Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 36

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 36
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GMP regulations, the clinical data generated in our clinical studies may be deemed unreliable 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