Nano24 Reports Positive Phase 2b Results for Inhaled EXO-CD24 in Acute Respiratory Distress Syndrome (ARDS) at the CHEST Annual Meeting 2026

• Primary endpoint met, with 85% free of respiratory failure at Day 7 vs. 33.3% with placebo (p<0.0001)

• 72% reduction in risk of death at day-28 (HR 0.28; p=0.033), with benefit sustained at six months

• Hospital stay cut from 14.4 to 6.5 days (p=0.0001)

• Well tolerated; no treatment-related serious adverse events

• Nano24 plans to advance EXO-CD24 into a larger, international Phase 3 trial

TEL AVIV, Israel, October 20, 2026--Nano24 Ltd., a privately held, clinical-stage biotechnology company developing engineered exosome therapeutics, today announced positive results from its randomized, double-blind, placebo-controlled Phase 2b trial of inhaled EXO-CD24 in patients with acute respiratory distress syndrome (ARDS). The data are being presented today by Shiran Shapira, Ph.D., Co-Founder and Chief Scientific and Technology Officer (CSO/CTO) of Nano24, in the "Top Late-Breaking Abstracts: New Drugs, New Targets, New Tools" session at the CHEST Annual Meeting 2026, hosted by the American College of Chest Physicians, in Phoenix, Arizona.

EXO-CD24 met the trial's primary endpoint and significantly reduced all-cause mortality, with the survival benefit sustained through six months. Treated patients also spent substantially less time in the hospital, and the therapy was well tolerated. Based on these results, Nano24 plans to advance EXO-CD24 into a larger, international Phase 3 trial to confirm its efficacy and safety in ARDS.

Phase 2b Trial Design and Results

The Phase 2b trial (NCT05947747) enrolled 90 patients with ARDS of any etiology and stage, randomized 2:1 to inhaled EXO-CD24 (n=60) or placebo (n=30). EXO-CD24 was administered at 1010 particles per dose, twice daily for five days. Patients were followed through Day 28, with longer-term follow-up at six months.

Primary endpoint: 85% of patients in the EXO-CD24 arm were free of respiratory failure (SpO2/FiO2 >315) at Day 7, compared with 33.3% in the placebo arm (p<0.0001).

28-day mortality: In an adjusted Cox model, the EXO-CD24 arm showed a 72% reduction in the risk of death compared to placebo (HR 0.28; 95% CI 0.084–0.902; p=0.033).

Six-month survival: The benefit persisted through six months, with all-cause mortality of 13.3% versus 43.3% (p=0.003), a 69% relative reduction.

Hospitalization: Mean hospital stay through Day 28 was 6.5 days with EXO-CD24 versus 14.4 days with placebo (p=0.0001), with potential to reduce the burden on patients, intensive care units and healthcare systems.

Safety: EXO-CD24 was well tolerated, with no treatment-related serious adverse events, and fewer serious and non-serious adverse events in the EXO-CD24 arm than in the placebo arm. The trial's size limits conclusions about uncommon risks.