Company: SION
Filing Date: 2025-02-07
Form Type: 424B4
Source: 0001193125-25-022709
Chunk: 80

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-02-07
Form: 424B4
Chunk 80
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 to payment of annual fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA or foreign marketing application. If we, or a regulatory authority, discover previously unknown problems with any product, if approved, such as adverse experiences of unanticipated severity or frequency, or problems with the facility where the product is manufactured or if a regulatory authority disagrees with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or us, including requesting revisions to the approved labeling to add new safety information, imposing of post-market studies or clinical trials to assess new safety risks or imposing distribution restrictions or other restrictions under a REMS program, requesting a recall or requiring withdrawal of the product from the market or suspension of manufacturing. If we fail to comply with applicable regulatory requirements following approval of any of our product candidates, a regulatory authority may:

| • |     | issue an untitled letter or warning letter asserting that we are in violation of the law; |

| • |     | seek an injunction or impose administrative, civil or criminal penalties or monetary fines, disgorgement or profits or 
 revenue, warning letters or adverse publicity requirements;                                                            |

| • |     | suspend or withdraw regulatory approvals; |

| • |     | restrict product distribution or use, including full or partial holds on any ongoing or planned clinical trials; |

| • |     | refuse to approve a pending NDA or comparable foreign marketing application (or any supplements thereto) submitted by us or 
 our strategic partners;                                                                                                     |

| • |     | restrict the marketing or manufacturing of the drug; |

| • |     | seize or detain the drug or otherwise require the withdrawal of the drug from the market; |

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| • |     | refuse to permit the import or export of product candidates; or |

| • |     | refuse to allow us to enter into supply contracts, including government contracts. |

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 event or penalty described above may inhibit our ability to commercialize our product candidates and harm our business, financial condition, results of operations and prospects. Healthcare and other reform initiatives may have an adverse impact on our business and results of operations. In the U.S. and some foreign jurisdictions, there have been and continue to be ongoing efforts to implement legislative and regulatory changes regarding the healthcare system. Such