Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 39

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 39
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, 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 service provider.                                                                                |

We require materials from
suppliers that are cGMP compliant. All of our raw material suppliers are cGMP-compliant at the present. If these suppliers do not successfully
carry out their contractual duties or manufacture our raw materials in accordance with regulatory requirements, we will not be able to
submit our NDA as planned or complete, or may be delayed in completing, the clinical trials required for approval of our Gelrin platform
product candidates. In such instances, we may need to locate an appropriate replacement third-party relationship, which may not be readily
available or on acceptable terms, which would cause additional delay or increased expense prior to the approval of our Gelrin platform
product candidates and would thereby have a material adverse effect on our business, financial condition