Ondine Biomedical (LSE:OBI) — Results for the year ended 31 December 2025

0:01 Good afternoon, and welcome to the ONDINE BIOMEDICAL INvestor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and they can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Just simply type in your questions and press send. Before we begin, I would like to submit the following poll. Today's presenters are Nicholas Lobel, President and Chief Technology Officer and Alan Thomas, CFO. I would now like to hand you over to Nicholas Lobel. Good afternoon to you. Thank you, Alex. Hello, and welcome to ONDINE's financial year twenty twenty five results presentation. Thank you for joining. My name is Nick Lobel, ONDINE's CTO and President. We will go through the presentation, which will be made available on our website, and we'll take questions after the presentation.

0:51 This presentation provides general information. It's not intended to be a comprehensive analysis. Please review the company's annual report available today to investors. As a reminder, ONDINE is focused on blocking hospital acquired infections before they start, prior to and increasingly now after surgery. Remember, eight thousand surgeries are performed every day in The UK, one hundred and thirty thousand daily in The US. To address this challenge, ONDINE has developed a novel light activated antimicrobial called photodisinfection. This is a painless and broad spectrum approach. It's designed to rapidly eliminate microbes from various areas of the human body to prevent or even treat potentially devastating infections.

1:37 For investors new to ONDINE, we're not an early stage research company. We have a proprietary technology platform. It's an active commercialization in Canada, The UK, and elsewhere. It's a growing hospital customer base, and we're at a pivotal US phase three study readout placing the company at an important value inflection point as we advance along The US regulatory pathway. So where do these pathogens hide, generating about a £2,000,000,000 annual cost to the NHS and requiring 5,600,000 additional bed days at a time when NHS is suffering from the worst backlog in history, some six million patients waiting for surgery. Well they often hide in the nose and they ride into operating theatres, ICU, CCU step down units, long term care facilities in patients who are otherwise completely unaware that they're transmitting these microbes.

2:37 Today only a few agents, primarily antibiotics, are used to treat the nose before surgery. These agents are becoming increasingly ineffective as bacteria evolve resistance to them and no antibiotic kills bacteria, virus and fungi in the nose as we do with Steriwave. Treatment takes only minutes, it's painless, it doesn't cause harm to patients and it doesn't generate resistance like antibiotics do. Crucially, this takes the patient out of the compliance loop and transfers infection control where it belongs to the nurse, infection control specialists in the hospitals themselves at the point of care. Please visit our website if you'd like a more detailed look at how this fast, painless, effective technology actually works.

3:26 And now I'd like to hand over to Alan Thomas, our CFO, for discussion of the results. Thank you, Alan. Thanks, Nick. Before we get into the financial results, I just wanna frame how we allocated our resources in 2025. As a small company approaching a major clinical and regulatory inflection point, we made a deliberate decision to prioritize clinical evidence generation while maintaining targeted commercial activity. That meant focusing both financial and management resources on three areas. Our large phase three clinical trial, which is central to The US regulatory pathway. The ICU pilot study to open the door to this high need critical care setting, and hospital and clinician pilots designed to build real world evidence, deepen clinical engagement, and support future expansion into new geographies and use cases.

4:17 You can see that focus reflected in the chart. R and D investment increased significantly year over year and represented the majority of 2025 operating spend. This allocation reflects our strategic investment in key clinical evidence to support future commercial growth. The year was marked by advancement of the phase three clinical study and regulatory pathway, completion of the ICU pilot study, expansion of our real real world evidence and commercial footprint, and continued preparation for scale up. The headline growth metrics are shown on the bottom right. Revenue increased 29%, gross profit increased 22% and hospitals increased 28%. I'll speak to the financial results on the next slide, while Nick will cover the clinical, commercial and operational progress in more detail later on in the presentation.

5:12 Turning to the financial results, revenue increased by 29% to $2,600,000 reflecting new hospital deployments and increased utilization within existing accounts. Gross profit increased 22% to $1,600,000 with a gross margin of 61%. This modest change year over year primarily stems from the company's hardware segment where strategic subsidized light source placements continue to support customer adoption and market penetration. Consumable margins improved during the year following the rollout of the company's next generation nasal illuminator in Canada. The key year over year change was the planned increase in R and D investment, which rose to CAD21.2 million from CAD9.2 million in 2024.

5:59 This was driven primarily by our Phase III clinical study, which accounted for approximately three quarters of r and d spend during the year. It's worth highlighting that phase three clinical studies in the pharma sector typically involve per patient costs in the tens of thousands of dollars. Our ability to conduct a larger scale clinical trial at this level of expenditure demonstrates disciplined execution at cost significantly below industry norms. In addition, our ICU hospital study costs were funded through an equity based arrangement allowing ONDINE to advance clinical evidence generation while preserving cash resources. With regards to other expenditures, sales and marketing expense remained stable at $1,100,000 reflecting a targeted commercial approach that supported customer growth, partner development, clinical engagement, and evidence generation initiatives.

