Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 16

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 16
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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, protect,                                                                                             
 and expand our intellectual property portfolio;                                                                        |

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| ● | seek to attract and retain skilled personnel;                                                                                        |
| ● | create additional infrastructure                                                                                                     
 to support our operations as a public company and our product candidate development and planned future commercialization efforts;    
 and                                                                                                                                  |
| ● | experience any delays or                                                                                                             
 encounter issues with respect to any of the above, including, but not limited to, failed studies, complex results, safety issues     
 or other regulatory challenges that require longer follow-up of existing studies or additional supportive studies in order to pursue 
 marketing approval.                                                                                                                  |

The
amount of any future operating losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding
through equity or debt financings, strategic collaborations or grants. Even if we obtain additional regulatory approvals to market our
Gelrin products and product candidates or any future product candidates, our future revenue will depend upon the