Company: SION
Filing Date: 2025-01-17
Form Type: S-1
Source: 0001193125-25-008474
Chunk: 129

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-01-17
Form: S-1
Chunk 129
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND

RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and related notes and other financial information included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements based upon our current plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this prospectus. You should carefully read the “Risk Factors” section of this prospectus to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Also see the section titled “Cautionary Note Regarding Forward-Looking Statements.”

Overview

We are a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (“CF”)
patients by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (“CFTR”) protein to deliver clinically meaningful benefit to CF patients. Our goal is to deliver differentiated
medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (“NBD1”). We believe stabilizing NBD1 is central to unlocking
dramatic improvements in clinical outcomes and quality of life for CF patients.

We are conducting ongoing Phase 1 trials of our two highly potent
NBD1 stabilizers—SION-719 and SION-451—evaluating the safety, tolerability and PK of single and multiple ascending doses of each product candidate in healthy subjects. These trials are randomized, doubled-blinded, placebo-controlled trials
being conducted in Australia. As of January 14, 2025, five SAD cohorts and three MAD cohorts of SION-719 have been completed, with over 60 healthy subjects dosed (randomized 3:1 active:placebo), and six SAD cohorts and three MAD cohorts of SION-451
have been completed, with over 70 healthy subjects dosed (randomized 3:1 active:placebo). Both SION-719 and SION-451 have been generally well tolerated based