• EMA approval covers study sites in Germany and Poland as part of the Company’s global Phase 2 RENEW trial
• Trial will evaluate LTI-03, a first-in-class therapy designed to both reduce lung scarring and promote repair

Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced that it has received authorization from the European Medicines Agency (EMA) to initiate the Company’s Phase 2 “RENEW” clinical trial of its lead candidate, LTI-03, for the treatment of idiopathic pulmonary fibrosis (IPF).

The approvals cover clinical trial sites in Germany and Poland, which will serve as key European centers for the global study. Rein has already received regulatory clearance from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).

Brian Windsor, Chief Executive Officer of Rein Therapeutics, commented, “These new authorizations mark another important milestone in our global RENEW trial. With approvals now in the U.K., Germany, and Poland, we are well positioned to begin enrolling patients in multiple regions and advance LTI-03 toward our goal of redefining how pulmonary fibrosis is treated. We are grateful to our clinical partners across Europe for their collaboration and commitment to improving outcomes for patients with IPF.”