REVIVE-ARDS execution starts as enrolment becomes the catalyst

Research evidence excerpt

REVIVE-ARDS execution starts as enrolment becomes the catalyst

Global Research

22 July 2026ab

First Read

EquitiesHealios K.K.

REVIVE-ARDS execution starts as enrolment Japan

becomes the catalyst Biotechnology

12-month rating Buy *

12m price target ¥800

Execution has started

UBS hosted a virtual small meeting with CFO Richard Kincaid and North America CSO Dr.

Sarah Busch from 9:00am JST. The conclusion is straightforward: Healios has moved Price (21 Jul 2026) ¥261

from planning to execution, with REVIVE-ARDS now initiated in Japan after PMDA RIC: 4593.T BBG: 4593 JP

clinical trial notification submission on 20 January 2026 and completion of the 14-day

Trading data and key metrics

PMDA review, making first patient enrolment the next visible catalyst. The study is a

global, randomized, double-blind, placebo-controlled Phase III in pneumonia-induced 52-wk range ¥713-238

ARDS, dosing within 48 hours of ARDS diagnosis, with Japan starting first before Market cap. ¥24.1b/US$0.15b

broader global expansion. Shares o/s 92.3m (ORD)

Free float 30%

Trial design looks regulator-aligned and investable Avg. daily volume ('000) 1,637

The trial design remains the cleanest part of the story: up to 550 patients, interim Avg. daily value (m) ¥479.7

analyses at 300 and 400 patients, early stopping if efficacy reaches statistical Common s/h equity (12/26E) ¥0.90b

significance, and ventilator-free days through Day 28 as the primary endpoint. P/BV (12/26E) 28.4x

Importantly, Healios has disclosed that the FDA agreed to the VFD endpoint framework, Net debt to EBITDA (12/26E) 0.1x

while PMDA agreed Japanese patients in REVIVE-ARDS can be used as part of the post-

EPS (reported, basic) (¥)

approval confirmatory package for Japan conditional/time-limited approval. This creates

UBS Cons.