Company: SION
Filing Date: 2025-01-17
Form Type: S-1
Source: 0001193125-25-008474
Chunk: 186

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-01-17
Form: S-1
Chunk 186
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 regions where we determine it makes commercial sense to do so.
Given the established CF patient care centers and identified teams of healthcare professionals, we believe we could commercialize our product(s) for CF with a relatively small specialty sales force that calls on a limited and focused group of
prescribing healthcare professionals. At the appropriate time, we will recruit a sales force and a medical affairs team and take other steps to establish the necessary commercial infrastructure. As product candidates advance through our pipeline,
our plans may change.

Competition

The biotechnology and
pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. While we believe we have competitive advantages, we face substantial competition from many different
sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic research institutions and governmental agencies, and public and private research institutions. This may include other small-molecule drug
discovery companies using similar approaches or other types of therapies, such as small molecule, gene 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