Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 42

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 42
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 finding additional
CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO
commences work. As a result, delays may occur, which can materially impact our ability to meet our desired clinical development timelines.
Though we carefully manage our relationships with our CROs, we may encounter similar challenges or delays in the future, which could have
a material adverse impact on our business, financial condition and prospects.

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Independent clinical investigators and CROs that we will engage to conduct our clinical trials may not devote sufficient time or attention to our clinical trials or be able to repeat their past success.

We will depend on third parties,
including independent clinical investigators and CROs, to conduct our clinical trials. CROs may also assist us in the collection and analysis
of data. There is a limited number of third-party service providers and vendors that specialize or have the expertise required to achieve
our business objectives. Identifying, qualifying and managing performance of third-party service providers can be difficult, time consuming
and cause delays in our development programs.

These investigators and CROs
will not be our employees and we will not be able to control, other than through contract, the amount of resources, including time, which
they devote to our product candidates and clinical trials. If independent investigators or CROs fail to devote sufficient resources to
the development of our product candidates, or if their performance is substandard, it may delay or compromise the prospects for approval
and commercialization of any product candidates that we develop.

Investigators for our clinical
trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.
Under certain circumstances, we may be required to report some of these relationships to the FDA or other regulatory authorities. The
FDA or other regulatory authorities may conclude that a financial relationship between us and an investigator has created a conflict of
interest or otherwise affected interpretation of the trial. The FDA or other regulatory authorities may therefore question the integrity
of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could
result in a delay in approval or rejection of our marketing applications by the FDA or other regulatory authorities, as the case may be,
and may ultimately lead to the denial of marketing approval of one or more of our product candidates.

In addition, the use of third-party
service providers requires us to disclose our