Rein Therapeutics (RNTX) investor relations material

Company focus and LTI-03 mechanism

• Focused on pulmonary orphan diseases; two respiratory programs are phase II ready, with IPF the primary focus. The business was rebranded in early 2025 after an October 2023 reverse merger.

• LTI-03 supplies a caveolin-1 scaffolding-domain peptide to restore regulatory activity that is missing in fibrotic states; the approach is intended to affect multiple cell types and fibrosis pathways.

• Dry-powder inhalation is designed for local lung coverage with limited systemic uptake; phase I-B experience supported patients’ ability to use the inhaler despite IPF.

RENEW phase II trial

• Global, 24-week IPF study evaluates HRCT and forced vital capacity; enrollment was reported 25% faster than expected and is underway in the U.S., U.K., Australia, Germany, Poland, Bulgaria and Romania.

• Trial permits approved background standard of care, including nintedanib, pirfenidone and nerandomilast, and stratifies patients by background therapy; preclinical data suggest LTI-03 may add benefit alongside antifibrotics.

• A blinded interim snapshot is planned before end-2026, covering safety, tolerability through 12 weeks and lung-function data from a portion of patients; it is not an unblinded or futility analysis.

• Last patient enrollment is expected around spring 2027, with trial data expected before end-2027; holidays may affect enrollment timing.

Phase I-B findings and tolerability

• In a 14-day phase I-B study, deep-bronchial-brushing samples showed movement in targeted biomarkers; five were statistically significant for one or the other dose, with dose response for some biomarkers.

• Biomarkers highlighted included IL-11, galectin-7 and surfactant protein D; the latter showed movement and was described as an indicator associated with progression to lung transplant or death.

• Doses in RENEW are 2.5 mg or 5 mg inhaled twice daily; phase I-B cough was generally mild, and the high-resistance device is designed for patients with low inspiratory capacity.