Company Interview / Next step in race to FDA approval

Key points:

Cleo Diagnostics (ASX: COV) starts US clinical trials for ovarian cancer testExpecting FDA submission by 2025 with aggressive project timelinesPlans to commercialise via pathology lab partners for rapid deployment

Richard Allman, CEO of Cleo Diagnostics (ASX: COV) shares that the company has initiated US clinical trials for its ovarian cancer blood test across eight centres. Richard reveals that these trials aim to bolster efforts to obtain FDA approval, expected to be submitted by 2025.

Richard emphasises the significance of the timely launch of this ambitious trial, which began only 12 months post-IPO. He underscores the logistical challenges involved and praises his team for maintaining the aggressive timelines set for the project.

The effectiveness of Cleo's (ASX: COV) technology, as indicated by multiple peer-reviewed publications, is highlighted. Richard notes the absence of suitable existing diagnostics and details the company's plan to commercialise the test through pathology lab partners, aiming for rapid deployment across the USA.

Full unedited transcript below:

0:00

Still with small caps, and Clio Diagnostics has officially begun U.S. clinical trials for its ovarian cancer blood test, with the first patients enrolled across eight recruitment centres. It should support the company's efforts to gain FDA approval for its ovarian cancer detection test. Clio CEO Richard Ulman joins me now. Well, Richard, thank you for joining us. Thanks for doing such good work. I think all the progress we can make in terms of cancer diagnostics is worthwhile. Um, how how early in the piece is this? I mean, this is, um, you know, a clinical trial, but still a long road ahead.

0:41

Well, not as long as you might imagine. Um, we completed our IPO on the ASX just 12 months ago, and we had some very aggressive timelines in place for that IPO. Um, with plans in place to complete this trial within the next ten months. And to submit our after FDA application in 2025. So the announcement that went out on Friday, um, it's important for a number of reasons.

1:11

Um, setting up a trial like this, even with the help of a clinical research partner, it's a pretty significant undertaking, uh, with a large amount of logistical support at our end to make it happen. And I think the fact that we've achieved that on schedule is testament to the team that we have in place at Clio, and I'm very proud of them. So in terms of the structure of the trial, um, as you mentioned, we've got eight active sites across the length and breadth of the USA, um, ranging from Arizona, Texas and Florida in the south to New York, um, and California in the north.

1:47

And our chief scientist, Doctor Andrew Stevens, has conducted multiple trials in the past here in Australia with very similar structure. So we understand the process. And in the background we've got multiple peer reviewed publications now confirming that our underlying technology is very robust. So the current clinical trial, um, just to mention about your timelines, it's really about verifying that test performance in a format that is suitable for our planned FDA submission. And again, I have to reiterate that to go from IRB approval to site contracting. And now the first patient samples in a matter of weeks. It really is an outstanding effort by the team. Yeah. Um, and sorry, um, just finally, of course, about the trials. Conducting these trials in the USA should be a pretty strong indicator to our investor base how serious we are, and that we are firmly on the path to commercialization in the USA,

2:47

which in financial terms, is the most important healthcare market in the world. Of course. Yeah, it is the holy grail. Um, so I've just read that you're still targeting, you know, your FDA submission in calendar year 25. Um, yeah. Yeah. So this is, as you say, a very big undertaking. Just talk to us about, you know, the unique properties, the not what's novel about your test.

3:16

Well, there isn't really a suitable existing diagnostic for ovarian cancer. It's an incredibly nasty disease, usually diagnosed at very late stage. And all of the evidence is that Cleo's underlying technology outperforms the existing clinical tests that are available to doctors today. And that includes ultrasound, um, the existing biomarkers A1 to five. And that's not just company PR. We have several high quality scientific publications which have been announced to the market in the past six months. Just providing that data to physicians and to our investor investors so that they can see how well the technology is actually performing for themselves. Um, and just to give you a little bit of color, why those publications are so important is that when we reach commercialization stage, they become our key marketing collateral, because they tell

4:16

doctors how well the test is performing compared to what they use in today. And given that it's performing so much better than those existing technologies, it's a very strong driver to persuade those doctors to start using our tests. Mhm. Okay. And so in a perfect world you get FDA approval. Have I'm sorry I didn't read your prospectus but like what are the plans to commercialize it in the United States as it stands right now. Like is it via a partner or or how

4:46

given the importance of this type of technology, we'd like to get it out to as many people as quick as possible. Um, so the intent at the moment is to start offering the test through pathology lab partners. And I'm thinking particularly about the larger players in the US so that we can get the test out quickly to larger number of numbers of people.