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Investor Relations14 Oct 2025
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Sionna Therapeutics (SION) investor relations material
Sionna Therapeutics Morgan Stanley 23rd Annual Global Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Morgan Stanley 23rd Annual Global Healthcare Conference summary8 Sep, 2025
Strategic focus and scientific background
Targeting cystic fibrosis through NBD1, a domain critical to CFTR protein function, aiming to address significant unmet needs in the market.
The NBD1 mutation (F508del) affects 85–90% of CF patients, causing protein instability and dysfunction.
The company’s approach is built on 15 years of research, originating from a Sanofi spinout and leveraging Genzyme’s foundational science.
The market is dominated by a single player, but two-thirds of patients do not achieve normal CFTR function with current therapies.
The CF patient population is over 100,000 globally, with 35,000 in the U.S.
Pipeline progress and clinical development
Advancing two NBD1 stabilizers, SION-451 and SION-719, both exceeding phase one targets for exposure and tolerability.
SION-451 is prioritized as the anchor for a proprietary dual combination, while SION-719 is being tested as an add-on to standard of care.
The dual combination aims to outperform the current triple combination standard (Trikafta) with only two drugs.
Healthy volunteer studies for SION-451 combinations with SION-109 (ICO4 corrector) and galicaftor (SION-2222, TMD1 corrector) have begun.
Both phase 2a trials (add-on and dual combination) are expected to report data by mid-2026.
Clinical trial design and endpoints
The SION-719 phase 2a proof-of-concept uses a two-way crossover in patients stable on Trikafta, measuring sweat chloride as the primary biomarker.
Safety, tolerability, and PK are key endpoints; FEV1 will be assessed in later, larger studies.
The dual combination will be tested in healthy volunteers for safety and PK before moving to phase 2b in CF patients.
The rationale for combining NBD1 with either ICO4 or TMD1 correctors is to restore wild-type CFTR function, which correlates with improved clinical outcomes.
The company will select the best combination based on safety, tolerability, and ability to reach target concentration zones.
What drove SION-451 choice for dual combo?
Why is FEV1 not primary endpoint for SION-719?
How will Sionna address the 2/3 of patients?
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Next Sionna Therapeutics earnings date
Q3 202511 Nov, 2025
Next Sionna Therapeutics earnings date
Q3 202511 Nov, 2025
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Frequently asked questions
Sionna Therapeutics Inc is a biotechnology company focused on the research and development of therapies targeting genetic diseases. The company specializes in discovering small molecule treatments designed to modulate protein function and address the underlying causes of certain conditions. Sionna Therapeutics conducts preclinical and clinical research to advance its pipeline of drug candidates, primarily in the area of rare and inherited disorders. The company collaborates with research institutions and healthcare partners to support its development efforts. Sionna Therapeutics Inc is headquartered in Boston, Massachusetts, and its shares are listed on the NASDAQ.
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