Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 22

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 22
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statements as of December 31, 2024 and our interim unaudited financial statements as of and for the six months ended June 30, 2025, contain
an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. This going concern opinion could
materially limit our ability to raise additional funds through the issuance of equity or debt securities or otherwise. Further financial
statements may include an explanatory paragraph with respect to our ability to continue as a going concern. Until we can generate significant
recurring revenues, we expect to satisfy our future cash needs through debt or equity financing. We cannot be certain that additional
funding will be available to us on acceptable terms, if at all. If funds are not available, we may be required to delay, reduce the scope
of, or eliminate research or development plans for, or commercialization efforts with respect to our products. This may raise substantial
doubts about our ability to continue as a going concern.

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Risks Related to Our Business and Industry

We may not succeed in advancing the development of 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