Company: SMNR
Filing Date: 2025-08-22
Form Type: DEFA14A
Source: 0001213900-25-079507
Chunk: 23

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-22
Form: DEFA14A
Chunk 23
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izations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP, consistently applied during the periods involved and applicable law, and to maintain asset and liability accountability, (iii) access to assets or incurrence of liabilities is permitted only in accordance with management’s general or specific authorization and (iv) the recorded accountability for assets and liabilities is compared with the existing assets and liabilities at reasonable intervals and appropriate action is taken with respect to any difference. Except as disclosed in the Form S-4, during the twelve months prior to the date hereof Semnur has not received any notice or correspondence from any accountant relating to any material weakness in any part of the system of internal accounting controls of Semnur.

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(x) Preclinical Development and Clinical Trials. The studies, tests, preclinical development and clinical trials, if any, conducted by or on behalf of Semnur are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by Semnur and all applicable laws and regulations, including the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. parts 50, 54, 56, 58, 312, and 812. The descriptions of, protocols for, and data and other results of, the studies, tests, development and trials conducted by or on behalf of Semnur that have been furnished or made available to the Buyers are accurate and complete. Semnur is not aware of any studies, tests, development or trials the results of which reasonably call into question the results of the studies, tests, development and trials conducted by or on behalf of Semnur, and Semnur has not received any notices or correspondence from the U.S. Food and Drug Administration (“ FDA”) or any other governmental entity or any institutional review board or comparable authority requiring the termination, suspension or material modification of any studies, tests, preclinical development or clinical trials conducted by or on behalf of Semnur.

(y) FDA Approvals. To Semnur’s knowledge, it possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs