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--(BUSINESS WIRE)--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.

“ARDS remains a serious clinical challenge, and patients need additional treatment options,” said Matthew Baldwin, M.D., a pulmonary and critical care physician-scientist and Associate Professor of Medicine at Columbia University. “The findings on the proportion of patients free of respiratory failure at Day 7 and on all-cause mortality are encouraging in this deadly condition. I look forward to taking part in the upcoming Phase 3 study.”

Beyond ARDS

ARDS is the first clinical proof of concept for Nano24’s engineered exosome platform, which the company aims to use to build a new generation of precisely engineered, biologically inspired therapeutics for diseases with limited treatment options. Nano24 is also evaluating EXO-CD24 in additional inflammatory conditions, supported by biological rationale and preclinical research.

“Exosomes offer a promising foundation for drug delivery because their surfaces and internal cargo can be engineered to perform complementary functions,” said Professor Robert Langer, Sc.D., head of Nano24’s Scientific Advisory Board.

Presentation Details
Title:	From Nature to Medicine: EXO-CD24 Reduces Mortality in ARDS in Phase 2b
Presenter:	Shiran Shapira, Ph.D., Co-Founder and Chief Scientific and Technology Officer (CSO/CTO) of Nano24
Session:	Top Late-Breaking Abstracts: New Drugs, New Targets, New Tools
Date:	Tuesday, October 20, 2026
Time:	11:35–11:43 a.m. MST (Phoenix local time)
Location:	CHEST Annual Meeting 2026, Phoenix, Arizona

About ARDS

ARDS is a life-threatening condition marked by severe lung inflammation and impaired oxygenation that can progress to respiratory and multi-organ failure. It can be triggered by more than 80 causes, including viral or bacterial infection, trauma and acute pancreatitis. Mortality remains 20–46% despite supportive care, underscoring the urgent need for treatments that improve survival and recovery.

About EXO-CD24

EXO-CD24 is an investigational inhaled therapy that combines engineered exosomes with the immunomodulatory protein CD24. It is designed to selectively control harmful, damage-driven inflammation while preserving the immune system’s ability to recognize and eliminate pathogens, delivering its activity directly to the lungs. EXO-CD24 has been administered to more than 260 patients in clinical trials and on a compassionate-use basis, with follow-up of more than five years.

About Nano24

Nano24 is a privately held, clinical-stage biotechnology company pioneering a new generation of precisely engineered exosome therapeutics. Founded on research at Tel Aviv Sourasky Medical Center, Nano24 harnesses exosomes, the body’s natural intercellular communication system, to develop targeted therapies for serious diseases with significant unmet medical need. For more information, visit nano24med.com.

Forward-Looking Statements

This press release contains forward-looking statements concerning Nano24’s investigational therapies, clinical development programs, regulatory interactions, manufacturing capabilities, anticipated development timelines, potential therapeutic indications, platform technologies, financing activities, and future collaborations.

These statements reflect the company’s current expectations and are subject to risks and uncertainties, including clinical trial outcomes, regulatory decisions, manufacturing and scale-up challenges, financing requirements, and operational considerations. Actual results may differ materially from those expressed or implied.

EXO-CD24 remains an investigational therapeutic and has not been approved for commercial use by any regulatory authority. Positive findings from earlier-stage clinical trials do not guarantee successful outcomes in subsequent studies or regulatory approval.

Nano24 undertakes no obligation to update these forward-looking statements except as required by applicable law.