Company: SION
Filing Date: 2025-02-03
Form Type: S-1/A
Source: 0001193125-25-018825
Chunk: 221

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-02-03
Form: S-1/A
Chunk 221
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 is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of services reimbursable by Medicare 
 or a state healthcare program;                                                                                                                                                                                                                      |

| • |     | the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended, which imposes                                                                                                                                           
 criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also establishes requirements related to the privacy, security, and transmission of individually identifiable health information which apply to many 
 healthcare providers, physicians and third-party payors with whom we interact;                                                                                                                                                                         |

| • |     | the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material                 
 fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; |

| • |     | the FDCA, which, among other things, strictly regulates drug product and medical device marketing, prohibits manufacturers 
 from marketing such products for off-label use and regulates the distribution of samples;                                  |

| • |     | federal laws, such as the Medicaid Drug Rebate Program, that require pharmaceutical manufacturers to report certain                                                                                              
 calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under governmental healthcare programs; |

| • |     | federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and 
 activities that potentially harm consumers;                                                                          |

| • |     | the so-called federal “sunshine law” or Open Payments which requires                                                                                                                                           
 manufacturers of drugs, devices, biologics, and medical supplies to report to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value to teaching hospitals, |

162

| physicians, and other healthcare practitioners, as well as ownership and investment interests held by physicians and their immediate family members; and |

| • |     | analogous state laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or                                                                                                                                    
 marketing arrangements and claims involving healthcare items or services reimbursed by non- governmental third-party payors, including private insurers, and state laws which regulate interactions between                                             
 pharmaceutical companies and healthcare providers, require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, require    
 pharmaceutical companies to report information on transfers of value to other healthcare providers, marketing expenditures or pricing information and/or require licensing of sales representatives