Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 36

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 36
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 may face difficulties raising capital through sales of
our Ordinary Shares or other securities and such sales may be on unfavorable terms. To the extent that future waves of COVID-19 disrupt
normal business operations, we may face operational challenges with our services, and we likely will have to adopt remote working and
workplace protocols for employees in accordance with government requirements and other measures to minimize such impact.

The
extent to which COVID-19 impacts our operations will depend on future developments, which are highly uncertain and cannot be predicted
with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain COVID-19 or treat
its impact. In particular, the extent to which any resurgence of the COVID-19 pandemic may impact our business and financial performance
will depend on future developments, which are highly uncertain and cannot be predicted with confidence.

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Risks Related to Our Reliance on Third Parties

We will rely on third parties to conduct certain elements of our preclinical studies and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.

We rely upon third-party
vendors, including CROs, to monitor and manage data for our ongoing preclinical studies and clinical trials. If our CROs do not successfully
carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy
of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for
other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or
successfully commercialize our product candidates. We rely on these CROs for execution of our preclinical studies and clinical trials,
and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted
in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the vendors and CROs does
not relieve us of our regulatory responsibilities. We and our CROs and other vendors are required to comply with good clinical practice,
or GCP, cGMP, the Helsinki Declaration, the International Conference on Harmonization Guideline for Good Clinical Practice, applicable
European Commission Directives on Clinical Trials, laws and regulations applicable