Company: SION
Filing Date: 2025-01-17
Form Type: S-1
Source: 0001193125-25-008474
Chunk: 43

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-01-17
Form: S-1
Chunk 43
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 planned studies, initiation of new studies or post-marketing clinical trials (including to assess safety risks), or additional analyses of existing data. Typically, we are required to provide annual updates on the progress of such required activities and to complete the activities by the assigned completion dates. Later discovery of previously unknown problems with our product candidates, including AEs of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

| • |     | restrictions on the marketing or manufacturing of such products, withdrawal of the product from the market or voluntary or 
 mandatory product recalls;                                                                                                 |

| • |     | restrictions on or revisions to the labeling or marketing of a medicine; |

| • |     | restrictions on the distribution or use of a medicine, including under a risk evaluation and mitigation strategy 
 (“REMS”) program;                                                                                                |

| • |     | fines, receipt of warning or untitled letters or suspension of clinical trials; |

| • |     | refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or 
 withdrawal of marketing approvals;                                                                                      |

| • |     | product seizure or detention or refusal to permit the import or export of our product candidates; and |

| • |     | injunctions or the imposition of civil or criminal penalties. |

Additionally, the FDA and other regulatory agencies closely regulate the post-approval marketing and promotion of medicines to ensure that they are marketed only for the approved indications and in accordance with the provisions of the approved labeling. Although physicians may prescribe products for uses not described in the product’s labeling, known as off-labeluses, in their professional medical judgment, the FDA and comparable foreign regulatory agencies impose stringent restrictions on manufacturers’ communications regarding off-labeluse, and if we market our products, if approved, in a manner inconsistent with their approved labeling, we may be subject to enforcement action for off-labelmarketing by the FDA and other federal and state enforcement agencies, including the Department of Justice and other comparable foreign regulatory agencies. Violation of the Federal Food, Drug, and Cosmetic Act and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription products may also lead to investigations or allegations of violations of federal and state healthcare fraud and abuse laws, state consumer protection laws and laws of other comparable foreign regulatory agencies. Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any