Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 16

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 16
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 of the risks and uncertainties frequently encountered by companies in new and rapidly evolving
fields, particularly in the medical device industry. To date, we have not generated any revenue from the sale of our product candidate
(see “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for additional information).
We have incurred losses in each year since our inception (except for 2024 as a result of a one-time research and development grant which
resulted in a one-time income), including net income of $4.8 million and a loss of $4.1 million for the years ended December 31, 2024
and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of approximately $42.1 million. Substantially all of our
operating losses resulted from costs incurred in connection with the development of our Gelrin hydrogel platform and from general and
administrative costs associated with our operations.

If we obtain the FDA’s
marketing approval for our GelrinC proprietary hydrogel platform we will likely incur significant sales, marketing, and outsourced manufacturing
expenses, as well as continued research and development expenses. Furthermore, in the period following this offering, we expect to incur
additional costs associated with operating as a public company. As a result, we expect to continue to incur significant and increasing
operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing a medical device,
we are unable to predict the extent of any future losses or when we will become profitable, if at all.

We expect to continue to
incur significant losses until we receive the necessary regulatory approvals to commercialize out lead product candidate, GelrinC, in
the United States, which we may not be successful in achieving. We anticipate that our expenses will increase substantially if and as
we:

| ● | continue the research and                                                                                        
 development of our Gelrin hydrogel platform, products and product candidates, including through clinical trials; |
| ● | seek additional regulatory                                                                                       
 and marketing approvals;                                                                                         |
| ● | establish a sales, marketing,                                                                                    
 and distribution infrastructure to commercialize our products and product candidates;                            |

| ● | rely on our third-party                                                                                                
 suppliers and manufacturers to obtain adequate supply of materials and components for our products                     |
| ● | seek to identify, assess,                                                                                              
 acquire, license, and/or develop other product candidates and subsequent generations of our current product candidate; |
| ● | seek to maintain