third Parties

| ● | We will rely on third parties to conduct certain elements of our