6:54 G and A expenses decreased to 8,700,000 reflecting continued cost discipline and operational efficiencies while maintaining the capabilities needed to support the business. Overall, the financial results reflected a planned investment year with total operating expenses increasing to $31,600,000 driven primarily by the Phase three trial and a net loss of 29,500,000 The company raised approximately CAD 24,000,000 during 2025 and subsequent to year end completed a further financing of over CAD 9,000,000 in April to support our continued execution of our clinical, regulatory and scale up priorities. I'll now pass it back to Nick who'll take us through the clinical progress behind these results in more detail.

7:43 Thank you, Alan. I'd like to cover the phase three study at a glance. We're talking about the first randomized controlled study of nasal disinfection ever. It was conducted across two countries, involved two clinical research organizations, 18 hospitals, excuse me, enrolled almost 5,200 patients. Over 350,000 pieces of data were generated that gives you a sense of the scope and scale of this study. You see here a generalized graphic of the study design. This is a classic crossover in over 5,000 patients. Initially, we split the hospitals into two groups.

8:28 The first half is the treatment arm and the second half is the control arm. After all hospitals have completed recruitment in that phase of the study, crossover occurs and the treatment arm hospitals become the control arm and vice versa. This is a really effective way to home in on the treatment effect because each hospital serves as its own control. We'd like to take this opportunity to thank our clinical partner HCA Healthcare for all of their tremendous work and focus over the past year running the LANTON study in 14 of their hospitals, with Doctor Ken Sands, HCA's Chief Epidemiologist and Patient Safety Officer as the lead principal investigator. Ken and the entire team did an incredible job ensuring good clinical practice across the study.

9:18 Note we deployed in multiple surgical specialties on the top right, cardiac, vascular, breast, neurosurgery, all of the places we'd expect to be used in hospitals and surgical suites throughout The US upon approval. Where are we? Well, we're nearing database lock. We're in excess of ninety five percent complete in the data cleaning and the endpoint adjudication. Most of the hard work and the expense of clinical operations, monitoring, patient follow-up, query resolution is now behind us. We're talking about this massive database with a great deal of information and we're being very careful about ensuring that all data is in appropriate form for FDA review. Remember, after database lock, nothing further can be added to the data, and we proceed with a pre specified statistical analysis.

10:08 We're pleased to say we're on track for top line readout before the end of spring, which is imminent. Top line results are an early high level summary of the data. We remind investors this is a first look. Detailed scientific data, clinical study reports, etcetera, are available towards the floor when we expect to be meeting with FDA prior to the NDA submission. Success means that we met the primary clinical endpoint, the primary efficacy endpoint defined as a statistically significant reduction in the number of surgical site infections within thirty days after surgery. And this is compared to a standard of care control. It also means that we met the primary safety endpoint with only common non serious adverse events like a runny nose being experienced by patients versus more serious adverse events.

11:03 A positive readout does not automatically guarantee FDA approval, but it brings us a major step forward towards the full NDA submission where FDA will review the totality of the data from the company. The phase three study Lantern was not the only study we engaged in over 2025. We also supported the first ever study of Steriwave in the intensive care unit at Royal Columbian Hospital under doctor Steve Reynolds and Elizabeth Rohr. The aim of the study was to see whether the technology could be deployed in patients who might be intubated with nasal and oral hardware in place and were much sicker than the average pre surgical patient. We looked at nasal pathogen control between treatment and control groups, and whether we could see a trend towards reduction of one of the most dangerous events in the ICU, which is pneumonia.

11:55 Pneumonia is a leading cause of death in the ICU. It drives severe complications like sepsis and shock and acute respiratory distress syndrome, and this sort of systemic stress on the body drastically increases the risk of cardiac arrest, shock, kidney and liver failure, so it's a very, very dangerous outcome in the ICU. Very pleased to have reported excellent results from the study. StereoWave implementation in instrumented patients was found to be feasible and safe with no device related serious adverse events. We found a highly significant reduction in nasal pathogen burden and most importantly, a nearly forty percent reduction in ICU acquired pneumonia with results published in the peer reviewed Journal of Critical Care.

