Company: SION
Filing Date: 2025-02-07
Form Type: 424B4
Source: 0001193125-25-022709
Chunk: 184

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-02-07
Form: 424B4
Chunk 184
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. The PK profile in CF patients was similar in healthy volunteers.

The
activity of navocaftor in patients with CF was evaluated in a randomized, double-blind, placebo-controlled Phase 2 trial in combination with a galicaftor dose range from 10 mg to 300 mg QD, as summarized above. Combination treatment of navocaftor
150 mg QD with galicaftor resulted in improvements in FEV and sweat chloride levels in the homozygous F508del population. As expected, treatment with 50 mg QD or 150 mg QD navocaftor
monotherapy for 28 days did not result in improvements in FEV or sweat chloride levels.

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Manufacturing

We have leveraged multiple third-party manufacturers to support the manufacturing of our product candidates for clinical trials and, if we receive
regulatory approval, we intend to rely on third parties for commercial manufacture. We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We expect this strategy will enable us to maintain a more efficient
infrastructure, outsourcing instead of building manufacturing and supply chain capabilities, while simultaneously enabling us to focus our expertise on the clinical development of our product candidates. We expect to enter into commercial supply
agreements with such manufacturers prior to any potential approval of our product candidates.

Commercialization

We have exclusive worldwide commercial rights to our product candidates. Given our stage of development, we have not yet established a commercial
organization or distribution capabilities. The CF patient populations are well-characterized and clearly identified in the U.S., Canada, Europe and several other regions around the world, with highly active and informed CF patient advocacy groups.
Most CF patients are treated at a limited number of centralized CF patient care centers by a team of healthcare professionals who are experts in and dedicated to treating CF.

We plan to independently commercialize our products, if approved, in the U.S. and other 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,