Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 36

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 36
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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 to clinical trials conducted in other territories, and good laboratory
practices, or GLP, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European
Economic Area, or EEA, and comparable foreign regulatory authorities for all of our product candidates in clinical development. Regulatory
authorities enforce these regulations through periodic inspections of study sponsors, principal investigators, study sites and other contractors.
If we or any of our CROs or vendors fail to comply with applicable regulations, including GCP and cGMP regulations, the clinical data
generated in our clinical studies may be deemed unreliable