Company: SION
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0002036042-25-000047
Chunk: 201

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-08-11
Form: 10-Q
Item: Part II, Item 1A
Chunk 201
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BD1 stabilizer product candidates, including SION-719 and SION-451, which are currently in development for the treatment of CF. Our NBD1 stabilizers are being developed for use either in combination with one of our complementary modulator candidates or the standard of care. We intend to advance SION-719 in a Phase 2a proof-of-concept clinical trial in combination with the current standard of care and we intend to advance SION-451 in a Phase 1 healthy volunteer dual combination trial with each of our two most advanced complementary modulator candidates, galicaftor (SION-2222) and SION-109. 

The success of SION-719, SION-451 and our other product candidates will depend on several factors, including the following:

•successful and timely initiation and enrollment of clinical trials and completion of clinical trials with favorable results;

•the safety, tolerability and pharmacokinetic profile of our product candidates observed in clinical trials, including in combination with the current standard of care;

•acceptance of regulatory submissions by the U.S. Food and Drug Administration (“FDA”) and/ or comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates, including acceptance by the FDA of an investigational new drug application (“IND”) for such product candidate, and the proposed design of our planned clinical trials;

•the frequency and severity of adverse safety findings in nonclinical studies and adverse events (“AEs”) in clinical trials;

•timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies and in vitro dose projection studies in animals, where applicable;

•acceptance of our products, if approved, by CF patients, the medical community and third-party payors, and their perspective on the cost, safety, tolerability and efficacy and perceived advantages of alternative therapies for CF, including the current standard of care;

•maintaining relationships with contract research organizations (“CROs”) and clinical sites for the clinical development of our product candidates and ability of such CROs and clinical sites to comply with clinical trial protocols, Good Clinical Practices (“GCPs”) and other applicable requirements;

•demonstrating the safety and efficacy of our product candidates to the satisfaction of applicable regulatory authorities;

•receipt and maintenance of marketing approvals from applicable regulatory authorities for our initial target indication and label expansions to include new populations;

•maintaining relationships with our third-party manufacturers and their ability to comply with current good manufacturing practices (“cGMPs”), as well as making arrangements with