Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 23

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 23
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 our product, achieve manufacturing stability and capacity, demonstrate sufficient clinical evidence or commercialize our product and generate significant revenues.

We are a development-stage
company and are subject to all of the risks inherent in the establishment of a new business enterprise. We have a limited operating history
and only a preliminary and unproven business plan upon which investors may evaluate our prospects. We have not yet fully demonstrated
the feasibility of our regenerative hydrogel technology for commercial applications. We may not receive, or may be delayed in receiving,
the necessary approval or clearance for GelrinC or our future products.

Furthermore, even if our
technology becomes commercially viable, our business models may not generate sufficient revenue necessary to support our business. If
we are unable to address any issues mentioned above, or encounter other problems, expenses, difficulties, complications, and delays in
connection with the starting and expansion of our business, our entire business may fail, in which case you may lose part of, or your
entire investment.

We have a history of net
losses and negative cash flow from operations since inception and we expect such losses and negative cash flows from operations to continue
in the foreseeable future. We anticipate our losses will continue to increase from current levels because we expect to incur additional
costs related to developing our business, including research and development costs, manufacturing costs, employee-related costs, costs
of complying with government regulations, intellectual property development and prosecution costs, marketing and promotion costs, capital
expenditures, general and administrative expenses, and costs associated with operating as a public company.

Our ability to generate revenue
from our operations and, ultimately, achieve profitability will depend on, among others, whether we can complete the development and
commercialization of our technology, our future products and our services, including our GelrinC product candidate and platform technology,
whether we can manufacture GelrinC on a commercial scale in such amounts and at such costs as we anticipate, and whether we can achieve
market acceptance of our products, services and business models. We may never generate any revenue or operate on a profitable basis.
Even if we achieve profitability, we may not be able to sustain it.

Clinical failure can occur at any stage of clinical development. Our clinical experience to date does not necessarily predict future results and may not have revealed certain potential limitations of the technology and potential complications from GelrinC and may require further clinical validation. Any product version we advance through clinical trials may not have favorable results in later clinical trials or receive a regulatory approval.

Clinical failure