Company: SION
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0002036042-25-000016
Chunk: 243

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part II, Item 8
Chunk 243
---
 doses, SION-719 and SION-451 exposures were achieved that have the potential, based on our preclinical cystic fibrosis human bronchial epithelial (“CFHBE”) model, to provide clinically meaningful benefit if SION-719 or SION-451 were administered as part of a dual combination or as an add-on to the standard of care. We recently completed dosing in the SAD, MAD and food effect and tablet bioequivalence parts of both Phase 1 trials. Both compounds continued to be generally well tolerated, and their safety profiles remained consistent with prior disclosures. Topline data from the Phase 1 trials are expected in the second quarter of 2025.

We intend to evaluate an NBD1 stabilizer in combination with the current standard of care in CF patients in a proof-of-concept trial, which we plan to initiate in the second half of 2025, following completion of a drug-drug interaction trial.

We are also developing a portfolio of complementary CFTR modulators designed to work synergistically with our NBD1 stabilizers to improve CFTR function, as seen in preclinical models. During 2024, we in-licensed three clinical-stage compounds from AbbVie Global Enterprises Ltd. (“AbbVie”) to expand our portfolio of combination product opportunities, including galicaftor (SION-2222), a complementary modulator which targets CFTR’s transmembrane domain 1 (“TMD1”), and has completed Phase 2 clinical trials. In addition, in December 

14

Table of Contents

2024, we completed a Phase 1 clinical trial evaluating another complementary modulator, SION-109, which targets CFTR’s intracellular loop 4 (“ICL4”) region.

We will determine the proprietary dual combination that we believe is optimal to advance into a Phase 2b dose-ranging trial in CF patients. We intend to initiate at least one combination MAD trial in the second half of 2025, assessing the safety, tolerability and PK of a dual combination of an NBD1 stabilizer with galicaftor (SION-2222) and/or SION-109 in healthy volunteers, following completion of combination toxicology studies.

We currently have exclusive rights to develop and commercialize our compounds.

Since our inception in 2019, we have not generated any revenue. We have historically funded our operations primarily with proceeds from the sale and issuance of our preferred stock. As of March 31, 2025, we raised aggregate net