Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 23

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 23
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 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 size of any markets in
which our products and product candidates receive approval and our ability to achieve sufficient market acceptance, pricing, reimbursement
from third-party payors for our products and product candidates. Further, the operating losses that we incur may fluctuate significantly
from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication
of our future performance. Other unanticipated costs may also arise.

We have not generated any revenue from product sales and may never be profitable.

While
our GelrinC has been approved as a device with a CE mark in Europe since August 2017, we have not yet begun to commercialize our products
and have never generated any revenue from product sales. Our ability to generate revenue and achieve profitability mainly depends on our
ability to find a marketing partner for Europe after we scale-up our manufacturing and prepare our GelrinC product for launch. In parallel,
we need to receive the necessary regulatory approvals to commercialize our GelrinC in the United States. We do not know when, or if at
all, we will generate any such revenue. Our ability to generate future revenue from product sales will depend heavily on our success in
many areas, including but not limited to:

| ● | complete research and development of our Gelrin hydrogel platform and any future product candidates in a timely and successful manner; |

| ● | complete our pivotal clinical study in the United States. and Europe successfully; |

| ● | obtain FDA approval for our GelrinC product |

| ● | obtain regulatory and marketing approval for any product candidates; |

| ● | maintain and enhance a commercially viable, sustainable, scalable, reproducible and transferable manufacturing process for our GelrinC product and our hydrogel platform and any future product candidates that is compliant with current good manufacturing practices, or cGMPs; |

| ● | establish and maintain supply and, if applicable, manufacturing relationships with third parties that can provide, in