Ondine Biomedical targets US regulatory milestone after £10m raise and positive Phase 3 results

You've indicated our top line results uh have just come through. They're very good. and now we can focus on getting those phase three top line results into our regulatory submission.

Hello you're watching Proactive. I'm joined by Ondine Biomedical President and CTO Nicholas Loebel. Nicholas, very good to speak with you. With the positive Lantern Phase 3 results behind you, why is this the right time to raise 10 million pounds and what does it allow Ondine to do next?

Thank you, Steve for the opportunity. Um, as you say, we've successfully raised 10 million pounds at 10 pence, which is a modest premium to the closing price immediately uh before the capital access window opened. And what makes this I think particularly exciting is the stage at which this capital arrives. Um, you've indicated our top line results uh have just come through. They're very good. and now we can focus on getting those phase three top line results into our regulatory submission, and importantly, we can now uh divert the resources which were going into a large 5,000 patient multi-country 18 hospital study back to commercial growth. And that's really what we're looking forward to doing there, progressing the regulatory and submission activities and then expanding our commercial capabilities um and activities in markets where we can already sell Steriwave including Canada and and supporting international growth.

as on around 35% of the proceeds will go towards commercial expansion and business developments, which markets and partnerships are your biggest priorities as you look to grow Steriwave sales?

Obviously, the United States remains the major strategic opportunity for Ondine. Our our announced targets in the near term are um the pre-NDA meeting with the FDA in the first quarter and then submission of the new drug application hopefully around the middle of the year. The FDA will obviously determine requirements, outcome of its review. But the commercial attraction is in the UK as our partner Mölnlycke Healthcare starts to really gear up um with hospitals and trusts in the UK and then of course expanding into the EU as well. And uh that is something that we're very keen on doing. We have large hospital systems across those two geographies and we have obtained approval, we can sell and building adoption across those uh commercial opportunities could be highly significant for the company. Canada remains our top selling opportunity where we are now expanding the sales force. Our use of proceeds was directed towards that. We disclosed that to investors. We are involved in expanding the sales team as we speak, interviews underway, commercial operations being refocused, manufacturing is now gearing up for enhanced demand.

You said you're targeting an FDA pre-NDA meeting in the first quarter of next year and an application in the middle of next year. What needs to happen to hit those milestones, Nicolas?

Well, the first thing we need to do, and we have been strongly, strongly engaged in doing all through our fundraising, the teams are working around the clock on ensuring that we have well over 350,000 pieces of data properly analyzed and associated uh together with all of the analytics that we're doing. After all, uh this study was analyzed using uh a Bayesian approach, which is a type of statistical technique uh that is acceptable. It is an approach where large clinical studies, especially ones that benefit from real world evidence. Remember, Ondine has well over a quarter million patients treated outside the US and that evidence base uh has been brought into our um work with the FDA. So, that kind of an approach is lengthy, it requires a lot of computation. There are many secondary, tertiary, exploratory endpoints. Did um length of stay reduce? After all, if you can reduce the infection rates like we did, presumably the average patient is exiting the hospital quicker. That's a big deal when it comes to the NHS, for example, where you have enormous waiting lists. You have waiting lists on waiting lists. So, uh it's really important that we show that signal. We are looking at microbiological signals. There's a lot of work to do. But once we condense all of that into a clear picture. Uh that gets submitted to the FDA in a pre-NDA meeting, as you say, around the first quarter of 27, we expect to have that meeting. We will notify FDA of our intent to see what the timelines look like. and then hopefully there are not too many concerns or too many additional questions that they uh provide to us and we can go for a middle of the year submission um for the new drug application. Remember we're a fast track company, so FDA uh has pledged to move quicker on the opportunity to uh review. Uh that means that um the fastest we could get through is somewhere by the end of the year if all goes well.

Nicolas, I hope you'll continue to keep us updated with your progress. Thank you very much for your time today.

My pleasure. Thank you, Steve.

That's Ondine Biomedical President and CTO Nicolas Loebel.