Company: SION
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0002036042-25-000047
Chunk: 476

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-08-11
Form: 10-Q
Item: Part I, Item 2
Chunk 476
---
 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 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 of our product candidates, if and when approved, whether alone or in collaboration with others;

•obtaining, establishing, maintaining and enforcing patent and any potential trade secret protection or regulatory exclusivity for our product candidates;

•maintaining an acceptable safety profile of our product candidates following regulatory approvals, if any;

•the sufficiency of our financial resources to fund our operations; and

•maintaining and growing an organization of people who can develop and, if approved, commercialize, market and sell our current or future product candidates.

31

If we are unable to develop, receive marketing approval for and successfully commercialize our product candidates, or if we experience delays as a result of any of the above factors or otherwise, our business would be significantly harmed.

We are early in our development efforts. If we are unable to successfully develop, receive regulatory approval for and commercialize any product candidate or successfully develop any other product candidate or experience significant delays in doing so, our business will be substantially harmed.

We are early in our development efforts. Each of our product candidates will require additional preclinical and/or