Rein Therapeutics receives FDA clinical hold on LTI-03 Phase 2 trial; cites insufficient nonclinical safety data

Rein Therapeutics, Inc.

FDA placed Phase 2 RENEW trial of LTI-03 on clinical hold on July 8, 2025 via formal letter.
FDA cited no NOAEL and minimal mucus cell hyperplasia in 26-week rat study; requests new inhalation toxicity study.
Company believes existing data supports safety, plans to work with FDA to resolve hold expeditiously.
Board approved bylaw amendment lowering quorum requirement to 40% of shares outstanding.

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