Investor Presentation of Phase 3 Topline Results

Primary Bayesian analysis showed 40.5% lower risk of 30-day surgical site infection with a 98.2% probability of treatment benefit.

Three standard frequentist models also reached statistical significance for the primary endpoint, with p-values between 0.016 to 0.022.

Analysis of complete dataset ongoing, including secondary and exploratory endpoints.

No treatment-related significant adverse events were noted.

IMC session and live Q&A for investors and sell-side analysts to be held today at 16:30 BST to present the results.

Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies to prevent hospital infections, is today hosting an investor presentation of the topline results, including further statistical details, from its 5,188-patient Phase 3 LANTERN trial of nasal photodisinfection for the prevention of surgical site infections ("SSIs"). LANTERN was a group-randomised, standard-of-care-controlled, crossover trial conducted at 18 hospitals in the United States and Canada. It enrolled 5,188 patients undergoing a range of surgical procedures and evaluated whether preoperative nasal photodisinfection reduced the incidence of SSI within 30 days of surgery compared to standard-of-care.

The trial met its prespecified primary efficacy endpoint. The primary Bayesian analysis showed a 98.2% posterior probability that nasal photodisinfection reduced the risk of 30-day SSI compared to standard-of-care, including a permitted mupirocin nasal antibiotic regimen. The estimated risk ratio was 0.60 (95% credible interval: 0.33-0.97), corresponding to a 40.5% lower risk of SSI. No treatment-related significant adverse events were noted.

Three additional exploratory frequentist analyses were conducted, all of which supported the strength and consistency of the primary Bayesian finding. The frequentist analyses demonstrated odds ratios of 0.47 - 0.48, p=0.016 - 0.022 (95% CI's: 0.25 - 0.88), each reaching conventional statistical significance.

Ondine plans to request a pre-New Drug Application ("pre-NDA") meeting with the U.S. Food and Drug Administration ("FDA") to discuss the detailed LANTERN results and the Company's planned future regulatory submissions. Detailed study findings will also be presented at a major scientific meeting and submitted for publication in one or more peer-reviewed medical journals.

Carolyn Cross, Chief Executive Officer of Ondine Biomedical, said:

"LANTERN has delivered strong and consistent Phase 3 topline results. LANTERN enrolled patients in a wide variety of facilities, from community hospitals to large metropolitan centers with hundreds of beds, and treated patients across many high-risk surgical categories such as neurosurgery, cardiac surgery and vascular surgery among others.

"There are more than 35 million major surgical procedures like these performed annually in the US, and surgical site infections continue to impose a substantial clinical and economic burden through avoidable complications, longer hospital stays, readmissions and higher costs of care.

"While nasal decolonization is already an established infection-prevention strategy, it primarily relies on nasal mupirocin, an antibiotic requiring 5 days of administration prior to surgery. This regimen creates practical compliance challenges and adds to concerns about antimicrobial stewardship. Ondine's investigational nasal photodisinfection technology is designed to address these challenges through a non-antibiotic, healthcare professional-administered procedure delivered shortly before surgery. By moving nasal decolonisation into the standard hospital workflow, the approach is intended to support consistent administration at the point of care."

Presentation and live Q&A via Investor Meet Company

• Nicolas Loebel, President and Chief Technology Officer, will host a session via Investor Meet Company today at 16:30 BST to present the LANTERN Phase 3 results and next steps. The presentation and live Q&A is open to all existing and potential shareholders as well as sell-side analysts.

Questions can be submitted at any time during the live presentation via the Investor Meet Company dashboard at any time before or during the presentation.

Investors can sign up to the Investor Meet Company presentation at the link below:

LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) is a multicentre, cluster-randomised, crossover, controlled Phase 3 superiority study evaluating nasal photodisinfection in addition to standard of care, versus standard of care alone for the prevention of surgical-site infections. The trial enrolled 5,188 patients undergoing major surgical procedures at 18 hospitals. The primary efficacy endpoint was the relative incidence of surgical site infection within 30 days of surgery, assessed and analysed according to prespecified criteria. Further detailed analyses of the primary endpoint as well as key secondary and exploratory endpoints are ongoing and will be reported in due course.

About surgical site infections

More than 300 million surgical procedures are performed globally each year, including more than 35 million major surgical procedures annually in the United States. Surgical site infections remain one of the most serious complications of surgery, causing substantial patient morbidity, hospital readmissions, prolonged hospital stays and deaths. U.S. data have estimated that patients who develop an SSI face a two- to 11-fold increased risk of death compared with surgical patients without an infection. The economic burden is also substantial. Published U.S. estimates put the annual healthcare cost of SSIs at approximately $3.5 billion to $10 billion. The CDC also reports that an SSI can extend a patient's hospital stay by approximately 9.7 days and increase hospitalisation costs by more than $20,000 per admission.

About Ondine's nasal photodisinfection technology

Ondine's nasal photodisinfection technology is a light-activated antimicrobial therapy designed to rapidly eliminate potentially pathogenic microorganisms in the nose, a major reservoir from which pathogens can spread to surgical sites and other parts of the body. Applied by a healthcare professional before surgery, the treatment uses a proprietary photosensitising agent activated by a specific wavelength of red light to produce a rapid antimicrobial effect through oxidative mechanisms. Because the mechanisms are non-antibiotic and act through multiple oxidative pathways, nasal photodisinfection is designed to have a low potential for development of microbial resistance.

About Ondine Biomedical Inc.

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U.S. Regulatory Status