Company: SION
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0002036042-25-000047
Chunk: 317

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-08-11
Form: 10-Q
Item: Part I, Item 1
Chunk 317
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 data also supported the use of a tablet formulation in future trials and indicated that both compounds could be dosed in a fed or fasted state. Both NBD1 stabilizers met exposure thresholds that we believe, based on our preclinical CF human bronchial epithelial ("CFHBE") model, have the potential to provide clinically meaningful benefit if administered as an add-on to SOC or in proprietary dual combinations with complementary modulators. 

Based on the Phase 1 results, we are advancing both NBD1 stabilizers —SION-719 and SION-451— to the next phase of clinical development. 

We plan to progress SION-719 into a Phase 2a proof-of-concept trial in CF patients evaluating the compound as an add-on to SOC, pending completion of a drug-drug interaction study to confirm that SION-719 can be dosed with the SOC according to its label. We are on track to initiate the Phase 2a trial in the second half of 2025. SION-451 will advance to a Phase 1 dual combination trial in healthy volunteers evaluating SION-451 in dual combinations with each of galicaftor (SION-2222) and SION-109, two of our complementary CFTR modulators. The trial will evaluate the safety, tolerability, and PK of varying doses of the dual combinations. Initiation is anticipated in the second half of 2025.

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Strategic In-Licensing & Complementary Modulators

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

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

Sources of Liquidity and Financing History

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