Company: SION
Filing Date: 2025-02-03
Form Type: S-1/A
Source: 0001193125-25-018825
Chunk: 86

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-02-03
Form: S-1/A
Chunk 86
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 or required to do so due to lack of coverage and adequate reimbursement. Even if we are able to demonstrate our product candidates’ safety and efficacy to the FDA and other regulators and receive approval, concerns in the medical community related to the comparative efficacy or side effect profile of our products may hinder market acceptance and uptake. Efforts to educate the medical community and third-party payors regarding the benefits of our product candidates, if approved, may require significant resources, including management time and financial resources, and may not be successful. If our product candidates do not achieve an adequate level of market acceptance, we may not generate significant revenue and we may not become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

| • |     | the efficacy, safety and potential advantages compared to alternative treatments; |

| • |     | whether a product candidate is approved, if ever, as an add-on to standard of care 
 or as part of a proprietary combination therapy;                                   |

| • |     | the prevalence and severity of any side effects; |

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| • |     | our ability to offer our products at competitive prices; |

| • |     | the convenience and ease of administration compared to alternative treatments; |

| • |     | product labeling or product insert requirements of the FDA or comparable foreign regulatory authorities, including any 
 limitations or warnings contained in a product’s approved labeling, including any boxed warning;                       |

| • |     | the product’s acceptance into current standard of care treatment algorithms by medical societies that could affect 
 payor and physician uptake;                                                                                        |

| • |     | the effectiveness of sales and marketing efforts, and the strength of sales, marketing and distribution support; |

| • |     | the availability of third-party coverage and adequate reimbursement for any product candidates, once approved; |

| • |     | the willingness of the target patient population to try, and of physicians to prescribe, the product; |

| • |     | any restrictions on the use of our products together with other medications; and |

| • |     | potential product liability claims and unfavorable publicity related to our products. |

Any failure by one or more of our product candidates that obtains regulatory approvals to achieve market acceptance or commercial success would adversely affect our business prospects. Due to the significant resources required for the development of our pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others. Moreover, we may fail to expend our