Company: SION
Filing Date: 2025-02-03
Form Type: S-1/A
Source: 0001193125-25-018825
Chunk: 188

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-02-03
Form: S-1/A
Chunk 188
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 therapy, gene editing and/or mRNA therapies.

In particular, we expect to compete with Vertex, which has multiple approved products, as well as additional product candidates in development, for the
treatment of CF that would compete with our product candidates, if approved. Vertex is the manufacturer of the five approved CFTR modulators, including the standard of care, Trikafta, a triple combination therapy approved for patients with at least
one F508del mutation or responsive mutations based on in vitro data. Vertex’s marketed products generated approximately $10 billion in sales in 2023. In addition, in December 2024, Vertex received approval from the FDA for a
second-generation, triple modulator combination, Alyftrek, for treatment of CF in patients aged six years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene. Alyftrek demonstrated non-inferiority to Trikafta in the primary endpoint of two Phase 3 clinical trials, providing patients with similar FEV as Trikafta and sweat chloride
improvements of 3 to 8 mmol/L. Any product candidates that we successfully develop and commercialize will compete with these existing therapies, as well as any new therapies that may become available in the future that are approved to treat the
same diseases for which we may obtain approval for our product candidates.

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We may also face competition from other companies attempting to develop therapeutics targeting CF. For
example, in August 2023, HIT-CF Europe announced plans to initiate a 52-patient trial of Fair Therapeutics, Inc.’s CFTR modulators in select European CF patients
based on organoid response to the experimental combination. Multiple companies are developing CF-utilizing nucleic acid therapies, which are compounds that allow expression of a functional CFTR protein and are
relevant for the more than 5,000 people with CF who cannot make full-length CFTR protein and are not eligible for CFTR modulators. In addition, multiple companies are developing candidates for gene therapy approaches to treat CF.

Some of our competitors have significantly greater financial resources than we do and an established presence in the market. Our competitors may have
greater expertise in research and development, manufacturing, obtaining regulatory approvals and marketing approved products and may obtain regulatory approvals for their products more rapidly than we can, if at all. Smaller or early-stage companies
may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. We also compete with