Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 17

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 17
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 primarily through the issuance of our equity
securities and convertible loans.

We have only a limited operating
history upon which you can evaluate our business and prospects. In addition, we have limited experience and have not yet demonstrated
an ability to successfully overcome many 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 approximately $7.2 million and a net loss of $3.2 million in the six months
period ended June 30, 2024 and 2023, respectively, and net loss of $4.1 million and $1.4 million for the years ended December 31, 2023
and 2022, respectively. As of June 30, 2024 and December 31, 2023 we had an accumulated deficit of approximately $39.7 million and $46.9
million, respectively. 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; |