Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 37

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 37
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 and the FDA, European Medicines Agency, or EMA, or comparable foreign regulatory
authorities may require us to perform additional clinical trials before approving our marketing applications. Our failure to comply with
these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.

If any of our relationships
with these third-party CROs or vendors terminate, we may not be able to enter into arrangements with alternative CROs or vendors or do
so on commercially reasonable terms. In addition, our CROs are not our employees, and, except for remedies available to us under our agreements
with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical programs. If CROs do
not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality
or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements
or for other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval
for or successfully commercialize our product candidates. CROs may also generate higher costs than anticipated, which could adversely
affect our results of operations and the commercial prospects for our product candidates, increase our costs and delay our ability to
generate revenue.

Replacing or 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