Company: SION
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0002036042-25-000016
Chunk: 4

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 3
Chunk 4
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 This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. Changes may occur beyond our control that would cause us to consume our available capital before that time, including but not limited to changes in progress of our development activities, acquisitions of additional product candidates and changes in regulations. Our future capital requirements will depend on many factors, including:

•the scope, timing, progress, costs, complexity and results of discovery, preclinical development and clinical trials for our current or future product candidates, including our planned Phase 2a proof-of-concept clinical trial to evaluate a nucleotide-binding domain (“NBD1”) stabilizer product candidate in combination with Vertex Pharmaceuticals, Inc.’s (“Vertex”) Trikafta, the current standard of care for the treatment of cystic fibrosis ("CF"), and at least one planned multiple-dose trial to evaluate a dual combination of an NBD1 stabilizer with a complementary modulator product candidate;

•the number of clinical trials required for regulatory approvals of our current or future product candidates;

•the extent to which we develop, in-license or acquire other product candidates in our pipeline;

•the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs as we advance them through preclinical and clinical development and, if approved, commercialization;

•the number and development requirements of product candidates that we may pursue;

•the timing and amount of the milestone, royalty or other payments we must make to Sanofi SA (“Sanofi”), the Cystic Fibrosis Foundation (“CFF”), AbbVie Global Enterprises Ltd. (“AbbVie”) and any other third parties;

•the costs, timing and outcome of regulatory review of our product candidates;

•our headcount growth and associated costs as we expand our research and development capabilities and establish a commercial infrastructure;

•the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;

•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

•our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors (or patients’ willingness to pay out-of-pocket for any approved products in the absence of such coverage) and adequate market share and revenue for any approved products;

•the revenue, if any, received from commercial sales of any product candidates for which we