12:44 The next step is a larger study designed to generalize these results to multiple endpoints across more varied multi center patient populations, with the goal of both clinical and statistical significance across all endpoints. While our clinical programs in 2025 were our primary focus, we continue to make good commercial progress. We've expanded our deployments, pilot programs, clinical collaborations with a number of facilities increasing by 28% on a year over year basis, now to 37 hospitals and surgical clinics. In Canada, we expanded adoption across major healthcare institutions, including the University of Ottawa Heart Institute adopting Steriwave as standard of care in all cardiac surgeries, Interior Health becoming the second health authority in British Columbia to standardize Steriwave for hip and knee replacement surgeries and continued deployment across Fraser Health hospitals and leading cardiac and surgical centres in Canada.

13:45 In The UK, we initiated a Steriwave pilot at Royal Papworth Hospital. Royal Papworth is one of the world's leading cardiothoracic centres, and we expanded the NHS supply chain access across England and Wales. In Europe, we expanded clinical collaborations and pilot programs in Switzerland, Germany and Spain, including studies evaluating Sterewave in preoperative nasal decolonization and ENT surgery, ear, nose and throat surgery pathways. And we launched the first Steriwave pilot in Mexico at ABC Medical Center, while continuing to advance other international opportunities including in Australia, where we're testing the impact of Steriwave in cancer patients. Real world impact is increasingly important in regulatory outcomes.

14:36 We reported significant real world infection control data from leading orthopedic and spine surgery centers over the year At Sherbrooke University Hospital in Quebec, in a one year retrospective quality of care, steroid wave was associated with a seventy eight percent reduction in spine surgical site infections, a thirty percent reduction in average hospital length of stay. These results were presented at the twenty fifth Annual Scientific Conference of the Canadian Spine Society. Mid Yorkshire Teaching NHS Trust, steroid implementation is associated with a seventy one percent reduction in knee and hip arthroplasty surgical infections, compared with another topical nasal antimicrobial agent and this was presented at IEPIC twenty twenty five.

15:24 And interestingly, the York Health Economic Analysis adds an important dimension, demonstrating the pharmacoeconomic return on the investment in Steriwave, with an estimated savings net of £1.49 to £2.38 per every pound spent across major surgeries. That's a major, major finding. This was also presented at ICPIC twenty twenty five. Well, the increases in the number of hospitals, clinics, and surgery centers using Steriwave means an increased demand on our manufacturing and our supply chains. During '25, we decided to bring manufacturing of our Popul line in house. This is a new high margin twist top device which delivers the photosensitizer.

16:11 I'd like to show you what this looks like in a short video. I'm just going to click over here. You see the units being oriented using a pick and place robot. Those get placed into the production line on the left and the swabs are inserted along with the fill of photosensitizer formulation. Here you see the swabs being ultrasonically sealed and then trimmed, and the red laser is being used to write the lot codes and the other date codes, variable information as you can see. After trimming, the unit produces one finished sealed populol every few seconds and this should be in production within the next few months after our facility is ordered by our notified body.

17:07 Zooming out, this slide shows the broader scope and scale of the opportunity. Our current focus is targeted hospital use, beginning with pre surgical nasal decolonisation in Canada, The UK and selected pilot markets. Over the medium term, we see the opportunity to expand into broader hospital use across surgery, in ICU, in other high risk patient populations, obviously increasing our exposure in The US should FDA approval be gained. We will continue to build our presence across Europe and North America as well. Longer term, our broad vision is to apply this photo disinfection platform across multiple indications, areas such as wound care, sinus disease, intrathoracic applications and other targets, all of which have multi billion dollar global markets.

18:02 As we progress through 2026, you'll see us advancing towards the NDA submission in The US, with engagement with FDA towards the fall as expected. We'll be continuing to focus on evidence generation. These are the peer reviewed publications, abstracts, particularly supporting the independent real world generation that is an increasing focus of regulators worldwide. You'll see us continuing to build commercial momentum with an expanded pilot program and expansion within existing placements into new surgical specialties as well as entirely new opportunities. And finally, as we discussed, we'll continue to focus on the potential US launch, which would require us to scale our business in readiness for the largest and most concentrated health care market in the world.

18:54 So in closing, 2025 was about laying the foundations for what we expect to be a pivotal year ahead with The US phase three study nearing readout, our next steps coming in The US regulatory pathway, and expanding our real world evidence and customer adoption. We're making key investments in manufacturing readiness and scale up, including in house production of the key components necessary to insulate us from global events and to maximize our gross margin. We're focusing on priority markets, including the new markets of The EU and EMEA with our OUS partner, distribution partner, Munich Healthcare, and we'll be planning an exciting expansion, excuse me, into the ICU after the promising results of the first ever study of StereoWave in critical care at Royal Columbian Hospital.

19:47 As always, I'd like to thank our investors and our stakeholders all over the world, your partners in delivering this groundbreaking technology to patients, families, and one day potentially even yourselves.