Company: SION
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0002036042-25-000016
Chunk: 104

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 4
Chunk 104
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1 stabilizers are being developed for use either in combination with one of our complementary modulator candidates or the standard of care. We intend to select a complementary modulator candidate from our two most advanced modulator candidates, galicaftor (SION-2222), which has been evaluated in Phase 2 clinical trials conducted by AbbVie, and SION-109, which has been evaluated in a Phase 1 clinical trial.

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 our NBD1 stabilizer product candidate prior to commencement of our planned Phase 2 trials and our proposed design of such 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 our third-party manufacturers for commercial manufacturing capabilities at a cost and scale sufficient to support commercialization;

•establishing sales, marketing and distribution capabilities and launching commercial sales