Page 1

This Announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation No. 596/2014 as it forms part of UK law by virtue of the European Union ( Withdrawal ) Act 2018 as amended . Upon the publication of this Announcement , this inside information is now considered to be in the public domain . 30 September 2026 ONDINE BIOMEDICAL INC . ( " Ondine Biomedical ” , “ Ondine " , or the " Company " ) Ondine Biomedical Reports H1 2026 Results Following Positive Phase 3 Topline Readout and Continued Commercial Progress Positive Phase 3 topline results , peer - reviewed clinical evidence , revenue growth and expanding authorised - market adoption highlight continued clinical and commercial progress . Ondine Biomedical Inc. ( AIM : OBI ) , a leader in light - activated antimicrobial therapies designed to prevent hospital infections , announces its unaudited financial and operational results for the six months ended 30 June 2026 ( “ H1 2026 " ) together with an operational update on post - period activity , including positive topline results from the Company's LANTERN Phase 3 trial and continued commercial progress in markets where Steriwave is already authorised . All figures are in Canadian dollars unless otherwise stated . Key Highlights , including post - period activity • • • Positive Phase 3 topline results : The large , multi - centre pivotal Phase 3 clinical trial ( LANTERN ) , in which 5,188 patients were enrolled , met its primary efficacy endpoint . The primary Bayesian analysis demonstrated a 40.5 % relative reduction in the risk of 30 - day surgical site infection , with a 98.2 % posterior probability of benefit , compared with standard of care alone ( under which a mupirocin nasal antibiotic regimen was permitted ) . Three exploratory frequentist analyses were consistent with the primary finding ( ORS : 0.47 0.48 ; 95 % CIs : 0.25 -0.88 ; p - values : 0.016 0.022 ) . No treatment - related serious adverse events were identified in the topline analysis . Full analysis is ongoing . - - U.S. regulatory next steps : Following LANTERN's positive topline results , the Company is targeting a pre - NDA meeting with the FDA in Q1 2027 and submission of its New Drug Application ( " NDA " ) in mid 2027. These are targets and remain subject to completion of the full analysis , preparation of the submission package , securing the necessary funding and ongoing regulatory engagement . Commercial progress in authorised markets : Ondine advanced targeted commercial activity in markets where Steriwave is already authorised , with Steriwave deployments and pilots progressing in Canada , the UK and Mexico . Recent milestones included Steriwave's first Scottish hospital deployment at NHS Golden Jubilee , a commercial , multi - centre pilot with Hospital Ángeles Health System ( Mexico's largest private hospital network ) , and expansion into additional hospitals in Ontario , Canada's most populous province . Advancing ICU : The SMURF ICU feasibility study , published in Critical Care , showed Steriwave was associated with a significant reduction in early cumulative nasal microbial burden , with an exploratory analysis observing a 39.5 % reduction in VAP / HAP pneumonia . Building on this critical care evidence , Ondine announced a strategic research collaboration with Mela Solutions , whose Medicus platform is used across 90 % of NHS ICUs , to support data - driven evaluation of Steriwave's workflow integration , infection impact , capacity utilisation and potential financial returns across NHS intensive care settings . Skull - base surgery ( Leeds ) : In a 200 - patient before - and - after single - centre service evaluation study in high - risk endoscopic endonasal skull - base surgery at Leeds General Infirmary ( Leeds Teaching Hospitals NHS Trust ) , Steriwave was associated with a 78 % relative reduction in surgical site infection risk compared with the preceding mupirocin- based period ( p = 0.0059 ) . The study results were published under the title " SteriwaveⓇ a Non - Antibiotic Nasal Photodisinfection Strategy Reduces Infection Burden in Endoscopic Skull Base Surgery " .