Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 43

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 43
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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 proprietary information to these parties, which could increase the risk that this information
will be misappropriated. Further, the FDA and other regulatory authorities require that we comply with standards, commonly referred to
as GCP, for conducting, recording and reporting clinical trials to assure that data and reported results are credible and accurate and
that the rights, integrity and confidentiality of trial subjects are protected. Failure of clinical investigators or CROs to meet their
obligations to us or comply with GCP procedures could adversely affect the clinical data, the outcome of the clinical studies or the development
of our product candidates and harm our business.

We rely on third parties to manufacture the raw materials that we use to create our product candidates. Our business could be harmed if existing and prospective third parties fail to provide us with sufficient quantities of these materials and products or fail to do so at acceptable quality levels or prices.

We rely on third party suppliers
for certain raw materials necessary to manufacture components of our product candidates for our preclinical studies and clinical trials.
Some of the critical materials and components used in manufacturing GelrinC are “off the shelf” components and others are
custom-made components for us. We do not have any control over the availability of raw materials. If we or our manufacturers are unable
to purchase these raw materials on acceptable terms, at sufficient quality levels, or in adequate quantities, if at all, the development
and commercialization of our product candidates or any future product candidates, would be delayed or there would be a shortage in supply,
which would impair our ability to meet our development objectives for our product candidates or generate revenues from the sale of any
approved products.

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We intend to rely on third
party suppliers for these raw materials, which will continue to expose us to manufacturing risks including:

| ● | reduced control for certain aspects of manufacturing activities;                                                                                    |
| ● | termination or nonrenewal of manufacturing and service agreements with third parties in a manner or at a time that is costly or damaging to us; and |

| ● | disruptions to the operations of our third-party manufacturers and service providers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or