Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119822
Chunk: 271

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 271
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 and export and import of products such as those we are marketing and developing. SP-102, SP-103, SP-104and any other product candidate that we develop must be approved by the FDA or otherwise authorized for marketing before they may be legally marketed in the United States and by the corresponding foreign regulatory agencies before they may be legally marketed in foreign countries. The processes for obtaining marketing approvals, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources. U.S. Drug Development Process In the United States, the FDA regulates drugs under the FDCA and implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable requirements at any time during the product development process, approval process or after approval, may subject an applicant or its products to a variety of administrative or judicial sanctions, such as imposition of a clinical hold, the FDA’s refusal to approve pending applications, withdrawal of an approval, inspection scrutiny, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, or reimbursements, restitution, disgorgement of profits or other civil or criminal penalties. The process required by the FDA before a drug may be marketed in the United States generally involves the following:

| • |     | completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory 
 Practices (“GLPs”) or other applicable regulations;                                                             |

| • |     | completion of FDA’s drug substance (Part 210), drug product (Part 211), combination of product and device                                                    
 (Part 820) and all Module 3, Chemistry, Manufacturing and Control (“CMC”), and the current Good Manufacturing Practices(“cGMP”) requirements for NDA filing; |

180

| • |     | submission to the FDA of an Investigational New Drug Application (“IND”), which must become effective 
 before human clinical trials may begin;                                                               |

| • |     | approval by an institutional review board (“IRB”) covering each clinical site before each trial may be 
 initiated;                                                                                             |

| • |     | performance of adequate and well-controlled human clinical trials according to the laws and regulations                                                                                                     
 pertaining to the conduct of human clinical trials, collectively referred to as Good