Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 32

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 32
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 and we may not become profitable.

<div align='center'>20</div>

We are dependent upon contract manufacturing organizations and raw material suppliers making us vulnerable to supply shortages and problems, increased costs and quality or compliance issues, any of which could harm our business.

Some of the critical materials
and components used in manufacturing GelrinC are sourced from single suppliers. Our suppliers may encounter problems during manufacturing
for a variety of reasons, including, for example, failure to follow specific protocols and procedures, failure to comply with applicable
legal and regulatory requirements, equipment malfunction and environmental factors, failure to properly conduct their own business affairs,
and infringement of third-party intellectual property rights, any of which could delay or impede their ability to meet our requirements.
An interruption in the supply of a key material could significantly delay our research and development process or increase our expenses
for commercialization or development of product. An interruption in the supply of a key material could significantly delay our research
and development process or increase our expenses for commercialization or development of products. Specialized materials must often be
manufactured for the first time for use in drug delivery technologies, or materials may be used in the technologies in a manner that is
different from their customary commercial uses. The quality of materials can be critical to the performance of a drug delivery technology,
so a reliable source that provides a consistent supply of materials is important. Materials or components needed for our drug delivery
technologies may be difficult to obtain on commercially reasonable terms, particularly when relatively small quantities are required or
if the materials traditionally have not been used in pharmaceutical products.

Our reliance on these third-party
suppliers also subjects us to other risks that could harm our business, including:

| ● | we are not currently a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours;                                               |
| ● | we may not be able to obtain an adequate supply in a timely manner or on commercially reasonable terms;                                                                                                |
| ● | our suppliers, especially new suppliers, may make errors in manufacturing that could negatively affect the efficacy or safety of our products or cause delays in shipment;                             |
| ● | we may have difficulty locating and qualifying alternative suppliers;                                                                                                                                  |
| ● | switching components or suppliers may require product redesign and possibly submission to the FDA or other similar foreign regulatory agencies, which could impede or delay our commercial activities; |
| ● | one or more of our suppliers may be unwilling or unable to supply components of our products;                                                                                                          |