Company: SION
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0002036042-25-000005
Chunk: 5

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 5
---
 with our NBD1 stabilizers to improve CFTR function, as seen in our CFHBE model. We have several CFTR modulators in development, including galicaftor (SION-2222), a TMD1-directed corrector which has completed Phase 2 clinical trials, and SION-109, an ICL4-directed corrector which completed a Phase 1 clinical trial in December 2024.

•Build upon our NBD1-centric CF franchise through a data-driven dual combination path. Our goal is to develop proprietary combination therapies that provide clinically meaningful benefit to CF patients. Based on the results of the combination MAD trial(s) we plan to initiate in the second half of 2025, evaluating dual combinations of an NBD1 stabilizer with galicaftor and/or SION-109 in healthy subjects, we plan to select the most promising proprietary dual combination to advance into Phase 2b dose-ranging trials in patients with CF.

•Fortify our CF franchise through continued research efforts and utilization of the translational CFHBE model. We aim to build a CF franchise anchored by our NBD1 stabilizers while executing on our mission to deliver medicines that provide clinically meaningful benefit to CF patients. The CFHBE model has been highly predictive of clinical outcomes for approved CFTR modulators, and our application of the model provides a key translational roadmap for us to prioritize compounds for further evaluation. We believe the model allows us to determine the target exposure needed to achieve a 

13

desired level of clinical activity, such as the level of improvement in a patient’s forced expiratory volume in one second (“FEV1”), a measure of lung function, and sweat chloride level, the clinical biomarker of CFTR function. We intend to invest in research activities and leverage insights from the model in our pursuit of delivering additional differentiated product candidates that meaningfully impact the lives of CF patients and facilitate our company’s long-term growth. We also intend to opportunistically consider strategic in-licensing opportunities to maximize the value of our pipeline.

Our Company’s History and Our Team

Sionna was founded in 2019 to continue to explore novel approaches to treating CF by targeting NBD1. Our co-founders, Greg Hurlbut, Ph.D., and Mark Munson, Ph.D., spent over a decade extensively researching the NBD1 target as research leaders at Sanofi SA (f/k/a Sanofi Genzyme) (“Sanofi”). Shortly after our inception, we entered into an exclusive