Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 22

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 22
---
 for 2024 as a result of a one-time research and development grant which
resulted in a one-time income), including net income of $5.2 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 $41.7 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, protect, and expand our intellectual property portfolio;                                                                       |

<div align='center'>14</div>

| ● | 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