Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 35

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 35
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 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 rely on third parties,
such as CROs, clinical investigators and clinical sites, to manage our clinical trials and perform data collection and analysis, and to
enroll patients for our clinical trials. Although we have and expect to continue to have contractual arrangements with these third parties,
we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted
in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on such third parties does
not relieve us of our regulatory responsibilities. If such third parties fail to comply with applicable regulatory requirements, the clinical
data generated in our clinical trials may be deemed unreliable and regulatory authorities may require us to perform additional clinical
trials before approving our marketing applications, which would delay the regulatory approval process. Furthermore, we may not be able
to control the amount and timing of resources that these parties devote to our studies and trials or the quality of these resources. If
these third parties fail to properly manage our studies and trials or enroll patients for our clinical trials, we may be unable to complete
them at all or in a satisfactory or timely manner, which could delay or prevent us from obtaining regulatory approvals for, or achieving
market acceptance of, our product.

In addition, termination of
relationships with third parties may result in delays, inability to enter into arrangements with alternative third parties or do so on
commercially reasonable terms. Switching or adding additional clinical sites involves additional cost and requires management time and
focus. In addition, there is a natural transition period when a new clinical site commences work. As a result, delays occur, which can
materially impact our ability to meet our desired clinical development timelines.

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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 ability to make scheduled
payments on or refinance our debt obligations depends on our financial condition and operating performance, which are subject to prevailing
economic and competitive conditions and to financial, business, legislative, regulatory and other factors, some of which are beyond our
control. We cannot be sure that our business will generate sufficient cash flows from operating activities, or that