Company: SION
Filing Date: 2025-02-03
Form Type: S-1/A
Source: 0001193125-25-018825
Chunk: 38

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-02-03
Form: S-1/A
Chunk 38
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 our product candidates
may be harmed, which could harm our business, operating results, prospects or financial condition.

Targeting the NBD1 domain of the CFTR protein is novel, and we do not know whether we will be able to successfully develop any products.

Our NBD1 stabilizer product candidates target the NBD1
domain of the CFTR protein, which is a novel target. Other companies have discontinued programs targeting NBD1 as they were unable to develop compounds that could successfully bind to NBD1. We intend to develop one of our NBD1 stabilizers as a
combination therapy with either one of our complementary modulators, galicaftor or SION-109, or as an add-on to the current standard of care. Given the novelty of our
product candidates and the inherent risk in developing a combination or add-on therapy, we may not be able to successfully develop any products.

While products modulating the CFTR protein have been approved by the FDA and comparable foreign regulatory authorities, to date, no product that
directly targets the NBD1 domain has been approved, and to our knowledge, no product candidate directly targeting the NBD1 domain is currently in development. As a result, it is difficult to predict the developmental challenges we may encounter as
our NBD1 stabilizers proceed through clinical trials, including our planned future clinical trials of our lead NBD1 stabilizer product candidate in combination with galicaftor or SION-109, or as an add-on to the current standard of care. It is also difficult for us to predict the time and cost of development of an NBD1 stabilizer-anchored combination therapy, whether any
of our clinical trials will be successful, and whether our novel approach will result in the successful development and regulatory approval of any product candidates. Any development problems we experience in the future related to our NBD1
stabilizer product candidates or any of our complementary modulator candidates may cause significant delays or unanticipated costs, and such development problems may not be able to be solved. The novelty of our product candidates and our combination
therapy approach may lengthen the regulatory review process, require us to conduct additional studies or clinical trials, increase our development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and
commercialization of our product candidates or lead to significant post-approval limitations or restrictions. For example, the FDA could require additional studies that may be difficult or impossible to perform, or prohibitively costly. Any of these